CVRx at Canaccord Genuity’s Conference: Strategic Shifts in Focus

On Tuesday, 12 August 2025, CVRx Inc (NASDAQ:CVRX) presented at Canaccord Genuity’s 45th Annual Growth Conference, highlighting both the challenges and opportunities in their strategic approach. The company discussed its innovative Barostim therapy for heart failure, addressing a $2.2 billion market with significant unmet needs. While the company is optimistic about its future, it is also navigating the complexities of sales force transformation and market penetration.

Key Takeaways

• CVRx is targeting a $2.2 billion annual market with its Barostim therapy for heart failure.
• The company has experienced a 41% turnover in its sales force, affecting short-term productivity.
• Financial guidance for 2025 is set between $55 million and $57 million in revenue.
• The company has $95 million in cash reserves, sufficient for at least three years.
• CVRx is planning a large clinical trial for indication expansion with the FDA.

Financial Results

CVRx narrowed its full-year revenue guidance to between $55 million and $57 million. The company maintains a strong cash position with $95 million in reserves, projected to last for at least three years. In the last quarter, CVRx reported a cash burn of approximately $8 million. The gross margin remains steady at around 84%, with US average selling prices at approximately $31,000 per device. Notably, real-world evidence indicates an 85% reduction in hospitalization for Barostim patients one year before and two years after implant.

Operational Updates

CVRx has undergone significant changes in its sales force, with 41% of quota-carrying representatives joining since the start of the year. This transition has been disruptive, but the company believes the foundational changes are complete. The team size has been reduced from 12 to 7 direct reports. CVRx has achieved a permanent inpatient payment of $43,000 and a category one code with a physician payment of $553 starting January 1st. The company’s manufacturing facility currently has a capacity of 2,000 systems per year, with potential expansion to 5,000 systems per shift annually.

Future Outlook

CVRx is working with the FDA on designing a clinical trial for indication expansion, which may involve 1,000 to 2,000 patients and focus on morbidity and mortality endpoints. The trial is expected to take 5 to 7 years to complete, with costs estimated between $20 million and $25 million. The company is optimizing its market segmentation strategy to include selective tier three and tier four accounts. Improving the productivity of the new sales team is a priority for the next quarter or two.

Q&A Highlights

During the Q&A session, CVRx reported sequential US growth in Q2 and a 15% year-over-year increase in heart failure revenue. The company acknowledged current sales force productivity challenges but expects improvements soon. CVRx also discussed the difficulties of penetrating large academic medical centers, opting instead to target satellite facilities. The company is advocating for a level six reimbursement code, potentially at $45,000, and views the physician payment of $553 as a necessary step to secure payments.

For the full conference call transcript, please refer to the detailed document below.

Full transcript - Canaccord Genuity’s 45th Annual Growth Conference:

Bill Plovanek, Senior Medical Device Analyst, Canaccord: Good afternoon. My name is Bill Plovanek. I’m a senior medical device analyst here with Canaccord. Welcome to our forty fifth annual growth conference. With us next, we have the management team of CVRX.

Kevin Heics, president and CEO, and Jared Oshheim, CFO. We’re gonna have a fire a short presentation followed by a fireside chat. With that, I’ll hand it over to Kevin.

Kevin Heics, President and CEO, CVRx: Okay. Thank you, Bill. I appreciate the chance to a little more about CVRx with you today. So CVRx has, pioneered the world’s first neuromodulation therapy for the treatment of a cardiovascular disease. We have a $2,200,000,000 annual TAM and a well defined patient population and few competitors and a very needy population that can significantly benefit from our therapy.

Heart failure, as you as you likely know, is a burdensome disease, a significant condition in The United States and other developed markets. It results in The US in about a million hospital discharges, one point three million emergency room visits, eight million physician office visits, and about 70,000,000,000 in spending by the end of this decade each year. It is also a condition that is progressive and characterized by an increasing decline in the quality of life of these patients and increasingly frequent hospitalizations. When patients are first diagnosed with heart failure, they’re started on guideline directed medical therapy, which consists of four drugs, otherwise known as quad therapy. A small percentage of them are also evaluated for something called cardiac resynchronization therapy or CRT.

I’ll talk about that in a minute. At the end of their journey, a lucky two percent of these patients received a left ventricular assist device or a transplant. But in the intervening five to ten years, they are largely home on these medications or not and suffering from increasing debilitating symptoms associated with the disease. The quad therapy drugs, when taken consistently and compliantly, can extend life by one to six years. However, only one percent of patients ever reach the maximal tolerated therapeutic dose on the four drugs, and at the end of the first year, forty percent have discontinued at least one of these drugs.

