Acarix AB (publ)

Hello and welcome to the Acarix Q1 2025 earnings call. Thank you for joining. We're going to get into a lot of dialogue today surrounding what we did in Q1. But most pertinently, we'll start off with all the macro economy and all the changes that are going on regarding the geopolitical situations and rhetoric, as well as a lot of these tariffs and macro economic environment surrounding logistics and most pertinently supply chain. There's many, many things that will be continually changing and evolving with the new administration in the US, but we want to make sure that our shareholders are understanding that we are very committed to understanding exactly how things are procuring as best we possibly can because they seem to change on a day to day basis. However, we're having minimal impact in regard to how we function as an organization because Most everything we do is coming out of Sweden and Denmark, where we're seeing a decent tariff per se of 10%. So it won't have a dramatic impact, but it will have a small impact on our margin as we continually move forward. But the hope is over the course of the next few months and quarters that things kind of settle and level out to something that's amicable for all governments in all different countries. With that, I'll jump in to give a little bit of an update. as I normally do regarding our company for any new shareholders that are joining us. So we are Carex. We have a medical device that is a rule out device for coronary artery disease at point of care. We are first in class. We have FDA approval. We have CE mark. We generate a test in four to six minutes. at point of care that provides a negative predictive value of 96.2%, which is fairly consistent with more invasive tests across the board. So we have a very incredible value proposition at point of care for patients that are presenting with low to moderate chest pain or shortness of breath per se. So that's something that's really a significant need. And we're trying to change behaviors as well as become a benchmark and standard of care with our device. We have over 15 years of R&D and over 45 patents that we have continually worked through over the 15 years and 6,000 patients in clinical trials and over 47,000 assessments to date. As I mentioned, we are a class two medical device in the U.S. and in Europe as an FDA cleared and CE marked and most all of our production and manufacturing is done out of Sweden and Denmark. Getting into a little bit of a highlight in regarding what we did. So our executive summary showcases primarily everything that we're gonna talk about in the course of this conversation and the earnings call. So really excited to present this to you all. We're very committed to what we're doing. We have significant growth as we continually push the momentum. But we still have some some variables that we need to work through. But to get into the details in the U.S., which is our target market, we've showed notable growth from over Q1 of last year. We delivered 19 systems in the United States, and that's a 46 percent increase. We had a 25 percent growth in patches, including robust adoption rates, specifically a global perspective. And the U.S. particularly patch sales surged over 104 percent. Our financial performance, as we've been acutely focused on, has a 30% increase in top line revenue. We did have a strategic sale that we did that pushed our gross margin down by 10 points, but it was a fairly large opportunity in which we had to provide a value proposition for them to engage. But the hope is and the goal is to increase significant usage over the course of time as we grow with them. Because as we've always talked about, we are a razor blade model, quote unquote. Our patch sales is what we're acutely focused on because that's the future of this organization. The subscription model, as we've talked about previously, our total revenue globally rose 11 percent compared to the Q1 of 24. So overall, we're very consistent with our business strength and resilience. And given the headwinds we face from a regard of reimbursement, we feel very optimistic about what we accomplished in Q1 and where we're going to go through the rest of this year. And for the long term, we have that significant partnership that was announced with GeoMed. That's going to increase our opportunities within the DOD as well as the VA, the Veteran Affairs Association in the United States. And they have procured quite a bit in the first couple of weeks and months that they've joined in Q1, which we'll get to a little bit later. Our operational efficiencies, we've continually looked at how we can transition our model, underscore our commitment to sustainability and financial management. And we were able to reduce our OPEX by 6% while increasing our FTE count and resources internally. So very optimistic about where we're at. And the additional resources we brought on, like our finance in the US, as well as our reimbursement commitment person, had really developed significant opportunities for us that we will get into a little bit later in this presentation. Again, a little bit of a commentary from my side, kind of summarizes what I just discussed. We are extremely optimistic. And one of the key focuses we have going through this year is continued adoption and growth with a really strong commitment to reimbursement and getting that accomplished, which