HYPR - NASDAQ

Ladies and gentlemen, thank you for standing by. My name is Desiree and I will be your conference operator today. At this time, I would like to welcome everyone to the Hyperfine Fourth Quarter 2024 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the conference over to Marissa Bych. You may begin.

Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ended December 31, 2024. 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, which are made pursuant to the safe harbor provisions 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 our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events 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 the live broadcast today, March 17, 2025. Hyperfine, Inc. disclaims any intention or obligation, except as required by law, to update or revise any future productions or forward-looking statements, whether because of new information, future events, or otherwise. And 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. I am pleased with the strategic milestones achieved in the fourth quarter. They set the stage to execute on our diversified catalyst and drive accelerated growth in 2025 across multiple sites of care and global markets. In 2024, we delivered revenue of $12.9 million, representing 17% year-over-year growth, meaningfully expanded gross margins, and further reduced cash flow. Since the close of the year, we have taken steps to strengthen our financial profile by completing a reorganization to lower our operating costs and raising $6 million through a direct offering to extend our cash runway to the end of 2026. Before I provide detail on our diversification and expansion strategy and the growth catalysts that are coming to fruition in 2025, I will let Brett first review our 2024 financials in more detail. Brett?

Thank you, Maria. I will recap our financial results for the fourth quarter and full year of 2024. Revenue for the quarter ended December 31, 2024 was $2.3 million, compared to $2.7 million in the fourth quarter of 2023. We sold nine units in the fourth quarter of 2024. Soft revenue was due to longer deal timing and processes for U.S. hospitals and lower average selling price associated with the heavier mix of international deals in the fourth quarter of 2024 versus the prior year period. Our pipeline remains strong, but U.S. hospital critical care deal sales cycles experience variability and are getting longer than previously anticipated. There are multiple stakeholders involved in the purchasing cycle that falls outside the traditional capital process. Also, in 2024, we had uneven performance in productivity across sales regions in the U.S., and in December, we took action to upgrade our sales talent, replacing 50% of underperforming regions in the United States field team. For the full year of 2024, we generated $12.9 million in revenue, compared to $11.0 million in 2023, representing an increase of 17%. Revenue growth in 2024 was driven by organic commercial expansion. Organic year-over-year revenue growth was a healthy 70%, excluding $3.4 million of revenue in 2023 associated with King's College London's one-time purchase order supported by a grant from the Bill & Melinda Gates Foundation. Gross profit for the fourth quarter of 2024 was $0.8 million compared to $1.0 million in the fourth quarter of 2023. Soft gross profit was due to our lower revenue and the higher international sales mix in the fourth quarter of 2024. For the full year of 2024, we have generated $5.9 million in gross profit, up 24% to the full year of 2023, and our full year gross margin was 46%, representing 300 basis points of gross margin expansion over 2023. We continue to drive healthy margins at our stage and believe we are well positioned for meaningful margin expansion at scale. R&D expenses for the fourth quarter of 2024 were $5.1 million, compared to $6.0 million in the fourth quarter of 2023. For the full year 2024, R&D expenses were $22.5 million, flat compared to the full year 2023, as 2024 was a year of continued innovation investment for Hyperfine. Sales, general and administrative expenses for the fourth quarter of 2024 were $6.5 million, compared to $6.7 million in the fourth quarter of 2023. For the full year 2024, sales, general and administrative expenses were $26.6 million, down 12% compared to the full year 2023, as we continue to exercise spending discipline. Net loss for the fourth quarter of 2024 was $10.4 million, equating to a net loss of $0.14 per share, as compared to a net loss of $10.7 million, or a net loss of $0.15 per share, for the same period of the prior year. For the full year 2024, net loss was $40.7 million, equating to a net loss of $0.56 per share, as compared to a net loss of $44.2 million, or a net loss of $0.62 per share, for the same period of the prior year. Our net cash burn, excluding financing, in the fourth quarter of 2024 was $8.2 million, and as of December 31, 2024, we have $37.6 million in cash and cash equivalents on our balance sheet. For the full year 2024, our net cash burn, excluding financing, was $38.4 million, down 9% from $42.3 million in 2023. Reducing our cash burn was a significant focus of ours in 2024, and we are pleased with the execution on this front. We will continue to prioritize spending discipline and optimize operating leverage in 2025, which I will discuss in the context of our guidance framework shortly. Our business fundamentals remain strong, with healthy year-over-year organic revenue growth, gross margin expansion, reduced OpEx spending, and reduced cash burn. I will now turn the call back to Maria to provide a business update before I cover financial guidance.

