Acarix AB (publ)

And thank you for joining the ACARIS Q3 2025 earnings call. Before we get into the Q3 outcomes, which we're really excited to present, I wanted to address all the challenges that are being faced across the globe in response to geopolitical challenges, geopolitical rhetoric. with incontinent structures, including the U.S., which is currently shut down. A lot of challenges globally, and we are evaluating them and address them very quickly and nimbly, including some questions that came in regarding tariffs and what that exposure looks like for our carrots. We are addressing it, and given our great value proposition, including our gross margin, we are not overly concerned with the tariff of 10% currently, but we are reflecting and leveraging resources to evaluate onshoring opportunity within the U.S. because we will effectively deliver on a redundancy capacity in the near future as well. So rest assured that we are watching it diligently, watching it on a day-to-day basis, even an hourly basis, to understand everything that's procuring, that we're making sure we're driving shareholder value and making sure our organization is ready for any changes that could procure. With that, we'll jump into the entirety of Acarix and our Q3 2025 earnings. But initially, we'll discuss GASCOR and Acarix as a company for a lot of the new investors that have joined us. So GASCOR is a device that leverages high-fidelity acoustics and computational learning to re-stratify patients at that point of care, meaning anywhere in the world, and it does so within four to six minutes. One of the key factors here is that Acaryx has had over 15 years of R&D, over 45 patents, 6,000 patients in clinical trials, and over 47,000 uses worldwide. Really established organization with a ton of potential. One of the key factors in regard to risk stratification across the world in clinical science is that negative predictive value. Negative predictive value is what provides you the acute efficiency in regards to ruling out disease or risk stratifying patients outside of disease state. So with our negative predictive value of 96.2% in the U.S. and 97.2% in Europe markets, it's extremely robust and a very high level of clinical validation on task-oriented use. Because when you compare it to the traditional standard of care and other diagnostic testing, we're at par or better than a number of them. We are CE marked. We are FDA cleared. We are a Type II class device. We're headquartered in Sweden, and all of our R&D and production currently is in Denmark. And we continually focus on U.S. as our key market to deploy and launch. But we are leveraging outside U.S. markets, including global commercialization, as we continually scale Acarix and CatScore worldwide. We'll go through a few parameters. We'll get started on executive summary. What's really exciting is to be here today to represent this because we are starting to see some of the fruit of our efforts over the last 20 months. We were able to increase our CASCOR deployment to 95% growth year over year. Twenty-two of those systems were consigned in the U.S. market, and 17 of those systems were sold in the MENA market. So a total of 39 CASCOR units were delivered. I'm really excited that we have now expanded into our first outside the U.S. market, and we continually see significant traction there, and we're cautiously optimistic on what can procure in that region, as well as additional countries in the region that we plan to execute on in the near future. U.S. revenue totaled 766,000 SEC, a 17% year-over-year increase. and we grew our patchy the patchy sales by over by 13 uh year over year maintaining stable demand uh despite what we engage in and that is selling in quite a few patches with the initial order so that they can scale but we typically see it after the second or third quarter from a reorder standpoint Our financial results and operational efficiencies we're very, very proud to showcase. Our gross margin stayed very, very healthy at 85%, a slight reduction over last year. However, that's due to the integration outside the U.S. in the MENA market with a vertically integrated distribution partner that we will discuss. With additional capacity here, we have reduced our total operating costs by 43% to 11.168,000 SEC. So that's really important for us to understand as we kind of continue the momentum, as we showcase our ability to really show significant cost savings but continually drive scalability and outcomes in a positive way from a revenue and trajectory standpoint. Our strategic reimbursement continually gets more robust. We'll talk about this in the coming slides, but we've expanded into a second fixed $300 reimbursement in physician office and emergency settings. And we've also integrated with Health Choice Oklahoma and implemented coverage October of 2025. expanding another 500,000 patients. That's really important for us to be able to address significant risk stratification opportunities with 12,000 PCPs and 69,000 specialists in over 3,000 facilities across four states, and they're planning to expand to an additional state in the near future. Our clinical validation continually remains robust, and our international expansion into the MENA market are really exciting opportunities. That was a $1.35 million SEC order for the MENA market, which is a major step for our global commercialization aspect. We also, myself, including the chairman of the board, purchased additional shares, reinforcing our commitment and confidence in our long-term opportunity. And we continually look at ways to grow our basis, and that is going to be leveraged by increasing our opportunities, and that is associated to heart failure. We have a device, and we are going to be showcasing that at AHA this