We're here with Castle Biosciences. I have, Derek and Frank. And I guess we'll just kick it off here. So you had really good, strong Q3 results. You guided up meaningfully. What were the drivers of growth in both volume and in revenue? Additionally, what opportunities are ahead, that give you confidence in, in raising the guidance as much as you did? The revenue, the number is primarily driven by revenue. We did see some ASP improvement in one of our tests that drove it as well. I think going forward, the primary opportunities are to enjoy the levels of penetration in our entire test portfolio that we've accomplished in our melanoma test. We think our melanoma test is maybe 25% penetrated on a patient basis, maybe 130,000 cases a year, and that's about where we get to on a run rate. If we can drive our other businesses to that same level of penetration, that's a significant opportunity for the next couple of years. We had visibility and confidence in our increased guide, based on the momentum we had with the volume, but also the supporting evidence that we've generated, over the past several years across the portfolio of testing. Gotcha. Can you talk about some of your 2025 financial goals and how you hope to achieve them? Yes, we... Let's see. Fall of 2022, we offered long-range guidance of $255 million-$330 million in revenue in 2025, and operating cash flow, which is effectively Adjusted EBITDA breakeven for the year. Getting there is a combination of discipline on the expense side in terms of R&D and primarily sales and marketing efforts, but also volume growth with some ASP. We don't have a lot of ASP improvement in there. We are chipping away at the commercial payers across the test portfolio. We aren't assuming any big stepwise improvements there. It's mostly driven by volume across the portfolio. Talk about how you think about the OpEx in that situation. I mean, I know you have a driver of, you mentioned R&D. How do you balance that with maybe solidifying your competitive advantage in the R&D spend? And, you know, how do you keep, as sales go up, keep the the sales and marketing expense in check? So, we are committed to continuing to develop evidence to support our tests. That's important for physician uptake and physician adoption. It's important for payer adoption and acceptance, and it's important eventually for competitive purposes. We, our melanoma test is our most mature test. I think we have 48 or 49 publications now at this point. But even with our most mature test, our uveal melanoma test, which is a test for a very small orphan cancer indication, we continue to publish to support uveal melanoma. It's important from a physician acceptance, but also to continue to support physicians who have converted and adopted. On the sales and marketing side, there are areas we would like to invest more. We would like to increase the size of our marketing efforts in a couple of areas, but we are being very mindful of the impact on cash and impact on spending. We finished the quarter at $230 million of cash, and actually in the third quarter, we generated $5 million of cash. We expect to generate cash this quarter as well. So we've got plenty of runway to get to that break-even point in 2025. But we are balancing that spend with ensuring that we don't push that break even out any. Gotcha. So we'll go to actually DecisionDx-Melanoma, and I'm gonna come back to a couple financial questions maybe towards the end. So the DecisionDx-Melanoma test, the volumes were up 21% year to date. From a patient standpoint, market penetration, you know, around a quarter penetrated. Can you talk about what are driving the strong test volumes, and where do you think they can go from a penetration standpoint? I'll take that, David. I think, maybe last, first. We see sort of three different plateaus, I guess, in diagnostics like this. Our uveal melanoma test, the breast cancer test, they're probably 85%-90% of appropriate patients are tested with those tests year in, year out. The next tier down are probably tests that have maybe kinda peak out around 60%-70%. I think based upon the utility that we see with our melanoma test, we think 60%-70% probably is where we should be estimating that from just a conservative standpoint. So we're sitting here at 25% today, so at least 2.5 times, we think, to kind of... prior to having us think where we get to. Now, what's the underlying drivers of that is exciting. One of them is to say that, certainly in melanoma, with the advent of immune checkpoint inhibitor therapy, which are still reserved for more later-stage melanomas, what's important is that if you can identify which patients you need to actively survey, which is largely in melanoma, CT scans of the pelvis to the neck, brain MRIs to pick up metastatic disease early, those patients survive longer when they get on therapy earlier versus a patient who has a symptomatic event. We had, in the second quarter of this year, two publications come out. One of them was a collaboration