Despite the ability to extend life, these drugs also have very little impact on quality of life. This slide represents a meta analysis of 18 studies, that show these four drugs and show a very modest improvement at best in exercise tolerance, which is the common surrogate for quality of life in this population. CRT, which I mentioned earlier, can both improve survival and quality of life, but only thirty percent of patients are eligible, and of those that receive the therapy, thirty percent fail to respond. So this leaves a very significant percent of the heart failure population suffering from debilitating symptoms to such a degree that multiple studies now in this population have demonstrated that these patients would gladly give up years of longevity for an improvement in their symptoms. They don’t want their death delayed.

They want to live a better life. So those are the patients that we address with Barostim therapy. Those are the patients that the physicians call the walking wounded or the forgotten middle, and Barostim is indicated in that population. Importantly, in December, for the first time, the Heart Failure Society of America, which is the most influential physician society that deals with heart failure and one that’s typically very pharma driven, addressed the thirty year old paradigm of treating this disease with drugs alone. And they issued a consensus statement published in December in the Journal of Cardiac Failure that said, if after three to six months on optimal medical therapy, the patient is still symptomatic, you need to consider device therapy.

That’s a very important step in breaking this paradigm that has existed since the start of these drug therapies. Our indication results in a net annual indicated population representing $2,200,000,000 that is currently less than two percent penetrated. So a little bit about the device and the therapy. What you see here is the device. It’s very pacemaker like.

It has a single lead that’s sutured onto the carotid baroreceptor, typically on an outpatient patient basis, but in some cases inpatient as well. Requires a very small incision in the neck and a second incision in the chest for the implantation of the generator. And most importantly, this is an entirely extravascular procedure. Some of our surgeon implanters call it bloodless, and so it’s a very simple forty five minute procedure. The the the complication rates are quite low, ninety seven percent freedom from significant events.

So it’s a very safe, effective, and predictable procedure for the surgeons. And our 24 data presented in the BEAT HF trial and published last year demonstrated durable and predictable quality of life benefits in this population, showing two times the clinically meaningful improvement in exercise capacity and quality of life, a 68% improvement in NYHA functional class, and a remarkable 94 responder rate in this population. To put this in perspective, the quality of life improvement with Barostim therapy is roughly triple that of the best of the drug therapies and and exceeds even that of CRT. So this is a significant improvement in what these patients experience. Importantly, the BEAT HF trial also showed a positive signal for the reduction in all cause death, LVAD, and transplant out past four years.

Unfortunately, due to COVID, this was not statistically significant, but it was an important signal to us that this therapy has a material impact on those hard endpoints. Also, importantly, in February, we published data on three hundred and six Barrostim patients from the premier health care outcomes database, one of the largest real world evidence databases in The United States. It represents 1,300 hospitals, and we showed that with one year prior to implant and two years post implant, an eighty five percent reduction in hospitalization in this population. So a dramatic and statistically very significant result and one that corroborated multiple independent small center studies that had been performed both before and after COVID. So this is a big step forward, and as you can imagine, this is of great interest to the payer community because of the cost of these hospitalizations.

When I joined the company eighteen months ago, my primary focus was and is now today the optimization of our go to market strategy, and that strategy has three key components. The first is building a world class program development sales organization. The second is going deeper in the adoption of this therapy and creating sustainable BarrelStim programs versus a wider approach. And third, it’s a systematic attack on the three main barriers to the adoption of this therapy in the market, those being awareness, evidence, and patient access. I’d like to focus on two of those before we go to q and a that were of great interest in our recent earnings calls.

The first relates to our necessary transformation of the sales team, and that is to bring in a team that are versed in novel therapy introduction and program building, the very skills we need to build a sustainable, predictable long term business. As a result of that necessary transformation, we’ve turned over a significant amount of our sales force. 41% of today’s quota carrying reps have joined us since the first of this year. So that’s significant, and it’s obviously had a disruptive effect on our business. Thankfully, that transition is now largely behind us, and our efforts are moving from hiring and attracting world class talent to onboarding and training and getting that team up to speed as quickly as possible.

