Good afternoon, everyone. I'm Robbie Marcus, the MedTech analyst at JPMorgan. I'm very happy to introduce CEO of CVRx, Kevin Hykes, our next speaker. Kevin will do a presentation followed by some Q&A.
Thank you, Robbie. Good afternoon. It's my pleasure to present to you today on behalf of CVRx. These are our forward-looking statements. Additional risk factors are available on our website. So CVRx has developed the world's first neuromodulation therapy for the treatment of heart failure symptoms. It represents a $2.2 billion market opportunity on an annual basis in a well-defined patient population who have limited treatment options. Barostim therapy is a highly differentiated therapy with a compelling safety profile and a remarkable responder rate. And as I'll show you a little later today, we believe we have a plan that will allow us to move Barostim therapy to standard of care for the treatment in this population. Heart failure is a burdensome, life-limiting disease that affects over 6 million Americans.
It results in over a million hospital discharges, a million emergency room visits, more than eight million physician office visits each year, and will contribute $70 billion in health care costs by the end of the decade. Heart failure is a progressive disease that's characterized by a steady decline in quality of life and punctuated by increasingly frequent hospitalizations. It's also a disease for which there are limited treatment options today. Early-stage heart failure therapy involves a combination of four medications, commonly called quad therapy. As the disease progresses, a small percentage of patients are eligible for cardiac resynchronization therapy, or CRT. Towards the end of their disease journey, 2% of patients receive an LVAD, a left ventricular assist device, or cardiac transplantation. Unfortunately, the other 98% do not. Heart failure drug therapies have been shown to improve survival.
A combination of these four drugs has been shown to improve survival between one and six years. However, very few patients are on all four of these medications at therapeutic doses. Furthermore, 30%-40% of patients discontinue their drug therapy at the end of the first year. While these drugs can improve survival, if they're taken consistently, they have very minimal impact on quality of life. What you see on the slide on the left in the gray is a meta-analysis of 29 studies showing these four drugs, plus ACE inhibitors, and their impact on exercise tolerance, which is a common surrogate for quality of life in this population. You see very limited single-digit improvement in exercise tolerance in this population. In the blue, you see the significant improvement in exercise tolerance as a result of CRT.
But again, only 30% of patients are eligible for that therapy. And of those that receive the therapy, 25% do not respond. So this leaves the majority of heart failure patients suffering significantly diminished quality of life. And one large study estimated that 66% of these patients have mobility issues. 76% find the activities of daily living to be difficult. 68% report pain. And multiple studies now have shown that these patients consistently suggest they would trade off longevity in exchange for quality of life. They're miserable. They don't want to live any longer. They want to live better. So this is the population that Barostim therapy addresses. The heart failure community calls them the forgotten middle or the walking wounded. This is the indication for Barostim therapy, Class II and III heart failure on optimal medication, but suffering from the symptoms of the disease.
This indication leads to a $2.2 billion net addressable market on an annual basis alone. And it's important to note that as of today, we are less than 2% penetrated into that annual incidence pool. So turning to the therapy itself, Barostim is comprised of three components. The first is an implantable pulse generator, a pacemaker-like device with a battery life of about six years that's implanted just below the skin, typically on the right side of the chest. The electrical impulses are carried to the carotid baroreceptors by a lead, and there's an external programmer that's used to adjust the system settings. The system is implanted in a 60-minute procedure, typically on an outpatient basis, but in some cases inpatient as well. It requires a small incision in the neck and in the chest. And importantly, it's entirely extravascular.
There is nothing in the blood vessels or in the heart, which leads to a remarkable 97% freedom from complications. Heart failure symptoms and the disease progression are driven by the body's natural fight or flight response. Heart failure starts with a weakened heart muscle, which results in decreased pumping function. This decrease in pumping function results in decreased signaling from the body's natural pressure sensor, the baroreceptor, to the brain. The brain interprets those decreased signals as a cardiovascular crisis. It interprets it as hemorrhage or severe dehydration. And as a result, it activates the body's fight or flight response, which involves a significant increase in sympathetic nerve activity, effectively jamming on the accelerator and the release of powerful neurohormones into the bloodstream in an attempt to rescue the body in this crisis.
