Perimeter Medical Imaging AI, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Perimeter Medical 2024 Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, March 26, 2025. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Thank you. Please go ahead.

Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include four linking statements within the meeting of applicable securities laws. These may include statements regarding the future financial position, business strategy and strategic goals, commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, the potential benefits of our products, including perimeter S-series OCT, perimeter B-series OCT, and perimeter image assist, perimeter's ability to broaden its user base and expected approval of its proprietary AI, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our public filings and press releases, which are posted on CDER+. Our results may differ materially from those projected on today's call. No forward-looking statement can be guaranteed. Perimeter undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than is required by law. For the benefit of those who are new to the Perimeter story, I would like to take a moment to summarize our business. We are a medical technology company working to transform cancer surgery with ultra-high resolution real-time advanced imaging tools to address areas of high unmet medical need. We are currently commercializing our FDA-cleared perimeter S-series OCT system, which provides real-time cross-sectional visualization of excised tissues at the cellular level. Our breakthrough device-designated investigational perimeter B-series OCT system, which combines our proprietary image-assist artificial intelligence technology with wide-field optical coherence tomography, represents our next-generation device. As we will discuss in more detail today, B-series OCT with image-assist AI 2.0 has been evaluated in a pivotal clinical trial in breast-conserving cancer surgeries, or BCS. On the call representing the company are Adrian Mendez, Perimeter's Chief Executive Officer, and Sarah Bryan, the company's Chief Financial Officer. With that said, I'll now turn the call over to Sarah.

Thank you, Steve. Good afternoon, everyone, and welcome to our fourth quarter and full year 2024 conference call. On behalf of the management team and everyone at Perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Adrienne in a moment. However, before I do, I'd like to provide a brief update on our financial results. To streamline things, all the numbers we will refer to have been rounded, so they are approximate and also reported in US dollars. For the three-month period ending December 31, 2024, the company recorded revenue of $293,000. which consisted of the sale of consumables and system leases, as well as from the sale of ESP warranty programs. That represented a 303% increase over Q4 2023. Operating expenses for the fourth quarter were approximately 4.7 million, down 6% from the same period in 2023. Fourth quarter 2024 net loss was approximately 3.4 million, compared to approximately 5.5 million in the three months ending December 31st, 2023. The 35% decrease in net loss was primarily a result of higher foreign exchange gain in 2023, partially offset by higher headcount and increased costs as we completed our clinical studies during 2024. Cash used in operating activities in the 12 months ending December 31st, 2024 was approximately 14.7 million, essentially unchanged from 2023. As of December 31st, 2024, cash and cash equivalents were approximately 6.2 million. This amount does not include the Cancer Prevention and Research Institute of Texas grant receivable of approximately 2 million, which was related to the reimbursement of our pivotal clinical trial project costs as of the end of 2024. The company continues to evaluate opportunities to add more cash to the balance sheet in order to continue to execute on our growth strategy. With that, I'll now turn the call over to Adrian.

