My pleasure to be hosting the team from Castle Biosciences here. Derek Maetzold, CEO, and Frank Stokes, CFO, and Camilla Zuckero, of Investor Relations in the audience. So great to have you guys. Thank you for the invitation, Puneet. Great to be here. Awesome. Okay. So, maybe just to kick off, you know, you had a strong beat in the quarter. I think mostly it was ASP for DecisionDx, cutaneous melanoma test, came in - that came in strong. You got paid on SCC as well. Volumes were sort of in line to us. But maybe, you know, just looking at the business where you are today, what... Maybe just walk us through parts which, you know, excite you the most, and, and what are the things that investors should - ought to be looking for, you know, in, in, in, in the second half? Yeah, thank you for that question. I'll, I'll take the non-financial aspects, and Frank can have the financial aspects. Yeah. So I think on a top-level perspective, we ended the quarter a little ahead of where we thought we'd do overall. Mm-hmm. We did have strong revenues. Notice the volume growth was stronger than we anticipated, but pretty much in line as well, so similar expectations there. We entered the second quarter, actually, all of 2024, I think in a very nice position across the whole company. We saw DecisionDx-Melanoma, we believe at the end of the first quarter, probably had 26% market penetration or market share out of 100. So what could that go to? I don't think it's unreasonable to say, for good patient care, especially with our survival data, why that can't double and more than double over time. So the question sort of is when we might get to 50%, 60%, 80%, not sort of, I think, if, maybe. On DecisionDx-SCC, we had also a strong quarter. That test is still in a sort of early infancy of launch, you might say, as well. We're kind of in the single digits from a market penetration standpoint. That marketplace is not quite double, we don't think, but we think there's about 130,000 people diagnosed each year with invasive melanoma that would fit our criteria for use of the melanoma test, versus about 200,000 patients for the squamous cell carcinoma test. Mm-hmm. So certainly, greater potential lives to be improved upon with testing in the kind of single digits in terms of market penetration. That feels good going forward in dermatology. We also have MyPath Melanoma, which is more of a dermatopathology call point. We resource that with a small kind of SWAT team, and they, again, I think, have their best quarter ever. So that's again, moving along quite nicely on a lower volume scale, but a very important scale to help patient care. TissueCypher, our test for Barrett's esophagus disease, is a gastroenterology-focused call point. We ended the quarter where we thought we should end the quarter, see the exact kind of test that we looked to acquire in December 2021, which is to say there's about 400,000 plus patients, maybe 415,000 patients, that are diagnosed each year or scoped each year with Barrett's esophagus disease. And this test enables a gastroenterologist to have an opportunity to really say, "Hey, pathology grading," Barrett's is graded, not staged, unlike cancer, and pathology grading is tough, and the majority of people come back as what's called nondysplastic Barrett's esophagus, or NDBE. And the question facing gastroenterologists is, if I have a patient who has Barrett's esophagus identified on a scope, I'll take a pinch biopsy, it goes to pathology. If it comes back in the U.S. marketplace as high-grade dysplasia or low-grade dysplasia, Barrett's esophagus, then we typically ablate those patients. We essentially kill off the Barrett's lesions so that we can stop progression to esophageal cancer. In the case of nondysplastic disease, which is 90%-95% of the overall patient population, the current standard of care, the traditional standard of care has been, we'll watch those patients. So we'll have them come back every 3-5 years to be re-scoped, to see if their nondysplastic disease might have progressed to low-grade or high-grade. Hopefully, we can catch it before esophageal cancer, and then take action then. Well, the problem with that methodology, which is good in terms of risk stratifying intervention, is that because we aren't intervening or killing off the Barrett's lesion in the nondysplastic patients, and because that's the biggest population by far, that means that patients who go on to progress to esophageal cancer, many of them come from that bucket. Because you can't 'cause as a population, they have a low risk, but individually, they can. So what TissueCypher does, as you know, is it lets us take the residual biopsy specimen and classify based upon our spatial omics signature into high-risk, intermediate-risk, or low-risk progression, with high-risk progression being actually similar to or greater than low-grade dysplasia. So the question we ask our customers is: You're going forward and recommending and counseling a patient with low-grade dysplasia to undergo ablation therapy because they have enough of a risk of progression that the side effects, the intervention itself, it's a favorable benefit-to-risk ratio. Why would you