HYPR - NASDAQ

Hello, and welcome to the Hyperfine Q4 '25 Earnings Call. [Operator Instructions] Now I would like to turn the call over to Webb Campbell. Webb, you may begin.

Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ending December 31, 2025. 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 that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are 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 relating to our operating trends and future financial performance, expense management, expectations for hiring, training and adoption, growth in our organization, market opportunity, commercial and international expansion, regulatory approvals and product development are based upon current expectations 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 these 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 the live broadcast today, March 18, 2026. 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, and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. Fourth quarter revenue of over $5 million demonstrated our very strong performance with the next-generation Swoop system for the second straight quarter. The mid-2025 introduction of our second-generation Swoop scanner, the Optive AI software and the addition of a new market with our launch into the neurology office setting mark a turning point in the adoption of portable brain MRI, the potential of ultra-low field MRI and the future of our company. We have now demonstrated that we hold a highly proprietary and differentiated technological position in our ability to produce diagnostic quality images with an ultra-low field magnet, making Hyperfine's technology, safe, acceptable and deployable across the continuum of preventatives, acute and chronic brain health settings. In 2025, we validated that the Swoop system offers unequivocal clinical and economic value to clinicians and providers ready for mainstream adoption and scale across a growing number of sites of care inside and outside the hospital. I want to start by summarizing some of the key highlights from the last several months to illustrate why I feel very optimistic about the future of the Swoop system for brain health and Hyperfine's unique position with ultra-low field MRI long term. From a market perspective, the feedback on Swoop's image quality with Optive AI software continues to be outstanding from the neurology, neurosurgery and radiology communities, leading to deal activation, reactivation, larger deals and interest from IDNs and health systems. The FDA clearance in December 2025 of our first update after the release of Optive AI software represents the 11th generation of soft -- Swoop software releases and confirms our commitment to continuous image quality advances with ultra-low field MRI. This latest Swoop software incorporates features in our diffusion-weighted imaging to further refine the value of the Swoop system in stroke workflows. The recently published [ SVIN ] stroke publication and the new PMR presentation validate the clinical diagnostic utility of the Swoop system for stroke triage and for patient care in neurology offices, respectively. The publication of the health economic impact data has an incredibly important element to our selling approach. We now have published evidence to support the cost savings in medical supplies, staff usage and the significant improvement in patient progress when using the Swoop system. Finally, the approval of the first generation Swoop system in India opens a new large geographic expansion opportunity for Hyperfine. Throughout 2025, we executed on our operational milestones across innovation, clinical and economic evidence generation and site of care and geographic expansion. We delivered strong revenue growth in the second half of the year. And importantly, we see market activation momentum continuing as we progress through 2026. This transformation was achieved in the context of a continued reduction in cash burn and gross margin expansion, demonstrating the scalability and leverage of our business model. We ended the year with a healthy balance sheet, and with the growth capital added from our recent financings, we're well positioned for sustained growth and investment in our technology, current market and potential future expansion opportunities into 2028. Over the past 6 years, we have maintained an unwavering commitment to continuous innovation and market development, transforming our original concept for an ultra-low field portable brain MRI system into a highly differentiated and clinically relevant platform, ready for broad adoption to help address the real limitations related to brain imaging. The next-generation Swoop system with Optive AI software represents the culmination of phenomenal innovations in electronics, physics and AI to make image quality at 64 millitesla approach that of high-field MRI. Looking ahead, these advancements represent a new beginning and a stronger platform to further increase clinical capabilities and expand into additional use cases across sites of care. We received FDA clearance for the next upgrade to the Optive AI software last December. Its latest software focuses on advanced multidirectional diffusion-weighted imaging to enhance stroke detection. Going forward, you can continue to expect a cadence of 1 to 2 software releases per year as we expand upon our leadership in the AI-enabled ultra-low field MR imaging space. We have now sold over a dozen next-generation systems since June and have launched incredibly busy and successful Swoop programs across critical care emergency departments and neurology offices. Exiting 2025, our primary call points are adult and pediatric critical care, emergency departments and neurology clinics and offices. More recently, we have actively begun pilot efforts in the neurosurgical and neurointerventional settings as well as in mobile units for dementia screening research. We will continue to lean on our strength, not only in continuous innovation, but also in clinical data generation to support a growing number of use cases and wide spread prevention. A good example of this is our contrast PMR study, a prospective multicenter clinical study to evaluate the feasibility and visualization benefit of contrast-enhanced ultra-low field portable MRI. I'm pleased to