Imricor Medical Systems, Inc. (IMR) Earnings Call Transcript & Summary

Good morning, and welcome to Imricor's First Half Results Webinar. On the line, we have Executive Chair, President and CEO, Steve Wedan; and CFO, Jonathon Gut. Before I pass it to Steve, I remind you that you can ask a question via the Q&A function at the bottom of your screen and we will endeavor to answer all of these at the end. I'll now hand it over to Steve to start the presentation.

Thanks, Max. Hello, everyone, and thanks for joining us today to discuss our first year -- our half year results for the first half of 2023. Again, I'm Steve Wedan, Imricor's Chair and CEO, and I'm joined today by our CFO, Jonathon Gut. Today, we'll provide you with a business update on the progress we've made during the first half of the year, including our key achievements. Jon will then discuss the financial results before I summarize our progress so far in the second half of the year, along with our focus for the rest of 2023. Then we'll move to a Q&A session. So in 2023, we got off to a great start with the IDE approval from the U.S. FDA of our VISABL-AFL trial and this is the clinical trial aimed at gaining FDA approval for our devices, which is, of course, then opening the U.S. market for us. And since then, our team has been working to organize and enroll sites and we expect to commence that trial in the next month or so. We also signed a master research agreement with GE HealthCare. This was significant. Under this agreement, GE will pay Imricor to develop the hardware and software needed to connect our products, including the Northstar 3D mapping system to GE MRI systems. When the project is complete, Imricor's products will operate with the vast majority of 1.5T MRI systems in our target markets, which are dominated by these 3 big players; Siemens, GE and Philips. So this really rounds out the whole thing for us. Our customers performed 44 atrial flutter ablations in the first half of the year, which included a record first quarter, but a disappointing second quarter. The reduced number of patients presenting to their cardiologists with standalone atrial flutter following the pandemic is still a major reason cited for low procedure volumes, but it is expected that this is a short-term effect now that people are getting back to pre-pandemic healthcare routines. In any case, the 44 procedures sets a post-pandemic baseline that we can build upon and I'll talk more about that later. Another highlight for the first half of the year was the sale of a research-only capital equipment package to a U.S. hospital. We received payment for the system, but the revenue for the sale is not yet recognized, and Jon will talk about that shortly. Finally, as you've heard me say before, we are very excited about our Northstar 3D mapping system. The first version of the system is frozen and it is progressing through its -- and towards its regulatory approvals, but we are not standing still with Northstar. We're planning the future of the product, which will include artificial intelligence or AI modules that we expect will deliver the full value of MRI guidance for interventional procedures. Northstar is a great application for AI and we're working to deliver its first AI functionality for the next release, which would be automatic heart chamber segmentation that is automatically creating those 3D geometries from the heart chambers of the MRI images. We'll keep you updated on how these efforts progress. So now, I'll hand it over to Jon to take you through our financial performance for the first half of the year.

