Good morning and welcome to Imricor's Q3 Investor Webinar following the release of the results to the ASX this morning. From the company today we have Founder and CEO, Steve Wedan, and the company's CFO, Jonathon Gut. Before I hand over to Steve to go through the presentation released on the ASX this morning, I'll just remind you that you can ask questions that will be conducted through the Q&A panel at the bottom of the screen, and we'll get to those post the end of the presentation. Steve, I'm gonna hand it over to you to get started. Thanks very much.
Thanks, Simon, and thanks everyone for joining us today. As Simon mentioned this morning, Imricor released its Appendix 4C for the Q3 of 2022, and we'd like to discuss these results as well as provide a general business update. John will begin by presenting the quarterly cash flow results.
Thank you, Steve, and hello, everyone. As a reminder, all numbers are unaudited and in US dollars. The net cash outflows from operating activities were $4.7 million for the quarter, which was up approximately $500,000 from the prior quarter. Receipts from customers of $246,000 during the quarter were primarily comprised of sales of consumable products and equipment. Overall, cash outflows in relation to operating costs were higher than the prior quarter. This increase was primarily driven by the payment of annual insurance premiums during the quarter, a portion of which were financed through a short-term arrangement that will be repaid in 10 monthly installments. Adjusted for this financing item, payments made in relation to operating costs were $4.2 million, which represents a decrease of 7% compared to the prior quarter.
Net cash outflows for investing were $121,000, largely relating to the purchase of property and equipment. Net cash inflows from financing activities were $2.7 million, primarily reflecting the funds raised from the oversubscribed placement we completed in September. This figure also includes the $839,000 received as part of the insurance premium financing arrangement mentioned earlier. At September 30th, we had a cash balance of $6.9 million. With the hospitals who use our technology being in Europe, our consumable products are priced in euros while our financial results are reported in US dollars. The strong US dollar negatively impacted our reported revenue during the quarter, with consumable product revenues totaling $115,000.
Without adjusting for the change in exchange rates between periods, these revenues were down 15% compared to Q2 2022 and down 2% compared to Q3 2021. If we remove the impact of the exchange rates, consumable product revenues were down 14% compared to Q2 and up 12% compared to Q3 2021. I'll hand back to Steve now for the rest of the presentation.
Okay. Thanks, John. For those of you who may be new to Imricor, I'd like to provide a brief overview of what we're doing and why it's significant. Very briefly, we are transitioning cardiac ablation procedures from the conventional electrophysiology or EP lab, which utilizes X-ray fluoroscopy imaging as its backbone, to a new kind of EP lab where magnetic resonance imaging or MRI is the imaging backbone. We call this new kind of lab an ICMR lab, or interventional cardiac magnetic resonance lab. In order to make this transition, we've developed a platform technology that allows us to develop the same kinds of tools that doctors use today for cardiac ablations, like ablation catheters for instance, with the additional characteristic of our devices being uniquely safe for use in the MRI environment.
This in turn allows physicians to perform cardiac ablations while imaging the patient with real-time MRI throughout the procedure. Meaning that for the 1st time, they can actually see the patient's heart, and they can see the physiological changes that occur as they deliver ablative therapy. The overall goal of what we call real-time ICMR ablations is to provide faster, safer, and more effective treatments of arrhythmias compared to conventional means, and to do so in an environment that is 100% radiation free for both the patient and the physician. Here are some investment highlights, which for this presentation I'll just pass over for now. Looking at our company timeline, you'll see that we've been at this for a long time. After 14 years of R&D activities, we launched our products commercially in Europe in 2020.
That launch, however, was thwarted by the pandemic, which effectively shut down our hospital customers and these types of procedures for over two years. However, we didn't stand still during those two years. We continued to develop the new products and third-party relationships that would open the door for new indications beyond our initial indication of atrial flutter. Now, as we relaunch our products for treating atrial flutter, we find ourselves prepared to take our next big step towards treating ventricular tachycardia or VT. Specifically, in Q3, we submitted for approval to initiate a clinical trial intended to prove the safe and effective use of our Vision-MR Ablation Catheter for treating VT. The trial is called ViVTal VT, which stands for Vision-MR Ablation of VT.
Looking at our path forward, you'll see that ViVTal VT is the next key step in our strategic plan as we grow our indications. As we continue to progress, we'll expand our geographies and continue to grow our indications until we're addressing the entire cardiac ablation market. Another very significant development for Imricor this quarter is the completion of our initial prototype 3D mapping system, which we plan to deploy for physician feedback and validation in the coming weeks at customer research sites operating with the Siemens MRI scanners.
