Good morning, everyone. My name is Mark Osbat. I work at Goldman Sachs covering MedTech and HCIT. I have the pleasure of hosting CVRx, specifically with the CEO to my right, Kevin Hykes, and CFO, Jared Oasheim. There's a lot going on, and I want to make this as interactive as possible for those online. I'll make sure to periodically stop in and ask for some questions from the audience. I think maybe we could start, there was a recent announcement and would love to hear how you guys are thinking about the new CFO transition. Sure. Thank you, Mark. We appreciate the chance to be here today and to chat a little bit about CVRx. Obviously with the news yesterday of Jared's intention to transition out of the company, it's a great opportunity for us to hear a little more from him about what that means. Just on behalf of the company, before I let him address that, we're thrilled after 11 years and significant innumerable contributions. He's ready for his next chapter, which we fully support, and he's been extremely instructive, not surprisingly, in constructing this transition process. We'll have him for another nine or 10 months, likely, but have the time to do this right and find the right next successor. Maybe Jared can share a little bit about that. Yeah, happy to cover that. This is something I've been thinking about for a little while, right? Been at the company for more than 10 years. Been in the CFO seat in the public world for more than five years at this point in time. Really starting to just get that itch for what is that next adventure, right? At the same point, I love this company. I love this product. Everything that it does for patients, I am completely bought in, right? I want to make sure that this company continues on in a very strong way and goes to the moon, right? When I came forward to Kevin and talked about the opportunity of transitioning out at some point in the future, it was really built on wanting this thing to continue to grow and be in a really healthy position moving forward. We constructed this approach where I am committed to stay on all the way through finding that new CFO, getting them up to speed over the 30-day period afterwards, and then even beyond being a phone a friend, right? In that consulting role to help that new person get up to speed and kind of take this thing to that next level. I'm excited for the next opportunity, but I'm here for a while, right? We've got to find the new person, get them up to speed, and I'm willing and able to help support them through that journey. That's great. Kevin, why don't you start with maybe providing a brief overview on CVRx and your background as well as framing what you all are working on for those that are newer to the story. Sure. Thank you. Maybe I'll start with the background piece. I'm a 35-year med device veteran, 17 years at Medtronic, now 17 years running growth stage, mostly private ventures, just like CVRx, very much at the same stage, dealing with the same issues. I was on the board of this company for a couple of years before I stepped into this role. I found a fantastic company that had very typical sort of early-stage commercial successes and challenges. When I joined two years ago now, we spent some time just looking at what those first three or four years had told us, what worked, what didn't, what sort of approach we needed, what were the fundamental structural barriers in the market to the adoption of the therapy. On that basis, we built the go-to-market plan that we began implementing roughly 18 months ago. I can talk about that later if we have time. Maybe just to back up a step. Barostim therapy was approved in the U.S. in 2019 for the treatment of heart failure. We treat patients. Heart failure as a whole has sort of two large halves. One is reduced ejection fraction, one is preserved ejection fraction. We treat patients that fall with the reduced ejection fraction. Those are EFs below 35. Our therapy is indicated for a subset of those patients who are on guideline-directed medical therapy. Those are the four commonly prescribed drugs today, but who are still symptomatic. The challenge we are dealing with in heart failure, especially in HFrEF, reduced ejection fraction heart failure, for 50 years, the disease has been treated with drugs. Patients are diagnosed, they're started on as many of these four drugs as they can tolerate, and they're effectively sent home for five to seven years to suffer with debilitating symptoms. At the end of their journey, seven or eight years later, if they're lucky, they're considered for a VAD or a transplant. If not, they're sent to hospice. We're dealing with a disease that's been largely undermanaged for many, many years. The quality of the four drugs, and I can tell you, only 1% of patients ever can take all four of those drugs. Of those that do, 40% discontinue in the first year. The drugs are tough to tolerate. They do nothing for quality of life, and many patients can't take them. We deal with the population that we treat are called the forgotten middle by the heart failure community. Those are patients between sort of two and three years in and six and seven years in, and they're suffering. Our therapy rebalances the autonomic nervous system by restoring signaling from a set of nerves, a bundle of nerves called the baroreceptors on the carotid artery that signal the brain on the status of the cardiovascular system. You've historically framed Barostim as a $10.5 billion U.S. market opportunity. Why don't you walk through how you size that market? Sometimes there's both deciding what is totally accessible as well