Second area of significant discussion is in the reimbursement front, and we’ve had a remarkable series of wins in the last year. The first in October was achieving permanent inpatient payment of $43,000 for our procedure, which for the first time then equalized roughly inpatient and outpatient payment for the procedure taking economics off the table. Second, in July last July, a month ago, we received a very favorable ruling from the OPPS preliminary rule that, for the first time, kept us in the $45,000 Newtek APC that for the last two years we had to fight our way towards. And so we think that is a significant development. We think it’s an acknowledgment by CMS that this procedure deserves to be reimbursed at that level, not at the level five $31,000 level.

Interestingly, CMS again this year asked for comments about the value of creating a permanent level six code at that same $45,000 level. So we think those are both favorable signals. There’s some chance that that could occur this year during the open comment period and would be finalized in the in the final rule in November, but it’s uncertain that that would happen. In any case, we’re confident in the future path ahead to secure that $45,000 level on a permanent basis. The second positive development in July was the physician payment established as as part of the category one code.

And so through the RUC committee and the AMA, they determined an 11 RVU value for this procedure, which equates to $553 on a national basis. So as of January 1, we will have a category one code, which is obviously very important, and we’ll have for the first time committed formal physician payment, surgeon payment for the procedure, which again is an important step forward. So, again, we believe we have an opportunity to positively impact the standard of care for heart failure to address a significant unmet need and in doing so, help a significant number of patients live a much more full life. So with that, I’ll turn it back to Bill. Thank you.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: Great, Kevin, and thanks, Jared here for joining us. Let’s kick off the q and a. We got about fifteen minutes here. We’ll we’ll start out with financials and then flow through. You know, Kevin, Jared, q two showed sequential US growth.

We had fifteen percent heart failure revenue growth year over year. Talk about the state of The US business today. Like, where are we?

Jared Oshheim, CFO, CVRx: Yeah. Kevin, do you wanna dive in?

Kevin Heics, President and CEO, CVRx: So I’ll start at a 100,000 feet perhaps. So as as I mentioned, you know, we spent a significant time amount of time in the last year working on our go to market strategy, developing and implementing that new strategy with the three core components I described, and building out our sales team. And I think we’re we’re quite happy with the strategies we’ve implemented. We’re happy with the progress we’re making against those barriers to adoption. We’re happy with the number of centers that are beginning to look like fully adopted, consistent, stable, users of the therapy.

Where we’re not yet seeing what we’d like is the productivity of the Salesforce, largely because a significant number have joined us even in the last six months. And so that’s really our focus today. We’re pleased with everything else we’re seeing. We think we’ve got the right people, but we need another quarter or two to get them productive and contributing.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: So it’s been eighteen months since you’ve joined. You’ve, we’ve had changes in senior management, changes Salesforce, change in strategy. Are we through all the changes?

Kevin Heics, President and CEO, CVRx: Yeah. I I can’t say there won’t be, further changes down the road, but what I can tell you, the foundational changes that were necessary, including the appointment of our first chief operating officer who joined us yesterday, are now behind us. And it’s about executing, getting these people productive, and executing the strategies that we’ve deployed.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: And I think, we were talking post your earnings and a discussion of, a lot of senior management changes, and it seems like you have a, you know, the team has gotten bigger, and you corrected me on that.

Kevin Heics, President and CEO, CVRx: Yeah. In fact, the team has gotten smaller. And so I went from, I think, 12 direct reports down to now seven. So that’s part of the process. We kept a lot of those people elsewhere in the organization.

But, again, trying to build a team, a leadership team that is scalable and has the skills and competencies to grow this business rapidly.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: And and then, Jared,

Kevin Heics, President and CEO, CVRx: you know,

Bill Plovanek, Senior Medical Device Analyst, Canaccord: you narrowed the guidance you provided on the second quarter call, to 55 to 57,000,000. You you mentioned that the Salesforce productivity, we’re not seeing it yet. What gives you confidence to the upper end of that range? What drives the upper end of that range?

Jared Oshheim, CFO, CVRx: Yeah. I think part of this just comes back to the type of people that we’ve been able to hire over the last six, seven months. Kevin mentioned it, 41% of the sales organization is new in that time period, and we’ve gotten really, really good people to join the company. And now it’s all about onboarding these individuals to get them up that productivity curve. So, as we narrowed the guidance to be 55 to $57,000,000 for the year, this follows our normal course with two quarters left to have a range of about $2,000,000 left.

We believe with the reps that we have in the stable at this point, getting up that productivity curve that we’re gonna be able to hit that. I think to hit the high end or be able to exceed those numbers, it’s seen more of those reps get up that productivity curve a little bit faster than expected.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: But do we need those new reps to hit the productivity curve to hit the low end?

