Hyperfine, Inc. (NASDAQ:HYPR) Q1 2026 Earnings Call Transcript

Hyperfine, Inc. (NASDAQ:HYPR) Q1 2026 Earnings Call Transcript May 12, 2026

Hyperfine, Inc. reports earnings inline with expectations. Reported EPS is $-0.09 EPS, expectations were $-0.09.

Operator: Good afternoon. And welcome to the Hyperfine Quarter 26 Earnings Call. I am Frank, and I will be the operator assisting you today. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press *1 on your telephone keypad. If you would like to withdraw your question, press *1 again. Thank you. I would now like to turn the call over to Webb Campbell, with Gilmartin Group. Please go ahead.

Webb Campbell: Thank you for joining today’s call. Earlier today, Hyperfine Inc. Released financial results for the quarter ended 03/31/2026. A copy of the press release is available on the company’s website as well as sec.gov. Before we begin, I would 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 2 thousand. 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 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 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 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.

Maria Sainz: Good afternoon, and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Brett Hale. The first quarter was a strong start to 2026 as we executed across our commercial and financial priorities. We delivered revenue of $3.9 million our second highest quarter ever, up 83% year-over-year. Q1 was our third full quarter selling our next generation subsystem in the U.S. market and selling into our new neurology office business. We posted a 51% gross margin and demonstrated operating leverage and spending discipline closing the quarter with a strong balance sheet. We also achieved several important milestones. We obtained CE and UKCA marks for the next generation subsystem and our advanced DWI Optive AI software.

We significantly increased enrollment in our contrast PMR study and now is at over 50% of our enrollment goal. We launched our advanced DWI Optive AI software at the 26 International Stroke Conference supported by a paper published in SPINS demonstrating the SUSystems enhanced stroke detection capabilities, And lastly, we saw compelling data from our neuro PMR study presented at the American Society of Neuroimaging highlighting broad clinical utility, high diagnostic value, and a strong patient preference with the subsystem in neurology offices. With our strong execution in the first quarter across revenue, gross margin, cash burn and milestones, we are reiterating our guidance to deliver transformative growth, healthy margin expansion, and lower cash burn for Hyperfine in 2026.

Commercially, demand for the next generation subsystem remains strong, and we continue to diversify revenue across our 3 business verticals. Hospitals, health systems, neurology offices, and international markets. I will now walk through updates from our 3 business verticals in more detail. In our hospital business, we are driving sales of our next generation subsystem with high interest from adult and pediatric critical care and emergency departments. We are also leveraging positive clinical and economic impact data from early adopters to expand our footprint and increase utilization across sites of care in the hospital. Programs launched since the introduction of our next generation system have demonstrated high utilization and positive clinical and economic outcomes.

Strengthening our foothold in the hospital at the International Stroke Conference in February, we launched our advanced DWI Optive AI software, extending our value in stroke workflows to the EV and across hub and spoke networks. The advanced DWI Optive AI software is now implemented in most scanners across our installed base. We continue to advance our health system and IDN strategy, and are seeing repeat sales within IDNs across multiple sites over the last couple of quarters. Our pipeline continues to shift towards multiunit and IDN opportunities. The leverage from selling into IDNs is a key part of our strategy to drive adoption of our technology across hospitals. These strategic accounts represent attractive expansion but have longer sales cycles with additional system wide stakeholders and steps in their procurement policies.

In our office business, placements were a solid contributor to our revenue performance this quarter and following strong exposure and market activation work at the American Society of Neuroimaging and NeuroNet meetings, in Q1 we have had mostly next generation subsystem placements in larger offices. We continue to build a healthy pipeline across practices of varying sizes. Also, during the first quarter, data from NEURO-PMR was presented at the American Society of Neuroimaging. In neurology offices for neuro PMR, the Swoop system was used for patients across several neurological conditions, including headaches, dementia, multiple sclerosis follow-up, and tumor follow-up. The study shows the high diagnostic value of the subsystem in this setting and the patient experience with the subsystem was rated very favorably compared to conventional MRI.