share that we are approximately 20% towards our enrollment goal. The study is designed to support a future FDA submission late 2026 to expand the Swoop systems intended use to include gadolinium-based contrast agents potentially unlocking new applications as we focus broadly on neurodegenerative diseases and surgical use. Brain scans with contrast will potentially broaden the use of the Swoop system across office and hospital settings. In outpatient care, scans with contracts are reimbursed using a dedicated CPT code 70553. Turning to our clinical work in the ED. We are seeing significant traction with accounts interesting -- interested in deploying the Swoop system in the ED for faster stroke triage using MRI. The excessive wait time for MRI in the ED is a costly and widespread patient care issue across hospitals of all sizes. Beyond the recently published SVIN paper, the PRIME study being led by the Yale School of Medicine, it's an additional project to validate the Swoop system utility, enabling faster triage of all comer patients in the ED. As a reminder, this study evaluates the potential of AI-powered portable MRI for broad patient triage in ED. I'm happy to share Yale's have completed enrollment ahead of schedule and expect to share an update on the findings later this year. The compelling image quality of the next-generation Swoop system with Optive AI software is activating our hospital pipeline to levels we have not experienced before, driven by interest from both clinical and administrative stakeholders and evolving deal discussions to multiple placements as well as first and subsequent deals at IDNs across the U.S. These larger, more strategic deals are very encouraging for the future growth of our business. Although larger deals have increased administrative processes are now more dependent on budget cycles, creating some potential for quarterly lumpiness and variability. With the recently published health economic impact data analysis as a reference, hospitals evaluating the Swoop system are now modeling 1- to 1.5-year return on investment time lines, substantially better than the 3- to 4 years typical for capital equipment. The recent publication summarizes the data compiled at Jefferson Abington across 143 scans related to their savings in cost of care, driven by reduction in supplies, faster clinical decision making, accelerated patient discharge and freed-up capacity on conventional scanners for elective procedures. These real world peer reviewed health economic data have become powerful catalysts for deals and elevating conversations to C-suite decision makers. With our device MSRP of $590,000 for our next-generation system, we can capture significant value while delivering strong ROI for our customers. The neurology office represents an additional growth vector for our business. Neurologists prescribe a high volumes of MRIs, yet only approximately 10% of private neurology practices have MRI imaging on-site, which creates an enormous addressable market opportunity with minimal incumbent competition. Our full commercial in to this market in Q3 has progressed rapidly through Q4. Our pilot program in the first half of 2025 come from the process through accreditation, training and reimbursement to scale portable brain MRI as an ancillary business in the office setting. We have proven that physicians can obtain diagnostic quality, MR brain images within their offices, providing patients with timely and convenient access at the point of care. In January 2026, data from our office study, NEURO-PMR, was presented at the American Society of Neuroimaging. In this study, patients receive brain imaging on both the portable Swoop system and conventional high-field MRI. In the study, portable MRI demonstrated 92% concordance with a standard MRI in identifying the presence or absence of intracranial pathology during a blinded review by independent neuroradiologist. In unblinded paired initial reviews incorporating clinical history, concordance increased to 98% as assessed by a neurologist and neuro imager. Furthermore, patients expressed a strong preference for portable MRI, reporting that they were 4x more likely to see portable MRI over standard MRI. Across all experience measures, including comfort, anxiety, claustrophobia, noise and overall satisfaction, portable MRI was rated superior to standard MRI. Trained clinical staff successfully operated the system within neurology offices without the need for MR technologies, highlighting its safe and straightforward operation. In Q4, we accelerated our selling efforts across both single and multi-clinician practices, building robust pipelines of both our first and next-generation Swoop systems. We deployed a segmentation pricing strategy, offering different configurations to serve practices of varying sizes and profiles. We're also leveraging our NeuroNet partnership to promote adoption across their network of neurology practices. The Optive market is still in its early days, yet reception has been robust and has been further fueled by the presentation of data from NEURO PMR. Turning to our international business, where we have made significant progress in the quarter. We have launched Optive AI software in 10 different European languages, with the software now available in the international markets we serve. We're going through the European regulatory process to bring the next-generation Swoop scanner to the U.K. and CE markets before the end of this year. Additionally, in late 2025, we also received regulatory approval in India, unlocking a key new market. With our local partner, we are planning to launch, engaging top KOLs in the country to help drive awareness and adoption. In accordance, we expect placements in India to scale at a measured pace throughout the year. Market feedback on the Swoop system with Optive AI software remains consistently very positive. I firmly believe the Swoop system today is ready for broad adoption our image quality positions us well to continue to broaden and deepen use cases. We have 3 diverse and differentiated business opportunities to drive growth in the near future through placements across the hospital, neurology offices and international markets. I will now turn the call over to Brett to review our financial performance and 2026 guidance.

