Acarix AB (publ)

Good morning, everybody. Thank you for joining the Carex Q2 2025 earnings update. Appreciate everybody joining. And as usual, we will give a little bit of an update on who we are and what we do for any new investors that are joining us for the first time. Carex has the CADScore technology, which is an early cardiac diagnostic tool that is implemented at point of care that can help in really rapid assessment of coronary artery disease. We have an incredible negative predictive value that's proven by clinical trials, and we are the only company in the world in this space that has gone head-to-head with the standard of care, which is CTA in our clinical trials. In those clinical trials, per FDA approval, we have a 96.2% negative predictive value, and in Europe, with the CE mark, we have a 97.2 predictive value. Well on course, and if not better, than more invasive and longer timeline testing for risk stratification in coronary artery disease. We've been in business for over 15 years, have R&D going for the entire period. We have 45 patents to date, and we have over 6,000 patients in clinical trials and over 47,000 uses worldwide. Fairly mature company for a relatively startup organization as we function today. As mentioned, we're a class two device. We have FDA approval as well as CE Mark. We're headquartered in Sweden, and most of our R&D and production is done in Denmark, in Copenhagen, and we have global sales initiatives all around the world. A little bit about where we're at. Continuous progress in Q2, as we all discussed last quarter, as well as this quarter, we've seen a tremendous amount of geopolitical tension, rhetoric, business challenges, new administration in the US, massive changes via Doge, and then implementation of reduction in force, and now we're increasing in force. So there's a lot of chaos. going on worldwide. But we continually remain astutely focused on the US. We're also expanding in different regions across the world. But overall in the US, which is our key focus, we delivered 19 systems, which is a 27% year-over-year increase. And we were implementing all of these sales via the consignment model. our patch sales rose 11 which is 1400 units versus 1260 uh year over year which is not not necessarily where we want to be but as we mentioned before this is anticipated because every quarter we are selling in so much from a opportunistic standpoint and also leveraging our pricing based on our reimbursement factors and headwinds we face. So we're really loading down patient offices and physicians with quite a bit of patches. So we anticipate the reorder rates will escalate in the coming months and quarters. We had a 53% growth in U.S. patch sales over the first half of the year, which starts to validate what we're doing and getting that cadence of usage up. Again, it's one of those things where when you look at it from a perspective of where we're at and what we're doing, we truly are a startup. We are working very diligently to deliver on the numbers and bypass any of the significant speed bumps or headwinds that we face with reimbursement and opportunistic in any regard regarding strategy or how we can implement for the long term. the more units we place the more patches we sell and as we've always discussed we are a patch company our financial and operations efficiencies was as was great as well we improved our margin almost three points to 94 percent uh our operating costs decreased by 24 percent we continually keep a very significant focus on our spend uh and our net loss improved 23 basically establishing much stronger financial discipline and much more aggressive focus on where we're actually implementing our cash and our resources, which are our most important factors. strategic reimbursement as you guys heard in the last couple weeks we've had tremendous success and starting to see the pendulum swing our way as a reminder you know reimbursement conversations are typical to take between 12 and 18 months we were able to secure two smaller regional players at 300 which is our goal for across the board in every major pair with pretty significant stature and the second one we got at 300 is a much larger than the first one at 500 000 lives covered and in multiple states. So we're really optimistic that this is the beginning of the continuum that we will see our reimbursement footprint become bigger and better over the course of the next few quarters. The good news is that on the largest payer that we've had the most deep conversations with, October 1st will be our 12-month anniversary. So we're getting to the timeline where we think we will start to see the reimbursement cascade and fall in place, going through all their policy meetings, going through their policy updates, And we're cautiously optimistic that we start to continually see progression as we continue with some of the larger payers. So with that includes not only the outpatient ER ASC setting, it's also inpatient in office. So it opens up the entire platform for us as we continue to move forward. The exciting part about the announcement we recently made for the publication of the ACC abstract that was done last year by Dr. Barron and Dr. Michael Gibson at Mass General and in cahoots with the Bain Institute of Clinical Research was published just a few weeks ago in PharmacoEconomics. Saw tremendous