5/11/2023

speaker
Operator

that they have a little bit more run time before we start feeling really confident in how they're predicting quarters to come. There was not anything there that was one time. You know, we have those two orders that we continue to deliver a little bit every quarter, and that just continued on the same pattern. So it was strong from the U.S. It had a little bit of contribution from international, a little bit of contribution from Gates. I just want to make sure that we give our new leadership and sales professionals a little bit more runtime until we can be more confident about where we're going to land the plane at the end of the year.

speaker
spk03

That's fair. And a couple of follow-ups. One, the action PMR trial. How long do you think that'll take to enroll? What's the follow-up there? How long before we potentially see data?

speaker
Operator

Okay. It's a little hard to predict. We're doing this as we continue to also improve what I would call our offering on the stroke side. So our first order of business with that evaluation is to make sure that our latest software, which is going to be one more than the one that is commercially available, is able to detect as clinicians want the stroke in the acute settings. We have to do a little bit more work to shorten the time that it takes to gather those sequences. So we need to shorten the length of the sequences. So we will be continued on that development work and want to actually include faster sequences at some point in time also in the action PMR. There really is no follow-up to the study. All of it is really in the acute setting, the ability to really detect stroke and be able to get to a clinical decision about what is best for that patient in this evaluation. So no time to wait for follow-up data. but I want to be a little bit prudent that our enrollment may take a little longer as I want to make sure that we have the opportunity to put in the study the latest software, which is now embedded testing, but also faster sequences, which are currently in development and available later in the year.

speaker
spk03

That's fair. And just one more for me. You know, there are two Alzheimer's drugs that have shown positive data recently, and I think the reimbursement requires four MRIs per year. So I guess my question is, first, are you seeing increased interest in your technology because of that? And what are you doing to capitalize on that opportunity? Do you need to do an equivalent study with standard MRI? Do you need to partner with a company? I'd love to hear your thoughts on that. Thank you.

speaker
Operator

Excellent question. Thank you, Larry. It definitely is a phenomenal opportunity that has presented in front of us, and you are right. There is a Biogen drug that got conditional approval a few months ago, should get reimbursed, and infusions should start in the fall. And there are even more attractive therapies coming behind them, I believe, from Lilly for one, and I believe it is Roche, the third one. We have gotten ourselves deep in the debate that is right now in the clinical community. We have some current users of our system that believe that we can play a role in that initial triaging of those patients as they're monitored with multiple scans. The numbers sometimes are even higher than four a year. So we're working at the individual center level There is also an ASNR working group that has actually focused on this topic. They had a meeting last week, and big magnet people were there, and so were we. Learning how the field, from a clinical perspective, is not fully aligned as to whether an ultra-low field scanner is going to be as effective as a 1.5 or a 3T, but we are not watching the movie from a distance. We are right in the movie. We have started to try to reach out to the companies to see if there's an opportunity to partner. And last but not least, we are, at the company, working to really put together what I would call an Alzheimer's package that may include two things. One may be a package of sequences. As you know, we develop sequences separately, and then we also combine them into the protocols that allow people to use them for clinical conditions. So that would be one. The other one is that one of the clear trends where there is more alignment from the clinical community is that a lot of these scanners are going to be sort of used or read by physicians that are not necessarily your traditional rats or neural rats. They are going to be a little bit more in the hands of dementia clinic professionals, memory loss clinic professionals, geriatric physicians. So there is a number of software companies that are looking to standardize sort of trend reports, monitoring reports to really understand how these patients evolve over the course of subsequent diffusions or subsequent doses of the drug. So the short of it is hopefully I've given you a sense that we are big into everything that is happening. I don't know yet, and I can't quite paint the picture as to how big the opportunity is for us and how near term it is. But it's definitely something that we're going to push really hard to play a role in. And in a few months or short quarters, I hope I can give you more clarity as to the size of the opportunity and the timing of it.

speaker
Larry

Okay. Thank you so much.

speaker
Operator

Of course.

speaker
Larry

Thank you. One moment, please, for our next question. And our next question comes from the line of Vijay Kumar with Evercore ISI.

speaker
Vijay Kumar

Hi, this is Kevin Dunn for BHA. Just the one on gross margin, 43% in the quarter. Can you talk to the drivers behind that number? I know in the past you've pointed to price, volume, and cost as the overall driver, but how about from a device versus services perspective? Is there any color you can provide there? And is the about 50% device margin and about 20% service margin a good base to to follow and build upon as the year progresses? Thank you.

