Acarix AB (publ)

Hello and warmly welcome to this live Q&A with Ackerix. With us now, we have CEO Amir Mahmoud and CFO Christian Lindholm. Warm welcome, guys.

Hey, thanks for having us. Glad to be here.

And you're going to go through your Q2 report that you released this morning. Just go ahead and present it.

Yes, sir. All right. Well, thank you, everyone, for joining. We're going to go through a quick update regarding our Q2 and a little bit about our first half. We'll go through the Q2 highlights and the Q2 financials, and then we'll have time for some Q&A at the end. So initially, what it comes down to is we looked at our business model when I joined just almost six months ago, and we really shifted our focus regarding our commercial activities as well as our opportunities for utilization and adoption in the field to remove some barriers, but also provide more focused and clinical acumen surrounding our commercial teams. So what we did, we remodeled our go-to-market model. We went to a more diverse opportunity in regard to target market. We did not just focus on cardiology. We focused on PCP. We focused on EDs, emergency rooms, as well as urgent cares. And we really started to diversify how we went to market, including the consignment model, the risk-sharing model. And what we saw was an increased utilization, and we grew 62% in the U.S. in our patches, which is something we're very key focused because we are a patch company, as we mentioned last time. And we also opened up six new clinics and had a number of reorders that came in. Our sales leadership that we brought on a few months ago, Jeff Thomas, has really been active, involved in the opportunities in the field and really opening up doors for us with our new reps that we brought on that were more clinically focused on cardiovascular sales and more specifically diagnostic sales in the cardiovascular market. We also had an opportunity to present at ACC this year our data that came from Mass General and Dr. Susan Barron, who presented the cost effectiveness of implementing the CAT score to the workflow, which showed significant savings into the system of $177 million per 100,000 patients. So if you break that down, that's just over $1,700 per patient, which is a material dollar impact to the bottom line of payers as well as CMS. So we're very, very acutely focused on what we're doing, and we're very excited about the momentum we've created, and we're very happy with the results that we've presented today as we continually move this market, move this opportunity into the gamut regarding healthcare and really, truly identify ourselves as a standard of care regarding chest pain patients. So evolution of our commercial team, as we've discussed the previous calls, we made some significant changes. We replaced reps in certain areas, including the blue areas in which we reorganized. And we've brought on a number of new teams that are, as I mentioned, specifically focused in cardiovascular and have history. and experience in the cardiovascular market. Some of them are making immediate impact. We hope to see additional growth as we onboard and train our new representatives because obviously there's a continuum and training involved. And so we plan to continually see the fruits of these teams that are coming together that will really position us well for the next few quarters as well, years to come. We saw great utilization in Louisiana, which is one of our largest usage states. We also have the most significant reimbursement there with our current CPT-3 code. We saw expansion into Oklahoma into concierge medicine, which we will also speak to a little bit down the road. That could be a very large market for us. In Arizona, we opened up our first freestanding emergency department, which is part of a PE-backed multi-unit nationally rolled out emergency room. So we're piloting it there, as well as expansion in the cardiology markets and clinics in Arizona, which is a brand new market for us. In Illinois, we've continued to expand our footprint there. We're talking to a number of big universities as well as EDs and PCP clinics, but we have seen expansion from where we're at. So we're continually growing from the concentric model where we're going to grow from within and out and we'll continually expand our footprint. So all of these things coming together is what has contributed to our success this last quarter to see some record-breaking results for this organization. So we're gaining traction in the U.S., and some of the key KPIs we were looking at, as we mentioned previously, is our new business model. And what that new business model, from a consignment perspective, does is it lowers the entry threshold for a lot of clinics, including any aspect of HCPs, which are healthcare practitioners. So removing the cost of the actual CAAT score unit and utilizing it in a consignment model, it benefits the end user by not having to provide that cash output up front. so they can adopt and move quicker into the process of CAT score and implementing it into their workflow. What it does for us personally from an ACARIC standpoint is it keeps it on our balance sheet as well provides us appreciation as we move forward. So KPI as predicted, our patch reorders have grown quicker because the adoption process is quicker as mentioned from a consignment perspective as well as lowering the barriers of entry. We've seen multiple reorders, including units and patches, where organizations have grown their unit base because they've adopted it and realized they need more to facilitate more patch usage, including patient diagnostics. And we've expanded our target verticals. So as we mentioned, the freestanding emergency departments, we've got the referring primary care. We've got the value-based care opportunities. We have the concierge and corporate wellness diagnostics, as well as when we have the at-home opportunities or in-office opportunities. Really what we wanted to showcase here is a wonderful example of what CatScore can do. This is Dr. Raghu Murthy, a very well-known cardiologist in the Jacksonville, Miami, Florida area. So we wanted to play a video for a customer experience that he had.

