Hyperfine, Inc.

Good afternoon, and welcome to Hyperfine's third quarter 2024 earnings conference call. Currently, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Marissa Beisch from Gilmartin Group for introductory disclosures.

Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ended September 30, 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 to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factor 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, November 12, 2024. 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. We delivered another strong quarter with revenue of $3.6 million, representing 56% year-over-year growth, over 270 basis points of sequential gross margin expansion, and continued reduction in cash growth. Revenue performance was driven by sales of our suitable imaging systems in both the U.S. and international markets. International contributions to revenue were healthy in the third quarter, and we did not experience the extent of seasonality that we had anticipated. Our growth going forward will be driven by expansion into multiple new sites of care and international geography. In the U.S. alone, we have a $6 billion-plus total addressable market opportunity for placements in hospital and office settings. Our expansion is enabled by our technical and clinical developments as ever-improving image quality and compelling clinical evidence are key catalysts for adoption of these new brain imaging technologies. An important development in the third quarter was the progress made on our commitment to further improve image quality to enable faster adoption of our technology. Early in the quarter, we received FDA clearance of our ninth-generation AI-powered software. This approval marked an important step forward in the imaging capability of our unique ultra-low-field portable brain MRI reducing acquisition times without compromising image quality, delivering higher overall clinical performance. Shorter scan times make subsystem images especially useful in time-sensitive medical settings, such as the ICU dealing with critically ill patients with unstable intracranial pressure, as well as emergency departments for the triage of stroke.

where time is bright.