week. And we're really excited to be able to procure some data and showcase to the world what our heart failure diagnostic can possibly do, which could add an almost $16 billion USD market on top of our current CAAT score market of $6 billion, pushing us to $22 billion over the course of implementation of heart failure SISMO and going through clinical outcomes in the coming years. Our systematic review, which was one of the two checks we needed to have the conversation with CMS to progress from CPT-3 to CPT-1, has been published, so we're excited to announce that as well. Again, really excited to be here for our shareholders and share this news. We grew our revenue 137% per year over year in Q3, driven by expansion in the MENA market and continued U.S. momentum. We reduced our net loss by 49% and also reduced our operating costs by 43%. So all the key metrics are going the right direction as we have associated and suggested we would. And we are doing what we said we would. We would evaluate every opportunity to reduce costs, as long as it doesn't inhibit our top-line trajectory and adaptability and adoption of CAD score. So that's reflected in this ability, inclusive of our discipline and what we're trying to accomplish. Getting into a new market in the MENA area is a very significant milestone. Because as you guys are aware, we do provide significant outcomes in rural populations, small villages, small cities where they don't have access to health equity or proper care. So we do provide that opportunity and we do see that opportunity expanding quite significantly. Our reimbursement portfolio continually gets more robust. Our innovation continually gets more robust with inclusion of this heart failure seismal algorithm. We're excited to be able to announce some of the abstracts that are going to be presented this week at AHA in the United States, which is American Heart Association. And, again, we're continually delivering on key metrics, including our gross margin, which is 85% for Q3. So we're looking and growing into Q4 with confidence and focused on adoption and reimbursement, adoption and commercial strategy, as well as global growth. Some of the Q3 key highlights. Again, Health Choice, which is a really exciting opportunity for us, has adopted our technology into their reimbursement portfolio at $300. We continually look at pushing that opportunity across all 150,000 members. And that's a really significant thing because it's a partnership within a state and a government because all of these are government employees. And so we feel that this will continually echo with additional reimbursement opportunities, and hopefully we'll see some more follow through with the waterfall effect. Expansion into the MENA market, again, this is a very significant milestone in regard to my administration since we've been here since February of 24. We were very clear on how we would go to market outside the U.S., very different than they did previously. And the MENA market is a massive market for us, so we're looking at different opportunities within that region. But as it stands today, we did sell in 1.35 million SECs. as the initial order, and we are cautiously optimistic that that will continually scale because it is a high population continent. And we're also looking at how we're doing that, and it's important that I spend a couple minutes here to discuss that. As I previously mentioned, we will be focused on aligning with vertically integrated distribution partners, meaning they are integrated in regulatory, quality, and commercial sales and activities, including marketing. So what we do is we transfer our device, including the unit and the patches, at a specific transfer price. And we also provide all the clinical validation as well as the training. But then they absorb all the costs associated to marketing and commercial activity. So something really important to understand is that we will not be participating in the costs associated to expand the market from a commercial standpoint because that's the onus of the vertically integrated distribution partner. And that's why you see a slight deviation on margin as we transition that because we won't participate in the expenses on the back end. So something really important and very good for our organization so that we can maintain our OpEx at a lower level and increase our margin on the top level. This opportunity that's been presented in the United States is a very significant one, and it's the Rural Health Transformation Program. So as we've discussed on previous calls, health equity is the narrative that's been associated with the last 12 to 18 months, and that is making sure that every person on this world, regardless of socioeconomic status, has access to good health care. And as you guys are aware, even in the U.S., only 50% of hospitals actually have a cardiologist, and less than 50% actually have imaging equipment to be able to risk stratify patients that present with low to moderate chest pain or shortness of breath. So this investment that CMS, Center of Medicaid Services, is making in the U.S. marketplace is quite a significant one and directly associated to CASCOR. It's a $50 billion investment over five years, meaning $10 billion will be deployed on a yearly basis to advance rural health access innovation. And when you categorize that definition with what we procure here at CASCOR CARES, it is fitting to the T, meaning we are the definition of what they're trying to do in a disease state that is the number one killer in the world, heart disease. So we're very optimistic that we can procure some opportunity to grow uh within the united states leveraging this uh this funding opportunity and a grant opportunity and we have the team has basically derived a dossier