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Good morning or good evening, and welcome to Imricor's Q1 of calendar year 2024 results webinar. From the company today, we have the Founder, CEO and President, Steve Wedan, the company's CFO, Jonathon Gut; and the company's VP of Corporate Strategy, Nick Corkill. [Operator Instructions] Steve, I'll hand it over to you actons.
Thanks, Simon, and thank you, everyone, for joining us today. This morning, Imricor released its Appendix 4C for the first quarter of 2024, and we'd like to discuss these results as well as provide a general business update. As Simon mentioned, I have with me on this call are CFO, Jonathan Gut; and our Vice President of Corporate Strategy, Nick Corkill. I got to say there's so much happening this year to Imricor, and we have provided a lot of detail on the quarterly business activities report that we launched through the ASX this morning, which I would encourage you all to read. But in today's presentation, though, I'll focus on some of the key value drivers to allow then ample time for Q&A. We're delighted to welcome some new investors onto the register, so I will start by giving a quick overview of where we are and what we're building here at Imricor, and then John will run through the financials before I give an update on some of the milestones that we achieved in Q1 as well as some of the milestones we have coming up in Q2 and the rest of the year. Imricor started as an idea over 2 decades ago, and it wasn't actually our idea. It came from the medical community itself, where doctors recognized the limitations that were holding them back when they performed catheter interventions to cure irregular heart beats. They figured that if they could actually see the hearts that they were working on, which is possible with MRI but not possible with the conventional X-ray imaging they were forced to use, then they can do a faster and better procedures individualized for each of their patients and free of all the radiation exposure for their patients and for themselves. MRI had come a long way by that time, making real-time MR imaging possible, but what was still missing were the interventional tools like ablation catheters that could be used in a patient in an MRI. Many large and small companies tried to make this idea a reality for the doctors, but no one could find a way to make the devices they needed safe and effective when used inside an MRI's enormous magnet and with its strong electromagnetic fields. This is where Imricor comes in. We have the only cardiac ablation devices in the world that are safe and effective in an MRI lab, what we now call iCMR or interventional cardiac magnetic resonance lab. This has been a monumental task, given every tool and every piece of equipment that doctors typically use in a conventional lab had to be redeveloped from scratch to be MRI compatible. And I'm very proud to say that this is a development work that is now behind us. We have proven technology, leading hospitals as early adopters and a commercialization program that is accelerating all around the world, all for an USD 8 billion market where we have no competition in the iCMR lab, meaning no competition for the capital equipment we sell to establish the iCMR lab, and no competition for the single-use catheters that we sell for every procedure performed in that iCMR lab. And now that we're rolling, the physicians couldn't be happier or more excited. And this is just the beginning. Here's a quote from Dr. Marco Götte at Amsterdam UMC after they became active this month, performing cases with our catheters and our new NorthStar 3D mapping system: "the dream is becoming a reality." And now I'll hand it over to Jon, who will present the quarterly cash flow results. Jon?
Thank you, Steve, and hello, everyone. As a reminder, all numbers are unaudited and in U.S. dollars. The net cash outflows from operating activities were $4.7 million for the quarter, which was up approximately $1.7 million from the prior quarter. This increase was primarily driven by the payment of regulatory review expenses related to our diagnostic catheter and the payment of certain third-party equipment inventory purchases. The third-party equipment purchases were the result of commitments made in a prior period and should be viewed as a nonrecurring item. The company expects this increase in operating outflows to be limited to Q1, with the payments for the quarter ending June 30 expected to decrease below $3.6 million. Net cash inflows from financing activities were $5.1 million, comprising net proceeds from the placements and institutional entitlement offer completed in February 2024. After the period, we completed the placement of the shortfall securities pursuant to the entitlement offer announced in early February. This resulted in gross proceeds of approximately $4.2 million, and brings our pro forma cash balance at March 31 to $5.4 million. It's worth remembering that beyond our current cash balance, we still have USD 1.5 million available on the LIFT loan from the North Dakota Department of Commerce, along with a letter of intent from North Dakota's Pioneer Capital Fund outlining an USD 8 million equity investment at a target price of USD 0.60 per share. We have a meeting scheduled with Pioneer Capital later this quarter; and Nick Corkill, our Vice President of Corporate Strategy, will be traveling to the U.S. to attend the meeting in person with Steve. Finally, we do have the AUD 30 million GEM facility available to provide additional liquidity if needed, but we do not have any current plans to draw on it. I'll hand back to Steve now for the rest of the presentation.