Thank you, Maria. Before I recap our financial results for the fourth quarter and full year of 2025 and our expectations for 2026, I want to touch on our recently strengthened capital position. Last October, on the heels of our first full quarter of our next-generation Swoop system launch, we strengthened our balance sheet by raising over $20 million in equity, welcoming multiple quality investors to the story. More recently, building on our business momentum and to complement this equity, we raised $15 million as an initial tranche under and up to $40 million long-term debt facility. The initial tranche extends our cash runway into 2028, and the broader ability provides growth capital and significant financing flexibility for the commercial phase of our company. We are adding this nondilutive capital on attractive terms and have sized the upfront tranche to extend our cash runway while continuing to responsibly reduce our cash burn. For purposes of modeling, we expect quarterly interest payments to be approximately $400,000, and these payments are contemplated in our cash burn guidance. Now turning to our Q4 and full year 2025 results. Revenue for the quarter ended December 31, 2025, was $5.3 million, up 128% compared to $2.3 million in the quarter of 2024. We sold 16 units net in the fourth quarter of 2025 versus 9 units in the fourth quarter of 2024. We saw demand across all businesses with placements in hospitals, neurology offices and in international markets. This quarter, some hospitals elected to grow with our technology through a [ forecharge ] technology upgrade comprised of multiple unit placements. For the full year 2025, we generated $13.6 million in revenue, up 5% compared to $12.9 million in 2024. As anticipated, 2025 was a tale of 2 halves, with significant growth in the second half due to multiple midyear product launches, generating $8.7 million in revenue in the second half compared to $4.8 million in the first half of 2025. Gross profit for the fourth quarter of 2025 was $2.7 million, up 226% compared to the fourth quarter of 2024. Gross margin was 50.9%, our second straight sequential quarter above 50% and representing 1,530 basis points of gross margin expansion over the fourth quarter of 2024. For the full year 2025, we generated $6.8 million in gross profit, up 15% compared to the full year 2024. And our full year gross margin was 49.8%, representing 410 basis points of gross margin expansion over 2024. We continue to drive healthy margins for our stage and believe we are well positioned for meaningful margin expansion as we scale. R&D expenses for the fourth quarter of 2025 were $3.8 million compared to $5.1 million in the fourth quarter of 2024, a decline of 25%. For the full year 2025, R&D expenses were $17.5 million compared to $22.5 million for the full year 2024, a decline of 22%. We continue to realize the reorganization -- the benefits of the reorganization we completed in the first quarter of 2025 as we transition to a commercial growth stage organization. Sales, general and administrative expenses for the fourth quarter of 2025 were $6.5 million, flat compared to the fourth quarter of 2024. For the year 2025, sales, general and administrative expenses were $26.4 million as compared to $26.6 million for the full year 2024. We continue to exercise spending discipline and realized sales productivity and operating leverage in the business. Net loss for the fourth quarter of 2025 was $5.9 million, equating to a net loss of $0.06 per share as compared to a net loss of $10.4 million or a net loss of $0.14 per share for the same period of the prior year. For the full year 2025, net loss was $35.6 million, equating to a net loss of $0.43 per share as compared to a loss of $40.7 million or a net loss of $0.56 per share for the same period of the prior year. The fourth