Acarix AB (publ)

Thank you all for joining the Q4 2024 earnings call of Acarix. Appreciate you all joining and the support we've received. Just to kind of kick it off, I want to make sure that we're able to identify who we are and what we do for any new shareholders or analysts that are following us. So CASCOR system by Acarix is truly transforming early cardiac diagnostics. We are able to present an opportunity, a point of care to rule out CAD with a 96.2 negative predictive value within four to six minutes, upwards to 10 minutes max. We are an FDA-approved de novo device, so meaning first-in-class. We're also CE-marked. We have over 15 years of R&D within the CareX and 45 patents. We've had clinical trials with 6,000-plus patients and over 40,000 assessments done to date. As I mentioned, we are FDA-approved and CE-marked organization and product. We're based in Sweden, Stockholm, and we have most of our R&D and manufacturing in Denmark. Our acute focus on sales is in the US, which is the world's largest market and represents over a billion dollar presence for us from a total addressable market capacity, but also focus in the UK and the Nordics with opportunities expanding that as we have conversations. Going to go through a few different points, an executive summary, our Q4 highlights and our Q4 financials. So when we get into this, I want to kind of categorize some of the key things that we were able to accomplish in 24. We had a growth that really was remarkable, a 333% increase in our CAD score systems installed. We had an 88% increase on revenue from patch sales. And if you recall, when I first joined the organization, we are a patch company. We are a subscription model that is very similar to Gillette and Razorblades. So we are very acutely and keenly focused on our patch sales, which 88% growth quarter over quarter from 23 to 24 is fairly significant and exactly what we want to see. We also saw 103% growth in actual patches sold. So again, two key metrics that are going to predicate our success going forward. One of the major things we announced in early November was a favorable CMS reimbursement code for our CAD score in the outpatient setting, meaning EDs, emergency departments, and ASCs, which are ambulatory surgery centers here in the U.S., where this can be done and reimbursed. We'll get into a little bit further, but that was a significant achievement for us to be able to procure, especially in a short amount of time. When you look at the positive results from our business model and transition, as I mentioned, we're going to do a top-down analysis and a bottom-up analysis to make sure we're acutely focused on sustainability and strategic financial management. We were able to reduce our OPEX down 27%, and we were able to increase our revenue globally by 45%. What that tells me is that the key things we are doing and the strategic initiatives we've created are hitting on all cylinders. This is what you want to see. You want to see costs go down. You want to see your revenue go up. And we'll get to profitability in short term if we continue these operational efficiencies. Our clinical trial update, we entered into an agreement towards the end of last year with one of the largest healthcare systems in Oklahoma. And that study was launched just a few weeks back in middle of January. And we've already seen approximately 10 patients enrolled. And we want to give a follow up to our UC Davis clinical trial that was specifically focused on emergency departments and outpatient cardiology clinics that has that was launched in Q2 or Q3 of last year. And we have now come to halfway through enrollment at approximately 100 patients. And we're hopeful to get to the end of that enrollment of 200 patients this year. Again, a little bit of a note for me, you know, just summarizing what we feel we achieved over the quarter. We were able to grow significantly from an installation standpoint, as well as a patch revenue and patch usage standpoint. We secured a pretty massive win with a new DOD VA partnership that we will discuss further. But what we really did was locked in a reimbursement from an outpatient setting. We're still acutely focused on the inpatient setting, but we're really creating the synergies and the efficiencies, not necessarily just from a go-to-market model, but also a financial model that are all starting to hit and we're starting to see the fruit of our efforts. Getting into some of the Q4 highlights. The GeoMed opportunity that we just released a press release on last week is critical to our success and a massive step up from where we were previously. When you look at the opportunity that GeoMed creates, it's really important to know their size and scale. They currently represent a number of significantly large med tech organizations within our market. Some of the key ones, just to provide the ability and the credibility of this organization, Johnson & Johnson, Medline, and Allergan. Those are some of the top 10 organizations in the world from a med tech capacity that GeoMed represents. For us to be part of that, just... in itself is a pretty massive win. But we're really excited about what they can procure with their entire group and organization and their scalability, as well as their reach within these VAs and DODs. So we're