with the National Cancer Institute and their SEER program, which demonstrated not only does our test risk stratify in patients who were clinically tested, so that is real-world patients, in the SEER registry program, which was a nice checkbox exercise confirming our clinical studies. But more importantly, from my perspective, is that patients who had their melanomas managed with the benefit of our test as part of the clinical care, compared to matched controls for clinical and pathologic factors, except they weren't tested clinically. The ones who received our test results as part of their care actually lived longer, had a longer survival, which we've seen previously with Oncotype for breast cancer. But see that in melanoma, I think is very, very attractive. We had a second study, a sister study, almost, you could say, which came out also in the second quarter of this year from Cleveland Clinic, Northwestern in Chicago, and Oregon Health & Science University in Portland. Though that study, although it's slightly different than the NCI SEER data, also said if you are clinically tested with DecisionDx-Melanoma, have your care guided by that test result, those patients actually live longer in those same institutions than ones who are not tested clinically. So those two elements of data, I think, make us very, very comfortable with the growth in 2025 and 2024 because of, of the newness of those publications and having more later adopter physicians come back and say: "Hey, why should I use your test?" Well, you should use our test because when you do, all things being equal, patients live longer because they're managed in the right risk group. Got it. Okay. So how penetrated could you be from an actual ordering physician standpoint? And how do you drive further penetration in the clinical market, as well as drive higher utilization from the docs that are currently ordering today? Currently ordering? Our target audience is a little squishy. It includes dermatologists that are more medical dermatology. It includes their nurse practitioners and PAs, and also includes some surgeons and surgical oncologists. So that's probably maybe around a 15,000 universe, maybe as a denominator. I think today we are probably anywhere from a third to half of that in terms of how you want to cut the apple. Now, where should we get to? I would hope at the end of the day, we'd have 80%-85% of physicians or clinicians using our tests for the right purpose. We do still have quarter-over-quarter increase in new ordering customers for the very first time. On the other hand, we also know that within our existing ordering customers, there are some ph... Clinicians who have niched or located us to what they think is a sweet spot of our test. So for example, for those clinicians who are using our test primarily to guide sentinel biopsy surgical procedures, or rather to avoid them, many times they will only use our test when a melanoma is 0.7 or 0.8 millimeters or thicker. That means they aren't using it on probably the 40% of the patients who are thinner than 0.7 millimeters. Our job is to generate data and to go in there and say: "Can we have a conversation about the cut point you picked? I understand that point, but let me show you the data from the NCI SEER database. It shows you that the thinner patients who use our test clinically actually survive as well as the thicker patients. Does that help you think about as a physician or a clinician ordering our test in patients you're currently thinking are not appropriate? So I think we can go deeper from a market penetration with a reasonable number of clinicians, and we can go wider in having more physicians on board. Gotcha. Let's move to DecisionDx-SCC. Test volumes are up 92% year to date. Can you talk about what's driving that? And where from a market penetration standpoint, are you, and how do you complement DecisionDx-Melanoma test with that test? How does it complement it? Do you want to do part of that, or you want-? Sure. So SCC is probably maybe about 5% penetrated on a patient basis right now. But there's a great synergy between the two tests in that they're the same prescribing physician, largely the same group of physicians. So, the sales guys would hate it when I say it's an easy sell. It's a logical sell, maybe. But you've got a doctor who's using our melanoma test, and you're able to say: "Look, this is a tool that's benefiting your melanoma patients. We have a similar tool that does the exact same thing for your squamous cell patients. Let me help you understand which patients it's appropriate for." So there's great synergy between them, and I think in the quarter we had, I think it was 75% of the physicians who used our squamous cell test were users of our melanoma test. Squamous cell is. There are about 1 million a year, squamous cell carcinomas of the skin. We are only appropriate for about 20%, which are high risk or have a high risk feature or high risk element. But because there's so many, a physician