quarter of 2025 and the full year of 2025 net losses includes a noncash change in fair value of warrant liabilities, recorded as a gain of $1.5 million and $800,000, respectively. Our net cash burn, excluding financing in the fourth quarter of 2025 was $5.7 million, down 30% from $8.2 million in the fourth quarter of 2024. For the full year 2025, our net cash burn, excluding financing, was $29.9 million, down 22% from $38.4 million in 2024. Reducing our cash burn was a significant focus of ours in 2025, and we are pleased with the execution on this front. We will continue to prioritize spending discipline and optimize our operating leverage in 2026, which I'll discuss in the context of our guidance framework shortly. As of December 31, 2025, we have $35.1 million in cash and cash equivalents on our balance sheet. This is inclusive of the $18.4 million in net proceeds raised from our October equity financing and subsequent green [indiscernible] but it is not inclusive of the $15 million initial change from our new long-term debt facility. In addition to the $15 million of initial funding, we have the option through the end of 2027 to access additional tranches totaling up to $25 million upon achievement of prescribed commercial targets. This additional $25 million of growth capital is not included in our cash runway expectations. Now turning to our financial guidance. Beginning with our revenue outlook. For the full year 2026, we expect revenue between $20 million to $22 million, representing year-over-year growth at the midpoint of 55%. Given the strength of our fourth quarter finish, which includes a multiunit system-wide upgrade, we expect a typical step down in capital revenue from year-end levels. Our pipeline remains strong across our 3 business verticals, including several multi hospital and IDN opportunities. While these deals will serve as meaningful drivers of our long-term growth and sales product, they typically progress over multiple quarters. We also anticipate commencing the launch of next-generation Swoop scanner in international markets in the second half of the year. As a result, we expect revenue to progressively strengthen through the quarters in 2026. Looking at gross margin. We are initiating a range of 50% to 55% for the year. We expect the progression of gross margin percentage increase to closely follow our sales growth, and we expect second half gross margin percentages to exceed the first half. We remain optimistic that we will continue the trend of surpassing 50% gross margin comfortably and sustainably as we realize higher volumes driven by our growth catalyst. Lastly, we are initiating total cash burn expectations in the range of $26 million to $28 million for the full year 2026, representing a 10% year-over-year decline in cash burn at the midpoint. This cash burn expectation includes debt servicing mentioned previously. From a spending perspective, we will continue to be disciplined with our spending while investing in commercially oriented projects, and will continue to operate with 1 U.S. sales team, covering both the hospital and office market opportunities and through distributors internationally. As mentioned earlier, with the initial incremental growth capital raised in March, we now see a cash runway for the business extending into 2028. We believe we are entering an important phase of growth, having strengthened our financial profile and position the business as a high-growth, derisked medical imaging platform with multiple durable catalysts across large, underserved sites of care. We have successfully transitioned to a commercial-stage business, supported by a compelling value proposition, robust pricing, attractive gross margins and increasing sales productivity and operating leverage. I would now like to turn the call back to Maria for closing comments.

