Castle Biosciences, Inc.

Today's call with opening remarks and introductions, followed by a question and answer session. I would like to turn the call over to Camilla Zuccaro, Vice President, Investor Relations and Corporate Affairs. Please go ahead.

Thank you, operator. Good afternoon, everyone. Welcome to CASEL Biosciences' second quarter 2024 financial results conference call. Joining me today is CASEL's founder, president, and chief executive officer, Derek Massold, and chief financial officer, Frank Stokes. Information recorded on this call speaks only as of today, August 10, 2024. 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 three 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 within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our financial outlook, TAM, and similar items referenced in our earnings release issued today, and statements containing projections regarding future events or our future financial or operational performance, including our anticipated 2024 total revenue, our expectations regarding reimbursement for our products and targeted launch dates, and the impact of our investments and growth initiatives and expanded commercial team. Forward-looking statements are based upon current expectations and involve inherent risks and uncertainties. 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. These factors and other risks and uncertainties are described in detail in the company's quarterly report on Form 10-Q for the quarter ended June 30, 2024 under the heading Risk Factors and in the company's other documents and reports filed or to be filed with the Securities and Exchange Commission. 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 generally accepted accounting principles in the United States, or GAAP. These non-GAAP items should be used in addition to and not as a substitute for any GAAP results. We believe these metrics provide useful supplemental information in assessing our revenue and operating performance. 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. I'm pleased to share that Castle Bioscience has delivered yet another outstanding quarter, continuing our long-standing history of strong execution and performance excellence. Second quarter 2024 revenue grew by 74% to $87 million, and total test report volume grew by 49% to 25,102 compared to the second quarter of 2023. Our strong performance is driven by the team's success in developing a differentiated and innovative portfolio underpinned by robust business fundamentals. Additionally, we believe there is significant room for growth across our portfolio, positioning us well for continued success. And we have a strong balance sheet to support our growth initiatives in alignment with our capital allocation strategy. Our second quarter results highlight our discipline execution of our strategic growth initiatives, including generating robust clinical evidence and the winning spirit of the entire CASEL team. Based on a strong first half execution and confidence in our business, we are raising our full year 2024 revenue guidance to $275 million to $300 million, up from the previously reported guidance of $255 to $265 million, reflecting year-over-year growth of somewhere between 25% to 36%. Today, I will walk you through execution and strategy highlights from the second quarter, and then friends will provide additional financial highlights before we turn to your questions. Starting with our core dermatology business, For DecisionDx melanoma, we delivered 9,585 test reports in the second quarter, an 11% year-over-year increase, and a 14% sequential increase. As you know, generating robust clinical evidence is a key component of our growth plans, and I'm exceptionally proud of the ongoing data development related to our DecisionDx melanoma test. We believe our significant body of evidence is a key driver for test adoption and also distinguishes our test from the competition, further expanding our leadership position. In fact, during the second quarter, we presented exciting new data at the American Society of Clinical Oncology Annual Meeting, or ASCO, demonstrating how decision DX melanoma can identify patients with earlier stage melanoma who have a higher risk of central nervous system, or CNS metastasis, within the first three years post-diagnosis. This study showed that decision DX melanoma is particularly valuable as it can help pinpoint higher risk patients who may benefit from more frequent imaging surveillance, leading to earlier detection of CNS metastases and improved patient survival. As background, cutaneous melanoma metastasis to the central nervous system generally has a poor prognosis. However, patients tend to experience better outcomes if CNS metastases are detected and treated early while they are still asymptomatic. Currently, CNS imaging is not routinely recommended for patients with early stage cutaneous melanoma, classified as stage 1 or 2 by the American Joint Committee on Cancer, 8th edition. Despite this, approximately 14% of patients with stage 2 melanoma will develop CNS metastases. Our study demonstrated that patients with a high-risk class 2B melanoma test result had significantly greater or higher rates of CNS metastases and lower five-year