Keeping with our steady pace of innovation, we plan to obtain clearance and launch our next generation AI-powered software in the first half of 2025. This 10th generation software will bring a step function image quality improvement over our recently launched 9th generation software. Feedback from key opinion leaders involved in our image development process is extremely positive. And their assessment is that the images from our 10th generation AI powered software are more like those obtained from conventional 1.5 Tesla MRI systems. This feedback demonstrates that our work to develop excellent decision enabling image quality through AI powered software releases It's paying off well. Not only will our next update benefit our existing customer base, but most importantly, it will also make adoption of ultra-low-field brain MRIs a faster process for new users, enabling a shorter learning curve for radiologists and accelerating market update of our technology. As the first portable ultra-low-field MRI for the brain, our device has collected over 150,000 images by now. We are continuously learning from this real-world data from the subsystem installed base to enhance the product and especially our image quality. Specifically, we leverage proprietary artificial intelligence to improve image reconstruction and processing. Artificial intelligence is central to the process of image generation with the subsystem. Upcoming versions of software will integrate new AI deep learning-based techniques to further improve the subsystem's imaging pipeline across all sequence types, that is, the T1, T2, glare, and diffusion-weighted imaging. The integration of deep learning does not require any additional steps from the user and enhances the image quality and consequently diagnostic value of the images generated at ultra-low fields. The algorithms are designed to improve the image quality of our scan output while reducing the impact of scan artifacts. The images created with these algorithms are validated by expert radiologists. As we move forward, we are continuously investing in improving our AI-driven image quality through each imaging-focused software release. I will now provide an update on our clinical studies. The CARE PMR study is progressing well. We are scanning to detect area complications in patients monitored with MRI as part of their amyloid targeting therapy. at three can-be inclusion programs. MRI is centered to the scientific and clinical dialogue regarding amyloid targeting therapy and to the expansion of screening, diagnosis, and treatment of the Alzheimer's disease. Workload challenges are recognized broadly as the field aims to increase access, convenience, and equity in Alzheimer's care. The impact of our technology for the treatment of Alzheimer's is real. At three major Alzheimer's meetings in the last three months, starting with the Alzheimer's Association International Conference this summer, and most recently, at the Clinical Trials in Alzheimer's Disease 2024 in Madrid, physicians from Washington University in St. Louis and Mass General Hospital presented very promising initial cases and data on ARIA-E detection with SOOP compared with conventional MRI scans, as well as on the use of the SOOP system for monitoring the progression of Alzheimer's. The most recent presentation at the Clinical Trials in Alzheimer's Disease Meeting included images of multiple ARIA-E cases and concluded that the soup system presents a promising and cost-effective alternative to the conventional free Tesla MRI with the added advantage of workflow optimization, and that this study highlights the potential of innovative imaging technologies to advance patient care and monitor neurodegenerative conditions. There are very significant workflow benefits bringing brain imaging closer to patients with Alzheimer's disease and their clinicians, with a potential to substantially impact access, cost, and equity in Alzheimer's care. Guided by key opinion leaders in this field, we have also started to explore other Alzheimer's applications besides ARIA-E detection, with a goal towards broadening and enabling monitoring of disease and screening of patients at multiple sites of care. In stroke, data from Action PMR continue to strengthen with the publication in Q3 of a subset of data from a study from MGH and University of Buffalo, providing early evidence that the soup system is a promising tool for enabling critical stroke treatment choices in urgent care settings. The data that was published in the August 2024 edition of Annals of Neurology highlighted ultra-low field MRIs' ability to be used as a tissue cloth to characterize acute stroke. In September 2024, data from a study from the University of Glasgow was presented at the European Society of the Neuroradiology Meeting. The study analyzed images from the SUP system to assess its performance in acute care probe workup compared to the current standard of care. They analyzed time to scan, diagnostic performance, specificity, and patient experience comparing ultra-low-field MRI, conventional MRI, and CT. Key findings showed that the SUP system was dramatically faster than conventional MRI with a median 90 scan of 2.5 hours compared to 27.7 hours. The data also demonstrated reliability in acute stroke diagnosis with comparable diagnostic performance of head CT and high specificity when compared to routine clinical MRI, i.e. 1.5 Tesla. We are collaborating with neurosurgeons and interventional stroke key opinion leaders planning studies to focus on the workflow benefits of using the soup system in the emergency departments and clinics and anticipate this work to initiate in early 2025. The workflow benefits associated with timely and convenient access to MRI are real in both growth triage and the management of patients with Alzheimer's disease. We have a highly differentiated opportunity to improve care pathways for both patient populations, which represent very large areas of unmet clinical needs globally. As a reminder, our studies aim to support the adoption of our innovative portable MRI system in different sites of care for multiple clinical applications. Our system has been cleared by the FDA for broadly scanning brains of patients of all ages, and the work we are doing in stroke and Alzheimer's is already covered by our existing indications for use. Further expansion will come from our plan to make the soup system available beyond the hospital setting and in the neurology office setting. By the end of 2024, we expect the Intersocietal Accreditation Commission, IAC, a leading CMS-approved accreditation body, to issue updated MRI standards that include the use of portable point-of-care ultra-low-field brain MRI. Offices can then pursue accreditation through IAC, and once completed, exams with subsystems in those offices will be eligible to be covered by CMS. This will bring us one step closer to having physicians obtain diagnostic quality MR brain images within their offices, providing patients with timely and convenient MRI access at the point of care, opening up a very exciting and transformative business for subsystem placement. We have taken steps to enhance our commercial capabilities to serve this new market with a comprehensive strategy, including the addition of a dedicated member of our executive team focused on these new business protocols. We already see strong early organic interest from the office setting for a portable MRI for several clinical use cases, including Alzheimer's disease. The neurology office is an instrumental site of care for the subsystem which we anticipate contributing to growth starting in the second half of 2025. Last, regarding growth drivers, we continue to make progress internationally with the expansion of our distribution network to commercialize our subsystem in European markets and have just obtained CE approval of our latest generation software. With CE approval of our ninth generation software and a broad distribution network in place covering all the major markets, we're well positioned for European commercial expansion going into 2025. At the recent European Society of Neuroradiology conference, we had the opportunity to witness firsthand the enthusiasm and positive feedback from European clinicians towards the utility and value of our soup system. 2025 will be a full year with our international distribution network in place, as well as our anticipated regulatory approval in India in the second half of the year. We have great momentum across all of our initiatives. I want to wrap my remarks by summarizing our plan to drive business acceleration and growth in 2025 and beyond. The use of soup in stroke triage will drive placement in emergency departments. And our work in Alzheimer's will drive additional soup system placement in hospital-based clinics and infusion centers. These new types of outpatient care will be incremental to our critical care business and will start contributing to the growth of our hospital business in the second half of 2025. Further, our strategy to expand into neurology offices provides a compelling incremental business opportunity beyond the hospital that will be a new focus area for us in 2025 and a strong contributor to growth in the second half of 2025 and beyond. I want to also emphasize that expansion into new types of care is supported by technology enhancements and clinical evidence. I am very pleased with the progress on technology and clinical evidence, and we will continue to drive those efforts with efficient allocation of capital and strong execution. We are in a strong place as a company. We delivered another solid quarter of revenue growth, growth margin expansion, and cash burn management, illustrating strong execution across the company. We're on the doorstep of a step-function improvement in image quality to drive faster adoption of our technology, which coupled with the expansion into multiple new sites of care and international markets, provides 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 teams. I would now like to turn the call over to Brett to review our performance in the quarter.

