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Operator: 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 Bych from Gilmartin Group for introductory disclosures.

Marissa Bych: 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 Web site 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 Factors section of our latest periodic filings 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.

Maria Sainz: 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 flow. Revenue performance was driven by sales of our Swoop portable imaging systems in both the US 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 US alone, we have a 6 billion plus total addressable market opportunity for placements in hospitals and office settings. Our expansion is enabled by our technical and clinical development as ever improving image quality and compelling clinical evidence are key catalyst for adoption of these new brain imaging technology. 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 marks 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 makes Swoop system 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 [indiscernible] [brief]. 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 tenth generation software will bring a step function image quality improvement over our recently launched ninth 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 tenth 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 is 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 MRI 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 selected over 150,000 images right now. We are continuously learning from this real world data from the Swoop system install base to enhance the product and especially our image quality. Specifically, we leveraged proprietary artificial intelligence to improve image reconstruction and processing.

Artificial intelligence is central to the process of image generation with the Swoop system. Upcoming versions of software will integrate new AI deep learning based techniques to further improve the Swoop system’s imaging pipeline across all sequence paths that is the T1, T2, FLAIR and decision weighted imaging. The integration of deep learning does not require any additional steps from the user and enhances of the image quality and consequently diagnostic value of the images generated at ultra-low field. The algorithms are designed to improve the image quality of our scanned output while reducing the impact of scanned 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 starting to detect ARIA complications in patients monitored with MRI as part of their amyloid targeting therapy as three LEQEMBI infusion programs. MRI is centered to the scientific and clinical dialog 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 an clinical trials in Alzheimer’s disease 2024 in Madrid, physicians from Washington University in St. Louis and Naas General Hospital presented very promising initial cases and data on ARIA-E detection in each group compared with conventional MRI scanners, as well as on the use of the Swoop systems 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 Swoop system presents a promising and cost effective alternative through the conventional 3 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 the 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 detections with a goal towards broadening and enabling monitoring of disease and screening of patients at multiple types of care.

In stroke, data from ACTION PMR continue to strengthen with the publication in Q3 of a subset of data from the study from MGH and University of Buffalo providing early evidence that the Swoop system is a promising tool for enabling critical stroke treatment choices in urgent care settings. The data that was published in the August 2024 addition of Annals of Neurology highlighted ultra-low field MRI’s ability to be used as a tissue clock 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 Swoop system to assess its performance in acute care stroke forecast 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 show that the Swoop system was [indiscernible] [dramatic] and faster and conventional MRI with a median [indiscernible] 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 and key opinion leaders planning studies to focus on the workflow benefits of using the Swoop systems in the emergency departments and clinics and anticipate this work to initiate in early 2025.

The workflow benefits associated with tiny and convenient access to MRI are real in both [stroke free] [indiscernible] 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 need 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 Swoop 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 Swoop systems 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 economy and convenience MRI access at the point of care, opening up a very exciting and transformative business for Swoop system [segment]. 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 verticals.

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 incremental site of care for the Swoop system, 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 Swoop system in the 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 Swoop 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 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 Swoop in stroke triage will drive placements in emergency departments. And our work in Alzheimer’s will drive additional Swoop system placements in hospital based clinics and in clinical centers.

These new sites 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 opportunities beyond the hospitals and will be a new focus area for us in 2025 and a strong contributor to growth in the second half of ’25 and beyond. I want to also emphasize that expansion into new sites 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, gross 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 team. I would now like to turn the call over to Brett to review our performance in the quarter.

Brett Hale: Thank you, Maria. Turning to our financial results for the third quarter of 2024. Revenue for the quarter ended September 30, 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 expanded 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 for 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 gross 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 30, 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 million to $14.5 million, representing approximately 30% year-over-year growth. For the full year 2024, we are also updating our gross 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% gross margin comfortably and sustainably as we realize the commercial acceleration from our growth catalysts. Regarding cash burn, we now anticipate total cash burn to be $37 million 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, gross 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.

Maria Sainz: 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.

Operator: [Operator Instructions] Your first question comes from the line of Larry Biegelsen with Wells Fargo.

Unidentified Analyst: This is Simran on for Larry. Congrats on a great quarter. 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 just following is there any color you can provide on US or in OUS split as well as any greenfield same store sales?

Maria Sainz: 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 placements. As you saw, there’s a slight improvement in ASP associated with the strength of the mix. So 13 is the answer to your question, Simran.

Unidentified Analyst: 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?

Maria Sainz: 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. So we get access to donor funds. There’s different mechanisms outside of the traditional capital budgets that end up funding the purchase of our system. So we don’t really have that favorable seasonality that other capital equipment sees. And when we look at this quarter, it’s actually a 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. 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 breadth of the capital budget.

Brett Hale: 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 on balance when we look at the full year, the $14 million 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.

Unidentified Analyst: And just one last one if I can squeeze in here, on the new software launch in the US. I saw that you guys have moved the full rollout in July. When do you expect all of the US system to add the latest upgrade? And can you talk about the impact you are seeing to the funnel as well as adoption?

Maria Sainz: 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 a 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 to patient is in the scan and making sure that there is less motion. So we closely track the number of the initial accounts where we release to get us much soft of inside info before we train the full sales force 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 the 2025 and that’s the tenth generation of software. And I have to say the team has done a fantastic job really taking these learnings, 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.

Unidentified Analyst: Just to clarify, you expect a limited launch of the tenth generation in the first half?

Maria Sainz: 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.

Operator: Your next question comes from the line of Yuan Zhi with B. Riley.

Yuan Zhi: Congrats on this quarter’s performance. Since you just attended AIC and CTAD, I’m curious if there is any perception difference between the US based doctors and EU based doctors on the criteria to initial treatment for Alzheimer’s, and then any difference on their perception on the MRI scan in follow-up scanning?

Maria Sainz: Great question, Yuan, and I actually was there at the CTAD 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 requirements 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 ATPs, 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 US. 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 US meetings. This is a meeting that is a little unique in that there is no booths and stand. So the session all happened in one big conference room and then there is the poster walk-through 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 ATPs 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 that systems work. Hopefully, that addresses your question.

Yuan Zhi: And maybe another question on the EU expansion [indiscernible] your 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 rather they are reimbursed at similar rate as US?

Maria Sainz: I think there is — there are differences. So clearly, the density of MRI per capita is very different even across European countries. Their 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 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’ve recently focused in Europe, and they believe the data is incredibly — the images are incredibly good and diagnostic quality.

Just the 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 they — their care delivery across both the stroke, emergency, medicine and neurodegenerative is a little bit different, there is higher appreciation of the value of our technology as it is today, because this is everything they’ve been exposed to.

Operator: 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.

Maria Sainz: 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.

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