We incorporated the CatScore system into our practice around six months ago and most recently ended up having a patient with low to moderate risk chest pain come in ended up having a CAD score of 49. We referred the patient over for a cardiac catheterization, was found to have three vessel disease, and ended up having bypass surgery. The CAD score system has provided us a comfort in these patients that are low to moderate risk chest pain to effectively rule out coronary artery disease. A 96% negative predictive value really helps us feel comfortable as well in combination with our clinical assessment. We plan on continuing to utilize the CAT score system as we roll out our chest pain practices across the city in an effort to help proper risk stratify our patients. And we view this as an extremely useful tool diagnosing and ruling out chest pain.

So what that demonstrates is truly a remarkable opportunity for us. We're going to be able to showcase this, but what's most important here is, and I know I spoke to Dr. Raghu Murthy, this patient was someone that comes in that doesn't look like your normal heart disease patient. They're very fit, works out very often, as well as healthy looking, and just happened to have chest pain. And so when they did the test and they assessed them and with the score coming in, greater than 20, they forwarded it for additional risk stratification and went in for a coronary artery bypass graft. That essentially could have saved his life. And had he not had the CATS-4, there would have been a lot longer process for him to get through the system, through the CT scan, through the stress test, through the nuke, or whatever that physician would have required. So this was able to provide immediate opportunity from a diagnostic and immediate assessment afterwards. So exactly what we're trying to accomplish and we'll continue doing moving forward. This is this is an exciting new vertical that we've looked into. So in the United States, self-insured companies, which means companies that absorb the cost of health care for their employee base versus going through a third party private payer like a Blue Cross Blue Shield, Aetna or United in the United States. What they're doing is they're taking the ownership of that and absorbing the risk regarding that. So what we opened up from a capacity of utilizing our relationships with concierge medicines physicians that go on-site to in-home visits or in-office visits, as they go in for these wellness checks, we have provided them the opportunity to present CAT score. And if the patients fit their HCP requirements and they're able to provide the test on location, which really was efficient and beneficial to the organization because the organization then understands what their risk opportunity looks like moving forward because they are their own payer. So this is something that we're very much so intrigued by. It's something that is growing at significant rates in the United States in the self-insured profile for companies, larger organizations that can afford to do so. And we think that that's going to be a big opportunity for us moving forward across the United States. Very excited to represent that we have now had our first, in Q2, had our first patients enrolled in the UC Davis clinical trial that we worked into that's going to show the opportunity for CAT score to be rolled into the workflow in the emergency department and reduce the cost effectiveness challenges, the time savings, as well as the side effects. by implementing CAT scores. So hopefully we'll see some of this data come to fruition before the end of the year based on their enrollment. But we're very excited, but most pertinently wanted to share that we have had the first patient enrolled and we are moving forward to provide that demographic for the U.S.-based patient as well. So I want to spend a little bit of time here regarding CMS, which is the Center for Medicare and Medicaid Services, which is an extremely important opportunity for us in the U.S. because what CMS does is what typical private payers follow. So there are two different verticals, and I know there's been a lot of questions and queries and conversations surrounding CMS and what does that mean. So I want to spend time to understand we are working two parallel pathways. Fortunate for this organization as well as the CAATS Corps, we have an opportunity to not only be in the private payer office and clinic, but we have the opportunity to be in the emergency room and emergency department as well as ambulatory surgery centers, which are called outpatient settings, right? So they're not necessarily involved in the hospital. They could be adjacent to the hospital, even within the hospital, but they're second organizations of that entity. And then you have the private physician fee schedule. uh for medicare so these are two different parallels as you can see in this infographic and i want to ensure that everybody understands our cpt 0716t code is applicable in both settings however reimbursement rates are different in both settings So we are currently focused on the left side of this chart, which shows the APC, the outpatient