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

Good morning, and welcome to Imricor's Financial Year 2022 Full Year Results. On the line today, we have Steve Wedan, company's CEO; and the company's CFO, Jonathon Gut. Before I hand it over to Steve and Jon to go through the presentation up on the screen, I'll just remind you that we will conduct a Q&A session at the end of the presentation, and you can ask questions through the Q&A panel at the bottom of your screen. Steve, I'll now hand it over to you. Thanks very much.

Thanks, and hello, everyone, and thank you for joining us today to discuss Imricor's full year results. Again, I am Steve Wedan, Imricor's Chair and CEO, and I'm joined by our CFO, Jonathon Gut. Today, we'll provide you with the business update on the progress we have made during 2022, including our key achievements and the progress we made on our overall strategy. Jon will then discuss the financial results before I summarize our progress so far in 2023, and our focus for the year to come. We'll then move to a question-and-answer session. So on Slide 3 here, our overall top level strategy is unchanged. The primary drivers of value for Imricor are expanding our indications that is growing the number of different arrhythmias that we can treat with our devices and expanding the geographies where we're approved to sell our products. The indications for which Imricor iCMR adds the most value or ventricular tachycardia and atrial fibrillation. For ventricular tachycardia, we're poised to initiate the VISABL-VT clinical trial this year in Europe, and at the same time, we're planning a pilot study with one of our partner research sites this year to demonstrate iCMR ablations for atrial fibrillation. You'll hear more about this in the coming months. When it comes to geographic -- geography expansion, we are pursuing markets such as the U.S., Australia and New Zealand, the Middle East and even Asia. We're making progress in all of these areas, as I'll discuss. Additional drivers of value include growing the number of active iCMR sites, focusing our sales on sites where they are adopting iCMR technology as a normal addition to their conventional electrophysiology or EP labs. And this means that the MRI scanner is owned and controlled by cardiology and is in the same area as the other EP labs. This has always been our long-term strategy for sales and now is the time to focus ourselves in that direction. We will want to continue growing the number of procedures performed at our active sites each month, which has been challenging post-pandemic, but an area in which we're making good progress. And we want to further engage our MRI partners to help grow the installed base. So let's take a look at some of the key achievements from last year. If we go forward to Slide 5, here we go. Looking back on 2022, we increased the number of active sites to 9, with more expected to activate in the coming months. We've contracted 3 new sites across Europe and expanded our footprint into Croatia and Italy. On the product side of things, we submitted our second-generation ablation catheter for approval in Europe, and we received a positive technical review for our diagnostic catheter, which is the first device we're running through the new medical device regulation approval process. The most exciting product to meet that we developed last year was the NorthStar 3D mapping system. And we completed the first clinical evaluations of this system in December. This was an extraordinary success and it's generating a lot of excitements in the field. We secured new funding in 2022 during challenging economic times, and we cut costs significantly while making sure to progress the important value drivers. Including the new financing was $1.5 million LIFT loan from the North Dakota Commerce Department. This was part of our larger effort to execute a manufacturing expansion in the state of North Dakota taking advantage of the economic development incentives that state offers. We also signed 2 new commercialization agreements with Siemens, which enable us to deploy the NorthStar 3D mapping system, a newer Siemens MRI scanners once it's approved. This means we no longer need to wait for Siemens to develop a 3D mapping system for their MRI scanner. We took control of that, and we're delivering quickly. We also completed all the product development, documentation and submission for our much anticipated VISABL-VT clinical trial in Europe, which I'll discuss in more detail in a minute. And under the other category, we opened the door for all U.S. investors to purchase CDIs on the ASX by lifting the U.S. foreign restriction that had been previously presenting such purchases. This, I think, has helped increase liquidity, and of course, Jon Gut has successfully transitioned into his new CFO role, replacing Lori Milbrandt upon her retirement. Let's go to the next slide. So NorthStar is such a significant achievement in 2022 that I dedicated a slide to it. This is a 3D mapping system that initiates MRI scanning. It receives MRI images in real time, it facilitates active tracking of our devices and provides 3D electroanatomical mapping for physicians. The NorthStar system currently works with Siemens MRI scanners, but we'll be expanding that as we move forward. The Imricor team did this development in less than 1 year, and the documentation and testing are being finalized right now for the supplemental submission of the VISABL-VT trial such that Siemens sites will have the opportunity to participate in the trial. We're also working, as I mentioned, with Philips and now GE to adapt the NorthStar for their MRI platforms. These 3 MRI manufacturers cover the vast majority of MRI systems sold around the world. And in the end, we like NorthStar to provide a consistent user experience, no matter which MRI platform, a site chooses for their iCMR labs. I also want to emphasize how significant the progress towards VT was in 2022. Following years of product development across more than half a dozen Imricor devices, as well as partnering with third-party companies for 4 other key products, our team did the exhaustive testing and documentation required for regulatory submission to initiate the VISABL-VT trial. I don't imagine that many people outside of the medical device field have a good appreciation for the extraordinary volume of work that's involved in something like this. Often, a clinical trial submission which itself is quite significant, involves a single device or maybe a small set of devices. Entitled Vision-MR Ablation of VT or VISABL-VT, our VT trial is designed to support expanding our indications for ventricular tachycardia ablations in the iCMR lab. The trial has been submitted for approval, has been approved, I should say, by the Ethics Committee at the Leipzig Heart Centre and is now under review by the German Compton Authority. We expect to initiate enrollment in the coming months once the final approval is granted. In addition, as we wrap up the final testing and documentation for NorthStar, we will submit for approval to commence the VISABL-VT trial in the Netherlands as well with the intent of adding some Siemens sites in that country. So now I'll hand it over to Jon to take you through our financial performance for 2022.

