Acarix AB (publ)

Good morning and thanks for joining us for the Acarix Q3 earnings call. I'm Amir Mahmoud, the CEO of Acarix and I've got Christian Lindholm, our CFO. We're going to get right into what we've accomplished in Q3 and I'm very excited to announce that our continued market expansion in the U.S., which is our concerted focus, continually goes on the right trajectory. For Q3, we placed 20 CatScore systems, which showed 100% increase. Quarter over quarter, we saw 89% increase in our top line revenue regarding patch sales. And we saw 116% growth in our patches sold. We're really excited to announce that just last week, November, Friday, we got a ruling from CMS regarding fixed reimbursement. So this is the first time Acarix and CatScore have fixed reimbursement in the United States. And as you guys remember, when I came on in February on our first call, I said that would be a very significant challenge and opportunity for us. But the single most important thing for the United States market, and that's reimbursement, which Carriage now has in the outpatient setting with CMS. Our model that we transition to continues showing positive results. Like I mentioned, we're going to have a systematic review of all of our processing procedures in every category or silo of our business, which we continually do. And with some of those opportunities brings results. So we were able to reduce our operating costs down by 12%. We've opened up new verticals that we'll discuss that will provide additional revenue streams for our CAS4 system in the United States. And we've increased both our patch and systems in the United States quarter over quarter. Additionally, at ESC this year, just a few months ago, we had one of our largest investments, which was the PiltersCAD trial presented. And that showed significant results that were positive for cats for reducing the actual basis of diagnostic tests that are conducted on patients that are unnecessary, but also really proved effective. our negative predictive value, as well as customer accessibility, as well as customer feeling regarding CAT score and appreciating the results as we'll showcase in the coming slides. Again, really, really optimistic about where we're at with the CAT score system in the United States and at Carats in general. We continually push on all the variables and objectives that we set. We're delivering on some of those objectives. We're opening up new verticals and we're getting reimbursements solidified. So really excited to see what our technology and growth capacity is in the coming quarters and years ahead. Very, very excited where we're going. So getting into some of the key three highlights, we're maximizing existing markets, meaning we're growing organically within where we're at. We're also opening these verticals such as the concierge medicine space. As you guys are aware, and as I mentioned, we've got to find ways to continually drive top line revenue. And so we can fix our fixed reimbursement, which we're working towards and we'll talk to. So we went into these different verticals that are cash paid. So these patients typically pay cash. for their health care. And the concierge business, as you guys have seen through press releases, continually accelerates. The good news is we're getting reorders. Not only reorders of patches from our current customers, we're getting additional orders of category units, meaning they're expanding the offering within their private clinics or practices or organizations. So that is a key KPI that shows what we're doing is working. One of the largest cardiovascular offices that is fully digital has implemented CatScore, ordered four units and has rolled that into their offering. We're continually growing our space. As mentioned a few weeks back, we landed a very significant customer that's going to have 10 facilities available. and locations in five different states by the end of Q1 2025. And their initial order was nine units and 500 patches, which we see them as a very significant customer that will provide the cash for and the opportunity for significant growth in 2025. What we're doing and what's procuring is underscoring our customers' trust into what Catspur provides and that we fill a need that was never able to be fulfilled until Catspur came to push. CMS. So I'm going to spend some time here so that everybody understands exactly what's procured as of last Friday, November 1st. and what that means for our carers. As clearly articulated in our last calls, there's two separate verticals within CMS regarding reimbursement for the CMS patient population, which is the older demographic. As you look at it, there's the inpatient and then there's the outpatient. Inpatient means Hospital, private clinic, and outpatient, as mentioned, is ERs, emergency rooms, the actual ambulatory surgical centers, OBLs, things that are separate from within the hospital infrastructure. So those are two verticals within CMS. What we were awarded is for the outpatient setting, which is very important to us and a very acute focus for us because when patients have chest pain or acute chest pain, they typically are going to present to the emergency room. That's this standard because it's going to be acute. It's going to be fast. They're going to want to be seen. And the fastest way to be seen in the United States specifically is in the emergency room. So we had two variables that we were requesting for. One was to separate us and create a fixed reimbursement specifically forecast for that is separately payable. And second was reassignment from APC 5733, which is a minor procedure to APC 5722, which is actual diagnostics. One of the nuances in bringing a first in class product to the United States or any