Thank you, Steve, and hello, everyone. As a reminder, all numbers are unaudited and in U.S. dollars. As set out on Slide 7, we generated total revenues of $199,000 for the half year, which was down 63% compared to the prior corresponding period. Much of the decline was attributable to equipment revenues, which were solely comprised of monthly rental fees during the first half of the year, while the prior corresponding period included the sale of third-party equipment to select sites that were preparing to resume procedures post-pandemic. Note the equipment revenues for the first half do not include the research-only equipment sale to the U.S. hospital that Steve mentioned earlier. Although, we did receive purchase orders and full prepayment during the period, the revenue for that sale will not begin to be recognized until the equipment is installed. We expect the installation will take place during the second half of 2023. For consumable product sales, revenue of approximately $161,000 was down 29% compared to the prior corresponding period. The period -- the prior period benefited from orders placed by sites that were resuming procedures post-pandemic, while the current period's revenues were comprised of reorders from existing accounts. Costs and non-R&D expenses decreased by $368,000 during the first half compared -- in comparison to the prior corresponding period. This reduction was primarily due to lower staffing costs and a decrease in charges for new inventory reserves. However, these savings were partly offset by increases in professional services and marketing expenditures. The rise in marketing spending was largely attributed to our participation in the 2023 Heart Rhythm Society Congress in May, an event where our presence was limited in 2022. R&D spend decreased by $548,000 in the first half compared to the prior corresponding period, primarily due to decreased spending on prototypes and a reduction in consulting costs related to the development of our Northstar 3D mapping system. It's worth recalling that we initiated the Northstar development at the beginning of 2022 and the early stages of the project incurred higher third-party costs. These reductions were partially offset by higher clinical and regulatory spend with the latter being driven by product submissions and the completion of our MDR certification audit in May of this year. The fair value change recognized in the current period is related to the convertible notes issued in December 2022 and March 2023. The net loss for the period was $9.2 million, a decrease of 6% from the prior year. Our balance sheet is provided on Slide 8. In general most of the items on the balance sheet remain consistent with our reported figures at the end of 2022. However, our cash balances decreased due to ongoing investments in new product development, geographic expansion, European commercialization and revenues which haven't yet reached a full level to support current operations. Regarding other significant changes in the balance sheet, the decrease in other current assets is primarily due to receiving the final refund of the employee retention credit, the pandemic relief program the company qualified for in 2020 and 2021, as well as the monthly expenses associated with our D&O insurance policy. This policy was prepaid in the previous year using funds obtained from a financing obligation and the remaining balance on that was pre-settled during the period. The outstanding convertible notes at the end of the period are recorded at their estimated fair value of approximately $4.4 million. For more detailed information, the accounting treatment of this liability, please refer to Note 7 of the financial statements we released earlier today. Moving on to cash flow on Slide 9. Our operating cash outflow for the half year amounted to $6.2 million, showing a decrease of $2.3 million in comparison to the prior corresponding period. This reduction is partially attributed to the lower operating costs and R&D expenses, which were detailed on Slide 9. These decreased costs and expenses were supported by reductions in non-cash charges related to inventory reserves and stock-based compensation. Alongside these non-cash items, we also received the full final refund from the employee retention credit, as mentioned earlier and the full prepayment of that research equipment for the U.S. hospital. During the period, we issued the second tranche of the convertible notes based on the securities purchase agreement we signed in December 2022, which resulted in proceeds of approximately $2.7 million during the period. The decrease in other financing activities is the result of lower monthly payments on our finance leases, which are related to the purchase of equipment. At the conclusion of the period, our cash balance stood at $1.5 million. However, it's important to highlight that subsequent to the period's end, we successfully obtained an equity funding facility. This facility grants us access to up to AUD 30 million over the next approximately 3 years. Because this facility was not established by the period's close, the potential funding it offers is not accounted for in our reported ending cash balance. I'll now hand back to Steve to take you through the rest of the presentation.

