Hyperfine, Inc. Q3 FY2025 earnings call

• The third quarter marked a new beginning with the launches of the next-generation subsystem and Optive AI software, driving revenue growth and record gross margins.
• In the US hospital setting, the new system has been placed in various hospital sites, converted the entire hospital deal pipeline to the next-generation subsystem, and there are robust pipelines with multiple deals.
• In the office setting, the full commercial launch commenced, with multiple clinical studies underway like Neuro PMR and Care PMR, and leveraging partnership with NeuroNet.
• In international markets, received CE Mark and UK CA Mark approvals for Optive AI software, expect to launch in 10 European languages by year-end and next-generation subsystem in Europe and Canada by 2026, and referenced in France's largest public hospital procurement body.

In the third quarter, Hyperfine, Inc. achieved revenue of $3.4 million, up 27% sequentially. Gross margins reached a record nearly 54%, supported by a record average selling price of $361,000. For the full year 2025, revenue is expected to be approximately $5 to $6 million, with the full year revenue range revised to $30 million to $40 million. Gross margin for the full year 2025 is expected to be in the range of 49% to 51%, and total cash burn for the full year 2025 is expected to be in the range of $29 million to $31 million, a 22% decline year-over-year at the midpoint. The revenue comes from the launches of the next-generation subsystem and the Optive AI software, with different performance in the hospital, office, and international markets.

• 2025 full-year revenue is expected to be approximately $5 to $6 million, with the full year revenue range revised to $30 million to $40 million.
• Full-year 2025 gross margin range is increased to 49% to 51%.
• Total cash burn for the full year 2025 is expected to be in the range of $29 million to $31 million, a 22% decline year-over-year at the midpoint.
• Cash runway is expected to last into 2027 due to the strengthened capital position.

• Forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied. Risks include market opportunity, commercial and international expansion, regulatory approvals, and product development, as detailed in the risk factors section of the latest periodic filings with the Securities and Exchange Commission.

Q: Can you provide an update on the composition of the backlog, maybe by setting, and what is supporting the $5 million to $6 million fourth quarter guidance?

A: Our pipeline is composed of US hospital deals, US office deals, and international business. The $5 to $6 million is predicated on the robust pipeline with more rows and more than one unit in some accounts. The fourth quarter is the second quarter of the launch for both the next-generation technology in the hospital and in the office setting, with deals working through the process and anticipated to land in Q4.

Q: Can you provide directional comments on 2026?

A: We are not going to provide a lot of direction around 2026 as we are on quarter two of the launch and prefer to reserve commentary until we get into the beginning of 2026 with a closed Q4.

Q: Can you provide an update on the timeline and initial trajectory of market penetration in the neurology office and international expansion?

A: In the neurology office, we have a segmentation approach with first model and next-generation systems, and a partnership with NeuroNet, and will attend a meeting in early December. In international, it's about hospitals with procurement processes, got CE Mark and UK CA Mark approvals, and will launch Optive AI in 10 European languages in Q4 and next-generation subsystem in Europe and Canada by 2026