Acarix AB (publ) (ACARIX) Earnings Call Transcript & Summary

October 13, 2023

Nasdaq Stockholm SE Health Care Health Care Equipment and Supplies special 59 min

Earnings Call Speaker Segments

Unknown Attendee

attendee
#1

Hi, all of you. Welcome to Erik Penser Bank in Stockholm. And in the U.S., we have acting CEO, Fred Colen, CEO of Acarix with us. And we wish you to -- wish you a warm welcome to this presentation with Acarix due to the capital raise they are currently conducting. They are raising some SEK 54 million. I will get back to that later into the show. First, we will give the word to Fred Colen and he will give you a presentation of the company and the focus in the upcoming months and also especially focused on the U.S. market. So I give the word to Fred Colen, please.

Fredericus Colen

executive
#2

Yes. Thank you very much, Dan. Good afternoon, everybody in Sweden. This is Fred Colen, I'm joining you from the United States. And I would like to go through a few slides with you to really give you a little bit of a background and information about the Acarix company. And I hope that you're able to follow me on the slide deck. I know it's being broadcasted. So let's just go through this. First of all, there are a couple of slides that are important for you to read as it relates to this presentation and put the presentation in context so that you understand the purpose of it and what we want to say and what we do not want to say, that's basically what's stated here on Slide 2. And then obviously, here we have the typical disclaimer that we always have to show. It's important that you read this and actually understand the meaning of the presentation today in the context of also this disclaimer. So with that said, let me just talk about Acarix. I'm very pleased to be joining the Acarix team and to continue the journey that Acarix is on. Obviously, we are on a mission to transform early cardiac diagnostics. That is the mission of the company. It's very important for us to stay focused on that mission to transform it early. And I would say, I would like to emphasize early cardiac diagnostics for patients that have suspected coronary artery disease. So let me just explain this a little bit more in detail. So basically -- and this is basically to put this in the context of what's happening. So there are a lot of patients that go to either clinics or primary care physicians that have chest pain. They have what we call stable chest pain. This is obviously not dealing with patients that have an acute infarct. That will be a totally different scenario. But this is with patients that have chest pain, some issues with maybe breathing on a more continuous basis. And there are a lot of these patients that are seeking attention and are seeking basically what's wrong with me, what's happening when they go to the doctor about this. It's a large problem for the medical societies in Europe and in the U.S. and it is estimated that there are something like 20% to 40% of the adult population that deal with these kinds of issues. Now when you have the situation, these patients go to their primary care physicians or the hospitals. It has -- it is shown and it's in the literature, that 9 out of 10 of these patients actually do not have a significant coronary artery disease. But obviously, these patients need to be dealt with. And how do you actually deal with that situation in the most appropriate and also cost-effective manner. And basically, that is our mission. We want to be able to provide for an early diagnostic tool to rule out patients that are at a low risk for a significant coronary artery disease. So that is to put it in further context about what we do. Now, what is it? How do we do this? Basically, what we have is a system that's based on acoustics. We basically listen in a very sophisticated and calibrated manner to the sounds that are coming from the heart and we can listen to the flow of the blood in the coronary arteries. And we can, by doing a lot of research and calibration on this in the last 15 years, we can now basically with a 96.2% certainty level rule out patients that have significant coronary artery disease after doing this test. And you see on the right, the picture there. It is a first-line diagnostic aid that basically provides for a much more sophisticated manner to deal with these many, many patients that go to their physicians and in a cost effective manner, like I said. The device has been used on more than 29,000 patients based on the 15 years of R&D work that we've done. And it is covered by 45 patents. We also have European CE Mark and FDA De Novo approval for this device. And we worked closely with the American College of Cardiology, ACC, to work on not only a workflow, how could this product be used appropriately in the diagnostic care process but also on obtaining a specific CPT III code for our diagnostic system, which is available and effective as of July of 2022. So here is basically how this works. Again, in the middle of the slide, you see in blue, transforming clinical practice, that is the key. And on the bottom, you basically see what happens to these patients that come to a doctor or a clinic with stable chest pain and suspected coronary artery disease. They can go through a lot of different tests. What we are saying is, well, we think there is a place for this device as a first-line diagnostic aid to be able to figure out how these patients really at a risk for severe coronary artery disease or not and hopefully to provide for better diagnostic and decisions for these patients. So that is basically the process that -- on the bottom, that is currently in place. And as you see, quite a few of these processes, not only provide for an expensive process to diagnose these patients but also have associated with radiation for the patients that can be avoided if you really don't need to go through these tests. Now again, we worked with -- in a collaboration with the American College of Cardiology on the proper workflow and you can see that workflow on the left. Basically, there is a distinction between patients that have -- that are older than 70 years old and might have multiple risk factors or comorbidities. They will not be going through the CADScor System but all other patients would be. That is the proposal and then you can see when you use the CADScor System, depending on the readout of the score on the CADScor