Thanks, Sarah. And thanks again, everyone, for your time and attention today. 2024 was a very exciting year for Perimeter. We made progress on almost every front within the company. We had significant growth in the number of surgeons using our product to help their patients. And with that, along with new revenue streams, this resulted in a significant increase in sales. We wrapped up our pivotal trial with positive results, and we made great progress in the development of our AI capabilities, which will make their way to market after we get FDA approval for our B series product. As Steve mentioned, we are currently commercializing our first FDA cleared interoperative imaging technology, the S series OCT. which provides surgeons with image resolutions capable of visualizing tissue structures down at the cellular level at the critical 2-millimeter depth while assessing margins real-time in the OR. It is cleared under a general indication and has not been evaluated by the FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. Our goal has been to seed the market with S-Series OCT in order to create a strong network of early adopters and technology champions in preparation for credential clearance off our next generation system, B-Series OCT with ImageAssist AI 2.0. The ultimate product promise of Perimeters B-Series is greater peace of mind, both for the surgeon who, no matter how skilled, currently faces nearly one in five odds of needing to perform repeat surgery due to positive margins, and for the breast cancer patient who under the current paradigm typically has to wait and worry for up to 10 days for their surgeon to receive a postoperative pathology report, which will determine whether they will have to go through the emotional physical trauma of a second surgery due to cancer left behind. In November, we announced positive topline results for the pivotal trial resulting, or sorry, for the pivotal study, evaluating the use of B-series with image assist in breast conserving surgery. The prospective multi-center randomized double-arm clinical trial enrolled approximately 530 women aged 18 years and older undergoing BCS for the treatment of stage 0 to stage 3 invasive ductal carcinoma and or ductal carcinoma in situ. Participants were recruited from 10 clinical sites across the US and randomized in a two to one ratio to the device and control arms. The pivotal trial met its primary endpoint, achieving a statistically significant reduction in patients with residual cancer during surgery. These results demonstrate a super superiority of the B series ability to aid surgeons in achieving clear surgical margins during surgery, potentially lowering the need for re-operation. And supported by this positive trial results, Last week, we announced our submission of a pre-market approval application to the FDA for the technologies used during BCS in the United States. The FDA PMA submission is a major milestone. Our first regulatory approval application for our AI-enabled wide-field OCT technology, as well as for a specific indication label, as we look forward to working with the agency as it reviews our PMA application. If and when FDA clears for permitters B series is obtained, that will allow for the full commercial launch of the B series representing the next major step in our go-to-market strategy and an opportunity to significantly broaden our user base across the US. Based off of all that, hopefully you can see from today's press release and call, we're quickly approaching what could potentially be a major inflection point here at Perimeter. So to summarize, We are seeing continued positive commercial traction with the current S-series product, as demonstrated by revenue growth in Q4 and all of 2024, and recent expansion to two new states, New Mexico and Tennessee. The pivotal trial of our next-generation AI-enabled B-series system met its primary endpoint, achieving statistically significant reduction in patients with residual cancer during surgery. These results demonstrated super superiority of the B-series ability to aid surgeons in achieving clear surgical margins during surgery, potentially lowering the need for reoperations. Based upon the positive pivotal trial results, we filed the PMA application for the B-series with Imagesys 2.0 last week. And finally, we're looking forward to several potential value inflection points throughout 2025, not the least of which will be the presentation of detailed results from the B-series trial at the 26th Annual Meeting of the American Breast Cancer Surgeons Conference, which will take place in Las Vegas, April 30th through May 4th. In 2024, our team laid a lot of groundwork for future growth. And in 2025, we are going to continue to build upon that foundation. This is an exciting moment for all of us at Perimeter, and we look forward to keeping you updated on our progress. And so with that, I'll now open up the call for your questions.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star four by the one on your telephone keypad. You will hear a prompt that your hand has been raised, and should you wish to cancel your request, please press star four by the two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Michael Freeman from Raymond James Company. Please go ahead.

Hey, good afternoon, Adrienne, Sarah, and Steve. Congratulations on a big year. My first question is on the actual PMA regulatory process. Congratulations on getting this in. I trust this was a ton of work. I'm curious if you can describe what the process looks like. What sort of interactions will you have with the FDA? What are you expecting on timelines? And then connected to this, I wonder if you could talk about the benefits of having a specific indication label. Sure.