is out of our control, but we continually focus on it. But the good news is with Daniel Burke on board, which we'll discuss a little bit later, we are now in front of 97% of the covered population in the United States based on the different payer mix that we have. we're going the right direction some of the q1 highlights really exciting uh news that we received uh early this year uh at the digital health awards um based in outside of london we we won two we won one major award and got an honorable mention so we won the 2025 digital digital innovation award which is a pretty well known and respected award uh we were in the we were in the vicinity of other organizations that like Boston Scientific and Heart Flow. So we felt very good about winning that award. And we also got a very significant honorable mention that is not very often that is given in that setting, in that award program. So we were very optimistic about our ability to really leverage that and increase our awareness, increase our narrative for people to continually adopt our technology, but most pertinently understand about our technology and understand that we're in the marketplace because That is one of the key things we've been working on is growing awareness of our technology as well as the outcomes that our technology provides. Again, talking about GeoMed, this organization is a fairly significant organization and we're very optimistic about joining them and them joining us in our commercialization efforts. And so giving a little bit of a timeline on what was has procured this quarter. So we ultimately finalized all the documents and engagements in February of 2025. We then onboarded their sales team and took their training via multiple modalities in March of 2025. where they really launched at the back end of March of 2025. And since then, we have also co-branded a lot of marketing material and collateral so that when they're in the facilities and showcasing our product, it both has both a Carex and GeoMed. And what's really exciting is we've already had two onsite meetings with two very significantly large VA organizations. And then we also have about five or six others that are on the back list of when we're going to be able to get in front of them. So very optimistic about what's procured really in the last 60 days after training and onboarding. And so when you look at it from a collective standpoint, we've got six to seven actual engagements that we're working towards. And one has actually already been submitted to the committee for approval. So really optimistic of what that can procure in the coming quarters. Our reimbursement, even though it's not fixed, has really continued to be significant at $387 nationally on average. And this is actually from EOBs, which are explanation of benefits. So that is actually what is paid out and we have documentation for it, which is helping us to continue these conversation with a lot of these major parties. But as you can see, what we're hoping for is to remain in the $300 range and it continually stays consistent over the past few quarters. And we're accelerating with Dan Burke, as I mentioned, a resource that we brought on in Q1, late Q4, but ultimately in Q1, where he started to provide some tangible strategy sessions. And so when you look at it from a perspective of where we're at, you can see this list continually grows. But what's really exciting is over the course of the first 60 to 90 days that he's been engaged, we have contacted and been now engaged with over 50 plus private payers, that are reaching over 97% of the covered market. So when you look at it from a perspective of what was accomplished in 60 to 90 days, that's pretty remarkable. We were able to create a dossier that is very succinct to exactly what these medical policy leaders are looking at from the private payer standpoint, because the good news is Dan Burke was on that side prior to joining the industry side. And so he knows exactly what they're categorically looking at and what they're actually making decisions on. So when we provide that data in a very pragmatic way, it's much more easy for them to be able to get through all the data and understand where we're at, what our value proposition is, and how we can impact them from not only a patient outcome standpoint, but also from a financial standpoint. Because as you know, we provide significant value to the payers in regards to savings. So over the next 90 days, we're pushing and establishing policies and looking at fixed reimbursement opportunities across the board. and we're starting to see a lot of engagement. We're actually starting to see some commitments on coming back to us with initial feedback in the next 60 days. But the course of time in regard to reimbursement and adoption is 100% outside of our control, which is very difficult and frustrating as an organization, but we wanna make sure we respect and adopt these technologies as most pertinent with the payer mix and not necessarily push too hard. So we have been very patient and we are working towards that. But to give a little bit of perspective, when you look at the paradigm shift in regard to adoption, it's approximately 12 to 18 months for the majority of private payers to adopt the technology and adopt the fixed reimbursement. But given our value proposition to the payer, which is very unique in the fact that we are saving them