as serviceably accessible. How do you frame that in that context? We would describe our population. The annual incidence for our indicated population is about 76,000 patients. That starts with all patients with heart failure. We take a cut for those who have an EF less than 35. We then take another cut based on a biomarker called NT-proBNP, which effectively describes the stability of their heart failure at a given time. Our indication is for patients that have an NT-proBNP between 400 and 1,600. A really sick patient could have an NT-proBNP of 20,000. We say under 35, 400- 1,600 on the NT-proBNP, and then we take another cut for access to healthcare comorbidities, kind of Medicare, Medicaid, sort of the typical cuts to come up with a very conservative 76,000 patients per year, about $2.4 billion on an incidence basis. On a prevalence basis, it's about $10 billion a year, that's about 340,000 patients. Maybe we transition to more of the clinical evidence side of things. You've conducted multiple studies, why don't you start talking about how physicians and patients have reacted to your current clinical evidence? Sure. The most recent trial that we've completed, large-scale trial, was our BeAT-HF pivotal trial. Our device and therapy was the first ever breakthrough designated device by the FDA. There's now 2,500 such devices, but ours was the very first. At the time, the structure of those trials involved a part one, which allowed you to get FDA approval on the basis of safety and efficacy, then a second phase of the trial that would study additional endpoints. In our case, we got approval for the therapy at the six-month point on the basis of an extremely safe procedure with significant impact on quality of life. We then began the second phase to further enroll the trial and look at two endpoints of hospitalization and mortality. Unfortunately, as we began that second phase in December of 2019, COVID was on the horizon. As a result, we were unable to fully enroll that second phase. Ultimately, when we published the data, we demonstrated extremely durable quality-of-life symptoms out to two years, but we just missed on the hospitalization endpoint and the mortality endpoint. Since that time, we've been marketing and formally on label on the basis of the quality-of-life impact of the therapy up until now, but have significantly built out the sort of range of evidence around that initial clinical trial. We now have very solid real-world evidence that shows dramatic 85% reductions in hospitalization. We have significant data showing the impact on arrhythmia, on kidney function, on diuresis, on some of the mechanistic underpinning. For the last four years, we've really tried to build around that initial BeAT-HF trial data that eluded us to some degree because of COVID, to provide clinicians with a much broader sense of why the therapy works and why it affects so many different elements of heart failure. I'll stop there. And. Can I just add, sorry, a question back on? Sure. Serviceable addressable market. On the one hand, I think investors get confidence when you take a big TAM and put it into a more direct serviceable market. On the other hand, when you start slicing the size of the market, you start to ask questions about, are the 76,000 patients treated in a small number of centers? Are they very diffuse? How do you actually access that? Maybe help us understand the unlocking of that opportunity. Sure. Yeah. Happy to cover that. We've gotten this question quite a bit over the years. I think if you go back to our investor deck and look at where we start with this heart failure population that Kevin was referring to, it's millions of patients in the U.S. that are currently suffering from heart failure. As we went through our FDA indication process, you take cuts against that. Kevin mentioned, we're cutting it for NYHA Class III or Class 2 with a recent history of three. We're cutting it for the ejection fraction being below 35%. We're cutting it for that NT-proBNP biomarker of 1,600. Every time we get this question, both from investors and even from physicians, of who is the perfect patient, it really is those patients. We're talking now about 340,000 patients in total out of the millions that exist in the U.S. today. We believe all 340,000 are serviceable. Now, the question is, how do you get access to those patients? As we've gone through this update to our go-to-market strategy, it really was focused on where is the most significant volume of these types of patients. You can do that through many different ways, right? You can look at other devices that they've been able to get for their heart failure, for example, a single-chamber ICD or maybe a diagnostics device like a CardioMEMS. You can look at heart failure admissions data at a hospital and try and understand how many of those patients are being referred into those specific hospitals when those types of events take place. That's how we've then identified which are the most important centers that we need to activate to capture the majority of those patients, the 76,000 new ones in a year or the 340,000 in that prevalence pool. Maybe just a follow-up question. Heart failure has been a really tough space for devices, and it really hasn't been, even on the drug side, there's really been no innovation. There was Entresto. That's done okay in terms of having an impact. As you think about you have V-Wave, which failed in the preserved ejection fraction segment. Now you have folks going after cardiac contractility modulation. You going after heart failure. Help us understand, just from a market landscape