Thank you, Brett. 2024 was a year of significant progress. We set course and began to execute on our diversification and expansion strategy, and we are transforming our business into a true commercial-stage company in 2025, realizing the operating leverage from our business fundamentals. We have multiple growth opportunities as we expand selling our subsystem into the office setting, multiple call points in the hospital, and international markets. Since the initial FDA clearance in 2020, we have been improving the image quality of our unique portable AI-powered MRI to drive clinical utility and mainstream adoption. In 2025, we plan to obtain clearance and launch two subsystem software releases, the 10th and 11th generation. These next-generation releases will bring a step-function image quality improvement, and the feedback from KOLs involved in our image development process continues to be extremely positive. Their assessment is that the images from our next-generation subsystems are like those obtained from conventional 1.5 Tesla MRI systems. This high level of image quality will be core to all of our expansion initiatives. We anticipate the first of these technology updates to be launched by mid-2025. We believe this level of image quality will make adoption of portable brain MRI quicker for new users, enabling a shorter learning curve and accelerating market uptake of our technology. Our growth going forward will be driven by expansion into multiple sites of care and international geographies. Based on the opportunities for subsystems at multiple sites of care, our total addressable market is in excess of $6 billion for placements in hospital and office settings in the U.S. market alone. Our FDA clearance allows the use of the subsystem for all brain images of patients of all ages, and subsystem scans have the same CPT reimbursement codes as conventional brain MRI. I will now cover in greater detail the three expansion vectors of our strategy, building an office business, expanding to multiple sites inside the hospital, and driving adoption in international markets. Starting with the office opportunity, we plan to launch the subsystem in neurology offices by mid-2025. We were very pleased to see in November 2024 the Intersocietal Accreditation Commission, IAC, a leading CMS-approved accreditation body, issue updated MRI standards to include the use of portable point-of-care ultra-low-field brain MRI. Offices can now pursue accreditation through IAC, and exams with subsystems in those offices would be eligible to be covered by CMS. Physicians can now obtain diagnostic-quality MR brain images within their offices, providing patients timely and convenient MRI access at the point-of-care, opening up an incremental, very exciting and transformative business for subsystem placements. We have begun preparing for the office business launch over the last few quarters. We plan to launch through our existing commercial team to leverage their knowledge and our implementation capabilities. One of the pillars of the launch in the office setting is conducting NeuroPMR, a prospective study to assess different use cases for the subsystem in this new setting. There are multiple clinical use cases in the office for the subsystem, from headaches to Alzheimer's disease, surgical follow-up, or multiple sclerosis. Two leading neurology practices will participate, and the study principal investigator is Dr. Laszlo Mechtler from the Dent Institute. During the launch preparation, we have initiated a pilot program and have had a small number of sites go through accreditation and the implementation processes. We are very encouraged by how seamless the processes are. To raise awareness across the neurology community, we recently participated in the American Society of Neuroimaging and the NeuroNet meetings and witnessed firsthand the KOLs enthusiasm for our technology as a very promising element to enable the building of more comprehensive practices and expansion of care in their offices. Now moving to the hospital opportunity. We have been commercializing the subsystem in the hospital setting and historically our focus has been in adult and pediatric critical care to bring MRI to patients that cannot safely nor readily be transported to a conventional MRI. We have begun to expand to the emergency department as an additional call point in the hospital supported by the clinical work we have done in stroke. MRI availability for the triage of stroke patients in the ER is very limited and patients often suffer long waits. Data from ACTION PMR continued to strengthen the evidence supporting the value of AI-powered portable MRI in acute ischemic stroke triage. ACTION PMR is our prospective international multi-site observational study to validate the use of the subsystem for patients with acute ischemic stroke where the subsystem could be used. Enrollment in the study is complete with 100 patients at four leading institutions in the U.S. and Europe with data presented at multiple leading conferences, including the 2024 European Society of Neuroradiology, and most recently, the 2024 Radiological Society of North America and 2025 International Stroke Conference. Before I leave our clinical programs, we remain excited about the potential of our technology in dementia and Alzheimer's care. CARE PMR continues to enroll patients and initial cases were again presented at CTAD during the fourth quarter in Madrid, Spain. We are strengthening work in the field of dementia with other KOL institutions. Dementia and Alzheimer's disease are also use cases in the office setting. Furthermore, we continue to support investigator-sponsored studies to augment the data to illustrate the clinical workflow and cost efficiency value of the use of the subsystem at the different sites of care. In 2025, we're also focused on selling in the hospital using data related to the very favorable economic impact, the use of the subsystem can have with information collected by two of our key centers. Missouri Baptist conducted the lean analysis and documented incremental conventional MRI scans enabled by the use of the subsystem in critical care. Additionally, a leading center in the Northeast has compiled their savings in cost of care associated with the use of the subsystem enabling faster decision-making and discharge as appropriate. We believe this real-world data can be a strong catalyst for adoption across the hospital setting. Last, regarding international commercialization, 2024 was our first year of commercial focus in international markets. We exited the year with 13 distributors in place, covering European, Middle Eastern, and Asian geographies. We had initial placements in most markets and witnessed significant interest from clinicians in the markets we have a presence. We have recently obtained CE and UKCA approval for our ninth generation of software and now have the subsystem in local languages in the major European markets. We also anticipate regulatory approval and market entrance in India in the second half of the year. I want to wrap my remarks by summarizing a plan to drive business acceleration and growth in 2025 and beyond. 2025 will be a tale of two halves. During 2025, we will launch two new [AI-powered] software releases with significant improvement in image quality. We're starting the year selling mainly in adult and pediatric critical care inside the hospital setting. And by the end of the year, we will be actively selling into several sites of care in the hospital, into the neurology office setting and in more international markets. These opportunities will grow and diversify our revenue and provide the foundation for growth acceleration in the second half of 2025 and beyond. I am confident in the opportunity in front of us and the execution and capabilities of our team. I will now turn the call over to Brett to review our 2025 guidance.