Chronic exposure to these circulating neurohormones is toxic to the heart, the kidneys, and the vasculature. And that exposure over time is what causes heart failure symptoms and what causes the progression of the disease. Today's drug therapies work by blocking these excess neurohormones. It's called neurohormonal receptor blockade, and it attempts to shield your heart and kidneys and vasculature from the toxic effects of these hormones. Barostim acts on that same mechanism upstream by restoring signaling to the brain, effectively telling the brain that the crisis has abated and causing the fight or flight response to be reduced. Barostim has been proven to be an effective, predictable, and durable therapy to improve the quality of life in these patients. At two years, the BeAT-HF post-market trial showed a two-times clinically meaningful improvement in exercise capacity and quality of life.
68% of patients improved by at least one New York Heart Association class, and a remarkable 94% of patients had a clinically meaningful response to the therapy. So to put that in perspective, Barostim offers a quality of life improvement that's comparable to that of CRT, but for the 70% of these patients who are not eligible for CRT. The BeAT-HF trial also showed a positive signal for all-cause mortality and a significant reduction in serious cardiovascular events. However, as with many trials that were underway in 2020, the COVID-19 pandemic significantly impacted our ability to test our hypotheses in the BeAT-HF trial. While we showed positive signals for mortality and morbidity, those were not yet statistically significant. Interestingly, a growing body of evidence free from the confounding impact of the COVID-19 pandemic suggests a significant and consistent effect of this therapy on hospitalizations.
What you see on the left side of this slide is pre-COVID data from our phase II trial, HOPE4HF, that shows a five-fold decrease in hospitalizations in the same patients six months before and after receiving our therapy. Several months ago, the first post-COVID data set was published by USC and showed a remarkably similar decrease, five-fold, in patients at one year after receiving Barostim therapy. This was, interestingly, a small data set that represented only those USC patients who were optimally medically managed. In fact, perhaps the hardest patients in which we could show an impact. So we were quite intrigued by this data. We are committed to leveraging a number of emerging real-world evidence data sources to try to further explore this potentially significant impact, which we think will be of great interest to the payer community.
We intend to publish the first results of some of that work in early February at the THT meeting in Boston and are looking forward to further exploring this potential very significant development. So turning to our commercial strategy, our revised go-to-market strategy is really focused on driving Barostim to standard of care. And there are three key elements of that strategy. The first relates to building a world-class sales organization. The second is really focusing on developing deep adoption, perhaps in a narrower group of centers, but with much more sustained and significant adoption levels. And the third is addressing the fundamental barriers to adoption for the therapy that exists in the market. On the organizational front, we're building a world-class sales team comprised of individuals that understand new therapy introduction and medical devices.
This has not always been the hallmark of our hiring processes in sales, but we increasingly believe that those program-building skills are critical to our ability to reach standard of care. We're improving our onboarding and training programs to help these reps be as effective as possible, as quickly as possible. And this year, we will begin to align sales compensation around desired behaviors that will drive this deep adoption in the market. As it relates to going much deeper in these centers, it starts with picking the right centers. And we have studied our early results in the commercialization phase and concluded that there are a certain group of centers that are of most interest to us today.
And if you think about the 5,000 centers in the United States that could implant this device represented by that cube, there are two or three hundred represented by the blue area that have three characteristics that we think are particularly applicable for this therapy. The first, perhaps not surprisingly, is a large volume of heart failure patients. That can be said about many, many centers in the United States. But importantly, the second is evidence of their adoption of some of the novel heart failure diagnostic devices that have been introduced in recent years, most notably the Abbott CardioMEMS device. Those are really the only device predicates in this population. And their adoption signals to us that these are heart failure teams that are thinking pragmatically about leveraging technology to better manage this disease.
Third, we're focused on centers that have a history of the successful adoption of cardiovascular therapies and the building of programs to build out their cardiovascular service lines. So our efforts will increasingly focus on accounts that fall into that blue box. In those accounts, we will seek to replicate the elements that we see present in our most successful Barostim programs today. This is effectively a map of what good looks like, and it involves not just a single clinical champion supporting the adoption of the therapy, but a clinical champion that has an administrative partner, a business person that understands the potential positive impact of this procedure on their cardiovascular service line, effectively providing air cover from an administrative level.