All right. Thanks, John. So we started the year with a great deal of excitement internally, and Q1 has already delivered a number of great milestones. I'd like -- as I mentioned earlier, this is just the beginning. And so here are some of our key value drivers for the quarter. One of the top priorities in Q1 was to launch our commercialization efforts and achieve consistent procedure volumes at active sites. This, along with steady activation of new sites through 2024, will create the momentum and the increasing revenue we expect as the year progresses. We have a pipeline of sites that are pending activation, and we've listed a few of them here to illustrate the activation plan. In the quarter, we started the year by establishing a consistent procedure schedule of Leipzig, and then we added 2 more sites to the active list in April. Amsterdam UMC started treating patients in the beginning of April, and Dubrava has ordered their catheters and will get started in early May. We'll continue to add specifics to this list in future briefings as we progress through the pipeline. Another top priority for us in 2024 is the progression of our U.S. FDA approval process. A process that is so important, not only because the U.S. market represents about half of the overall global USD 8 billion market, but also because reimbursement is so much more favorable here in the United States than it is in some EU countries like Germany, in particular. One of the most important things we'll do this year with regard to the FDA is to execute a pivotal clinical trial we named VISABL-AFL to provide the safety and efficacy data to support FDA approval. Four sites are planning to participate in the trial, and they are each at various stages of getting started. After the FDA gave the green light to the trial overall, Johns Hopkins received IRB approval in the first quarter. After IRB approval, there are start-up activities to perform, and those are all done. That means we're all set at Johns Hopkins, and the patient enrollment is underway. In fact, we expect to treat the first patient in the coming days. In addition, also in the quarter, both the Cardiovascular Institute of Sud Paris and the Lausanne University Hospital in Switzerland obtained their respective ethics approvals to join the trial. Then in April, the French competent authority, that's the government agency, followed with the required country approval, and installation in Paris is now being scheduled. We'll expect that they'll start enrollment process in May and begin treating patients in June. We also expect the Swiss approval is shortly coming behind and in Lausanne, we expect that they'll start treating patients later in June. Amsterdam UMC will also be the last hospital joining the trial, only because our focus at that site is first to get them started with our VT trial, which I'll talk about in a moment. But before I do talk about VT, I want to outline the VISABL-AFL trial that is for the FDA approval. The plan is to treat 91 patients in the trial across 4 sites. If we meet our endpoints after 76 patients are treated, we can exit the trial early. And in any case, we expect to complete all the procedures in the calendar year 2024, opening the door for FDA approval in mid-2025. Note that this is not like a Phase I, II or III drug trial, or even like a new technology device trial. We already did this in Europe to support CE mark. In that trial, we achieved 100% chronic effectiveness after 3 months. With VISABL-AFL, we simply have to systematically do, in the context of and with the documentation required for a formal clinical trial, do what our customers do routinely as part of their normal clinical practice, that is successfully treat patients suffering from atrial flutter with our tools and technology. We just have to turn the crank and collect the data so it can be submitted to the FDA. A third priority for us this year is to demonstrate the world's first ventricular tachycardia or VT ablation [ provided ] by real-time iCMR with our technology. This will include the first transseptal puncture under MRI guidance and the first use of real-time iCMR to help doctors identify specifically where to ablate. This is the kind of procedure that doctors had in mind for MR guidance in the very beginning, and this is why we started the company. That will not only be an enormous milestone for Imricor, but also a huge step forward for the medical field. What we're showing you on this slide is that we have spent almost 2 decades inventing technology, designing devices and systems and building partnerships with third parties like, for instance, MRI manufacturers, so that everything works together seamlessly. Following all of that, we've gained the approvals necessary to start a VT clinical trial in this