recurrence-free survival compared to those with a low-risk class 1A or an intermediate-risk class 1B-2A test result. moreover the study showed that a class 2b decision x melanoma test result was the only significant predictor of cns metastasis under multivariate analysis this is to say this is data that demonstrates the significant clinical value that decision dx melanoma brings to improving patient care decisions and outcomes moving on to our decision dx scc test We continue to see strong test report volume momentum with 4,277 test reports delivered in the second quarter, an increase of 60% compared to the same period in 2023. DecisionDx SCC continues to be supported by a robust and growing body of evidence, including several publications this year demonstrating the test clinical and economic value in guiding adjuvant radiation therapy, or ART, decisions in patients with high-risk cutaneous squamous cell carcinoma. We are particularly excited about a recent study published in the American Society for Radiation Oncology's flagship journal, the International Journal of Radiation Oncology, Biology, and Physics, also known as the Red Journal. This study demonstrated how DecisionDxSCC can identify patients who are eligible for consideration of adjuvant radiation therapy and identify those patients who are unlikely to receive meaningful clinical benefit from ART and consider deferring radiation therapy. On the flip side, the study also showed that our decision DXSCC test can apply those patients who are expected to receive a significant clinical benefit from ART, with the result being a significant reduction in the likelihood of metastasis. Separately, we also share new data supporting the use of our test for patients with cutaneous squamous cell carcinoma tumors on the head and neck. Presented at the American College of Mohs surgery annual meeting, the data showed DecisionDxSCC's ability to identify high-risk patients, enabling more appropriate surveillance or adjuvant treatments to reduce metastasis risk. Specifically, DecisionDxSCC testing before tumor removal significantly improved the prediction accuracy of metastatic events, both alone and when combined with NCCN guidelines BWH staging or AJCC version 8 staging, guiding better patient care decisions. Stated differently, this means that our tests add significant accuracy when used with these three staging systems, thus improving treatment pathway decision making. Now let's turn to our gastroenterology franchise. In the second quarter of 2024, we delivered 4,782 tissue cipher test reports compared to 1,447 in the same period of 2023 and 3,429 in the first quarter of 2024. This represents a 230% year-over-year growth and 39% sequential over the first quarter growth. We believe this momentum is driven by the test clinical utility to determine a patient's individual risk of progression from Barrett's esophagus, or BE, to cancer. Supporting our belief, the American Gastroenterological Society, or AGA, recently released new practice guidelines in endoscopic eradication therapy for Barrett's esophagus, stating that Barrett's esophagus can be treated effectively with endoscopic procedures like ablation, But identifying high-risk patients is crucial. Importantly, our tissue cipher test was highlighted as the first prognostic assay capable of identifying Barrett's esophagus patients at risk of progressing to high-grade dysplasia or esophageal cancer. This recognition by the AGA reinforces tissue cipher's role in providing personalized and clinically validated risk stratification, helping patients better manage their patients with Barrett's esophagus disease. With our recent commercial team expansion, sufficient capacity in our Pittsburgh laboratory to meet accelerating demand, and very early stages of market penetration in an estimated $1 billion US TAM, we believe tissue cycle represents a significant long-term growth opportunity. Turning to our mental health business, We delivered 4,903 IgGenX test reports in the quarter, compared with 2,681 in the second quarter of 2023, which is 83% year-over-year growth. IgGenX was recently selected as the winner of the Best Overall Mental Health Solution Award in the 8th Annual MedTech Breakthrough Awards Program. The MedTech Breakthrough Awards honor excellent and recognized innovation, hard work, and success in a range of health and medical technology categories, attracting thousands of nominations from over 18 countries across the world. To sum up our commercial test highlights, we are enthusiastic about the long-term prospects across our entire portfolio. With six proprietary tests available in the early innings, we see significant opportunities ahead. Lastly, moving on to our pipeline, we continue to make progress on our inflammatory skin disease pipeline initiative and expect to provide you with additional development updates before the end of 2024. As you recall, this pipeline genomic test is for patients with moderate to severe atopic dermatitis, psoriasis, and related conditions, and is targeted for launch by the end of 2025, assuming a positive outcome of our discovery, development, and validation efforts. I now turn the call over to Frank, who will provide details relating to our financial results.