System after doing this test, either it is being ruled out that you have a significant coronary artery disease or if you have a CADScor that is more significant, obviously, we will then, with urgency, actually refer the patient to a cardiology for further diagnostics and potentially treatment. This workflow that was developed together with the Association of -- American College of Cardiology was -- and the very first clinic adopted by the Southeast Louisiana VA, the Veterans Administration facility. And actually, it was adopted by them and it was released in their standard operating procedure. So this was a major step. This happened earlier this year where the VA in Southeast Louisiana adopted this proposed new workflow and actually released it in their standard operating procedure. There are other institutions that we are working on that are considering to do the same. But obviously, this is an extensive path that you have to go through to convince these people that this is indeed the right workflow for a diagnostic -- for optimized diagnostic pathway. So basically, historically, this is a bit of a historical perspective. The company was mostly focused on the European market with work done primarily in the DACH. That's mostly Germany, Switzerland and Austria, as well as the Nordics regions and some clinical work in the U.K. And now the focus really has shifted to the U.S. market. The company is really focused on expansion and in that expansion plan is focused on doing that in the United States of America. And when you talk about the U.S., again, we have FDA De Novo approval of our system. There are about 13.5 million chest pain patients per year that are happening in the United States and we estimate the total -- what we call available market for this product in the United States to be about $1 billion. So it is a phenomenal opportunity as it relates to a potential market size. We are also aiming at an attractive high-margin business with a gross margin of greater than 80%. We are selling the system itself and then there's recurring sales with the ongoing use of the single-use patches. And the single-use patches are identifiable by the system. So it is very, very difficult, if not impossible, to use other patches than the ones provided by us to have a functional system. Then the next one is basically laying out -- again, now in particular for the U.S. market the opportunity. Here we have on the left, 13.5 million patients. We offer unique solutions. This is actually very unique, which is also what attracted me to take on this temporary role. This is quite an interesting novel diagnostic tool and it is unique. There is nobody else. There is no direct competition for a scoring system for coronary artery disease, that's basically the way we are doing it. There's nothing else available in the market. And obviously, we are in the process of getting more visibility and getting this into the market in the U.S. We're going through a market development activity in the United States since this is novel and unique. We have approval by the FDA and a specific CPT III usage code, meaning that the clinics who use it, use this particular CPT III code to basically document the use of the system for reimbursement purposes. And on the right, you see the workflow that we've collaborated on with ACC and that we are working on introducing in more and more clinics in the United States. Now as it relates to growth over time, here you basically see where we started. We started in 2022 on a very, very small scale. In December, we had a bit more coverage and then you see on the right in 2023, how we further expanded. We have a hybrid sales model. That means we have 1 team under 1 sales head that is essentially a hybrid sales organization. You should think about this as a small group of direct and fully employed employees and then we have a much larger group of reps that are basically paid by a commission on the sale. So these other reps, the majority of these reps are not on our payroll. This is an important point to understand. That keeps our expenses down. These reps, the majority of them are already working in clinics and sell all kinds of different products, including ours. And then when they do sell our product, they are being rewarded by a commission on our products. So this is the model behind how we're going into the U.S. and how we are developing the sales. It's a low-cost model with experienced reps that are in the clinics and the only drawback is they don't just sell our system. They sell several devices and products, including ours. The sales channels, there are several. We have, as a priority, the Veteran Health Administration, VA system in the United States. That is important because the VA is completely responsible for all health care expenses of their military personnel as well as their veterans. And so they are very interested in savings. If there is any waste in that system or ways to do it more effectively with less cost, they are quite interested in that because they are completely responsible for all of the health care-related expenses for their personnel. That is why the VA is really important for us to focus on. And -- but outside of that, we have other IDNs, integrated delivery networks. So you can call the VA, the largest integrated delivery network with 100% coverage of what they need to provide for. There are other groups in the U.S., IDNs, where you have more of an integrated approach between ownership of clinics as well as provision of insurance and that is the second highest category of interest. There you will not have a 100% coverage of all the patients, not all the patients that are treated in those hospitals will have the insurance of that same hospital system but a quite a percentage of them do. So that is an important next phase for us to focus on. And then obviously, we are interested in looking at primary care facilities and clinics to expand the sales. And as you see on the targets, it is obviously very important that we get cardiologists on board, that they understand the system. And it is very important that the utilization happens primarily in the primary care because that's what we like to do. We are -- we like to provide for an early diagnostic tool, so obviously, primary care is a focus of that. ED stands for emergency departments. Also there, there are quite a few patients that actually go to the emergency department