that we have now disseminated across all 50 states in all the health authorities of all these states because each each state has its own healthcare authority That'll be applying for this grant, and then they will deploy these funds interstate to all the rural populations. And we have created a dossier that we have sent that showcases how we can impact the program, as well as potential outcomes and costs associated. Our diligence showcases that $10 million per state could procure a significant opportunity for Acarix, as well as driving better patient outcomes in those states. And it positions us to be a very strategic partner in rural health innovation. And that is exactly what we want to do because our device provides access to all the early onset diagnostics that are not currently available. We expect our assumptions and expectations is that we can reduce unnecessary referrals by 30%, unnecessary travel by 20%, and increase faster cardiac assessments. As mentioned, only 50% of U.S. hospitals have a cardiologist, so if they present in a rural population, they have to be transported to a hospital where there's a cardiologist to be able to do a risk stratification program. The good news is, CASCOR can eliminate that and provide that derivative of a CASCOR risk stratification at point of care, four to six minutes, right there, right then, when they present. Really important factor. We think that this will be able to help us scale quite significantly. Our reimbursement continually gets robust. We showcase this every single quarterly report. And as you can see, the logos continually get better, meaning more payers have adapted to our technology and are starting to provide reimbursement. As we mentioned, we've secured an additional reimbursement of $300 USD for in-physician and outpatient ED settings. Three of the largest top five payers in the United States have removed the experimental label as well as the prior authorization to leverage a cash score, which is really important to understand because that typically procures when you get to CPT-1. So what we're showcasing in our value proposition being comprehensive, inclusive of the payers, that's why we think that this is moving and it's going according to our plan. It is taking a lot longer than we had expected, but that's tradition. We are not involved in the actual decision-making process, and we are at their mercy and on their timeline. But we are cautiously optimistic that we will continue the momentum, and we'll hopefully see more accelerated adoption and leveraging of our technology. Our reimbursement numbers continually stay healthy. As you can see, we're maintaining a $387 average in regard to reimbursement. And one of the couple of key points to notice here is that UnitedHealthcare a few quarters back was at $250 in reimbursement. It's really exciting to see that they have increased it. Now, while they have not told us specifically why they increased it, but they have increased it from $250 to $350. And our assumption and our hope is that they're starting to see the actual outcomes of reducing the cost in the system but driving better patient outcomes by leveraging CatScore into the workflow with ACPs or healthcare practitioners. So we will continually push this forward. The second key important factor here is we as an organization are lobbying for $300 per patient check with CatScore. So if you can look at this slide, there's only three people that are not paying north of $300, and they are really close to $300. So we're still optimistic that we can engage and move forward at the $300 level, which will provide a significant ROI to the physician users, which makes very important factors for us. And again, as mentioned on a previous slide, is that as of August 2025, Cigna, Humana, and United have removed the investigational device designation as well as prior authorizations. We're working very diligently to get the other two payers to do so. And, again, we're at their mercy, but we have not had any negative associations with it or pushback. It is just taking the time. So we're hopeful that we're able to present more data in the near future or possible coming quarters where we can leverage the ability to integrate them as well as non-experimental as well as non-prior authorization requirements. Our clinical update, the exciting thing is that our systematic review, which was very important because it's one of the two check boxes we needed to move forward with CMS for a CPT-1 transition conversation. It was published in July, and we're very, very excited about that because, again, it mitigates one of the two things we needed, and it continually reinforces our ability for CAS4 and the clinical validation. So that's exciting. Our UC Davis study continually, it's 100 patients and growing to 200. The team at UC Davis has presented an abstract for presentation at ACC in 2026 based on the first 100 patients. So that's exciting to hear. We'll update you as soon as we know whether that's been accepted. And then the Alborg partnership we have has deployed the heart failure seismal algorithm in abstract, and it was accepted, and it will be presented this week at American Heart Association. And we're really optimistic and excited to showcase to the world what our algorithm can do in regard to any HF. Because remember, there's two heart failures, preserved ejection fraction and reduced ejection fraction. And we feel very optimistic that we're going to have some opportunities in both markets. A little bit of an update on our marketing and driving the noise of CatScore across two platforms. One most significant one is LinkedIn. And as you can see, we had over 44,000 impressions in Q3, over 4,400 engagements, 2,500-plus clicks, and a 10.5% engagement rate. It's really important