On the ground, it means a network of referrers in the community made up perhaps of heart failure physicians, electrophysiologists, interventional cardiologists, nurse practitioners, and APPs that follow these patients. It's not just a single physician championing this, but a network of physicians in the community where the bulk of our patients are being followed today, referring patients into that center and referring them into not one prescriber, but multiple prescribers who are working with not one implanter, but multiple surgeon partners. When we see these elements in place, this ecosystem, it's a signal that our therapy has been adopted and integrated into their treatment continuum and has become part of how they treat the disease, and that's an important precursor to reaching standard of care.
In the coming year, we will increasingly compensate our sales team on the consistency of implants at these centers, on the number of referrers that exist, on the number of prescribers to really try to drive behaviors that will build these sustainable ecosystems in each and every center. Finally, we'll continue to chip away at what we believe are the three most significant barriers to the adoption of this therapy in the market. We've covered these before in the past year, but it's therapy awareness, clinical evidence, and patient access. In the first instance, we will invest significantly in 2025 to drive awareness of this therapy at the referrer level. That involves expanded regional medical education programs focused on heart failure, EP, and general cards in the community.
It involves the launch of a new series of programs targeting the heart failure nurses that bear the brunt of managing these patients on a day-in and out basis. And finally, we've recently launched what we believe is the only industry-sponsored heart failure fellowship program that helps new heart failure specialist graduates understand the role of new technologies as they start their practices. Second, we remain committed to developing a steady cadence of publications on the evidence that supports this therapy in two key areas. The first is evidence supporting the mechanism of action, so further describing and proving the physiologic underpinnings of this therapy and why it has such a dramatic impact on patient symptoms.
The other area is obviously clinical outcomes, not just quality of life and exercise capacity or heart failure hospitalization, but some of the secondary, but very important clinical outcomes, such as the reduction of arrhythmias, improvement in cardiac ejection fraction, or decreased diuretic needs. We'll source this data from a variety of internal and external data sets, including our randomized control data, our very robust Barostim Investigator-Initiated Research Program , our multiple registries, such as REBALANCE and BiRD, and again, importantly, real-world evidence data sets. Finally, and I'm pleased to say we made significant progress in the area of patient access in 2024 with three very important milestones in the second half of the year. The first was the establishment of a permanent inpatient payment and the doubling of reimbursement for this procedure when performed in that setting to $43,000.
The second milestone was the successful defense for the second year in a row of the $45,000 outpatient reimbursement for this procedure. We believe that eventually we will prevail at establishing a permanent Level 6 code at that level as we build greater and greater evidence supporting the need for that code. Finally, in October, we achieved approval of our Category I Permanent Procedure Code from the AMA, which is perhaps the most important of these three milestones. It signals to the community and the payers and the clinicians that this is no longer an experimental therapy and that we will no longer be a Category III procedure, which accompanies an automatic denial from most payers, but will have a permanent Category I code. And that affects almost every facet of our business over the long term.
Turning to the financials, in 2024, we reported this week worldwide revenue in the range of $51.1 million-$51.2 million, or a 30% growth rate. Q4 worldwide revenue of $15.2 million-$15.3 million, or a 35% growth rate, and Q4 U.S. heart failure revenue of $14.2 million-$14.3 million, or roughly a 40% growth rate. We increased our U.S. territories by 3- 48 and increased our active implanting centers by a net of 15- 223 and finished the quarter with $105.9 million on the balance sheet. That impressive revenue performance led to a 71% growth rate since the inception of this therapy in 2020. In 2025, for the full year, we expect total revenue between $63 and $65 million, gross margins between 83% and 84%, and operating expenses between $100 and $104 million.