dollars in regards to unneeded testing, we feel that that may be pushed a little bit quicker. However, that's going to be left to them and it is up to them. When and if they do decide to engage us and create that fixed reimbursement. So we are diligently pushing. But what you can rest assured is that we have really established an incredible team. Daniel Burke has done a phenomenal job and we expect great things to come over the next six to 12 months. Our U.S. performance trial, as you guys might remember over previous earnings calls, this is a requirement for the inpatient CPT-1 transition from CPT-3. So we have initiated our trial, and we are growing that inclusion basis. We are looking to do exactly what we did, basically a duplication of DANI-CAB-1 and 2. And we are hopeful to engage with enrollment of over 900 patients And we are currently in negotiation and looking at IRB approval in two very well-known world-class centers that will help us to get to over 900 patients before the end of the year, pending the approvals internally from their side. But we're very optimistic, and these two institutions will bring a ton of credibility in regard to the US footprint, but also globally because they're recognized worldwide. So very optimistic about what we're gonna be able to accomplish there. In addition, we are continually focusing on our UC Davis trial, and we're hoping to fulfill that conclusion of enrollment before the end of Q3. Again, so what we're doing, as I mentioned from day one, we've continually evolved and evaluate our cost management and operational efficiencies. So as you can see here, we have reduced our loss over the same period last year by approximately 800,000 SEC. would continually look for implementation of what strategy and what operational efficiency that we can truly look at that was most beneficial to the business, but not detrimental in any facet from the commercial standpoint. And that's kind of where it comes in. We obviously have a slightly smaller loss, but we've engaged so many more resources and FTEs to assist us in growing the commercial footprint, just like we mentioned. We're not necessarily just looking to cut costs. which we are, we are looking to optimize our cost basis as well as our spend to really look forward to what we could procure in the future. And that's exactly how we're executing at a very high level. So we're also looking at how we can continually manage different strategic relationships, just like GeoMed. And we are currently talking to a number of distribution partners outside the U.S. and inside the U.S. to really broaden our presence and really diversify our revenue streams. And we're looking forward to possibly bringing some of those to fruition before the end of this year. This is a really exciting couple of slides we're going to showcase because, as you know, one of the biggest challenges we face in the U.S. as well as globally is understanding of who we are, what we do, and what the outcomes we can provide. And the best way to do that is really engagement from a marketing standpoint, social media standpoint. And as you guys are probably well aware, LinkedIn is a very significant resource for industry, businesses, but as well as, you know, providers and healthcare practitioners uh so when you look at this opportunity it's pretty significant from a kpi standpoint as you can see we grew 48 000 impressions which is a 70 percent increase our reactions are over a hundred percent increase and our comments which are pretty critical because that is truly engaging in regard to communication is up over 370 percent but one of the key notes here and kudos to the team as well as our partners at saxum we've gotten significantly better than traditional benchmarks in medical devices. As you can see, our engagement rate is 4.26%. Traditional average in the medical device space is 2.8%. So we're almost double, maybe not almost, but quite a bit significantly higher than what traditional benchmarking is in the medical device market. So we're really optimistic, and it kind of confirms that we're doing what we're supposed to do, and we're executing at such a high level that we're surpassing benchmarking within our own segments. X, Twitter, this is something that is truly growing, and we're going to continually evolve and get more engaged on X. But as you can see here, our impressions have grown over 60%. Our engagements have grown over 100%. And our ability to really deliver on that benchmark is consistent here, too, much stronger than at LinkedIn. We've got a 12.4% engagement, which traditional medical device benchmarking is 1.3%. So we're really excited about these opportunities and we'll continually push on both of these platforms, as well as additional ones as we continually manifest our resources. So getting into more of the details regarding Q1 financials. Again, extremely excited to showcase that in the US we delivered 46% growth quarter from Q1 24 in regard to systems delivered. And we have 104% growth in patch deliveries. So again, I wanna take a minute and remind everybody, we are acutely focused on patch sales. Patch sales are our futures. It's a subscription model. And this is a testimony to what we're pushing and pushing quite significantly. Our U.S. patch revenue grew 30%. And again, that's due to that strategic sale. But we anticipate this to continue the upward trajectory. And we're cautiously