speaker
Operator

I think I'm going to let Brett address that. It was a little – your line was a little hard to understand, so I'll pass it over to Brett.

speaker
Brett

Yeah, I'll walk through this and clarify if I don't capture the full essence of the question, but I think the question was effectively on margin and the drivers and were there any subcomponents to that. So if you look from a progressive basis, we talked about the increase in ASP. If you go back to early 2022, we put new pricing in place that followed into the pricing we had in 2021. We put new pricing in place here in 2023. Really, most of the margin increase that we've seen sequentially and year over year is a real direct result of the pricing that we've been able to realize as a business. We do break out the margin or the device and the service components. That may vary over time, but really I think the vast majority of our revenue is coming from device. And you can think about the ASP playing a very heavy role in that. And then I think, you know, from a guidance margin, I think we've guided to the 40 to 50% range for the full year. So we landed kind of in the middle of that here for Q1.

speaker
Larry

Thank you. One moment, please, for our next question. And our next question comes from the line of Neil Chatterjee with B. Riley.

speaker
Neil Chatterjee

Hey, guys. Thanks for taking the question. I might have just missed this, but just quickly just on the sales funnel and installs for the quarter, I know there were some that slipped from fourth quarter. Do we say if any of those hit

speaker
Operator

in first quarter and what kind of expectations for those sorry um i'm not sure i got your question you were talking about whether things to sleep from q4 and and made it into q1 maybe repeat it sorry yes yes that and then if and if not like you know how that's tracking okay so there was Okay, there were some deals that took a little longer and didn't close in Q4 and ended up actually materializing in Q1. That's a little bit of the nature of the beast, which our deal flow is strong, but the deals do take long. We estimate an average of six months, but sometimes they end up taking longer through MR safety scrutiny or cyber scrutiny. I think overall the quarter was healthy. We also had, as you remember, the putting in place of the full sales team. So there was a little bit of a topic quarter in a way with territories with brand new people versus other territories open for a few weeks. So I overall feel that the results in Q1 We're very good, and I feel really good about the pipeline that I see. I don't see the deal taking shorter, but I do see a robust pipeline, and I'm encouraged that it is, as I've said before, well distributed across all of our U.S. territories, and in some cases, very positive green shoots from some of the newer reps that seem to have hit the ground running, although for the most part, we need to give them their six months really

speaker
Neil Chatterjee

get totally comfortable with the sales process implementation process customer knowledge customer acquisition and all of the different sub functions within their new role got it right um and again sorry i might admit this but on the on the gross margin guidance uh the 40 to 50 um just curious on the cadence you know how to think about that you know after this first quarter um Is that going to be sequentially stronger through the year or, you know, how do you think about that?

speaker
Brett

Yeah, I'll take that, Neil. This is Brett. So we talked about, I think, in our prepared remarks about a gradual increase in pricing throughout the year. And so I think you can think about, you know, margins kind of going along with that. With one thing that we've talked about, I think, previously, mix does have an impact in terms of any individual quarter. We have three different channels. We've got the U.S. direct commercial. We've got our international distributors. And then we have the units that are part of the KCL, King's College. So any individual quarter may, you know, have some variability based on, you know, mix. But the general trend of pricing we talked about being exponentially stronger and gradually increasing given the price increases that we've taken in the U.S.

speaker
Neil Chatterjee

Great. And then just one last one for me, just curious if there's any update. It's not like there was maybe some of the prepared, but just on the Viz AI partnership, is there any progress there?

speaker
Operator

We continue to make the progress that we expected. Again, we're gearing towards starting pilot evaluations in accounts with the sort of technology development, which has been around the integration of our images into the workflow. and making sure that they can actually use the VSAI platform to manage their patients with the use of our images. So I can't give you an exact timeframe as to when we will see it go live at the couple of accounts that have been identified, but that continues to move along well.

speaker
Neil Chatterjee

Great.

speaker
Larry

That's it for me. Thanks, guys.

speaker
Operator

Thank you.

speaker
Larry

Thank you. I would now like to hand the call back over to Hyperfine CEO Maria Sainz for any closing remarks.

speaker
Operator

Well, thank you very much for your interest in Hyperfine. I look forward to updating you again in a quarter. Talk to you soon.

speaker
Larry

Thank you. Ladies and gentlemen, this concludes today's conversation.

Disclaimer

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