For the first quarter of 2025, we expect total revenue between $14.5 and $15 million. So in closing, we've spent 2024 building a strong foundation for the continued growth of this business. We have significantly strengthened our executive and commercial teams. We've implemented a market development and commercial strategy focused on driving this therapy to standard of care. And we've expanded the body of clinical evidence, including the publication of our impressive 24-month quality of life data. Finally, we secured fundamental improvements across a number of key aspects of reimbursement and patient access. So in closing, I hope you can sense my enthusiasm for this opportunity as I approach my one-year anniversary with the company. I'm thrilled at what I found. It exceeded my expectations coming into this role.
I'm proud of the team we built and the strategies we have in place and the number of patients whose lives we've been able to very favorably impact. I'm looking forward to continuing this story as we move forward. Thank you.
Well, great. Just shy of the 12-month mark here. I think you started in February of 2024. I think it'd be good just to get a recap of your first year, what you were able to do as CEO, come in, what were your priority action items, and how you feel about the company going into 2025.
Yeah, thank you. So it's been quite a year. It's not the first instance in my case having come into a company just finishing their first commercial experience and transitioning into their second chapter. So a lot of familiar themes for me, but it really came down, not surprisingly, to getting the right team in place, the right executive team, the right sales leadership, the right sales director-level leadership, and really trying to understand the skill sets we need going forward to tackle this challenge in the market and grow the therapy to standard of care. The second came to establishing the right approach to the market, understanding the barriers, understanding how you create and drive and measure and incentivize deep adoption. And the third was addressing a number of these very important patient access issues and delivering some significant milestones on the way towards full coverage for this therapy.
So, nothing terribly surprising, lots of hard work, a remarkable team, but few therapies I've had the opportunity to do this multiple times, few have the size of market opportunity that this one does, $2.2 billion, with a therapy that's this highly differentiated and a need that is this significantly underserved.
So, I'm excited at what we're able to do and the opportunity to move this business forward. So, when you came in, what did you find was the most common reason that centers and physicians weren't adopting Barostim? And what are you doing to help address that?
So, I think we were not always talking to the right centers. As is often the case with an early-stage therapy, we were talking to anyone that would listen, right?
And we were relying on relationships and history and some luck and some favors to try to grow this business from scratch. That's always the case. I think as we've learned more, we understand now that the centers like those I described with that three-dimensional cube, large population, a commitment to using new technology in heart failure, and success at an institutional level, leveraging technology, those are really the key factors. Those are the necessary ingredients for the kinds of centers that adopt a therapy like this deeply and make it part of what they do, not just something they do once in a while because somebody reminds them. So that's really probably the biggest, not a surprise, but discovery. We also really now understand the barriers that exist for this therapy. They're different for each and every therapy.
Thankfully, it's not the requirement that we connect two physicians that never talk to each other or don't know each other. It's not the responder rates. It's not the complication rates. It's really some fundamental stuff around, are you aware how this should fit into the way you treat heart failure? Number two, do we have the evidence that you need to feel comfortable prescribing this therapy? And number three, can we help you and your patients get covered? And so are you brave enough to talk to someone about this therapy and comfortable enough that they will get it covered and be able to benefit? So those are three sort of fundamentals, but it's really grinding away at those three barriers consistently.
Great. I want to touch on coding and coverage, but first I want to talk about the quarter and the guide. Came in better than the street on fourth quarter. Maybe speak to the trends you saw, anything one-time in the quarter and how you think it went.
Yeah, I'll be happy to answer that one, Robbie. So I think for the quarter, we came in just above consensus, above the midpoint of the range. I think we saw pretty consistent performance throughout the quarter. No major surprises as we went through. We did see a few more centers added in than what were expected. I think coming into the quarter, we were initially expecting high single-digit, low double-digit net adds. We were able to land at +1 5 new centers treating their first patient in the quarter on a net basis. I think part of that is twofold.
Number one, we're still looking at the types of centers that we want to continue working with on a go-forward basis, as Kevin mentioned, really focused in on those centers in the blue cube. So making sure that the ones we're adding are cut from that cloth. But I also think we have some of these smaller centers that treated one patient maybe 10, 11, 12 months ago and making active decisions to sunset those centers, maybe spend a little bit less time focused on them and more time focused on these newer centers that could provide much more help for patients in larger quantities as we move forward. So as we look back on Q4, probably got a few more centers than were expected. We were able to consistently add another three territories.