Thank you, Brett. Before we open the call to your questions, I want to briefly share a call I just had with 1 of our customer sites. This is 1 of our first programs that launched with our next-generation Swoop scanner. They purchased 2 units in the third quarter of 2025 and have been using the Swoop system since late Q3 across typical care, emergency department and most recently, in a hub and spoke model with a satellite there -- site. To date, they have performed over 200 Swoop system scans, reporting a high degree of satisfaction and great clinical and economic impact for the patients they care for and their workflow. On that very positive note, we can now turn to your questions. Operator?

[Operator Instructions] And our first question comes from the line of Frank Takkinen with Lake Street Capital Markets.

Congratulations on all the progress. I was hoping to start with 1 on the key assumptions surrounding 2026 guidance. What can you tell us you're assuming in that guide as it relates to U.S., OUS, anything, any color around multisystem unit ordering? I'm assuming there's a price component in there given the MSRP you quoted throughout the call? And then anything else we should consider as we're thinking about how you built the guide for 2026?

Thanks, Frank. This is Brett. I'll take that one. So yes, the way we built 2026 is really tied to the growth catalyst of the business. I think you commented on a couple of them. We have 3 business verticals that comprise the revenue stream that we've modeled out and are predicated in our guidance. So in the hospital side of the business, you're right, the multiunit systems and the IDNs will play out over time. I think as we mentioned, those take several quarters. So as the year progresses, we'll see more and more of those in our financial numbers. The office business, which we launched in the middle of last year, we'll continue to see traction on that in regards to the neuron meds -- excuse me, NEURO-PMR data as well as the penetration into that space. And then international, we commented in there that we've got a second-generation scanner that we expect in the second half of the year. So really taking all those pieces together, we see a progressive strengthening of the top line throughout the balance of 2026. Bigger deals, obviously, are tied to budgetary processes. And so those will probably play out more in the second half of the year, but we will see a progression of the top line starting in the beginning of the year and then continue to strengthen throughout the year.

And maybe on pricing -- and Frank, we did comment on the MSRP at $590,000, so that is something that changed. So we increased it from $550,000, which was the pricing at the launch of our Model 2 and moved it to $590,000 at the beginning of the year. That is primarily in our U.S. hospital business. We also commented on the fact that we are doing price segmentation in using both Model 1 and Model 2 in the office because not all offices are made equal, some are single practitioner, relatively small, and the volume doesn't support the Model 2. So we're using Model 1 at a different price point in the office setting. And last but not least, of course, internationally, since we operate and transact through distributors, we're doing that at distributor pricing. So not different than -- previously, we do have the blended combination of all of those that ends up being our ASP. But we can receive the health and the improvement just because there is 1 of the business verticals, which is a U.S. hospital, that is predominantly Model 2, and is enjoying sort of the advantages of the price increase. The reason for mentioning also $590,000 in the prepared remarks was that when you run really the ROI calculation, given the quick impact data that was recently published with any hospital, even at a $590,000 pricing, you do get to that 1- to 1.5 year ROI, which makes it incredibly compelling from an administrative standpoint.

Very helpful color. I was hoping on the second one, I could ask a little bit more about the pipeline. I think in the Q3 call, you've referenced the Hyperfine time being at its strongest and most diversified following a really strong Q4, would you say that, that comment still holds true? Or are you still in the camp of building up the funnel in the front half of the year?

So the comment around the pipeline continuing to be the strongest we have ever seen is very true. It is also very true that it is comprised of more multiple deals and more IDN deals. We have several deals with big IDNs in progress. It is also true that those deals are a little bit more now mainstream procurement, and in some cases, dependent on budget year. So remember, we were really stealth with the -- before the introduction of Model 2. So when it launched in June of last year, truly the very first budget year that we are able to take advantage of is the 1 that kicks in July 1 for more -- for a lot of the hospitals. So I think we've commented that some of these bigger, more strategic multiple deals are actually a little heavier in process and may create some variability. There is something also that happened in Q4, which is a -- for revenue upgrade of an institution where we have multiple systems and they wanted to standardize and move their installed base to Model 2. That is probably a onetime event as it relates to Q4, that I'm not seening in sort of the forecast for every quarter going forward. So hopefully, that gives you color around how we're looking at the pipeline, incredibly robust and totally full with very big IDN names, multi-deals, but those come with a little bit more process and the budget year being more naturally that July to the end of the year is something that may create this sort of progressive strengthening of our revenue line over the course of the year.

