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Spectral AI(MDAI) - 2025 Q2 - Earnings Call Transcript
2025-08-12 22:00
Financial Data and Key Metrics Changes - Research and development revenue decreased to $5,100,000 from $7,500,000 in the second quarter of the previous year, reflecting reduced reimbursements under the BARDA Project BioShield contract [12] - Gross margin slightly decreased to 45.2% from 46.6% in the same quarter last year due to lower reimbursed expenses under the BARDA contract [13] - General and administrative expenses were significantly reduced from $5,800,000 in 2024 to $4,400,000 in 2025, primarily due to a focus on operating efficiencies [13] - The company reported a net loss of $7,900,000 in 2025 compared to a net loss of $2,900,000 in 2024, attributed to an increase in the fair value of publicly traded warrant liability [13] - Cash and cash equivalents totaled $10,500,000 as of June 30, 2025, up from $5,200,000 on December 31, 2024, due to successful financing [14] Business Line Data and Key Metrics Changes - The company is focusing on the commercialization of the DeepView system, with significant progress made in FDA submission [6][9] - The FDA submission is considered a key driver in the evolution of the business, with expectations for further interaction in the coming months [10] Market Data and Key Metrics Changes - The company does not expect material contributions from sales of the DeepView system in the UK or Australia for 2025, focusing instead on usage and learning from these markets [15][31] Company Strategy and Development Direction - The company emphasizes three principles: finance, focus, and finish, with a strong start to the year and a focus on commercialization plans [6][48] - The company is developing a thorough commercialization plan involving BARDA, which will assist in rolling out initial devices upon FDA clearance [22] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about future prospects and is focused on the commercialization of the DeepView system [48] - The company is studying the UK market to gather insights that can be applied to the US market [33] Other Important Information - The healthcare intellectual property subsidiary, Spectral IP Inc., is undergoing SEC registration for its initial public offering, requiring limited management resources [11] Q&A Session Summary Question: Discussion on the submission for DeepView and commercial organization preparation - Management expects FDA clearance in the first half of next year and is developing a commercialization plan with BARDA's involvement [20][21] Question: Utility outside of burns for the DeepView system - Management indicated potential applications in wound care and other medical assessments, emphasizing the device's ability to differentiate healing and non-healing tissue [25][26] Question: Activities for deployment in the UK and Australia - Management highlighted the UK market's approval and its usefulness for burn care, focusing on learning from these markets rather than immediate sales [31][32] Question: Regulatory pathway for the handheld device - Management confirmed that the handheld device will use the cart-based device as a predicate for regulatory approval, with funding from military pathways [38] Question: Dialogue with BARDA regarding system rollout post-approval - Management refrained from speculating on BARDA's actions but noted that the contract includes methodologies for device rollout [43]