CVRx, Inc. (NASDAQ:CVRX) Q1 2024 Earnings Call Transcript

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Kevin Hykes: Sure. Thanks. I’ll take that one. We watch, like many of you probably have great interest a couple of Saturdays ago at ACCC have to RELIEVE-HF trial result release. And it was I think somewhat paradoxical. I’ve spoken to a lot of physicians about that. But intriguingly, the population that was expected to benefit actually did not. And the one that was not expected to be in as much, in fact, did. And in both cases, with placebo patients the control patients did as well or slightly better. So lots of very sort of, I guess, straight or paradoxical sort of results from that trial. I think the only thing we have discerned from lots of conversations, with physicians is that there’s a lot more work to be done. Those results I quoted, as you probably know, are not powered.

And there’s some hypothesis generation here perhaps, but significantly more work to be done on sort of the appropriate population, for intra-atrial shuts and the appropriate role in the treatment of heart failure. I think a number of physicians have suggested even as recently as this week that on some level, shunts are creating a pathophysiology to address a pathophysiology. And so, I think there’s some mechanistic question still about how they might work, and how they best fit into the treatment paradigm. But in the short term, we’re not hearing much about them. It has had no effect on our work in the market at all. But we’re watching it with interest.

Bill Plovanic: Thank you.

Operator: The next question we have is from Frank Takkinen of Lake Street Capital Markets. Please go ahead.

Frank Takkinen: Hi. Thanks for taking the question. I just want to follow up on one point. And I apologize if you said it already. I was jumping between a couple of calls. The commercial disruption, did you guys talk about the exact net number if there was the turnover in reps and then the number of reps that you’ve hired back since that turnover has occurred?

Kevin Hykes: Sure. Thanks, Frank. We did not give specifics on that number. We would prefer not to. As Jared said, we normally seek to open three new territories each quarter. And in this last quarter, we opened only one new net territory. So obviously, significantly fewer than we had hoped, largely because we were replacing backfilling territories with some of the newer reps results of the turnover instead of opening brand-new territories. So, I think we’ll hold on further detail there. But again, we’re confident that we have seen the stabilization of that dynamic and that with strong hiring in Q1, we’re able to rebuild the momentum that we lost in February briefly.

Frank Takkinen: Okay. That’s helpful. And then maybe just turning over to the label expansion late from last year. I know we’re only a quarter into it. I guess a quarter plus a month, but maybe talk about any anecdotal feedback you’re hearing in the market? Any planned changes related to some of the marketing initiatives you may put forth. Just any update related to how that label change has impacted the market dynamics?

Kevin Hykes: Sure. I’ll take that one as well. So, I think we’ve been quite pleased at the response both to the label expansion and the publication of the BeAT-HF data in the last couple of weeks. It was published, as you know, in the European Journal of Heart Failure and shown the sustained symptomatic improvement over 24 months, a 34% reduction in the likelihood of death or need for an LVAD transplant and continued very favorable sort of long-term safety profile. So overall, both as it relates to labeling and the durability of our therapy, there’s been a lot of positive response. Now I should point out a couple of instances where we are now mining that data set for additional. I spoke of the sort of cadence of evidence that we’re trying to build cost market evidence.

We presented two brand-new abstracts at the THT conference in March, one of which showed a 74% reduced risk of advanced heart failure interventions with Barostim therapy over those 24 months. And those advanced interventions would include transplant LVAD, CCM, CRT, CardioMEMS, et cetera. So really sort of compelling data that was within that data set. Secondarily, some additional interesting work on the quality of life scores over time for patients that receive this therapy. So we’re pleased with the response. We’re continuing to push that data set and the expansion of the labeling out through our sales team. And from the podium as well at the various conferences as well as through our DTC channel. So we’re, it’s still early, but there’s a rich data source there that we intend to mine for quite some time to come to build that cadence of evidence.

Frank Takkinen: Perfect. I’ll stop there. Thanks for taking the questions.

Operator: Our final question is from Chase Knickerbocker of Craig-Hallum. Please go ahead.

Chase Knickerbocker: Good to have you on board, Kevin.

Kevin Hykes: Thanks.