Thank you, Maria. Turning to our financial results for the third quarter of 2024. Revenue for the quarter ended September 30th, 2024 was 3.6 million, up 56% compared to the third quarter of 2023. Year to date, we've generated 10.6 million in revenue, up 27% from the first nine months of 2023. Gross profit for the third quarter of 2024 was $1.9 million compared to $1.1 million in the third quarter of 2023, resulting in a record gross margin of 52%, and our second straight quarter of gross margin percentage of 50% and above. Year-to-date, we've generated $5.1 million in gross profit, up 36% from the first nine months of 2023, and year-to-date gross margin is 48%. representing over 330 basis points of gross margin expansion from the first nine months of 2023. R&D expenses for the third quarter of 2024 were 5.9 million compared to 5.7 million in the third quarter of 2023. Sales, general, and administrative expenses for the third quarter of 2024 were 7 million compared to 7.1 million in the third quarter of 2023. Net loss of the third quarter was $10.3 million, equating to a net loss of $0.14 per share, as compared to a net loss of $10.8 million or a net loss of $0.15 per share for the same period of the prior year. The improvement in net loss was a result of our strong revenue, expanding growth margin, and the spending discipline and cost-saving initiatives we have implemented across the business over the past year. Our cash burn for the third quarter of 2024 was 8.9 million, and as of September 30th, 2024, we have 45.8 million in cash and cash equivalents on our balance sheet. Year to date, our cash burn of 30.2 million is down 6% compared to 32 million for the first nine months of 2023. Turning to guidance. We are narrowing our revenue outlook for the full year 2024 to a range of 14 to 14.5 million, representing approximately 30% year-over-year growth. For the full year 2024, we are also updating our growth margin to 47 to 50%, which represents the high end of the previous range. We continue to drive healthy margins at our stage and believe this positions the company well for additional margin expansion at scale. We remain optimistic that we will surpass 50% growth margins comfortably and sustainably as we realize the commercial accelerations from our growth catalyst. Regarding cash burn, we now anticipate total cash burn to be 37 to 40 million for the full year 2024. We continue to see our cash burn decrease and operating leverage increase, providing us a cash runway for the business in the early 2026 funding the commercial realization of the growth catalyst Maria mentioned previously. We expect to continue to deliver steady progress of revenue growth, growth margin expansion, and cash burn reduction ahead of our growth catalyst that will drive business acceleration in the second half of 2025. At this point, I'd like to turn the call back to Maria for closing comments.

Thank you, Brett. The team made great progress in the third quarter, driving technical and clinical development to drive site of care expansion, all while delivering a strong quarter financially. With line of sight to several meaningful revenue catalysts in 2025, I have never been more optimistic about the business. With that, I want to thank you all for your time and open up the line for questions.

In order to ask a question at this time, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Larry Beagleson with Wells Fargo. Please go ahead.

Hi, good afternoon. This is Emma Renaud for Larry. Congrats on a great quarter and thank you for taking the questions here. Maybe just starting off on capital trends in the quarter. I don't think I heard in your prepared remarks how many capital placements there were. And, you know, just following there, any color you can provide on U.S. and OUS splits, as well as any greenfields and same-store sales.

Sure. And good afternoon. You didn't hear because we didn't mention it, but we actually placed 13 systems and it was a strong balance between US and OUS placement. As you saw, there's a slight improvement in ASB associated with the strength of the mix. So 13 is the answer to your question, Simran.

Got it. Very helpful. And maybe just On guidance, guidance at the midpoint implies flattish sequential sales in Q4, which is typically your strongest capital quarter. I guess given all of the momentum you're seeing, why wouldn't you see an acceleration into the quarter and maybe just talk about what gets you to the low and the high end of the range?

Sure, I'll address it and maybe Brett, if you want to add anything else. I think for all intents and purposes, maybe let's start by reminding you, we don't really get funded for the placements of our systems by the traditional capital budget. So there's not usually that rush to use the budget or lose it at the end of the year. Often we actually get access to strategic funds or we get access to donor funds. There's different mechanisms outside of the traditional capital budget that end up funding the purchase of our systems. So we don't really have that favorable seasonality that other capital equipment sees. And when we look at this quarter, it's actually slightly shorter in terms of selling days for us in getting all the deal specifics lined up. We feel really strong about the quarter. We think it will be another strong quarter. We've been on quite a nice streak of strength of the quarters, and at the midpoint roughly we're still talking about 30% year-on-year growth, and we see Q4 as a solid quarter to wrap up the year, but we don't see any of that special seasonality that is sometimes associated with folks that are relying on the final breaths of the capital budget.

Yeah, I would add in Q3, we didn't see the seasonality that we had talked about in the prior earnings call. One or two deals actually closed ahead of schedule. So in balance, when we look at the full year, the $14 to $14.5 million of revenue range, as Maria indicated, we feel very good about that, 30%, roughly year-over-year growth at the midpoint.

Got it. Very helpful. And just one last one, if I can squeeze in here. On the new software launch, in the US, you know, I saw that you guys have moved to full rollout in July. When do you expect all of the US system to have the latest upgrade? And can you talk about the impact you are seeing to the funnel as well as adoption? Sure.