offering, which is the EDs and ambulatory surgery centers. But in parallel, we are working with the CPT-3 to CPT-1 transition for in-office diagnostics. So go to the next slide. what we'll show here is regarding the apc so this is our near-term opportunity this is something that will come to fruition here in the next few weeks but will also be available for us january 1 2025. so the way we're going about this so 716 t code is applicable to applicable to both pathways but regarding the apc and the outpatient opportunity for the ers and eds it's specific what we're asking is a reassignment of what the reimbursement code is as it stands today we don't feel that the reimbursement provided is adequate for what we are offering and because we're first in class and novel it's understood and typical of cms to assign a random number to the assessment based on what they think it could be you know it could they could categorize it as ekg they could categorize it as a number of things uh but what we were able to do is get in front of cms with our council and provide them an update which we did in uh q1 and then on august 7th we had a subsequent further meeting that was really more of a deep dive and more conversational and a significant amount of dialogue that procured uh really identifying what we're asking why we're asking it what our outcomes are based on our product as well as our clinical data and where we feel that the adequate pricing is per patient uh per use i should say And this would open up an addressable market of more than 6 million patients. And what we've asked for is a recategorization to APC 5722 level two diagnostic tests. And as you can see, what that could do is it could possibly provide us a rate around $311. And, you know, we fit right into that angle. We are very cautiously optimistic that this could come to fruition for us. But however, it's the government and we have to wait for their assessments. the assessment from what we're told we will know in november for sure and it will be applicable january 1st 2025 so next year but this provides us the opportunity to open up a very significant market and and understand that what we look going forward will be able to forecast and model much more efficiently and be more predictable in our forecasting because as as i've mentioned previously in the united states we are not socialized medicine we are for profit in the private pay sector and so regarding reimbursement while we do have a cpt3 code that does not mean that it's fixed reimbursement and when i say fixed reimbursement i mean it is going to be paid by the payers or cms and that is very important when you're going to make sales right so when you're talking to a physician or a hospital or an emergency room administrator, the first question they're going to ask is, what is the reimbursement? Meaning, what are they going to be paid to make this investment? So making that investment is important for them, but to make sure they're going to recoup an ROI on their investment is even more important. Even if it's a great benefit to them or even if it does provide opportunity for the patient, they still require that reimbursement. Otherwise, it's a lost leader for them or they will lose money on the opportunity. And with CPT-3, the opportunity is there to provide for billing of reimbursement or submission for reimbursement. However, it is not a guaranteed return. for them regarding the actual reimbursement done. And sometimes you have to go through a process of appeals and continually submitting to try to identify what they need to hear to get the reimbursement. So it's a lot more work, but getting the fixed reimbursement is going to be very, very important and very, very clear differentiator for us to be able to predict where we're going to go in the future. So as I mentioned, this is the first category of the APC opportunity. Now we're going to talk about the CP3 to CPT1 for private clinics, the second offering that was to the right of that infographic that you just saw if you were looking at it. We have certain requirements in this. This one is much more of a distinguished and defined process for CMS. It is a much more difficult process. And as you can see, there's requirements that you have to meet to even get in front of of CMS to have this transition conversation. So a couple of the minimum requirements are demonstrated widespread uses measured by Medicare and major US payer claims. The unfortunate reality, as we all know, dealing with government entities, the term widespread usage is not necessarily defined. It's subjective based on frequency of the disease state, which is significant in cardiovascular health, as we all know. It's the number one killer in the U.S., actually worldwide. So there's a little bit of questionable ambiguity there surrounding what we feel we need to be, but we continually have adoption. We continually drive that focus, and we feel pretty good at where we're going. The second factor, which is most pertinent to us, is you have to have five peer-reviewed published papers. Published is a key term there. It has to actually be published. And you have to submit a minimum of two. So two reports, or actually two of the reports must have different patient populations with no overlapping authors. And the minimum level of evidence, the LOE for one study, is evidence obtained from systematic review of cohorts. So here, that's where our gap comes in place. We currently have overlapping articles because most of our clinical trials have been done in the Europe area. And the level of evidence is not currently met. So here are two targets that we're focused on acutely and we are pushing forward as we speak. We have a U.S. additional cohort study in development that will reach the author requirement because we will have separated U.S.