to note that this team we've created and the PR and marketing team is executing at such a high level that that 10.5% engagement is extremely healthy, especially when you look at the benchmark for medical devices. It's 2.8%. So really excited to be able to showcase that and very excited to see how that's moving along. The click-through rate is even as exciting because it's 5.7%, 5.76%. which is extraordinary given the fact that the industry average is sub 1%. So, again, executing on a high level and really acutely focused on continually driving the noise for cash score because the more noise we create, the more awareness that's created. On X, our Q3 highlights are as good, 6,700-plus impressions, over 800 engagements, 400-plus clicks, and a 13.2 engagement rate. Again, an engagement rate that's pretty significant considering the benchmark in MedTech is 1.3%. So 10X, really exciting to see that. Our engagements have increased to 11.5%, so that's exciting for us to do, as it was 8.6 last quarter. And I think we're leveraging this to our U.S. strategy and creating that noise and awareness that people are starting to realize exactly what CatScore does, and they're intrigued to learn more. So that's really exciting to see. So we're executing on a high level from that perspective. Let's get into our Q3 financials. Excited to showcase this. As we've said before, the arrows are all going in the right direction. 95% yearly quarter-over-quarter growth in systems delivered. Patch sales increased 80% year-over-year, and our operating cost was down 43%. Again, all the right directions for the key metrics and KPIs that we're looking to leverage, inclusive of investor outcomes. Our expansion of CAD score installation continues to drive recurring patch sales, so the trajectories that are going in both facets, quarter over quarter, are showcased and showing the right trajectory. While we all want to see that hockey stick, that we are going the right direction, and we'll procure that hockey stick in the future. Our wider clinical adoption continually is a focus of ours. As you guys remember, 20 months ago when I joined the organization, there was an acute focus on cardiologists specifically. We have broadened that to four different disciplines, ED, urgent care, concierge, cardiology, and primary care. Primary care being one of our most acute focuses because it is the largest population of healthcare providers across the world. So that is where patients are primarily presenting. So we're focused on that demographic and acute legal. going as far and deep as we possibly can. Our Q3 global revenue was up 137% at 2.35 million SEC. Again, shows significant growth, and a key proponent of that is the introduction of a new outside-the-U.S. market in MENA. So we're cautiously optimistic that we can continue this trajectory. Obviously not at this rate, but we're hopeful to continually open up new countries outside the U.S., But, again, we will not deviate from our focus on the world's largest MedTech market, and that is the U.S. Q3 global cash score units installed grew by 95%, 20 to 39 last quarter. So year-over-year growth is quite significant. We're really excited to be able to present that and continually push every opportunity we have. Our global past sales grew 80%. So, again, very excited to see this momentum. This has obviously contributed to our new distributor in the MENA region, a significant opportunity for us that we're cautiously optimistic we'll continually see great returns from our investment standpoint. our gross margin uh reduced five points uh and again it's 100 attributable to launching a new outside the u.s market in which we do take less margin because we are not participating on the commercial costs and execution inclusive of personnel marketing and any other commercial activity including marketing opportunities so something really important to understand and embrace because we want to do this across Any outcome outside the U.S. with vertically integrated distribution partners, so the expectation is that we will take less margin because we are not participating on the back end. But more importantly, we will continually look at ways to grow outside the U.S., but keep the margins in the U.S. very significant to where we want to procure. Our U.S. CAS score at stall base grew 10% to 22%. Again, 22 new ads, growing our base, getting our footprint, and ensuring that the adoption is tracking. So we're excited about where we're going. And our past sales grew 13%. And, again, one of the key markers of this to understand is that when we do sell in a device initially and a new customer, we do provide quite a bit of patches for them to be able to leverage and utilize. And what we typically see is post-initial onset, the second or third quarter is when we start to see reoccurring patch orders. So we're optimistic that we'll see some more growth in the near future on the back end of the initial launches. And, again, as I mentioned from day one, we continually evaluate every opportunity to drive savings into the system, including driving better shareholder value, and that's represented here by a 43% reduction in OPEX, yet we grew, which is exactly what we're suggesting we were going to do initially, and we are executing at a very high level. We were able to reduce our OPEX, yet grow our basis as well as our revenue. So, again, the team is executing at a very high level. Our net loss reduced almost 50% to 9.4%. And we're really excited about that because, again, we are reducing the net loss, driving shareholder value, and trying to reinvest our funds that we're saving and looking towards in the future to more commercial activities or activities that provide a significant ROI. Our monthly burn rate is down 45%. Again, executing at