Good afternoon. My name is Bill Pavonic. I'm a Senior Medical Device Analyst here with Canaccord Welcome to our 45th Annual Growth Conference. With us next, we have the management team of CVRx, Kevin Hykes, President and CEO, and Jared Oasheim, CFO. We're going to have a short presentation followed by a fireside chat. With that, I'll hand it over to Kevin.
Okay, thank you, Bill. I appreciate the chance to share a little more about CVRx with you today. CVRx has pioneered the world's first neuromodulation therapy for the treatment of a cardiovascular disease. We have a $2.2 billion annual TAM and a well-defined patient population, few competitors, and a very needy population that can significantly benefit from our therapy. Heart failure, as you likely know, is a burdensome disease, a significant condition in the U.S. and other developed markets. It results in the U.S. in about a million hospital discharges, 1.3 million emergency room visits, 8 million physician office visits, and about $70 billion 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 2% of these patients receive a left ventricular assist device or a transplant. In the intervening five to 10 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 1% of patients ever reach the maximal tolerated therapeutic dose on the four drugs, and at the end of the first year, 40% 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 30% of patients are eligible, and of those that receive the therapy, 30% fail to respond. This leaves a very significant % 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.
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 of last year, 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 30-year-old paradigm of treating this disease with drugs alone. 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 $2.2 billion that is currently less than 2% penetrated. 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 basis, but in some cases inpatient as well. It requires a very small incision in the neck and a second incision in the chest for the implantation of the generator. Most importantly, this is an entirely extravascular procedure. Some of our surgeon implanters call it bloodless, and it's a very simple 45-minute procedure. The complication rates are quite low, 97% freedom from significant events. It's a very safe, effective, and predictable procedure for the surgeons.
Our 24-month 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 exceeds even that of CRT. 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 of this year, we published data on 306 Barostim patients from the Premier Healthcare 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 85% reduction in hospitalization in this population. This is 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. 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 18 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 Barostim programs versus a wider approach. 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&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.
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. The 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 of last year 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 new tech APC that for the last two years we had to fight our way towards. 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. 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 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 part of the Category I code. Through the RUC committee and the AMA, they determined an 11 RBU value for this procedure, which equates to $553 on a national basis. As of January 1, we will have a Category I 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. 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. With that, I'll turn it back to Bill. Thank you.
Great, Kevin, and thanks, Jared, for joining us. Let's kick off the Q&A. We've got about 15 minutes here. We'll start out with financials and then flow through. You know, Kevin and Jared, Q2 showed sequential U.S. growth. We had 15% heart failure revenue growth year- over- year. Talk about the state of the U.S. business today. Like, where are we?
Yeah, Kevin, do you want to dive in?
Sure, yeah. I'll start at 100,000 ft perhaps. As I mentioned, we've spent a significant 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. I think 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 sales force, largely because a significant number have joined us even in the last six months. 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.
It's been 18 months since you've joined. We've had changes in Senior Management, change of sales force, change in strategy. Are we through all the changes?
Yeah, 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. It's about executing, getting these people productive, and executing the strategies that we've deployed.
I think we were talking post-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.
Yeah, in fact, the team has gotten smaller. I went from, I think, 12 direct reports down to now seven. That's part of the process. We kept a lot of those people elsewhere in the organization, again, trying to build a team, a leadership team that is scalable and has the skills and competencies to grow this business rapidly.
Jared, you narrowed the guidance you provided on the second quarter call to $55 million - $57 million. You mentioned that the sales force productivity, we're not seeing it yet. What gives you confidence to the upper end of that range, and what drives the upper end of that range?
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. Now it's all about onboarding these individuals to get them up that productivity curve. As we narrowed the guidance to be $55 million - $57 million for the year, this follows our normal course with two quarters left to have a range of about $2 million left. We believe with the reps that we have in the stable at this point, getting up that productivity curve that we're going to be able to hit that. I think to hit the high end or be able to exceed those numbers, it's seeing more of those reps get up that productivity curve a little bit faster than expected.
Do we need those new reps to hit the productivity curve to hit the low end?
It's a good question. 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 $55 million- $57 million. 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.
Okay. 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?