country is you have to really clarify and have the ability to articulate what we are, because as a first in class device, you're not you don't have a predicate to follow suit. So CMS doesn't know where to drop you. So they unilaterally make the decision as to where they feel it fits. And we then have to challenge it as a company, which is what we did. Very exciting. As Pierre mentioned, we were able to secure the separate payable fixed reimbursement for CASCOR. Monumental success, monumental step forward for our carriers. We're very excited for what that means for the CASCOR system and our growth potential, specifically in the United States. The second factor that we were asking for was the reassignment of the code from 5733 to 5722, which is more specific to what we do and we fit that category. However, given the fact that CMS uses specific variables to make decisions and does not deviate, they reflected on 2023 claims submission. Given the fact that we had no claim submission, they were not able to provide us the reassignment from ABC 5733 to 5722. Therefore, we have remained at the approximate $60 in reimbursement. What was really great to see in their final ruling that was written and available to everybody online, publicly available, they put in that they will reevaluate the CAATS score and the claims early in 2025, which is just 60 days from now, just a little under 60 days from now. So we're cautiously optimistic that our 2024 claims submission is north of 2000. So we feel very optimistic that we're able to get to the APC 5722 reassignment next year, which again is only a few days away. so very very excited very very much so pleased with the team's delivery uh and the and the work that was put in with cms to really get the specs reimbursement because as previously mentioned the private payers which is going to be the majority of our business for cat score that the patient population will be majority driven by private private payers cms will probably constitute less than 20 percent of our actual market and revenue opportunity but Everybody looks at CMS. That's why it's so critical for CMS to have the fixed reimbursement in place because it typically is a waterfall effect, right? So the payers will then follow suit, and then that reimbursement will come into play. So very clearly, there's the inpatient and there's the outpatient. We have now fixed reimbursement for outpatient, which is our largest market, and very excited. Now let's talk a little bit about the private pay sector and what we're trying to do there. Mm-hmm. In the private pay sector, which is in hospital and private clinic, you can see our reimbursement average now is $391. So acutely different than the $60 reimbursement. And it's very typical for private pay to pay a significant multiple higher than what CMS offers. So we are very optimistic about what we can procure in the conversations we are ongoingly having with some of the largest payers in the United States. And we're close to having a decision with the single largest one in the coming days, coming weeks, months. And we're hopeful that that provides a significant uptick, which we've requested in the $300 range. And what typically will happen in that perspective is these other payers will follow suit. And our hope is that we continually see the waterfall effect create fixed reimbursement across many of these platforms that you see. Again, working acutely in all these variables, you can see that we're being paid by a number of different private payers and CMS. So we continually see the adoption with the payers and we're continually growing and working towards having multiple meetings with multiple players to continue focusing on reimbursement. Because as I mentioned, and still today, reimbursement is critical for success across the medical technology platform. but will be wildly successful if we can implement here and grow pretty rapidly and get adoption and fixed payers for what we can do in 2024, the remainder of 2024 and beyond. But the CMS decision, I want every shareholder to understand that that is critical and a massive, massive win for Carex and the cash flow system in the United States. FilterSCAD, really excited about what procured from FilterSCAD. It was presented just recently in the past few months at ESC in Europe. Some of the key takeaways here are we saw a 23% absolute reduction in cumulative number of diagnostic tests. So again, we're doing what our device is supposed to do. We're going to rule out patients that don't have the risk of significant coronary disease and get them out of the system so that the patients that truly need that risk stratification are pushed through the process faster without a bottleneck of patients that don't need to be there. So 23% reduction is fairly significant. What was really more important that we saw was CAAT score and the results were trusted by the patients and the physicians, and they did not pursue additional testing. There was two verticals in this clinical trial, one that was the CAAT score and one that was non-CAAT score. And what was really, really eye-opening was in the CAT score vertical, the patients got the CAT score test, only 2% asked for additional testing. That truly means that they were confident in what CAT score did, confident in what the report provided, and decided they didn't want additional testing or need additional testing, which is exactly what CAT score does and provides with a significant negative predictive value that we'll get to. Conversely, in the second group that was non-CATS4, you saw 23% of patients meeting additional testing. So that shows CATS4 is doing what it's intended to do. It provides the value proposition that we've talked about over and over, the