not want to do the same thing with a patient who has a favorable benefit-to-risk ratio, but located not on pathology, but on a molecular basis through our test? Mm-hmm. That's an easy head-shaking opportunity. We left the first quarter, I think, very strong. Mm-hmm. We ended up increasing our sales force during the course of the second quarter here from 24 to around 40 sales representatives across the U.S. They're in training right now. So we have expectations throughout the rest of the year that we'll go and see that begin to go in layer and faster growth for TissueCypher. Mm-hmm. And that's also, you know, low single digits market share, single digits market share. So we've got great opportunities there for upside. And then, as you know, IDgenetix was the pharmacogenomic test that we acquired in 2022 to again, give us dermatology, gastroenterology, and this mental health position, so we can, we can, we can, we can work on all three tiers going forward, as opposed to only having one. Mm-hmm. That test has performed as we expected, which is to say, it's—there is clearly a need for a pharmacogenomic test that combines not just drug-gene information, but also drug-drug information and lifestyle factors in a single test report, so that physicians and clinicians are able to go ahead and get those results, look at their patient and say, "Hey, I usually try drug A for my first therapy, for instance, depression. But based upon what I'm seeing in this report, actually, drug C or D might be the better choice for you. Let's start there. Mm-hmm. That hopefully gets people on the right therapy quicker, and they get a quicker response to their mental health illness. That feels very good in terms of first quarter sales- Sure. going into the rest of 2024. That's great. I want to, you know, touch on a topic that is, sort of front and center for investors, right now. You know, last quarter call you talked about, squamous cell carcinoma, coverage, potentially get the coverage ambiguity getting resolved there by June, July timeframe. Maybe just help us understand what's behind that, and for those who are, you know, maybe don't understand the background here, maybe just if you could take a minute and describe the issue at hand, and how are you trying to address it in sort of multiple ways? You want to take it or me? Sure. So, we're working on two with two contractors on coverage for SCC. Mm. We have draft negative policies for both. The Novitas policy is not a Castle policy. It's a broad cancer biomarker policy that it impacts our tests, but several other... There are 13 individual tests, plus a large number of cancer panels that groups like MD Anderson run, and it purports to not cover them. It's not really based on medical review. It's our view that it's not within the legislation that delegates coverage decisions to Medicare contractors, and it's factually flawed. So, we are hoping to see that withdrawn or changed. We also have a negative draft from Palmetto, which was more thoughtful, to be sure, than the Novitas policy. But there were some misses in there, some data that we believe Palmetto missed, so we supplied them with incremental data since the time of that draft. And we're hoping that they will either withdraw that or change that to positive coverage. Interestingly, it seems like both timelines are going to line up about the same time, you know, by the third week of July. And we'll see what happens, but for now, it's out of our numbers. I think most of you guys have it out of yours. And based on what we hear, we'll take it from there. Got it. And so is it fair to say Palmetto MolDX, a resolution is what you'd be looking for, for the, on the coverage decision on that, and that's the best way to resolve the situation? I think either one is good for patient care. Yeah. Mm-hmm. There were a number of analyses in the MolDX draft policy from last summer that we thought missed some of the literature that we had actually published- Mm-hmm. But they were asking questions that we thought, "Okay, we already have the data out there. Mm-hmm. It's not just quite as transparent as you can see. Mm-hmm. As Frank mentioned, we presented that and submitted that last summer. We also have published that data in peer review publication since that point in time. Our hope would be that they will take that information in a thoughtful manner and say: "Actually, we had questions one, two, three, four, five, and we have answers now that we can see," and that should hopefully go to a positive coverage policy, which is appropriate. On the Novitas front, though, the question becomes there was a thorough medical review, in our mind, conducted in the first quarter of 2022, which is when they first provided us notice of coverage, that we meet Medicare's definitions of reasonableness and necessity, and we've been covered since that point in time. Mm-hmm. As Frank indicated, this broad sort of oncology biomarker LCD really isn't targeted towards our test specifically- Mm-hmm -it's targeted towards the whole, the whole oncology field. And, we believe that a, that a thoughtful, correct review of the data for DecisionDx-SCC should result in positive coverage for that, for