Good afternoon, and welcome to Castle Biosciences' Third Quarter 2025 Conference Call. As a reminder, today's call is being recorded. [Operator Instructions] I would like to turn the call over to Camilla Zuckero, Vice President, Investor Relations and Corporate Affairs. Please go ahead.

Thank you, operator. Good afternoon, everyone. Welcome to Castle Biosciences' Third Quarter 2025 Results Conference Call. Joining me today are Castle's Founder, President and Chief Executive Officer, Derek Maetzold; Chief Financial Officer, Frank Stokes; and Senior Vice President, Medical, Dr. Matthew Goldberg, Board-certified dermatologist and dermatopathologist. Information recorded on this call speaks only as of today, November 3, 2025. Therefore, if you are listening to the replay or reading the transcript of this call, any time-sensitive information may no longer be accurate. A recording of today's call will be available on the Investor Relations page of the company's website for approximately 3 weeks following the conclusion of the call. Before we begin, I would like to remind you that some of the statements made today will contain forward-looking statements, including statements about expected addressable market, statements containing projections regarding future events or our future financial or operational results and performance, including our anticipated 2025 total revenue and the impact of our investments and growth initiatives, including our ability to achieve long-term growth and drive stockholder value. Forward-looking statements are based upon current expectations and involve inherent risks and uncertainties, and there can be no assurances that the results contemplated in these statements will be realized. A number of factors and risks could cause actual results to differ materially from those contained in these forward-looking statements. Please refer to the risk factors in our most recent SEC filings for more information. These forward-looking statements speak only as of today, and we assume no obligation to update or revise these forward-looking statements as circumstances change. In addition, some of the information discussed today includes non-GAAP financial measures such as adjusted revenue, adjusted gross margin and adjusted EBITDA that have not been calculated in accordance with U.S. GAAP. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted on the Investor Relations page of the company's website. I will now turn the call over to Derek.

Thank you, Camilla, and good afternoon, everyone. Today, I would like to start with some exciting news. Earlier today, we announced the launch of AdvanceAD-Tx, our first-in-class test designed to guide systemic treatment selection for patients with moderate to severe atopic dermatitis. Before I get into our test, let me talk about the critical need facing patients with moderate to severe atopic dermatitis. Generally, patients with moderate to severe atopic dermatitis have spent, in many cases, years on topical therapeutics and have reached the point that they are ready to cross the threshold of switching to an advanced systemic therapeutic. There are also patients who are already on an advanced systemic therapeutic but continue to experience significant symptoms. Today, there are 2 general classes of advanced systemic therapies. Biologic therapies that primarily impact the Th2 pathway are those that broadly inhibit multiple pathways, including the Th2 pathway. This latter class of drugs are known as Janus kinase inhibitors or JAK inhibitors for short. All of these systemic therapies require prior authorization for initiation of a prescription. They are expensive, and they carry -- as do all therapies, the potential for adverse events. The question facing these patients and their clinicians is which class of therapy is going to be more effective for that individual, that specific patient? We know from longitudinal prescription data that most patients start in a Th2-targeted biologic therapy today. And while these work well on many patients, around 40% to 45% of patients require adding on additional therapies or switching altogether. This lines up with data from studies that have shown anywhere from 20% to 50% of atopic dermatitis disease is driven by both Th2 and additional immune dysregulation pathways, such that a Th2 targeted therapy may not address all of the molecular underpinnings that are…

Thank you, Derek, and good afternoon, everyone. Reiterating Derek's sentiment, we're very pleased with our strong third quarter results and the continued positive momentum we are seeing with our business. Net revenues for the 3 months ended September 30, 2025, were $83 million. For total revenue for 2025, we are raising our revenue guidance to $327 million to $335 million, up from the previously provided range of $310 million to $320 million. Our gross margin during the third quarter of 2025 was 74.7% compared to 79.2% in the third quarter of 2024. Our adjusted gross margin, which excludes the effects of intangible asset amortization related to our acquisitions and excludes the effects of revenue adjustments in the current period associated with test reports delivered in prior periods was 76.8% for the quarter compared to 81.9% for the same period in 2024. Turning to expenses. Our total operating expenses, including cost of sales for the third quarter of 2025 were $89.8 million compared to $80.7 million for the third quarter of 2024. Sales and marketing expenses for the quarter were $32.8 million compared to $29.8 million for the same period in 2024. This increase is mainly due to higher personnel costs, higher expenses associated with travel and higher marketing expense. General and administrative expenses were $23.1 million for the quarter compared to $20.7 million for the same period in 2024. This increase is primarily attributable to higher personnel costs and higher information technology-related costs. Higher personnel costs reflects headcount expansions in our administrative support functions as well as merit and annual inflationary wage adjustments for existing employees. Cost of sales expenses were $18.7 million in the third quarter of 2025 compared to $15.6 million in the third quarter of 2024, primarily due to higher personnel costs, higher expenses for lab supplies…

Thank you, Frank. In summary, our third quarter performance was strong. The momentum we built reflects our continued focus on strategic priorities, disciplined execution and commitment to delivering value for patients, clinicians and stockholders. Thank you for your continued interest in Castle. Now we will be happy to take your questions. Operator?