Thank you, Steve, and good morning, everyone. As a reminder, all numbers are in U.S. dollars. As set out on Slide 9, we generated total revenues of $816,000 for the year, which is up 17% compared with 2021. For total product sales, 2022 revenue of approximately $647,000 was up 74% compared to the prior corresponding period. Non-product sales, comprising service and government contract revenues totaled $169,000 for the year. Costs and non-R&D expenses decreased by $1.1 million in 2022 compared to the prior corresponding period due primarily to lower staffing costs and a decrease in charges for new inventory reserves. The decrease in staffing costs in this area was driven by lower stock-based compensation charges in the current period. R&D spend decreased by $1.8 million in 2022, primarily due to lower staffing costs, decreased spending on prototypes and a reduction in regulatory spending. These reductions were partially offset by higher consulting costs, which were driven by the development of our NorthStar 3D mapping system. The fair value change recognized in the current year is related to the convertible note issued in December 2022. The net loss for the period was $17.4 million. Our balance sheet is provided on Slide 10. Generally, many balance sheet items are consistent with what we reported in the prior year. The main exception to this is our cash balance, which has reduced due to our continued investments in new product development and European commercialization coupled with revenues which are not yet at a level to fully fund existing operations. In terms of other key balance sheet movements, the financing obligation represents the remaining amount owed on premium financing that was obtained for our corporate D&O insurance policy. The convertible note issued in December 2022 is recorded at its estimated fair value of approximately $2.2 million, with further details on the accounting for that liability disclosed in Note 8 of the financial statements to be issued earlier today. Our [Technical Difficulty] expenses decreased approximately $860,000 as a result of the overall decrease in spending levels during the fourth quarter and the suspension of the 2022 corporate bonus program for the company's leadership team. Moving to cash flow on Slide 11. Our operating cash outflow for the year was $16.5 million, down $1 million on the prior corresponding period due to decreased R&D expenses as outlined on Slide 9. These decreased costs and expenses were aided by reductions in non-cash charges related to inventory reserves and stock-based compensation expenses, but the spending reductions implemented earlier in the year to conserve cash are also reflected in these results. Those cash conservation efforts are also evidenced by the decrease in investing cash outflow in the current year. During the period, we completed a placement focused on U.S. investors, which resulted in net proceeds of $2 million. Additionally, in December, we entered a new agreement for the issue of unsecured convertible promissory notes to be issued in 2 tranches, the first of which resulted in net proceeds received of approximately $2.3 million in 2022. The second tranche of approximately $2.7 million is subject to shareholder approval, which we are seeking at our special meeting of stockholders to be held in early March. We ended the year with $5.7 million in cash. I'll now hand back to Steve to take you through the rest of the presentation.