Jared Oshheim, CFO, CVRx: Yeah. It’s a good question. So our expectation is that we will be on track to add three active territories on a quarterly basis. This is what we’ve been able to do historically, and that’s baked into this guidance of fifty five to fifty seven million dollars. So seeing some of those reps that were hired in January, February, March get up that productivity curve, become productive, and be included in that active territory number that we’re disclosing on a quarterly basis.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: Okay. And then, from a commercial team standpoint, something notable from the call, allowing the reps to keep or go after tier three and tier four accounts. Can you talk about this dynamic a bit?

Kevin Heics, President and CEO, CVRx: Yeah. So let let me address that. I’m glad you asked. The, so what we implemented in q four of last year was our first attempt to to segment our market and specifically guide targeting of centers, and we used something we were calling tiers one through four. And the criteria we used at the time was the best evidence we had that described high potential accounts, and it was three things.

One is a high volume of heart failure patients. The second was the use of CardioMEMS, which is an Abbott device, really the first diagnostic, but the first device in this population that signaled that these were centers that were progressive heart failure programs. And the

Bill Plovanek, Senior Medical Device Analyst, Canaccord: third

Kevin Heics, President and CEO, CVRx: was noted success in in developing cardiovascular programs like Watchman or MitraClip or CardioMEMS. Right? So we thought those were the three things that mattered most. What we found after three quarters of implementing that program is that that there are, in fact, some three and four tier three and tier four centers that are worth talking to, some of which are already performing at extremely high levels. So I think it’s it’s more of an optimization.

What we found is that there are certain territories where they’ve exhausted their ones and twos, and we need to help them pick the right threes. There are other territories where we’ve approached an academic medical center. University of Michigan is one example we use, where the chief of cardiology for the entire Michigan system said, this is a big bureaucratic flagship academic center. It will take forever to get you in this door. Go down the street to Flint or or or Dearborn or wherever it was.

Start there at our sister satellite. It happens to be a tier four, but go to the satellite, get this in the door, treat some patients, and that gets a much quicker path back to the flagship. So sort of nothing novel there, but what we’re finding is some of these tier fours are in fact worth pursuing. And so we’ve sort of adjusted it slightly. We’re we’re still using our brains where we can, and there’s still lots of mom and pops that we will not approach.

But I think it’s a very typical sort of learning that we’ve been through and and optimization of of the original strategy.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: And and to flip that on its head, is there a reason the academic centers wouldn’t let you in? Is it a reimbursement issue? Is it

Kevin Heics, President and CEO, CVRx: a Oh, no. It had nothing to do with us. That that’s a generic the academic centers, as as probably everyone knows, are are remarkably bureaucratic and slow moving. And we have instances in lots of businesses I’ve worked in where it can take one or two years to penetrate the administration. So this was simply a physician saying, hey.

A full frontal approach is gonna take us two years. If you go down the street with I’m sure he’s counseling other new therapies similarly. Go down the street, get in the back door, and come back and see me when you’ve got three patients treated, and I can just flow this right into what we do here. So it’s more pragmatism than anything specific in our therapy.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: You’ll keep the frontal attack, but you’re coming from the side too. And the reimbursement story definitely has stabilized with the CMS keeping the new tech APC. What what advocacy are you doing for the level six code, and, ultimately, what reimbursement level could that be, do you think?

Kevin Heics, President and CEO, CVRx: Yeah. So I I would say we’re it’s the exact same advocacy playbook that we’ve used each of the last two years successfully to move ourselves from level five to the new tech. And so in this case, thankfully, we’re starting out already in the new tech, but it involves, you know, a a letter writing campaign. It involves advocacy on Capitol Hill. It involves letters from congresspeople.

It involves the physician panel that we’ve now twice successfully secured support from. And so it’s the exact same set of things that caused us to be successful in the past. There’s some chance that they would, in fact, create a level six this year as part of that comment period. I think it’s probably not likely, but it it has happened in the past. But I think either way, the fact that we’re starting out at $45,000 and they’ve asked for comment is a

Bill Plovanek, Senior Medical Device Analyst, Canaccord: very positive sign. So likely 10%, 20%.

Kevin Heics, President and CEO, CVRx: Probably something in that range. 10%.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: Okay. And, how should we think about the the physician payment of $553 starting Jan one? Does that is it really a needle mover? What what does it do for you?

