My name is Bill Plavonek. I'm one of the senior medical device analysts here at Canaccord. The format for CVRX is going to be a short presentation followed by Q&A. And today we have the president and CEO, Kevin Hikes, and our CVRX's CFO, Jared Oshime. With that, I'm going to pass it over to Kevin. Thank you, Bill.

Good afternoon. Thank you. I appreciate the chance to address the group today about the status of CVRX. These are our forward-looking statements. So just as a little bit of background here, CVRX is commercializing the world's first autonomic neuromodulation therapy to treat heart failure. It consists of a device that looks a fair amount like a pacemaker with a single carotid sinus lead and a wireless programmer. It's implanted on the carotid, the outside of the carotid artery on top of what's called the carotid barrel receptor, which is effectively the body's thermostat. It's the place where the brain senses the status of the cardiovascular system. It is implanted in a 30-minute procedure that's largely bloodless. It is extravascular and extracardiac. Our device treats a segment of the heart failure population that are commonly called the walking wounded or the forgotten middle. So when you're diagnosed with heart failure, you have roughly 8 to 10 years typically of longevity. The first thing they do is try to put you on as many of the four guideline-directed medications as you can tolerate. A small percentage of patients are considered for cardiac resynchronization. But otherwise, and for 50 years, patients are sent home to suffer the debilitating symptoms of heart failure, including increasingly frequent hospitalizations for decompensation. Towards the end of that journey, a very small percent of patients, less than 1%, are considered for transplantation or a left ventricular assist device. So for 50 years, physicians have been treating this disease with pharmacologic therapy. We know today that only 1% of patients are ever able to tolerate all four of those medications, and at the end of the first year, 40% of them discontinue at least one of those guideline-directed medications. So the medications, if taken, can preserve life but do nothing to improve the quality of life. So Barostem fits in that middle paradigm for these patients called the walking wounded. Those patients who have an NYHA class 2 and 3 designation, so sort of the middle of the heart failure continuum, with an ejection fraction less than 35% and a blood marker called NT-proBNP, that's a measure of the stability of their heart failure, below 1600, which is a bit of an artificial ceiling, but it relates to our original pivotal trial. So when you take out the customary exclusions for surgical candidacy and access to health care, that results in about a $10 billion prevalence-based TAM in the United States. So a very significant population. Interestingly, given the size of heart failure, that's only 5% of the heart failure population. So a massive, massive chronic disease, as you well know. So when I joined the company two years ago, we took a look at the results of the commercialization in the first three years and implemented a brand new go-to-market strategy in the tail end of 2024. That involved three very distinct strategies. The first was to get the right sales force in place, a sales force focused on market development. The second was to develop a set of selling programs that drove deep adoption at the account level and to move from a customary sort of mile-wide, inch-deep approach that many early-stage companies have to start with to a much more targeted approach with the goal of driving deep, sustained, predictable adoption in the right sorts of The third piece of the strategy was to address what we understood and validated to be the most fundamental barriers to the adoption of this therapy in the market, those being patient access, awareness amongst clinicians and patients of the therapy and its role in the disease continuum, and evidence, right? A little bit of apple pie and motherhood, but for this therapy, at least, those were the primary barriers to the adoption. And what we're seeking to do in these accounts is to drive deep adoption, and that starts with a network of aligned stakeholders, starting with a clinical champion, often with a CFO or administrative champion alongside them, and then a group of referrers in the community who understand what patients look like, patients who are candidates for Barostim, prescribers in the center that understand how to evaluate a patient, and surgeons who are partners to those prescribers