Thank you, Derek, and good afternoon, everyone. Reiterating Derek's sentiment, we are proud to report excellent financial results from the second quarter of 2024. Revenue was $87 million, an increase of 74% over the second quarter of 2023. The increase was driven by higher ASPs and test volume growth for our dermatologic and non-dermatologic tests. Adjusted revenue, which excludes the effects of revenue adjustments in the current period related to tests delivered in prior periods, was $86.6 million for the second quarter, an increase of 72% over the second quarter of 2023. Our gross margin during the second quarter was 80.7% compared to 73.5% in the second quarter of 2023. 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 83.2% for the quarter compared to 78% for the same period in 2023, an improvement of 520 basis points. Turning to expenses, our total operating expenses including cost of sales for the quarter were $82 million compared to $71.3 million for the second quarter of 2023. Sales and marketing expenses were $32.7 million compared to $28.3 million for the same period in 2023. The increase is mainly due to higher personnel costs and marketing expenses associated with travel, training events, and speaker conferences. General administrative expenses were $18.4 million compared to $16.4 million for the same period in 2023. The increase is primarily attributable to higher personnel costs and, to a lesser extent, higher expenses for professional services, subscriptions, and licensing. Cost of sales expenses were $14.5 million in the second quarter, compared to $11.1 million in the second quarter of 2023, primarily due to higher personnel costs and increased expenditures on supplies. The increase in personnel costs primarily consists of higher salaries and wages, bonuses, stock-based compensation, and employee benefits, reflecting headcount additions made to support business growth, as well as merit and annual inflationary wage adjustments for existing employees. Supply and service expenses increased largely due to our higher test volumes. R&D expenses were $14.1 million compared to $13.3 million from the same period in 2023, primarily due to higher personnel costs and clinical studies. Total non-cash stock-based compensation expense, which is allocated among cost of sales, R&D expense, and SG&A expense, totaled $13.2 million for the second quarter compared to $12.8 million for the second quarter of 2023. interest income increased by 0.7 million dollars for the quarter compared to the second quarter 2023 and the increase primarily reflects higher average balances of marketable investment securities and slightly higher interest rates our net income for the second quarter of 2024 was 8.9 million dollars compared to a net loss of 18.8 million dollars for the second quarter of 2023. diluted earnings per share for the second quarter was 31 cents compared to a diluted loss per share of 70 cents in the second quarter of 2023. Adjusted EBITDA for the second quarter was $21.5 million compared to negative $5.3 million for the comparable period in 2023, an improvement of $26.8 million. The substantial year-over-year improvement primarily reflects strong top-line growth along with continued disciplined expense management. Net cash provided by operating activities was $24 million for the second quarter of 2024, and $17.2 million for the six months into June 30. As you recall, cash used during the first quarter of 2024 was due in part to annual cash bonus payments and certain healthcare benefit payments that are not expected to occur during the remainder of 2024. Net cash used in investing activities was $41.1 million for the six months into June 30, 2024, and consisted primarily of purchases of marketable investment securities of $113.2 million and purchases of property and equipment of $14.4 million partially offset by the maturity of marketable investment securities of $86.5 million. Net cash provided by financing activities was $10.7 million for the six-month end of June 30, 2024, and consisted primarily of $10 million of proceeds from issuance of long-term debt and $1.7 million of proceeds from contributions to our 2019 employee stock purchase plan, partially offset by $1.1 million of employee taxes attributable to the vesting of restricted stock units. We ended the quarter with cash equivalent to marketable securities of $259.7 million. We believe that with continued strong execution and financial stability, we have the flexibility to invest in future growth opportunities while maintaining a healthy balance sheet. As Derek mentioned, we are raising our 2024 revenue guidance to $275 to $300 million, up from $255 to $265 million. In conclusion, I'm pleased with our execution through the first half of the year. We look forward to continuing to achieve the financial goals we set for 2024 as our focus remains on driving both near and long-term shareholder value. I'll now turn the call back over to Derek.