[Operator Instructions] Our first question today will be from the line of Subi Nambi with Guggenheim.

Congratulations on launching the AdvanceAD. Could you provide more color on who would be addressable from the 13.2 million patients? And if it is all of them, how many of these patients are Medicare age?

So good to hear from you. This is Derek. Based on our calculations, the 13 million and change patients are the target marketplace in the U.S. of patients who have moderate to severe atopic dermatitis. That would be the largest denominator. In terms of the Medicare exposure, we're estimating what, Frank, I think around 10% to 15%, maybe 15%, 20% max could be of Medicare age. So it's really a -- in our case, children above the age of 12 through sort of middle age and then there's another hump later on in life.

A quick follow-up. Could you tell us a little bit more about the multiple reimbursement pathways? What do you mean by that? Is it Novitas and MolDx? Or is it more to do with commercial or something else?

I think that certainly, this is a test that will result in more medically appropriate selections or recommendations by clinicians who are seeing Medicare patients. We have to understand what the commercial payment section might look like. There's also other payer opportunities, but we don't want to provide much more color than that at this point in time until we see how the next spring plays out.

The next question will be from the line of Kyle Mikson with Canaccord.

Congrats on the quarter. First one is going to be on SCC. So kind of a multipart question. The first is on the reconsideration. The requests were approved, I guess. Anything you can kind of share on timing and likelihood and next steps and things like that? I know it's obviously probably tough to get a handle of that. Then secondly, the SCC volumes seem kind of flattish to down, let's say, quarter-over-quarter. But the gross margin for the company, it seemed to decline sequentially. So maybe what's happening there? I would have thought -- yes, some of the dynamics into gross margin and that kind of like debt cost volume is interested to hear.

I'll take the first couple; and do you want to handle the gross margin, Frank?

Yes.

So on the reconsideration request, the Medicare manual is pretty, I guess, straightforward and direct, which says if there's new -- I can't remember the exact words. But basically, if there's new clinical information that was not reviewed or considered as part of the kind of current LCD, whatever that LC would be in terms of how many years since it was issued or finalized. Then, a reconsideration request should be deemed as being valid if, in fact, there is new information that was not considered as part of the initial LCD. So that sort of is the threshold there. And as we've talked about, I think, publicly now for quite some time. The fact that the open comment period is closed down in the -- I guess, the fall or 2023 in some cases. We had a significant number of new publications, new data coming out, including, of course, both of the seminal publications regarding the use of our tests or demonstrated our tests could predict responsiveness to adjuvant radiation therapy. So I think the evidence was there to go ahead and say these should be valid considerations. And in fact, they were deemed so by both Medicare -- by both Novitas and MolDx. As it relates to timing, the Medicare manual or the [indiscernible] manual doesn't have any specific kind of start and stop dates. So that's really up to the working pace of either one of those contractors. So that's an unknown outcome, Kyle. Regarding SCC volume, keep in mind that until the -- I guess, towards the end of the second quarter, our dermatology commercial teams were being focused or bonus, I guess, whatever you want to call that, roughly 50-50 on melanoma and squamous cell carcinoma. I think that we certainly know that these are promotionally responsive marketplace. That's why we have field forces against them. We are working on those products. But we also know that these tests and this one in particular, the SCC test provides clinicians who are ordering the test with tremendous information that they realize they can't get elsewhere. So I'm not sure if the -- I mean, flattish to me is actually quite strong in terms of saying, if the volume went down tremendously, you would say, gee, there really wasn't much use of that clinically anyway. So the fact that we actually maintain close to the same volume, I think, is quite important from how our clinicians are using the test and adopting it for ordinary patient care. Frank, do you want to...?

Yes. And Kyle, we did have some modest revenue in the quarter from some commercial claims on SCC, not really material. But there were some dollars there, which helps the gross margin line.

The next question is from the line of Catherine Schulte with Baird.

This is Tom Peterson on for Catherine. Congrats on a really solid quarter here. I wanted to ask a first question here on the DecisionDx-Melanoma volume outlook. 3Q volumes were up about 5% sequentially versus the guidance of kind of flattish in the back half versus 2Q levels. So I guess, what did you see in the quarter outside of typical seasonality? And then with that in mind, how should we think about the 4Q volume growth for DecisionDx-Melanoma given the reiteration of the high single-digit outlook for the full year?