uptick from that and 7.3 to 15.3 million say per 10,000 patients or 153 million per 100,000 patients. so that's pretty remarkable and we anticipate that this continually helps our efforts now that it is actually published which gives it a lot more credibility than an abstract with the payers and all payers are leaning in we have validated the cost savings potential with most all the major payers which is fairly significant. And as I mentioned previously, with the largest payer in the US, we showed a conservative $6 billion save by implementing CatScore into the workflow. Now, that's not just an overnight deal. It takes 12 to 18 months to get reimbursement. It takes time from implementation. We are changing behaviors. We are a first in class technology. So all these little nuances need to be understood by our investor base so that they understand the timelines to get to where we need to be. And we will be as forthcoming with news as we have been as we continually get a little bit more momentum and some positive news down the road. We also launched our first outside the U.S. initiative under my leadership in the MENA region. we saw a pretty incredible distribution partner and remember we're going straight vertical in distribution and everywhere outside the us and that is meaning we're providing a transfer price and the distribution companies are leveraging our training platforms and then executing on their level from a sales and marketing standpoint So that is a really good financially astute model that we will continually implore because as you guys remember and did have some impact on our numbers this quarter, we divested from the European sales force, which where we were losing money on every dollar we sold. And we are integrating this vertically integrated distribution model and we are continually having conversations with some targeted sites. or countries, and we will continually provide updates on that as well as we get a little bit more momentum and come close to maybe possibly signing another deal. However, getting back to this MENA opportunity, we saw 1.35 million first order, and this team is very aggressive and very excited about where they're going. As we concluded the 2025, some of the key wins were obviously the reimbursement traction we're getting with some of the regional players. We saw the great Pharmaco Economics publication. We're pushing very diligently on our financial aspects. Every metric in financial, we're working towards maintaining and growing in a better way and reducing our OPEX to a much more manageable perspective for the burn, but also set us in tone for getting to profitability over the quarters ahead. We are continually focusing on what we're doing in the U.S. as our key point. That is our focus. It is the world's largest market and we continually push diligently to get where we need to be from a reimbursement standpoint as well as a personnel standpoint. And as a reminder, in the U.S., we are a full consultant 1099 Salesforce. So as we continually move the needle, we will look to incorporate a few more FTEs or direct field force sales representatives and management to help us progress as we get some traction. Some of the Q2 highlights, as mentioned, the peer reviewed U.S. study validates our savings for CAAT score. This is pretty impressive, but also very important when you're having conversations with the payers, but also health systems. Right. So health systems need to understand the value proposition of CAAT score and mitigating unnecessary admissions, especially as you guys look at the U.S. health care and that 72 hour window post uh inclusion into the hospital on what could possibly procure so lots of moving parts in regards to payers and how they're working with hospitals and paying hospitals based on admissions so we're very optimistic that this continually helps us being that it's published as mentioned is much more uh critical and valid when you're presenting to payers and hospitals because when they look at an abstract and they look at actual published article that was peer reviewed, two very different dramatic personnels as to what it means to the people. Expansion into the MENA region, of course, this was our first major push. As I mentioned in our annual report, we focused on the U.S. for the previous time that I was here, and just this last quarter is when I really started focusing on distribution platforms outside the U.S. My previous roles in other organizations had many relations, so we're very quickly moving with quite a few of these distribution partners to kind of identify and scale if it makes sense. uh again a lot of the places in the bigger countries will work through regulatory reimbursement processes there as well but given our value proposition to outside u.s countries with health ministries um they're significant leaning in when you look at these different countries like uk or middle east or japan the health ministries look very closely at what the product does and what it says because a lot of it is socialized medicine where the ministries are paying or the government is paying uh for health care costs so we feel we're gonna we're gonna have a lot of traction We're going to have a lot of excitement as we continue to look and partner with the right spaces to kind of get moving as quickly as we possibly can in targeted markets that