Now turning to our financial guidance. Beginning with our revenue outlook, we want to start by providing visibility into our expected first half performance. For the first half of 2025, we expect revenue to be approximately $6 million. We are still experiencing protracted processes with U.S. hospitals and in early 2025, uncertainty related to funding associated with deals supported by grant funds. We believe we'll be able to more precisely forecast our second half of revenue over the coming months as our growth catalysts play out. And for the full year, we expect revenue growth to be in the range of 20% to 30% over 2024. Looking at gross margin, we are initiating a range of 47% to 52% for the year. We expect the progression of gross margin percentage increase to closely follow our sales growth and we expect the second half gross margin percentages to exceed the first half. We remain optimistic that we'll surpass 50% gross margin comfortably and sustainably as we realize higher volume growth driven by our growth catalyst. Lastly, we are initiating total cash burn expectations in the range of $25 million to $27 million for the full year 2025, representing a 32% decline in cash burn at the midpoint. We have taken several steps to enhance our financial profile. We completed a restructuring at the beginning of the year to reduce operating costs, extend cash runway, and transition the organization from a development stage to a commercial stage company. We recently bolstered our balance sheet with a $6 million financing. We will execute upon our plan with strong spending discipline while maintaining appropriate investment in our growth catalyst. We see our cash runway for the business to the end of 2026. Before turning the line back to Maria, I want to touch briefly on the topic of tariffs. We have been closely monitoring recent government commentary and actions and their potential impact for our business. Our guidance assumes that our business will not be materially impacted by tariffs. We will continue to follow the situation closely and provide updates to the market as needed. At this point, I'd like to turn the call back to Maria for closing comments.

