Hyperfine reported second quarter 2025 results on Aug. 13, highlighting $2.7 million in revenue for the first half of the year, a 26% sequential increase, and the sale of eight systems in the second quarter. Hyperfine(HYPR 13.39%) achieved an 800 basis point sequential gross margin expansion to 49.3% and reduced cash burn by 19% quarter over quarter, excluding financing. The company reached key milestones, including FDA clearance and the first commercial sales of its next-generation portable MR subsystem and Optive AI software, while reiterating full-year revenue growth guidance of 10% to 20% over 2024 and projecting accelerated sales in the second half of the year. These updates demonstrate accelerated adoption, expanded product capabilities, and improving financial efficiency, providing several strategic insights for long-term investors.
FDA clearances accelerate Hyperfine’s next-gen pipeline
Hyperfine received two major FDA clearances in May, executing ahead of its plan to introduce one new product every half year. Within ten weeks of clearance, the company sold its first two next-generation systems, expanded manufacturing, and began building inventory to meet commercial demand. The next-generation subsystem, powered by Optive AI software, demonstrated transformative image quality and was launched in both hospital and office settings.
"First, we received FDA clearance for two major new technologies. We have discussed our plan to bring one new product to market every half year, and with these two clearances in May, we are executing well ahead of schedule. Second, we completed our office pilot program. In the U.S., we now have launched our new next-generation subsystem powered by Optive AI software with transformative image quality and additional user and patient-friendly features. Optive AI software was also cleared as a standalone software and we have now begun rolling it out to our installed base of systems, bringing significantly improved image quality to our users. Our AI technology is among the leading AI-enabled health products cleared by the FDA. The market response to the next generation and the Optive AI software has been immensely positive thus far."
-- Maria Sainz, President and Chief Executive Officer
The rapid regulatory progress and swift commercialization underscore Hyperfine’s execution capabilities and first-mover advantage in portable AI-powered MR imaging, expanding its addressable market and strengthening its competitive position in a $6 billion imaging segment.
Margin and cash efficiency improve as Hyperfine scales
Gross margin increased 800 basis points quarter over quarter to 49.3%, driven by a higher average selling price from the next-generation subsystem, increased sales volumes, and prior MSRP increases. Net cash burn, excluding financing, declined 19% sequentially to $8.1 million, while research and development and SG&A expenses also decreased, reflecting benefits from organizational restructuring and a shift toward commercial scaling.
"Gross profit for 2025 was $1.3 million, and gross margin for 2025 was 49.3%, representing an 800 basis point increase sequentially driven by the increased number of units sold and increase in average selling price. We continue to drive healthy margins for our stage, and we believe we are well-positioned for meaningful margin expansion at scale. R&D expenses for 2025 were $4.5 million, a sequential quarterly decrease from $5 million in Q1 2025. We are realizing the benefits of the reorganization completed in the first quarter, as we transition to a commercial growth stage organization. Sales, general, and administrative expenses for 2025 were $6.4 million, a sequential quarterly decrease from $6.7 million in Q1 2025. Net loss for 2025 was $9.2 million, equating to a net loss of $0.12 per share as compared to a net loss of $9.4 million or a net loss of $0.12 per share the prior sequential quarter. Our net cash burn, including financing in 2025, was $7.7 million. As of June 30, 2025, we have $25.4 million in cash and cash equivalents on our balance sheet. For 2025, our net cash burn excluding financing was $8.1 million, down 19% sequentially from the prior quarter."
-- Brett Hale, Chief Administrative Officer and CFO
Management’s ability to expand margins and reduce operating expenses during product launches and channel expansion enhances sustainability, supporting a cash runway into 2026 and margin upside as volumes scale.
Strong demand and diversified pipeline drive revenue acceleration
Guidance indicates that the sequential revenue increase from the second to the third quarter is expected to be at least 50% higher than the increase from the first to the second quarter, supported by multiple launches across hospitals, office settings, and expanded international channels. The MSRP of the next-generation hardware is $550,000, representing a 15% premium over prior systems, and funnel management is now stratified by geography and channel.
"So we posted about $560,000 increase in Q1 to Q2, and we would see it being at least 50% higher going into Q3 versus from Q2 to Q3. Maria Sainz: And then maybe I can comment off sort of our confidence. I think as we think about the inflection point that we have crossed, we really now have different layers that are all incremental revenue contributors. So the U.S. hospital business with the new technology is going to accelerate. You add to that moving from pilot phase to full launch phase in the office business in the U.S., that is another layer. The third layer is the continued expansion into international markets. We did message that we still expect India approval by the end of the year. And all of that is now fueled by what is really a remarkably improved product, whether we're talking about the first generation of the product, the latest software, which is Optive AI, or the brand new system that also has Optive AI. That is getting market traction, which market activation which really we were confident we were going to see, but sort of ten weeks into it, we are seeing."
-- Maria Sainz, President and Chief Executive Officer
The combination of higher average selling prices, a diversified channel strategy, and rapid go-to-market execution positions Hyperfine for a step-change in quarterly sales velocity in the third and fourth quarters, establishing multiple engines for long-term growth and reducing revenue concentration risk.
Looking Ahead
For the full year, management guided to 10% to 20% revenue growth over 2024 on a GAAP basis, with gross margin expected between 47% and 50%, and total annual cash burn anticipated at $27 million to $29 million (a 27% year-over-year decrease at the midpoint). The third quarter sequential revenue increase is expected to be at least 50% higher than the $560,000 improvement from the first to the second quarter. Key strategic milestones include European and Indian regulatory approvals by the end of 2025, commercial availability of next-generation hardware internationally in 2026, and publication of major office study results in early 2026.
