Acarix AB (publ)

Good morning and welcome to the Q1 2026 earnings call from Acarix. I appreciate everybody joining this morning. And before we kick off, it's important for us to all kind of understand and realize that the world is in a very dynamic shift as we speak. The geopolitical tension most pertinently in the Middle East markets right now. are ongoing and we don't see an end in sight. However, what I want to rest assure is all operations from a caret standpoint are fully functional. While we do have a lot of entry and focus within the MENA region, nothing has come to a stop. So things are moving along slower than expected. However, Given the rhetoric and the challenges we face across the board globally, I think that everybody recognizes it, but it's important to make sure we address those situations as we continually press forward. Second, I'll apologize in advance. I have a mild cough due to my allergies, but nothing to be concerned about. So let's go ahead and move into the deck. For all our new investors, thank you for joining. Just a quick update on who we are. We're a care, we have the CAT score system and we're really trying to revolutionize early onset diagnostics in the cardiovascular range. We have a point of care device that is fairly quick within 10 minutes and can calculate a CAT score for patients feeling low to moderate chest pain or shortness of breath. We can quickly and very easily identify those things using high-fidelity acoustics, listening into the arterial flow. And our negative predictive value is 96.2% in the United States and 97.2% in the European markets. We have over 15 years of R&D, over 45 patents, and we have over 6,000 patients in clinical trials. And to date, we have over 60,000 assessments and accountants. As mentioned, we are FDA cleared as well as CE marked in the MDR facets just as recently. Our headquarters are in Sweden, our manufacturing and R&D is in Denmark, and we have a focus on global commercialization. A quick update on where we're at in regards to Q1 of 2026, which the team delivered remarkably. Our revenue increased over 40% to 2.4 million sec, and that's driven by 63% growth in the U.S. And when you look at the U.S. on a consistent currency basis, that's 90% growth, which is really, really exciting for us to see and one of the largest growth factors we've had in history. We've delivered 29 cash score systems in the U.S. reflecting accelerated adoption because we grew quite substantially quarter over quarter, but also quarter over quarter from a year perspective. Our financial discipline and performance is continually marked by significant improvements. Our margin remained consistent year over year at 81%, but we reduced our actual operating costs by 32% and improved our net loss by 38%. Again, great, great delivery from the team and looking at all the right parameters in regard to finance and going the right direction. Our U.S. market grew and continues the momentum. Our patch sales grew 15% year over year, and we are continually building our installation base of our cash score unit, which then transpires to additional adoption and growth in regard to patch utilization. Only four of those systems we placed in Q1 were actually consigned, where 25 were actually sold. So continued performance in that regard, helping our balance sheet. And then from a strategic standpoint, one of the really important things that's really difficult to achieve is the CE European Union MDR certification. This is a very rigorous certification that takes significant time in our quality and R&D teams delivered at a high level. We have our regulatory approval underway in the Kingdom of Saudi Arabia, which represents a very large opportunity and market for us to expand into. And as mentioned previously, we do not see anything stopping, but the progression has been slightly slower due to the challenges they're facing in the MENA market. But we do anticipate approval expectations in Q3 of 2026. So in the short term and looking forward to what procures after that in regard to entering the KSA market. some of the q1 highlights so really exciting data that came out of the uc davis uh trial that we conducted uh the abstract was approved and presented and what is really key for what's shown here is it continually emphasizes our very robust and negative producing value but also the impact we have on the cost associated in the system for patients which everybody is looking at ways to reduce we provide that derivative And based on this clinical trial, as well as the trial done by Barron at Mass General, we saw exceeding over $100,000 saved per inpatient and over $400,000 saved for outpatient. This is really important because it continually demonstrates our value proposition across the board, from the patient to the provider to the payers. And we're really excited about that and continually look for ways to prove our and demonstrate our clinical validity in not only the patient outcomes, but also cost-saving measures. We also, as mentioned, got the MDR certification in the EU. This is a very difficult thing to achieve and something that should be celebrated because what it does is it provides not only EU certification of very rigorous standards and processes in regard to manufacturing and quality and serviceability, but more pertinently, what the impact is on markets outside of the EU. Just like many others, they leverage the FDA approval as well as a CE mark and MDR certification as leverage versus going through regulatory processes in each individual country. So we're really excited about achieving this feat, but more importantly, where