All right. Thanks, Jon. So let's take a look at where we are now here in August and where we'd like to go for the rest of the year. And frankly, this is the fun part, and I think some exciting stuff that's happening. I discussed some of our highlights from the period earlier, but really, the first half of 2023 was about building momentum, doing the heavy lifting behind the scenes to put ourselves in a position to achieve some of the significant milestones in the second half of the year and beyond. And this momentum building started paying off already in July. Since July, we've executed a distribution agreement with a distributor in the Kingdom of Saudi Arabia and this distributor specializes in sourcing entire cardiac care centers. We feel that they are a perfect partner for us. They're shepherding our regulatory packages through the approval process, which is abbreviated due to our CE Mark and we expect the process to be complete later this year with a full launch early next year. This marks our first entry point in the Middle East where we expect continued growth as we move forward. We also importantly bolstered our balance sheet. First, with the equity funding facility we executed with GEM Global Yield, as Jon just mentioned. This provides us access up to AUD 30 million of equity financing that we can draw upon at our discretion, a little by little to fund our operations while we grow value in the business. This on top of our cash balance, which we also increased by AUD 4.29 million through the 2 recent placements gives us a significant runway to execute our strategy of growth and our mission to change global standard of care in interventional medicine. Along that mission, the most exciting milestone to happen in many years was the approval to commence our VISABL-VT clinical trial at the Haga Hospital in The Hague, Netherlands. We firmly believe that commencing the VISABL-VT trial, showing the world the first real-time iCMR-guided ventricular tachycardia ablations will spark action and adoption from sites all over. I said it before, but I'll say it again here. We can do atrial flutter ablations guided by real-time ICMR and that's where we had to start for sure. But I founded the company with the complex ablation procedures in mind and ventricular tachycardia is arguably the most complex of ablation procedures. This is where we expect MRI to add significant value in terms of time, cost and effectiveness and even help grow the market for ventricular tachycardia ablations. For me, it is literally a dream come true and I see all the hard work now coming together. So what's the key message. We're on a mission to establish a new standard of care in the $8 billion worldwide cardiac ablation market and our plan to achieve our goals is working. We're working to grow value by expanding our indications to ventricular tachycardia and eventually atrial fibrillation. And we're working to expand our geographies to include the U.S., Australia, New Zealand and the Middle East. And as we progress those priorities of primary drivers of value, we also need to remain focused on commercialization efforts in Europe. For the remainder of this year, that means establishing more intimate relationships with our customers, including especially those who have signed but have not yet become active sites. We expect to see these sites activated through the remainder of the year. Increasing our install base in this way will then increase the procedure volume and revenue. And as we look further along to adding new sites to the pipeline of adopters, we will continue to focus on sites that have or are establishing an iCMR lab that's controlled by cardiology, just like all the other conventional electrophysiology or what we call EP labs. This is important to avoid the resource conflicts associated with cardiology and radiology, both competing for a time on a single MRI. In the end, an iCMR lab should not be an MRI that we adopt or adapt for interventional procedures, an iCMR lab should be an EP lab that happens to house an MRI system rather than X-ray fluoroscopy. In other words, we're not bringing ablation to the MRI, we're bringing MRI to ablation and that's an important distinction as we move forward. So finally, reviewing our focus for 2023. From the very beginning of the year, these 3 buckets are the same. We have learned and adapted our approach of course, especially in #1, but these are the goals we have been focused on and these are the goals we are delivering. I said it earlier, the first half of 2023 was about building momentum and doing the heavy lifting behind the scenes to make these big milestones achievable. Now, we've already seen and started to see the results and I cannot wait to share with you more big milestones as we achieve them through the rest of this year and beyond. And with that, I'd like to hand it back to Max for questions.

Thank you, Steve. I'm going to let Sarah speak. She just raised a hand, Sarah Mann.

Can you guys hear me okay?

Sure, we can.

Just first question for me was just around the VT trial. So clearly, great news that you've got an approval to commence at Haga. Just wondering if you could, I guess, give us an outline around how quickly you think they'll be able to commence and then also I guess, the timeline around when are the trial sites might be able to come on-board and take part in the VT trial?

Yes. So first of all, I have to say, every time I make a prediction of the future, I've got to note that this is a -- it's a thing full of unknowns. Patients have to come and be available and all sorts of things have to come together. But here's where we are and here's where I think we're going. Starting from Monday this week, our team has been on site at the Haga installing the VT system, training the staff, running through every aspect of the procedure workflow and work with all the personnel across all the functions. That includes like imaging, cardiology, electrophysiology, anesthesiology to ensure that everyone is prepared and the lab is ready. I'm leaving for Europe, myself tomorrow for customer meetings around ESC, that's the European Society of Cardiology. That Congress is happening this weekend. Imricor is not presenting at it or frankly, spending any money on it. But it doesn't prevent us from having visits with doctors and partners around the meeting. So I'm doing that. And then on Sunday, I'll present at Haga Hospital's iCMR Summit and hopefully, stay the week to do a VT case at Haga next week. So I hope that works out, but -- and that's what we're tentatively planning now. So it's really -- I'm looking forward to a very exciting week. But full of unknowns, so we'll -- if it doesn't happen next week, it will happen the week after or something very, very soon. Everyone is ready. We're set up. We've done everything we need. Now, we just have to make sure the patient arrives. And then I think the second question you asked was when -- what's the timeline for it look like. And that is another one that is full of a bunch of unknowns. So what I will say is as soon as humanly possible. We have approval in Germany that we're waiting for and that is -- and so we have -- let me go back. We have approval in the Netherlands that's complete. So we can expand to other sites in the Netherlands and leverage the competent authority's approval and the regional ethics committee's approval. And those are some of the conversations I'll be having this weekend with other sites. The German competent authority, we're waiting for that approval as well. But that approval is awaiting one final report from our partner who makes the defibrillation system and the German competent authority wants to see that final report. And that's not due till the end of September. So we expect that at that time, we'll be able to submit the final response to them and get started after that. Now, we've already been meeting with sites in Germany and getting them all set up and approved as best we can in anticipation of that. So once we start, we'll see how enrollment is going. It's another unpredictable thing, how many patients that fit the enrollment criteria essentially come into the hospital to see their cardiologist, but we can combat slow enrollment as everybody does, slow enrollment with more sites as well. So we've got some levers to pull. We'll keep a close eye on and we'll get this thing done as quickly as we possibly can. I want to say one more thing about the trial. It is important that we get it done quickly and that we complete it and move the process towards the VT approvals. But just as importantly, I think, and I mean this sincerely, is that we start because what we'll be doing with that first VT study is something that's never happened on the planet before. And that will show everybody definitively, just like we did years ago when we said, hey, we did an ablation procedure, albeit a simple one, but catheters were in patients and patients were in the MRI. And some people thought that was impossible. Now we're doing that again, but we're doing it with something very significant and it's a big, big deal. So while we do that, when we do that, we actually are already seeing it spark, I don't know if new interest is probably not the right word, but certainly, new action at places that have been sort of sitting around on the sideline, watching us and paying attention to what's happening. So getting started is almost as important as finishing and we think that we will start growing our installed base with just the trial being operational and doctors presenting their results and talking about it on podiums and so forth.