is seeing squamous cell skin much more frequently, so it keeps the test top of mind. I mean, a small, you know, a community dermatologist in Rye, New York, might see five melanomas in a year maybe. But they're going to see squamous cell skin much, much more frequently. So it's a larger market for us. The clinical utility is at least as good or better than our melanoma test, and it's a patient group that physicians are thinking about a lot more frequently. Cool. Great. Can you bring us up to speed in what transpired over the last year regarding your coverage of tests? Sure. So, specifically, DecisionDx-SCC or all of our tests? Let's go with all your tests, but I mean, I do want to specifically... That was toward SCC, but you might as well- Our test portfolio. You might as well talk about the other portfolio. So we offer a number of proprietary assays. Our DecisionDx-UM, for this rare cancer Frank talked about earlier, uveal melanoma, which is about 85% penetrated. We have enjoyed Medicare reimbursement, both under just a medical policy review in the earlier part of last decade, with a formalized LCD in the latter part of last decade. That continues to be used day in, day out, in about nine out of ten, eight out of ten patients who are diagnosed each year. It receives Medicare reimbursement rate in the $7,000+ range. And it's now under a test-specific LCD. Our DecisionDx-Melanoma test, which first received coverage under a MolDX LCD in 2018, continues to be covered under the same, although it's now shifted to a foundational LCD. From a Medicare coverage standpoint, that reimbursement rate is also in the $7,000 range for Medicare, and that continues to be maintained, we think, for at least the next couple of years, based upon current private payer, medium ranges. We have a third test, which is TissueCypher, which we obtained from an acquisition with Cernostics in the fall of 2021. That test is run out of our Pittsburgh laboratory. It's a protein-based spatial omics assay. We received Medicare coverage following a Medicare review, I guess in early 2020, probably about a year and a half, two years before our acquisition. Mm-hmm. That Medicare reimbursement rate is $4,950 per test. Then we acquired a second company, which gave us IDgenetix. That is also covered under a MolDX LCD. We did receive word last week that Medicare is going to increase the reimbursement rate from $900 and change to $1,330 and change, effective January 2024. Then the last one here, which is the SEC question- Mm-hmm. is that we have a test, as Frank talked about, for use in high-risk squamous cell carcinoma of the skin. We had that test undergo medical review by Noridian in the first quarter of 2022. They reviewed that in a positive fashion, and since that time, it's been covered and remains to be covered as of certainly this morning. Some of the overhang, though, on the stock issue is to say: Well, gee, Noridian posted a broad oncology biomarker LCD here- Mm-hmm In July this year, that purports to essentially delegate out review of test services to three guidelines, NCCN, and two other more mutational database guidelines or curation services. That draft LCD would suggest to finalize as is, that they'd like to remove coverage from DecisionDx-SCC upon finalization, the effective date of that. That still remains under review by the Medicare contractor and by CMS as we speak. And then separately, the MolDX program also reviewed our DecisionDx-SCC, and they also put out essentially a draft LCD that's also undergoing finalization, as we speak today. I'd expect both of those LCDs at the latter end, probably to go and finalize in mid-second quarter of next year. Got it. So let's move on to TissueCypher, that acquisition you talked about. What's been driving the recent growth? What are the dynamics that have make the test so successful from an adoption standpoint? So I'll handle part of that. You can handle the second part-first part. I think for TissueCypher, what attracted us was that when we were doing diligence work prior to finalizing an offer in the summer of 2021, what we heard from gastroenterologists, which is our target ordering customer base, about 10,000 medical gastroenterologists, we think are our customer base in the U.S.. What we heard them say is to say, "We have an issue with these people who are diagnosed with Barrett's esophagus. And the issue that we have is that we know that this is the only known precursor to esophageal adenocarcinoma. So it's a very important precancerous condition, and we also have tools that we can actually eliminate Barrett's esophagus disease by either using an ablation technique or even a surgical removal technique. But we can't do that on 400,000 patients a year. That's just too many interventions on patients because the likelihood of progressing is so low that not everybody should be treated with an intervention like that. However, when we look at your data on this TissueCypher test, we see here is you can take the 90%+ of the patients who