perspective, what is the status of, on the one hand, devices in heart failure and where is it going to? Take to really move the needle here on adoption? That's a great question. At 100,000 feet, this is a very conservative specialty, whether you're talking about the HFpEF-focused physicians or the HFrEF. Things move more slowly in heart failure, perhaps than in some other fields, even within cardiology. There's point number one. Point number two is, as I mentioned, there's a 50-year paradigm here of using medication to treat this disease, undertreat it, frankly, and to do nothing for quality of life. There's a paradigm that we and others like, you mentioned cardiac contractility modulation. We think often about Abbott and CardioMEMS. We're all in the same boat trying to introduce the idea of devices to this very conservative physician population. The good news is the earlier stage physicians, even mid-stage now in heart failure, have been exposed to these devices. Abbott has been at work with CardioMEMS now for 11 or 12 years. They're really the predicate device, and they spent a lot of very difficult time in the trenches introducing the idea of a device in the treatment of this disease. In their case, it's a diagnostic device that has a pretty significant workload associated with it. That was a heavy lift. We're the beneficiaries of that work, and I can tell you for the first time ever, in 2024, the Heart Failure Society of America, who are typically thought of, they're sort of the keepers of the pharma flame, if I can say it that way. They published a consensus document that said, if after six months a patient on best tolerated guideline-directed medical therapy is still symptomatic, it is time to think about end and intermediate devices. That was a very significant threshold event for the specialty and certainly for companies like ourselves who are trying to change that paradigm. It doesn't mean people change their behavior overnight, that's yet another element of getting physicians comfortable that there is a role for an invasive therapy like a medical device in treating this disease, and that sending a patient home for six years to suffer and just telling them, "Sorry, that's heart failure. It's a horrible disease." That's not enough. There are options now that can get paid for and that are demonstrated to be safe and effective and that should be considered. As we stand today, you're in the process of preparing for another meaningful data release. Why don't you provide an update on your BENEFIT-HF trial, current enrollment, and other considerations? Sure. Do you want to take that? Yeah. Maybe just kind of taking it up a level first. The trial itself is a large trial to prove morbidity and mortality in an expanded patient population. We're looking at around 2,500 patients enrolled for patients that have an ejection fraction below 50%. Again, remember, our current cutoff is 35%. Also expanding this population for our NT-proBNP cutoff up to 5,000. Again, our current cutoff is 1,600. By enrolling 2,500 patients, by expanding the patient population, we could gain access to potentially triple this market opportunity from a $10 billion prevalence pool up to $30 billion. As far as the trial itself, we did get FDA approval towards the end of last year. We also applied for and received Category B IDE designation from CMS, where they will cover the cost of the procedures of this trial. That was received early in 2026. With that in hand, we were able to go out and start activating centers. That, at times, can be a long and arduous process. Depending on the types of centers you're engaging with, it can take more than a year to actually get on contract and go through that IRB approval process to get a new trial off the ground. We have already activated several sites, some of those faster movers where contracting can happen at a quicker rate are signed up and are already enrolling patients. We're still single digits in both arms. As we think about how the year started, we had not really factored in any of this trial enrollment into our guidance. The fact that we're activated in several centers and seeing patients enrolled is a positive story from our perspective. It will take probably 3-5 years to enroll, a couple of years of follow-up afterwards. We're set expectations on the data release to be about 5-7 years from today. During that time period, we're expecting a net cost of this 2,500 patient trial of about $20 million-$30 million. Again, the reason we're able to keep that cost of a trial that size down is because we're selling these devices to these hospitals because CMS has agreed to cover the cost of the procedure. That will net down the overall cost of this trial. There's been a lot of excitement coming into the year and throughout as you transition onto the Category I CPT code. How has this impacted your reimbursement and overall market availability? Sure. That's an important question, thank you, and an area of great focus over these last 3 years. What I can tell you, one of the things we reaffirmed when I arrived 2 years ago were the sort of fundamental barriers to adoption of this therapy in the market. Each therapy has a slightly different. They're like snowflakes, right? They each have a different set of issues that are slowing or accelerating the adoption when you're introducing something new in medicine. There's a different sort of recipe for each therapy. In our case, our barriers are quite. They're almost motherhood and apple pie. Are physicians aware of where this therapy fits in the treatment of a disease? Number 2, is there enough