We call this 3D mapping system NorthStar MR because it helps physicians navigate through an ICMR procedure and with a nod to our home state of Minnesota being called the NorthStar State. NorthStar MR is extremely significant to our business as it removes our reliance on others to develop 3D mapping systems needed for complex ablation procedures, and it puts control of our timelines back in our hands. Those of you who have followed the Imricor story for a few years will appreciate, multiple 3D mapping systems from various MRI partners were supposed to be commercially available by now, yet none are. With NorthStar MR, we're changing our partnership relationships, and we're taking back control. Everyone, including the MR manufacturers, is excited about this change.
Developing Northstar MR ourselves also ensures that we design the system to have the functionality that our physician customers need, and that we can continue to improve and expand its capabilities rapidly as we evolve this new standard of care of real-time ICMR ablations and other interventions. The 1st targeted MRI systems for Northstar MR are the Siemens platform systems, but we're also progressing toward making Northstar MR work with MRI systems from GE Healthcare and Philips. In the end, we plan to provide physicians with the same tools and the same 3D mapping environment no matter what MRI system they employ. Next, I'd like to share a brief update on the business and the outlook for Imricor. Our key focus areas are largely the same as we've discussed previously, with one new additional focus in the area of commercialization.
That is, our sales team has a renewed focus now on establishing new sites with ICMR labs that are owned and controlled by cardiology. One thing we found this quarter was that sharing a radiology-owned lab with cardiology presents logistical and schedule difficulties despite everyone's best intentions. With this new focus, we're emphasizing that we are bringing MRI to the EP lab rather than bringing EP into the MRI lab. This is an important distinction. ICMR labs should be just like conventional EP labs, same owner, same location, but only different because there's an MRI in the room instead of an X-ray fluoroscopy system. This has always been our long-term strategy and plan, and now that we have gotten a base set of sites operational in a very short period of time, it's important that we grow this new field properly and predictably.
I've touched on some of the highlights from the quarter already, such as ViVTal VT and NorthStar MR, but we also commenced procedures across three additional sites, and we continue to pursue various financing opportunities across many different areas. In the quarter, we raised AUD 2.92 million from US investors via an oversubscribed private placement, and we advanced the process of pursuing various economic development incentive programs that exist for companies like ours in our space. Plus, we continue to pursue additional financing options outside of a standard ASX placement, and I look forward to announcing these as we progress through the Q4.
As we stand now with nine active sites, more sites ready to activate in Q4, visible VT on the immediate horizon, NorthStar MR ready for clinical use and validation, and a renewed and updated sales strategy that focuses on delivering controlled, predictable, and sustainable growth. We're well-positioned to fulfill our mission to make a huge impact on patients' lives and do nothing less than change the standard of care for interventional medicine by bringing 21st-century imaging into the interventional lab. With that, I'd like to hand it back to Simon and open it up for questions.
Great. Thanks, Steve. Thanks, John. Just a reminder, if you did wanna ask a question, you can do so through the Q&A panel at the bottom of the screen. We'll just pause to see if any questions come through. Thanks. 1st question, Steve. Can you just talk through the timeline that we can expect with regard to VT approvals and procedures and what that sort of looks like in terms of importance?
I'm not sure what you mean by in terms of importance. I can talk through the timeline. It is, of course, a regulatory timeline, meaning that we're not in control of every aspect of it. The process goes like this. We submit to the ethics committee at our primary investigator site, and after the ethics committee at that site approves the package, then it gets submitted to the competent authority, in this case, in Germany. When they approve it, then we have authority to begin the trial. We've gotten the 1st feedback from the ethics committee. We are talking with them next week. They're actually traveling this week, but next week we'll talk with them, clarify all the points and submit our responses to that.
We hope that this will be a pretty streamlined procedure, and we'll move on to the BfArM. That's the German competent authority, submission and approval pretty quickly. It just is impossible for me to say how long the process will take, but we are preparing to start procedures as soon as we get the authority to do so. Meaning that we're talking with our primary investigators. We are planning the preclinical practicing and all of the protocols are worked out and workflows are discussed and practiced. It's all ready to go as soon as we have the authority to do so.
Great. Thanks, Steve. We've just got a question from Sarah Mann at Morgans Australia. Please unmute yourself and go ahead, Sarah.
Hi. Can you guys hear me okay?
Perfect.
Yep.
Great. Look, just wondering if you would give us a bit of an update on monthly procedure volume. It's fully acknowledged, you know, the quiet period during the European summer, but can you give us an indication of what kind of the monthly run rate was in September and kind of how you're tracking in October, just to get a feel for what the Q4 might look like?
Sure. What we found is that we did have a long bit of an elongated European summer holiday, I think, after folks were locked down for so long. That notwithstanding, we sold as many kits as we did in the previous quarter. It's just to different sites, and because of the strong dollar, the revenue looks a bit different. I will say this is not the quarter we expected to have. We scheduled many more procedures than we actually performed, and it's where we learn those lessons that we are immediately putting in place now. One of those primary lessons is that we have to be very realistic with our early sites to know how many procedures they can do on, for instance, day one.
