Acarix AB (publ)

Good morning and welcome to the Acarix 2025 Q4 earnings call. Thanks for joining. As a reminder to shareholders as well as new shareholders, I want to give a little bit about what we do and how we do it. So we are Acarix with the CADS4 device, which is a high fidelity point of care diagnostic that helps to risk stratify patients with coronary artery disease symptoms like low to moderate chest pain or shortness of breath. We have quickly and easily risk-ratified patients with a 96.2% negative predictive value, which is on par or better than a number of more invasive testing that has procured for today. We have over 15 years of R&D, over 6,000 patients in clinical trials, 45 patents worldwide, and over 60,000 assessments to date. We are CE marked, FDA de novo cleared, and we're designated a class two medical device. We do have a CPT code in the United States for reimbursement, and we are headquartered in Sweden with our production in Copenhagen, and we have a focus on global sales. A little bit about our executive summary highlighting what we did in Q4 of 2025. We had revenue increase of 26%, which is pretty exciting to us, driven by 87% growth in the U.S. market, which is our most important market and our strategic focus. Our cash score deliveries grew 64% worldwide. Our financial performance and cost discipline was effective as we've procured ever since we've joined the organization. It remains strong from a gross margin standpoint at 83%, which continually reinforces our reoccurring revenue models. Our operating costs declined 23%, which provided a 27% improvement in our net loss. Our U.S. market momentum continually focused on reimbursement, which with another additional payer joining us. And we delivered four systems on consignment and 19 systems on a sales standpoint, continually effectively demonstrating that both of our sales models work in parallel and work to mitigate barriers of entry. Our strategic progress continues to focus on the Rural Health Grant that was announced last year that we are a clear definition for in driving better health outcomes in the number one cause of death worldwide, but most specifically in the U.S. And we'll continue to look to see how we can participate and where we can participate over the next few quarters. And our ongoing efforts in evaluating and launching in outside the U.S. markets continues, as recently I mentioned in a press release yesterday. So we're really optimistic about what we procured in 2025. We had gross revenue up 26%, driven specifically by 87% growth in the U.S., our most strategic market. Our costs declined by 23%, and we improved our net loss by 27%. All really important double-digit numbers that truly reflect our discipline in what we're doing and how we're doing it. Our U.S. market remained our key growth driver with 23 systems delivered, which is a 64% growth. And when I look at our PAT sales, which is our recurring model of PAT sales, it grew 73%. So again, the right numbers in regard to what we're trying to procure for shareholder value. We had another adoption in regard to payer on the reimbursement side, which continued to build our robust platform. And we continually look at ways of expanding our consigned models to lower adoption barriers while also driving patch revenue, but also look at ways we can sell the model in as well as continually keep our gross margin north of 80%. When we look at our international distribution footprint, you can see we were working very diligently in the MENA region, and we had a lot of opportunities to be able to deliver and execute on that while continually utilizing that space for parallel growth as we continually focus on the U.S. markets. Q4 highlights. So as we mentioned, we had a new pair adopt, which was Health Choice, which has over 150,000 members within the Oklahoma setting. And again, as we mentioned, there's always gonna be a cadence of bringing payers on and leveraging those payers with payers that have not adopted. So everyone we get only builds our portfolio bigger and provides a more compelling value proposition to payers that have not necessarily fallen in line. uh with reimbursement with cat score so very important win for us and we will continually work to drive that that payer adoption across all parameters One of the key things we accomplished just recently was certification of the MDR in the European Union. This is a very difficult and stringent test that demonstrates our abilities from a safety, quality, and clinical performance perspective. This has got so many different nuances that really make this difficult, but once secured and done, it's a compliment to the organization as well as the procedures and processes we have in place. So kudos to the team for effectively delivering on this aspect. Now what this should do is provide a growth catalyst because When you look at the underdeveloped countries or countries that don't necessarily have their own regulatory organizations to review and authorize devices, they typically lean on the FDA or the MDR now. The MDR seems to be gaining much more traction worldwide in regard to recognition, and we feel that it will provide us an opportunity to continually scale in markets that will adopt the MDR versus going through their own regulatory process. We continually scale our pathway and reimbursement, which is one of the critical things we've focused on and will continue to focus on. But as you can see here, we continually build our portfolio of logos. And we had added Health Choice, and we've added another $300 in regard to what we're trying to accomplish. As a reminder, three of the top five payers have removed us from experimental as well as prior authorization, opening the door for us to be able to move forward quickly and adoption continually scales. These developments all compound to be able to provide more data and accessibility to two of the largest payers that we are still working diligently towards solidifying, as well as CMS adoption as we continually push the needle in regard to claims. So all these things are combining and really creating a robust pathway for us to continually accelerating our adoption. Our reimbursement, this is nice to see because the number is consistent last year from 24 at $387 on average. You can see here some of the Medicaid's are paying. So slowly but surely we are incrementally growing our reimbursement portfolio to where we can get to a point where hopefully in the near future we can align with one or two of the last holdouts. in regards to the top five payers. And we continually work towards that progression every single day because this is as vitally important as getting CPT-1. Our Q4 financials. Great side to look at. It's a slide that showcases that we're effectively delivering on every parameter within our business. So we're driving our CASCOR system deliveries by 64%. We've driven our U.S. patch