are diagnosed with the lowest risk of Barrett's esophagus disease, which is called nondysplastic. And we can pick out people in that group that have a chance of progressing to esophageal cancer or high-grade dysplasia that's greater than as if they had low-grade dysplasia. Why is that important? Because we ablate everybody with low-grade dysplasia under guidelines in the U.S. today. The opportunity of us taking this TissueCypher test and finding all those bad apples in the apple basket, to be able to hopefully cure them from progressing to cancer is wonderful. So the unmet clinical need, I think, was self-evident, and they had a tool at their disposal that they're already using, but only in a select group of people, and to have it open it up to the other people they're missing, was a very, very easy educational selling effort. And from that point, you want to handle the rest? Yeah, and so, Barrett's esophagus can progress to esophageal cancer, and it's a very small number a year, only about 10,000 a year. But that's a cancer with an 85% 5-year mortality rate. And more importantly, it's a cancer that there ought to be, there ought to be none because there's very good data that suggests and demonstrates that ablation will prevent a Barrett's patient from progressing to esophageal cancer. So I think many GIs, I would say most, but many GIs have in their memory that patient who they saw with low-grade or nondysplastic Barrett's, and 3-4 years later, they progressed to esophageal cancer, which intuitively doesn't make sense because they were, by pathology, a low-risk patient. They shouldn't have progressed, but somehow they did. And so it's quite similar. When we first looked at it, it's quite similar to our... what we saw in melanoma, which is on a population basis, nondysplastic or low-grade dysplasia, is a very low risk from a population perspective. But because it's so many of the patients, that's where the majority of cancers are coming from. And so, gastroenterologists will talk about, they'll call it a Barrett's conundrum. You know, it's a: I've got a patient, they're, they have Barrett's. I know they have Barrett's. They're low risk, but statistically, most of my cancers are going to come out of that group. What do I do? How often do I see them? When do I bring them back for surveillance? When do I ablate them? And so there was a real need, and I think that we're undersized on the sales and marketing effort. We need to increase that, and find a way to do it without impacting our long-range financial metrics that we've put out there. But you know, if numbers are fun, one of the fun metrics to look at is if we could get our TissueCypher test to the penetration level of our melanoma test. That test would be bigger than our entire company today. Oh, yeah. Maybe actually we can go into that. On the TissueCypher, I mean, what does it look like from an annual testing standpoint, and how many GIs make up that market? So we think there's around 10,000 gastroenterologists that should be our targeted group of audiences to go after. And as Frank said, we have roughly 24 salespeople today, which is clearly undersized for that customer base, and we'll be scaling it up over to 2024, 2025. In terms of of the size of the category, there's been some recent publications that would and, and third-party claims that would well, that would suggest there's endoscopies done every year on roughly 420,000-460,000 patients with a diagnosis of Barrett's esophagus disease. Most of those people, 90%+, would fit our target profile or indicated use. That's a very, very large category for us to go after. Well, you know, you mentioned how big this testing opportunity is. How do you feel from a capacity standpoint? Do you feel like you have the capacity to meet demand in 2024 and 2025, and beyond? The short answer is yes. The intermediate answer is that we knew when we acquired Cernostics in December 2021, that we needed to go ahead and build out a larger laboratory facility to handle what we believe was going to be forecasted growth. That growth outpaced our ability to complete our laboratory move in April of this year. So we did have an interim period where we said, "Hey, we need to go ahead and stop taking orders from today, because the turnaround time, I think, is not going to be satisfactory to you as a gastroenterologist and your patient who wants our test results." And so we entered into a pause period in the start of the third quarter. We were able to successfully scale up our laboratory and reopened up ordering in the latter part of the third quarter of this year. At this point in time, based upon the advances that we've made and the people and instrumentation investments we made today and plan tomorrow, we think we will stay nicely ahead of any kind of demand curve going forward. Gotcha. So, let's move to IDgenetix. You have a newer test in the mental health market. Can you talk about the need for your test? What it addresses, what are the market opportunities, and