We have to make sure that they've scheduled enough time at their MR scanner over multiple days to get these procedures done, because the 1st ones take a couple of hours. It takes a while before you get into the workflow of doing these procedures in the normal time. What we found is this availability of scanner time was resulting in our procedures being canceled and having to be shifted to the conventional lab. That's a big takeaway of what happens when cardiology is renting or borrowing time from radiology. It's why it's so important that as we move forward, we have more sites that are where the ICMR lab is simply another EP lab that the cardiologists have at their disposal.
As some cases go along, which in any intervention will happen sometimes, that you just shift the same way you would do in a conventional lab. There was a week, for instance, where we had 12 procedures scheduled, and in the end, only four procedures were performed. It's because of these scheduling difficulties, and that is something that we already made large changes to combat that in the future. We won't see that as we move forward. I expect that this next quarter will be better, both because we'll have, you know, hopefully three solid months, although Christmas holiday, you know, tends to disrupt the end of December.
Not only that, but because we'll have better planning and setting better expectations with our customers and making sure that we're stressing with them regular procedure rates. Not three procedures one week and then three procedures a couple of weeks later, but procedures every week, getting them into the good workflow, getting the efficiencies built into the procedure and the familiarity that comes with you know with that muscle memory and repeating the same procedure over and over.
Got it. Just in terms of numbers, like, I don't know, did you do 20 procedures in September? How has that changed with those learnings that you've kind of taken going into October?
Well, Sarah, that's a good question. I don't have the procedure number in front of me here.
Okay. It's fair to assume that.
I'm just trying to get the answer.
It's fair to assume that, you know, given you have the learnings of what happened in September, like, the October run rate has improved on September in a way.
Yeah. We expect the October run rate to be better. Well, actually, we're in October. Yeah.
Yeah.
We expect the October and November run rates to be improved. It's true.
Got it. Okay, cool. You also flagged, in kind of your outlook commentary that, the plan in the Q4 is to be able to sign more sites. I mean, how confident are you that, those sites will be able to come through or is timing, I guess, still a question mark around that?
Well, yeah. We're actually very confident. One of the sites that we thought we would announce last quarter is a site where the whole system and our multi-year contract for guaranteed volume went out to tender. The tender was approved. It's all in a process that should have been wrapped up already. A new attorney started at the hospital and wanted to review again to make sure that everything was following all of the rules. That review is happening now, but it should be complete, you know, any moment now. That's not a new site. We've been talking about that site for a while, since the tender was issued and since we won that tender. Yeah, these things continue to, you know, it just takes time.
These are large, you know, commitments that hospitals are making when they start doing our procedures. They're dedicating not just, you know, the time of the physicians, but also space in the hospital, and they're buying capital equipment to outfit these spaces. We have also learned that it takes a bit of time. One of the things the sales team is also refocusing on is having realistic expectations for establishing lab and giving the hospitals the time to properly budget and properly plan for installing an ICMR lab that's cardiology-owned. We also still have the two sites that were under construction. They're still under construction. They'll finish that construction, it seems, on time. We expect that they'll be signing it this year also.
There's a third one who's in the late process now of budgeting for a new construction project that will happen early next year. That's what we hope to see as we move forward, is that our people will be talking about new construction projects and new labs that are cardiology-owned. It's gonna make a big difference because instead of, you know, limping along at some of these sites where they can't get the MRI time, it would all be in control of the physicians that are doing these procedures. That'll be a very positive step forward. I'll also say this, though.
I think a better metric going forward is how many sites are active rather than how many sites we sign, because as we look at a longer-term strategy of establishing cardiology-owned ICMR labs. That as I've said before, we're the furniture that goes in the room. So the last thing that they'll do, even after 18 months of planning, budgeting, and building a lab. At the very end of that process that they've been doing the whole time so that they can do our procedures, it's only at the very end that they'll have a contract signed with us. So I think a better metric for growth is the number of active sites that we have. You'll see that grow as sites come online, as they sign with us and as they start doing procedures.
I've also gotten some pushback regarding, you know, what is a price-sensitive announcement. I think it's probably appropriate time for us to save the announcement for new lab signings and new activation of labs for these types of quarterly results. I wouldn't expect that we'll send an announcement out the moment the site that won the tender, for instance, the moment that they sign. I hope that at the next quarterly result briefing that I'll be talking about having started procedures at that site.