Turning to our international business. In Europe, our Optive AI software was launched during the quarter and is seen strong reception. In India, the first 2 systems are now live in clinical use at a leading KOL center in Delhi through our distribution partner. Additionally, we are very excited to have received CE and UKCA marks for our next generation subsystem with the latest version of Optive AI software. We are working to complete all translations and documentation processes to be in a position to launch in Europe in the third quarter. This has positioned us for a stronger second half of 2026 internationally. Looking ahead, we remain committed to increasing the clinical value of the Swoop system through technology, innovation, and clinical evidence.

We plan on introducing the next software upgrade with additional improvements in image quality and clinical capabilities by the end of 2026. Driven by clinician interest, we are also evaluating and conducting pilot activities in new sites of care for our subsystem. Namely the use of the subsystem in the Operating Room or Angio Suite to support timely scanning of patients following procedures as well as the use of the Swoop system on mobile units for community based brain screening programs. Finally, I would like to provide an update on our contrast PMR study. I am happy to share that enrollment is progressing well with 3 study sites now active. And enrollment over 50% of target. Over the long term, we believe expanding the subsystem indication for use to include contrast, is of value in all sites of care.

As it will increase clinical utility. Brain scans with contrast represent a meaningful percentage of all brain MRI. As a reminder, the contrast PMR study is a prospective multicenter clinical study designed to evaluate the feasibility and visualization benefits of contrast enhanced ultra low field portable MRI. We currently expect the study to support a potential submission by 2026 to expand the subsystem’s intended use to include gadolinium based contrast agents. Also, a contrast indication can further support the office opportunity as cases in offices are all elective and use CPT codes for reimbursement. As a reminder, brain MRI exams with contracts are reimbursed using a dedicated CPT code 70.6 thousand. I am very pleased with the strong market traction we continue to generate and the level of image quality the subsystem provides.

I am proud of the Hyperfine team’s execution not only in the last quarter, but over the last 2 years, delivering numerous milestones to get to this point. We continue to see our business progressively strengthening through the year, and I remain confident in our commercial traction pipeline, and opportunity. With that, I will turn the call over to Brett to review our financial performance and guidance.

Brett Hale: Thank you, Maria. I will recap our financial results for 2026 before providing an update on our guidance. Revenue for 2026 was 3.9 million compared to $2.1 million in the 2025. Representing an increase of 1.8 million or 83% year-over-year. In the first quarter, we sold 10 units versus 6 units, in the prior year period. With contributions across all 3 business verticals. The majority of unit sales were our next generation system, supporting a strong average selling price. Gross profit for 2026 was 2 million compared to $900 thousand in the 2025. Gross margin was 50.7% compared to 41.3% in the prior year period. Representing approximately 940 basis points of gross margin expansion. This is the third straight quarter with gross margin exceeding 50% and we believe we are well positioned for meaningful margin expansion as we scale.

R&D expenses for 2026 were 3.8 million compared to $5 million in the 2025. A decrease of approximately 24%. We continue to realize the benefits of the reorganization completed in the 2025 as we transition to a commercial growth stage organization. Sales, general, and administrative expenses for 2026 were 6.7 million flat compared to the 2025. We continue to operate with 1 U.S. sales team covering both the hospital and office market opportunities and are focused on driving sales productivity and operating leverage. Net loss for 2026 was 8.6 million equating to a net loss of $0.09 per share. Compared to a net loss of 9.4 million or $0.12 per share in the 2025. The first quarter 26 net loss included a $200 thousand loss from a noncash change in the fair value of warrant liabilities.

Compared to a 1.6 million gain in the 2025. Net cash burn excluding financing in the 2026 was 8.8 million compared to $10.1 million in the 2025. An improvement of $1.3 million or approximately 13%. The first quarter is typically our highest cash burn quarter during the year, due to several annual onetime payments such as annual bonus and insurance. Reducing our cash burn remains a significant focus. And we will continue to prioritize spending discipline and improve operating leverage in 26. As of 03/31/2026, we had 40.8 million in cash and cash equivalents on our balance sheet. This cash balance is inclusive of the $15 million initial tranche under the up to $40 million long term debt facility put in place during the first quarter. In addition to the $15 million initial tranche, we have the option through the 2027 to access additional tranches totaling up to 25 million upon achievement of prescribed commercial targets.