extremely excited about what this could procure. And while it was just announced, we're not going to see immediate results because we do have to integrate, we have to train and we have to get them launched. But we anticipate seeing some significant movement within before the end of Q2, early Q3. When you look at the existing market, we were able to generate some significant wins, one of them being launching within a healthcare provider that has nine locations in seven different states that placed nine CAT score systems and 500 single-use patches on their first order. We anticipate that we're fully integrated into all nine facilities before the end of Q1, early Q2, which we should see significant traction as we scale and get them ramped and trained. We integrated into an IDN, which is an integrated delivery network in the U.S. that has 14 locations, including an emergency room, where we were able to install four CAT score units and 10 single-use boxes on their initial order. Then what that does is that kind of shows that the reimbursement that we procure for the outpatient ED setting is starting to come to fruition for us. We also delivered to a key opinion leader that is specifically focused on digital healthcare. So it's a significant win for us from a capacity of who we're working with and what we're doing. But this is an early adopter that has already generated additional sales from a rural community, as well as additional people within his space that have seen his usage and are trying to adopt with it. And again, as I mentioned in a couple others, we are now starting to see some momentum within the emergency medicine space. And that is a predictor of success based on reimbursement, because I've been pretty clear that reimbursement is key in the United States. And this is kind of showing that it actually comes to fruition once you receive the reimbursement from CMS or any of the private payers. So we're acutely excited about what we've accomplished. We're looking at the go forward and we're looking to continually drive that daily patch utilization. Some of the key KPIs that was requested by a lot of questions that came in that we integrated within this presentation, you know, people and investors and analysts want to really understand what we're doing and what's going to provide us a pathway to success. The first and foremost is getting aligned with GeoMed as a partner in the VADOD. Massive win. We were able to hire two significant leadership team members that we'll showcase next. One is the head of reimbursement and market access. As you guys have heard me say, and even heard me on this call, reimbursement is key. This gentleman, Daniel Burke, is a key 20 plus year vet within the reimbursement space that we're very excited to have. And we also brought on a US financial manager who has incredible experience himself that we'll discuss next. The third KPI that we were able to achieve was the new CMS reimbursement code. The request we had was multifaceted. One was to get reassigned from a standpoint of what we do from an APC code. And the second was to extrapolate ourselves from the global code and create a separate indicator code, meaning that CAT score can be billed separately and not part of a group code. The second and third, I'm sorry, the fourth and fifth KPIs that we're still working towards. One is the transition from CPT-3 to CPT-1 that we'll discuss a little further. And second, as I mentioned in the last earnings call, we have started conversations with major private payers. One of the most important and largest ones in the U.S. we're in negotiation with and we're hopeful to hear something soon. But those two last remaining KPIs will predicate our success moving forward and inclusive of our ability to get to break even and profitability. Talking about the key hires, very excited to announce Jeffrey Rudd as our new head of U.S. finance. Jeffrey comes to us from a similar space within the subscription market and technology, has been with an organization from seed to exit. So that's a key metric for us to know in regard to what he has accomplished in his past experiences. And Daniel Burke, who is very well known in our organization and industry, in regard to his abilities to procure reimbursement for novel new technologies and market access. Most recently, he was the head of reimbursement for Bardi Diagnostics, which was from concept to exit. Daniel was part of that. And as we all know, they were acquired by Hill Rom and Baxter. So again, two gentlemen who have done what we're trying to do in their own silos. Very excited to have them on board. Talking about our CMS reimbursement, I want everybody to really understand that this was a massive win, especially in the amount of time we were able to accomplish it. This was specifically focused on the inpatient setting, meaning the EDs, the ASCs, as I mentioned, the ambulatory surgery centers. When you come to market as a de novo, they automatically assign you to a code as well as an indicator. So we were grouped into a group code, which was all part of a number of different offerings within the ED or ASC. And our request to CMS was to extrapolate ourselves and give us an S code, which is separately billable, but also reassign our APC code to be more in line with what our cost basis is and