that as well. And from a patient care standpoint, we really just need to have, maintained coverage in one of those two reviews. Got it. Okay. On the volumes for SCC, what is the sort of the right normalized growth rate that you imagine for SCC longer term? And, you know, how should we think about the sort of the growth that you are already seeing? Sort of how durable is that? And I think you've you know, Derek, you pointed out that, you know, this, you know, market for cutaneous melanoma, I mean, that could double, maybe this one not necessarily double. So maybe just help us understand how do you think about the sort of long-term growth rate? Sure. So I think that, we're just starting to scratch the surface on- Mm-hmm -SCC. I think that there's no reason we shouldn't see penetration rates equal to melanoma in a reasonable amount of time. We would hope to get there more quickly because we're bigger, we're smarter, we know, we're more skilled at growing these tests. And we're also a fully known entity to the dermatology community. They've been using our test for years, so our melanoma test for years. So, I would expect to see similar penetration levels there, and hopefully, it doesn't take us quite as long to get there as it did on melanoma. And as Derek noted, it's a bigger market. Mm-hmm. And just to clarify, we're appropriate for about 20% of the squamous cell carcinoma diagnoses, the higher risk proportion, which is about 200,000. And that's another factor, though, because there are so many squamous cell diagnoses a year, there's about 1,000,000, doctors are thinking about that a lot more frequently. So it's more often top of mind than melanoma, as melanoma, they might not see quite as much. So, a lot of things that line up in favor of continued growth in SCC, and I think we're just getting started. Got it. Okay. Okay, that's helpful. You know, talking about... I want to ask about guidelines on... on both of the assays, but maybe SCC first. You know, when do you think we get to NCCN? How material is that? So, the annual meeting for the squamous cell carcinoma, I guess, workgroup or panel, occurred, I think, around the American College of Surgeons, so earlier in May of this year, same time as last year. I don't, they're a newer group. They've only- Mm-hmm ... formed, or they split off of non-melanoma skin cancer a few years ago, so their cadence of reporting is a little not quite lined in history. Mm-hmm. So I would expect any adjustments they would make to their current guidelines to probably be printed somewhere between maybe December and February of next year is probably the likeliest scenario, but it could come earlier. Mm-hmm. Guideline changes for NCCN could be nine months away or could be two years away, just based upon the meeting cadence. For melanoma, that meeting's in the summertime. Mm-hmm. Historically, except for this year, they've usually updated their guidelines in sort of the December time period for January first effective date. This year came out, what, in early February, late January. Yeah. So they're kind of a month and a half off for some reason, but that's probably the right cadence for melanoma. It's probably December-ish. What's your expectation on the practice pattern change once you do get NCCN? So I don't think. On both of the tests. Yeah. Yeah. Yeah. Let's take melanoma first. Yeah. I don't believe that there are many clinicians- Mm-hmm ... who know about our test today- Mm-hmm -who are purposely avoiding use clinically because it's not been adopted by the group of 25 or 35- Mm-hmm cancer centers that make up NCCN. And that's largely because I think, one, is that we're dealing with an early-stage skin cancer, not- Mm-hmm metastatic skin cancer. Maybe once you get to a tertiary care center, they view NCCN guidelines as well, how they should treat patients, versus you're a physician who's trained to treat patients. Mm-hmm And that's just a helpful tool. So I do think that should we get in the guidelines this winter, we would see some uptick in demand. That's some of the institutions that are looking for, "I don't want to make the decision on this. I'll let somebody else run that part of my patient care." So maybe there's some volume uptake. The more important element I would see would be moving over commercial payers who are using NCCN in some cases as a roadblock, as a stop sign. Get that, and we'll talk further. So that's the benefit I would see, but again, I wouldn't see reimbursement or ASP growth immediately in a stepwise fashion. That would just be one accelerator over the course of the next couple of years, I think. On squamous cell carcinoma, I think a similar dynamic exists. Mm-hmm ... largely because, again, it's early-stage squamous cell. Even though I think the use of our test is really to rule in or rule out the early-stage treatment decisions, not necessarily how you remove the tumor. So if you're undergoing Mohs surgery to remove the squamous cell tumor through that method of excision, that doesn't change. But everything after that in terms of do you consider radiation therapy or not? Do you consider lymph node assessment? That could be as simple as a palpation, or it could