quarter, and continuing in April, we have progressed the Ethics Committee approval at Amsterdam UMC, including the required site contracting and patient forms, and we are nearly done. Meanwhile, the team at Amsterdam UMC is planning and preparing to do the first VT procedure in this present quarter. The last priority I wanted to highlight today is our geographic expansion. We've talked a lot about this over the years, and now it's happening. In this quarter, we received Saudi FDA approval, opening the first country for us in the Middle East, along with Qatar, our second country in the region, and we expect sales through our distributor partners in those countries later this year. The Middle East expansion, along with our pending TGA approval and launch in Australia and our progress towards FDA approval that I talked about earlier and our continued growing of the installed base across Europe along with getting the EU sites active and consistently performing cases, all combine to demonstrate our global reach and our momentum towards changing the standard of care for interventional medicine with superior image guidance. And speaking momentum, April resulted in more consumable device revenue than all of Q1, which is to be expected because sales tend to lag procedures as reorders happen. We're all doing exactly what we said we would do in 2024, and this slide lists some of the highlights of the first quarter. The best part? Like I said, we are just getting started. Ours is not a technology looking for a market. Remember, we simply solved the technical problem that no one else could solve so that doctors could treat their patients better. And it was the market that said, we want this. We want you to do this. The demand is already there. Over the past 18 years, Imricor has done all the work required to meet that demand and make their dreams a reality. Now in 2024, we're rolling it out. And with that, I'd like to open it up to questions.
[Operator Instructions] Our first question is from Sarah Mann at Moelis Australia.
Steve, just wanted to ask about adoption. So nice to see that you've got a little bit more momentum coming back as I guess you reactivate the -- your sites. Would you be able to give us some color around how many procedures were performed in April? So you mentioned that you had 3 sites that are active. Just curious what the volumes were in April.
Yes. We decided that since we're still at just this early activating stage, I should say, at this early stage of activating sites, that we shouldn't disclose the procedure numbers until volume increase a bit across more sites. Otherwise, we are concerned that it could potentially reveal the commercial terms at each site, which are naturally confidential. But what I can say is they did a lot more procedures in this first quarter, actually, in each month of this first quarter than they did in the last quarter of last year. And it was a big focus for us in 2023 to reengage with each of these sites, meet the new leadership or help them establish their MRI technology, upgrade it, for instance, to get it where it needed to be, or whatever it was that we had to do at each site to set ourselves up for 2024, where it's not fits of stops and starts in procedures for various different logistical reasons, but a regular work -- a clinical workflow of doing these procedures routinely. And that's what we had accomplished, just like we thought we would, in Leipzig, it's what we accomplished in April in Amsterdam, and it's what we believe and feel very strongly that we will accomplish now in May as we move into Dubrava. And you saw on that slide that behind that, we have summarized the Charité in Berlin. We've got ICPS and Lausanne, which actually -- that the ICPS is in Paris and Lausanne is of course in Switzerland. Those 2 sites in early times are going to actually be working on the clinical trial, so less like revenue-generating sites. But nonetheless, installed base and doing something very important for us for the first few months, which is getting that FDA trial done.
Great. That makes sense. I mean I suppose another way to frame it without going into specifics would be, I guess, over the -- by the end of calendar '24, would you hope that the majority of your sites would kind of be tracking around that 1 procedure per week run rate?
Yes. That's very reasonable, Sarah.
Great. All right. And then my next question was just with regards to kind of the clinical trial. So you've been pretty clear that there's essentially no other roadblocks, at least for Johns Hopkins in the U.S., and that enrollment should start pretty quickly. Just wondering with the European VT trial, are there any other roadblocks kind of remaining before you can kind of commence patient recruitment in your European side?