evidence for enough of the different physician groups for them to be convinced that it's safe and effective? Number 3, most importantly, can patients get access to it, right? Ours are pretty right up the middle. We've been heavily focused for 3 years now, 2 and a half years focused on breaking down those barriers wherever we can. The reimbursement piece, the patient access piece, has probably been the most productive in the last year. We've made tremendous progress both in terms of the codes, the payment and the coverage. Most recently, 2 weeks ago, Humana, perhaps as a result of Category I, which went into effect in January, Humana announced a written policy for our therapy. Humana is the Number 2 largest Medicare Advantage provider out there. They're one of the toughest, and frankly, this was a surprise, a welcome surprise to us, probably 18-24 months sooner than we would have expected. That on top of Category I, which began in January, has really created a tailwind in our business. If we look back at the numbers, I think the Medicare Advantage 30-day approval rate in 2024 was 31%. When we ended 2025, it was 44%. As of the end of April, it was 49%. It's steadily creeping up. I can tell you the exit rate in April was over 60%. Category I is sort of floating all the boats. Humana, which is a very important threshold event for us, has provided an additional tailwind in terms of Medicare Advantage coverage. What the Humana written coverage policy, our first, allows us to do is reference that policy in every single prior authorization that we submit, regardless of payer, to use it in every appeal that we fight, which we fight day in and day out with these payers. Importantly, it allows us to go in terms of coverage discussions, policy discussions, we can reference it with Humana's competitors and say, "Look, the second-largest Medicare Advantage payer is covering this procedure. Why are you not doing so?" That's a really important tool for us as we work on that third barrier, which is probably the most significant for any therapy, and in our case, obviously one we've been very focused on. Maybe we could segue a little bit now into commercialization and further adoption. You talked about a three-pillar approach to overall commercialization. Can you dive into each of these and maybe talk about how you're going into improving rep productivity and territory growth? Sure. As I mentioned, we revised and implemented our next-gen 2.0 go-to-market strategy about 18 months ago, and there were three key areas. Number 1, was getting the right sales team in place, and driving their productivity. Number 2, was understanding the types of accounts that will adopt this therapy in a deep and sustained manner. Moving from a mile wide to as deep as we can get in the right sorts of centers. Number 3, it was working on those three barriers, as I mentioned. To go back to Number 1, we have ultimately transitioned over 70% of our sales team over the last 18 months, and that was necessary because we still had a relatively relationship-driven sales force. Typical for any early startup, we have not yet made that transition, so that's something we've now done. We brought in sales reps. Probably the least common denominator is they understand how to introduce a novel therapy. That's a very different skill set than selling a slightly better pacemaker or a new approach to a procedure that already has reimbursement and access and referral patterns established. We want people that understand how to introduce novel therapies, largely within cardiology, if we can, but in some cases, in other fields. Because it's that process itself that's so important. Then it's a matter of getting them up to speed, teaching them how physicians think about Barostim, where they can create awareness and visibility and leverage in their markets. Each rep, we believe a rep takes between six and 12, sometimes 18 months to get up to speed. That's dependent on their background, their understanding of heart failure, and the status of the territory that they're inheriting. We're still, as Jared Oasheim mentioned, we're still in the process of transitioning some accounts. We inherited a lot of typical early-stage dabblers scattered across the country. We're pulling back on a lot of those dabblers who we don't think will ever adopt this deeply, replacing them with the kinds of centers that we think will in fact adopt the therapy into how they treat the disease. Step one is getting that team up to speed. Step two is understanding the right process in an account to develop the support you need. You need referrers, you need champions, you need surgeons, you need an administrator and a CFO that understands the profitability, which is very attractive for this procedure right there. You need to build the ecosystem at this account of support, then you need to stitch them together with a workflow that says, "Here's what an appropriate patient looks like. Here's who you send them to for evaluation. Here's who the prescribing doc sends them to for an implant. Here's how you make sure that the right patients get treated and get the right outcome." That's part of building the right center. That's number two. Number three, as I've mentioned already, is constantly working on awareness, on evidence, and on patient access. I'll stop there, and we can dig into any of those three. Got it. Yes. Maybe we do dig into the center levels specifically. When you think about overall and peak productivity, how do you frame your current center's performance relative to that? Yeah. We've shared some data over the past few quarters as it relates