be imaging, or it could be simple biopsy procedure. Those are the kinds of things that we're impacting. The sample for biopsy procedure, nodal assessment, I think is probably similar to melanoma in that there are some tertiary care centers, academic centers, where that might funnel into- Mm-hmm But most of these patients are seen in the private community. Radiation oncology, who'd be a recipient of our test results, to say, "Hey, this is a patient who is eligible under guidelines for ART consideration. Mm-hmm. I've got a high-risk squamous cell carcinoma, Class 2B test result. This is a patient, not only has a high chance of metastasizing, but also could see a great benefit from ART. Let's make sure we give that patient that." But then over half the patients that we've tested so far in our radiation therapy response study show that they don't get any discernible benefit. So they have a low risk of metastasizing anyways with a Class 1 signature, and we don't see any benefit from ART, probably because the risk is so low. So the question then becomes, wow, if you're a radiation therapy oncologist, and you see 100 patients come to you with a Castle test- Mm-hmm ... only a handful really will benefit on the worse end. Half of the patients can probably be counseled safely on watching and waiting, or we can go forward as you want as a patient. But otherwise, this is a group of people who have a high-risk tumor based upon pathology findings, but low risk molecularly, and no discernible benefit from our ART study of gain, and we remove that half of that population. Mm-hmm. What a wonderful impact. So I don't know, within NCCN, what do radiation oncologists need to have us in there to be able to act and kind of dissuade that conversation? In my experiences so far in talking to our radiation oncology customers and end users of our test results, that they don't seem to be that guideline-driven, as opposed to, I have a tool, which is radiation therapy. I've got people who are waiting to get into a course of therapy. Removing people who don't benefit is an easy- Mm-hmm No-brainer from a patient care standpoint. So we aren't seeing resistance there in terms of that aspect. No, that makes sense. Just wanted to touch very quickly on a guideline question. You know, this is not frequently asked, but it's AJCC is, you know, the primary guidelines there. What is... And maybe a sort of a higher bar, so to speak, but what does it take to get into that guideline longer term for distribution? AJCC, that's a funny group. So one is that their cadence is typically once every seven or eight or nine years updating. Mm-hmm. So they were, like, this last major update was probably 2018, so they're due for one now in 2024, 2025, 2026 timeframe. ... If we look at other cancer stages, they really are trying to mirror themselves with the international version of AJCC. Mm-hmm. Which means that whatever they put into AJCC in terms of diagnostic criteria, can be done in countries around the world, not just US-centered focus. And so for that purpose, if you take even breast cancer testing, I mean, it was a couple of decades before you begin seeing them put into molecular characteristics of actually what you should use from a breast cancer diagnosis standpoint. So AJCC, to me, is unlikely to move forward in many other cancers, including melanoma or squamous cell, by saying, "Hey, we think you should be running a gene expression profile test to sort of create a substage. Mm-hmm. That's probably unlikely in general, and my expectation in the near term. More likely would be care guidelines, NCCN, AAD, et cetera. Got it. Okay. Okay, super. I want to touch briefly on reimbursement side for... I mean, ASP was up, you know, 40% year over year, and I think for DecisionDx-Melanoma. Maybe just talk about the effect that you—I mean, what's driving the ASP uptick? How much is commercial reimbursement? But, you know, today, what do you expect from commercial reimbursement contribution or commercial payer contribution sort of going forward? So on a year-over-year basis, just keep in mind that the squamous cell test got an increase through ADLT. I see. So- That's right. Q1 against Q1, you have to make that adjustment. But if you look sequentially- Mm-hmm. There was good ASP growth, and, you know, it's most of that sequential growth comes on the commercial side for melanoma. And I think a lot of that was just driven by a number of small payer wins that went into effect at the beginning of the year. Mm-hmm. You know, insurance companies are great when they decide they're going to cover you. They don't start covering you when they decide. They put it in some kind of cycle, and for a lot of them, it was the beginning of the year. So I think we had a number of those that kicked in. I wouldn't model that same increase repeatedly. That was probably more of an annual cycle-driven impact. We still are getting paid on about half of our commercial claims, either through coverage or appeals. And, you know, the job, the need is to get as many of those zeros to paid as possible. The cost of those tests is in the P&L already. The COGS is in there, the marketing costs associated, all the