who put the device in. again in a 30-minute very simple procedure. And so by developing alignment across those stakeholder groups and by implementing a workflow that lets each part of that team understand what their role is. What does the right patient look like? How do I make sure they can benefit? How do I send them to a surgeon for implantation? And then at the end of the process, send them back to their physician in the community to be followed. So that's an important piece of this. If you do that well, those two things, you can in fact start to drive consistent utilization. This is how you change the practice of medicine, how you develop a market for a therapy that has not existed before. And only through that consistent repeat utilization do you ultimately move something towards standard of care. We have made significant progress over the last 18 months against those three barriers to adoption. I'll talk about these in a minute, but certainly and most obviously in terms of patient access and coverage in this environment today, which is extremely difficult, as you know. Secondly, we've driven significant awareness within the medical community and in patients themselves on the role of this therapy in the treatment of heart failure. This is a novel concept to use a medical device to treat heart failure and a novel idea to do something for the patients that are in the middle of this journey, the walking wounded. On the far right, you see our evidence strategy has been producing now an increasingly steady stream of both clinical and physiologic data to support the therapy beyond that which was proven in our pivotal trial. So a couple final slides. Importantly, in March of this year, we announced the initiation of a trial called the Benefit HF trial. This was approved by FDA and has a CMS category B reimbursement designation. So this will be the largest device-based therapeutic trial in the history of heart failure, almost five to eight times larger than the next biggest trial. And so So this is a leadership investment by CVRX to revisit our initial indicated population and to triple the size of our TAM by adding two adjacent populations as well. So it'll enroll 2,500 patients at 150 centers, largely in the United States, looking at morbidity and mortality, and as I said, is fully covered by Medicare. So that's a significant benefit for us. We expect that the trial will take roughly three to five years to enroll with a two-year follow-up. So it's a long-term investment, but one that's seen as a credible signal of our confidence in the therapy and our commitment to science. Lastly, we've made great progress in terms of reimbursement. And a third of our population who are traditional Medicare are now being covered at almost 100%. So the seven max across all of the regions are covering this therapy when it's properly billed and coded. Another segment of our population, which is not advancing with this clicker, let me try that one more time. So for some reason the slide, so witness in your minds, if you will, the bottom of this represents two populations, both commercial on the right and TRICARE VA Medicaid on the left, which are not a current focus of our therapy, but with the category one approval in January of this year, are now more eligible to receive this therapy than they have. been in the past. The upper piece of the pie, which you can't see, represents the 33 percent of our population who are covered by Medicare Advantage. So our focus is really traditional Medicare and Medicare Advantage. And within that population, those patients require a prior authorization to receive our procedure. Importantly, in May of this year, the second largest Medicare Advantage provider, and one that is notoriously difficult, Humana, issued our first written coverage policy for Barristan. And that was a huge step forward for us. It was somewhat of a welcome surprise several years earlier than we expected that that might happen. And that written policy now gives us significant leverage as we work with United and Aetna and Cigna and the other Medicare Advantage payers to themselves write coverage policies for this therapy. So that's a very important new step for us. It allows us to better fight for prior authorizations, to appeal rejections by the payers, and ultimately to drive for coverage. So we can talk about that further, but I'm pleased to be here. We're excited about this therapy and the impact it has on this horrible chronic disease that impacts patients' lives to such a significant degree. I'll stop there. Thank you.