Got it. Okay. Just maybe with regards to the VT trial process, I know you-- someone already asked, a question, and you said kind of the review's underway, but I noted in your presentation it says, you know, it's tracking along on time. Can you, like, give us any indication as to when you expect to commence the 1st patient? Like, are you still kind of holding to before the end of this calendar year?
It can still happen this calendar year, and that's still what we're planning for and all hoping for, but with the caveat that we cannot control that timeline. If it doesn't start this year, it will start shortly in the following year. We have a plan to speed enrollment, to open sites up more quickly and get on track for the six months or so of enrollment that we're planning.
Okay, great. Like the issues that came out of the 1st round of questions, was it all kind of as expected and easily addressable?
I think so. I mean, I'll give you an example of the feedback we got. One of the comments was, "Gosh, there's a lot of investigational devices." It's true because what we're doing, as we've said many times, everything you use in a VT ablation case in an ICMR lab has to be a MR-compatible MR core product. Plus, we have third-party partners like MiRTLE Medical for 12-lead ECG and MIPM for their MR-compatible defibrillator. When you do something this significant, there are going to be necessarily a lot of new devices in the mix. We just have to talk through that. One of the things that we don't want to do is just write a response and then, you know, send it over.
We'd like to wait out this week, and when they're all back at the ethics committee in Leipzig, have a phone conversation, a call like this, to make sure we understand what they're asking and that they understand our responses to that. Yeah, it's moving forward well.
Okay. No worries. Is there any more, I guess, color you can give us around kind of your various funding opportunities that you're pursuing? You mentioned, you know, kind of ones beyond raising capital on the ASX, like, for example, some of the, I don't know, regional grants. Can you give us an update around how you're going on that front?
Yeah, that front is in terms of the economic incentive programs that exist in our region, and in nearby cities, we are still pursuing that just the same way we had talked about before. It's a process, and they are strung out over, you know, a given amount of time. The process is happening the way we had hoped it would. It's one month delayed more than I was hoping, but they didn't have a meeting one month. We're on the agenda, for instance, for a 1st program in November, and that's where they decide whether we can come and present the business and the opportunity in December. It's all moving the way we think it should. We're talking to the right people.
We're engaged with the right leaders, and they know that when we talk about, you know, helping grow a med tech space in an area that wants to incentivize that we mean it. And we're really gonna do that growth and support the initiatives that they're, you know, trying to forward.
So-
Yeah, go ahead.
If you're presenting in November and you get the cash in December, are there other initiatives or any other things you can do to kind of reduce costs? 'Cause it's yeah, just looking at the quarterly, you've only kind of got cash runway through to kind of the end of the year.
Yeah, we do have other things that I'm not prepared to talk about, but I'm not concerned. I hope that gives some comfort. I hope we'll be talking about them and we'll announce them relatively soon.
Very good. All right. Thanks very much, Steve. I appreciate that.
Mm-hmm. Sure.
Great. Thanks. Final question, Steve. Since Imricor does not have direct competition in this market, what is the largest hurdle to convince a hospital to purchase? There are many clients interested but waiting for the necessary budget to build out a lab.
It's a really good question. One of the things that the sales team has been asking for that now we are actively providing, working with them and an outside consultant and our MRI vendor partners on providing is essentially a business plan that doctors who want to do these procedures can present to the administration at their hospital. 'Cause you know, they're just saying, "Look, we need some help to make the money case. I'm a physician. It's not my wheelhouse. So can you give us the metrics that I can present to my administration?" We think that will have a good positive impact on budgeting. The other thing is that we give them the time to budget and properly plan.
In the past, we wanted to get a bunch of sites up and running, even if they have to borrow time from their radiology partners, because we needed sites to do clinical trials, and we wanted to get some publications going and all those types of things that build momentum. That a lot of times means us being a bit pushy, maybe, placing systems rather than selling systems because we can't ask people to, you know, create money out of a budget mid-year. Now we can take the time to do it properly. In the end, we'll make more money and we'll spend less resources on, you know, working at sites where it's just not they're not fully set up yet to do these procedures because of that MRI availability.
In the end, there's a couple of tools that we need to provide our team to provide physicians to help them make that case in their hospital. Otherwise, this is pretty straightforward and it's gonna be a big deal when we do ventricular tachycardia ablations. Not finish the trial, but when we do our 1st ventricular tachycardia ablation and show the world that it's not a dead-end technology at just atrial flutter, but we are doing what we said we were gonna do, which is delivering advanced imaging capabilities to complex arrhythmias that need that imaging those imaging capabilities in order to improve their effectiveness. These will all be things that we expect to catalyze the market in the way we've talked about for years now.
Great. Thanks, Steve. That concludes the Q&A segment. I'll just hand it back to you for closing remarks.
Well, thanks and thank you everyone for joining us today. We will, of course, continue to keep you updated as things progress, and I hope you all have a wonderful day.