and they are also essentially primary care facility in many ways. So that's another area where we see a potential utilization of our system. So that's basically the context of the U.S. Let me just say, again, this is important. We are very much focused on the VA's health care system. And that is because of the fact that they are responsible for their personnel. It is a huge organization in the U.S., has a budget of [ $190 billion ]. There are 9 million veterans enrolled in almost 1,300 facilities. There are 170 medical centers and over 1,000 outpatient clinics. So this is a large, large network. We were very, very fortunate to have a very first order in early this year with the first order of some systems. This is from the Southeast Louisiana VA, that's where we made the biggest progress so far. And that is obviously important because that provides for what I call a beachhead to go further into VA system and to convince more VA organizations about the utilization and the benefits of the CADScor system. And here you see on the map, the different regions of the United States, you see here #1 and #2, it's Louisiana. That is the biggest area where we are in terms of VA. But there are other important VA centers, you see #2 up there on the upper right-hand corner in New York and above. There are some important centers there as well. So basically, what we were able to do in the VA system is we were able to convince the cardiologists at the Southeast Louisiana facility to adopt the proposed rollout of the model of how to incorporate the CADScor system in daily practice and they actually adopted this into the standard operating procedure. That process has started. The VA in Southeast Louisiana is actually starting to utilize that system. I have to say and I'm probably going to talk about that some more later on, the VA system is also notoriously slow. This is an obvious correct target for us to go after but they're also extremely slow in adopting changes and incorporating new systems. It's very well-known across the industry that the VA is about the slowest organization to adopt new therapies and new diagnostic tools. So this will take time. It will take time to roll this out. We are working with other VAs and we have made some good progress in about 3, 4 other VAs in the U.S. that are interested in actually also adopting this workflow into a standard SOP for them. And in those VAs, we are basically waiting for getting it approved in their system from a budgetary standpoint. Don't forget, this is a major savings for VA and we can demonstrate that and they actually are convinced of that but it starts with an investment. They first have to invest in this before they will see the savings. So it needs to be worked into a budget and the overall budget for these VAs is provided for on a national level and then on a per VA system. And in the other VAs, we have made the progress of convincing the cardiologists. They want to incorporate this into their SOP as well but there is what we're waiting for the approval of that approach into their budgets. That is basically where we are on this. And then as it relates to other institutions, other organizations that are interested in adopting the CADScor system, obviously, when they use it, they have to request for payment from insurance companies. This is not the VA but this is other organizations where we're starting to penetrate the market and that's a mission of getting paid for by these insurance companies sometimes run through without any problem and sometimes it gets denied. And then they -- these organizations have to go into an appeals process to appeal the fact that they weren't immediately reimbursed. And so then there is a process in place where we actually assist them with appealing the decision and to obtain still an approval for payment. So this also takes time to work through. This is not something that starts from day 1 and just rolls up. It is -- it's a process to go through. We have seen good payments for the CPT III code, on average at a level of about $170 per use, per assessment and sometimes even up to a level of $635 from certain payers, where we've also been denied by certain players. So this is a gamut of opportunity and -- and actual payments. So this is a work in process. This is an ongoing battle. This is very normal and standard in the United States, even very well-established procedures are typically overbilled and then actually reimbursed on a much lower level. This is a constant tuck-in battle in the U.S. health care system. It's not just, well, here's what you should pay and then you pay it. It's a much more complicated for us in the United States to get paid for your services. Then I'd like to just point out a few key players on the team. It is not so that Helen is the only person in the company. We actually have quite a good team in place. I'd like to point out that we have Christian as a CFO in the company very, engaged. Thomas, a very dynamic and active individual as the COO. He holds together a lot of the processes and initiatives in the company. And as of the last couple of months or last few months, I should say, we also gave him the opportunity to grow and to actually manage the European sales side. So Thomas is actually doing that now. He's very much focused on keeping the European sales going since a few months. We have a very long-standing member and I think a founder of the company at the bottom left here, which is Claus Christensen. He is the Head of R&D. He has been involved in the company for a very long time in developing the system. We are very proud of having him and the team and to provide a lot of the backbone for the device. And then we -- and then from there on, we have, I would say, a newer team in place since about a year or thereabouts, Jennifer Matson, our Head of Medical Affairs, a very experienced individual, who really works on the medical affairs side and putting together all the clinical evidence and data that we need to convince physicians and institutions to adopt our product. On the right, we have Jennifer -- Jen Anderson, the Head of Marketing and Communications, also a very experienced individual. She's actually at a conference in Tampa, in Florida at the moment for osteopathic physicians. So that's where she is, with a little [indiscernible] and making sure that people know about us. We have Carma Connely, the Head of Market Access & Customer