to our centers. We're in 257 active centers. Kevin noted that some are kind of in this bucket of centers that we want to be active in driving deeper adoption, some are not. We aren't actively firing those centers that don't meet our requirements, but maybe we spend a little bit less time marketing to those types of centers. On the ones where we are trying to drive deeper adoption, we have seen pretty good utilization, where we're now north of one patient per center per month. That's data from Q4 of last year. I think we were doing about 19 patients a year in those top 20% of our centers. Our goal for the entire cohort of centers that are active is to get them treating at least one patient a month, [so] that we can get them to the stage where they're thinking about this therapy on a regular basis. The fact that a fifth of our centers are already at that threshold is a positive story, we want the whole cohort to get there. Even in those centers where we are seeing the deepest adoption of 18 or 19 patients per center per year, we're only about 7% penetrated. There is still a lot of room to run to go out and educate the rest of the referral groups and the nurse practitioners that are helping to treat those patients on a regular basis. As far as the center adds go, we've talked about trying to add a net number of high single digits per quarter throughout 2026. Maybe we're adding seven or eight centers per quarter on a net basis. That includes the ones that are sunsetting, going more than a year without an implant. [But] there will be some choppiness as it relates to those numbers, because it really is dependent on, is that one center who treated a patient a year ago going to come back with a new patient at the last minute and stay alive for another year? Or is the new center that's gotten on contract and ready to start treating patients, did they get the right type of patient that could be treated this month? Or is it going to have to wait till next quarter going through their prior authorization process? We'll see a little bit of choppiness as far as the net number of adds per quarter, averaging around high single digits throughout is the expectation. Got it. The U.S. is still the majority of your revenue base and your focus, maybe we could talk a little bit about international markets and how you think about the overall opportunity there. I would say we were approved in 2014 in Europe for the treatment of hypertension, and we have a heart failure indication there as well. Europe has changed dramatically since that time. We are still active. We have a small team there. We are active in seven or eight markets. But it is not a focus today, just based on the reimbursement challenges in those markets. We do not see it as a viable alternative to investing in the U.S. We are continuing to serve customers. We are growing that business, but it is really more of a holding pattern to some degree until we see further progress on the reimbursement front on patient access in Europe. It is really largely our focus is in the United States, where, as Jared said, we are only beginning to scratch the surface of this indication. Great. Now let us shift focus a little bit more into the business performance and the overall financials. We are roughly six months into the year, and your current guidance is for $63 million-$67 million. You guys beat in the first quarter. How do you think performance has tracked relative to your original expectations so far? This is a year of execution. That is how we framed it up at the beginning of the year when we released this guidance back in early January. In 2025, our annual growth rate was around 9% or 10%. It was the lowest growth that we had seen since commercializing this opportunity. In a large part, it was tied to the fact, like Kevin had mentioned, that we transitioned 70% of that sales force on the U.S. side of the business over the last two years. Now that we reestablished that new team in place in 2024, in 2025, the expectation is more of those reps are going to start working their way up that productivity curve. As we set guidance in 2026, the midpoint of that number was set at 15% the number saw from 2025. Q1 results were closer to 20% growth across the worldwide business. Even greater if you just look at the U.S. side standalone. We were really happy with the performance we saw in the first quarter, but it is one data point, right? Now our expectation is as we go through the year and we continue to repeat that growth of 15%+ in 2026, knowing that our long-term goal is to continue to accelerate into the mid to high 20% as we get into 2027 and beyond. Again, not giving guidance for those out years at this point in time, but we believe this is a massive market opportunity, and we are just scratching the surface. As we bring down those barriers to adoption, like with reimbursement and getting this coverage policy with Humana and seeing our approval rates and prior authorization for the standalone month of April achieve 60% at 30 days, we're happy with the performance we've seen to this point in the year. And. Can I ask just a question on you're talking about this year as a year of execution? I mean, every year is kind of the year of execution. You've got this massive opportunity in front of you. You're at a point in revenue where you're in the sort of build phase of the company. I'm guessing like other early-stage medical device companies, breakeven is probably in the $250 million revenue run rate range. Can you execute this strategy fully effectively as a standalone independent company, or do you need to partner or consider