Thank you, Frank. In summary, we are very proud of our second quarter results, which highlight the effectiveness of our innovative portfolio, commitment to ongoing robust clinical evidence, and the winning spirit of our entire CASEL team. We thank you for your continued interest in CASEL Biosciences. We will now be happy to take your questions. Operator?

Thank you. We will now begin the question and answer session. In order to allow everyone in the queue an opportunity to address the council management team, please limit your time on the call to one question and only one follow-up. If you have additional questions, please return to the queue and please stand by while we compile the Q&A roister.

We have the first question from Catherine Schultz with BED.

You may proceed.

Hey, guys. Thanks for the question. Just first on tissue cycle, a big quarter here for you, volumes up almost 40% sequentially. What's driving the growth there, and how should we think about your expectations for sequential volume growth for the rest of the year, and any change to commercial investments you plan to make there, just given the strength you're seeing?

Yeah, good to hear your voice, Catherine. This is Derek here. From a tissue cycle perspective, maybe investments first, we had expanded the tissue site for sales team, I guess it was April 1st, May 1st, early, mid-second quarter. And that group of expanded area managers is, I think, just completing final training maybe in the next couple of weeks. And so we would expect them to be effective or fully effective probably in the early fourth quarter, mid fourth quarter. So really, really driving hopefully additional appropriate use in 2025. Maybe obviously some impact now, but more so three or four months out from now going forward. From a demand perspective, I just think this shows us and maybe everybody the high clinical need out there for a population. I think we underestimated We were doing diligence a couple of years ago. There are some data now suggesting that there should be a target market of probably over 400,000 endoscopic biopsies performed per year in people with a definitive diagnosis of Barrett's esophagus disease. So that's by far our largest sort of disease orientation that's tissue based like that. And I think we're just seeing the efforts of our medical education programs to really educate gastroenterologists regarding the the benefit that our test brings to identifying people who have Barrett's esophagus disease, you could have effective interventions at blocking or halting that progression to esophageal cancer and adopting it for appropriate use. Frank, do you want to add anything?

Great. And then can we get your response to the MUL-DX non-coverage decision for DecisionDx-SCC you know, are there any studies you're running or plan to run to address some of the areas of pushback, be it around performance versus individual NCCN risk categories or generating outcomes data? And then, you know, have you had any follow-up conversations with MOLDI-X to discuss their vision and next steps there?

Yeah, I guess, first of all, as you know, or the audience should hopefully know, we had a review completed in early 2022 from Novitas, and as of today, we remain covered by Medicare. So, the Palmetto Moldy X LCD doesn't particularly, doesn't impact our business in the immediate term. That being said, what we did look at when we read through the final LCD was that none of the articles that have been published and that were actually developed as a result of the first of the initial draft LCD were reviewed or included in this final LCD. So we believe there's an opportunity to work in a positive manner with Palmetto to say, hey, there's a really singularly focused benefit of our test to patients with high-risk STC, which is really helping to rule out or rule in adjuvant radiation therapy. So our intention is to have dialogues with them and understand a path forward so that Medicare patients, should we need backup laboratory systems in Phoenix, are able to access our STC test.

Thank you. Great. Thank you. Your next question comes from Mason Carrico with Stephen Sinks.

Hey, guys. Thanks for the questions. Frank or Derek, sorry if I missed this, but could you provide some detail behind what's baked into the guide, specifically from the DecisionDx SCC test standpoint? Are you assuming a full quarter, next quarter only a partial quarter? How should we think about that?

We're assuming that comes out of our numbers for the fourth quarter.

Got it. Okay. On your broader portfolio, you guys have published a lot of clinical evidence over the past year. Could you just give us your latest thoughts, really, on how you're thinking about the commercial coverage opportunity, looking at tissue cipher as well as the melanoma test?

Yeah, I can. I would concur with you that the team has done an excellent job of really driving what we see as impactful publications, primarily to help establish the clinical outcome benefit of our test and patient care. We have seen, although we don't announce these in a public manner, a number of individual commercial carriers and even some laboratory benefit managers switching from sort of a non-coverage or no statement to positive coverage. Some of those policies rolled out, I think, July 1st, that right, Frank, effective data this year, and we'll see more, I think, early next year. So we are seeing progress there, Mason. We just don't Called us out specifically at this point in time, given our life cycle.