All right. Well, thank you for taking the time today. Let's get comfy here. So I'm going to start off, and we're not softballing you today, given some challenging times, and I think it's always best to get right down to the crux of things. So, I mean, you've got a differentiated option for a subset of heart failure patients. It improves their symptoms when the guideline-directed medical therapy has failed. The journey to commercialization here has been probably harder than most medtech companies we see. I mean, despite having clinical data that shows the improved quality of life for these patients, And secondly, having both the reimbursement and new tech APC code since 2024, the CPT1 code since January 1st, 2026. So you have a lot of the kind of reimbursement tailwinds hitting and you're chipping through things. But from a high level, it's been challenging despite this. Why do you believe it hasn't been adopted? Why do you think it eventually will be fully adopted in the marketplace? And what's going to be the catalyst to really open up this market opportunity? I think investors are looking at it, right? You've got X amount of cash. Here we are. You know, the stocks. And I think, you know, a level, if this works, this is a very good level. But convince us why it's going to work or what's going to make it work.

So thank you for the question. I appreciate that. So let me just kind of take it up a level. So I joined this company from our board about two years and three months ago because I saw a massive market that had yet been really touched by medical devices with a highly differentiated therapy that had been proven and that was based on the very same mechanism of action that the pharmacologic therapy relied upon and a very interesting strategic landscape with five or six or seven companies who would very easily fit this into their bag. Not that that's our intention, but this fit very closely with other adjacent cardiovascular markets and device companies. So those all hold true today. It is true that this is a difficult market. The heart failure physicians are among the most conservative. There's a reason that this has largely been untouched by devices up until now, despite the fact that it is a massive chronic condition that's costing the government $80 billion a year by the end of this decade. So it's not an easy market, but I believe that this is a remarkable therapy that has the fundamentals to be successful. So to kind of echo an earlier comment, so 18 months ago, we put a new strategy in place that said we need to be driving deep adoption. We need to be gradually reducing these three barriers to adoption that exist. And we've been pursuing that strategy. And what we can say today is that strategy is working. So in five of our nine regions where we have limited turnover and seasoned leaders who are running our strategy, we're seeing strong double-digit growth. Our challenges today, as we discussed last week with our earnings release and our guidance, relate to the last mile of our commercialization work. And it's an execution issue with the number of new hires that we've added and their concentration in four of those nine regions. And in those regions, we have new leaders and significant numbers of new people who are not able to run the strategy. So we think we have the right strategy. We think we've made significant progress even in the last six months in these barriers, as I've described. And we're steadfast in fixing these remaining execution issues that we think are largely, it's not about the people we've hired. It's about our ability to get that many people up to speed as quickly as we can. And that is where we perhaps didn't anticipate the bolus of people coming through and the slowdown in productivity ramp that we saw in Q2.

So I think, you know, the investors always want to know, you know, most investors haven't worked inside of a company and they're always like, how do you get insights to the changes that they're making are working? So now you've made some sales leadership changes. You're changing out some other people within that sales organization in those territories, as you said. Outside of a printed number at the end of a quarter, what can we as investors look for that gives us confidence that that's going to be, it is an execution issue and not a market issue?

Yeah, so we are, as you saw last week, we have decided to take a very conservative posture for the back half of this year. So we are going to put our heads down and ensure that we are creating job-ready new hires and placing them into their territories confident and competent and ready to develop this therapy. So for the next couple of quarters, we'll be taking somewhat of a back seat, and we won't be able to share much about their productivity. What you will see eventually when we do that is those four struggling regions behaving like the five that are delivering and an increase in the revenue units per account or per sales rep that we're able to deliver.

What are you doing different on the training and onboarding of these new reps that you weren't doing with the ones that weren't successful? What do you change in to make it work?

Great question. So I would say there's three things we're doing to address this execution issue. The first is further tightening down our hiring and making sure that we are certain in the profiles of reps we're bringing in and that we are living by that profile even as we are hiring and making hiring decisions. The second, perhaps more importantly, is the onboarding process, and that involves a significant increase in curriculum focus on how you do your job, not just how does heart failure work, what are the basics of cardiology, how does the technology work. So it's a lot more time understanding practically how do you access an account, how do you build the network of stakeholders like I described in my earlier slide, what is a workflow, so a lot more of the hands-on practical work. We did not need to do as much of that earlier when we were training one or two people a quarter. When you're training 10 or 12 and you can't do it as well or with the same hands-on touch, you need to be more aggressive. And so we're increasing both the curriculum as well as the resources and the training support that we're providing to them so that we deliver more readily effective new reps to the field. The third piece relates to our ASDs, our area sales directors, and ensuring that whether they're veterans or some of the newer ads, that they have the bandwidth they need to mentor and train and coach these new hires and to focus on the simple set of key deliverables for driving the business forward. We have to some degree distracted them and not supported them fully, and that's in part what's going on in these four regions as well. So those are kind of the three legs of the stool in what we're doing to try and improve execution.

And how much of this was profile versus training?

I would say largely training. We think we have a really good team. We don't think we have a people problem. We think we have a productivity problem. And not everywhere.