So just on that point, like can you give us any color around what kind of new interest you've seen given the fact that the VT trials are about to start? Like are you seeing more customers engage in discussions around potentially implementing their own iCMR lab? Any color around that?

Well, we're seeing -- the first sign that we saw are sites that are inactive site, sites that have signed with us. But after the pandemic, thought maybe we'll just sort of hang out here and see how this progresses with VT. We're seeing those sites take some action now. So it will be fun to announce new activation of sites and the enrollment of patients for atrial flutter ablations at those sites in the coming weeks and months. That's the first sign that we've had. We have a pipeline. We've narrowed that pipeline to those folks who are actually installing or planning to install new labs that are cardiology owned. So we can stay focused on a smaller number of new customers. And that is a process that is also progressing. But I can't say that I've seen an acceleration in that process just yet from the VT because those folks were already moving down the road. But again, our new -- our installations or Sarah, are growing of our sites is going to be something that we're more careful about than we were before. We're really going to push hard to find sites where cardiology owns that MRI because ultimately, we can get started at a place, but then for that place to routinely do procedures in conflict with these people coming in for 20-minute diagnostic imaging scans all day long, it's really difficult from a logistics standpoint. So we want to focus on these folks that are building a new EP lab with MRI rather than folks who just want to try MRI, sorry, try an EP inside of an existing MRI lab. So that's where we're focusing. That takes a little bit more time, but it will have better results in the end for sure.

And then in terms of the number of hospitals that you've signed up, can you give us any indication around how many of them are actively doing procedures? And what you can do to kind of drive further adoption amongst the existing signed customer base?

The #1 thing that we can do, we're at a tricky time right now. And what I mean by that is, for instance, we just have this Northstar mapping system available for evaluation at sites and everybody wants to see it, but not everybody has the MRI system software or even sometimes the computer systems on their MRI that are new enough to get started. So you end up with this short-term problem of these MRI systems first needed upgrading before they can take advantage of an evaluation period with Northstar. That's just kind of an example. And it's, again, transient, right? Because as new sites come on, all of the new MRI systems would be capable of connecting and so forth. So we've got some sites to call aside active, what I've been saying an active site is one that is capable or has performed procedures during the last 6 months during this first half of the year. But we know one of those sites, they lost their license and now they're gaining it back and they're negotiating to get it upgraded so that they can -- when I say they lost their license, it just expired and they didn't know how to upgrade just yet. So they are working through that process. And then they'll get back on again. It's -- other sites like just one site where a nature of flooded patient just literally hasn't come through the door in the last 4 months, but they did a case in the beginning of the half. So it's really sporadic for these different reasons. But what's working is for us to go to these sites, increase this customer engagement, less sales and more market development, right? Less transactional. Here's the devices, do your procedures and let me know when you want to reorder. And more talking to sites about what their short-term blocks are, how we can help them through that, show them what's coming down the pipeline in terms of future products and talk about VT, demonstrate Northstar, these types of things are really starting to move the ball forward, which we think is pretty exciting.