-based authors and PIs for this study, and we're hopeful to have that off the ground within the next 30 to 45 days. We also are going to establish a systematic review of planned publications to meet the minimum level of evidence. So both of those are being worked in parallel and both of them are required before we submit for a meeting with CMS regarding the CPT-3 to CPT-1 transition. So again, things we have very quickly identified and very quickly positioned and organized the actual efficiencies to make sure we provide that minimum requirement for CMS so that we can get in front of them as quickly as we possibly can. Our goal internally is to get through this clinical trial as quickly as possible and hopefully have published by the end of the year, which is a very significant ask. But we're hopeful to try to achieve that, if not by first quarter of next year, to where we can get in front of CMS in the middle of the year at their second meeting. CMS has three meetings a year to discuss this transition. There's one in Q1, one in Q2, Q3, and one towards the end of Q3, early Q4. So we're hopeful to get in before the second one, if not the first one. Again, so regarding CPT-3, we've had some great strides. We have had the opportunity to present to some of these private payers. They see the value proposition, most particularly with the ACC study that was presented that shows a tremendous amount of cost savings by implementing a CAT score, which was, as a reminder, over $1,700 per patient. So we're seeing significant adoption. However, if we had fixed reimbursement, this would not even be a question. We would be going fast and furious, and we will as soon as we get that. But for reference, we added three new pairs here to the left of the slide. UnitedHealthcare and Medicare Advantage, which is great, so that you can start seeing that Medicare is now realizing that this is an opportunity. We also got Aetna Federal and Cigna Connect. There are a number of these organizations. There are some of the larger ones like Blue Cross Blue Shield, which is the world's largest, or I'm sorry, the United States' largest. But you'll see there's multiple divisions within each. But we're continually growing this portfolio of reimbursed platforms, which is good for us on the internal side for the short-term sales perspective. This is something I wanted to share with you, as we've significantly invested in an economic calculator that provides a value add to our end user base, most specifically the private payers, because we see a very significant opportunity with the private payers. In traditional U.S. standing, it's typically that private payers will wait for CMS to make their decision on the CP3-3 to CPT-1 transition. And whenever they provide that fixed number for reimbursement, the private payers like Blue Cross Blue Shield, Aetna, Cigna, United, they all just follow suit. That is the traditional way. But given the CAAT score's value proposition being comprehensive and including cost savings into the system, which directly impacts the private payers, we have gone a step beyond and started to target the private payers at the exact same time we're targeting cms because our value proposition is different than everybody else's so for us we're able to provide significant cost savings to the private payers which are for profit and they may implement this quicker than cms and not wait for cms's reimbursement so the good news is we've already started these conversations and i wanted to provide you this one and as you can see There's substantial savings here. This is with one of the top five private payers that we are currently in conversation with. We represent here that there's 8 million patients that visit an ED or physician offices a year. This is a significant player in the United States. One out of three patients in the US is part of this program. And we were able to very conservatively go in and showcase for them that, theoretically, if we were to implement the CAT score workflow into their system, There's potential savings of $1.6 billion, and that's a very significant material number that would add value to this organization. So when you look at these kinds of numbers and you look at the material impact to the P&L, any business-minded person would be leaning forward, which they are, and we're continually having those conversations. So we're cautiously optimistic that we're able to provide this value proposition and take this direct to private payers quicker than we will get in with CMS. So we're