Castle Biosciences, Inc. (NASDAQ:CSTL) Q4 2023 Earnings Call Transcript

And so the ability of our tests to say, hey, you can take a non-dysplastic Barrett’s disease, which has a lower chance as a population of progressing compared to a high risk on pathology Barrett’s patient, we can demonstrate with our test that the risk of progression is actually higher, or the same as depending on what study one looks at, as a high-risk pathology patient, that therefore the use of intervention like RFA ablation would be a fantastic way to basically halt those patients likelihood of progressing. And so that was a fairly easy concept to present to guest neurologists during diligence, and I think on the side sort of under sizing the market opportunity during diligence a couple of years ago, and that obviously having impact in terms of volume.

The other areas that the assumptions we made in terms of physician interest and really getting to a better treatment plan for their patients is being realized.

Operator: We will go next to Mason Carrico of Stephens.

Jacob Krahenbuhl: Hey, guys, this is Jacob on for Mason. Thanks for the questions here. Just one on SCC real quick. So on the potential of updated NCCN guidelines, including DecisionDx-SCC, do you perhaps have any insight into what level inclusion or what the language would have to look like in NCCN guidelines to meet the threshold of the Novitas draft LCD, based on how it’s currently written? Or maybe what are the different ways that SCC could be included in the updated guidelines, but for whatever reason, still not be covered?

Derek Maetzold: So we don’t have any insight in terms of how that might be considered or discussed. I can tell you we think is probably appropriate, maybe. So within the current squamous cell carcinoma NCCN guidelines, there is a table that sort of defines patients in the categories of risk. Having one or more of these clinical pathologic factors puts you in kind of a high-risk patient population, and having of subset or multiple factors puts you in what they call the very high-risk patient population. Both of those populations are eligible for adjuvant radiation therapy. We would think it’s probably appropriate, given how it’s structure in the NCCN guidelines to basically add our DecisionDx-SCC test result as a molecular factor in that sort of clinical pathologic and now molecular factor table, putting people in the categories of high-risk and very high-risk disease.

That to me makes the most logical sense under the current structure. That might be an expectation we would kind of have because it seems to be the easiest way to have a clinician contemplate on the value of our tests. The second question is, if the Novitas LCD finalizes as is, what does that mean, I guess, was your question, if I got that right, Jacob. I would think that, one, that nobody has any experience with this Novitas LCD to see how different inclusions are approached with different tests, but I assume if it was included somewhere like I just described, then that should be considered a covered tests, at least based upon, I don’t want to say just natural common logic there, but that seems to make the most sense.

Jacob Krahenbuhl: Yes, that makes. That makes sense. And that’s helpful. Thanks for that color there. And then one follow-up here on your pipeline atopic dermatitis test. You mentioned it on the call that you plan on launching it by the end of 2025, and maybe some additional data this year. But just on, in terms of reimbursement for that test, is there a foundational LCD in place that you could obtain Medicare coverage for? Or would it have to go through the whole submission, draft, final LCD process?

Derek Maetzold: That’s an excellent question. So there is no foundational LCD or even test specific LCD. covering these kinds of tests that can help guide on which systemic therapy one should use for psoriasis or atopic dermatitis patients. So that with this, that doesn’t exist at all today. However, it’s also important to understand that we think that the inflammatory skin disease test is likely to be a younger population anyway, so you’re looking at different reimbursement opportunities besides Medicare playing an important role relative to say, melanoma or skin cancer.

Operator: We now have Catherine Schulte of Baird.

Tom Peterson: Hi, everyone, this is Bob Peterson on for Catherine. Thanks for taking our question, and congrats on a solid quarter, and a solid 2023. I guess maybe one for Frank to start, how should we be thinking about OpEx growth in 2024? And I heard your comments on sort of the cash flow from operations cadence here in ’24, but, you know, given the reimbursement outlook, I guess how confident are you in achieving that net positive cash from operations target in 2025 that you’ve previously set?

Frank Stokes: Hey, thanks for the question, as we said before, we still we haven’t changed or amended that long-range target guidance that we gave, I guess, a year and a half ago, maybe at this point. So we’re still on track for that. I think you’ll see OpEx growth will be will be lower than revenue growth. But like other companies, we continue to see pressure on costs, and inflation is real. So it impacts every every aspect of your business at this point. So yes, there’s growth to grow the business. There’s growth as a result of inflation in the economy, and then there’s also we’re working hard to be financially disciplined to make sure we manage to that. So still maintaining the guidance we gave and feel good about getting there.

Operator: We now have Thomas Flaten of Lake Street.

Thomas Flaten: Hey, thanks. Congrats on the quarter. Just to clarify, Frank, it was implied in an answer you gave earlier, but if Novitas finalizes as it is, you will continue accepting SEC claims, even though you’re not going to get paid on them. Is that is that a fair assumption?

Frank Stokes: We have a — that’s a bigger question, Thomas, as you do you stop making a test available if it’s not being appropriately reimbursed? I don’t know that we’ve made that decision. I think that and there’s a lot lot that goes into that. It’s a valuable test. It’s important for patients. We’re seeing every day with literally thousands of doctors how it’s changing the way they’re treating their patients, and you and I talked about it, you know my dad’s 85, and if he had a small squamous cancer on his on his head, and just because it was a little bit over a centimeter and the doctor wants to do head above the shoulders radiation therapy, that’s awfully tough. I mean that’s, — that would be tough to put a patient through. So, um, we haven’t made any decisions about keeping or dropping availability of the test, but we would have to have to wrestle with that at some point if it got there, I guess.