And then final question from me. So clearly, the U.S. is a big new market for you as well. Can you just give us an update now that you've got IDE approval, like what hurdles are to get on those 2 U.S. trials, I guess, up and running?

Yes. So we have -- so first of all, Jon talked earlier about cutting expenses and we have been very careful about not overstaffing and erring maybe on the side of understaffing. And so there's only so many trials our clinical team could focus on. The first priority was to get VT started and ready and that sort of is in place. Now or actually, a few weeks ago, the team was able to start really focusing on the U.S. trial and getting those sites up and running. And there were some initial contracting and enrollment things that had to happen anyway. And those are long holes. The IRB process at sites in the U.S. can be a very long thing. But we've got the team going out next week, I believe, to meet with 2 of our sites on the East Coast to get them started and hopefully, not started doing procedures but started on the path of getting that IRB completed so we can start scheduling patients. Our goal was to do that within the next several weeks and to get actual enrollment started. But if there's a distraction or if there's any, would you call it a challenge for one of our resources, VT is going to win. Ultimately, we think the flutter trial can enroll faster and may even finish up before the VT trial. But the VT trials are different top priority. So we should start to see some movement in the flutter trial very soon.

Next question, Steve. Could you please give us a gauge of the revenue opportunity over the next 5 years? Happy for what -- wide ranges considering the large amount of unknowns. As shareholders, it's difficult to estimate the potential revenue.

Yes. So that is -- what I'd love to be able to do is say, here's what the market is for these different indications and when we expect to get those indications in what percentage of those markets. But frankly, we haven't done -- haven't spent the money on an updated market report for several years. So I don't have great new data associated with that. And also any data we show, especially associated with VT is not going to include what we think will be an increase in VT procedures because of the efficacy improvements that we expect to see from our guidance. But the math is still what the math has always been. You can take about USD 3,500 per procedure and multiply that times the number of procedures happening at a site each month, for instance, and then how many sites we have. So right now, the procedure volume is extraordinarily low, frankly. It's -- we -- these sites that we're at right now, where we're seeing the 44 procedures over the first 6 months, we had initial estimates for what those procedure rates would be by pulling those individual hospitals because we knew who they were going to be at that time. Unlike now, where I look forward and say I don't know what the fifth or sixth next site might be. But we knew at that time who they were going to be and we asked them how many cases do you do each year. That's how we got our numbers. But those numbers aren't true now after the pandemic. And I think they will be true again, but certainly, people who had stand-alone atrial fibrillation or I'm sorry, atrial flutter are not coming into the doctors at the same rate they used to be. And many of the doctors expect and tell me that they think that, that atrial flutter has progressed to both atrial flutter plus atrial fibrillation or other arrhythmias, which then we can't treat yet in the iCMR environment. So I wouldn't say that 44 cases across 8 or 9 sites is going to be the typical rate. We're going to grow from there. But I wouldn't go back to the 150 to 200 patient rate either that seems like that would be aways away before we get back to those types of levels. And VT changes everything, because every site immediately can do VT fibrillations once we have those approvals. So again, to model it out, it doesn't take much to make it look crazy and it doesn't take much to make it look dismal for the next at least 6 months. I think the truth is going to be somewhere in between there, of course. And then what we want to show is in the second half of the year, we are activating sites. We're doing more procedures than we did in the first half of the year, the revenue is ramping up, the VT is sparking that interest and that's where we think we're going to gain the most momentum for the next at least 6 months.

Thanks, Steve. That concludes the Q&A session. I'll just hand it back to you for some closing remarks.

Okay. Well, thanks. I guess I don't have anything else to add. I just want to thank you for joining Jon and me today. And as I always look forward to catching up, I think we're going to have some great announcements coming soon and I look forward to keeping you all informed on how we're doing. Have a great rest of your day.