what does the competitive landscape look like? Sure. So unfortunately, that's the largest patient population that we address today. Mental health continues to... It grows every year, and many, many people with mental health issues are untreated. When... We all metabolize drugs prescribed for depression, other mental health conditions, we all metabolize them differently. And the one thing you can be sure of is they're not all going to work for every patient. And so, the old way, if you will, or the old practice was really we politely call it physician's choice. I would tell you it's really more trial and error. Patient comes in, doctor says, "Yeah, you know, I think you've got, you've got some depression issues. Let's try a drug." And so they would try, you know, what would they try? What's in the sample closet, what rep was in the day before, what worked for the last patient. And they say, "Come back in 60 days." The patient comes back in 60 days, and doctor says: How are you feeling? Because mental health is a very subjective condition. There aren't many biological tests for these conditions. And so patient comes back and says, "Well, I felt pretty good last week, but I'm kind of having a bad day." The doctor doesn't know, you know, I just be having a bad day. But you also might not be responding to the drug, and so they switch. And so there's frequently a large number of switches. And so what our test does is it gives the doctor a readout for that patient based on drug-gene interaction, but also drug-drug interaction and lifestyle factors. One important lifestyle factor is smoking. Smoking changes the way people metabolize these drugs significantly. And so it gives the doctor a list of the drugs. Here's the drugs that'll definitely work per the label. Here's drugs that'll work, but you're going to have to adjust off, from the label. And then these drugs are contraindicated, typically a drug-drug interaction issue. Ours is the only test in this category that has all three of those factors in one test report, because that's the way the test was developed. Certainly, a physician or a physician's extender can do drug-drug work on their own. You can go to Dr. Google or wherever your favorite source is and find out which drugs don't interact with the others well. But there's real value we learned with our, our customers in having all that on one page that's just simple and straightforward. We do have competitor there that has a significant lead on us. Myriad sells a test called GeneSight. They acquired that test in 2015 or 2016. All these tests were pulled from the market for a period of time, and I think Myriad, I think GeneSight was relaunched in 2018 or 2019, circa, circa that period of time. And it's a big business. They, I think their last investor day, they expected about $130 million in revenue from that test. So we're very early there, but we do have a lot of confidence that we have a differentiated test and that we have all three factors on one report. We're undersized. We have a fraction of the sales and marketing team that our competitor has there. But, again, we're balancing the appropriate expansion there with making sure we're staying within our financial discipline that we've committed to. Gotcha. We have one minute left if anyone from the audience has a burning question, I could... All right, so, we'll maybe go to some of the OpEx. You know, there was a free money period in 2020, 2021. And, you know, you're now talking about cash flow break even targets, you know, kind of the near term. So, you know, what made you control your OpEx during that free money period to make you into that kind of position? And what could make you pivot to maybe deploying more cash? And would it be on internal investment, or would it be more towards capital deployment, towards acquisitions? I wouldn't call it free money. I would say that was an era when investors more appropriately valued our company and versus today. So when we raised money in our IPO in 2019 and again in 2020, at the time, we had no competition for any of our tests or our pipeline tests that we were working on. And so we felt like it was critically important to build a significant lead so that when we ultimately do inevitably have competition, it'll be that much harder for a new entrant to catch up. And that's in terms of our sales and marketing effort, physician penetration, but also evidence development and the wall of data, if you will, that protects our tests. So we did that, and we now have, we are, as you said, we're growing into our expense base, if you will. We invested early to make sure we could build that lead and protect it. And now, as we're maturing as a company and the PNL is maturing, we're approaching that break-even period. So it's. We are, like many companies, I think we could grow revenue a bit faster if we were less disciplined, but clearly that financial discipline is important today, so we're sticking to it. I appreciate it. Thank you so much for coming. Thank you.