Castle Biosciences, Inc. (NASDAQ:CSTL) Q3 2023 Earnings Call Transcript

Unidentified Analyst: Hi, this is [indiscernible]. I am on for Kyle Mikson. Great update, guys. Congrats on the performance. Just kind of getting back to DecisionDx-SCC and the reimbursement. So obviously, we organized the comment period, I know the talks ended roughly September 9. I was just curious regarding if you were able to simply reenter any data that you previously used with perhaps new context or any new data prior to the ending of that comment period? Thanks.

Derek Maetzold: Yes, I think…

Frank Stokes: The question is can we add more data since the comment period has ended?

Unidentified Analyst: Hi, essentially, before the comment period ended, I guess and since the last update, yes. Thanks.

Derek Maetzold: Yes. So we did submit new data with our comments in early September that was presented to Novitas in the, I guess, earlier part of August. So new data was submitted, including I think the most important dataset or two datasets. One of them is the benefit that we have now seen in our SCC test, being able to discern patients who are likely to have no benefit or no response to adjuvant radiation therapy and find those who may or who are likely to get a nice response to adjuvant radiation therapy. That’s an important advance in the marketplace that nobody has right now for which patients, even though they might be eligible for radiation therapy, actually will receive a benefit. The other element that we also presented during the open comment meeting and submitted similarly this data from a large 920 patient population study to examine within various subgroups, subgroups of patients, different risk factors – different groups of risk factor patients, how our tests performed.

And it basically adds value to every one of those subgroups or sub-stages of patients, which I think was also important clinical information to help the medical reviewers understand, appreciate the appropriate use of our tests in people with one or more risk factors.

Unidentified Analyst: And one other kind of high level question here. So you discussed how you feel the market is roughly 25% penetrated currently. I was curious how you feel that this level of market penetration will evolve over 2024 like at what level you could see it increasing to over time? Thanks.

Derek Maetzold: Yes. So I think in the last couple of years, we have seen what about 3.5% to 4% growth in penetration kind of every 12 or 13, 14 months or so, is that right, maybe 3.5% to 4%, not 4.5% to 5%. We see no reason why that kind of progress won’t continue until maybe we hit 50%, 60%, 65% market penetration. So I think we’ve got a good runway ramp there. Now what might cause that to go higher or grow more rapidly next year, I guess is the question that we should think about, right? I believe that the more recent data that was published in the late second quarter, both from the NCI SEER paper as well as the paper from Dillon, et al., that I talked about in the prepared script, are two elements where you can say, hey, when your peers doctor adopted the use of our tests, their patients live longer than when they didn’t test them.

Now I would ask you if that’s something that you would want your patients to receive a benefit from as well. So I think that kind of data, which will take time to work into top of mind for our dermatology and surgical customers or colleagues that might help accelerate that a bit higher than previous trends. But I think that would be what we’ve seen in the past couple of years is to me what we would expect in the next year.

Unidentified Analyst: Alright. Thank you very much.

Operator: Our next question comes from Mark Massaro with BTIG. Please go ahead, Mark. Your line is open.