Thank you, Brett. The team made solid progress in 2024, driving technical, clinical developments, and a strategy to support the site of care expansion in 2025 and beyond. We have built a very strong foundation for business acceleration over the course of the year ahead, and we're more optimistic about the future of Hyperfine than ever. With that, I want to thank you for your time and open up the line for questions.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And our first question comes from the line of Larry Biegelsen with Wells Fargo. Your line is open.

This is Simran on for Larry. Thanks for taking the questions. And I want to say first off, congratulations on the announcement this morning, the partnership with NVIDIA. Any additional details that you can share regarding what that collaboration will entail? From the press release, it did sound like there could be some R&D products in the works. So, if that is the case, what are the timelines there? And then as well as, if there are any financial implications associated with the partnership?

Simran, hi. Thanks for the question. It is an initiative related to our future technology, and there's really nothing further that we're going to be commenting at this stage. So, we're going to leave it at what was out this morning.

And maybe just turning to 2025, how are you thinking about capital trends? In the year particularly, given there does seem to be some concerns around potential recessionary headwinds? And are there any offsets that we should be considering in the year? I know office -- the in-office expansion is one.

Sure. So, I think -- as we think our business, we really think about the office separate from our hospital business. And I think Brett was right in commenting that we have seen more protracted and complexity in the processes for hospitals to go through capital allocation and finalizing the purchase of something in the neighborhood of our $400,000 to $500,000. So, I would say there is a little bit of tempered enthusiasm about how quickly hospitals are going to be moving through the capital process. I want to say that although I would say that our processes are now longer than I have even commented in the past in the hospital setting. We also have a lot of things in the pipeline that will be moving through throughout the year. I think there is a difference in the office setting. There is a very reduced number of decision makers and there is really more of a business case built up to whether this makes sense or not. So, it was critically important for us to be able to have the accreditation from a CMS accredited body so that we can run sort of a little bit of a pro forma as to what this could look like for them in the office. And I think it is less tied to capital allocation. It is more tied to does this make financial and clinical sense for the practice I'm running. I think we commented in prepared remarks that we're really making a strong push to talk economic benefit coupled with clinical benefit in our selling process for both the hospital environment and the clinic environment because we definitely understand that people want to make sure that there is ultimately sort of an ROI thinking around buying any of these devices. The one area where I would say there is a little bit more maybe pause at this point is any kind of systems that were going to be funded with grant funding. And that is a number of our systems sometimes have been funded through grant funding. That has more uncertainty as of the last 10 weeks or so.

And maybe just my final question here. How should we be thinking about contributions from the U.S. versus international given that you are scaling pretty meaningfully in both geographies? And how should we think about the durability of your ASPs in 2025 as you scale both of those geographies?

I'll make a comment about ASPs and I will let Brett comment as well. As you know, we have been increasing the selling price of our device in markets where we sell directly. So that is primarily the U.S. The difference in ASPs, of course, because we do sell through third-party distributors outside of the U.S. We have raised the selling price of the system as of the beginning of this year. And we believe, again, that the actual price, the MSRP, is not the reason why people are not buying or not buying faster. That said, mix is what ultimately creates some degree of variability quarter to quarter as we think about really the mix between the U.S. and O-U.S. I would say at this point, we expect in the second half of the year both to have significant ramp. I don't know if we're going to provide a lot more color on how to think about the mix specifically in the coming quarters. But, Brett, feel free to add any commentary here.