patient, because they get immediate results, the payer, because they're able to justify what that patient needs with a tangible report and able to discharge those patients with a tangible report that they've never had before. And three, we're reducing the cost in the system for the payers. And whether that's CMS or private pay, we are providing a value proposition that is comprehensive and great. So really excited for that. And lastly, it revalidated our negative predictive value, which is the single largest variable that is used in rule out devices. And with a negative predictive value of 97.2, it is phenomenal. All right. So you're looking at negative predictive values that are provided by more invasive tests, more costly tests like CTE. So really excited about what this what this trial did for us. And we expect that private or not the private, the actual investigators to provide additional data and additional submissions for publication, showcasing even further opportunities for what cats were provided in the data in the coming months and years. Dr. George Kersan, a strong advocate for us, realized how important that this filter scan trial was. It shows that it's safe, to show it's effective. It reinforces our negative predictive value, which is critical in these kinds of devices as mentioned. And he believes that this is gonna be the anchor for future trials that we're about to launch, including in the United States. Again, so what we're doing in the U.S., We're starting a new clinical trial that should be launched within the next 30 to 45 days that will be another complementary clinical trial for filter scab and DENICAD 1 and 2. There's opportunity for us to continually expand our clinical basis and have the demographic in the United States that we need because the United States is going to be our concerted focus for years ahead. So we need that data and we need this data to also get us into that second vertical of CMS, which is the CPT-3 to CPT-1 transition for fixed reimbursement. So these trials will help us in that conversation and fulfill the obligations needed to get to CPT-1 in the United States, as well as defining a systematic review of all of our clinical trials and other associated trials to submit to CMS for CPT-1 and CPT-3 transition. So Really excited. It's going to be 900 patients in the United States, and that will be very, very important for us to be able to demonstrate and showcase our outcomes in the coming months and years. Investor confidence continually remains strong with the carrots, which we're very pleased to see. We were making significant moves in regard to what we're doing internally and externally. And it was demonstrated in this last T03 warrant, which is the last of our warrants. And we had 96.2% subscription rate from current shareholders. So that showcases significant optimism with shareholders. And we're very, very pleased to have seen that. You know, our operations and with the funds we've raised, both with the T03 warrant issues and direct issues, we're very confident in our longevity that provides our cash flow as we continually grow and expand this business. And considering the recent announcement from CMS with fixed reimbursement, we expect our revenue trajectory to continually go to the up, which will provide us cash, which will extend our pathway of longevity cash flow standpoint. So we're very excited about that and feel very confident that as we move forward, we're able to generate the cash flow we need. So getting directly into the P324 financials, across the board upticks, right? So we got 116% patches sold, increased quarter-by-quarter, 89% increase in patch sales in the United States quarter-by-quarter, an 8% gross margin uptick, and we were able to reduce our operating costs by 12%. So what we're doing is we're literally executing on all variables and generating the savings that also is repurposed for more commercial and strategically activities that make sense. From a CAD score placement standpoint, we generated 100% growth. We placed 20 units in Q3 2024. Very excited because what that demonstrates is the model is working and they're adopting and able to implement it, even though we don't have fixed reimbursement in Q3. We're very optimistic about what this procures going forward. Patch sales, again, we're a patch company. Our acoustic adapter is the most important variable because the CAT score is the CAT score and then patch is what is gonna be the disposable. That's gonna be our future growth as mentioned in previous calls. So we had 160% growth in the United States and that's pretty remarkable and great for the team to generate. And keep in mind, without reimbursement, growing at these triple digit levels is really something to be looked upon. Now, are we where we need to be? No. But with what we needed to happen was fixed reimbursement. And we've got one piece of that puzzle and we've got multiple opportunities in front of us to continually fix and grow that portfolio of fixed reimbursement. And that's where we'll see this grow significantly. Our utilization continually escalates. Our top customer uses five patches a day. Our top five customers are using two patches a day. And the top 20 customers are using one patch a day. Again, as reimbursement continually escalates, higher force and fixed reimbursement becomes much more static in our business proposition. These numbers will continually grow. So we're looking forward to see what these look like in quarters to come. Again, the trajectory is what we expect to see, what shareholders expect to see. Our CAT score unit systems placed are continually escalating in the right direction. Our acoustic adapter patch is continually escalating in the right direction. You can see that