we're looking forward to. We continually push the narrative that is evident today everywhere. ACC brings it up. AHA brings it up. It's health equity. Every person around the world needs to have accessible health care and good health care. Acarix defines that. Our CADScore system defines that and provides the opportunity for patients worldwide in any area to have our CADScore device and an adapter put on them and understand what's going on with their low to moderate chest pain or shortness of breath within minutes. So we feel that this is going to be a great opportunity for us to continually progress in the worldwide narrative of health equity. And we are very clearly the leaders in providing that opportunity in the cardiac space. Establishing our scalable reimbursement framework, as you guys know, this is, this is our single largest obstacle. We need this to procure across the platform and every linear function with the five major players. But as you can see here are our logo list here continually expands. We have a lot of things moving along. We're over in front of 97% of the covered lives in the United States. And we feel that all of our engagements with the payers and the conversations with the payers are progressing in the right way, meaning there's not been any significant pushback. There has not been any significant. No, everybody is still in conversation. And it's just a process that takes time. They're working through every disease state. So there's policy meetings associated to urology, just like there are in cardiology. So everything goes on a cadence of time. that is dictated by them. Unfortunate for us, but that's just the unfortunate reality of the way it works. And once we get through this process, though, it should establish us for the long term and success. The good news is looking at 2025 AOB's explanation of benefits, we are consistently staying where we were last year as well, which is our average of $387. As you know, our goal is to get to 300 across the board in a flat rate across all major payers. And you can see There's only one payer currently paying less than $300, so we feel very optimistic that we can get to that point, and we have not had significant pushback on that dollar amount based on what's being paid. So the good news is we are going in, we're going in heavy, we're going in very diligently, very strategically in these conversations, and we are positioning ourselves to be in a really good position for them to say yes. uh we do want to implement your program it provides value to the patient it provides value to the payer it provides value to the provider so we're cautiously optimistic that we are doing the right things and we will continue doing those things and provide updates as they come available Our U.S. performance trial, which as you guys know, is one of the requirements for a CPT-1 transition with a meeting with the CMS group. We are continually focused in the integris model. We've implemented over 100 patients and we're working towards bringing on two world-class organizations to facilitate that with significant CT volumes. So we should be able to get to our 900 plus patients for inclusion to bring the study to an end very, very quickly. The nuances of going through the systems and the IRBs with these two institutions is taking a little bit of time, which is traditional. So hopefully we'll be able to see some of this come to fruition in the coming quarters. As I mentioned, this is a CPT-1 requirement. And so as soon as this is done and published, we will be able to go back to CMS for CPT-1 conversations. Additional trials we have going on. The UC Davis trial has approached 100 patients and making steady progress. The great news there is Dr. Trehar, our PI, has submitted an abstract on the first just approximately 100 patients to the AHA meeting coming up towards the end of the year in November in New Orleans, and we are awaiting confirmation as to whether that abstract was going to be accepted. The other great news is out of Alborga in partnership with our seismal heart failure device, we have submitted an abstract as well. And the good news for this one is it has been accepted to AHA and we are very optimistic as to see what can procure in the coming weeks as we are at AHA will be presenting. So the lead PI from that study will be coming in town. And we're going to be working together with them to present our abstract and hopefully make some noise and get some traction in regard to what we're working towards from a heart failure perspective. And as you guys know, and I think I'll discuss this a little bit more, but our heart failure diagnostic presents a 4X on our total TAM, our total addressable market, which will increase it once approved to $22 billion in potential. Q2, what do we do and how are we getting to where we need to be in regard to efficiencies and scalability? Our operating costs decreased by 24%, which is our continued focus and discipline on driving financial astuteness. Our net loss narrowed 23%. Again, as you guys know, we need to address the elephant in the room. Our revenue was down. However, we are losing less money, meaning the reason our revenue is down is attributable to European sales, which we divested from because we were losing money in every sale we were making. And we're going to transition to the vertically integrated