Thanks, Jon. So let's take a look at where we are now in February and where we'd like to go for the rest of this year. January and February were actually really significant months. First, we received approval from the U.S. FDA for an investigational device exemption, or IDE, to commence a worldwide clinical trial to support FDA approval. This speaks directly to the primary value driver of geographic expansion, and the U.S. is, of course, one of the world's major markets. The IDE approval is a huge step forward, and we expect to start the study enrollment in the coming months. We also signed a memorandum of understanding with GE, which is the first of a few contracts we expect to execute with them to open the door for our products, including, of course, the NorthStar 3D mapping system to operate with the GE platform. There will be more news to come on this soon as well. And I'm happy to note that while the fourth quarter was relatively slow for procedure volumes, we saw a rebound in January. And we don't expect a completely steady growth pattern month-to-month at this early stage of post-pandemic commercialization, but I hope January in which we did more procedures than November and December combined demonstrates that procedure rates are growing and reorders are happening. We are also finalizing a distribution agreement to commercialize Imricor's products in the Middle East, again, speaking directly to the value of growing our geographies. And we sold a research-only capital equipment set for over $580,000 to a U.S. site that is currently constructing a new iCMR lab from the ground up. This is an example of the demand that exists for what we're doing and the willingness of sites to invest in establishing an iCMR lab ahead of our device approvals in the U.S. This is what happened in Europe prior to our CE Mark approval as well and history is repeating itself here. Finally, similar to the successful licensing programs that we initiated in the past, we are in talks with the group to potentially license Imricor's technology for commercialization within the Chinese market. So 2 more slides to wrap up with, which sort of set the stage for 2023. First, on this slide, let's review how we grow. We talked about major value drivers earlier, and this fleshes out those concepts just a bit. Today, we're treating atrial flutter in Europe, this is and always has been just the start. Doing something easier like atrial flutter gives us the opportunity to establish iCMR ablations as a clinical procedure and to obtain approvals for the devices we and others produce to support such procedures. So atrial flutter allows us to establish iCMR labs, labs will need for their clinical trials. It allows our customers to be able to gain experience in this new lab before tackling something more challenging and provides the opportunity for early adopters to publish and present in this new field, it's just a foundation. Next, we want to expand our indications to treat more complex arrhythmias where we believe MRI will add the most value. These are the kinds of procedures ahead of mine when I started the company in the first place. The 2 main targets, again, are ventricular tachycardia and atrial fibrillation. And as I mentioned earlier, we progressed this plan significantly in 2022 with the submission and subsequent approval by the Leipzig Heart Center's ethics committee to commence the VISABL-VT trial. The approvals are still ongoing, but we are getting close, and we expect to commence the trial in the coming months. Next, it's important that we expand beyond Europe, and we're progressing on this in many fronts, including Australia, New Zealand, the Middle East and in China. But one of the most significant geographic markets to break into is the U.S. And as I mentioned just a moment ago, we now have IDE approval from the FDA to commence a clinical trial again, starting with -- in the U.S. with a atrial flutter. And I noted how significant it is to have packaged up the and submitted the VISABL-VT clinical trial in Europe, in fact, submitting for IDE approval to commence the VISABL-AFL trial for the FDA is, as you can imagine, just as challenging and just as significant. Essentially, as we cut staff and reduced resources in 2022 for cost reasons, the Imricor team executed 2 massive programs simultaneously, each of which dwarf the efforts required for a normal device company with a single product. We are aiming to change the standard-of-care, and -- so we have to do more, and we have to be better. The last major step is to fold in atrial fibrillation, so we can address the entire $6 billion worldwide market. This, again, will require clinical trials, but we're getting a head start. As I mentioned earlier, we, along with some of our leading positions are planning a pilot study to gather data on the benefits of iCMR-guided ablations for atrial fibrillation with Imricor's products. These won't be enough for regulatory approval, but they will be an important input to that process, and we expect to show the benefits to further catalyze. We expect to show the benefits of the ablations and that will further catalyze the iCMR site growth and adoption. Looking ahead then to our primary focus for 2023, we're going to continue with the post-pandemic relaunch of our products in Europe and, of course, in other geographies that can leverage the CE Mark certification of our products, and we're going to commence the VISABL-VT trial in Europe to support VT indications there, while we also start the VISABL-AFL trial worldwide to support FDA approval. These are the 3 big items that every Imricor team member is focused on, and I look forward to keeping you informed on how we progress in these areas throughout the year. With that, I'd like to hand it back to Simon for some questions.