So we have been progressively rolling it out. I would say we have a very large number of accounts and we prioritize appropriately to the bigger users. So we see the rollout going as expected. Probably the majority of the accounts will be done clearly as we wrap up this year. This software, as you know, has the benefit of having no image quality compromise, but a significant gain in the time it takes to acquire the images, and that has been incredibly well received. We have received a lot of very positive feedback on that as it relates to just also managing the time the patient is in the scan and making sure that there is less motion. So we closely tracked a number of the initial accounts where we released to get as much sort of insight info before we trained the full Salesforce and started the broader rollout. So that process went really well with a very good understanding of the value proposition. I think what I'm most excited, Simran, since you're talking about software, is what we're working on now, which would be real in the first half of 2025. And that's the 10th generation of software. And I have to say the team has done a fantastic job really taking our deep learning techniques and our AI techniques up a very significant level. And we're getting to image resolution and images that look quite close to what a 1.5 Tesla system is, which to me is really not just a one more software version, but really a departure in a very positive way towards a significant sort of level of familiarity with the images that is going to make adoption faster as the radiologists are going to get a lot more comfortable with reading the scans, the exams, the images than maybe in our earlier days of the technology.

Got it, Maria. Very helpful. Just to clarify, you expect a limited launch of the 10th generation in the first half?

I expect that we would get clearance, and if it is as good as we believe it is from our R&D work and the early validation and the early images, we'll probably go quite quickly into a rollout in the first half.

Got it. Thank you guys so much. Sure. Thank you. Thanks for your question.

Your next question comes from the line of Yuan Ji with B Reilly. Please go ahead.

Congrats on this quarter's performance. Since you just attended AEIC and CTAP, I'm curious if there's any perception difference between the U.S.-based doctors and EU-based doctors on the criteria to initiate treatment for Alzheimer's and then any difference on their perception on the MRI scans in follow-up scanning?

Great question, Yuan, and I actually was there at the CPAD myself, so I can report firsthand. I want to say there's a lot of similarities in the fact that everyone agrees that the bottleneck is this MRI monitoring requirement and how inconvenient that is to the patient workflow, to how burdensome it is. to the care partners and the patients themselves. And a lot of people that are starting programs are already talking about the challenge of really orchestrating all of the different appointments. So I would say that's a global theme. The European community is a little bit up in arms in the fact that their regulators have actually been a lot more conservative. And as you know, there is no CE approval for any of the ATTs and the UK approval came with a more restricted labeling than the US approval. So there is a lot of enthusiasm and optimism that the regulators will see the light. I think the UK approval was really a beam of bright light in the fact that the world will actually in Europe catch up quickly to the U.S. I think I have to say that our poster was up for three full days, and the traffic and the level of interest was significantly higher than I've ever anticipated in some of the U.S. meetings. This is a meeting that is a little unique in that there is no booths and stands, so the sessions all happen in one big conference room, and then there is the poster walkthrough. for all of the interactions but we had a lot of people actually come by and they were not only from clinical sites but also from a lot of the pharmaceutical companies that are either commercializing today or developing any of the ATTs or the future therapies and really for us it was a great understanding also on how Alzheimer's care is organized which is quite different in Europe than it is here given the social medicine sort of environment there. So probably a little easier to penetrate with more structure in the way the systems work. Hopefully that addresses your question.

Yeah, thanks for the helpful comment there. That's great to hear. Maybe another question on the EU expansion. Great to see you. a quarterly performance there as well. You mentioned the workflow issues. I'm wondering, is the demand of MRI the same between the EU and the US that they have this capacity issue and whether they are reimbursed at a similar rate as US?

That is a great question. I think there is There are differences, so clearly the density of MRIs per capita is very different, even across European countries. The issue of the wait list in the UK is quite unique to the NHS system, so that's more UK than the rest of Europe. And reimbursement is in the hospital environment, very often covered under a DRG equivalent. kind of reimbursement, but that also may vary by country. I think what we see with our system is, as you know, we just got approval of our ninth generation software. The European clinicians have only really had exposure to the eighth, ninth generation software for all intents and purposes since we recently focused on Europe, and they believe the data is incredibly valuable. the images are incredibly good and diagnostic quality. Just a month before CTAD, we were at the European Society of Neuroradiology and actually Glasgow presented stroke data there with incredible value assessment around the time to scan advantages of using our system and the fact that this was head above, a head CT, no pun intended, in terms of the triage of stroke. So I think their care delivery across both the stroke, emergency, medicine, and neurodegenerative is a little bit different. There's higher appreciation of the value of our technology as it is today because this is everything they've been exposed to.

Got it. Yes, this is very helpful. That's all from us. Okay, thank you.

There are no further questions at this time. I will now turn the call back over to Maria Sainz, President and CEO, for closing remarks.

Well, thank you very much, all of you, for listening in today and for your questions, and we look forward to further updates throughout the quarter and then at the end of Q4. Thank you very much.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.