Hyperfine targets 10–20% revenue growth for 2025 following FDA clearances and next-gen Swoop system launch

Earnings Call Insights: Hyperfine, Inc. (HYPR) Q2 2025

MANAGEMENT VIEW

* CEO Maria Sainz stated that "in the second quarter of 2025, we delivered revenue of $2.7 million up 26% sequentially with the sale of 8 systems, including the sale of our first next-generation Swoop system in a hospital before quarter end with a second hospital deal closing one day after the end of the quarter on July 1." Sainz emphasized the expansion of gross margins by approximately 800 basis points sequentially, reaching 49%. She highlighted the FDA clearance for two major new technologies, noting, "we have discussed our plan to bring one new product to market every half year. And with these two clearances in May, we're executing well ahead of schedule."
* Sainz elaborated, "our new next-generation Swoop system will be the platform to drive adoption, growth and scale for Hyperfine going forward." She added that the advancements in image quality now allow the Swoop system to be used across multiple sites of care for various neurological conditions, representing a total market opportunity in excess of $6 billion.
* The company achieved the first commercial sale of the full next-generation system within 30 days of clearance and has scaled manufacturing to support broader commercial efforts. Sainz observed, "the market response to the next-generation Swoop system and the Optive AI software has been immensely positive thus far."
* CFO Brett Hale stated, "revenue for the second quarter of 2025 was $2.7 million, up 26% sequentially. In the second quarter of 2025, we sold 8 units with a strong average selling price." Hale emphasized, "gross profit for the second quarter of 2025 was $1.3 million, and gross margin for the second quarter of 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."

OUTLOOK

* Hale reported, "for the full year 2025, we continue to expect revenue growth to be in the range of 10% to 20% over 2024. This guidance equates to a significant revenue step-up in the second half of 2025 and accounts for the multiple growth drivers recently put in place going into the second half of 2025."
* The company expects gross margin to be "47% to 50% for the year, representing a 280 basis point increase in gross margin on a year-over-year basis at the midpoint."
* Sainz explained, "we expect improved financial performance across our P&L quarter-over-quarter, driven by strong commercial execution across our channels and disciplined capital preservation."
* Cash burn guidance was updated to a range of $27 million to $29 million for the full year 2025, with a 27% decline in cash burn on a year-over-year basis at the midpoint.
* Sainz stressed, "our first half performance was based on our legacy business... In the second half of 2025, we expect our two new product launches, our entry into the office setting and our increased traction in new and existing international markets to serve as tailwinds."

FINANCIAL RESULTS

* Revenue for Q2 2025 was $2.7 million with 8 units sold. Gross profit was $1.3 million and gross margin reached 49.3%.
* R&D expenses for the quarter were $4.5 million, a decrease from $5 million in Q1. SG&A expenses were $6.4 million, down from $6.7 million in Q1.
* Net loss for Q2 was $9.2 million, or ($0.12) per share, compared to a net loss of $9.4 million or ($0.12) per share in the previous quarter.
* Net cash burn, excluding financing, was $8.1 million, down 19% sequentially. Cash and cash equivalents stood at $25.4 million at quarter-end.

Q&A

* Gursimran Kaur, Wells Fargo: Asked about the full-year revenue guidance and what would drive results to the low or high end, and sought clarification on sequential growth in Q3 and Q4. Hale responded that Q3 is expected to see a 50% greater sequential revenue increase compared to Q2 and attributed growth confidence to "different layers that are all incremental revenue contributors" including new technology in hospitals, office business launch, and international expansion. Sainz noted, "we are seeing... market traction, which -- and market activation which really we were confident we were going to see, but sort of 10 weeks into it, we are seeing."
* Kaur also asked about the launch cadence for the next-gen Swoop system and pricing. Sainz replied, "we have a step up in ASP, which is clearly there. We also have the opportunity to do brand-new placements, but we also have a more modest revenue opportunity to upgrade all systems."
* Kaur sought insight on office traction and utilization. Sainz explained, "the handful of offices have taught us a lot of things of what we need to do right. We've also been very engaged with... the neuron network."
* Frank James Takkinen, Lake Street: Asked for quantification of the funnel to support second-half guidance. Sainz described managing separate hospital and office funnels and highlighted "multiple funnel." She emphasized the improved sales team maturity and process compared to the first half.
* Takkinen asked which business driver would be most powerful for growth in the second half. Sainz said, "the primary driver is how we show what the technology can do now," citing new use cases and broader adoption.
* Brandon Carney, B. Riley: Asked about ASP drivers. Hale linked the increase to a favorable mix and higher MSRPs in the U.S., plus next-gen sales. Carney inquired about international timeline shifts; Sainz explained new hardware will be available in Europe at the end of 2026, with software arriving by end of 2025.

SENTIMENT ANALYSIS

* Analysts' tone was inquisitive and slightly positive, pressing for clarity on sequential growth, business mix, and market adoption while expressing enthusiasm for the new product launches. Kaur and Takkinen focused on guidance drivers and sales funnel details.
* Management maintained a confident and slightly optimistic tone in both remarks and Q&A, using phrases such as "we are seeing... market traction" and "we are incredibly focused" while addressing analyst questions with detailed explanations.
* The tone in Q2 was more upbeat than the previous quarter, reflecting improved confidence due to product launches and positive early market feedback. Analysts' sentiment shifted from cautious to more constructive, while management's tone moved from cautious optimism to heightened confidence.

QUARTER-OVER-QUARTER COMPARISON

* Q2 saw revenue increase from $2.1 million to $2.7 million, with units sold rising from 6 to 8 and gross margin expanding from 41.3% to 49.3%. Both R&D and SG&A expenses declined sequentially. Net loss narrowed slightly.
* The company maintained full-year revenue growth guidance of 10% to 20% over 2024, consistent with Q1 guidance. Gross margin outlook remained at 47% to 50% for the year.
* Management's tone shifted from cautious optimism in Q1 to stronger confidence in Q2, reflecting the successful launch of next-generation products and early sales traction. Analysts' questions became more focused on execution versus risk factors.
* Strategic focus moved from pilot and preparation in Q1 to execution and scaled commercial launch in Q2, with specific emphasis on the next-generation Swoop system and Optive AI software.

RISKS AND CONCERNS

* Management noted that early 2025 deals were delayed due to NIH grant cancellations but clarified that "our broad forward-looking pipeline does not rely upon NIH grant related funding."
* Sainz highlighted the importance of utilization and economics in the office market, stating, "the economics are predicated on three things: the #1 is volume of scans... the second one is really the mix of use... and of course, the third one is what you multiply in terms of dollars."
* Hale emphasized continued focus on reducing cash burn and prioritizing spending discipline.

FINAL TAKEAWAY

Hyperfine management emphasized that Q2 2025 marked a critical inflection point for the company, driven by the FDA clearance and initial commercial success of the next-generation Swoop system and Optive AI software. With diversified sales channels across hospital, office, and international markets, and a strong focus on execution, the company reaffirmed its full-year revenue growth and gross margin guidance, signaling confidence in its ability to deliver sustained financial improvement and capitalize on expanding market opportunities.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/hypr/earnings/transcripts]

MORE ON HYPERFINE

* Hyperfine, Inc. (HYPR) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4813350-hyperfine-inc-hypr-q2-2025-earnings-call-transcript]
* Seeking Alpha’s Quant Rating on Hyperfine [https://seekingalpha.com/symbol/HYPR/ratings/quant-ratings]
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