Thanks, Michael. Okay, so I'll start. I'll answer your questions in order. First, from a timeline standpoint, Estimating about a year for approval, that's on average what a PMA application kind of takes to work its way through the FDA. We're hopeful that possibly it can be quicker than that. We have breakthrough device designation, which has allowed us to have what the FDA calls sprint conversations with the review team, which we've taken advantage of a few times last year. So there's some familiarity already in the review team of our technology, how it works, what we're trying to achieve. We designed the trial design, the study design was in close collaboration with the FDA. So we're trying to do everything we can to speed up that process. The key things that need to happen are there's a few different audit points. So there's obviously, we're a device company, right? So there's a manufacturing audit that needs to occur. There is an audit of our, an internal audit, you know, systems control process audit that we have within the company itself. So that'll be over the next six to nine months. There's a, I guess the next key milestone is at the 100-day mark. So 100 days from a few weeks ago. There's a sort of a timeline at which we, within that timeline, the FDA has to provide questions back to us. We have to answer to them. So we're looking towards the next sort of concrete deadline the FDA has to work towards within that 100 days from, you know, three or four months from now. um and um and it kind of goes from there so we'll keep everyone updated as that goes along obviously there's a big area of focus for us um so to the second question about the indications yeah this is this is a big deal for us um as i mentioned our s series has what's called a general tissue indication but no indication around specific indication around breast you know, breast tissue specifically or breast cancer specifically or re-operation rates. And so, you know, as you know, as a company, what you're allowed to market your device and talk about the benefits of your device is very tightly controlled by the FDA and has to be on label. Because we don't have those labels on the S-series product, it somewhat constrains us in how we would like to talk about our products. what the B series with the trial that we ran, once it gets through approval, allows us to talk very explicitly about those points. And the reason for that is because the trial design was such focused on breast cancer, focused on re-operation rates, so it's right on point. So a part of her application is to provide to the FDA those claims we would like to make, which includes all those things I just said, and a part of their approval process would then allow us to attach those claims to the B series products. From a business standpoint, what that allows us to do is it really, I mean, it doesn't take a great stretch to understand. That allows us to make our marketing, our advertising much more precise. If you look at the types of words and messaging we're able to provide right now, it's not as strong as it will be with the B-series. And so what that then allows us to do feeds into the acceleration and growth of the business with the B-series and really target that market very precisely.

Does that answer your question, Michael? Oh, definitely, Adrian. Thank you. Now, the next question, I'm curious how, you know, you're going to go through this regulatory process, and that will be its own bit of work. I'm curious how you are preparing for and investing behind the potential launch of the B-series in the meantime. I trust this is a narrow path to walk. How are you guys thinking about it internally? Okay.

Yeah, great question. So the biggest variable we have to work with is actually the timing of that approval, right? There's a lot. So there's a, you know, we have to build up commercial organization. We have to ensure we've got customers, potential customers lined up. We have to build out our marketing organization. So there's investment we can make on those fronts to really move the company footing from a sort of a clinical trial R&D focused footing to a commercialization go-to-market focus. So we've started that work, obviously. Well, we started a long time ago. We've accelerated that work since we've launched into the updated PME application. The trick, and here's the fine line we have to walk, is investing towards that in such a way where we're not investing too early, such that we're now fully ready to go and waiting another six months for approval. or investing too late where we lose opportunity, where we get the approval and we're not ready. So it's a continuous management process, a continuous reevaluation of how fast and how quickly we're spending the money, and then keeping close tabs with sort of the progress of the application through the FDA. Fundamentally, what we're doing with the S series right now, and you saw from the results, we had pretty good success last year with the S series, you know, growing revenue streams and surgeons and users is, You know, those are the advocates we'll have for the B-Series. Those are folks that we will use as the, you know, when they move over to the B-Series, we'll use them as our alpha customer base. We'll be able to really ramp them up quickly on the next generation product. So it's really important for us and big focus for us is making sure we have that initial sort of core base of customers this year that when we get B-Series approved, we have a really fast ramp on that. Got you.

Very helpful. I'm just going to show you one more in here. As you are threading this needle, how are you thinking about cash?

We're thinking a lot about it. So I think you can kind of see from the numbers and you see from our run rate, we are, as we've said before, we are going to have to raise capital to be able to fund this growth. And so that's always on our mind, and it's always a big part of what we have to do. What we don't want to be is a situation where we have approval to go to market, and we've constrained ourselves from a balance sheet perspective to not be able to really put energy behind that initiative. So I think this is important for us.

It's a big focus for the management team and for the board. Okay. All right. Thank you very much. I'll pass the line.

Thank you. Once again, should you have a question, please press star four by the one on your telephone keypad. Your next question comes from the line of Scott McCauley from Paradigm Capital. Please go ahead.

Thank you. Afternoon, Adrienne, Sarah. Thanks for taking the questions. Just on the current S-Series, so you highlighted some of the new kind of first in state installations you've had over the past few months, which is great. I was just wondering if you could give an update on kind of the current number of commercial installations of the S-Series that there are throughout the U.S. today.