Excellence. He is very close to the customers. She works a lot on training and reimbursement. So for example, if a clinic says, yes, we want to get going on this, we obviously need to train the individuals in the clinic as to proper use of the system. Alongside our experienced reps, we have actually sold some systems, who will now have a certain level of experience. Carma is very much involved in the what we call onboarding and training of a new facility. And she's also helping them with any issues on the payment side, as I talked about earlier. And then last but not least and most importantly, we have Mike in the middle there at the bottom, who has joined us in the springtime and Mike is the Head of the U.S. commercial sales side. Mike is actually the one who has the day-to-day activities under control for the U.S. sales side. He communicates with all of our sales reps in the field and pushes for U.S. sales and sales growth. So there, you have the leadership team on the right, you have the Board of Directors. I think that picture is known by you, so I won't go and dwell on that. Again, here is Mike. I think he is a key individual in our company. He has a lot of experience on the sales side, has been engaged in it for a long, long time and especially on the cardiology side. We're very happy to have Mike on board to assist us with the sales growth in the U.S. and the adoption of our early diagnostic tool to change the diagnostic care of patients with suspected coronary artery disease. Then another important thing is, we are in the process of building a new medical advisory board, in particular with clinicians and well-known physicians in the United States. We are in the process of setting that up. And we are very happy and this was recently also announced that Dr. Deepak Talreja has joined us as an adviser and as a first medical member of the Medical Advisory Board. We are in the process of working on additional individuals to add to this Board. I think it's very important that we get first line expertise and advice from these physicians as to how to best utilize our system and how to best penetrate the different medical work streams, in particular in the U.S. So more to come on this. We are working hard on establishing this Board. It is important to get the proper advice for us to how to penetrate the market. It's also important because of visibility in the United States. We need to maintain and grow visibility in the U.S., in the U.S. health care system and these physicians are very important for us to continue to grow in terms of visibility of the company. So last but not least, let me basically finalize this and kind of give you the summary slide here and what we are focused on. We are absolutely focused on revenue growth. It's all about sales. And in particular, in the U.S., we are investing in the U.S. -- in U.S. expansion and sales. The vast majority of our funds that we are getting into prior financial rounds and this one in particular, is focused on investments in the U.S. market, to penetrate the U.S. market, to expand in the U.S. market and to grow sales. That is the most important part of where your investments will go, to continue to grow the sales in the United States. And I went through why that's important. We see that as the biggest opportunity for the company. It's prioritized over Europe. That doesn't mean that we don't have Europe. We will continue to do what we are doing in Europe but we are not investing further into the European market. We are basically keeping that at a level that we have invested in so far. In the U.S., it is highly important that we keep working on the VA, although the VA is notoriously slow in adopting change. We are seeing a lot of progress in adapting this in other VA systems but it just takes time. I am confident that we will get there, just a matter of working through the different phases that you have to go through in the VA system. And we are also targeting other networks, in particular, IDNs that are also quite interested in this product. Again, like I said, we are working on expanding the scientific leadership and developing the Medical Advisory Board that is a key activity that we are also focused on in order to assist us with the best possible plans and more and more visibility, in particular, in the U.S. market. We are very focused on U.S. data and health economics. So what is the utilization of the system in the U.S.? Can we -- not right now but shortly, also provide information on the adoption of the system in the U.S. with real data. So is there data to be gathered in the U.S. that can actually help us with the snowball and making a snowball up faster, a lot bigger, faster. So real-world clinical experience in the U.S. is important and health economics, we will continue to work on the proper payment for our system by these insurance companies. That's an ongoing workflow with a lot of work to be done to convince these health insurance companies that this actually is to their benefit. Yes, there is an initial investment that's not very big and it has the potential for a lot of savings for them in particular. So this is important for us to continue to work with the U.S. insurance organizations. We have gotten to a point now where we also have scheduled meetings with insurance companies outside of just the claims and the appeals that we have streamlined and where we provide for a proper package of information to be used by the users. We also now have a first meeting with a particular insurance company in 1 region on the books on November 2. We will talk to a major insurance company in 1 region and present them with what we have and why this is beneficial to the patients and physicians. And in particular, the insurance companies in terms of potential savings to them. So I think that's an important initiative that I've actually pushed for a lot already in the first, almost 2 weeks of my workflow with Acarix. And then I already talked about this, visibility within the U.S. market. Conference presence. I already mentioned that Jen is at a conference in Florida at the moment. And we continue with the social media outreach and information -- and to give out information on social media. So I think that gives you a pretty good overview of what Acarix is and what we stand for. And I think Dan, you had some questions that you wanted to get -- that you wanted to get answered. So maybe we get to that next.

