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Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward looking statements. Within the meaning 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, 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 SEDAR plus 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 as 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 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 system, which provides real time cross sectional visualization of excise tissues at the cellular level. Our breakthrough device designated investigational Perimeter B Series OCT system which combines our proprietary image assist artificial intelligence technology wide field optical coherence tomography represents our next generation device. As we will discuss in more detail today, B Series OCT with ImageAssist AI two point zero has been evaluated as a pivotal clinical trial in breast conserving cancer surgery or BCS. On the call representing the company Aitri Mendez, Perimeter's Chief Executive Officer and Sarah O'Brien, the company's Chief Financial 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 twenty twenty four 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 Adrian 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 12/31/2024, the company reported 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 twenty twenty three. Operating expenses for the fourth quarter were approximately $4,700,000 down 6% from the same period in 2023. Fourth quarter twenty twenty four net loss is approximately 3,400,000.0 compared to approximately $5,500,000 in the three months ending 12/31/2023. The 35% decrease in net loss was primary 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 twelve months ending 12/31/2024 was approximately approximately 14,700,000.0 essentially unchanged from 2023. As of 12/31/2024, cash and cash equivalents were approximately 6,200,000.0 This amount does not include Cancer Prevention and Research Institute of Texas grant receivable of approximately 2,000,000 which was related to the reimbursement of our pivotal clinical trial project costs as of the end of twenty twenty four. 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 intraoperative 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 two 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 use in breast tissue, breast cancer, other types of cancer margin 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 potential clearance of our next generation system B Series OCT with ImageAssist AI two point zero. The ultimate product promise of Perimeter 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 positive margins. And for the breast cancer patients, who under the current paradigm typically has to wait and worry for up to ten days for their surgeon to receive a postoperative pathology report which will determine whether they will have to go through the emotional physical trauma second surgery due to cancer left behind. In November, we announced positive top line results for the the pivotal trial resulting or sorry, for the pivotal study evaluating the use of B series with ImageAssist in breast conserving surgery. The perspective multicenter randomized double arm clinical trial enrolled approximately five thirty women aged 18 years and older undergoing BCS for the treatment of stage zero to stage three invasive ductal carcinoma and or ductal carcinoma in situ. Participants were recruited from 10 clinical sites across The U. S. And randomized in a two:one ratio to the device and control arms.

The pivotal trial met its primary endpoint achieving a statistically significant 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 a preoperation. And supported by this positive trial results, last week we announced our submission of a premarket 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 Perimeters for Perimeter 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 SIDICIT statistically significant reduction 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 re operations. Based upon the positive pivotal trial results, we filed the PMA for the B series with Imagesys two point zero 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 twenty sixth Annual Meeting the American Breast Cancer Surgeons Conference which will take place in Las Vegas, April 30 through May 4. 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. You will hear a prompt that your hand has been raised. And should you wish to cancel your request, please press star followed by the two. If you are using a speakerphone, please leave the hand Your first question comes from the line of Michael Freeman from Raymond James Company. Please go ahead.

Hey, good afternoon, Adrian, Sarah and Steve. Congratulations on a big year. My first question is on the [indiscernible] regulatory process. Congratulations on getting this in nitrous. This was a ton of work. I'm I'm curious if you can describe, like, what this what the process looks like. Like, sort of what sort of interactions were you 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. So I'll start. I'll answer your questions in order. First, from a timeline standpoint, we're 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 achieve. We designed the 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 audit, systems control process audit that we have within the company itself. So we'll so that'll be over the next six to nine months. There's a, I guess the next key milestone is at the one hundred day mark. So one hundred days from a few weeks ago. There's a sort of a timeline at which we that timeline the FDA has to provide questions back to us, we have to answer to them. And so we're looking towards the next sort of concrete deadline the FDA has to work work towards within that one hundred days from three or four months from now.

And 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. So to the second question about the indications, yes, this is this is a big deal for us. As I mentioned, our S series has what's called a general tissue indication. But no indication around specific indication around breast breast tissue specifically or breast cancer specifically or reoperation rates. And so, as you know, it what 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's somewhat constrains us in how we would like to talk about our products. What the B Series with the trial that we ran it gets through approval allows us to is talk very explicitly about those points. And the reason for that is because the trial design was such focused on breast cancer, focused on reoperation rates, So it's right on point. So a part of our 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 product. From a business standpoint, what that allows us to do is it really I mean, it doesn't take a great stretch understand that allows us to make our marketing or 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 BC 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? Definitely Adrian. Thank you. Now, next question is, I'm curious how you're going to go through this regulatory process and that will be its own bit of work. I'm curious how 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? Yes, great question. So the biggest variable we have to work with actually the timing of that approval, right? There's a lot so there's 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 and D focus 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 the you know, into the FDA to PMA 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, 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, growing revenue streams and surgeons and users is those are the advocates we'll have for the B Series. Those are folks that we will use as the, when they move over to 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 folks for us is making sure we have that initial [indiscernible] core base of customers this year that when we get B Series approved, we'd have a really fast ramp on that.