a very efficient and high level, but yet not mitigating any of our scalability or top-line revenue trajectory. Financing, as the group and investors all know, we continually evaluate the opportunities for us to look at long-term financing and ensure operations of the business. Everything is balanced at all times, as you can see in our financial astuteness. We establish the growth that is driven by market demand. and we might require additional funding in 2026 we're looking at many different ways as we procure this there could be dilutive ways but non-dilutive ways and and we're making sure that we represent shareholder value in anything we do including financing so the board of directors and all the executive management team has a very positive view on being able to carry out additional capital raises on really favorable terms Some previous go-forward objectives, you know, what are we looking to accomplish in the past? So the GOMED partnership has created massive opportunities for us. The biggest challenge we're facing is the new administration and the challenges procuring in the new administration. And last year we were challenged with the new administration and the vote to see who the new administration would be, so there's a lot of delays. Our biggest challenge today is that the United States is shut down, as many of you guys are aware. It's been shut down for months. quite some time, and they're looking for an amicable resolution amongst both parties. So we're cautiously optimistic that something can procure, but we are continually focused on the VA and any government setting, and we are having continued conversation and a lot of positive momentum in that space. But we will get to a healthy return in regard to VA opportunities, I'm hopeful, in the near future. Our systematic review was published. There's a requirement for CPT-1, which is really important. We continually work towards our U.S. performance trial by adding new centers to get our inclusion criteria fulfilled for submission for publication. And our UC Davis continued enrollment to 200 is moving, and the abstract has been submitted. So when you look at the heart failure seismal algorithm, as mentioned, really excited that we will be presenting that abstract this week at American Heart Association. So stay tuned for that. Exciting information that will be disseminated. And second to last, our second payers, our reimbursement robustness continually gets better. While it's not moving at the speed we would all like, it is not – our decision. It is purely at the mercy of these payers making the decision and adopting our technology. But what we can say is we are 100% focused on it. We are leveraging all resources to make sure we are focused on it and being in front of these payers. And we haven't had any significant pushback. As a no, we are continually providing additional resources, additional data, and as we continually manifest additional payers, we share that with them too because, as mentioned initially, it is a waterfall effect. Each one waits to see what the other is going to do, and if they adapt, they potentially will adapt as well. So cautiously optimistic that we will continue the robustness of our reimbursement platforms. And lastly, we're going to continue evaluating every single opportunity outside the U.S. in regards to vertically integration distribution partnerships. Future key go-forward objectives. We will continually focus on our reimbursement. As you guys know, that is super important in the U.S. markets to make sure we are providing the reimbursement to the physicians and executing on a high level. And second, this rural health grant will be quite impressive for us to be able to leverage as we continually scale our Because in the U.S., as I mentioned, there's $10 billion of quote-unquote free money that will be going to states to deploy key objectives in rural patient populations, and we fit that definition to a T. As mentioned, we drive significant patient outcomes in rural populations with our point-of-care diagnostic that really will help rule out disease in the number one killer in the world worldwide, which is heart disease. Our clinical trials, as mentioned, We're focused on getting the trial completed in the U.S. by adding new centers. It is the last requirement we have to fulfill to have that conversation with CMS, so we're cautiously optimistic that we'll integrate two new centers in the near term that will help us scale to the 900-plus patients for inclusion. And the UC Davis study continually gets momentum to 200 patients, and we, as mentioned, we have submitted the abstract to showcase in the near future at Congress's next year. So we'll continually focus on driving our adoption in the U.S. physician education and behavioral changes by adapting to utilization of CASPOR into the workflow. And then second to last, we did discuss a guidance in previous quarters that we will provide. We are still acutely focused on being able to provide that with some finite details, so we hope to be able to present that in the future. And again, lastly, we are going to continually evaluate big opportunities outside the U.S. with regard to distribution partnerships because those partnerships are really critical to drive our continued success globally. in a vertical integrated distribution pathway, while we continually focusing on most of our resources on the U.S. and continue driving the world's largest medtech market. So with that, I thank you for your support and continue to support with Acarix and what we're trying to achieve. I do feel we have a game changer. We have a disruptive technology that can be utilized worldwide, and we will continue moving forward, and we will continually update you as things progress for Acarix. Thanks again.