14-05-2025
Spectral AI Inc (MDAI) Q1 2025 Earnings Call Highlights: Strong Financial Performance and ...
Research and Development Revenue: Increased by 6% to $6.7 million from $6.3 million in Q1 2024.
Gross Margin: Improved to 47.2% from 46.6% in Q1 2024.
General and Administrative Expenses: Reduced to $4.1 million from $5.1 million in Q1 2024.
Operating Loss: Decreased to $896,000 from a net loss of $2.1 million in Q1 2024.
Net Income: Reported at $2.9 million compared to a net loss of $3.2 million in Q1 2024.
Cash and Cash Equivalents: Totaled $14.1 million as of March 31, 2025, up from $5.2 million on December 31, 2024.
Shares Outstanding: 25,588,121 shares as of March 31, 2025.
Revenue Guidance for 2025: Approximately $21.5 million, excluding potential sales from the UK and Australia.
Warning! GuruFocus has detected 2 Warning Signs with MDAI.
Release Date: May 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Spectral AI Inc (NASDAQ:MDAI) reported a strong start to 2025 with significant accomplishments in product advancement and operating efficiencies.
The company is on track for its FDA de novo classification submission by the end of the second quarter of 2025.
The burn validation study results demonstrated the superior performance of the DeepView technology, which will support the FDA submission.
Spectral AI Inc (NASDAQ:MDAI) successfully completed a debt financing agreement with Avenue Capital, securing up to $15 million in funding.
Research and development revenue for the first quarter rose 6% to $6.7 million, reflecting increased activity under the BARDA Project BioShield contract.
The company anticipates less revenue from the BARDA contract in the second half of the year as it focuses on further developments of the DeepView system.
General and administrative expenses, although reduced, still represent a significant cost, with a focus on operational efficiencies needed to maintain a long cash runway.
The FDA submission process involves known and unknown risks, and the outcome is not guaranteed despite efforts to de-risk the submission.
The commercialization of the DeepView system outside the BARDA environment is still in early stages, with efforts needed to expand beyond the initial contract.
The development of the DeepView SnapShot M for military use is ongoing, with no guarantee of meeting the 2027 timeline for availability.
Q: On the guidance, you're calling for $21.5 million just from BARDA revenue. You're tracking ahead of that, so any pull forward there in terms of what you saw in the first quarter? A: Vincent Capone, CFO: We had a strong start to the year, reflecting our focus on the FDA submission by the end of the second quarter. The second half of the year may see less revenue from the BARDA contract as we work on further developments of the DeepView system. We are confident in the $21.5 million revenue guidance, but may restate it if we continue to outperform.
Q: You're going to submit to the FDA by the end of the second quarter. How are you preparing for that submission, and what interactions have you had with the FDA? A: Vincent Capone, CFO: We have a 12-year relationship with BARDA, which has been very helpful. We've had over 10 pre-sub meetings with the FDA and are working hard to get the submission ready. The burn validation study results support our submission, and we've identified key metrics the FDA will consider. We feel confident but acknowledge we don't control the outcome.
Q: With respect to the 10 pre-sub meetings with the FDA, have there been any additional requests or deliverables? A: Vincent Capone, CFO: We have been working through the submission process with the FDA. While I won't get into specifics, our rigorous analysis and burn validation study results are benchmarks the FDA will consider. We are excited to submit and have tried to de-risk the process as much as possible.
Q: General and administrative expenses seemed lower than expected in the first quarter. How do you see that for the rest of the year? A: Vincent Capone, CFO: We've focused on operational efficiencies, resulting in lower expenses. We anticipate general and administrative expenses to remain consistent with the first-quarter results, which helps us maintain a long runway with our cash on hand.
Q: Regarding the SnapShot M device, you mentioned prototypes are ready. Is there a chance it will be available for military use before 2027? A: Vincent Capone, CFO: While I can't confirm an earlier timeline, we are focused on the FDA submission for the DeepView system and continue to work on the MTEC contract. SnapShot M is a promising second indication of our technology, and we are committed to supporting the US military with this device.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