Yes. I would comment that I think Maria commented that we have several growth vectors that will be in our numbers in 2025, specifically in the second half. We'll have the office setting. We'll have multiple call points in the hospital, and then we'll have a continued expansion internationally. I think individual quarters, there could be variability. You guys have seen historically where we've had quarters where we have heavier international mix. There's been kind of an effective ASP, and there's been quarters where we have a more domestic mix where there's been higher ASPs. I would expect that our price between those two anchors, but as Maria indicated, pricing increase has been something that we've looked at here for the value proposition as well as just thinking about gross margin expansion.

Our next question comes from the line of Yuan

This is Brandon Carney for Yuan. Yes, congratulations on that NVIDIA announcement. Just wondering, if you can provide some color on how it benefits NVIDIA and Hyperfine separately. Is NVIDIA getting something like access to Hyperfine's data sets? And is there any specific deliverable we should be looking for there?

Hi, Brian. I'm going to say what I said a few minutes ago. It really is about an initiative that relates to future technology. And at this stage, we're not going to provide any additional commentary. We have been developing, and as I mentioned in the prepare remarks, we're incredibly enthusiastic and excited about the two new technology upgrades that are going to come to the market in 2025. I'd be happy to share with all of you that we do have a filing with FDA already for one of those technology releases that we expect in the middle part of the year. But related to the news this morning, as I said, it relates to our future technology, and there's nothing else that we will share for now.

So maybe I can ask about the expansion efforts into the neurology offices. I know that the launch is scheduled for mid-year, but I'm wondering if any inroads have been made at this point, and if you're getting any feedback from the customers, you've already been talking to?

Sure. So definitely. So we've been in pilot mode, and there's a number of initiatives that have been brewed through that pilot mode, but we have had the opportunity to work with less than a handful of offices through the process, through application into IAC for accreditation, through understanding, how that application translates into, receiving accreditation, what are the expected timelines, how that then translates into being registered with CMS, to be reimbursed by CMS for the exams, and also understanding the use case. I believe in the prepared remarks, I mentioned NeuroPMR, which is a study that we are going to do in relatively short order with two very large offices to really validate and understand the use case in the office as it goes the spectrum from looking at headaches and what could be the underlying disease that causes the headaches to surgical follow-up, dementia, Alzheimer's, multiple sclerosis. So, we want to make sure that we understand very well how the suit plays in all of those different types of patients. I'm happy to report that through the pilot sites that have gone through the process, the process has been relatively seamless. Probably you get things done in short months, not quarters. We have also seen the ability for some of these decision-makers in the offices who are very often both the clinical and the administrative decision-makers, sometimes [indiscernible], sometimes just a very small group, to be able to reach decisions very quickly. NeuroPMR is done with two very high-profile centers. The Dent Institute is in Buffalo, New York. It's a very large conglomerate of neurology offices. And Texas Neurology is the other one, which is a very large single practice in the Dallas area. We're very excited by how they think this really augments their offering, their clinical reach, their ability to build an office practice that has more than what they may now have, which would be consult service, consultation services, as well as sometimes infusion services. And they're thinking about imaging more broadly as the next way of really building a more comprehensive practice. The American Society of Neuroimaging is an interesting group that we've now established a relationship with. They are neurologists by training, but they did enough additional training to be certified to read imaging. They are a group that has a strong interest in our technology and very often is the group that resides in offices. And then there is a meeting, more of a business meeting for neurology practices, which is NeuroNet, that I also mentioned in the upfront remarks. And there was a tremendous amount of interest there. We brought a system, we scanned a lot of people, and we took a fair number of very healthy leads to use as we get ready to launch.

Maybe just one more on customer mix. I know you already talked about how O-U.S. is going to be affecting it, and you just talked about the expansion into the neurology offices. But maybe just something more general about customer mix as we evolve throughout that inflection point you mentioned in mid-year. How should we just be thinking about it more generally as you expand outside of critical care?