No. We're ready to go, but we are targeting June. We're getting started with that. There's a process of probably 2 weeks left to -- for the Ethics Committee there to review the final patient forms and approve the budget in the contracting, but it's a pretty low bar of approvals. Because in the Netherlands, once you have ethics approval at one site, you get it at all the other sites. I mean they have a chance to review it, but they can't turn you down. So we are just finishing the final documentation with them. And meanwhile, we've sent 3D silicone-printed hearts to the site, so they can use the new tools and the NorthStar mapping system to work the workflow, to get fully ready for the first patient who I think is actually already identified. So it's coming, and we're pretty excited about that when it happens.
And then just last question for me in terms of the Pioneer Capital funding. You've mentioned you have a meeting sometime in this quarter. Just wondering if you could give us an update on where the allocation of funding is. Like from the government's perspective, has it been allocated to the various funds yet? Or where in that process is it up to now?
I don't know the answer to that across all the funds, but I think the answer is they have not yet allocated and they're still working on that process, but that's precisely why I wanted to meet. And we had a meeting on scheduled for May, but that's in the Heart Rhythm Society, HRS. It's our largest U.S.-based trade show [ is ], and so we put that meeting off until after HRS when Nick will come to town and we'll go up to North Dakota together, and we'll really get some plans in place to see where this -- where they're at and how we get it moving forward.
Next question submitted. When do you expect to break even?
Well, look, that's a good question, and it's something I'm very focused on. But the great thing is that our cost base from here on out can remain pretty stable even as we start to scale up revenue. So we'll be in a position to deliver significant operating leverage as we move forward. And we're not going to guide anyone at this point on when that will be, but you can do the math. It's pretty simple. If we had, for instance, just 40 labs doing, say, 100 procedures each, we would be in a really good place. And entering the U.S. and Middle East on top of Europe will kick this off even more rapidly. So if you think about the 1,000-plus labs in Europe, the 1,500-plus labs in the U.S. and the many more across the rest of these countries in the world, it doesn't take much market share for us to generate significant revenue and profits. So it's coming. It's something that I am, like I said, very, very focused on. And yes, that is -- it's sort of job one for me.
Steve, just a continuation on that question. How many quarters of funding have you got left? And what's the funding plan?
Well, as I think everybody knows, this is an area Nick Corkill, our Vice President of Corporate Strategy, has been focused on quite slowly. So Nick, why don't I let you address this question?
Sure, Steve, and good morning, everyone. Funding is something we are very, very focused on at the moment, and it's exciting to have quite a few things on the horizon. I joined Imricor in March, which has allowed Steve to focus most of his attention back on to the commercialization efforts. I think he's been to Europe 3x in Q1, and we can already see the positive impact that is having on the business. So the first thing, and we discussed this with [indiscernible], Pioneer Capital, they are -- they're still highly engaged. And as a reminder, they have already completed all the due diligence. So now it's just working through the mechanisms with the state government to have those funds to spur so they can make the targeted investments. So we'll give you an update once we sit down and work out timing. It sounds like it's not a matter of is it going to happen, it's just what the month it's going to land. And so that's a very attractive source of capital, one, because it's coming in U.S. dollars, and with the Aussie dollar being quite weak, that's quite attractive, given our cost base is mostly U.S. And the other thing is that it's at a target price significantly above the current share price. So that reminds me, Imricor has been quite successful in the past of raising money at a premium to the current share price. So HR Global out of Florida, they started as a small investor and then they did a site visit to meet the team and look at our lab in Minneapolis and were so impressed that they ended up participating in a placement at a 27% premium and have now become a substantial shareholder, owning over 6% of the company. The other thing I'd say is Imricor is becoming and is going to be a global company. And so as we now enter the Middle East and we start getting closer to entering the U.S., we're getting a lot more inbound interest from global investors. So we're having meetings in London, New York, some conversations in the Middle East. And it would make sense, I guess, because the past has really been about the R&D investment that Steve mentioned. The future, now that all that work is done and the products are complete, now proven to be safe and effective, now it's the exciting part, which is commercialization, scaling up and building revenue. So that's naturally becoming -- having broader appeal to investors. So look, we're feeling pretty positive about the future and some of the options we've got in front of us. But yes, it's a key priority, and we'll get that done because there's no use delivering these positive milestones unless we've got the balance sheet shored up to deliver on the future.