Unknown Attendee

attendee
#3

Very interesting presentation. Yes. And I was thinking to start likely with a question and focus on you. And my first question of interest is what made you interest in and also to accept the offer to become the acting CEO of Acarix?

Fredericus Colen

executive
#4

Yes. Thank you, Dan. That's a good question. So let me kind of give you all a context for this. So I was contacted by a member of the Acarix Board recently who informed me about the situation they faced with a 6 months hiatus by the current Acarix CEO, Helen due to some serious health-related reasons and that they needed an interim acting CEO soon that could swiftly take up the day-to-day leadership and continue to execute on the company's strategy. It was actually quite urgent. It was an urgent situation. I was available. I had recently finalized the exit of another startup company called Neovasc, where I was CEO for a bit over 5 years and I was able to finalize an acquisition by a company called Shockwave Medical. And so this was finalized in April of this year. And so I was available and I was willing to assist Acarix and Helen with their unexpected and sudden situation. Given the urgency, I did actually very little due diligence. There was little time. And I really was intrigued by the CADScor system itself. So the board and I worked out an agreement within a few days and I saw their take on what needed to be done here. So that's basically how that came together, Dan.

Unknown Attendee

attendee
#5

Yes. And then now you're 2 weeks into the show basically. Could you please summarize the first impressions that you have of the company, of Acarix?

Fredericus Colen

executive
#6

Yes, of course. So first of all, I think it's important we put out press releases and I think it's really important to point them out to you. There is a press release from October 2. I think it's important and I would refer you to that and encourage you to read it, to get a lot more background information about myself and the company. I think it's important. Secondly, let me share with you some of the things that I found here at Acarix when I started here less than 2 weeks ago. So first of all, I found a good team. There is a good team here. They are working very hard. They're very dedicated to making this novel diagnostic system a success, very much so. I continue to emphasize the need to focus on sales, sales, sales. That is what we need. We need the sales growth, net revenue growth. And that will take a lot of hard work and lot of technical work, disciplined in the process, lots of energy and it will consume some time and to continue the journey of growth. And we are confident that we will continue to put growth on the board, in particular in the U.S. And that will actually consume the vast majority of the investment proceeds. The third point and the third point is, we do have a good and quite interesting product, which generates a lot of interest in the broader U.S. medical community. And quite a few of these doctors in the medical community in the U.S. are beginning to see the overall great potential of this potentially first-line diagnostic tool to rule out patients suspected of coronary artery disease and do that very early on in the process. And, however, let me also put this in perspective for you. One has to understand that we are a novelty in the U.S. medical community and most are just starting to learn about us. First of all, we are trying to change the clinical practice of diagnostic care for these patients with suspected CAD. And that, if you want to change the practice of care, that takes time. This is something that doesn't happen overnight. This is not just a matter of -- here's a product, why don't you buy it and pay for it. Acarix, I want to point this out, obtained FDA approval without doing a U.S. clinical study, which is great on the one hand but it's also unusual. It's actually highly unusual. Normally, during a clinical study in the United States for FDA purposes, it provides for a first level opportunity of medical professionals in the United States to getting acquainted with a novel system and to build the support. And we need to overcome that deficit because we don't have any history of doing a clinical study in the U.S. So it's not just a matter of physicians don't have any experience with us, they don't even know about us. So we have to do a lot of groundbreaking education for the physicians from the ground up for them to understand what we have to offer. So we need to keep working on that. We need to get more visibility and we need to keep building this market development activity.

Unknown Attendee

attendee
#7

Yes. Thank you. And to continue a little bit on the sales efforts and also on your personal experience, you mentioned you can go to the press release of October 2 to review Fred's past experiences. So I think it could be interesting for viewers to if you could give an insight of a typical sales cycle in the U.S., for instance? And how do you get to the right person? How is the evaluation of the product, how is that conducted, time to sales and so on?