distribution model. So we are seeing those. So we're in a transformational type quarter over the next two quarters to where we're going to pivot and rotate to where we start scaling and starting seeing additional revenue from outside U.S. distribution, but also inside U.S. from sales in the commercial space as well as the cash pay space. Again, great news. Our gross margin rose three points up to 94%, which is extraordinarily healthy. And for our folks on the call that don't know, our traditional med tech averages between 60 and 70. So we're extraordinarily healthy at 94%. Our operational momentum and strategic investments including the U.S. consignment model as well as pushing forward on all these reimbursement platforms is really helping our financial performance as we scale and will provide significant rewards on the back end. Our expanded U.S. operation has brought on four new 1099s which are consultants in the U.S. who sell and are paid a commission. We continue to look at opportunity markets where reimbursement is key. So if reimbursement that we see is heavy in one city or one state, we're going to focus on that and grow from an opportunistic standpoint, from a concentric circle standpoint. The good news is, through the last two quarters, our Gen 2 device, our CatScore Gen 2, is close to being complete. It's actually in its final stages of testing that we should hopefully see procure the final data by the end of August, early September. And hopefully implement production by early October, if not late September. The great news about this device is moving forward from a financial standpoint is we've reduced the COGS approximately 30%, which is huge for an organization of our size. But secondarily, and probably more importantly, we have also implemented all the mechanics for our heart failure SISMO device so that we can then move into an IDE or investigational device exemption trial to be able to get the device approved in both Europe as well as the US, which will then take us to a 4X TAM. So that could be really exciting for an organization our size. Because as you guys know, we're first in class in the CAD space with our module and we'll be first in class in heart failure to providing the exact same derivative at point of care within a rapid period of time. So the other exciting news is this device will have both applications in one. So it's going to provide a double whammy for our providers and provide significant value propositions across the board. But as mentioned, we're hopeful to have all this finalized by the end of this month, early next. And I'll provide an update on that. But the goal is to have this rolling out and production by Q4 of this year. a lot of updates on our marketing side given our limited resources we really focus on things that provide a natural reward or roi with little cost up front and linkedin is something that we're really busy on and we try to stay very very uh open and do quite a few posts and you can see here we continually drive new followers but the key thing here for me is is the impressions Just under 32,000 impressions over the quarter. That's over 10,000 a month. Our reactions are up and our engagement rate, which is really key, is 4.33%. When you look at it from the industry average in medical devices, it's 2.8. So we're significantly above engagement rates as our peers, as compared to our peers. we continually see a better audience we continually see reposting we see comments so things are moving the right direction on linkedin and we will continually have a concerted focus on this because it's a great platform to reach our customers investors and payers and providers On X, our quarterly overview was pretty impressive. We've got 7,400 impressions. We need to get a little bit more active on X. I need to be better about that myself. But our engagement rate here also is pretty remarkable when it comes to industry averages. So the medical device industry average is 1.3. Our engagement percent is 13%, so fairly significant increase. And we're going to continually post and repost. As you can see, it's 48% up on the quarter. So exciting times here from a marketing standpoint on both LinkedIn and X, which really doesn't cost the company very much in a resource capacity. Our ACC paid media pilot. As I mentioned, we did do an investment in ACC this last year, and did it pay off? Now we have significant proof of digital impact. This is the first true media pilot that we ran. And you can see here from the performance highlights, we reached just under 1 million impressions. So we feel really good about this, and this provides us a benchmark of where we're going and what we're going to procure in and and probably pretty much have an idea of what we're going to do from a paid media standpoint and where we're going to implement these types of opportunities that provide the biggest impact so really excited about the outcome from the acc paid media we feel that it generated quite a bit of reward and roi for us and even provided some opportunities from a from a demo standpoint and sales standpoint our q2 financials And as we mentioned, you know, the factor here is we're in a transitionary phase. We did divest in Europe. We are slightly lower on the income level. We did do all consignment this last quarter. So there's lots of things to look through. But to understand