Yeah, we've got 15 now under contract that are out there. We've got another handful that are in evaluation. And then we've got a pretty deep and you know, deep pipeline beyond that. Not only within the hospitals, we've already got presence, but also kind of expanding that. And one thing that's super exciting about the pipeline is we're getting, you know, I've mentioned this before, where we're starting to get referrals from surgeons to their peers. So we're getting inbound now, not only within the same hospital group, but also to others as well. And that's super exciting just from us building up the pipeline. So you know, 15 right now and then growing from there.

That's great. That kind of touches on what was going to be my next question on the pipeline. I guess a bit of a follow-up. So I believe the systems that have been placed to date have been leases and then there's the consumables on top of that. Within either the S-series pipeline or the way you're thinking about the B-series pipeline, Can you talk about your expectations around facilities buying the capital equipment and then purchasing the consumables? Do you expect most of them to do that? Do you expect most of them to lease it and then buy the consumables? Or are you looking at a more kind of pay per use where you pay a higher kind of fee for the consumable but there's no kind of down payment required for the for the capital like how are you thinking for the model both kind of for the next 12 months and then as you go forward with with the b-series yeah great question so as you mentioned you know to date we've been placing the devices at no cost in the operating room and then charging a per procedure

fee, uh, which we monetize in the form of the consumable, um, which has used one per procedure. Um, we are, but that business model is evolving and will continue to evolve as we do a couple of things. One is create more demands sort of, um, I mean, one way to say a sort of market power, although that seems a weird thing to say, cause we're pretty early right now. Um, but with the evidence we're starting to see, um, the ability to have, um, sell devices as well as charge for the consumable. We've got some early indications that that actually is going to happen even on the S series. So that's super encouraging for us internally. And the good news is that we would, and so let me just say this, what's very important for us is to ensure that we're maintaining that revenue stream on a per procedure basis, right? Having that close contact and that continuing revenue stream As a surgeon season device is just very good for not only from the financial perspective, but just also from an operational perspective, making sure we continue to be very close to all our customers and making sure that their usage maintains and they're not not using it. So that's very important. We won't sacrifice that, but We are getting indication that there are hospitals that are willing and able to pay for the device. And we will take full advantage of that, especially when that's their preferred method. So stay tuned for more to come on that. But we've got some very positive early signs of that happening.

That's great. And I guess, can you speak to the utilization that you're seeing? Is it increasing? Are you finding that it's hitting what you're expecting? Are there variations, either geographically or in some other form that either you were or weren't expecting?

Yeah, so this is important for us. It's an area we started focusing on last year and will continue to be a big focus for us. So yes, utilization is increasing a few different ways. One is we are starting to get multiple surgeons per machine. Um, which is wonderful because now you just don't have that one surgeon's volume on the machine and they tend to have their surgery days. And so we can put those together. So that's number one, number two, as we get new users onto them onto a new machine, um, they're ramping up faster. So we have a big focus on how do we get, uh, you know, them up to speed much more quickly. So revenue is coming earlier on in the curve than it was historically. And then three, and so like, so both those things are things we're pushing on. Number three, which we're pushing on, but this is where the surprising things come in, is where we find surgeons using our product in ways that we didn't originally anticipate. So in a couple different early signs of some surgeons using it to scan lymph nodes, as an example, look inside the nymphos to see what they're seeing there. Another for nipples bearing mastectomies. Primarily, most of our customers are using it for lumpectomies. So for nipple-sparing mastectomies, there's some value that some surgeons are seeing in that use. So all this is great, right? We can not only increase utilization from those particular surgeons, but as they discover utility, we can then start to spread that around the rest of our customer base and future customers. So this is one of these areas we, you know, especially with a placement model, it's a big focus for us to get more and more. Absolutely.

That's great. That's fantastic. And then I kind of two, just two more quickly for me on the B series. So you kind of walked us through the process already, which was great. You know, obviously there's been some news articles and things around changes at the FDA, some relatively new hires being let go in the kind of AI, you know, medical device space and how they were thinking about that. In your interactions with the FDA, have you noticed any changes? Are they slower to get back to you? I know the PMA application process is defined within the FDA regulations, so don't expect much slippage there, but have you noticed any change in your communications with the FDA over the past few months?