sales up by 73% quarter over quarter. And we reduced our OPEX by 23%. Again, delivering a reduction in spend but growing our top line. Exactly what shareholders should look for for driving shareholder value. Our usage and installation base continually scales. As you can see, CatScore utilization is going the right trajectory as well as the patch sales is going the right trajectory. While it's not the hockey stick we're looking for, we're slowly getting to the upward trajectory where we should see something develop in the coming quarters and years ahead. We focus on four different parameters of customer segments. We have the primary care, we have the cardiology, we have the concierge, and we have the ED, emergency department, or urgent care settings. And you can see that they all continually scale incrementally. When you look at our global revenue, we grew 26% to 2.1 million SEC up from 1.7 million SEC last year. And our CAS score installed base went from 14 units to 23 units, representing 64% growth. Our gross margin did decrement down slightly by five points, but that was anticipated, as I mentioned previously. We are working with vertically integrated distribution partners that carry all the expenses in regard to commercial efforts. So we anticipated coming down a bit in those regards. And as we continue to develop these distribution partners, we should see a scale. But we anticipate we can stay in the 80 north of 80 range pretty consistently over the years to come based on our ability to generate better margins and better partnerships and that can carry these product for us in multiple different countries. When you look at Q4 patch sales, this is something that's really important because this is our model. Remember, we're the razor blade model. The patch sales are most meaningful to us. And when you can see a 73% growth from Q4 24 to Q4 25, representing 73 box growth to 126 box growth, that's pretty impressive in regard to the scale of our organization and what we're trying to accomplish. So if we can continue this trajectory and continually add partnerships to help us scale, we should see great adoption in the coming months and quarters. When you look at our cost savings, which I told you we would implement the day I came, which was just over two years ago, we continually erode on our OPEX, and we repurpose funds that we save to drive better commercial efforts. But when we obviously feel we don't need to spend it, we'll reduce it. And you can best demonstrate it here by dropping it 23% from $17.8 million SEC to $13.7 million SEC, driving better operational efficiencies. Our net loss was also driven down 27% based on savings from 16 million SEC to 11.6 million SEC. Our monthly burn here was pretty significantly reduced by 37% from 5.5 million SEC to 3.5 million SEC. Also, demonstrating the processes and procedures that we're effectively executing on are delivering the right outcomes. Our go forward objectives have not changed. So we have two of the check boxes we had was one was systematic review, which we have now got published and check the box. Our CPT one transition is the US performance trial. There's the one we're lacking. We're working diligently to bring on another center before the end of Q3 of 2026. And our hope, as mentioned, is that we'd like to get in front of CMS in one of their three meetings they have a year. And the last meeting they have is at the end of Q3, early Q4. And if we can get an inclusion criteria complete and get it published, we will be able to get in front of CMS and hopefully present our case for CPT-1 transition. Our UC Davis study, as we mentioned, has been accepted at ACC this year, which is in March at New Orleans. And we are looking forward to seeing Dr. Atreha's presentation of her findings. Really optimistic. And lastly, as you can see here, we're continually working parallel to our objective in the US with outside US partnerships and growth where we can drive definitive top line revenue and really compliment our efforts in the US. That being said, this is exactly what just procured. We opened up the market of the kingdom of Saudi Arabia. We have a new distribution aside with a very, very significant local partner. who is going to drive the regulatory adoption of cat score in ksa and this partner is is in the space and has been in the space for a long time in specifically cardiovascular disease so we're really optimistic about what they can procure uh as many of you know ksa is is a very wealthy country that has really driven the adoption and built out their entire healthcare organization platform to drive better patient outcomes for their for their their citizens and you can see here that upon receiving regulatory approval, they have a forecast of potential orders of 9.8 million sec within the first six months. So really optimistic. This is the largest deal we've landed thus far, and we're really proud of what the team has accomplished here. This expansion not only represents exactly what CASCOR can do, but it's giving us an effort to really deploy in regions and go deeper in larger countries where we will be able to facilitate all the surrounding countries to adopt as we move forward. We've had a significant amount of inquiries and we're driving every conversation we can to the best outcome ability we can possibly procure. So that being said, my goal is to always reassure shareholders of what they're doing, not only financially, but from a patient standpoint. Because effectively, that's what we do what we do. We are here to save lives. We are here to drive better patient outcomes. And this one is quite sincere. This is actually a patient who is a physician. He's a medical doctor, and he had had a number of chest pain incidents and low to moderate or shortness of breath incidents. And he had gone through other testing and nothing was clearly articulating whether he needed to move forward or not move forward. So he was referenced to the CAT score. The CAT score system showed his number north of 20, which means you need to go through further risk stratification and went in to get a CT and showcase blockage. So we ultimately helped them to drive better patient outcomes and get the testing he needed as well as receive the appropriate treatment. So again, This is driving better patient outcomes. This is saving lives. And that's why you invested in a company like this, not only because of the business value proposition, but also the fundamental gratitude we get when we deliver these kinds of outcomes to people that are near and dear to us or have families and are able to live another extra day or two and really live life better by knowing what procured and were able to get the delivery of the therapy they needed. So with that, I reassure you that what we're doing is really powerful, it's impactful, and we are changing lives. And I look forward to speaking to you again in the near future.