[Operator Instructions] Over to the first questions, Steve, in the past, you disclosed a number of sites in the pipeline. Can you provide some insight into how the pipeline is looking now? Has it expanded or moved forward as you get closer to VT trial and now that NorthStar is nearly ready?

So we've actually redefined the pipeline a bit. And what I mean by that is, with this focus of our sales team to direct their efforts towards sites that are constructing, cardiology owned or maybe already have a cardiology owned MRI facilities that can be an iCMR lab, that has refocused their efforts rather than trying to chase too many people with interest, but not a great short-term opportunity to move forward. So it's -- I don't have actually off the top of my head what that number looks like right now, but we do have a target list of the key dozen or so sites that we are currently focused on.

We just got a question from German by the audio.

I hope you can hear me okay. Just wanted to ask, firstly, you mentioned your January procedure volumes were strong. Can you give us any context around how that compares to, say, like record monthly procedures in the past? And any color around how February has been performing as well, please?

Sarah, I didn't hear the very last thing that you said.

I just said at the end, just any context around how February is also performing from a procedure volume perspective as well.

Yes, right. Okay. So in January, we did 11 procedures, it's not a ton. But again, that's just as many procedures as we did, it is actually more procedures than we did in November and December. And we're finding right now the rate to be slower than everyone expected for lots of reasons, some of which I identified at our fourth quarter results briefing. And that is -- primarily one of the reasons is that patients right now are presenting to their physicians, not just with atrial flutter, but with a combination of atrial flutter and atrial fibrillation. And there's no science data on this yet, but there is a suspicion that people who got atrial flutter during the pandemic did not see their physicians, did not see their doctors, didn't get that treated and it has progressed to be now a combination of atrial flood or natural fibrillation. And we can't treat the atrial fibrillation yet, so those patients have to be treated somewhere else. Now we think that this is something that we'll resolve in the short-term, but also what's really important that we do progress ourselves towards being able to treat atrial fibrillation and ventricular tachycardia as well. So that's one issue that's been limiting the number of procedures that we're able to do. The other one is the reason why we have shifted our focus more intensely on cardiology on labs, no matter what the best intentions are between cardiology and radiology at sites where they're partnering together to do iCMR lab or iCMR procedures. The logistics associated with doing that are challenging, because you're trying to fit in procedures in the middle of days or weeks when you have patients scheduled to come into your hospital and get diagnostic imaging. So if anything happens, for instance, a patient says I can't make it on this day, I have to come a different day, typically, you can shuffle those things around because you have a set of EP labs that you can easily adjust timing. When that happens in iCMR lab that you're borrowing for someone else for a very specific amount of time, it's difficult for scheduling that. So it's not that folks don't want to do it, but logistically, it can become challenging. And we've seen that -- what it means is for this week, the patient couldn't be treated on Thursday at 10 o'clock. So there was no other option, we just had to do it in the conventional x-ray lab and we'll have to look to next week. That to us is a canceled procedure. But there's just -- logistically, it is just a challenging thing for people to work with. So our sales team is working with each site to try to overcome those challenges from a scheduling standpoint, but also really importantly, focusing on those sites that are establishing iCMR as just another type of EP lab that they have at their disposal. I think the last thing you asked was how is February going. February actually have riddled with a couple of cancellations for these vary reasons, but March looks to be a very good, potentially best month that we have for procedures. Some of the things that we're doing, we see them working now, and we're excited about that.

