Castle Biosciences, Inc. (NASDAQ:CSTL) Q1 2024 Earnings Call Transcript

Derek Maetzold: That’s an excellent question, Corey. So our guidance so far has been that we believe we are on track or remain on track to launch the initial version of our tests for inflammatory skin disease therapy response prediction by the end of 2025. There are a number of things of areas within the final rule that the FDA indicates they’re going to be clarifying in the next period of time. I’m not sure if that means two months or two days or six months. We certainly plan to had discussions around what this means for future marketed test since there’s no way that will be launched by May 6 of this year. But as of right now, I would say that we’re so far out between now and 2025 that I wouldn’t have — we wouldn’t be positioned to go in and say that timing should change at this point. But obviously, as we work through the final rule and understand how we want to — how we could have newer tests managed, we can provide clarity in future quarters.

Corey Rosenbaum: Great. That is great insight. Appreciate it. And also, you previously mentioned potential expanded market opportunity for uveal melanoma in the early detection of the disease. Are there any updates in terms of the development time-line there and we might be able to get some updates on that initiative?

Derek Maetzold: Not on this call here — but that’s a good question there. So I can’t recall the internal milestones that provide clarity on that. But let’s get back to you guys in the summertime.

Operator: Our next question comes from Thomas Flaten with Lake Street. Your line is open. Please go ahead.

Thomas Flaten: Great. Appreciate guys, taking the questions. On the fourth quarter call, you mentioned that in early 2Q, you would be evaluating a sales force expansion for TissueCypher. Do you have any updates for us on that?

Derek Maetzold: Yes. So we have actually expanded our sales force for TissueCypher. The majority of the expansion territories were filled, I think, effective April 1, and there’s a couple that have come in — in the last week or two. So the initial expansion efforts in 2Q are essentially done. We do plan on kind of watching the expand the territories once we have the representatives trained up in the field full time, see how the response in this is — and may look to do an additional expansion here in the second half of 2024, depending on what we are seeing in terms of territory productivity growth. But otherwise, though that expansion — you could say was largely completed by now. So you are really talking about sort of beginning to see I think, an impact of that, we estimate five months to six months from the date of higher begin to see good productivity coming out of a new area manager.

So I’d think towards the end of the third quarter, fourth quarter, we should be able to see publicly a nice impact kind of expansion.

Thomas Flaten: Got it. And then, Frank, the updated 2024 guidance is within the range of your 2025 original long-term plan — like how should we think about 2025 in the context of having increased the guidance to this level for 2024?

Frank Stokes: We’ll recall that our guide, Thomas assumes that we — even though the evidence is, in our view, even [till-late] (ph) person clear that our SCC test has great clinical utility. We are assuming that — that comes out of our revenue in the back half of this year in ’25. So we would have that headwind there. But you’re right, we are close to there as we sit here today.

Thomas Flaten: Got it. Appreciate it. Thank you.

Operator: We now turn to Paul Knight with KeyBanc. Your line is open. Please go ahead.

Paul Knight: Hi, Derek. A question on the TissueCypher and IDgenetix, you’re seeing obviously big growth there. Are you kind of pull-through? Or are you really putting in a focused marketing effort on those two tests?

Frank Stokes: We — Paul, thanks for the question. We definitely market all of our tests in a very thoughtful and deliberate way. So we do see great demand for those tests, but the hurdle to achieve that or to recognize that demand is physician education, and that’s really what our marketing effort is focused around as physician education, making sure that the target — targeted health care providers understand the benefit to their patients of using our test. So with both of those tests, once the health care practitioner understands that benefit — then there’s really good pull-through. They get it and they become adopters in many cases, pretty quickly. But to get them there, we have to educate. So these are still fairly pinpoint use here on these tests.

It’s not — it’s a very distinct subset of patients. And so we need to first illustrate to the physician, which subset of his patients will benefit and then to help them understand what that benefit is. And then for many of them, then they want to say, okay, I get it. I get which patient. I get how it can help now — now walk me through your data and let me get comfortable that you are going to do what we think we’re going to do here. So — we have a very — I mean, it is very detailed, very in depth. The team has done an incredible job. Our physician facing materials are incredibly well-developed. We’ve got a large team of very smart people that work very hard to put that together and it is very effective, but you still have to get in front of the physicians.

So that tip of the spear interaction is still very important.

Paul Knight: On SCC, are physicians ordering that test, are they also ordering more and more Dx-Melanoma test as well – I mean, is there a halo effect of having them see better utility for both disease states you mean?