Hyperfine, Inc. Q3 FY2024 earnings call

• Revenue growth was propelled by sales of Swoop portable imaging systems in both US and international markets. - International revenue contributions in the third quarter were robust, and seasonality was less than expected. - Future growth will stem from expanding into multiple new sites of care and international regions. - In the third quarter, the company received FDA clearance for its ninth generation AI-powered software, which enhanced image quality and reduced acquisition times. - It plans to launch the tenth generation AI-powered software in the first half of 2025, which will bring a significant improvement in image quality. - Clinical studies such as CARE PMR and ACTION PMR showed promising results. - The company has enhanced its commercial capabilities, including adding an executive focused on new business verticals. - It obtained CE approval of its ninth generation software in Europe, positioning itself well for European commercial expansion in 2025.

In the third quarter of 2024, Hyperfine Inc. achieved revenue of $3.6 million, representing a 56% year-over-year growth. Gross margin expanded by over 270 basis points sequentially, and cash flow continued to decrease. Revenue was driven by sales of the Swoop portable imaging systems in both the US and international markets. International revenue contributions were healthy in the third quarter, and the company didn't experience the seasonality it had anticipated. The US has a total addressable market opportunity of over $6 billion for placements in hospitals and office settings.

• The company narrowed its full-year 2024 revenue outlook to a range of $14 million to $14.5 million, representing approximately 30% year-over-year growth. - For full-year 2024, the gross margin is updated to 47% to 50%, which is the high end of the previous range. - The company anticipates total cash burn for 2024 to be between $37 million and $40 million, with a cash runway extending into early 2026.

• Forward-looking statements made during the call involve material risks and uncertainties, including but not limited to regulatory approvals, market adoption, and commercial expansion. - Risks associated with the business are detailed in the Risk Factors section of the company's latest periodic filings with the Securities and Exchange Commission.

Q: Inquired about the number of capital placements, the split between US and OUS, and same store sales A: Maria Sainz responded that 13 systems were placed, with a strong balance between US and OUS placements Q: Question regarding guidance where Q4 is typically a strong capital quarter but the guidance implies flat sequential sales A: Maria Sainz explained that the company doesn't rely on traditional capital budget funding, so there isn't typical seasonality, and Q4 is expected to be a solid quarter Q: Question about the new software launch in the US, when all US systems will get the latest upgrade and the impact on the funnel and adoption A: Maria Sainz stated that the rollout is progressive, prioritizing larger users, and the majority of accounts are expected to be updated by year-end, and the software is well-received Q: Question about the perception difference between US and EU doctors on Alzheimer's treatment criteria and MRI scan perception A: Maria Sainz discussed the similarities in MRI monitoring challenges, differences in EU regulator conservatism, and the high interest in Europe for their poster presentation Q: Question about EU expansion, demand for MRI, and reimbursement rates A: Maria Sainz talked about differences in MRI density per capita, varying reimbursement rates by country, and the high appreciation of the company's technology in Europe