very optimistic about that. We have additional meetings next week and as well as into October to prevent the clinical to their clinical committees to see if we can get this rolled out as quickly as possible in the U.S. to make sure we're getting it in front of patients and HCPs as quickly as we can with fixed reimbursement in this specific payer. But as I mentioned, we're going to work with every large payer that we can as we quickly move towards effectively commercializing our efforts. some exciting news for our u but us-based shareholders uh and as you can see with the increased volume we have uh opened our markets to the otc market in the us so it's a much easier process for our us-based investors and people that are interested in in following us from an analyst standpoint uh we've seen a number of companies uh picking us up from an analysis standpoint we've also seen our volume go significantly uh in regard to our total volume of a carrot shares traded uh so we're very optimistic about this we're hopeful that this continually uh progresses for us as well as builds our u.s shareholder base and as we continually grow our analyst base because that's what's going to help propagate our narrative and create the noise uh in the u.s markets with investment banks as well as shareholders This is something that we wanted to showcase for you all because we've had a lot of inquiries about this. And this is our most near-term opportunity with CMS. And that is, as I mentioned, the first vertical, which is the outpatient opportunity for emergency rooms and ASCs. So when you look at the actual numbers, and this is based on numbers that we found through market research, there's greater than 6,000 emergency departments or emergency rooms in the U.S., And when you look at the demographic of patients that roll into those with chest pain, there's approximately 8 million patients that roll in to these locations or facilities with chest pain. And when you look at the low to moderate patient profile, which is what we are indicated for, there's 6.5 million patients presenting out of those approximate 8 million. If we were to absorb 100% of that opportunity, because this is a market opportunity assessment, you can see that it's an opportunity of $650 million USD or 6.61 billion SEK. Sizable market, extremely large, great for our organization because we are first in class. We are the only opportunity out there for direct patient diagnostics within seven to 10 minutes at ease of use at point of care with our one unit and our one patch. So this is something that I wanted to present because I've had a lot of questions on it and we've had a lot of submissions online about it. So this just shows the US emergency department opportunity. Remember, there's multiple verticals we're working on. This will continually grow for us as we continually expand our footprint and continually analyze our opportunities because you've got the private payer clinic setting, which will be larger than this. You've got the concierge medicine, which will not be as large as this, but still large. You've got the other facets of what we are looking at, including life insurance companies for their risk assessment, including different opportunities for CAAT score and modalities as well as indications. We believe our market will continually grow. And again, being first in class is great in regard to the opportunity, but it's also a difficult proposition because you have to build this market. You have to build this awareness. You have to build this reimbursement platform to be wildly successful. And that is what we are acutely focused on to make sure we hit the ground and run as fast as we can over the next quarters and years to come. Some key performance indicators from Q2 before we get into the actual financial side. We increased our customer base in the first half by 18 new clinics or users. Our number of active accounts in the United States is 31. Utilization of patches per day in our top five customers are 2.2 patches a day, which is great. We would love to see that across the board. Our top 20 customers are at one patch a day, which is actually fantastic as well. Our top customers, which would probably be the top two or three, are using four patches a day. What I want to share is these numbers may not seem large, but given our current position, our current process of reimbursement, this is fantastic. Being an expert in the US regarding MedTech and being in it for greater than 20 years, I can tell you that a new organization like this with a CPT-3 code, this is fantastic news. We are seeing people adopt us with a wild card on whether they're going to get paid back or not because they see the value in the product. So what I hope everybody can see is the value proposition and what we can look at going forward. Once we have reimbursement fixed and it's at a good amount, This can be positioned in any healthcare environment in the United States, including rural communities, including the American Indian tribal nations that facilitate their own stuff and are their own pairs. This thing can be wildly successful, but there's pieces of the puzzle that we need to put together, and