And, you know, reimbursement historically is something that, you know, it's a blocking and tackling game. And it sounds like, you know, you got the hiccup right now, but that seems like a blocking and tackling issue that you'll kind of go after with the payers that are pushing back.

Yeah. And I, yes, you're referring to the UnitedHealth situation that we're all experiencing. So that's a hiccup, certainly. But our macro reimbursement trends are very favorable. And some of the work we're doing, I mentioned that third bucket trying to keep our area sales directors focused on the sales. We're adding reimbursement resources at the field level to do more and more reimbursement support locally and take more of that off the plates of the area sales directors and territory managers. So we're seeing actually now our Medicare Advantage rates, despite United going from an 80 percent something approval rate at 30 days down to 25, we've seen Humana go from 10 percent to north of 90. And so our overall approval rate for that invisible piece of the pie is now above 60%. And that's up from 46% at the end of last year. So we're seeing steady progress there, even as United, you know, continues to evolve and play tricks with prior authorization. So overall, that's good. And, you know, our Medicare Advantage as of the end of 2025 is now at 90, sorry, traditional Medicare is at 97%. So we're getting solid coverage there from all seven MACs across the country.

And is there a cycle that UNH or Aetna or the others play on that we should be aware of that maybe can be okay? There's maybe a light at the end of the tunnel?

Yeah, so great question. So the bulk of the large Medicare Advantage payers have a January review cycle. There are some that have May, as was Humana. There are some that have September and October. So it sort of plays out across the calendar year. You can appeal for an early review. That's not often an easy path. But you can imagine the day we got the Humana policy, we reached out to each and every payer and told them that their competitor was now covering and they should be strongly considering that. So and you mentioned the, you know, the daily battle or whatever you called it, the blocking and tackling. The way that you get a payer like Humana to finally agree to write a policy is that you pursue each and every denial all the way through the first, second and third denial. And then if necessary, you take it to an administrative law judge, which they have to pay for. And the more you win at the administrative law judge level, the more you get their attention. And once they're losing more than 50 percent of those cases, that's when they write the policy. And it works. And that's what we're doing with Aetna and Cigna and now United. So we will continue to run that playbook and we believe will ultimately be successful.

So the big fears in MedTech right now is just the ACA trade and, you know, less people being insured because they're kicking them off the rolls and their co-pays have gone up. And is that something do you think we're also seeing maybe under the surface or any thoughts on that?

Yeah, I'm happy to jump in, Kevin, if you want on that one. So I think we've looked at this, you know, from many different angles. We still see this as a massive market opportunity and the number of patients that are covered by Medicare. So over the age of 65, whether that's traditional Medicare or Medicare Advantage plans, is still two thirds of that $10 billion market opportunity. So we do not believe that this is a demand issue, whether it's driven by, you know, physicians wanting this for their patients or the patients having insurance, that this comes back to the process and getting our team up to speed and productive in their new roles.

You know, one thing I would mention, and it relates to, you know, the reimbursement scene, what we're seeing from United, historically physicians, United had been covering our cases at 80 percent within the first 30 days, often within the first few days. So physicians became very comfortable referring a United patient for our therapy because they came to trust and believe that virtually every one of them would get the therapy. That's really important to them. Conversely, up until May, they were unwilling to even talk to a Humana patient about our therapy because they knew the chances of them ever getting it covered were nil. And they were afraid to do that. They personally felt responsible when the patient would get excited and then not have access to the therapy. Ironically, those have now flip-flopped, but we believe there are physicians who are no longer talking to their United patients right now about our therapy because they've been burned through the early first quarter of this year and have seen that dynamic. So there is probably a temporary impact there on United patients flowing through our funnel.

So you ended the quarter with $65 million in cash. You burned $9 million, right? You got access to another $40 million. But as you think about this, I mean, six quarters of cash if you don't use the debt. Why wouldn't you scale back the organization and focus on the benefit HF, given the potential opportunity, which one of your competitors or potential, somebody similar in the space did, not direct competitor, but similar in space, did a couple of years ago, given what you believe the outcome of benefit HF could do for you? why wouldn't you do that? Like, I'm going to make you defend why you're going to keep investing.