what our reimbursement hopes are. The most significant one and the most difficult to achieve was the S code, which we were able to achieve, which was a massive win for us. The second code, which was to reassign us from the 5733 to 5722, which also procures a little bit more of a reimbursement standpoint of 311 versus the 5907. They had to keep us in the 5907 and it was written in their ruling that they would reevaluate it. on their timelines. But the problem was, is that 2023, there was zero submissions or claims. So they had nothing to go on, meaning they could not change it. So we're hopeful that they have significant enough reimbursement and claims from 2024 to be able to put us in the next slot that we've requested, which we will go back to this year for request. And hopefully within the cycle year 26 or before, we will be able to transition into a new APC code, but more likely as we go in the future, as we get some of the key markers that we still need to deliver upon for that conversation to go from CPT3 to CPT1. So we're very excited about how we're accelerating our growth in regard to reimbursement. Again, Dr. George Kersant, our chief medical advisor, was very optimistic about what procured. Getting the S code, as I mentioned, was the most difficult, but we were able to achieve that. And now as we progress and we all understand and know that reimbursement is a predictor of success in the U.S., we're seeing some of the fruition of the efforts we put in place, and we're very optimistic about where we can go. Again, we've continually focused on gathering data from our actual claims that have been submitted. You can see that our average reimbursement in the United States stays fairly significant at $387. But the key factor here to look at in regard to this slide is five of the major private payers in the United States are listed here. United, Cigna, Blue Cross, Aetna, Humana. Those are the five that pretty much have 90 plus percent of the private pay market. So it's very significant to note that their payments all except one are pretty much where we want to be, which is $311 per reimbursement. So a lot of acute excitement here, a lot of conversations taking place. And again, we are in negotiation with one of the largest and we're waiting for their response in regard to our requests, which we can get any day now, but again, we're on their timelines. As you can see, we're continually accelerate through Q4 in regard to our payer market. You can see that we've added more logos as to whom is now paying for us and where we're seeing additional opportunities for reimbursement and market access. And again, this opens up a total addressable market greater than one billion dollars. And we're going to continually expand on that as we get into the. Outpatient setting. So when you see here and you see these and you see this grow from a logo capacity, understand that what we're doing is working and bringing on Daniel Burke as the head of reimbursement and market access, we believe will accelerate these opportunities in a significant way. Our U.S. performance trial that we recently announced at one of the largest health care systems in the Oklahoma City, we are looking at driving the adoption and driving the sensitivity to duplicate Danikad trials in Europe. Because in the U.S., they want to see U.S.-based data because the demographics are different as compared to Europe. So we're looking to enroll more than 900 patients. As I mentioned, we just kicked it off mid-January, and we've already enrolled approximately 10 patients. And we want to continue that by expanding our sites as well as expanding our reach. And then also provide an update on the UC Davis trial that we launched last year in Q2, towards the end of Q2. And they have now come to halfway enrollment of 100, approximately 100 patients. So we're cautiously optimistic that we will get that wrapped up here in the near two to three quarters from now. We have had a very acute focus on operational efficiencies and cost optimizations. As I mentioned, when I first came here, we're gonna do a top-down bottom-up approach and understanding every facet of our business, including every dollar spent to make sure we're delivering for our shareholders. We have continually grown our cash basis that we had a new issue of approximately 87 million sec that we've have completed. We've gone through our funding and operations, and we believe that we've got a runway of greater than 12 months And we're also effectively looking at our cost optimization on a daily basis that we have seen procure. And you'll see in the coming slides how much. And we also feel that we will fully realize that hopefully within Q1 of 2025. The board of directors, myself and the management team feel that we're very positive in regard to additional raises if needed on favorable terms. So we're all very optimistic about where we're going and what could procure in the future. And then lastly, when we talk about the new administration in the US, as we just went through an election, one of the things I wanted to note is that they are driving significant focus on ongoing cost savings and operational efficiencies. And when you look at our offering, as I mentioned, we are a multifaceted, comprehensive value proposition. We're not only affecting the