CVRx, Inc. (NASDAQ:CVRX) Q4 2022 Earnings Call Transcript

Matthew O’Brien: Got it. Okay. And then we can get into margins and all the other stuff, which are positive updates, I guess later. But the other question I did have was really on the DTC campaign. It seems like there’s a lot of patients out there and I know it’s just a pilot study, but what are you seeing as far as running some of those studies getting in front of patients that could be good candidates for this and then transitioning them all the way through to potentially getting an implant.

Nadim Yared: So the — Matt, this is Nadim. Thanks for the question. our DTC pilot, and why we kept it as a pilot still for a little bit longer is to understand exactly those questions that you’re asking. They need to have no idea what form of heart failure they have if they have an ICD or a CRT, they think they have a pacemaker. And I’m over general it’s a disease that’s harder to characterize. And when you look at our incidence rates that we calculated, because new patients every year, that’s about 4% to 5% of the heart failure patients overall. So it’s a small percent , it’s a game of numbers and we track every single click, every single patient when they provide us the information we try to get as much as possible. in medical condition as much as we are allowed to know.

And if they are seeing their own physicians versus seeing how to pass diverge, and if the heart failure specialists they’re seeing happen to be on the site where we are already activated, as well there is a it will go much faster, on the other hand, much slower. So it’s all of those uncertainties now that keep this for the timing being as a very difficult one because all centers.

Matthew O’Brien: Got it. Thanks so much.

Nadim Yared: Thank you.

Operator: Thank you. One moment for our next question. And that will come from the line of Margaret Kaczor with William Blair. Your line is open.

Margaret Kaczor: Hey, good afternoon, everyone. Thanks for taking the question. Just because BeAT-HF obviously is a short-term catalysts. I was just curious if you can walk us through any commercial and marketing changes that you would make based on, let’s call it, three scenarios where the first is positive on morbidity, mortality or on all events, maybe a more gray area, but numerical improvement mortality, but not on events. And then third of maybe a less good morbidity outcome or whatever gray area that would be less good that you would look at? How would that change your behavior? I guess, relative to the guidance that you have?

Nadim Yared: Thank you, Margaret. Thanks for the question. of the three scenarios that you mentioned, let’s start from the most negative to the most positive. And the most negative the data is neutral, there is no until what we have been doing. Our plan is built on that scenario. As Jared just mentioned earlier, it’s not that we don’t believe that we will win, it’s just, you know, us that I would like to establish a baseline that is conservative and consider all of the past and use as upside. If it’s base positive trending positive, but not meaning the endpoint itself, then probably there’ll be no change in our marketing sales strategy. Now if it’s a clear-cut positive where we met the most accretive endpoint and that FDA will give us the labeling that this device improves heart failure’s outcome.

Then it is possible that Jared and I with the approval of our Board, we may decide to accelerate the in our sales and marketing efforts in the United States. And when that would happen, it will take time. You don’t see it adding territories, you have to identify the talent, hire them, train them and so forth. So that ramp will accelerate, but you will not see it overnight. answered your question?