does it impact us and how does it impact us, which we will see in the coming months. We continually push very robust outcomes in our reimbursement platform. One of the key wins is SoonerCare, which is actually Medicaid, as we're working towards CMS CPT-1 approval. We were able to bypass that and convince the SoonerCare brand to pay for our device, as well as the patients that present. And it will be retroactive to January 1st of 2026. We continually move along the path with all the major payers. We have clinical policy meetings with the Blue Cross Blue Shield. As you guys know, Blue Cross Blue Shield is the largest payer in the United States where one out of three patients are covered under. And we continually push and receive good feedback. While it's not going as quickly as we want, everything is outside of our control here. But one of the key things that I always suggest is it's very easy to say no and at this point we continually move forward and progress with all these different payers and we continually build as you can see from the logos our robust platform so we're very optimistic and continually push uh which is reimbursement is probably the most significant challenge and difficult thing to accomplish outside of clinical research As we've demonstrated over the last nine consistent quarters, our average reimbursement remains consistent at $387, which is pretty remarkable. And we hope to continue this pathway as we continually have our conversations with Blue Cross Blue Shield, as well as CMS, as we'll discuss here in the short term. Some great marketing highlights. As you can see, we continually generate above benchmarks in the MedTech space on LinkedIn and X. As you can see, our CTR is increasing to 7.1% and 26,000 plus impressions on LinkedIn. And with over just about 5,000 engagements, increased 24% quarter over quarter on X. So we continually do well and continually extend our reach to patients and providers via both of these platforms. And we hope to continue this momentum. And one of the key things to demonstrate here is that we are significant multiples above our peers in the med tech industry when you look at these statistics and analytics. So really excited about the team and our marketing team really executing at a high level. We also were able to get some additional media coverage on both TV with Fox News and the Oklahoman, which is a newspaper. And it really was demonstrating all the key things that we suggest to the market. And what that is enabling for us is it's enabling a broader perspective and delivery for patients outside of our reach. So really exciting to see that and hope for more to come or follow through. Let's get into the numbers. So as you can see here, and as I always mentioned, we always want the arrows pointing in these directions, right? So we're up 53% quarter over quarter in delivery of cad score systems. We're up over 15% quarter over quarter on patches, and we're reducing our operating costs by 32% quarter over quarter. So when you look at these digits and these analytics, it's really exciting to see Not only that our trajectory continually goes up and our efficiencies and operations continually goes down, no goes up, but however it goes down from a cost perspective. So when we got here in 2024, we have reduced that over 45% and we continually look at ways to refine, not only ways to become more efficient, but we will always reinvest the dollars that we save if it proves fruitful from an ROI standpoint, from a commercial standpoint. So really excited about these numbers. Our utilization and installation base continually grows. As you can see, the trajectory continually climbs higher. So we're continually optimistic about where and how we're delivering our commercial efforts. And the team is executing at a good level. And as you can see here, one of the key things from Q1 of 26 was the adoption in the primary care setting. This is the largest from a volume standpoint perspective in the United States as well as abroad. And we are seeing significant penetration in the primary care markets where this is where the majority of our patients are presenting. And right now, the actual primary care settings do not have the tools that are necessary to be able to rule out and risk stratify patients before sending them to cardiology. So we are seeing the adoption procure with the CAT score device, and we anticipate that this continually escalates as we continue our push from a commercial standpoint. Our global revenue was up 40%, and it's very important to note, while that's fantastic, on an apples to apples basis, on a consistent currency basis, we were up 61% globally and up over 90% in the United States. When you look at our CAD score base, we delivered 29 units as compared to 19 units, which represents a 53% growth. Again, one of the larger numbers we've had on record since I've joined the company in 2024. So really optimistic that this is a telltale as to where we're going in the near term. Our patch sales increased to 122 boxes from 106. That's up 15% year over year. And our global gross margin, which is really exciting to see, remained consistent at 81%. Something to make sure I continually emphasize, in the grander scheme of MedTech across the board, really exciting margins are typically ranging between 60% and 70%. As you can see, we are well above the norm or the benchmark per se. And so we hope and we continually push to make sure that we're able to generate the gross margin between the 80% and 90% range for the long term. We continue our cost-saving initiatives, as demonstrated previously, but as well as