ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q4 2023 Earnings Call Transcript

So these accessories that I’m talking about will allow us to do that same exact workflow these sites are already doing, where they use someone else’s navigation like a robotic system or like [CellFrame] or something like that, place a ClearPoint PRISM laser catheter at target and then move the patient to the MRI just like they would do with any of the laser systems out there today. So that’s something that I think we expect to have in the first half of this year. And if we can get into the LMR and the full market release in the second half of this year, that again unmasks and opens up a lot of new opportunities for us as well. So it’s really those two primary triggers, one in the first half of this year and then one hopefully by the end of this year, that would get to the point where any hospital could be using ClearPoint PRISM if they wanted to.

William Wood: Understand. Thank you for that extra color. In terms of your three sort of drivers of growth, you’ve got BDD, which clearly looks like it’s going to be the main driver with over 50%, I believe you said for the revenues. But then you also have your capital equipment and then your functional — your FNN. So just when we’re thinking about sort of parsing those out, it sounds like CapEx or capital equipment already has a pretty strong first quarter. When thinking about 2024 revenues and sort of modeling that out, where should we think about the growth occurring? Or how should we think about the growth occurring in each of these segments through 2024 when we look to model these?

Joe Burnett: Yes. I mean I think I made one comment in the remarks that this is going to be an interesting year for us where really all of our different segments are growing. So we expect significant growth from capital placements as well as capital revenue. Even if a little bit of that revenue is deferred based on rental or lease programs, it’s still going to be a significant growth over prior year. So that’s one contributor. If you look at our device business, we have an opportunity here to launch two or three key new products here, the SmartFrame OR, which gives us access to navigation in the operating room, which we’ve never had before. So that’s growing from 0. And every new PRISM account is an additional new growth where we’ve never had a laser therapy system, and we do now as well.

So that device business, including navigation and laser therapy together, those are going to be significant and exciting growers for us. And then as you pointed out, biologics is doing what we continue to do. I mean if you look at what we did in the fourth quarter of $4.1 million, there’s no reason that we expect that to decline at all. So even if you take the $4.1 million, $4.2 million, whatever million, multiply that times four quarters, you’re already looking at 20% growth. And that’s assuming we just stay flat there, which is not the plan either. So it’s exciting to be part of something where last year, we kind of had an anchor relative to capital in some of our device business. Now we’ve got three different segments that we expect growth from all of them.

William Wood: Got it. And then one last quick one. Just thinking about the EU MDR approved certification that you got recently, how will this really affect or help your international adoption, specifically the EU adoption and expansion? And does not having this — how does that affect other companies who have to still go through this approval process?

Joe Burnett: Yes, really, it’s an important decision that a lot of companies have to make right now, and sometimes they’re going to partially make it. So if you’re trying to get a new product approved in Europe right now, it’s more challenging than it has ever been based on increased documentation and in many cases, increased clinical evidence and usability studies that makes the development — mathematics of launching a new product much more expensive than they have in the past. So if you have to add time and add studies and even do some clinical work, you could look, in some cases, a doubling or even tripling the cost of bringing a new product to market. So in some cases, if you’re making Tylenol there, sure, there’s a big enough market that you’re going to go after it.

But if you have a product that’s sort of a niche right now, like we kind of do in biologics and drug delivery because nothing is commercially available and it’s really participation in clinical trials, it makes it a little bit more difficult to justify this added spend to go into Europe. And quite frankly, if we didn’t have such important pharma partners that are there by our side to help us with some of the work and funding of it, we probably come to the same conclusion that some other smaller companies would as well to say, now is not the time. Let’s see how this EU MDR plays out, and we’ll make a decision down the road. But we’ve taken a different approach to say, look, let’s invest. Let’s solidify these partnerships. Let’s show them that we might be the one company that has the full suite of products in Europe, in the United States, in Canada, in Asia, in Japan.

So if we can be that one partner where a pharma company says, hey, wherever I want to go, ClearPoint is going to be there for me, we think that’s going to help us win additional business as well.

William Wood: Thanks, Joe, I appreciate that and congratulations again on a really nice quarter.

Joe Burnett: Thanks, William.

Operator: Thank you. There are no further questions at this time. I’ll hand the floor back to Joe Burnett for closing remarks.