Now turning to guidance. We are pleased to share that we are tracking well to achieve our financial outlook for the year. And we are reiterating those growth and margin plans today. We continue to expect revenue between 20 million and 22 million representing year over year growth at the midpoint of 55%. Our pipeline remains strong across our 3 business verticals, including several multiunit hospital and IDN opportunities, and the second half of 2026 launch of our next generation Swoop system in Europe. We continue to expect revenue to progressively strengthen through 2026. We continue to expect gross margin to be in the range of 50% to 55% for the year. We expect gross margin to improve over the course of the year as sales volumes increase and expect second half gross margin percentages to exceed the first half.

We remain optimistic that we can sustain gross margins above 50% as we execute on our growth initiatives. We continue to expect total cash burn to be in the range of 26 million to $28 million for the full year 2026. Representing a 10% year over year decline at the midpoint. This cash burn guidance includes our quarterly debt payments of approximately 400 thousand We will continue to be disciplined with our spending while investing in commercially oriented projects and initiatives. Lastly, we continue to see a healthy cash runway extending into 2028 reflecting the strength of our balance sheet and our continued focus on operating leverage and disciplined capital management. This cash runway expectation is inclusive of the $15 million initial tranche of debt financing but exclusive of the additional $25 million of growth capital available under that facility.

We remain committed to spending discipline while investing in our highest priority commercial clinical, and technology initiatives as we scale. We believe we are executing upon an important phase of growth, supported by a strengthened financial profile, and a commercial stage operating model. We are positioned as a derisked medical imaging platform with multiple durable growth catalysts across large, underserved sites of care. Supported by a compelling value proposition robust pricing, attractive gross margins and improving sales productivity and operating leverage. I will now turn the call back to Maria for closing comments.

Maria Sainz: Thank you, Brett. Before we open the call for your questions, I want to take a brief moment to reflect on our progress. It has been just under 1 year. Since we received FDA clearance for our next generation subsystem and Optive AI software. And in these 3 commercial quarters since, we have meaningfully improved our revenue and margin profile entered new markets, and continue to innovate. I am proud of what the team has accomplished, and we remain energized by the opportunity ahead as we expand access to brain MRI across hospital neurology offices, and international markets. With that, we are happy to open the call to your questions. Operator, Thank you. And we will now begin the question and answer session.

Q&A Session

Operator: If you would like to ask a question, please press 1 on your telephone keypad. To join the queue. If you would like to withdraw your question, simply press 1 again. Participants may ask 1 question and 1 follow-up during their turn and can just simply join the queue again after that. Thank you. If you are called upon to ask your question and are listening via loud speaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. And your first question comes from the line of Frank Takkinen from Lake Street Capital Markets. Please go ahead.

Analyst (Frank Takkinen): Hey. This is Nelson Cox on for Frank. Congrats on all the progress and for taking the questions. Maybe just starting with the IDNs and the multiunit ordering a bit more. Can you maybe talk a little bit more about the typical decision criteria and timelines you are seeing there? And how many of these IDN conversations are at that standardized standardization stage versus kind of the single site pilots. And then is there some assumption of in guidance of these single site pilots standardizing deeper in 2026? Or how are you yeah. How’s that?

Maria Sainz: Sure, Nelson. I will take a crack at it, and Brett can add any commentary. So again, remember, we have only had the next generation subsystem for 3 quarters. So our history with it and the idea and strategy is about 3 quarter deep. I can tell you there is an IDN that has moved from the first to multiple in 1 site to a second site and to a third site. The rest of the conversations are in the beginning of the first site doing the initial or initial placement. Before they go system wide. We have an appreciation of the process, which is slightly more involved than a single-hospital process in that there is either a regional or a divisional or a national sort of level of approvals and procurement steps. That need to be fulfilled.

And we expect that once we land the first systems, similar to what we have experienced already, it takes implementation plus probably 2-3 months worth of data before the rest of the sites that are interested are going to be moving forward with their own procurement processes. We do have visibility to multiple sites within an IDN, it is not that we need to start the selling process. But we are not gonna be able to start the procurement process for the additional sites within an IDN until the first 1 goes through that implementation and initial data collection for about, call it, 8 weeks or so by the time this data gets tabulated and shared across the IDN.