Fredericus Colen

executive
#8

Yes. Yes. Yes. Let me talk about that in a little bit more detail. So we have several sales cycles going on in parallel. And I already pointed out a few of them but let me just go through them. So first of all, the VA system, which I spoke about. The VA is our highest priority since the VA is not dependent on specific and sometimes challenging cost reimbursements. The U.S. Department of Defense is responsible for all of the health care-related expenses associated with its military personnel and veterans. They are the largest U.S., what we call, integrated provider. Hence, this is our priority and focus. VA decision makers are very interested and can appreciate the ultimate potential savings in their overall cost for patients with respect to CAD plus the potential to decrease the pressure on their intervention cardiologists who are often overloaded with [indiscernible] procedures. They do understand that. However, the VA is also notorious. Notorious in the industry for extremely slow implementation of new processes. We have made great progress, for example, in the VA center of Southeast Louisiana with big support from the deciding doctors there. However, just the rollout of this SOP as well as the rollout of this newly implemented process within this 1 center, with at least 6 satellite primary care offices, including getting other doctors within that system and within that VA on board, getting new procedures signed off internally and implemented and getting through the required education and training takes time, which is why we have not yet seen a follow-on order from the order in the springtime, which we do expect. So just last week, I can tell you, we provided additional training in this VA center because of their satellite offices, they still need additional training for the use of this system. So this gives you a sense for the rollout. It just takes time to get the rollout even in this 1 center. Furthermore, we have made great progress with decision makers in other VAs, if you have already endorsed the VA, Louisiana SOP and are interested in implementing it in their center and satellite offices as well. However, the next step is to establish a budget within that specific other VA because also for a VA center, they first need to invest in our system before they can potentially realize the savings that they can see. And unfortunately, right now, the overall VA system is just in the turnover from one budget -- from the last year's budget to the new budget. They are just going into a new budget. And the new budgets in many of these VAs is not yet in place. So the -- getting the budget approved in just the turnover from an old to a new budget cycle is difficult. So these things play a role in the rollout. It's not just to convince some physicians, it needs to be agreed upon on a higher level within the VA and within the budget. So last but not least, I also would like to say from an overall standpoint, that there's a looming shutdown in the United States government in Washington. I'm sure you realize that. It's not there but it's looming. And so the VA, knowing that situation, they're also careful in adding additional expenses just right now. The timing is just not really good to make a quick amount of progress in the VA system, although that is our highest priority. We will continue to make progress. I'm convinced of it. It's just a matter of time. But I would also like to say that not only have we worked from the bottom up in the VA system, we have also started and we have contacted and we started the educational and the negotiating process, on what we call the national VA level. So also -- so from the top down, is there a way to actually penetrate the VA system from the top down? And we started the process of education and negotiation through the approved third-party that's involved in these kinds of things with the top level VA from a national VA standpoint. We are doing that. We're in the process of that. Also, that process goes very slow. There's nothing I can say about it yet but we certainly hope that we have more good -- more news on that as well sometime in 2024. Our second sales targets are other integrated delivery networks, where there essentially is an overarching organization that owns the hospitals and also provide for insurance, at least for a certain percentage of the patients in those hospitals. We have ongoing initiatives in quite a few of these IDNs. And in one particular IDN, we now have a line of sight to an initial quite sizable purchase contract. So that is good news. It's in line of sight. We can see that we're making progress with some of these IDNs and there is real clear interest and we have line of sight to another contract with an IDN. And we hope to bring more good news on that, hopefully in the next several weeks. And then outside of that, there obviously are initiatives ongoing in general clinics, in other primary care facilities as well as with this osteopathic doctors that are hearing about the over wellness of patients, they also have expressed an interest in our product. So there's a lot of moving parts, a lot of work going on in parallel to convince physicians that this indeed is a good new system for them to get their hands on.

Unknown Attendee

attendee
#9

Yes. And if we go to the -- like the smaller clinics, the value proposition for them, it's different compared to the VA and also the bigger hospital networks. Here, the reimbursement is a critical -- key actually. And what is the status for Acarix regarding reimbursements? Is there any development there? Or -- and what are the plans for the further expanding of the reimbursements?