There's reps that are fully ramped up in the quarter, so that was kind of on par or on expectation. And then it's just about utilization, revenue units per center. And I think that number came in just slightly above what was expected coming into the fourth quarter.
It feels like that's the biggest lever in the model. If you can get utilization up, that's where you start to see multiples of the growth if centers do one, two, three more per month. So what's the focus there that CVRx is really placing in it? Anything you could do to really help move that higher in a more substantial way than we've been seeing?
Yeah, let me start with that. Yeah, and it's a great question. You're right. So utilization is really the driver here. We're less than 2% penetrated today in the annual incidence pool alone. So it's the things I had described. It's choosing the right centers that can and will adopt this and use it not just once a month or once a quarter, but every single week. It's the muscle memory that comes from building this into the way they treat the disease and that makes it just part of their disease algorithm. And it happens automatically like a flywheel. The more centers that we can choose correctly and start correctly and build that ecosystem, the more we can rely on utilization on a consistent basis to drive the business.
If you look at your user base and you segment it, however you do, quartiles, quintiles, how big is the dispersion between the top and the bottom?
You want to take that?
Yeah, it's a good question. There is quite a range, right? And I think part of this comes back to learning in this first chapter, as Kevin mentioned. We had a lot of centers that were added over the first four years of commercialization of this product. I think as we now look back, we are understanding which centers had the possibility to treat more and more patients over time and what activities actually drove to seeing more productivity or more utilization at those centers. We're now learning from those centers and starting to apply those to, number one, the types of centers we're going after, but number two, the activities that are necessary to really drive that adoption moving forward.
So, I think we've seen quite a range as far as the amount of productivity happening at each center, but I think now it's trying to learn from those top centers, the ones who had treated the most patients, and apply those same learnings to those other centers where they have the potential. And if maybe they don't have the potential, maybe spending a little less time at some of those centers and more time focused on those ones that do have the higher potential.
Kevin, you said it's the muscle memory. We want to make this the muscle memory. Is that a comment related to the referring cardiologist, to the implantor? It seems like there's one option really for these patients. So it shouldn't have to be a muscle memory. It should be the go-to. I guess, how do you get from the point here where you're doing $15 million a quarter to $150 million, $1.5 billion, whatever, you know what I mean? How do you take it from it doesn't have to be muscle memory. It's just the first thing people think of.
I would say those two are synonymous in my mind. It's a great question. It is the introduction of a novel therapy. As our Chief Medical Officer describes it, you're trained as a specialist in this country in medicine under an apprenticeship model. You're taught a certain way to manage a disease. That's your personal algorithm. Getting someone to change that is a little bit like getting them to change their religion, right? It's a big deal.
And different physicians, based on their degree of conservatism, need different amounts of data or conviction or confidence in payer behavior to adopt this therapy. And so what we believe is that whether it's a referrer or a prescriber, a heart failure specialist, they need to feel like, "I have enough evidence here that I know this works in this population. I have enough confidence that it'll be paid for. I understand where this fits in the context of my own disease algorithm." If we can get them comfortable with those things, it just begins to happen. And maybe muscle memory is not the right word, but it's almost automatic. It's how they consider, "I have a class two patient who's stable, on meds, and miserable. Barostim is the right answer for them." And that should just sort of happen. Yeah, that's the goal. That's what good looks like.
I would just add to it too. I think the goal for us internally as a company is to get each one of these centers treating at least one patient a month. We want to see that level of consistency at each one of these centers. We know there's dozens, if not hundreds, of these patients that are eligible for Barostim at each one of those centers in that blue box. We want to get at least to a level where we're treating one patient a month so that physicians are thinking about this on a regular basis, that the administration is understanding the impact that it could have to their hospitals and their patients, and then so that we can see more and more patients coming through those centers.