optimistic that we're on the right path. So from a Q1 profit loss statement, when you look at it from a perspective of what we were able to accomplish, our sales were 1.7 million SEC as compared to 1.5 million SEC. We were able to sell six or put six on consignment and sold 14. And that's really a derivative of managing our basis as well as our resources and balance sheet. So if the opportunity presents itself, we will sell the device because that helps us from a cash standpoint, but also helps us from a balance sheet standpoint. But if one of the challenges or roadblocks of engagement of that patient or that provider is the ability to purchase the device, we will focus on consignment. Consignment is truly representing a significant opportunity for us, and we're continually pushing that. But again, when we can sell the device, we will sell the device. So looking at that, that's a 46% increase year over year. From a patch growth standpoint, again, extremely excited about the 104% growth in the US and a 25% growth globally. So again, hitting on all cylinders, given the challenges and roadblocks we face, we're very excited to be able to deliver these news. Our gross margin trend, as mentioned, it dropped about 10%, but that is specifically and acutely focused on a very significant sale that we made, and that was a strategic sale in which we had to deliver the products as well as the patches at a little bit lower rate, which was to be expected, but the long-term profitability as well as the long-term usage is what we're looking at, and we're fairly confident that it will procure. Our operating expenses, as mentioned, from a global perspective was a 6% reduction as compared to 2024. And then that loss was 14.1. It was an improvement to 822,000 SEK, which is the representation of 6%. So again, we're looking at all ways to reduce costs, but we're gonna repurpose those funds if it makes sense, as I mentioned with reimbursement, as well as finance. When you look at the actual basis, it showcases here, we went from 13 to 19, from Q1, 24 to Q1, 2025. Pretty exciting news for the US. Our patch sales, again, it's hard to dismiss a growth of over 100%. When you look at these trajectories on these graphs, all are going the right direction. We'll continually push. And one of the key KPIs we look at, which again, we're a very immature company, and as things kind of grow and we have more succinct forecasts and predictability in regard to deliverables as well as usage, these things will change. But as of today, we've grown from our previous Q1 to 5.25% patches per day or 5.2 patches per day for patient assessments, which, again, continually reflects what we're doing is working, and it's increasing the actual usage of our device as well as patient outcomes. This chart continues to show that we are doing what we're supposed to do, again, We continually grow in all parameters of our business. As you guys know, our cardiology and concierge medicine continually grows. It's really important to have the cardiologist buy in. And the concierge medicine standpoint is because that's a cash pay opportunity. So it disregards reimbursement. So we've seen a very significant adoption there, which we think we will continue to see that over the next six to 12 months as we continually push on the reimbursement front for inpatient services. But what we're truly focusing on for the rest of this year, aside from not discounting the focus we have on cardiology and concierge medicine, is the ED and the primary care, right? So we have the ED reimbursement, which was lower than we expected, but hopefully next year that can change. But we are continually pushing and we are in front of a number of opportunities, which we'll discuss one here shortly. But primary care, that is a very significant physician population. And they are the ones who are seeing the patients the most. So we have a very significant focus on them. We're actually currently in the negotiation phase of piloting in a couple of large group PCP firms. So cautiously optimistic that we'll have more to present in the coming months. Revenue of patches grew 30 percent. The patches sold in the U.S. is huge. Pretty remarkable for our headwinds. And we're really excited to see where we're going. And the hope is that this continually climbs as we continually focus on breaking even and getting to profitability. Our gross profit, as you can see here, was pretty flat from Q1 to Q2, Q1 to Q1 2025, 1% deviation. But again, it's really a derivative of the sale we made, which was a significant sale. And that was at a lower margin, but it was strategically placed that way. From a patch gross margin standpoint, you can see the consistency. Again, this is our model. This is what is truly important in all regards. And we were able to keep that margin at 93% from quarter over quarter. So very optimistic that we can continue that. Now, as we scale, I can only anticipate, as I mentioned on the last quarter, Our goal is to stay above 83%, but I think we'll be able to see that thing scale in a pretty significant facet as we scale the number of patches as well as numbers, cat score systems in play. Because as we continually evolve and get in front of large players, there will be discounts offered, as well as administrative fees that you pay to IDNs and GPOs. We anticipate all those things. So while quarter one, 24 to 2025 remain consistent, which