Hyperfine, Inc. Class A Common Stock 2026 Q2 Earnings Call

Thank you for joining today's call. Earlier today, Hyperfine, Inc. released financial results for the quarter ended June 30th, 2026. A copy of the press release is available on the company's website as well as sec.gov. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the Federal Securities Laws and made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements, including, without limitation, those related to our operating trends and future financial performance, expense management, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon our current estimates and various assumptions.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our latest periodic filing with the Securities and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of today's live broadcast. Hyperfine, Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. With that, I will turn the call over to Maria Sainz, President and Chief Executive Officer.

Good afternoon, thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. The second quarter was another strong quarter for Hyperfine as we continue to execute across our commercial, operational, and financial priorities. Second quarter revenue was $3.9 million, our second highest quarter ever, up approximately 45% year-over-year, bringing our first half revenue to $7.8 million. We sold 12 systems in the quarter, up 50% year-over-year, with a majority of placements coming from our next-generation system and a high percentage of international sales. We also delivered our fourth consecutive quarter of gross margin above 50% and improved our cash burn both year-over-year and sequentially. Mid last year, we launched our next-generation Swoop system powered by Optive AI and entered the neurology office market.

We now refer to this next-generation version of the Swoop system as Model 2. At the time of launch, we believed improvements in image quality, expanding clinical utility, a growing body of real-world evidence, and a broader, more diversified commercial strategy could unlock meaningful growth opportunities across hospitals, offices, and international markets. One year later, we have accumulated important proof points supporting that thesis. We have broadened adoption across sites of care, increased IDN engagement, entered new geographies, expanded our clinical evidence, strengthened our balance sheet, and improved the financial profile of the business. As a result, we are now more focused on translating this stronger foundation into broader commercial scale. With our strong execution in the first half of the year, we are reiterating our full year in 2026 revenue and cash burn guidance and remain confident in our growth, margins, and long-term opportunities.

Market demand remains healthy. We are driving growth across our three verticals: hospitals, including our growing presence in health systems, neurology offices, and international markets. I will now walk through updates from each of these businesses in more detail. The hospital market remains our largest commercial vertical and an important source of clinical and commercial validation. Over the past year, the Swoop system has moved beyond niche use in critical care toward broader platform utility across critical care emergency departments and hospital-based clinics, with emerging use in neurological workflows and mobile deployment models. Hospital programs launched over the last few quarters with a Model 2 Swoop system have reported high utilization, increased the scan volumes, and meaningful clinical workflow and economic benefits. This broader utility and strong utilization matter because they support repeat deployments, deeper health system engagement, and enterprise-level adoption over time.

We have made progress with large health systems and IDNs. In recent months, we have sold Model 2 systems to several new health systems Including an initial placement within one of the largest national IDNs in early July, while also expanding beyond the first site within other health systems during the second quarter. As hospitals enter their first full capital planning cycle since the Model 2 launch, our hospital pipeline is increasingly supported by clinical evidence, economic validation, and more strategic IDN-level conversations. Expansion into emergency departments has been a priority in 2026. PRIME data presented at SAEM 2026 meeting provided compelling evidence to support the use of the Swoop system to triage patients in the ED.

PRIME showed that portable MRI reduced the median order to scan start time in the ED from 7.76 hours for conventional MRI to 1.28 hours with portable MRI. Faster access to imaging can help hospitals reduce workflow bottlenecks, support more timely clinical decision-making, and integrate the MRI more easily into ED workflows, where conventional scanner availability can be constrained. These proof points and near-term catalysts give us increasing confidence in hospitals and IDNs as a durable growth engine supported by the success of initial programs, clinical evidence and economic validation. We are seeing a different but complementary opportunity develop in neurology offices, where the Swoop system can bring imaging closer to patients and reduce friction in the care pathway. Our office market continues to develop into a distinct growth vertical supported by utilization, reference site development, patient preference, and ease of access to imaging.

We have now placed a Swoop system in over a dozen offices since launch, supporting the office value proposition. Office staff have been able to operate the system without an MR technologist, underscoring its ease of use. Several offices report very high scan volume. We continue to see increasing interest from adjacent use cases, including dementia screening applications as well as from concierge and wellness practice models seeking convenient closer-to-patient imaging. Our NEURO PMR data supports this opportunity, with 92% blinded concordance with conventional MRI identifying pathology, rising to 98% with clinical history, and patients four times more likely to choose portable MRI. Our planned expansion to add contrast to our labeling is expected to be an important catalyst for the office vertical by broadening clinical utility and supporting additional use cases with established reimbursement under dedicated contrast-related CPT codes.

These proof points give us increasing confidence that the office market can, over time, become a meaningful second U.S. growth vertical supported by utilization, patient preference, ease of use, and planned contrast labeling expansion. Beyond our U.S. hospital and office opportunities, we're also beginning to build a stronger international foundation. Following CE Mark and UKCA mark approvals earlier in 2026, our Model 2 Swoop system is now commercially available in Europe and the U.K., and we sold the first two Model 2 systems in the quarter. We expect to advance the European rollout of the Model 2 system with our distribution partners in the second half of 2026. In France, inclusion of Model 2 in the UniHA procurement listing creates a more efficient purchasing pathway across French public hospitals.

In India, following CDSCO approval of Model 1 late last year, AIIMS, New Delhi became our first India deployment, serving as a high-profile clinical reference site in the region. These milestones give us increasing confidence in international markets as an emerging growth vertical, with regulatory approvals, initial sales, procurement access, and reference sites creating a stronger foundation for broader execution. We are pleased with our diversified commercial profile and the progress made in each of the verticals. We continue to invest in product and software capabilities that can expand the Swoop system's clinical utility across existing and new sites of care. Looking ahead, software remains a key driver of the Swoop system as a continuously improving AI-enabled platform. We expect our next software release later this year, building on our cadence of frequent software-driven enhancements that improve image quality, clinical utility, scan speed, workflow, and user experience.

We're making good progress on our plan to expand labeling to include brain MRI with contrast. Enrollment in Contrast PMR is approximately 75% complete, and the study is progressing well. We continue to target an FDA submission by year end 2026 to support an expansion of our labeling to include gadolinium-based contrast agents. In addition, we see early interest in neurosurgical workflows and mobile deployment models, both of which reinforce the broader platform potential of the Swoop system beyond traditional fixed-site imaging. In surgery, a newly formed advisory board and the operating room pilots are evaluating the potential for portable MRI to support immediate post-procedure assessment, while mobile models could expand access to brain imaging across distributed care settings where conventional MRI availability is limited. These initiatives reinforce our view of the Swoop system as a scalable, AI-enabled platform with increasing clinical utility and multiple future growth catalysts.

With that, I will turn the call over to Brett to review our financial performance and guidance.

Thank you, Maria. I'll recap our financial results for the second quarter of 2026 before providing an update on our guidance. Revenue for the second quarter of 2026 was $3.9 million, compared to $2.7 million in the second quarter of 2025, representing an increase of $1.2 million, or approximately 45% year-over-year, and modestly above the first quarter of 2026. First half revenue was $7.8 million compared to $4.8 million in the prior year period, an increase of $3 million, or approximately 62%. In the second quarter, we sold 12 units compared to 8 units in the prior year period, an increase of 50%. First half we sold 22 units compared to 14 units in the prior year period, an increase of approximately 57%.