that's what we are working towards very diligently, very acutely, and very focused that we can make sure that we can get all those things under our umbrella so that we can continue to grow this space. as that fixed reimbursement comes in play. Again, Exciting, exciting Q2. Revenue was up 27% quarter over year over year. Our gross profit is up 38%, which we'll get into more details. Our gross margin is 90%. As we talked about as soon as I came on, we are a patch-based company and our patches are what's going to drive our revenue, our usage, as well as our gross profit, seven points globally. And our U.S. patch sales, which as we know, the U.S. is our target market, uh grew 62 percent uh from q2 23 to q2 24. so we're really excited and most acutely excited at the fact that this is record gross profit for this organization and record patch sales something to be very proud of i'm phenomenally proud of our team and what how they've executed and i can only see great things coming in the future More fidelity regarding actuals. So 62%. So we went from 780 patches in Q2 2023 to 1260. So 62% growth. We actually saw a pretty concerted focus on our high margin opportunity, which is patches, as we mentioned. And so what we're seeing is that as we continue this drive regarding our new model and consigning the CAD score unit and really pushing the patch and the utilization of patches as well as subsequent orders, we continually hope and continually believe that this will grow and continually grow at significant rates as we grow into the future. Our group revenue globally was up 27% and our US-based revenue was up 34%. So 1.5 million SEK up to just under 2 million SEK. Our revenue in the United States, which again is our target market being up 34%, is really exciting because you really need to factor in the fact that we are not trying to sell the CAD score unit. We have taken that out of our value proposition to make sure we reduce the barriers. We are selling the patches. So if we're seeing a much cheaper variable as the patch as compared to the unit. And we're seeing this kind of tremendous growth in revenue. Just imagine what the future can bring. Gross profits, record-breaking gross profits. Globally, we were up 38%, and U.S. specifically, we're up 59%. So again, these numbers speak for themselves. We went from 1.3 million SEK approximately to 1.8 million SEK. That's significant growth. As we mentioned, we're doing many, many things to become much more lean, much more efficient, and much more predictable in our processes and procedures. Gross margin, probably one of the key markers that most companies use and investors use in their investment opportunities. When we can suggest we're up seven points globally to 91% and in the U.S. up nine points and 93%, that's something to think about. Our blended opportunity from gross margin grew from 84% in Q2 2023 to 91% in Q2 2024. Again, we're acutely focused on our patch sales. We're acutely focused on driving that continuum and driving that volume up, and it'll continually see significant opportunities from a gross margin standpoint, whereas these are pretty high, and if we can continue to maintain these with a plus or minus one or two, we will be very, very pleased with our outcomes. EBIT, again, across the board, we saw fantastic results. We were able to improve our EBIT by 25%. So as everybody knows, we're in a loss factor right now. So we lost $23 million, SEK 2023, and we reduced that to $18 million in 2024 Q2. We will continually look at ways to strategically become more efficient, reduce OPEX where we don't feel that it provides immediate impact or ROI, and we will repurpose those funds in any facet we feel that will continually grow our ROI in double-digit opportunities. Most pertinently, we feel that that's going to be associated to our reimbursement efforts as well as commercialization efforts. We see that this thing is propelling very quickly. As I've mentioned, it's been six months. We've had two great quarters where we're continually showing cost reduction, yet increase in units, volumes, and revenue. So we're hopeful that this continues and our momentum will continue as we refine our processes, our procedures, become more efficient, become more predictable in our forecasting, and continually push the opportunity for CAT score, which we see as a significant, greater than $1 billion opportunity. So group two, Q2 group operating result improved 24%. Again, this is something that's really exciting for us as we continually refine our processes, as I just mentioned on the last slide. But what's really important to note here is when you exclude one-time operating results, we improved to 29%. So one-time charges that we had in Q2 that will not be predicated for the next ever, we grew to 29% regarding operating result, which is really great for us to be able to showcase for our investor base and hopefully echo that we are doing the right things and just follow the process and the process will predict our future. And if that is true, things look really great. So with that, Philippa, we are wrapping up our actual presentation. So we're open to conversations and questions.