And just last question submitted, can you just give us an update around TGA approval was expected late last year? What's the update there?
Yes. That's a great question as well. I mean I can't wait for TGA approval. I think it's going to be super exciting to be able to talk to everyone in Australia and New Zealand about technology as it's finally made available to you and your loved ones. I mean the TGA process has certainly taken longer than the guidance we received last year. But all Class III products are facing the same kind of delays in Australia, and it's not just an Imricor-specific thing. What we have learned is that once the TGA completed their work, the submission then goes to an independent clinician for review, and our understanding is that the clinician has started working on ours then got relocated. It got sent to another clinician, and the whole process started over again, right back to the beginning of the Q. As we understand it, as of last month, they were reviewing -- this clinician was reviewing the submissions from last July, and our submission got to him or her last August. So we're feeling pretty good that it's coming soon. And really, we can't wait for that. We've got our distributor, Regional Health Care Group, across Australia and New Zealand, all set up and ready to go. Our sales team has met with them. I've met with them personally in Sydney, and we are -- we have a list of first sites to go and target. So it's going to be awesome. And -- but we can't control when it comes. I just do believe it's coming quite soon now.
And just one last question. How many of these labs have dedicated installed MRI machine, and is this a bottleneck to grow?
Well, that's a great question too, because this person has been paying attention, right? We've been talking about this shift, especially last year and maybe even 6 months into the year prior to that, that we -- this idea that you are borrowing an MRI lab from radiology to do these procedures is technically possible, medically possible, but logistically challenging. So what we started focusing on about 1.5 years ago now is -- are sites that have dedicated iCMR labs. That means an MRI that the cardiologist owns, which isn't necessarily a commonplace, but this is exactly what happened to X-ray equipment many, many decades ago. It's what happened to ultrasound equipment about 3 decades ago. You can't go to your cardiologist, for instance, today without finding an echo machine. But when I was making ultrasound machines in 1990, that wasn't the case. They were owned all by radiologists, and cardiologists sort of adopted them. That's happening in MRI now. And so we are giving a good reason for that to happen along with the cardiac diagnosis that cardiologists want to do with MRI. So as we look forward, we still have a mixture, but we're really focused on dedicated labs. The 2 you see on the screen right now, those are -- actually no, that the top one is a dedicated iCMR lab and the bottom one is a radiology lab where we bring in the equipment, and Dr. Chaldoupi does her procedures in that lab. But we're always talking to any one of these sites where it's a borrowed resource about their longer-term plans of adopting. And one of the greatest examples of that is the top site here. Dr. Marco Götte, when the pandemic hit, he had a temporary borrowed lab. And then during the pandemic, that lab was shut down, and the lab you're looking at here, he found after COVID subsided. He found another lab that he could work in, and this is where we're doing procedures today. But the overall goal, which is in place now, is a brand-new cardiology center that is entirely centered around geographically, architecturally, and conceptualized around an iCMR lab where they'll be doing these procedures. It's a big part of their new cardiology session. And down below there, Dr. Schwitter in Lausanne at the CHUV, which -- I mean, if you follow hospitals, if you look up the Newsweek Best Hospitals in the World, you're going to find Amsterdam as the best hospital in the Netherlands, and the CHUV in Lausanne University Hospital is top 5 in the world, as is Charité and Johns Hopkins and on and on. But that is a brand-new dedicated iCMR lab that you're looking at the bottom left of the screen. So that's not a process that he started last month and got done this month. That's a process we started with him 1.5 years ago. And it was tight for a while because funding after COVID was difficult, but that's loosening up and the time lines are accelerating. And this is one of the reasons why ventricular tachycardia ablations are going to be so important. Not necessarily even that we finish the trial, but that we show the world what you can do with MRI doing a VT ablation, a complex ablation, where the MRI shows you where to ablate, and the MRI shows you that your lesions are durable. That is going to tell all the doctors in the world who want to do this, it's going to give them a great reason to go to their administration and go, all right, now is the time. If we want to be not behind in 1.5 years from now, we have to start working now to establish our dedicated cardiology iCMR center so we can do state-of-the-art ablations like they just did in Amsterdam.