So it's somewhere around that 11 procedures, 10 procedures or maybe 15 max is kind of what you're expecting on a monthly basis. So...

No, with the sites that we have now -- with the -- active sites. And some of those sites are doing just one procedure a month, because that's all the MRI time they have. So lifting will be done at other sites.

Yes. And then the other question was so the sale to the -- of the capital equipment to the U.S. customer, it's essentially a research [indiscernible]. Can you tell us what exactly you sell in there? Like was it just your capital equipment or did it include, I guess, some of the other third-party equipment that you help resell like the RF generator, for example? And then is this kind of the obvious site for U.S. clinical trial? Or is it just another site that happens to be interested in eventually doing guided promotions?

It's not a site that will likely participate in the clinical trial. The reason is because they'll be putting in a GE scanner, and it won't be until later this summer. And I don't think that we'll have our work with GE complete yet in order to be able to work in that particular scanner. But that's one of the catalysts for us to be doing this work with GE and for them to be doing this work with us. It is a site that is simply -- they found themselves in a position where they were doing some new construction. They wanted iCMR capabilities, especially in the future, but even now for right heart catheterization for instance, and these are pressure management, so they wanted to try doing as several sites are in an MR-guided environment. And while they have the funding to establish an iCMR lab, they want to make sure they got it fully set up for the future. So we won't be treating any patients there, of course. But -- and when we do get FDA approval on all these devices that we're selling for research only, we'll just swap those out for FDA-approved devices, and then there'll be a fully setup lab. It's one of the important things that our sales team has to do, it's not just about interest, it's about also at each site, who's in that capital equipment budgeting or planning and installation cycle that it makes sense for them to consider new capabilities like iCMR. And that's a new question that, if not new today, but new over the past couple of years, new question that we're addressing with each of the sites that we talked to.

Okay. Got it. And then in terms of the VT trial in Europe, do you have an approximate timeline around, when do you expect to be able to kind of commence first patient permit?

Yes. We're targeting our summer, so call it midyear. We are in now the 45 day window where BfArM, that's the German competent authority owes us a response to our first submission. But it might not be the first -- it might be not the last, I should say, a word we hear on it. They may ask some questions, and we have to go back to them again. And Germany can be quite challenging, especially when you talk about as many devices as we're talking about with this trial. It's not just our devices, but it's third-party devices as well. And we -- so it's hard to say for sure, but we're feeling pretty confident, we can start midyear. Now at the same time, I mentioned that we are going to submit in the Netherlands as well once we have the NorthStar documentation and testing finalized, which is just another week or so. And when we do that, that starts to mitigate the scheduling risk associated with Germany, because if they go slower in Germany, then we'll have sites in the Netherlands that we can get started at instead. Ultimately, we want all these sites to participate in the trial, but where we start is not so important. We just want to make sure we get started as quickly as possible. And there is another thing, Sarah, that you asked on the previous question I forgot to answer, which is what did we sell to that site in the U.S., it's all the equipment, all our stuff and all the third-party equipment.

Okay. And then on the U.S., so you've got [indiscernible] now. So what's the view around commencing a trial in the U.S.? Or would it be for flutter or you're doing retail [indiscernible] the strategy there?

