Good afternoon. Welcome to Hyperfine Second Quarter 2023 Earnings Conference Call. Currently, all participants on a 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.

Great. Thank you for joining today's call. Earlier today, Hyperfine Inc released financial results for the quarter ended June 30, 2023. 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 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 opportunities, 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 that is accurate only as of the live broadcast today, August 14, 2023. 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. And with that, I will turn the call over to Maria Sainz, President and Chief Executive Officer.

Good afternoon, and thank you all for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. Since late last year, we have realized the benefits of our strategic financial initiatives, and the organization has delivered a meaningfully improved financial profile. We have nearly doubled our revenue on a year-over-year basis, demonstrated strong growth and healthy gross margin progression and dramatically reduced our spending and net cash burn while continuing to invest in our core value drivers. I am very proud of the execution of the team and the resulting transformation of the financial profile and prospects for our business. In the second quarter, we made substantial progress on our mission, achieving record revenue of $3.4 million with the sale of 14 commercial Swoop System. Our performance was driven by strong international marketplace and commercial activity in part through our collaboration with King's College of London, where we continue to strengthen our team and commercial pipeline in the U.S. During the second quarter, we also drove meaningful progress against our 3 strategic pillars: innovation, clinical evidence and commercial expansion. On innovation, we are continuing development efforts across all elements of the Swoop System. This includes significant investments in hardware and AI-driven software to further advance the image quality and clinical utility of ultra low-field MRI. We have dedicated programs and product teams across these areas, and we are pleased with the strong cadence of system improvements our team has implemented year-to-date. As part of these improvements, we have been upgrading our proprietary AI and deep learning algorithms, which are central to the process of image generation with the Swoop System and are adding significant value to the utility of our platform. The Swoop System integrates deep learning, a form of artificial…

Thank you, Maria. Turning to our financial results for the second quarter 2023. Revenue for the quarter ended June 30, 2023, was $3.4 million compared to $1.5 million in the second quarter of 2022. Gross profit for the second quarter of 2023 was $1.4 million compared to negative $0.2 million in the second quarter of 2022 and reflecting a 43% gross margin. R&D expenses for the second quarter of 2023 were $5.3 million compared to $7.3 million in the second quarter of 2022. Sales, general and administrative expenses for the second quarter of 2023 were $7.8 million compared to $15.7 million in the second quarter of 2022. The Net loss for the second quarter was $10.6 million, equating to a net loss of $0.15 per share as compared to a net loss of $23.1 million or a net loss of $0.33 per share for the same period of the prior year. Our cash burn in the second quarter was $10.1 million, and we ended the second quarter of 2023 with $93.9 million in cash and cash equivalents. Turning to our 2023 outlook. We are opting to maintain our full year expectation for $10 million to $14 million in revenue. Our approach to guidance incorporates our progress as we build and lead this new market for point-of-care MR imaging and sell systems into a new cycle for customers. We know our clinical value proposition with customers is strong, and we remain confident in steady price improvement in the back half of the year and going forward. For the year, we continue to expect gross margins to be approximately 40% to 50% as we began recognizing scale and average Swoop System pricing moves gradually higher. And lastly, we are maintaining expectations for a total cash burn of $40 million to $45 million for the full year 2023. This incorporates an expectation for continued investment in R&D and substantially streamlined investments in SG&A versus history, while we maintain customer-facing resources to continue to drive adoption and growth. In line with this, we've allocated a greater relative portion of OpEx spending to R&D in 2023 versus 2022. With R&D spending projected to be approximately 40% to 50% of total OpEx dollars this year. We will continue to focus on our 3 strategic pillars and maintain spending discipline. We are excited about the momentum we are building for the remainder of the year and beyond, and we are pleased to have the cash and flexibility to invest in the right areas for continued Swoop system adoption. At this point, I'd like to turn the call back to Maria for closing comments.

Thank you, Brett. I'm proud of the progress the Hyperfine team has made in recent months, and I am very optimistic as to what this team can deliver. Before closing, and on the note of our team, I would like to celebrate a recent change within our leadership structure. Specifically, the promotion of Tom Teisseyre, formerly our Chief Product Officer to Chief Operating Officer. In this expanded role, Dr. Teisseyre, we now oversee provide dine-in development, clinical science, operations, cybersecurity and technical service. In his 2 years with the company, Tom has overseen substantial improvement in image quality through multiple and frequent AI power software releases and the development of a robust product road map of future air-powered software and hardware products. This contribution spend strategy to operational execution and have set a high bar of excellence. We look forward to the many achievements his ongoing leadership wire. With that, I want to thank you for your time and open the line for questions. .

[Operator Instructions] Our first question will come from the line of Larry Biegelsen from Wells Fargo.

This is Charles on for Larry. First, congrats on a nice quarter. I wanted to ask about your second half expectations here. So you had $6 million in the first half, and you maintained your guide which implies about $6 million at the midpoint in the second half, which is essentially flat. I mean, what assumptions are kind of baked into this? Is this conservatism? Or are there any particular headwinds? Or I mean, maybe the if the King's College orders fulfilled already or maybe there's seasonality in the second half, you could talk about that would, I mean, cause it to be other flat or just not improve over the first half sales? And then I have a quick follow-up.