Steven, just one continue on question. Is NorthStar compatible with all 3 brands of MRI machines?
It is technically, yes, but not regulatorily-wise yet. So the first place we -- the first system we made it work on was the Siemens system, and that's what is out in the world in various studies to be used as part of the routine clinical work. The next system will be the Philips system, and it will -- NorthStar will replace what used to be the Philips iSuite mapping system. But that's going to require a software upgrade that won't be released until later this fall. And then following that is it's working on the GE system, which GE, [ in fact ], they're the last to come to the party, but they're paying us to adapt NorthStar and the rest of our devices for their systems. So that's coming soon as well. And both of those, we're hoping will be sort of ready at the end of this year. But for now, it's -- practically out in the field, is a Siemens solution for now.
We just got a question from Charlie Manchester.
No question from me. Thanks for the update.
Another question. Are you working on a pulsed ablation device?
So you know what we did is quietly in the background, we tested our existing ablation catheter, the Vision-MR Ablation Catheter, the one that we're using every day for RF ablation. So we tested that with a third-party PFA, pulsed field ablation, generator. And that work was first released at the German Cardiology Society and then at the European Heart Rhythm Society -- or Heart Rhythm Association, I should say, just last month and the month before. And it works. So we're pretty excited about that. Now we don't -- and we've never wanted to be too distracted by every new technology that comes along, because since I started this company, there have been -- we started with RF ablation. That was the gold standard, and is still today the gold standard. But in the meantime, there was high-intensity focused ultrasound ablation, there was microwave ablation, there was cryo or freezing type of ablation, there was laser ablation. And everyone got really excited about all of these, and none of them really panned out. PFA, we've had an eye on for a long time. I've been talking about it for a long time, and I felt like it had legs, and I do think it does. So we started doing the research work last year. It doesn't cost us anything to do this with some universities. They just can do the work and publish the results. And now we're in the process of thinking what our PFA strategy would be and how we can move forward. But what we do know and we've shown is that our MR compatibility technology doesn't stand in the way of PFA. And what I've always said is this: no matter what energy source you use to ablate, you still suffer from a fundamental limitation for these devices -- for these procedures, which is you don't have a procedural endpoint. You don't know when you've ablated enough, but not too much. And in fact, Dr. Vivek Reddy, who's one of the strongest proponents of PFA and has done much of the early work at the EHRA, the European Heart Rhythm Association Congress, said exactly that. So the biggest limitation for PFA right now is a procedural endpoint. We don't quite know when we're done. We just have to wait and see when the patient goes home if what we did was durable. Well, that's what MRI can add to PFA exactly the same way it adds it to RF. So it's not a competing technology, but it's one that we're going to want a fast follow on so we could offer that to our iCMR customers as well.
Thanks, Steve. That can close the Q&A. I'll just hand it back to you for closing remarks.
All right. Well, thanks, and thank you, everyone, for joining us today. I know we've covered a lot of ground, but the message is really quite simple. We're growing our revenue base across Europe and soon in the Middle East, we are making rapid progress towards FDA approval, and we're on the verge of doing our first VT case, which we expect will accelerate adoption of new hospitals and drive increased revenue. We have so much look forward in 2024, and we're off to a really great start. I'm excited to share the updates with you as the year progresses, and I wish you all a great day.