Very helpful. If I could sneak 1 in. When you speak about the multiunit orders, my assumption for Q4 is maybe that was single-digit but multiunit. Is there -- one is maybe that's accurate, if you care to comment on that? And then two, as you look at some of the multiunit deals in the pipeline, is there a potential for double-digit multi-unit deals?

Double-digit number of deals or numbers number of units?

Number of units.

I think I understand your question, Frank. When you talk about multiunit, you can think about things 2 ways. One is an individual hospital where there is multiple placement opportunities. So for example, someone might want to have it for both critical care and the emergency department and maybe pediatric and adult in the case for critical care. So you might have 3 or 4 placement opportunities in an individual hospital. And then when you talk about an IDN, IDNs obviously are multiple hospitals. The deals will likely not be all the hospitals at once, but it will probably start at 1 of the hospitals, but then we'll go across the IDN network where they will want to standardize care. So over time, that could be, but really in an individual quarter, we're talking about single digits at an individual transaction level.

And your next question comes from the line of Yuan

Congrats on a strong 2026 guidance. Maria, the business had its up and down over the past couple of years. I think it will be very helpful to investors if you can provide a quick review, especially what we have learned that can be used for the current business momentum.

Sure. Thank you, Yuan. So I think we have defined our technology as portable brain MRI, but the real product that we offer is high-quality imaging that is accessible, affordable and easy to get. And I don't believe in the last few years, we were there until the introduction of both the Model 2 as well as the Optive AI software. So I have personally witness an increasingly sharp change towards endorsement and approval of our technology and interest in on our technology as we have brought up substantially the image quality, all the way to what we have now said, which is very, very close to high-field MRI. So the clinical value has now been totally transformed into something that is a very useful tool. I know I commented on a small anecdote on one important new account with Model 2, but the reality is they're using it all the time as a go-to tool for the triage of their patients with suspected stroke symptoms, and they're doing it as a [indiscernible] institution as well as they're doing it in their ED. And they are able to make clinical decisions every day. Our technology wasn't there when we started. We were portable, we were low field, but our imaging was not at the level of clinical decision-making. So I have a totally different appreciation for the opportunity now that we have established that base of clinical utility. And I have also witnessed because of this high level of image quality now and interest to take our unit, to take our technology into even more use cases and sites of care than we have planned thus far. I know I've mentioned mobile. I know I've mentioned surgical, but those are places where we are being pushed, where we are being asked to play because the technology now offers that great combination of high clinical value with that access, affordability, ease-of-use component, safety component pretty much anywhere. Does that make sense? I really think we're leaving behind a development phase of getting to that level of clinical utility as we have refined and improve really the image quality.

Got it. Yes, that's very helpful. And maybe 1 question for Brett. I noticed the service revenue is lower in fourth quarter. As we imagine you have more devices in store, the service revenue should grow year-over-year. So can you please provide some additional color on that?

Yes. Thank you, Yuan. Yes. So you would expect service revenue to progress over time, and that is the term trajectory of that line item. In Q4, we mentioned we had done some [ forecharge ] technology upgrades. And as part of that, we had to go through an accounting contract assessment and that -- there's some adjustments in the service line item related to that. But going forward, you would expect that trajectory to be what you had articulated.

There's no further questions at this time. I will now turn the call back over to Maria Sainz for closing remarks. Maria?

Sure. Thanks, everyone, for joining us today. We look forward to keeping you updated in the next several weeks. Thanks, everyone, and have a great rest of your day.