Acarix (Stockholm:ACARIX) Q1 2026 Earnings Call

0:00 Good morning, and welcome to the q one twenty twenty six earnings call of 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 a very dynamic shift as we speak. The geopolitical tension, most permanently in The Middle East markets right now, are ongoing, and we don't see an end in sight. However, what I wanna rest assure is all operations from a Acarix 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, those situations as we continually press forward.

0:50 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. This is we're a Carriage. We have the CatScore system, and we're we're really trying to revolutionize early onset diagnostics in the cardiovascular rent range. We have a point of care device that is fairly quick within ten 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 ninety six point two percent in The United States and ninety seven point two percent in The European markets.

1:36 We have over fifteen years of r and d, over 45 patents, and we have over 6,000 patients in clinical trials. And to date, we have over 60,000 assessments and counting. As mentioned, we are FDA cleared as well as CE marked in the MDR passage just as recently. Our headquarters are in Sweden. Our manufacturing and R and D is in Denmark, and we have a focus on global commercialization. A quick update on on where we're at from in regard to q one, of 2026, which the team delivered remarkably. Our revenue increased over 40%, to 2,400,000 set, and that is driven by 63% growth in The US. And when you look at The US 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.

2:25 We've delivered 29 CAD score systems in The US, with rep reflecting a set accelerated adoption, because we 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 our margin remained consistent, year over year at 81%, but we reduced our our actual operating cost by 32% and improved our net loss by 38%. Again, great great, delivery from the team and and looking at all the right parameters in regard to finance and and going the right direction. Our US market grew and continues the momentum. Our patch sales grew 15% year over year, and we are continually building our installation base of our CAD score unit, which then transpires to additional adoption and growth in regard to patch utilization.

3:14 Only four of those systems we placed in q one 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 and d teams delivered at a high level. We have our regulatory approval underway in in The Kingdom Of Saudi Arabia, which represents a very large opportunity and market for us to expand into. And we expect we as mentioned previously, we we do not see anything stopping, but the progression has been slightly slower due to the the challenges we're fit they're facing in the MENA market. But we do anticipate approval expectations in q three of twenty twenty six. So in the short term and looking forward to what per appears after that in regards to entering the the KSA market.

4:11 Some of the q one highlights. So really exciting data that came out of the UC Davis, trial that we conducted. The abstract was approved and presented. And what was 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 Verint, 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.

5:09 We also, as mentioned, got the MDR certification in the EU. This is a very difficult thing to achieve and something that should be, you know, celebrated because what it does is it provides not only EU certification certification of very rigorous standards and processes in regard to manufacturing and quality and and serviceability, but more permanently, what the impact is on markets outside of the EU. Just like many others, they leverage the FDA approval as well as the CE Mark and MDR certification as leverage, versus going through regulatory processes in each individual country. So we're really excited about achieving this 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.

5:57 One of the key wins is SoonerCare, which is actually Medicaid, as we're working towards CMS CPT one approval. We were able to bypass that and and and convince the the SoonerCare brand to, pay for our device as well as the patients that present, and it will be retroactive to 01/01/2026. 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, which is reimbursement is probably the most significant challenge and difficult thing to accomplish outside of clinical research.

7:02 As 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 med tech space on LinkedIn and X. As you can see, our CTR is increasing to seven point one percent and twenty six thousand 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 man extend our reach to patients and providers via both of these platforms, and we hope to continue this momentum.

7:54 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 and our marketing team really executing at a high level. We also were able to get some additional media coverage in in on both TV with Fox News and the Oklahoma, 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 per perspective and delivery for patients outside of our reach. So really excited to see that and 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.

8:40 Right? So we are up 53% quarter over quarter in delivery of CASCORE systems. We're up over 15% quarter over quarter on patches, and we're reducing our operating cost 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 op operations continually goes down. No. It 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 continually climbs higher.

9:33 So we're we're continually optimistic about where and how we're delivering our our commercial efforts, and the team is executing at a good level. And as you can see here, one of the key things, from q one of twenty six was the adoption in the primary care setting. This is our the largest, from a volume standpoint, perspective in The United States as well as abroad, and we are seeing, me, 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 the tools that are necessary to be able to rule out and restratify patients before sending them to cardiology. So we are seeing the adoption ProFure with the CAD score device, and we anticipate that this continually ex escalates as we continue our push from a commercial standpoint.

10:23 Our global revenue was up 40%, and it's very important to note, while that's fantastic, on a 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 cat score base, we we delivered 29 units as compared to 19 units, which would represent 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 past sales increased to a 122 boxes from a 106. That's up 15% year over year. And our global gross margin, which is really exciting to see, remain consistent at 81%.

11:11 Something to make sure I continually emphasize, in in the grander scheme of med tech across the board, really exciting margins are typically ranging between 6070%. As you can see, we are well above the 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 8090% range for the long term. We continue our cost saving initiatives, and you 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 and and and from a from a OpEx standpoint, but more importantly, 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.

12:02 When you look at the q one net loss, it reduced 38 percent. 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 three just around 3,000,000 set a quarter. So we are really looking at this as a very, clear evidence in in regard to our ability to deliver efficiency as well as reduce OpEx where needed. Some of the key go forward initiatives, as many are are very well aware, the RHDP or the Rural Health Transformation Program in The US, is a five year program that is gonna leverage $50,000,000,000 over the course of five years, 10,000,000,000 annually, over five years, and we are a significant 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 restratify patients presenting with our indications.

13:18 So we are very optimistic, and we have put in a tremendous amount of effort to ensure that we are in the conversation in regard to this with 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 Acarix is truly set us apart. Because for five years, we can leverage this grant and utilize the grant to deploy our CAD score system effectively driving better patient outcomes in rural populations, which as we continually deploy systems, the natural way it transitions to new 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.

14:03 Our clinical trials, as you know, is a very important deal for CPT one transition. We had two objectives to fulfill. One was the systematic review, which has been published, and the second was the 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 as you remember, this is the requirement the last requirement we have for CPT one. And once it's published, we can then go to, CMS and request the meeting to then continue the conversations for CPT one adoption. So really optimistic and and and really excited that this has now come to fruition, and we can now look to see where we're going.

14:48 Again, on The US, 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 CADScore, it does what it's intended to do, and we need to continually push this narrative across The United States and globally. Outside The US, 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, in in introductions as well as interest in regards 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.

15:40 As mentioned, the GCC country partners are currently under regulatory review, and we are expecting additional approvals in additional countries within the q three timer 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 the US 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 we 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 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 regard 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.

16:38 So with that, you know, 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 I'll conclude the call, and appreciate everybody. Thank you.