I think as we look to the guide that we had for 2025, the utilization numbers assumed in there are not even at that level. So right now, we have about two revenue units or 2.1 revenue units per center per quarter. And as we go through 2025, our expectation is that we would continue to add high single-digit to low double-digit accounts on a quarterly basis. And you don't need to see significant movement in that utilization to hit the guide that's baked into 2025. Our hope is that by implementing this new go-to-market strategy and the efforts internally, that we're able to start driving that utilization to see that growth rate pick up again in the future.
The other component, units times price equals sales. Let's talk about price here. And for reimbursement, 2024 was a pretty important year for the company. You had the Category I CPT code finalized, which maintained the NTAP pricing that you had, about $43,000 versus $23,000 prior. Maybe just walk us through the impact you're seeing of stable reimbursement here and how that's helping or not really helping the business and the uplift of adoption.
Want me to start on that?
Yeah.
It's a great question, so I think what we saw, so for the first time since October 1st, our inpatient permanent rate went from $23,000- $45,000, $43,000. Outpatient is now $45,000 and has been $45,000. So for the first time, they're equal, which takes economics off the table, and it allows physicians to treat patients where it makes the most sense clinically. In the past, there's probably been some disincentive to an inpatient treatment because it was done at a loss.
They were being paid $17,000-$20,000 for a device that in and of itself costs $31,000. And so that's not a winning proposition. So we're excited to see how this will now level out once economics have been taken off the table. So that's one important element. Obviously, the Category I code gives physicians a sense of confidence and will result in a more predictable prior authorization process. That's a net positive, right? It's not a threshold event, but it's, again, part of reducing the friction and building the confidence in the minds of the referrers and the prescribers that this is something that's here to stay and it's going to get easier and easier to get access to.
So just to address the ASP portion of that question, so I think understanding that reimbursement being stable going into 2025, the guide is assuming that we would continue to see U.S. ASPs in the $30,000-$31,000 range, knowing that the reimbursement to the hospital is in that range, as Kevin mentioned, on average $43,000-$45,000.
Any anticipated changes in 2026 or beyond, or are these rates in a fairly stable final position?
Yeah, good question. So just to address the outpatient proposed rule that we saw this last year. So for anyone who was following the story, I think they were surprised. I think we were a little bit surprised by Medicare or CMS coming out with a proposed rule in July suggesting to move us to a Level 5 neurostim code out of our New Tech APC that would have resulted in the reimbursement to the hospitals dropping from approximately $45,000- $30,000 in an outpatient setting.
I think as we go into the proposed rule for 2026, which would be announced in July of 2025, we have really high confidence that we're either going to land in a situation where we are going to see a proposed rule to create a Level 6 neurostim code, which we would expect to reimburse at about the same rate as our new technology or new tech APC of $45,000, or that we would stay in the New Tech APC for 2026 because there's been precedent of other companies like us staying in that code for multiple years beyond the two years that we're already there. So I think we have a little bit more confidence that we'll be in a good position going into 2026 to support us maintaining these ASPs.
I think the nice thing is with the inpatient rule that came and took effect this past October, there is a bit of a safety valve in place, a little different than what we were dealing with last July when we saw that proposed rule come forward, because you could still see a bit of a shift in where patients are being treated, either inpatient or outpatient, if CMS would come down and say, "We have to stay in a Level 5 neurostim code for 2026."
First quarter guidance came in $14,500,000-$15,000,000. Street was at $14,000,000. Anything to point out in first quarter? And I had to think about the cadence of sales through the rest of the year.
Yeah, I think we tried to allude to the fact that we would expect to see seasonality in the move from Q4- Q1, seeing sequentially flat revenue levels. I think it's based on what we've looked at other companies that reached this run rate, that you start to see a bit of a flat revenue level moving from Q4- Q1 as you move from one fiscal year over to the next. Our expectation is that we would see that seasonality, see kind of a flat quarter from Q4- Q1, but then see growth off of that point to be able to hit the rest of the guide for the year.
We've seen some companies, especially since the pandemic, have sharper seasonality down in third quarter and then back up in fourth quarter, and it's been holding pretty much for the past few years. Is that a good way to think about as we model?