Yeah, we're making progress space and we would agree with you that there is clearly. More than enough evidence published on all of our tests to demonstrate clinical utility and. economic savings, economic benefit to the system. So the evidence is certainly sufficient to find coverage. It's a matter of just continuing to kind of push that rock up the hill. Perfect. Thanks, guys.

Thank you, Mason. We now have Thomas Flatton with Lake Street. You may proceed.

Great. Great. I appreciate you taking the questions. On ID genetics, I know it's still early innings, but are you seeing kind of a physician profile starting to emerge of who's adopting the test and then maybe following on to that? Are there specific patients for whom these doctors are using the test?

I can comment on that level of detail, Thomas. Our primary call points are a mixture of psychiatrists, obviously, who are interested in helping or having a pharmacogenic test like ours, help improve their therapy decision-making processes, as well as higher volume primary care or first-line clinicians, both physicians and also MPs and PAs who are treating more of an elderly complex population, and then some long-term care facilities thrown in there. And that's primarily because Certainly, those latter two customer groups are wrestling with concomitant drug-drug interactions. And, of course, with our report always having provided a drug gene plus a drug-drug and also, of course, an environmental factor reporting structure in the output of the report, it provides those clinicians with a streamlined way to interpret the drug gene combined with drug-drug and environmental bodies. Beyond that, I'd be skating on thin ice.

Got it. And then flipping to Novitas, have you had any engagement with them following this delay or maybe even leading up to it? And are there precedents we could be looking to to understand how this might play out over the coming months?

We haven't gone back far to see about precedents per se. I think it's a reasonably unusual Impact if you look back and you want to kind of look at moldy X timelines in the past years, like 3, 4, 5 years ago, you can see some. LCDs that might post from draft to final letter. You know, appear to be 370 or 80 days. I don't know if those represented just. Time for the CMS website to update items, or if that was actually a formal request that was granted. So I can give, you know. flavor on that. We and others are seeking some input from both Novatos and CMS to try to understand what this might mean in terms of timing, in terms of not necessarily precedent, but any information they give us. We have heard back, no information at this point in time to share.

Got it. Appreciate it. Thank you.

Thank you, Thomas. We now have Puneet Sutta with the RINC partners.

Yeah, hi, Derek, Frank, thanks for taking my question. So first one is, you know, you had a beat here, 18 million or so, guide raises about 27 and a half. And just wondering, you know, third quarter, you are including the SEC coverage, if I heard that correctly. So, just wondering, you know, shouldn't the guide raise be more than that to reflect if you are, if I think Frank said you will be covered in the fourth quarter as well? So, I just want to understand sort of the dynamic of SCC volume growth and the ASP that we ought to be thinking about over the next two quarters with respect to the guide.

So our new guide assumes that we don't have SEC coverage in the fourth quarter, and I wouldn't have any comment or any change to our ASP. I don't think you'll see a change in ASP from now until then.

Okay. And then, you know, Derek sort of stepping back and just looking at the MALDX, you know, maintaining their non-coverage decision. Novitas disclosing an extension now, which is unclear exactly when they will come back and, you know, cover this test. So, you know, the question here is, you know, should we assume, you know, essentially, first of all, should we assume no coverage for 2025? That's just wanted to clarify that. And, you know, I do hope that you get coverage here from Novitas. But if that wasn't going to happen, then what are the other avenues, And then ultimately, how do you bring this test to the commercial population? You know, just help us elaborate on the path forward for this test and the path for getting paid for this test.