we're very pleased with, our goal is to continually put it between 83 and 88%. from a standpoint of top line and gross margin. So this is essentially what I was discussing on the strategic sale we made. So the deviation here, 91 to 81 points was attributable to that one sale. But again, when you look at consistency and benchmarking, as we did with the KPIs and marketing, the average gross margin in MedTech is 65%. So we're still well above that. We're still very healthy in regard to margin. So we are not challenged with this at any point. And we do see this as a transient for Q1, let alone. Our continued cost savings. So as you can see here, we've reduced our OpEx by 6%. And we're looking to really leverage any of those savings in a more strategic way. But if we can't, we will continually push the savings and include those savings going forward. So everything is about strategic operational efficiencies in our regard. So we will continually focus on those things. Our net loss, you know, 6% reduction, pretty significant, especially when you consider the resources we brought in and the partnerships we've created that did cost additional funds, but they have provided a significant return on our investment. So when you look at the burn rate, this is pretty important for everyone here as investors. We've reduced it by 27% from Q124 to Q125. That's a fairly significant role, but that is exactly what I was telling you guys I will do. And so we have delivered on that. And the goal is to continually push that down where needed. If it's more strategic and if it is going to provide commercial ROI, we will invest heavily in those opportunities. But if it's something we feel that we can do without, we will continually reduce those expenses. So the key go forward initiatives, you know, the GeoMed partnership is very significant to us because, again, that's a vertically integrated opportunity where there is no reimbursement. The payer is paying for itself. So that is something we anticipate we see sales in the next three to six months, hopefully a little bit sooner on a couple that we've already presented to. And as I mentioned previously, that are in front of the approval committees. So really optimistic about that. We have a very acute, significant focus on our clinical trials, because, as you know, One of them is very important to the CPT-1 transition as we get back in front of CMS. And we also anticipate the systematic review, which is the second bullet point. I mean, the third bullet point. That should hopefully get published in the near future. Those two are the two requirements we had for the next meeting with CMS to have the ability for them to approve us to transition to CPT-1 at their discretion. So one of them is almost complete, and the second one we hope to complete before the end of the year by adding these two centers hopefully before the end of Q3 2025. So we're also aiming, as mentioned previously, And this is a goal, and I want everybody to understand we're at their mercy with payers. And the hope is that we have some sort of fixed reimbursement by the end of Q3 2025. And the goal is to really align significantly with one of them in which we will see the waterfall effect procure. This is something I kind of want to bring it full circle towards the end here. This is NewTex Health. We started a pilot with them. NewTex Health is a standalone private equity-backed organization that has over 30 centers in the United States, ranging from EDs to inpatient hospital settings. And we were able to scale an opportunity with them in regarding opening up two pilot sites And after the first week they had training, the first week they saw actually started implementing cat score into the workflow, they were able to identify patients. And I received a text from Dr. Blue Ball, who is their chief medical officer and partner at New Text. And they had two patients that presented that received cat scores or three actually presented. But one, two of them had some significant numbers in regard to their CAT score and went on for intervention. And both of those patients had intervention and had 96 and 98% occluded LADs, which is technically the widow maker or quote unquote, the widow maker. That's pretty impactful. That's what we're delivering. We're delivering patient outcomes that are saving lives. And that's what I want to leave this message with for this Q1 earnings call. We are focused and delivering a product that not only saves lives, it provides a tangible benefit across the board in health care. And so we should all feel extremely excited and extremely embrace our technology because it is a game changer. we have a significant opportunity to change the behaviors as well as the standard of care. As we continue down this track and the momentum we're creating, I think that there will be significant opportunities in our future. But I wanted to make sure I shared this because it was impactful to me and these patients and even the physicians that came back to me with the really a kudos as to, wow, this is incredible technology. And we more than likely save these patients' lives because they were not aware of any CAD whatsoever. So with that, I want to thank you all for your support. I want to continually focus on what we're doing and we will continually communicate at the cadence we feel appropriate. And we look forward to future calls as well as future successes.