NeuroPace, Inc. (NASDAQ:NPCE) Q4 2022 Earnings Call Transcript

So early days, more anecdote than anything that I can say beyond that, but I am very encouraged by both the sales synergy as well as the impact that we think that’s going to have for us on the pipeline.

Operator: And thank you and one moment for our next. And our next question comes from Frank Takkinen from Lake Street Capital Markets. Your line is now open.

Frank Takkinen: Congrats on the progress. I wanted to start with one on the guidance. I heard the comments a lot and clear about the drivers of growth, your initial implants and DIXI offset by replacements. Can you maybe just walk through how you’re thinking about low end versus top end? What needs to occur to hit the top end? What could happen to hit the bottom end? And then what’s kind of the upside scenario to — what needs to occur to exceed the top end of the guide?

Michael Favet: Great. Thanks, Frank, and looking forward to being able to execute this against this in 2023. As you stated, drivers of growth are initial system implants of the RNS system and the DIXI revenue being the growth drivers. The pieces that are behind that, for the DIXI component, it’s going to be about a combination of the market growth and how much share are we going to be able to take in that market. I feel very good about where we started the distribution of that product in the fourth quarter of last year, giving us a nice base to be able to build off of. And then for the NeuroPace RNS revenue, which again is the significant majority of our revenue coming from that, there is an element of the range that comes from how fast the market recovers — does the market recover and how fast the market recovers.

We’re building into expectations that the normalization that we’ve seen over the last three quarters continues through 2023. There is more upside with that if the market recovers more quickly, meaning gets back to 2019 levels and grows from 2019 levels. That provides upside for us in terms of the range that we provided. And then the other primary factor is going to be about how fast can we increase the utilization within these centers. The primary growth driver of initial implants is how fast we grow initial implant utilization. And that’s going to be the effectiveness of the commercial efforts and the work that we’re doing to manage the pipeline for more patients coming through. The other factor that goes into that is how many new centers can we bring on.

We’re taking steps to be able to expand access of RNS system to more patients, more centers and so that provides some of that range for revenue as well.

Frank Takkinen: Okay. That’s helpful. And then maybe for my second one on the generalized population. Can you provide any update around the enrollment, and if unable to give a specific patient numbers, maybe if you can share some goalposts around timing for enrollment completion expectations?

Michael Favet: Yes. Thanks for the question. So I’m really excited to have brought all of the centers into that study at this point, so being able to really focus now as we go through 2023 on driving enrollment through those centers. But the expectation is that it’s going to take us on the order of a year from where we stand now to enroll the remaining patients in the NAUTILUS study. We have really all efforts around being able to get that done as soon as we can, but expect that it’s going to be on an order — on the order of about a year to be able to get through that process. And then as a reminder, it’s about — it’s a one-year follow-up for the primary endpoint for that study, but very happy to be through the process of getting the sites online. A lot of excitement within the medical community about this, and so we were very pleased to be able to get the number and the quality of sites that we were able to participate in the trial.