A lot of questions to unpack there, Puneet, to try and be brief and organized here. I think first of all, we remain a covered test by Medicare, I guess, point number one. Point number two, in terms of forecasting SCC in your guide going forward, I would, I think as Frank said, take it out October 1st going forward just because it's a prudent overhang there. So that would be our recommendation. That's how we're thinking about our business as well. In terms of next steps, there are a number of approaches one could consider taking with Novitas as well as Palmetto, which would include reconsideration requests if it was negative, which would include challenges to the LCD, other interactions with CMS, as well as individual claim appeals. All of those are on the table, and as we see the outcome here, we can pull the triggers on what the appropriate approach should be. I guess, other questions? I think so.

Okay, just briefly on EBITDA improvement was strong in the quarter. Frank, any thoughts on how should we think about that for the rest of the year and 2025, if you could elaborate? Thank you.

What improvement, Puneet?

Just that EBITDA came in strong versus our estimates and just wanted to get a view on continued ramp there. Obviously, some of it is from SCC getting paid, but just

Yeah, we've continued to see this grow into the P&L, and we're seeing leverage across the P&L as you see revenues growing more than expenses, and that obviously drives a better margin. Going forward, what that profile looks like depends on coverage for SEC, among other things. So, as we said before, our long-term guidance, which we've reiterated for 2025, assumes no SEC coverage, but still hitting a positive adjusted operating cash flow.

Thank you. Your next question comes from Kyle Mixon with Canaccord.

Yeah, hey guys. Thanks for the questions. Congrats on the quarter. Yeah, just sticking, going back to SAC, I guess. If you, you know, if that remains non-covered by both these MACs here and there's nothing you can do in the near term for that, what can you do in your dermatologic cancer side of the business to, you know, like keep growth and kind of maintain margins as well? Like could you shift resources to marketing? decisions you have to melanoma, or is there something about the past practices that kind of prevent you from beefing up the melanoma marketing effort?

Excellent question, Kyle. Many of our programs today, because it's what we're primarily calling on, interacting with, medically oriented dermatologists who who see patients with skin cancer is kind of the same kind of clinician you might say i mean there might be a few less mo surgeons who are who are seeing or or applying most surgery to invasive melanoma like they would be to squamous cell carcinoma so i think that we feel like we're sized right from a field poor standpoint There are certainly some other marketing and other educational activities that we would kind of redirect. I guess you would call it our dermatology spend and marketing and medical education over towards melanoma specifically so that it would have hopefully the intended expectation you have here, which is, would we go ahead and be able to improve upon the sort of market penetration adopted of appropriate patients for the melanoma test? I don't know what that would look like. Execution at the end of the day, but certainly we're thinking about the same things.

OK, that was great. Thanks Eric and maybe just two more questions. So first is the It's really interesting that the kind of the attached rate, basically like the kind of synergy rate between SEC and melanoma is 68% for the first half of the year. That compares to 55% in 1Q. What is that? What benefits have you seen there? And again, as you think about this, like flip possibly, maybe that's in fourth quarter or something like that. You know, how does that really like kind of, you know, give you confidence for 25 growth, basically? That's the first part of the question. And just given your second part is going to be about your cash balances. How do you think about M&A going forward? which side makes sense to bolster, that dermatologic side or maybe like this GI side that is super promising? Thanks.

Sure, Kyle. So starting with the cash here, I think that We're pleased to have the cash position we do. It's enabled us to run the company as we think the company needs to be run and to cautiously and carefully invest in continued growth. And so those are our first priorities is sales and marketing of our existing products. And then R&D to support those products as well as new products. M&A is further down the list. Obviously, we never say never, but we've got a tremendous opportunity at hand with the products that we currently have available. Kyle, what was the first part of your question? So, that was really our thesis, you know, in developing our SCC test is, you know, having more than one test to sell for the same physician. And there's a balance there. You can only have so many, you can only have conversations about so many things in a physician encounter. So, because those tests are largely the same physician base, there's great opportunity and great leverage. And for a non- A medical person like me, it's a pretty simple thesis. Each of those tests answers a similar question just for a different group of patients. And so once a physician has been educated on the benefits of a test for melanoma, for example, it's an easy adjacency to say now you've got these other patients over here and we have a test that answers the same question with the same clinical utility. So there's great synergy there and it's a powerful leverage between the two. So that was part of our thesis originally when we set out to develop the SCC test. We heard from clinicians that they had a clinical question that needed to be answered. And it struck us that those were the same clinicians for whom we were answering a similar question in melanoma. So, there's great leverage between the two.