So we had, I think, signaled or stated, I'm not quite sure what the word is. Early in the year with our guidance back in -- when was that given May or March, that we expected upper single-digit volume growth year-over-year in the melanoma test. And that was met with some head scratching, I guess, in some places in the world. But it looks like that's what's coming in at. So we are running on our model, which is good for us from the standpoint of modeling accuracy. I don't think there was anything special in terms of third quarter to second quarter this year. We continue to have additional support from a medical communication standpoint at congresses and publications. We also had our dermatology sales force, of course, be switched over to, I think, either 95% or 100% focused on the melanoma test beginning in July of this year. So perhaps that quarter versus quarter lift was due to that complete focus on the melanoma test with the squamous cell test being service, I guess, you would say, versus being educated on. In terms of fourth quarter, as you may recall, in years past, we typically see the fourth quarter to be flattish or down a bit to the third quarter in terms of normal seasonality. That's due to a combination, we think, of both holidays, both Thanksgiving, Hank and Christmas in the fourth quarter, shorter working days as a result of that, coupling that with people actually wearing pants and long sleeve shirts and hats on. So you sort of pick up less incidental melanoma or looking mold. So I don't think anything would tell us that we would expect something differently in the fourth quarter than what we've seen in the last 2 or 3 years. Is that correct, Frank?

Tom, are you still there, is there another question?

The next question will be from the line of Mason Carrico with Stephens.

So on DecisionDx-Melanoma, good acceleration there. Could you give us a bit more insight into how refocusing the derm team has had an impact? What are you seeing drive the majority of the growth, at least in Q3? Was it new ordering clinicians ramping up? Was it higher utilization among existing docs?

Yes, we see both avenues of growth. I call it same-store new store sales growth. We've seen both. We do continue to have new ordering physicians that convert and then we do try to penetrate deeper into their practices and into their patient base. So both areas were continue to grow for us. And as we said before, it's lots of room to go on that test yet. More physicians to penetrate for sure and then more patients that we'd like to see expand in individual practices.

Frank, any additional insight you can give on the guide update? I think the previous guide may have assumed non-DecisionDx-SCC revenue growing 21% to 26% this year. What does the guide imply now? And could you just clarify what DecisionDx-SCC did contribute in the quarter?

It was a kind of mid-single-digit millions, Mason, on SCC, not material, but we do see some commercial claims coming through on the test. So a modest contributor there. But as we said, we're expecting kind of high single-digit year-over-year growth in volumes on melanoma. I don't really model ASP improvement. We certainly continue to make some progress and hope to continue to make progress. But we really keep ASP advances as upside, just given the difficulty in predicting how and when they may come. And so yes, we're -- I would not assume continued SCC revenue. We're sort of assuming that falls off here just to be conservative.

The next question today is from the line of Puneet Souda with Leerink Partners.

You have Michael Santa on for Puneet. Congrats on the quarter. I just wanted to ask one on TissueCypher. So it looks like you're approaching roughly double-digit market penetration. I was kind of wondering if you could offer some insight on the penetration of physicians in that market? And how you expect the momentum to look, I guess, as you're rounding out the year heading into 2026?

So we haven't necessarily disclosed this quarter, not last quarter, I guess, number of ordering clinicians in the U.S. I would say we are still in the, obviously, early growth phase there, both from a penetration of patients being diagnosed by gastroenterologists plus number of gastroenterologists who are adopting our test across the board. So I think both areas, as Frank said, same-store new store sales is on the upswing for TissueCypher. Keep in mind that based upon third-party data, we think there's what, roughly 420,000 patients diagnosed each year with Barrett's esophagus that could be potentially benefiting from our test. So there is a nice long way to go to get to 105,000 tests a quarter if that was fully penetrated. So I think that reflects upside. Regarding the other part of your question, Frank, do you want to?

Are you just looking for where we kind of where we think the test is going to go penetration-wise?

Yes. I guess there's any color if you see potential for, I guess, similar market penetration rate into 2026, or if there's anything like a broader awareness or any sort of guideline or coverage wins that you think could potentially drive an acceleration?

I'm not aware of any guideline activity going on that would impact it.

Yes. I'm not sure how much that would drive market share upward. I think it really is more about continuing to educate the marketplace and accessing our customers at the right frequency and new customers at the right level. They appreciate the value of ordering a test like TissueCypher to help guide patient care decisions about do I go ahead and watch and wait and have this patient back every 3 to 5 years or I have to have it back every 6 months or 1 year? Do I go ahead and even intervene and eradicate the Barret's esophagus lesion. So I just think we're seeing early upswing -- from a modeling standpoint, as Frank had said last quarter, I would not go ahead straight-line growth percentage. As our denominator gets bigger, we would expect to go ahead and see the percent growth be lower. But I think that there's a lot of upside, obviously, in getting patients the kind of care they deserve.