Jared Oshheim, CFO, CVRx: Yeah. It’s it’s a good question. To us, this is just more of a check the box activity. We haven’t had as much of a concern as it, comes to identifying surgeons to actually do this procedure as we’re going and opening new doors. So the $553 was as expected.

The RVUs that were assigned to it were in line with the numbers that we assumed we would see coming out of this survey. So to us, all of all of all that does is secure payment for those physicians. Whereas in the past, they may have been a little bit uncertain as to whether or not they were gonna be paid after procedures were performed under a category three code.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: Okay. I’m gonna flip over to clinical trials. You’ve you’ve talked about, discussions with the FDA on indication expansion. Just, do you have a trial design yet? Any updates you wanna provide there?

Jared Oshheim, CFO, CVRx: Yeah. Happy to oh, go ahead. Jump in on that one. So they you know, we are still working and negotiating with FDA on that trial design. We’re not gonna get into the weeds, but as you can imagine, you know, cardiovascular trials specifically towards heart failure, there’s gonna definitely be involvement of morbidity and mortality endpoints.

We’ve talked generally about trial size, with with the public market saying, you know, one thousand to 2,000 ish patients, but still working with FDA to lock in on what that final trial design would look like. As far as timeline goes, we’re expecting to hear back and continue those discussions in the back half of the year, so we’re hopeful that we’ll be able to talk more with you about that maybe after the q three, results come out or maybe in q four time frame. But that’s step one in this process. There is always the second step which is taking that trial design to CMS to see if they will cover the cost of the procedures under that trial. So once we get past the FDA discussions and negotiation, then we start discussions with CMS which can add a couple of months to the timeline.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: And and how long, you know, let’s say we have final trial design end of this year. It’s 2,000 patient trial call. Let’s go to that. How long does this take to enroll?

Jared Oshheim, CFO, CVRx: Yeah. I think based on enrollment rates that we’ve put together and, you know, estimates for costs on early trial design discussions, you know, it it can take five to seven years to see this thing play out to get to a final conclusion. So by the time you fully enroll all the centers, enroll all of the patients, do a couple of years of follow-up associated with that clinical trial, you’re you’re talking a range of five to seven years out at this point.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: K. And in terms of financials, you know, I’ll start with given, you know, long trial, I don’t know, the cost of that, embed that in, future cash needs, and especially given where the stock is today.

Jared Oshheim, CFO, CVRx: It’s it’s a great question. Question. With $95,000,000 in the bank, we burned about $8,000,000 in the last quarter. We believe we have at least three years of cash on the balance sheet. So there is absolutely no need at this point to go out and raise additional capital.

On the clinical trial specifically, with CMS expected to cover the cost of that trial for us to actually move forward with it, the total cost of the trial on a net basis is expected between 20 and $25,000,000, and that’s spread over that five to seven years. So you’re not seeing too much of additional cash burn because of the addition of that individual trial. So with $95,000,000 and the price point where it is today, we don’t feel there’s a need to go out and raise additional capital.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: In gross margin, where it sits today, and what do you kinda think about where can we go?

Jared Oshheim, CFO, CVRx: Good question. So we go up? Pretty pretty consistent at that 84 percent range, you know, based on ASPs in The US kinda hovering around $31,000 per device. I think as we think longer term, we’re looking at, you know, just facilities and understanding capacity planning. Right now, we’re building about 2,000 systems in our facility in Minneapolis, Minnesota today.

We’ve run a a capacity planning for that and determined we can build about 5,000 systems per shift per year. So there is a lot more room to run to spread those overhead costs over additional device. So we believe longer term, there’s an opportunity to reduce the cost per system, which could in turn have a positive impact on margins. How high that can go, I think we wanna wait and kinda see how it plays out first.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: K. We have a couple minutes left. I’ll see if there’s any questions from the audience. If not, I I’m gonna circle back to where I started. So you’ve been eighteen months, you know, year and a half.

We got all these changes. We don’t foresee any other changes. And now at this point, it’s just execution of all the plans in place. And it sounds like we should see the benefits of those as we exit this year going into next year. Am I catching that all?

Kevin Heics, President and CEO, CVRx: I think that’s a fair statement. Yep.

Bill Plovanek, Senior Medical Device Analyst, Canaccord: Alright. I think we’ll end it there.

Kevin Heics, President and CEO, CVRx: Thank you. Thank you.

Jared Oshheim, CFO, CVRx: Okay.

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