All right. Great. Thank you for a very nice and interesting presentation. So I wanted to ask first, compared with the previous years, you have changed your business model slightly and you have opened up to install the system online. also on consignment. Does this mean that you have a little bit lower revenue in the short term, but higher in the long run? Or how should we think about this? Can you elaborate a bit on what this means?

Yeah, yeah. Good question. So we don't anticipate that it, the good news is it didn't lower the revenue. We saw the revenue grow because patch utilization grew as well as adoption grew. So removing that initial barrier of having to purchase the CAD score unit without fixed reimbursement really was a great opportunity for us. And we're glad we did that. As you can see, the adoption grew faster. The purchasing of patches grew faster. So what we like to see is the revenue grew, which it did, which was fantastic. And we'll continually see that grow because if we continually keep that barrier away until we have fixed reimbursement, we believe that the revenue will continually grow because patch utilization will grow. So we like the model. We will continue with the model. But it doesn't mean we're not opposed to selling the cap score unit when a customer requests to purchase it instead.

Right. And speaking about the gross margins, can we expect them to stay at the same level or could they be even higher in the long run?

You know, that will kind of be predicated by our reimbursement and our opportunity to increase prices. As we stand today, our goal is to maintain a hundred dollars per patch uh from a revenue capacity um we have had to deviate that here and there due to our reimbursement challenges but once we have fixed reimbursement we anticipate that we will have no challenges keeping that benchmark of 100 um and so that should create the opportunity to keep our consistent uh margin uh in the 90 range um i think like i mentioned i think if it fluctuates between one and two percent up or down we're still in a great position because average medtech um margin is between 60 and 68 uh so we're really really focused acutely on that patch and i think that will provide for a significant opportunity in the future but we hope to maintain around the level we're at today

Makes sense, thank you. And the patch sales are up nicely, as you say. Is this related to one or a few bigger customers or is this like a across the line development?

Yeah, so good to say that it's across the line, right? We didn't have one person just purchase a ton of patches. Now, there are a lot of larger facilities that we rolled out in Q2 that ordered multiple units that did get a larger amount of patches, but they would be unit and patch sales. And we also have a lot of reorders. For example, there's one clinic that is a very high-volume clinic, and they order approximately four boxes a month. patches, which would be 80 patches. So we're seeing consistent opportunity amongst the lower volume and the higher volume. And we think we will continually grow that base significantly.

Right. Great. And any financial targets for 2024, 2025? Do you have that?

Yes, we are very, very focused on that. We know that's something our investors want. We did say in our first earnings call that I was a part of in February earlier this year that we are looking at everything, you know, a top down, bottom up, a complete analysis of this organization. I am not completely through with it. But we also have a lot of variables that are coming to fruition, including CMS, including private payer conversations. So what we're waiting for is to see what that brings for our CARICs and the CAT score unit, and then we will provide more guidance as we get towards the end of this year into 2025 as we have some very clear delineation on some of the key aspects and variables to be able to predicate efficiently what our forecast should look like.

Yeah, perfect. And changing the subject a little bit, you did another directed share issue in July. Can you tell us something about the investors that participated in this issue?

Yeah, these are all U.S.-based investors that are extremely passionate about what we're doing. They're all accredited investors and business owners, some in healthcare, some in different segments of industry. So very, very acutely focused people that are looking for long-term opportunities. These are not institutions or day traders. These are long-term holders. that are very focused and see the opportunity for Akerix in the US and globally, and what the future can predict.

Great. Perfect, thank you. I only have one last question from me, and we have gotten quite some questions online, but just finish the questions from me. The most important key takeaways from Q2, and what will be the most important triggers going forward?

Yeah, I think the key takeaway from Q2 is we're doing the right things. We are acutely focused on processes, procedures and commercialization, which also includes reimbursement efforts. So what? Q2 shows is the changes we're making are working. We are growing. We are not necessarily just growing financially. We are growing from a volume standpoint, from utilization standpoint and adoption standpoint. So what's happening is working. We're going to continue the process. You follow the process, things will work. And that is what we're doing. Secondly, we feel that as things continually grow, we will purely focus on reimbursement and commercial. And some of the most important things that we're focused on for before the end of this year and Q3 and Q4 is CMS. for the ED outpatient setting, getting that reimbursement fixed in November. We're also acutely focused on a minimum of two large players in the private pay sector to continually focus on those efforts and hopefully establish some sort of reimbursement before the end of the year, if not early next year. Those would be our key points that we're acutely focused on.