The next question is from the line of Mark Massaro with BTIG.

This is Vidyun on for Mark. So I have one on DDM. I think you're pursuing FDA approval there. Could you just educate us on if there's any upside to your current Medicare rate as a result of that FDA approval? And just remind us of the timing of when you're expecting that?

You're talking about our DecisionDx-Melanoma test, correct?

Yes, correct.

Okay. So I thought, want to double check. So we are preparing the application following the achievement of breakthrough designation status earlier this summer. Our intention -- our rationale for doing this, number one, is because it's our option as opposed to be forced to that to provide some benefits to us from a review standpoint. In terms of upside potential, I don't see this changing our Medicare rate, because as an ADLT through the novelty route as opposed to through the FDA approval route, we sort of already there, I think. So I wouldn't bake that into a benefit. What our hope in pursuing this line, not only with the melanoma test, but looking at our other tests as well is that there are these state biomarker laws that many of us have talked about in the industry for the last couple of years that I think are covering more than 25, maybe less than 30 states so far and more likely going forward. And while those biomarker laws have not proven yet to be the -- to have the impact that they were meant to have by the state legislatures. Our belief is that over the next couple of years, we're going to see improved enforcement amendments, I guess, to these current laws and regulations such that insurance carriers will be having to follow in Hawaii to do the right thing and follow the intent of these biomarker laws in the first place. And one of the core elements of I guess you would say, coverage under the majority biomarker laws is your test FDA cleared or approved. And so that's our hope is that downstream, not immediately in, call it, '26 or '27, but maybe towards the end of the decade, not only Castle, but others of those who are pursuing an FDA route towards our test will begin to go ahead and reap the benefits of having commercial payers actually stand up and actually reimburse us fairly.

Perfect. Then I just had one follow-up on TissueCypher. Could you just remind us of what your current sales force there stands at? I think it was 65 reps that you may have added since then. And then I'm just curious, you put up a record quarter for TissueCypher. So did you realize any benefit from that prebuys acquisition that you did a couple of quarters ago? I think it was kind of an adjacent technology. Yes, I'll stop there.

Yes. There was no impact on TissueCypher from Prebuys in the quarter. And we have -- on the sales force side, for competitive reasons, we're not giving specific numbers going forward. But what we've said is that we think these therapeutic areas can be targeted with sales forces of under 100 people. And we still think that is the case in NGI.

The next question today is from the line of Thomas Flaten with Lake Street.

A couple of quick questions. One on Advance-Tx. Have you guys just by chance had any engagement on the biopharma side with the manufacturers of JAK inhibitors? I can see there being a strong interest on their part in ensuring that patients get tested appropriately more so than maybe the Th2 therapies.

Yes. We aren't going to comment a whole lot there. I think as you would expect, though, Thomas, that there should be a natural synergies between being able to identify patients who may get a better response versus a less and better response. So we'll see how those kinds of interactions would benefit today. And of course, the initial version, we didn't quite call it version 1.0, but call it 1.0 was really focused on the data that we presented in the press release plus the accompanying corporate presentation on atopic dermatitis. Going forward, as you know, from Castle, we are continuing to invest in studies and the atopic dermatitis field is no less. We are hopeful. But we don't know, of course, right now that by having 487 genes sort of paper over these 12 different immune or skin-related pathways that we may be able to find signatures even for other classes of therapies or even potentially specific drugs themselves, depending on how unique there kind of action is. So there's opportunities, I think, not just near term, but also midterm to go ahead and improve the utility of our test beyond this initial area, which is personally fantastic to me.

Then finally, I know you get asked this every quarter. But philosophically, on SCC, you're going to continue accepting orders and processing those for the foreseeable future. Is there any trigger that would cause you to no longer accept orders for SCC at this point?

I don't see one right now unless there's some really bad actor playing by the Medicare contractors and even then we'd have to take a really thoughtful internal discussion. We have always believed that if we are developing or acquiring in some cases, a high-complexity assay like our squamous cell carcinoma test. Being in the health care business, we should be offering that test clinically for advancing patient care. And a sort of interim or intermediate blip in sort of the reimbursement landscape would be a terrible way to run a business and say we're going to yank it away from our patients because of a couple of contractors' decisions that we think weren't necessarily in the best interest of patient care. So I don't think there's any short-term trigger like that per se. We're aware of that. Do you want to add to that, Frank?

I think that's it.

With no further questions in the queue at this time, I'd like to hand the call back to Derek Maetzold to give closing remarks.

Thank you, Harry. This concludes our third quarter 2025 earnings call. Thank you again for joining us today and for your continued interest in Castle Biosciences.

This concludes today's conference call. Thank you all for joining. You may now disconnect your lines.