the light blue represents quarter over quarter. So we're going the right direction, and we expect that these curves become much more steeper as we continually drive our fixed reimbursement plan. Mm-hmm. Again, this is a really exciting slide and a KPI to continue to focus on. What you can see is in previous quarters in 23, we were generating top line revenue from really only two verticals. What we've opened up here, as you can see with a different color scheme, we've opened up additional verticals, which made a differentiated revenue pathway. So we now have four different pathways driving revenue for us in the U.S. And we will continually expand in these verticals as we continually have focus and acute efforts where we can get to these businesses and get to these verticals and start to mature these verticals. We will add more as we expand. Revenue of patches, really exciting. As mentioned, we grew 89%. So what that shows is that the model is working. The implementation, the efficacy, and the execution is working. And that's reducing the financial burden by not charging for the CAT score unit. And instead, it's increasing our top line revenue with patches sold, which patches are going to be our subscription type business, which will continually escalate higher with adoption and growth. So looking at our Q3 revenue, I want to spend a minute here because as mentioned, when I first got here, we went away from selling the CAAT score unit to remove that obstacle and that capital cost upfront, especially given the fact that we don't have fixed reimbursement. And we have seen in the previous slides that that model is working. So when you look at the Q3 group revenue from Q3 2023 and Q3 2024, you can see that it is a 37% decline, which was expected. We have transitioned away from the lease model that did not prove effective, especially given the fact that there's not fixed reimbursement. so that model we we terminated uh and significant dollars in regard to q3 2023 went to that lease model because that's when they launched it and they took full revenue recognition for the lease in q3 2023 but when you look at it from an apples to apple standpoint and what our strategy is moving forward the adjusted revenue as you can see here is plus eight percent so again Great opportunity, great reflection on the execution from the team to have grown that 8% in the U.S. And we continually expect that with fixed reimbursement, as mentioned, this number will continually escalate higher too. Our gross profit, as you can see, reducing optics where it doesn't make sense, reinvesting it in opportunities for commercial and strategic growth, we were able to generate a adjusted growth profit of plus 87% quarter over quarter. Again, recognizing that what we're doing is making sense and driving shareholder value. Our gross margin, again, wildly excited at a 90% gross margin. That is a very, very healthy gross margin. It's up eight points quarter over quarter, and we expect it to stay in this range as we continually grow. Again, as I mentioned, in February when I joined, we're going to do a systematic review of every facet of our business, every silo of our business. And we continually do that and we'll continually operate in those functionalities. Even after we become a mature business, we always want to revisit our OpEx and what we're doing. We were able to reduce our OpEx by 12% quarter over quarter, which is really exciting for us. And again, we We want to rest assured that our shareholders that it's not just about reducing OPEX, it's reducing unnecessary OPEX, but reinvesting those OPEX dollars that are saved into more strategic commercial based activities, very similar to a clinical trials we're launching in the U.S. and reinvestment in distribution opportunities and feed on the street to really generate the noise and awareness for canceling. Our operating result, great to see here, a double digit reduction in our operating results adjusted for what our transitions are, including non-occurring costs. So really excited to where all the trajectories are going. Are we where we need to be? No, but again, this isn't a process that can be done overnight. This is a process that we need to rectify and fix. But as you can see, every quarter since we've joined, since this team has been executing in February earlier this year to today, everything is going the right direction so staying the course staying and following the process is showing that it's working and we will continually deliver on these efforts Our monthly burn rate, which is very important to shareholders. You can see we've reduced it by 30%. So we're very, very acutely focused on where we're at from a cash flow standpoint, which is our most significant resource, and how we can extend our longevity on that without doing additional raises or direct issues. We're going to continually focus on this. And where this is really going to come in play is as we grow our top-line trajectory, this should continually decrement down. Thank you very much. As you can sense from our excitement, we're very pleased with where we're at. Again, we're not saying where we need to be, but we are getting to where we need to be. And if we stay the course and we follow the processes and procedures as predicated by the previous double quarters, we will continually see our growth. We'll continually see our operation grow, our top line revenue grow, and we'll get to a profitability as soon as possible. And most importantly, we will continue our acute focus on our reimbursement pathways because that is critical to our success. And that's where we're going to see opportunity and excitement for the future. So thank you for listening and I look forward to continuing the conversation.