Analyst (Frank Takkinen): Okay. That is helpful. And then maybe on yeah.

Operator: I was going to comment on your question about the guidance and what is baked in there.

Brett Hale: So for our 2026 guidance, it reflects really as we mentioned in the last call, the 3 initiatives and growth vectors of the business. So the hospital, which includes the IDN, the office business, international, all of them are contributing towards the growth that we see in our 2026 guidance. I will highlight that, as Maria mentioned, given when we got clearance for the next generation system, we see the second half of the year being more lined up for budgetary cycles, especially for these IDN initiatives.

Analyst (Frank Takkinen): Okay. that is helpful. And then maybe on the office, can you help us think about the profile of your adopters there so far and maybe some encouraging signals you have seen? I know you mentioned the healthy pipeline across varying sizes, but maybe talk about what is resonating within the larger more specifically, and then whether that and how that pipeline and smaller practices maybe varies.

Maria Sainz: Sure. I will start with that as well, Nelson. So I think we said in the prepared remarks, we were predominantly placing second generation system in larger offices. Remember, the larger offices are usually grouped under an and their meeting annually is in the month of February. So we got some very good leads and interest out of that meeting that translated into deals in the first quarter. The neuro PMR data with the multiple sort of utility of the subsystem resonates very well because at the end of the day, the more utility they see across their patients, the easier it is to justify the investment and see the return on investment with bringing in this as an ancillary business ancillary activity to their practice.

By definition, a single practitioner practice has lower volume and often has either a little bit of specialization or a little bit of everything but has less resources. So I think over time, we are going to see that it is the larger offices that are going to have the volume that makes the investment attractive, the investment actually translate into an attractive return and an attractive additional business. Brett, I do not know if there is anything else you would like to add.

Brett Hale: No. I think you have covered it well.

Analyst (Frank Takkinen): Okay. I will stop there. Thank you, guys.

Maria Sainz: Sure. Thanks, Nelson.

Operator: Your next question comes from Yuan from B. Riley Securities. Please go ahead.

Analyst (Yuan Zhi): Well, thank you for taking our questions. Maria, can you comment on what you are hearing related to the helium shortage in The US? And whether that impacted your interruptions with potential customers recently.

Maria Sainz: Thank you, Yuan. So we remember, our system does not need any helium, and it is not something and to a certain extent, we always talk about our system being like in terms of maintenance requirements, both from a complexity as well as the cost So we make sure people understand that our system is helium free, So I know it has been in the news, but I have not really heard it very from any of our customers. We often hear our customers talk about some of their challenges with Highfield. So any customer that may have just 1 high field magnet, we often hear the pain point is that if they are either replacing it or it is down for maintenance. How our system comes in very handy in those times. But there has not been really much of a surge in the noise level around helium availability that I have heard. Brett, I do not know if you have anything else to add.

Brett Hale: No. I think you highlighted, I mean, being helium free, being able to be plugged into a standard wall outlet. Being portable, no shielding, siding, construction. All of those have been kind of elements that we have been highlighting throughout the years. Obviously, in the recent news flow about the helium shortages, that just kind of amplifies that. But it is been part of our overall, thesis as we talk to hospitals and sites. Got it.

Analyst (Yuan Zhi): Got it. I am learning from the recent use case from the recent stroke care seminar when your team sells swoop to a new customer, what are the key economics, the numbers that you want to highlight? Such as, you know, the ROIs, the backup options, or freeing up other cities. Those main characters that you want to highlight.

Maria Sainz: Sure. So I will start there. So starting with the stroke use case, the most important piece of data that and helps our potential customers understand how valuable this is the wait time in stroke suspected patients for an MRI. So there is a bit of a joke that we make around the spreadsheet, which is for these patients that came into an ED with symptoms of stroke, how many hours did it take you to be able to get them into the MRI? And, unfortunately, those numbers with high fill are ridiculously high, sometimes 60, sometimes 80, sometimes 40, hours. So the number 1 is okay. How much shorter can we make that? And that builds a very strong case. For the economics in the ED and the faster triage. That was also what the PRIME study wanted to do out of Yale, which is all comers in the ED, how much faster do you get a patient that MRI that is needed to understand why they are there.