Yes. So the first trial in the U.S. will be for atrial flutter, same as it was in Europe. And the difference, though, in the U.S. is that, we have the opportunity because the products are developed now in a way they weren't before. When we first started with flutter in Europe, we had a couple of years of product development before we would have the extra devices we would need to go from flutter to VT. But those devices are done now, because that's what we're using in the VISABL-VT trial. I mean, in the U.S., we could start a flutter trial. And in theory, we could start in parallel with that a VT trial here for FDA approval as well, maybe shortly afterward. That gets costly, and we're not quite prepared to pull the trigger on that, but we know we have a shorter window and certainly, it's more in our control to start a VT trial here in the U.S. I should also say that the work that we're doing now in atrial fibrillation is also something I'm very excited about, because the kind of pilot study that shows finally putting all the pieces together to show the benefits of MRI are for atrial fibrillation ablation, we think will be a significant publication and a significant driver of interest across the board.

And then lastly, can you just talk through, I guess, your cash runway and, I guess, potential funding solutions outside of, I guess, the capital markets to kind of get you toward VT trial?

Yes. We continue to pursue the further North Dakota initiatives that we have talked about in the past. The LIFT loan was the first of 3 things that we are doing there. The second one, which is the development fund is also a debt instrument, and we are pursuing that currently. That's a larger loan, but also it's one that can be addressed or that can be applied to capital equipment, which the LIFT loan is not allowed for. So those 2 things combined really to set us up for the manufacturing expansion that we're planning to do in the area. And this is just sort of the natural progression that we've been working with them on all along. The third thing is a grant funding opportunity that should be, I think, is planned to -- their fiscal year starts on July 1, and that's when that will be funded again. And of course, I can't promise that we'll get that, but I'm highly confident that we will receive that grant funding as well, which is used to be $1.5 million, but I think they're limited to $1 million now. Outside of that, we continue to look at different types of unique or novel ways that we can own the business and without having to slow down in the U.S. or slow down in Europe and really get this thing going, because the pandemic is behind us, and I think it's important now, it's been a long time. And I don't want Imricor to be seen as something that is taking too long to develop when, in fact, we all just sort of took a pause for COVID for a couple of years. So getting NorthStar out there creates a lot of excitement, people are feeling, okay, this is back on track, everyone is moving forward, there's lots of progress. I want to keep that momentum moving. So one of the things that was really successful for us in the past was when we were a private company, we licensed our IP to fields that are outside of interventions for implant companies essentially. And that was a pretty successful program, very successful program. And so we are looking at the same thing now in a slightly different way. And that's where it comes to the license opportunities for our technology in China. When we look at the Chinese market, we don't think that's something we'll be able to get to in the short-term or even the medium-term, it would be a very long-term. And if we get difficult market for us to commercialize in anyways, we are talking to groups about the potential of licensing our technology, commercializing and manufacturing it for just the Chinese market and staying inside the Chinese market. And that can be a significant opportunity for us as well.

Just next question, just on the Chinese opportunity and licensing. Can you provide any color on timing and potential size of the deal and how the economics would work for Imricor in terms of cash upfront and/or royalty on future sales in China?

Yes, I think the only thing I'd be really comfortable about talking about right now is the structure. And the structure would be upfront milestone payments, payments in the -- immediately payments in the short-term as we do technology transfer and get them set up. And then a royalty stream down for future sales. And so it's both the upfront and royalties, so which I think could make it a pretty significant opportunity for us. The size of the deal, I just -- it's probably best not to comment on right now, but we think it's worth our attention, so it's not insignificant.

And just final question. Once the VT trial starts, will you disclose results in the first case or wait until you have a larger sample size?

The very first case or 2 are what we call roll-in cases and there may be some workflow things that we work through. And so we'll see how it goes. It might be that some piece of equipment doesn't work and the case doesn't get off or something like that, and it never gets started even for instance. These things can happen when you do a procedure for the very first time. So I hope that it's -- it all comes off just perfectly. And of course, when we do our first cases that are completed, we will not just let investors know, we'll let the whole world know that we did this. This is going to be a very significant milestone for us.

Thanks, Joe, thanks, Jon. That concludes the Q&A segment. I'll just hand it back to you for closing remarks.

Sure. Thank you. So Jon, I just want to thank you again for joining us today. If there's questions come up, we're not really planning a road show right now for this, but if anyone ever wants to get in touch with us, please do and we look forward with catching up with you in the future. So have a great day.