being part of a larger organization? Yeah. Maybe I'll just call out a couple of points in that question. Again, not drawing a line in the sand, I think that is a bit high for what we're modeling for a breakeven point. The way we've described it as a business is trying to get each of these active territories treating about 60 patients a year or generating about $1.8 million in revenue. We're going to continue to add active territories, but to reach breakeven as you continue to improve productivity on a per rep. As far as executing this strategy on a standalone basis, that is very much our intent, right? We have built this business from the ground up, building a commercial sales force, and now it's all about optimizing it and starting to see leverage in this model. As we continue to see these individual reps treat more and more patients in their individual territories, we expect that to come through on the bottom line, helping to reduce that cash burn. From a standalone balance sheet perspective, with $72 million in the bank, we've stated we have at least two years of cash available to us. We could draw an additional up to $40 million from this debt facility, allowing us to have access to three-plus years of cash available today. That being said, it doesn't mean that we won't go raise money at some point in the future. Right. We believe in the opportunity and the ability to grow this business at a faster pace. If the timing is right, we may consider raising capital at some point in the future. The nice thing is, with our balance sheet and access to draw on this debt facility, we don't have to do anything today. You know, maybe I would add as well, to Jared's point, that we believe we can absolutely successfully commercialize this therapy without the need of a much broader team or organization. We have built, we believe, a world-class distribution channel into heart failure. There are very few heart failure-specific channels in our markets. Abbott has one, we have one, but the others are relatively smaller and in their infancy. Our intention. This trial, interestingly, Jared mentioned it triples our addressable market, but it does that by addressing two very adjacent patient populations who are being seen by the same physicians in the same clinics for the same disease. That's patients with slightly elevated ejection fractions, slightly elevated NT-proBNP. We have a really unique opportunity with our given channel to dramatically increase our market opportunity without the need for a different channel or a different call point or a different set of skills. We think we can build critical mass, we can build a world-class team, and as Jared mentioned, we're only now scratching the surface in terms of the patients we can help. As we go down the P&L and thinking about the rising input costs, and we've seen where oil is, we've seen where freight is. How do you guys think about the margin progression through the year? Yeah, it's a great question. Obviously exceeding expectations in Q1 compared to our annual guidance was a positive story, and it was done twofold, right? By seeing higher than expected average selling prices and being able to drop that cost per unit. We actually produce the device at our office in Minneapolis, Minnesota. We have very clear visibility as to the overall cost structure of each of these units. We know we have additional capacity to be able to expand how many units we're building on an annual basis, which should help drive that overall cost per unit down as well. From a gross margin perspective, that range of 85%-87% on the year, we still believe is just a starting point. There are opportunities to see improvements in that number in the coming years as we continue to produce more and more units to drive those costs down. On the spend side of the house, so much of our spend goes into headcount today, and it really is in those early reps that are getting up to speed, where we're spending money, but not necessarily seeing the full productivity out of them. As they get more tenure and get up that productivity curve, that's where we see the most leverage coming within our model today to bring that overall cash burn and loss down moving forward. Great. With the minute we have left, Kevin, maybe I turn it back to you for any closing remarks and make sure you really are able to send the clear message as to what you hope that investors and the audience really are capturing here. Yeah. Thank you. We obviously, we're operating in a largely historic pharma market, one of the last massive markets that has limited device exposure. There are millions and millions of patients who can benefit from medical devices. We believe hundreds of thousands from Barostim therapy specifically. We think we have all the necessary components to both serve those patients and create significant value. Highly differentiated therapy, obviously clear safety record, solid quality-of-life data, and more and more data now on hospitalization that suggests that this could be a very meaningful alternative for these patients who are sitting home, the forgotten middle, that are home on these medications or not, and suffering. We've got the right team. We think we have the right strategy. We've got the capital we need. It's our intention to put our heads down. As Jared said, this is the year of execution and to build this business and build from this new foundation we've created to serve these patients and create significant value. Great. Well, that's all the time we have for now. Thank you all for coming. You're welcome. Thank you. Jared, good luck on your next role. Thank you.