Sure, because we think, I mean, we believe there is more than enough evidence. We haven't spoken at length about the evidence, but there's a significant stream of evidence that we've created in the last 18 months and a significant additional number of data sets and opportunity with real-world evidence that will continue to produce data. So we have more than enough evidence for the bulk, we believe, of today's heart failure community. There are certainly, we call them curmudgeons, but there are certainly senior heart failure physicians who've lived in the pharma world for so long that they will probably not change their ways unless we deliver a 5,000 patient trial, right? We're not talking to them. There are more than enough physicians who look at the data we produced already and who are themselves confident that this therapy can work. So we don't believe we need to wait for evidence. The second piece, we have a category one code, which is granted by the AMA on the basis of widespread use. We have a Humana policy, a written policy. We have 97% Medicare coverage. We have 60% approval on the Medicare Advantage side. Those are the toughest critics of all, and they are saying that this therapy is ready for prime time today, right? So it doesn't mean this is easy, but we think we have enough of the components, and those are both getting better with each and every month that we can in fact commercialize today. We need to be thoughtful about where we go and who we call on, and we need to get much better at execution. But we think that this business is ready to be commercialized today and that that's worth an investment.

So if you had a crystal ball, tell me, when do we get through United, Cigna, Aetna? When do we get all of them on board? Is this a 12-month, a 24-month, a 36-month? You got Humana, and you're using that as your poster child to go after everybody else. What is this going to take? Because it seems like you said maybe it was an execution issue, you're going to redirect and work on that. But it's the payer issue is the other issue.

Yeah. And I, you know, as I understand, and as I have experienced, there's a bit of a domino effect here, right? And once you get one of the big payers to fall, that gives you tremendous leverage to go after the other large payers who then are forced to follow suit. And that can take 18 months, 24 months to get most of them or the biggies. So I think we have started that process sooner than we anticipated. And I'm excited about the potential for this next round of reviews. So that could be 6 to 12 to 24 months to get Aetna, Cigna, United eventually, yes. So we're starting that process, which is exciting and not exactly what we thought we'd be able to do this year. There's no magic crystal ball. We know that with AI, as we saw with United, that the tricks keep changing. That's not a CVRX thing. So the battle will continue to evolve, I'm sure. But we are gaining momentum, certainly. And the ability for an administrative law judge to look at United and say, 97% of traditional Medicare get this device, if it's coded correctly, your largest competitor is paying for this on a written policy 100% of the time, why are you not offering that to this patient? How can you claim it's experimental? So that's a really important piece of leverage.

All right. Any questions from the audience? Can you repeat the question?

So there's a question about how that process works. So I'm not an expert, but after typically the third denial, you can appeal to the law judge on behalf of the patient, right? That's not us doing it. It's the patient doing it, and we support them. We have an agreement with them, an AOR. So it's a standard process. The process, unfortunately, is somewhat opaque. It takes about 100 days from the initiation of that administrative law appeal, the last stage, to the ultimate decision by the judge. So the judge has 60 days to schedule, 30 days to consider, something like that, and then they publish their opinion. So it's a pretty – we didn't invent it, obviously. It's been – that process has been in existence for a while, but we're really good at it. And that's, again, the battle. Yeah, I would say – I don't know if we've shared specific numbers, but more than 10 and less than 30, right? And they ebb and flow, and they're across all the payers. But again, that's an investment that we're making to push each and every one of these to the bitter end. And it works because it works.

And we're out of time. Anything to leave us with?

No, I appreciate this has been a last Thursday's guidance revision was not what we had planned to do. It is not a change in our strategy or a vote of no confidence in the team that we built. or, you know, a suggestion that the opportunity is not what we expect it was. This is bumpy. This is a tough market, but we are confident these turnarounds are not linear, unfortunately. But we're committed. We believe that this is a remarkable therapy that has a place in the treatment of the disease, and we're not giving up. Thank you so much.