Gotcha.

Very helpful. I'm just going to shoo on 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've you've seen you can kind of see from the numbers and you see it 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 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 the management team and for the board. [indiscernible] Thank you very much. I'll pass the line.

Thank you. Your next question is comes from the line of Scott McCauley from Paradigm Capital. Please go ahead.

Thank you. Good afternoon, Adrian, 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 US today.

Yes, 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 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 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. 15 right now and then growing from there.

That's great. That kind of touches on was you remember an 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 F Series pipeline or the way you're thinking about the B Series, can you talk about your expectations around facilities buying the capital equipment and then purchasing the the consumables? Do you expect most of them to do that? Do you expect most of 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 capital like how are you thinking for the model both kind of for the next twelve months and then as go forward with the B Series.

Yeah, great question. So as you mentioned, to date we've been placing the devices at no cost in the Operating Room and then charging a per procedure fee, which we monetize in the form of the consumable. Which is used one per procedure. We are but that business model is evolving and will continue to evolve as we do a couple of things. One is create more demand sort of I mean, one way to say is sort of market power, although that seems a weird thing to say because we're pretty early right now. But with the evidence we're starting to see the ability to have cell 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 the surgeons use the 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. So 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 that that's 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 kind of variations, either geographically or in some other form that either you were or weren't expecting?

Yeah, so So this is important for us. It's an area we started focusing on last year and continue to be a big focus for us.

So yes, utilization is increasing. A couple different ways, a few different ways. One is we are starting to get multiple surgeons per machine, which is wonderful because now you just have that one surgeons 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 on onto a new machine, they're ramping up faster. So we have a big focus on how do we get them up to speed much more quickly. Revenue is coming earlier on in the curve. It was historically. And then three, and so like both those things are things we're pushing on. Number three, which we're pushing on, but is where the surprising things come in, is where we find surgeons using our product in ways that we didn't originally anticipate. In a couple of different early signs of some surgeons using it to scan lymph nodes, an example, look inside an impulse to see what they're seeing there. Another for nipple sparing mastectomies.

Primarily most of our customers are using it for lumpectomies. For nipple sparing mastectomy is some value that some of surgeons are seeing 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. Is one of these areas we you know especially with a placement model it's a big focus for us. To get more That's great. That's fantastic. And then I kind of two just two more quickly for me. On the B Series, so you had to walk us through the process already, which was great. 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 medical device space and how they were thinking about that. Have you noticed in your interactions with the FDA, have you noticed any kind of changes? Are they slower to get back to you? Or is it I know the PMA application process is defined within the the FDA regulations, so don't expect much slippage there. But just have you noticed any change in your communication 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 breached through device designation and having spring conversations is 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 and if that term should affect our application.

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 endpoint So how you get there is one thing, but where you're looking to land in terms of either number of people or kind of general SG and A expansion over the next twelve to eighteen months, so that 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, I'll talk about it in terms of how I want to get coverage across The US. So there's a couple variables that move in tandem with kind of the stage of the business we're at right now. One one's the easy obvious one, which there are certain geographies we don't have a local salesperson. Like the Northeast, like the Northwest. So we cover those areas with our existing force. But you know, if I look fast forward eighteen months or whatever, twenty four months from now, we're gonna have to have local salespeople in those regions. Our sales team is made up of both salespeople 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 So but as we move into into post BCER's 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, 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 get one system in place takes a lot of time, but then you open up 100, 200 hospitals after that. So the efficiency of the sales side of the health goes down.

Okay. And then on the clinical side of the house, as we get AI into markets, the amounts of effort in 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. 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 geographical coverage And simultaneously, as we continue to need to hammer down on efficiency of our sales team. Because we have AI coming out, makes it more efficient and we get more system level agreements. In place, which makes it more efficient. The way I look at it a dollars per sales like revenue dollars per sales are spent today is how we just multiply that out. It's going to get a much more efficient as time goes on.

We'll kind of see how the pattern emerges. As we get the B Series into market.

Fantastic. Thanks, Adrian, and 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 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 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. You may all disconnect.