Sure. So let me start with some comments, and I'll let Brett add on to this. So we have chosen to be prudent with our guidance. We continue to see nice momentum in how we're building really the U.S. pipeline, and we believe the U.S. will we definitely drive a lot of our success in the second half now that we have completed all of the shipments in the King's College London, which was funded with the second ground from Bill and Melinda Gates. There is always a little bit of summer potential variability or even seasonality. We're not seeing something too dramatic, but again, couldn't point at least account for some of that could still happen in the next few weeks. But again, the momentum is strong. The momentum around pricing as we've messaged, continues to be strong, and we expect that pricing will continue to improve through the second half of the year. And as we've made some changes to our field force in the U.S., we also expect that, that will continue to pay dividends as our team gathers more seasoning and more experience in the field. The one thing I would like to remind, and I think it was there from our opening remarks is that we are building a new market we're not just competing in an existing market. And that is a big undertaking that comes with some variability and some sort of to edit. So that has driven us to be prudent in the way we are reiterating guidance, Brett feel free to add any other commentary.

No. Thanks, Maria. I think yes, I would echo those comments that we're building a new market and given new markets and some variability, we wanted to maintain a prudent approach to our outlook. .

And then 1 quick follow-up on what if you might be able to give early thoughts on 2023. I know it's far too early for a formal guidance, but maybe if you might be able to quick talk at a high level about potential tailwinds or headwinds you might see -- might expect to see in 2023, including like the software upgrade pricing and the changes you made to the field force, things like that. How to think about the next year?

Okay. So I assume you meant '24.

24, sorry. Yes.

Definitely it's too early. But as I think about what we're doing in terms of investing in the 3 pillars that are drivers of our business. So innovation and clinical evidence and commercial expansion, more time should only allow us to continue to make greater progress. Again, the pricing trend is favorable and gets a little bit better every quarter. We will have by early 2024, yet a new version of our software and we have other programs as we said, it will be later this year that we give you all more visibility to our product road map for 2024. But as we mentioned on all of the clinical studies that we are funding and supporting and being involved in, we will see the data from the saved MRI MO at the very end of this year, which is an important study for the work we're doing in critical care. We're going to see the publication and the presentation of the data from the HOPE PMR, which supports a pediatric use through the balance of this year, along with the 3 things that, that study was hoping to achieve, which was demonstrating the safety of using our system with a variety of different kinds of funds, the ability of our system to allow clinicians to access ventricular volume changes. And last but not least, the ability to use our system in a variety of settings to test the suns anywhere from hospitalized kids to just emergency department visit. So all this data we meeting 2024, I think will be coming out in the fourth quarter for all intents and purposes. We see more traction from ACTION PMR. So I don't foresee the headwinds I foresee more tailwinds, but it's probably too early to be any more precise than that.

Our next question will come from the line of Neil Chatterji from B. Riley. Your line is open.

Maybe just first, any color you could provide just kind of on the makeup of the kind of the 14 orders in the quarter maybe as far as like institution type or any of that came from the BJC or King agreements? And then also any update on expectations for the sales funnel in the back half, including on Kings and BJC.

Including sorry, say that again, Neil, I didn't catch.

King and BJC. Sure. So we're not going to provide the geographic split of support in orders. We only don't do that. So no different this time. Fair to say that the second quarter was dominated by international shipments. We have said publicly that we have completed now all of the shipments in the King's College 2022 order. So that should not really factor into anything in the second half. And that is now completed. We had a busy Q2 on international as we were deep with Bill and Melinda Gates negotiating the third grant. We also had IS MRM and again, completed the shipments of the outstanding devices on that team's college order. So it's fair to say that the second half, we have more U.S. than international. And that's going to be also a result of some of the changes that we have made and the hiring of new and different kinds of people to accomplish these 3 different things we need to do commercially in the U.S. and then gaining more experience and with that actually accelerating and broadening the pipeline of deals, which we're starting to see as we are moving here even through the weeks of the third quarter. Brett, anything I have missed?

No, I think that summarizes well.

And then maybe just if you could maybe just talk about the progress you've seen kind of on the software improvement side, maybe elaborate on kind of the AI and deep learning development and then anything high level you could potentially share on what that software update in early '24 could address?

Sure. So we feel really good about the feedback we're getting from the latest that is now in the field, which we've rolled out to sites in the March, April time frame. We see that primarily around the DWI sequence. As we think about how we're driving software in the future, we really have some levers to pull. We have the actual team that develop sequences. We also have a software team and very, very parting to all of that effort is an AI team. We're also, I believe, doing more around being collaborative with the outside world on sequence optimization through some of the research collaborations we have. So I'd like to think that we're moving from just finish quality improvement, Neil, to something that I've chosen to label image performance. Because we're incorporating not only quality but really how AI and this learning enhances the images and the ability for the images to inform decision-making at the clinical level. And in some cases, it's not just about the quality of the images, but also the time to cross. So we know on the acute stroke side, the time to generate images is going to be important, and we are very conscious of that, and we are also turning our development efforts not only on just better quality but we feel we have that quality that is to buy but producing the same quality images at a fraction of the time that it takes right now. We are funding, and I think it was in our prepared remarks as well, a number of feasibility efforts around images that we don't have right now in our portfolio, and that will probably take a little bit longer than just the next revision of image performance, which we focused primarily on DWI, but the feasibility work will start bearing through later in '24 and into '25 around some things that will continue to position us well to broaden our use cases. And some of those are around all timers, but there are other areas as well.

And I'm not showing anything -- any further questions in the queue. I'd like to turn the conference back over to Maria Sainz for any closing remarks.

I just want to close off by thanking you all for your interest in Hyperfine and look forward to updating you in another quarter. Thank you very much.

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.