Yeah, it's a good question. It's not something that we've experienced at this point. As we mentioned, we're seeing about two revenue units per center per quarter, so one or two every quarter. If we see docs who take vacations in the month of August, there is room to make up for that level of revenue units at each one of these centers on average. So we don't expect to see as much seasonality hitting us at this point in the third quarter.
Maybe we can move down the P&L. I forget, about $100 million. Correct me on the exact numbers. For 2024, OpEx, yep. And 2025, you guided, I think.
$100 million-$104 million.
Thank you.
Yep.
Close at $100. Yeah. Which is obviously a lot higher than the revenue. So how are you thinking about the drive towards breakeven and ultimately profitability? Is the OpEx base in the right spot to support a much higher revenue base? Does the OpEx base have to shrink further? Is it a combination of both? How do we think about the drive towards breakeven? And if you're going to venture a timeframe for us, we'd be happy.
Yeah, it's a great question. I think the first step is kind of understanding what we were spending money on coming into 2024 versus where we're intending to spend money as we go into 2025. As we looked at some of the projects where we were investing some money, we decided to pull back in certain areas, including in some of our spend that was going on outside of the U.S. in trying to commercialize this business in Europe as well.
We've right-sized some of that spending coming into the fourth quarter and setting us up, I think, to a certain level where we don't need to see significant increases in OpEx in 2025 compared to 2024 to deliver pretty healthy growth on that top line. I think as we move forward, our expectation is that we're going to continue to invest in this business. The vast majority of that investment is going to be into the sales and marketing organization, specifically focused on the U.S. side of the business, but also in clinical evidence. We think that by going and continuing to gather more and more evidence, that we're going to bring more doctors to the table to start to treat more and more patients.
We think that that's going to pay off by looking at as a result of that, we would continue to see growth rates top line of mid- to high-20% longer term.
How should we think about the cash burn in 2025 and just remind us where you stand in cash?
Yep. So we have $106 million of cash in the bank at the end of 2024. Our expectation is that the cash burn rates would come down from 2024 into 2025. So I think in 2024, we burned around $40 million. We expect to burn less than that in 2025. We believe we have enough cash to get to the breakeven point with $106 million left in the bank. And as an example, I think our fourth quarter cash burn number came down to about $8 million. So we're trending in the right direction. We expect that to continue as we move forward.
What about international? The typical playbook is get to scale in the U.S. You have a great technology. Move outside the U.S. once you have reimbursement. What's the thought process on moving outside the U.S. at this point?
Yeah, that's a great question. So we are sort of treading water, holding position in Europe right now with a relatively small business as we assess with actually a fresh set of executives what the barriers are to the adoption of the therapy there. Obviously, much higher reimbursement challenges than we have in this country. And so I think we will continue to study that. We'll maintain our presence there. We've invested in regulatory approvals and a small infrastructure on the ground. But for the moment, the opportunity in the U.S. is so much more accessible and compelling. I don't see us significantly increasing investing in Europe until we see some of those barriers start to fall.
Got it. What about on the competition side? Do you see anything on the horizon that could encroach on you or you're worried about?
Yeah. So that's a great question. I think at this stage, we are in a position where whether it's shunts or Impulse Dynamics, they're sort of floating all the boats. There is no history or very little history of therapeutic device use in this population. So each of these new ideas is helping raise the profile and change the paradigm historically that it's a medication-only population or disease state. So in the short term, we think we probably benefit from some of these companies and their work on developing additional device therapies.
We would say our therapy, we believe, is the only one that builds upon the fundamental basis of heart failure progression, that complicated diagram I showed earlier, and is likely very complementary to drug therapy today. So there are potential to include some of these new emerging approaches with ours along with drug therapy. We think as well, our focus on the disease manager, on the heart failure specialist, not necessarily the surgeon or the EP, we're focusing on the people that manage this disease. And if we are going to move this therapy into the mainstream and get it to standard of care, that starts with the heart failure community and the people that manage heart failure day in and day out.
So we'll watch with interest what occurs on the competitive front, but right now, I think it probably helps us more than it scares us or scares anyone.
Well, great. I think that's a perfect place to leave it. We're about out of time. Thank you for a great discussion, and thank you everybody for attending.