better where we're going, these are the factors that make most sense. We grew 27% on delivered systems in the U.S. We delivered 11% increase on year-over-year quarterly. Not where we want to be, but as we load these providers every quarter, we will continually push higher and higher as we get more momentum on reimbursement as well as utilization. Our operating costs are down 24% quarter over quarter. This will provide us longevity in our current financing and to get where we need to be. And the ultimate goal here is profitability. So we continue to remain very financially disciplined while executing on all parameters that we actually control. The Q2 profit loss statement. So when you look at it, as mentioned, the revenue decrease was expected. We divested from the European sales team that was direct and costing the company a fortune and not generating any profit or ROI on the sales that we're procuring. But we are concertedly focused on the U.S. and we feel okay on where we came in on the U.S. We do want to see that incrementally get higher. Obviously, at the first half, we grew 53% in the U.S. from a batch placement standpoint. So we're going to hopefully continue the momentum, continue duplicating these kinds of opportunities and growing a lot faster as we continually manifest these reimbursement platforms, including the two that were recently announced that should hopefully be implemented by coding in the next couple of weeks. We also are looking at our operating expenses and financial performance. So a 24% reduction in our operating costs, which was great. And we also improved 23% on the net highlights by operational efficiencies and cost controls. So again, from a financial modeling standpoint, we are executing on all the parameters that will help us to sustain and grow profitably. We do need to generate additional revenue and sales, which will procure as we open up more reimbursement, as we scale more sales reps, and as we open up more vertically integrated and distribution partnerships worldwide. So all those things are on our to-do list, and we are acutely focused on a daily basis on implementing on all three of those parameters. Continue momentum. You know that the scale here continued to goes the right direction. We're cautiously optimistic that we're moving the right direction. We do have our best users averaging 5.3 patches per day. The great news is we're seeing more and more people or providers using more and more patches on a consistent basis so the the amount doing 5.3 is not one it's multiple the amount doing three is not one it's multiple so we feel really good about where we're going we're seeing reorders come in from from the same provider over and over and we're typically seeing those where we know there's reimbursement and it's executing at a high level and providing great care for those patients and driving better outcomes wider clinical adoption. As you can see, we continually grow the space. We do have a very significant focus on all four of these parameters. And we're going as faster in the concierge medicine and cash pay environments. And we're working really diligently on the ER and urgent care. We really have to manifest the right payment. And that's also part of reimbursement because as you know, in the first CMS ruling for outpatient settings, we got a 59 approximately reimbursement. So we're having to reduce our patch, which also reduces our revenue, but we're pushing for the option to get that to 300 across the board with these payers. So continually focused on it, but again, we're seeing the right trajectory. So units installed, as mentioned, we went from 15 in Q2 of 24 to 19, which is a 27% increase on units installed. And more installed units mean more patches utilization. So hopefully those will continually see the cadence as to where it's going and continually adoption and usage from a day-to-day basis and getting everybody closer to the three to five patches per use per day. patch sales you know not exactly where we want to be but again we're loading down customers every quarter so we don't anticipate quarter over quarter uh reorders we anticipate a quarter in between reorders so hopefully we'll see the q1 uh reorders in q3 and q2 and q4 as we progress our global gross margin it does is very difficult to get any better than where we're at today. It's 94%, a three-point increase from Q2 of 24. Very proud of that, and we're continually focused on remaining, as I mentioned, between the 88% and 93% range as we continually progress and mature as an organization. Continued cost savings. As I mentioned, we will continually evaluate on a day-to-day basis where we're spending and how we're spending. As you can see here, we've made a pretty significant reduction in OPEX from Q2 2024 to Q2 2025. 