great perfect thank you very much um and can we expect an idn agreement during q3 a very direct question yeah so idns and i know there's been a lot of conversations surrounding idns which are independent distributor networks um those are

larger hospital chains that kind of group together. We do have a number that we're talking to, but again, in the US, what I want everybody to understand is having fixed reimbursement is such a significant variable in any decision. from the small clinic all the way up to the IDNs and GPOs, CMS and the private payers. You have to have some sort of reimbursement for them to feel adequate and comfortable in acquiring a large number of units or suggesting to their large groups to acquire these large opportunities. So we are having these conversations. We do believe some IDNs will come to fruition, but It is a process, and part of that process is reimbursement. And I know there's been lots of stuff that's been said prior to my arrival. I am a very transparent and candid person. I will never try to oversell anything. So while we are working on them, we are very aware that that's what this investor base wants to see and has heard, and we are working diligently towards it. But a lot of this will be predicated based on what CMS says and what private payers will say in the near short term that we have in the next 30 to 90 days. Hopefully we will have some more development over the course of the next 90 days and something we could share with the investor base via PRs.

Great, thank you for that. And certain VA regions were supposed to attempt purchasing CAD score through a critical pathway. What is the current status of this?

All of this is ongoing. Some exciting news, we just had another VA implement this into their ED, a current customer that was already part of the process. So that was really exciting. That's something that will be rolled out from a clinic standpoint and ED standpoint. So now technically we are system wide. So that was good news. We've got a lot of usage in a number of our VAs, but we have not heard any outcome of using the critical pathway at this time. Again, and a lot of people know the US and government situation is very unique. We were in an election year, lots of stuff happening. Budget was required to be updated and approved, which has not been done yet. So a lot of nuances that are out of our control regarding the VA or any government entity. But we're actively pursuing and actively pushing as diligently as we can because we understand how important that is for our shareholders.

All right. You previously mentioned GPO as a potential major client. How significant could such an agreement be and can we expect one within this year?

Just as an understanding of GPOs, GPOs are group purchasing organizations for our Nordic investors. They are groups that are consultant type organizations that have a membership. And what they do is they take that membership, that purchasing power, and negotiate direct with vendors, right? And then be able to drive the price down. And the way they work is they charge the membership a fee. for every acquisition cost right so if you spend a million dollars there could be some sort of vendor that's paying two to five percent and the the hospital itself is paying two to five percent so they're a overlying overarching group that facilitates the purchasing opportunities for larger hospital chains and organizations some up to three or four thousand hospitals Yes, we are talking to a few. Yes, there are opportunities. Yes, they are acutely focused on the reimbursement aspect, at least in one segment. As I mentioned, CPT-3 is not guaranteed reimbursement. So once some of these puzzle pieces fit in play regarding reimbursement or even private payer confirmation of reimbursement, that's when these things will really move.

Right, perfect. And regarding the CMS decision that we're expecting in November, what risks are associated with it? Could it be rejected and could it cause further delays?

You know, anything could happen. It's the government. However, we know what we presented and we know that the value proposition was respected and conversed about during the call. So we feel good that something positive will come from that meeting. However, it's hard for me to predicate what could possibly procure or speculate what could possibly procure. But we're we're we're cautiously optimistic is how I would leave it. But the good news is we there is a mandatory response that they have to provide for us, and that response will come in November. So we will we will know here in the next 60 days.

Okay, great. Perfect. And a few more questions here until we close this. What do you believe are the chances that we'll see a $320 static reimbursement level from the CMS? Maybe that's tough to answer.

Yeah, I can't answer that. It's 100% going to be done by them. But what we presented, we feel good that it will be... What we presented is a very strong case for that level and that's why we chose that level.

Yeah, perfect. Okay, when mentioning a number of sold devices, does that include devices pushed to the market with the new lease model? Or do we actually have more devices in the market, but just on the lease model?

No, those are total devices in the market. And if you look at our annual report, we clearly articulated which ones are on consignment and which ones were sold.

Perfect. Dan, we thank you very much.

Yes, sir. Thank you very much and appreciate all our investors.

Yeah, perfect. Thank you.

Thank you.