Chase Knickerbocker: I just want to dig in a little bit more on existing customer utilization. So it was actually down sequentially despite a better label and much better reimbursement. Should I think of the entirety, the only reason that it is down sequentially was because of the sales turnover? And then on the other side of that, just maybe speak to those sales reps in those territories that were stable, and did have the same person in that seat. Maybe speak to what utilization trends look like there, because did they see a benefit from that better reimbursement effective January 1?

Jared Oasheim: I can handle that one. I just want to make sure we’re all on the same page from some of those updates we saw towards the end of 2023. So the first one is on the reimbursement front. So as everybody remembers, we moved from being mapped to one APC plus having an add-on payment that gave total reimbursements to hospitals on average of about $45,000 in 2023 when they would do a Barostim procedure to in 2024 being mapped to a new tech APC without an add-on payment. And in that case, the hospital still receives on average about $45,000 for the procedure. So the change from ’23 to ’24 was technically net neutral, but the positive note moving into ’24 was we didn’t lose the difference of an add-on payment, right? So overall, the change was net neutral from a reimbursement perspective.

The data for those currently active implanting centers, a lot of them had seen it, right? They had an interest in Barostim. They knew the long-term data, the pulse market data was going to be coming out at THG, so a lot of them were aware of this long-term data. And so the FDA approval in December maybe didn’t affect a lot of those centers as much, because a lot of them were well educated and stayed up to speed, as we release that data back at THC. The benefit for us now is we can actually go out and proactively promote this data to those newer centers or those newer referring physicians that have not seen Barostim or seen this long-term data, because they didn’t have an interest of the year prior at THT. So I think, that’s where we’ll see some benefits, but activating those new centers, utilizing that new data is just going to take some time in 2024, and then, to get them ramped up and starting to treat patients.

As far as the territories that had stability, yes, we definitely saw a difference, right, for those folks that were here and stayed on staff in what they were able to do as far as productivity, within their territories versus those that had turned over.

Chase Knickerbocker: And is that true kind of relative to Q4 as well? And then kind of talking about that pass-through payment no longer being required? Is it not the right way for us to think about that as it is kind of a catalyst to adoption just, because they don’t have to deal with that separate payment pass-through? Or are we thinking about that incorrectly?

Jared Oasheim: Yes. So going from Q4 to Q1, again, overall utilization rates were down, right? But we did see, some of those active territories the overall utilization increase. As far as the reimbursement goes, that is a good point. So transitional pass-through or that add-on payment for the outpatient procedures is a complicated calculation. Nadim and I would previously talk, about how it was a bit of a barrier because many of the hospital administrators were not aware of that transitional pass-through or they didn’t see it very often. And so, they would often want to test out a few patients, see what reimbursement would come back at before they would start treating more and more patients. So the hope is that as we move forward, with just having one code that the hospitals need to utilize that it removes one of those barriers, for the hospital administrators to put a hold on these types of procedures.

Chase Knickerbocker: Got it. And then maybe just quickly on BATwire. Have we kind of adjusted our thinking on thinking that if we can kind of keep this with EPs that it would benefit adoption ramp? Or just kind of walk me through some of the thinking there?

Jared Oasheim: Yes, I can take that one as well, Chase. So going back to 2020 when we were initially kicking of this clinical trial, we were very early in our commercialization stage. One of the hypotheses that we had was that we would have to get an electrophysiologist involved in the program, to see this program be able to be built out more fully. As we’ve continued to develop new centers and bring on new surgeons, the referral pathway is not as complicated as we had once thought. Seeing the general cardiologists work with the vascular surgeons, it’s worked quite well. And in many of the centers, where we had both a commercial program available in the BATwire tool available, many of the patients were actually electing to go with a commercial path rather than be part of a clinical trial.

So I think the old hypothesis that we needed an electrophysiologist, to be involved to see this ramp is maybe less important to us. That being said, we do utilize, or work with some electrophysiologist champions at specific centers, and are very happy to work with them, as they’re identifying patients that could be treated with Barostim as well.

Chase Knickerbocker: Got it. Thanks, guys.

Operator: Thanks, that concludes the Q&A session. And I would like to turn the floor back over to Kevin Hykes for closing remarks.

Kevin Hykes: Thank you, operator, and thanks again to everyone for joining us for our first quarter earnings call. We appreciate your ongoing support, and we look forward to updating you on our progress on our next update. Thank you.

Operator: This concludes today’s conference. Thank you for joining us. You may now disconnect your lines.

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