promotional costs, that's in the P&L. So when you take a zero and change it from a zero to a something, that just drops to operating income, straight down leverage. And so, it has a big impact on the financial profile when we convert those. I think part of the wins we're starting to kind of get slowly see here. So part of the wins we're seeing- Yeah. is driven by, data- Mm-hmm. -and the continued evidence that we generate. That's okay. They can probably hear me now. [crosstalk] I'll move. Oh, hold on. Thank you. How about now? Now. Back? Okay. All right. Sorry for the interruption. Yeah, there we go. Much better. Technical difficulties. I'll probably lean back and turn it on. So I think part of that we're seeing is certainly the body of evidence, the weight of evidence that we've developed, and then I think the penetration helps us as well. At some point, when you've got, you know, half the physicians are using the test, it's more and more difficult for an insurance company to say, "Hey, that seems to be experimental, really. Mm-hmm. Well, half the docs are using it, or are half of them experimenting with their patients? And so it becomes a little bit more, a little bit more credible as you increase that penetration. So I would expect we'll continue to see small wins. I think that, there are other, other, some of the bigger payers probably will wait for NCCN. And then on the other tests, we're still just early, early innings yet. Okay. Then just following up on that, I mean, sort of, how should we think about operating margin, sort of outlook and then, you know, path to cash flow, you know, profitability? Yeah. So, if we do not continue to have appropriate reimbursement on our SCC test, we still maintain our long-term target of operating cash flow positivity, for 2025, and that's basically adjusted EBITDA, taking out the non-cash stock compensation expense. If we appropriately retain coverage, which we should, then we will have pulled that forward. And what you've already seen is you see that our revenues are growing at a higher rate than our expense lines. We've kind of grown into the P&L, if you will, or we're getting leverage on the P&L, and, you know, part of that is just through critical mass, and part of it is conscientious and mindful management of our expense lines. You know, we saw most of our categories were only modestly grew in the fourth quarter sequentially, but most of the growth was in sales and marketing, which is where you'd expect to see it as we continue to build the sales force. So, I think that our gross margins would be impacted somewhat if reimbursement for SCC is discontinued, but would still be very healthy, particularly compared to the rest of the sector. We would still compare very favorably there. And that gross margin through, you know, we've talked about it before, but it's thoughtful placement of our labs in lower-cost cities to operate. Phoenix and Pittsburgh are lower cost than Cambridge and the Bay Area. So, our real estate costs are lower, our people costs are lower, and with all of our tests, except TissueCypher, are run on QuantStudio qPCR from Thermo, which you may be familiar with, and that's just a very, very efficient platform. It's very very cost-effective and the consumables cost is very manageable on that platform. TissueCypher is a little bit more expensive to run. There's some more manual steps to that, and it's a different technology. That's our spatial omics technology. So it's a bit more manual, but we've done. Gosh, that lab's only been open, what? A year and a month, right? And we've already done, made huge steps in terms of automating much of that process, adding informatics in the middle to increase the throughput on the informatics side. The part of that process is an algorithm reading high-resolution images of proteins, and adding more computing power has allowed that annotation and that curation to go more quickly. So we've significantly increased turnaround time, but also reduced COGS, and I think we'll keep working on that, and keep moving that the right way. So the gross margin helps us with the rest of the P&L, obviously, starting at a higher point. So we'll continue to improve our ratios and decrease the percentage of revenue of each of our expense lines. Some things are gonna be a little bit more variable. R&D is gonna be a little less linear, because we're somewhat dependent on third-party centers and study sites, and we can sometimes control or influence their behavior, but we can't completely influence. And so sometimes things go a little more quickly, a little more slowly, so that line, that category may not be purely linear here. But everything else, I think, will grow at a level less than revenue. Got it. And when you think about the question is about sales force, and when you think about the sales force on the melanoma side and then SCC, IDgenetix, and TissueCypher and overall, maybe are there certain areas where you still need to continue to hire, or are they, which areas would you say, which assays are fully staffed at this point? I think on our dermatology-focused- Mm-hmm ... sales team, which is the melanoma test, the SCC test, that's in the mid-70s, I