We then add to that the use case and the value in the ICU, that is all about cost savings. So then we actually challenge people to run the numbers on how much they spend on tubing, pumps, MRI compatible things that they need to fit a patient so that they can safely go to a high field MRI. And the shortening of the time to MRI plus the savings on those MRI compatible supplies very quickly build up this case for a 1 to 1.5 year ROI that we have discussed. Even with our current MSRP of 590 thousand. Got it.

Analyst (Yuan Zhi): Yeah. that is very helpful. I will hop back in the queue.

Maria Sainz: Thank you. Thank you, Yuan.

Operator: And your next question comes from the line of Maria Tybalt from BTIG. Please go ahead.

Analyst: Good afternoon, Good afternoon, Brett and Maria, and congrats on the progress here. Wanted to ask quickly about contrast PMR. Really pleased to hear the progress with the trial there. Wanted to understand what you think the impacts of having that gadolinium contrast will be on adoption in the hospital and office channels? I guess another way of asking it is how often are purchases getting put off because a doctor says they want to wait for the contrast indication?

Maria Sainz: Great question, Maria. Thank you. So I would say I cannot think of any case in a hospital environment where the purchase has been put on hold awaiting contrast. I will definitely say there is a lot of excitement from both sites of care. The office and the hospital for the use because it is a substantial number of scans that they do with and without contrast. What I am most interested in, and I know we shared with you the recent webinar, there was a question to 1 of our top leaders and it was doctor Fabrizio from Jefferson Abington. And the question was, do you only use Swoop when the other is not available, or do you just use Swoop? And I think her answer was no. We just use it. So I want to drive to a point where they can trust this device to cover most of their cases.

And today, they have to do it off label if they wanna use contrast in the hospital environment. So it increases the utility With the increase of utility, it is going to make the multiple systems clearly more needed because sharing the systems is gonna be more challenging. And it is gonna be more a reflex from a workflow where there are fewer cases that they cannot do with our system. In the office, it clearly also has an economic element where I believe adding the contrast cases at a higher reimbursement rate, which is somewhere between 30% to 50% higher, will also change the economic sort of calculation as to how many cases they need to do for how long before these things turn into a green business for them. Does that make sense? It does. that is a great amount of detail.

I really appreciate it. I will use my follow-up here to try to dive in a little bit more into what you hinted at in terms of new sites of care in the hospital, things like the operating room and the Angio Suite. Are there new accessories, new sequences, new indications, anything that you are needing to be able to move into that, and any timelines, even very general might be helpful for us. Thanks so much for taking the question. Sure. Thank you, and thank you for asking because it is really exciting to see the surge in interest from surgeons. And interventionalists in the neuro space to bring the subsystem into their environment. We will see this year, publications and presentations of single cases and small case series from some of these pioneering sites that have already brought it in what I would call the immediate post procedure.

Imaging of the patients with significant benefit across a number of cases. We are assembling also an advisory group, and we would like to exit this year with a plan that really answers the first part of your question, which is exactly, is it all in the software? Is it probably is it in the coil, which is just a piece of the hardware, or does it take more? Think about sort of the cranial access If that needs to be happening while the patients are in the scanner, there may be some adjustment to the coil. that is only 1 component. So that is not quite an accessory. it is a modification of the hardware. But it is gonna be the result of the exposure of these initial cases case series, as well as the work we are gonna do with our initial advisers that will form really a plan for us by the end of this year.

And I think there are cases where the surgeon is already driving the decision in a hospital for that immediate save postoperative scanning in the OR If we want this to be more incremental, it is probably going to take us thinking about how there could be something on the either pre operative or intraoperative, and that definitely will take a little bit more work. And I will know more probably in the next couple of quarters. Very interesting. We look forward to hearing about it. Thanks so much. Thank you.

Operator: There are no further questions at this time. And I would now like to turn the call back over to Maria Sainz, for the closing remarks. Please go ahead Thanks, everyone, for joining us today.

Maria Sainz: We look forward to continuing to update you on our future progress, and have a great rest of your day.

Operator: Ladies and gentlemen, thank you all for joining, and that concludes today’s conference call. All participants may now disconnect. Thank you.