patients, and the providers, we're also impacting the payers. So what we're doing is exactly aligned with the new administration's memo, and that is for cost-saving initiatives and operational efficiencies. We implement those when we are adopted into the workflow process. So we feel very aligned with that, and we feel that that could procure something significant for us in the future. Getting into the Q4 financials. Exciting to show this, all the arrows going the directions you want them to go. Three hundred and thirty three percent year over year quarterly growth in regard to systems installed. Eighty eight percent growth on patch revenue and one hundred and three percent growth on patch sales patches sold. So those are three very significant markers. And when you when you complement it with a twenty seven percent reduction in our OPEX, That tells you that the team is effectively delivering on the variables we anticipated to deliver on, because when you're reducing your costs and you're growing your sales, that's exactly what you want to see in a healthy organization. So when you look at 23 versus 24, I wanted to spend a minute and have a slide specifically dedicated to understanding that they are not apples to apples. They're very difficult to compare to one another in regard to specific things like top line revenue. When you look at our 2023 model compared to our 2024 model, we changed it. As soon as we got here, as soon as I joined the organization, we changed it. We went away from the leasing and selling, which we do try to still sell. However, that's a barrier of entry when you have no reimbursement. So we went to a consignment usage model and that model continually delivers for us. But when you look at it from a comparison standpoint, you've got to remember in 2023, they were selling the CAD score system, not as much as they wish to. However, they were selling it and there's significant revenue generated from that. most specifically in q1 of 2023 but when when you look at the deliverables that we delivered on in 62 systems 52 of them are on consignment so when you look at it from an apples to apple standpoint and you extrapolate the actual cat score revenue for units uh in 2023 compared to 2024 it's fairly significant uh in regard to growth but when it comes down to the bottom it is a break we're fairly flat But again, when you take into consideration that that revenue that's flat was pretty much 95% of patch sales as compared to any CAT score unit sales, that's a fairly significant plus from our standpoint. And we also need to reflect on the fact that when you're adjusting for non-recurring costs, we're 27% down. in regard to OpEx, but we're still delivering on the top line. So the main factor there is the consigning of systems. So when you look at the consignment model, we feel that it's delivering for us. It's mitigating the roadblocks from an entry standpoint and will provide a sustainable growth as we continually open and operate into new installations. When reimbursement hits, we will be ready to hit the ground running with usage of patches and growing that specific market for ourselves. Talking about the CAT score units that have been installed, you can see that we had 333% growth. Q4 of 23, they implemented three and we implemented 13. So really excited about what that could procure in regard to patch utilization. And when you look at the patch sales, you can see we went from 720, actual units to 1,460. So it's 103% growth, which is exactly what we want to see. The more installation, the more patches. That is exactly how subscription models work. And we anticipate that that continues. We sold 73 boxes last year, which represents significant growth, as you can see, triple digits. And we have now operating an installed base that's being utilized in 12 states in the U.S. We have a lot more opportunity. But again, quarter over quarter, you can see this map expanding on where we're actually located. Again, we see the right trajectory in regard to our U.S. system installations and patch sales. You want to see this kind of upward trend quarter over quarter. And we are very optimistic about where we're going. And we continually see our top users at approximately 4.5 to 4.7 this quarter patches per day. And we anticipate that that will continue as reimbursement continually solidifies and becomes fixed. And when you look at these, you know, as a startup, you want to see that hockey stick. And I think we're getting close. I think the opportunity within reimbursement is coming to fruition, hopefully in the next quarter or two. And we will see a significant trajectory on that and get to that hockey stick that all investors want to see. Again, you can see that our expansion into multiple specialties that we identified as the ED, urgent care, concierge medicine, cardiology and primary care opportunities continually grows quarter over quarter. And again, I hate to continue to reemphasize it, but reimbursement is key. But to see this type of growth is fairly significant when you do not have fixed reimbursement. But what you can look at from this perspective is that we have grown in the ER urgent care because of the cycle year 25 reimbursement in the outpatient setting. But you can also see that our concierge medicine, which is cash pay in the United