think, right now, and- Mm-hmm ... that's probably about right size for the marketplace of dermatologists- Mm-hmm ... as customers. I do see us increasing, 1 or 2, 2 or 3 here or there, as we kind of see territories hitting the $3 million-plus mark. Mm-hmm. Those usually occur adjacent to each other. So we can take $2 million-$3 million territories, divide them up, and then the actual sales representatives have a chance to really continue to hunt for new customers. Whereas we get around $2.5 million-$3 million in revenue projection, we finally spend a lot of time managing current customers and not enough time finding new customers. So that's about the break for us on that side of the business. On gastroenterology, we were at 24 area managers or sales representatives. We did that expansion in September of 2022, held that until April first of this year, and now we're running about 40 people going through training today. And that's probably undersized still. We think there's around 10,000 clinical gastroenterology customers who we should be talking to and could impact patient care. Gastroenterologists are in a little bigger practice settings than dermatologists are, so maybe there's more that are in the same surgical center or same practice. As opposed to- Mm-hmm ... dermatology, have more practices out there. So maybe 60-ish is the right place to end up. We are planning on kind of seeing this new group of 16 people get their feet wet here, watch early third quarter, and probably make a call to either expand earlier or else hold off a second expansion into 2025, depending on kind of what we're seeing as result-wise. We've had a firm belief over the years that we don't really necessarily want to double the sales force because that's a lot of handoff of customers, and do you lose momentum with current customers who are used to seeing Frank, and then 2 months later, Derek comes in, and, "I used to see Puneet. Mm-hmm. That's a lot of customer change we need to cause. So that's really our only concern about kind of going up again this year is saying, you know, what's the right for the clinician customers? What's too much change? Mm-hmm. Well, that grabs us. For IDgenetix, we knowingly are underinvested there. We still have, what? Around 20, 24- 20 couple. 2022 territories in the U.S. Mm-hmm. That's clearly insufficient for the marketplace size. However, we closed that acquisition, as you may recall, back in the second quarter of 2022, right as inflation, high interest rates, and whatever you do, Derek, don't go and spend a lot of cash out of the banks. We've managed that expectation, but I think going forward here, as we kind of see the health of the balance sheet and the growth of our other divisions in GI and dermatology, we can begin to go ahead and make good measured investments there, so we can get closer to where we could be and then see that product materialize in terms of the contribution that we expect it to do, so that we if we turn back in 2028 or 2029- Mm-hmm ... we hopefully have three solid bases of businesses of revenue, which would be dermatology as one, gastroenterology, and this sort of mental health division over here, and that was our goal when we made the acquisitions a couple years ago. Okay, makes sense. Just a very rapid question in the last minute here, last few seconds. ADLT has come up a lot from within an investor mind. Is there, you obviously have two successful tests with ADLT pricings, in the market currently. Do you, you know, do you expect any, I guess, for lack of a better word, risk to the ADLT pricing or that whole mechanism, how companies get funded here? That's a good question. So, one, I haven't checked the last couple weeks, at least through, I think, May. Mm-hmm. There were 16 ADLTs- Mm-hmm ... that CMS had granted a status to. We have five of them. Mm-hmm. So almost one-third of the ADLTs are actually Castle tests, which I think also shows you the kind of innovativeness and first-mover advantage- Mm-hmm ... that we invest in to grow our business to meet unmet needs clinically. I'm sure there will be future changes and gyrations on the whole PAMA legislation going forward- Mm ... for the non-ADLT tests, which are all CDLTs, of course. Yeah. The remainder of those thousands of tests, they've had delayed implementation of PAMA in terms of pricing impact there. Mm. My impression is that legislatively, the calculation method for ADLT status is well known. Mm-hmm. It's been out there for, I guess, what? 10 years now. I don't see that calculation methodology change, but it's something Medicare could always try and do. Mm. I don't think they could do it themselves. It has to go through a legislative process- I see ... and amend the PAMA legislation. But as far as we're concerned, if we can have our tests be reimbursed at the median private payer rate that commercial payers are paying, then that seems a fair way to price testing services- Yeah ... that Medicare should pay for, as opposed to an arbitrary rate that, that's set arbitrarily. Yeah. Okay, no, it's very helpful. All right, that's all the time. Thank you. Thank you again. Thanks for being here. Thank you. Thank Thank you, Puneet. All right.