24% reduction is pretty sizable, and we hope to continually do that without mitigating any additional expenses towards initiatives that drive strategy, drive sales. So we're refocusing or re-implementing those resources that are saved into adjunctive opportunities that drive value as well as sales as we continually press forward. Our net loss reduced 23% quarter over quarter over the year. So the 23% reduction is great. And we all know we want to get to profitability. We're all focused towards getting to profitability. And we do feel we see the light at the end of the tunnel. The reimbursement conversations are going well, and that will be a key in the U.S. But as I mentioned in the last 60 to 90 days, we have been really focused on where we're going next outside the U.S. And we can drive incremental sales in tangent to the U.S. sales that will help us to get this burn back to a profitability standpoint. Again, on the burn rate, we're down to 4.2, 18% reduction from Q2 2024. We're optimistic that we can continually either remain or maybe even reduce this a little bit more. But as we get these reimbursement opportunities coming to fruition, we will have to reinvest. uh in our commercial efforts and our teams uh so we are cautiously optimistic that that's going to procure in the near term to where we'll see some really significant opportunities to bring on some some key pivotal uh players uh onto the team to help us drive that innovation of casco into the into the field and hopefully get some things going with the heart failure seismotrial in the us Some of the key go-forward objectives. As you guys know, we finalized an agreement with GeoMed in Q1. They are pressing on every cylinder. There's a lot of challenges in the U.S. with administration, as I mentioned previously. A lot of disconnects, a lot of chaos, a lot of people that were let go in institutions, including the VA, now are being brought back in. So there's a lot of moving parts and a lot of moving people. uh in all of these facets and when you get to the bureaucracy and the administration there's so many hoops to jump through what i can say is we expect significant returns on this investment with geomed in the va we provide a really great resource to the veterans that have served this country. But more importantly, we're going to drive better patient outcomes in a facility or an organization that needs to drive better patient outcomes. And we anticipate that it's going to take three to six months as we continue to progress. I know there's a significant number of opportunities at VAs across the U.S. that we're already working on, and we're cautiously optimistic that we procure something before the end of this year. Our clinical trials, as I mentioned, we have these two requirements. One is the U.S. performance trial that we talked to at length that we're getting moving on and getting new centers coming in. But the good news is the systematic review, which was the second checkbox that we needed to procure, has been completed. It has been submitted to publication. It has not been published yet, but we anticipate that something procures in the near future. So that'll be great because that'll be leave only one box left for CPT-1 transition conversations, and that'll be the U.S. performance trial. The good news is the UC Davis trial is continuing on to its 200 patients inclusion. And as I mentioned, we have submitted, Dr. Atreha and the team have submitted a publication or an abstract to AHA, and we're cautiously optimistic that it'll be accepted. And as I mentioned, in conjunction with Aalborg University out of Denmark, we have submitted an abstract on our heart failure SISMO algorithm, and that has been accepted. So that'll be one of the very first times that we're gonna be presenting our heart failure SISMO opportunity to the world and it'll be on a very significant stage at aha so really optimistic about that we're aiming to secure at least one private fixed payer by the end of q3 2025 that's a very aggressive goal uh the hope is that we can procure that but if not hopefully before the end of the year uh as mentioned with the largest payer we are coming up on our 12 month anniversary which is october 1st uh and as we know it takes anywhere between 12 to 18 months so we're cautiously optimistic that the conversations that are already positive will procure to some sort of reimbursement in in the short term um we're aiming we're also evaluating all the outside u.s distribution partnerships as i mentioned I think that there's going to be significant opportunity for Acarix to generate long term, high level income and revenue from these third parties. And we have a ton of excitement and a ton of inquiries regarding our products and what we're doing. And we think that will continually manifest itself, that we're going to be very selective in how we go to market and where we go to market. But again, our offering provides health equity across the world. including some third world countries and underserved populations where they really need some significant help. And we will continually work towards partnerships to help facilitate those needs, including with ACC who has reached out to us in the form of humanitarian efforts. So we will continually work towards those objectives and driving better patient outcomes and health equity as our organization as a whole. So with that, I really want to thank everybody for joining us. We're on the right track. I'm a very transparent leader, and I hope that you guys understand that we're going where we're going. There will be these transformational periods, and I think that as we procure over the next three to six months, things really start taking shape as to where we need to be and get to where we need to be, which is ultimately profitability, aside from making sure patients are taken care of. So with that, I thank you for joining us, and we sign off as of today. All the best.