Yeah, so good question. You're right. The FDA is bound by, you know, rational law or whatever the right phrase is to timeline service level agreements. You have to get back to us. So there's something there. Now, one of the good things about us being through device designation and having spring conversations that we have been, we know who our review team is and we do track that closely. And so far as we can tell, our review team is still intact and these layoffs has not affected them. So that's good. We're in a dynamic environment. That's what our information is right now. We shall see. But right now there's no indication that any of those, any of that charm should affect our applications.

That's fantastic. And then just lastly, I know taking up too much time already, but you just spoke to the expansion of the commercial team and kind of threading the needle on the timing, which makes sense. I guess, do you have a sense of the end point? You know, so how you get there is one thing, but you know, where you're looking to land in terms of either, you know, a number of people or kind of general SG&A expansion over the next, you know, 12 to 18 months. So that once, you know, once you do get that approval, kind of you're hitting the ground running. Do you have any kind of guidance there on where you're hoping to end up?

Yeah, I think there's, you know, I'll talk about it in terms of how I want to get coverage across the U.S. So, Um, there's a couple of variables that move in tandem with kind of the stage of the business we're at right now. One is one's the easy, obvious one, which is there's certain geographies. We don't have a local salesperson, um, like the Northeast, like the Northwest. So we cover those areas with our existing force, but you know, if I look fast forward 18 months or whatever, 24 months from now, we're going to have to have local salespeople in those regions. Um, our sales teams made up of both sales people, as well as clinical support people two different, very different profiles. Right now, we have a clinical support group that is right-sized. I feel like it's probably approximately right-sized, maybe a little bit more growth there, but not too much for the rest of this year. Okay, so, but as we move into, you know, post-BCRS approval, some of the workflows change. So, One variable is geographical coverage. We certainly need to expand from there. Right now, we've got three salespeople plus a manager around the US. Probably, if we look over the next little while, we have to expand out double or triple that, let's say, from a salesperson standpoint. But with the B-series, certain things change. One is we get more efficient at our selling process. Two is the product with AI gets out there and becomes much easier to use, which means our sales team can close deals faster. Three is that we start to get system level agreements in place, which means the sales, you know, you get one system in place, it takes a lot of time, but then you open up 100 or 200 hospitals after that. So the efficiency of the sales side of the house goes down. Okay. And then on the clinical side of the house, as we get AI into markets, The amount of effort and training and ramp up of the new surgeon from a usability standpoint goes down also, which means our clinical support group can now support many more customers. So these are the variables that are moving. Now, the precise answer around that is still unclear because those are moving variables. But I do know we need to invest more. We need to get more geographic coverage. And simultaneously, we continue to need to hammer down on efficiency of our sales team. because we have AI coming out, which makes it more efficient, and we get more system-level agreements in place, which makes it more efficient. The way I look at it isn't a revenue dollars per sales dollar spent today is how we just multiply that out. It's going to get much more efficient as time goes on, and we'll kind of see how the pattern emerges as we get the B-series into market.

Fantastic. Thanks, Adrian, and I appreciate taking the time answering the questions.

You bet, Scott.

Thank you. And there are no further questions at this time. I would now hand the call back to Mr. Adrian Mendez for any closing remarks.

Okay, thank you. So thanks, everyone, for listening and joining. We closed out. I feel like 2024 was, like I mentioned, a lot of groundwork was laid in 2024 to prepare us for 25 with the S Series and then 26 with the B Series. I feel like we got a number of our systems running much more efficiently and effectively than we have historically, which is great because that then gives us the foundation upon which to scale the business. So tons more work to do, obviously, but we're in a very exciting place right now with the business fundamentally. And so really looking forward to 2025. The team's super excited about where we're at. I think we've demonstrated, especially within the team, that we can execute, demonstrate to ourselves that we can execute. I think some of the results are showing that we've turned ourselves into more of an execution sort of focused organization. And so more to come this year. I mean, I'm looking forward to keeping you guys updated on all the good stuff. Thank you.

Thank you. And this concludes today's call. Thank you for participating and may all disconnect.