Spectral AI Announces 2024 Fourth Quarter and Full Year Financial Results

Core Insights - Spectral AI, Inc. reported a significant increase in Research & Development revenue for FY 2024, reaching $29.6 million, a 63.5$18.1 million in FY 2023, primarily driven by the BARDA PBS contract [11][10] - The company is on track for regulatory submission of its DeepView™ System for burn treatment in the US, with expectations to generate commercial revenue from multiple platforms within the next three years [2][3] - The successful results from the Burn Validation Study indicate that the DeepView System significantly outperformed traditional clinical assessments in identifying non-healing tissue, with image-wise sensitivity at 86.6% compared to 40.8% for burn physicians [5][6] Financial Performance - For Q4 2024, Research & Development revenue was $7.6 million, up from$5.3 million in Q4 2023, reflecting increased work on the BARDA PBS contract [10][11] - Gross margin for Q4 2024 was 44.0%, a slight decrease from 46.1% in the prior year, attributed to a smaller percentage of direct labor on the BARDA PBS contract [12] - The net loss for FY 2024 was $(15.3) million, or$(0.85) per share, an improvement from a net loss of $(20.9) million, or$(1.48) per share, in FY 2023 [16][17] Business Highlights - The BARDA PBS contract, valued at up to $150 million, is the largest in the company's history and includes an initial award of approximately$54.9 million for development activities [4] - The company plans to submit regulatory filings for the DeepView System's burn indication in the first half of 2025, aiming for FDA approval by early 2026 [3][5] - Recent financing agreements have strengthened the company's financial foundation, with an equity financing and long-term debt transaction raising $11.2 million [13][22] Product Development and Clinical Trials - The Burn Validation Study, one of the largest burn studies in the US, involved 160 patients and demonstrated the DeepView System's superior performance in assessing wound healing [13][5] - The company is advancing the development of a handheld version of the DeepView System, called DeepView SnapShot M, supported by a$500,000 contract from the Defense Health Agency [13] Future Outlook - The company forecasts revenue of approximately $21.5 million for FY 2025, not including potential contributions from the sale of the DeepView System in international markets [19] - The ongoing development and commercialization of the DeepView System are expected to change the standard of care in wound management, providing faster and more accurate treatment insights [2][21]