Fredericus Colen

executive
#10

Yes. So a very good question. So reimbursement is a very important topic. I certainly have also besides the day-to-day tackling of sales opportunities and driving sales, reimbursement, in my mind, is the second most important workflow that we are focused on. It's a very important topic and it will need a lot of additional work. There's a lot of activity going on. And actually, some of the money that we are raising right now will also be utilized to continue to work on and get more wins on the reimbursement side as well. So the situation that we have is that sometimes certain regional insurance organizations, they do not reimburse the users in certain accounts for payment of the use of the system. And if and when that happens, we assist those users with that issue. We had a boat load of information for these users available and they used that, it wasn't very pinpointed. We have streamlined that now. We now really have, I would say, a to the point, very comprehensive, small package of key information that we make available to the users. And we actually assist them in this, what we call, appeals process. So in the course of the last couple of months, this more to the point, key package of information to convince payers was developed. And actually, we can see more positive results from that in a quicker process to convince insurance company to pay for this. But I've also really pushed already in the last, I don't know, 8 or 9 days that I'm on the job, for -- we also need to really have meetings with some of these key insurance companies. And so I'm very happy to say that we have engaged consultants that are well, well versed in payment and reimbursement matters. And we now have not only a package of information together, we have a first meeting scheduled on November 2 with a large insurance company in 1 region, where we are fully prepared. We have all the information available. We also have lined up 2 physicians, local physicians to assist us with that discussion, a cardiologist, as well as a primary care physician. And we will together go to that meeting with that particular source of -- with that particular insurance company to convince them of the need for this system and for the payment and why this is beneficial to them. So that is a process that is just starting. We have put together a prioritized list of -- and more insurance companies to go after this first one. There are another at least 5 targets that we have identified as most influential and most important to go after next. So that's a workflow that we have identified and is in the works. So I'm actually quite happy about that process. I think that will add a lot to overcome some of the challenges on the payment side.

Unknown Attendee

attendee
#11

Right. So lots going on in the U.S. And the focus there, it's also -- it's quite understandable. But does this mean that Europe, is it not longer on the map for Acarix ?

Fredericus Colen

executive
#12

Yes. Good question, a good point. So first of all, I'd like to point out that I'm actually originally European. I spent about half of my life in Europe and half of my life in the U.S. So I will never forget about Europe from my side, just because and my roots were there. That's important to know. But no, Europe is still on the map and it continues to exist for us as a company as well. And we have ongoing sales activity in Germany, in DACH, which is Germany, Switzerland, Austria, as well as in the Nordic region. We will continue those. Again, I already pointed out that we, in the last few months asked Thomas, our COO, to focus also on managing that, to focus on the European side to make sure we maintain a certain level of sales activity there, so that we don't forget about it. But in terms of investments for the future, we are investing in the U.S. market. That is our focus, our attention, yet we won't forget about where we already are in Europe.

Unknown Attendee

attendee
#13

Okay. And except for the sales effort for the whole company, what would you say would be the most important focus here close to midterm?

Fredericus Colen

executive
#14

Yes. It's -- it's all about sales, it's sales, sales, sales and the sales supporting payment activities that I just talked about. That is the most important. But let me point out something else. I -- in my own career, I found it the most convincing is always if physicians have their own experience, they have their own experience with a novel new therapy or a novel new diagnostic tool. When they have their own experience in their own clinic in daily life, that is the most powerful testimony and sales tool you can have. And that is just starting. They are just -- there are just a few physicians that have engaged with us early on that are now seeing the results of what they're doing. And I can tell you, they are enthusiastic about it. They see, oh, yes, this really has legs. This really is important. And as such, we have -- once he uses here and there, of these kinds of physicians, that are saying, hey, I would like to do a U.S., what we call investigator-initiated clinical study on the real-world use of this device and we encourage that. We think that, that's very important that physicians are, not only have their own experience and then become more and more convinced and convince others but also that we can benefit from this and leverage that in terms of seeing some sort of a, what we call real-world post market after we got approval from FDA, clinical study in the U.S. where these physicians are able to document and talk about in a clinical publication about how it worked in their clinic. So we are very much in support of that. We encourage that and we actually have I would say, one for sure on the table, of 1 physician that really wants to do that and a second that just came up in the last few days with quite a bit of interest in doing this kind of work. So that is important. And the last point, which I already talked about is to develop this network of key opinion leaders to build this medical advisory board, to get more influencing physicians on this advisory board so that we get the best possible advice as a company and also for more visibility in the market. So I think those are the key things here then.

Unknown Attendee

attendee
#15

All right. It sounds like you will have some busy months ahead of you. But it's all very interesting. And I was thinking to just finalize here the question moment with the final question. And that is -- you're quite new but you are coming also with a fresh pair of eyes into the company. Will you make any changes going forward here?