I mean, I think Brett said it before. There are multiple growth vectors in front of us. The neurology office expansion applies only to the U.S. market. The hospital expansion applies to both international and domestic markets. And incremental geographies, of course, will be primarily international. And we are excited about the opportunity to enter into India. Some of those expansions have a little bit of a knobby office in the U.S. because we've cleared what I could have called a pseudo-regulatory with IAC accreditation. But the India approval is in the hands of the India FDA. So, depending on how much of the year we have access to those opportunities, that will dictate sort of a big contribution those make for us. I think the portfolio of opportunities for us is how we feel that the second half of this year is going to be significantly richer than how we're starting. But how each of them is going to play may have some of that variability. We will be a little bit more specific around the mid-year timeframe as we see how we progress through some of the go-to the opportunity initiatives that we are undertaking right now. Brett, feel free to add anything else.

No, I think you've covered. I think the only thing else I'd add is, thinking about the second half of 2025, we'll see a diversified revenue stream. So, I think, where we've historically been more focused on that critical care, we'll be entering a space where we'll have a kind of a balanced portfolio and a diversification of revenue streams. So that will result in a kind of a more, I think, steady, predictable overall results quarter to quarter.

And our last question comes from the line of Young Li with Jefferies. Your line is open.

I guess to start, it's March 17th, first half guidance is $6 million. I was wondering if you can provide any high-level color on 1Q versus 2Q split?

Brett, do you want to take that one? Hi, Young.

Yes. So, I think, when we gave kind of more specific guidance for the first half of the year, given where we are, we definitely see the second half of the year being more catalyst-rich, all the growth drivers and vectors coming into play, ranging from the market expansions, the office international, as well as the timing of clearances and technology releases that we've talked about being kind of at the core to business acceleration. So, that's why we came up with the first half guidance and then we've pointed to what we believe our expectations are for the full year. So, we do have a tail of two half years where we see significant growth in the second half off of the base of the first half.

But I don't think we're going to get down to the quarter split to your very specific point, Young.

I guess just on the second half ramp, pretty big number even though you have a lot of catalysts and new initiatives coming to play, but I think you did replace like half of your underperforming reps, who are sort of the new reps that you hire? How experienced are they? To your level of confidence that, those guys can get up and running to the second half.

Yes, I'll be happy to take that. So earlier in the year, in 2024, we started seeing pretty significant separation in performance across territories, and we started seeing what good looks like, and there were some territories that were definitely falling behind. We took an interim step which was around combining leadership that we had some regional leaders and we thought everyone under one leader probably would make more sense. We still observed that very uneven performance, and we decided to take action at the end of the year. The reason for that was that we wanted to make sure that we had the new group of people ready to go when we're introducing the new upgrades in the image quality, the software, and the technology. So, one of the things we did was hire them with a number of skills that we thought were really important around understanding how to build new markets, also some degree of understanding of the brain space. So, they don't all come from the same place. They came from different successful sales assignments. I have to say that all of them I think were employed before, so we were looking for people that were really just jumping on the first thing that they had. But what I'm proudest of is the fact that we put them through a very rigorous training program at the crack of the year when they joined us, and we've been incredibly impressed with what we have seen. I have seen some of that firsthand as they have evolved through their training. They've shadowed some of the experienced people. We have our implementation leader and our commercial leader also spending a lot of time with them. They have been at other people's accounts. Some more experienced people have been with them at their accounts, and we think that we have a team that will be ready to really do the good things that we're expecting when we have also the new releases here and the image quality that is going to be highly differentiated from anything we've had before.

That concludes the question-and-answer session. I would like to turn the call back over to Maria Sainz for closing remarks.

Thank you all for joining us on today's call. I believe we are in a transformative year for Hyperfine. We will keep everyone updated on the multiple growth catalysts for our business as we progress through 2025. Thank you very much.