here. We are down 32% from a quarter-over-quarter basis, and we continually, as mentioned, will look at ways to reduce those from an OPEX standpoint, but more pertinently, reinvest those funds where we think that it could procure better ROIs. We will continue to look at ways and evaluate every single opportunity when it comes to spend. When you look at the Q1 net loss, it reduced 38%. Again, very consistent delivery from the team. And we're very excited at where we're at right now. And we feel that we're coming to a place where we can equalize and from this point continually manifest our way up into profitability range. Our monthly burn, as you can see, was down 21%, which is quite significant from the day we joined in 2024. So we're down to just around 3 million sec a quarter. So we are really looking at this as a very clear evidence in regard to our ability to deliver efficiency as well as reduce effects where needed. Some of the key go-forward initiatives, as many are very well aware, the RHDP, or the Rural Health Transformation Program in the U.S., is a five-year program that is going to leverage $50 billion over the course of five years, $10 billion annually over five years, and we have the significant opportunity to be a benefactor of this Rural Health Population Grant because what we can do is make sure we're identifying all these rural clinics, which if you remember from previous presentations, less than half have cardiologists and less than approximately half have actually imaging equipment to be able to risk stratify patients presenting with our indications. So we are very optimistic and we have put in a tremendous amount of effort to ensure that we are in conversation in regards to these grants and distribution of the funds. So we're hopeful for some excitement and some news in the coming days or weeks. And we anticipate that what this can do for Carix is truly set us apart. Because for five years, we can leverage this grant and utilize the grant to deploy our CADS Core system effectively, driving better patient outcomes in rural populations. which as we continually deploy systems, the natural way it transitions to patch utilization and the reoccurring revenue as we expect based on the razor blade model, we're very well positioned for future opportunities as we continually move and push our efforts into this process. Our clinical trials, as you know, is a very important deal for CPT-1 transition. We had two objectives to fulfill. One was the systematic review, which has been published, and the second was the performance trial in the United States. We have now looked at different ways to push that forward more quickly. And we have now assessed that our enrollment is complete. We are now reviewing the data for publication. And as you remember, this is the requirement, the last requirement we have for CPT-1. And once it's published, we can then go to CMS and request the meeting to then continue the conversations for CPT-1 adoption. So really optimistic and really excited that this has now come to fruition. And we can now look to see where we're going. Again, on the U.S., UC Davis, excuse me, the ACC presentation, we had significant negative predictive validity as well as significant savings in the system. So, again, another very clear demonstration that CAT score, it does what it's intended to do, and we need to continually push this narrative across the United States and globally. Outside the U.S., we continually evaluate on a day-to-day basis different markets to enter. What I can tell you is we receive a number of weekly introductions as well as interest in regard to opening different markets. We are being very selective in how we go about that because we need to truly demonstrate understanding of the market and understanding of the potential partner because it's a long-term decision, but we are looking at every way to do so effectively to drive shareholder value. As mentioned, the GCC country partners are currently under regulatory review, and we are expecting additional approvals in additional countries within the Q3 time range. So really excited about these opportunities as they come to fruition. One other thing I'd like to talk about is the VA. And as you guys know, the U.S. government and administration is also in a bit of disarray. There are a lot of challenges with budgets, including DHS, as well as a number of other things where The VA is moving quite slowly. What I can demonstrate, because there's been a number of questions about the VA, we do have open purchases that are going through the system. They are going extremely slow due to administration challenges and roadblocks. But what we do know is we have continued momentum. And as soon as things can start to settle down a bit and we remain somewhat consistent in regards to what's going on globally as well as nationally, we anticipate that we have opportunity in the near term. hopefully to come to fruition in the VA. So with that, I'd really love to continually thank you for your support. We are getting to where we need to go. We're very excited about the delivery from the team this quarter, and we anticipate that things continually go positively here moving forward. And we still have the ultimate objective to break even and get to profitability quicker than we possibly can. And we will continually do so and push for every opportunity that we progress or comes to our table. And rest assured that the team is working very diligently to make sure ultimately we're driving better patient outcomes and shareholder value. With that, I'll conclude the call and appreciate everybody. Thank you.