Fredericus Colen

executive
#16

So a good question. And obviously, I had quite a bit of discussion about that with the Board and also with the team. And first of all, I'd like to say that my plan is to continue on the path the company is on. Keeping to the overall, the same overall strategy is important. I'm sure I will make some tweaks here and there, where important, like, for example, I'm pushing for these meetings now on a higher level with insurance companies, I think that's 1 little tweak in an overall strategy. But I'm very much a believer in continuity. I think continuity for a company is highly important even though Helen is going to be out for 6 months, we are certain she will be back. She has very positive reports from her medical team that what she needs to go through is -- has a high -- very high probability of cure. So we believe that's all going to fall in place. The company will have to go through this period of 6 months. And I believe that continuity for that time period and in that time period is highly important. So I want to continue to work on the strategy the company have. I want to continue to work with the team we have. I think that's very important as well. Obviously, if I see important things here or there, that I think need to be addressed, I will certainly address them with -- in discussions with the Board. And so obviously, I will not just stupidly continue to do some things. I will do it with a lot of attention and making tweaks here and there and if there's a need to change something, in discussions with the Board. You should also know that I have promised the Board that during this time period, I will gather my thoughts and more towards the end of my engagement, my 6 months engagement, I will provide the Board with my own strategic insight, my own strategic views on the future of the company, how to maybe fine-tune the strategy here or there, maybe do something different. That I promised the Board as well but more towards the end of my 6 months engagement. And so then, since we are getting to the top of the hour, let me just finish by saying that I really and truly believe that the Acarix CADScor System holds a real promise for the future and that I'm really excited to be part of its journey. And with that, I would really like to thank you all for your attention and for your support. Thank you very much.

Unknown Attendee

attendee
#17

Thank you very much, Fred. Very happy that you could join us here today.

Fredericus Colen

executive
#18

Thank you so much.

Unknown Attendee

attendee
#19

And if you, viewers, if you remain here in the presentation, I will shortly go through the capital raise itself and the technical issues there. So the company, Acarix, they are raising some SEK 54 million through a fully secured rights issue of units. And as you heard, the proceeds of this capital raise, it will mostly fund the market expansion on the U.S. markets and go to increase the sales there. And you can all read more about it in the prospectus that has been prepared due to the transaction and we need to point out that all investment decisions, it should be based on reading the prospectus. So you can find it on the Acarix web page, along with other fruitful information, you can find it on Erik Penser Bank's homepage and also on the Swedish Financial Supervisory Authority's homepage. And the terms of the capital raise is that each shareholder that was a recorded shareholder on the record date, the second of October, they receive 1 unit right per hold share and then 5 units rights. It is entitling to subscribe for 1 unit and the unit itself, it contains 3 new shares and then 1 warrant of series 2024:U1 and 1 warrant of series 2024:U2. The price is SEK 0.6 per unit, which is equal to SEK 0.2 per new share. The warrants in the units, they are included free of charge. So you don't pay anything for the warrants. And the U1 warrant, it entitle you to subscribe for 1 new share during the period of 6th to 20th of March next year, 2024. And U2 warrant, it will allow you to subscribe for 1 new share during the period of 11th to 25th of September next year, 2024. And the subscription price for the units, it will be between SEK 0.25 and SEK 0.5 and it will be calculated based on a 30% discount to the volume-weighted average price during a measurement period that is directly before these exercise periods. And also the unit rights that you use to subscribe for new shares, they are traded until today, the 13th of October. So if you want to buy rights to participate in the rights issue, it is still time. And just remember, if you do buy rights, then you will also need to notify your bank that you wish to exercise the rights. Unexercised rights, they will debit out from your accounts without any compensation. And you can, of course, also apply to subscribe for shares without using rights but it will be a second priority according to the rules those were set up in the capital raise resolution. And how to subscribe? It actually depends on what kind of accounts that you have your shares in. It is -- you can either be a directly registered shareholders or you can have your shares through a custodian. And the easiest way to find out which type of account you have, is to ask your bank if you're a directly registered shareholders or if you are put up in the shareholder register through the custodian. And directly registered shareholders, they should have received information how to subscribe through the ordinary mail. So please check your mailboxes. And they -- you pay according to the instructions on these applications form that has been sent to you. And if you wish to exercise a different number of rights than your pro rata share or if you have bought or sold rights in the markets, you can find a special application form on the Acarix and Erik Penser Bank home page. Shareholders that have their accounts for a custodian, which are most of the shareholders, you need to follow the specific rules that is set up by your specific custodian. So please go and check on your online bank in the -- normally, it's under a company event section in a logged-in position in your shareholder account or you can also contact your personal bank contact and ask for more information. The subscription period ends on October 18. But custodian shareholders, they need to be aware that specific custodians, they may have other rules. So you might have to exercise your rights before the end of the subscription period. So please check what date is according to your bank or custodian. And with those words, I want to thank you for your attendance here and also a final reminder to read the prospectus. Thank you all.

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