Let me address that. I'm glad you asked. What we implemented in Q4 of last year was our first attempt to segment our market and specifically guide targeting of centers. We used something we were calling tiers one through four. The criteria we used at the time was the best evidence we had that described high potential accounts. 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, it's diagnostic, but the first device in this population that signaled that these were centers that were progressive heart failure programs. The third was noted success in developing cardiovascular programs like Watchman or MitraClip or CardioMEMs, right? We thought those were the three things that mattered most.
What we found after three quarters of implementing that program is that there are, in fact, some tier three and tier four centers that are worth talking to, some of which are already performing at extremely high levels. I think 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 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." Nothing novel there, but what we're finding is some of these tier fours are in fact worth pursuing. We've sort of adjusted it slightly. 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 optimization of the original strategy.
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 a...
Oh, no, it had nothing to do with us. That's a generic... The academic centers, as probably everyone knows, are remarkably bureaucratic and slow-moving. We have instances in lots of businesses I work in where it can take one or two years to penetrate the administration. This was simply a physician saying, "Hey, a full frontal approach is going to take us two years. If you go down the street," 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." It's more pragmatism than anything specific in our therapy.
You'll keep the frontal attack, but you're coming from the side too. The reimbursement story definitely is stabilized with CMS keeping the new tech APC. What advocacy are you doing for the level six code, and ultimately what reimbursement level could that be, do you think?
Yeah, I would say 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. In this case, thankfully, we're starting out already in the new tech, but it involves 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. 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 has happened in the past. I think either way, the fact that we're starting out at $45,000 and they've asked for comment is a very positive sign.
Likely 10%- 20%?
Probably something in that range,
10%. Okay. How should we think about the physician payment of $553 starting January 1? Is it really a needle mover? What does it do for you?
Yeah, 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. 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. To us, 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 going to be paid after procedures were performed under a Category III code.
Okay. I'm going to flip over to clinical trials. You've talked about discussions with the FDA on indication expansion. Do you have a trial design yet? Any updates you want to provide there?
Yeah, happy to go ahead and jump in on that one. We are still working and negotiating with the FDA on that trial design. We're not going to get into the weeds, but as you can imagine, cardiovascular trials specifically towards heart failure, there's going to definitely be involvement of morbidity and mortality endpoints. We've talked generally about trial size with the public market, saying 1,000 - 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. We're hopeful that we'll be able to talk more with you about that maybe after the Q3 results come out or maybe in the Q4 timeframe. 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. Once we get past the FDA discussions and negotiation, we start discussions with CMS, which can add a couple of months to the timeline.
If we have final trial design end of this year, it's a 2,000 patient trial call, let's go to that. How long does this take to enroll?
I think based on enrollment rates that we've put together and estimates for costs on the early trial design discussions, it could take five to seven years to see this thing play out to get to a final conclusion. 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 talking a range of five to seven years out at this point.
Okay. In terms of financials, I'll start with given a long trial, I don't know the cost of that, embed that in future cash needs, especially given where the stock is today.
It's a great question. With $95 million in the bank, we burned about $8 million in the last quarter. We believe we have at least three years of cash on the balance sheet. 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 million and $25 million, and that's spread over that 5 to 7 years . You're not seeing too much of additional cash burn because of the addition of that individual trial. With $95 million and the price point where it is today, we don't feel there's a need to go out and raise additional capital.
Gross margin, where it sits today, and what do you kind of think about where can we go?
Good question. We're going to go up pretty consistent at that 84% range, you know, based on ASPs in the U.S. kind of 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 capacity planning for that and determined we can build about 5,000 systems per shift per year. There is a lot more room to run to spread those overhead costs over additional devices. 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 want to wait and kind of see how it plays out first.
Okay. We have a couple of minutes left. I'll see if there's any questions from the audience. If not, I'm going to circle back to where I started. You've been 18 months, you know, a year and a half. We get all these changes. We don't foresee any other changes, and at this point, it's just execution of all the plans in place. It sounds like we should see the benefits of those as we exit this year going into next year. Am I catching that all?
I think that's a fair statement. Yep.
All right. I think we'll end it there.
Thank you.
Thank you.
Okay.