States, has grown. Patients see the value of CAD score and they are willing to pay out of pocket for it versus go through insurance. So that's a key metric of success for us. And you can see that the cardiology and primary care grows. Cardiology is key because we want them to be adopters of our technology and that because that resonates with other facets within health care. When you look at our Q4 U.S. revenue of patches, you can see that we grew 88 percent, 464,000 SEC to 873,000 SEC. So that is, again, confirming on what we're doing is doing the right things. to look at getting into the systems because again, the barrier of entry was selling the cash score system when you don't have reimbursement. That's a significant cash outlay for these private clinics. So we mitigated that and we're seeing the upward trajectory that was a predicator of our success. The Q4 group revenue was fairly significant. We went from 1.17 million SEC to 1.7 million SEC, which represents a 45% growth from 23 to 24 of Q4. So really excited about that opportunity. And again, it's a factor of our reduced OPEX as well. A gross profit, as you can see, grew 34% from Q4 23 to Q4 24. from 628,000 to 843,000 SECs. So as you can see, we have a very healthy gross profit and we will get to where we need to become in a more break-even profitable standpoint as we continually scale our installation base and patch utilization. Our gross margin, which is one of the healthiest of my career from different companies, as you guys are probably aware, MedTech in general in the U.S. is anywhere between 60 and 70 percent gross margin. As you can see, we incremented one point from Q423 to Q424 to 88 percent, which is extraordinarily healthy for a MedTech organization. And we're very optimistic that we can keep it above the industry benchmarks and norms over the course of the next few years. Again, as I mentioned, we're going to look at every cost, every dollar that's spent to drive shareholder value. And we were able to generate a 27 percent reduction from 23 to 24 in Q4 of our OPEX. And that is predicated by the savings initiatives that we've done without the impact to our sales and commercial efforts. As you can see, those have gone up while we've reduced costs. Again, the things that we want to see as KPIs driving our success factors moving forward. Our Q4 adjusted net loss was reduced by 32%, again, hitting the metrics that were optimistic that will continue. So we were down 22 million SEC, down to 14.9 or 15 million SEC from Q4 23 to Q4 24. Our monthly burn, which is a very important factor for our investors and longevity of the organization, we were able to reduce 33% on an adjusted basis, down to just under 5 million SEK. So a couple of the questions, as we mentioned, we integrated into the presentation. And what it was acutely focused on and requested was, what are our go-forward objectives and what will they procure for the organization? As we discussed, GeoMed partnership within the VA and DOD is a pretty massive win. We're very excited about that. While it won't impact immediate sales like as of today, as we scale them, get them trained and get implemented across the U.S. with their entire team, we expect to see significant opportunity within the three to six months within the VA and DOD. We also are looking at our clinical trials. As I mentioned, UC Davis is on track to reach full enrollment by Q3 2025 based on current volume today from patient standpoint. So hopefully we'll see that procure before the end of the year. Our U.S. performance trial, which is we're hopefully targeting two additional centers for enrollment by the end of Q3 2025. And again, this is a requirement for CVMS CPT-1 transition as well. The lastly that's needed for a requirement from CPT-3 to CPT-1 is the systematic review of clinical trials. We expect that to be completed before the end of Q3 2025. So very optimistic about what we're doing from a clinical trial standpoint. That will also be a need to have to transition from CPT-3 to CPT-1. We are aiming to secure at least one private payer out of the five major ones for fixed in-office reimbursement before the end of Q3 2025. And we are going to hold ourselves accountable and deliver company financial guidance, hopefully before the Q3 2025 call. So with that, what I want to make sure I emulate here is that we are extremely excited about the future of Carex and what we're procuring here as a leadership team. We are hitting on all the variables that we have expected to hit on, and the deliverables are right here in this report. So we're seeing the reduction in our OpEx. We're seeing the increase in our top line. We're seeing the increase in our usage. All these things are predicators of our success. And if we're able to generate a check on all of these boxes, getting into the reimbursement phase of having fixed reimbursement, I do feel that this organization is on a track to profitability, if not break even before the end of Q2026. So with that, I want to leave you guys with some very significant excitement, some dedication to the organization, and we will keep pressing and moving forward. and continually deliver on the things that the shareholders and investors expect from us. Thank you again for joining us. Look forward to continued momentum in the future.