Okay. Perfect. Thanks, guys. Appreciate it. Absolutely.

Thank you. Your next question comes from . Hi. Thanks for taking the question.

Maybe starting with tissue cipher, congrats on getting that mentioned in the AGA publication. The same publication talks about forthcoming guidelines on surveillance in Barrett's esophagus and was wondering, you know, if you have any insight into kind of the timing for that and whether you guys might be engaged with the AGA, you know, in terms of providing data and things like that.

Yeah, their cadence of guidelines update is a little opaque, Sanjeev. I would think we're talking a couple of quarters out at least, and certainly our teams are working as they should to make sure that appropriate stakeholders are aware of the tissue cipher data and hopefully how to consider it against sort of not using a tissue cipher test. But timing of that I would think would be a couple of quarters away, but it's a little bit of a more opaque organization than say, NCCN, where you can have a history of updates and you see where they-or meetings updates are coming out, usually in a routine cadence. MARY JO GIOVACCHINI.

Got it. And then maybe following up Catherine's question earlier on the Moldex determination, just kind of curious about-it seems like they're pretty positive, you know, in terms of the use of decision DFSCC in patients for adjuvant radiation therapy. And so I was wondering if you're, you know, if you guys have additional studies, you know, what are your strategies in terms of potentially implementing additional studies around that? Are there ways to incorporate, you know, kind of get involved in some of the larger scale studies that might be underway? Just kind of curious if you could touch on that.

Yeah, excellent question. So, we're always doing more studies. So, how's that for not answering? I don't mean to be cynical to you. When we first saw this data on ART, I guess about a year, year and a quarter ago, we certainly said, okay, this is quite interesting. We will end up publishing with Rebecca May, of course, the most, I guess the best controlled article that we've seen out there evaluating the effectiveness of ART, which is good. And so we began additional programs to look at highlighting that, replicating the data, essentially. So we expect to see things coming out later on this year that would support that study that came out in May of this year by Aaron et al. as being confirmed from a performance standpoint.

Thank you. Great. Thank you. Great. Thank you. We now have Suvi Anandi with Guggenheim. Suvi Anandi.

Hey, guys. Thank you for taking my question. I don't think this is the case, but I just want to make sure, from a risk perspective, given that Novotel says reviewing, is there any retrospective risk to the revenue from SCC? That's one, and I have a follow-up. Retrospective risk. Good. I hear a question. Retrospective risk to SCC given Novotel says To the revenue from the SEC.

Is there a retrospective risk to SEC?

To the revenue.

Oh, claw back to revenue? Novitas reviewed us back in the first quarter of 2022, included us in a billing article, I think in April or May of 22, indicating that we're a covered test. We bill specifically with our unique PLA code, which We received, I think, in April or March of 2022, so I don't think that's any kind of realistic expectation. There would be a clawback when they know exactly what they're paying for.

Got it. That's helpful, Derek. It is good to see this melanoma grow 14% sequentially, and it also alleviates the concern around volume growth moderating. Do you still anticipate growing double digits until you reach 60% market penetration?

That was about CM, Subbu?

That is decision DX melanoma, yes.

Yeah. So, you know, ever since the IPO, we have a – there's a chart in our MD&A that shows the volumes for all of our tests. Obviously, at that point, it was just CM and UM. But – and what you can see is with the exception of – 2020, which was, if you recall, the year that we all let them convince us that some groups of positions were not essential and they closed their offices. But since that time, you see a real, just a very, very clear seasonality pattern on on our CM test or melanoma test. And, you know, this year I think winds up exactly with what those other, you know, those other years are. So, you know, as we said earlier, quarters, what we've seen is just really just the typical seasonality for the test. I do think at some point, Our squamous cell test will become penetrated enough that you'll see similar seasonality there. And we believe the drivers are really related to the number of physician encounters around melanoma, which is related to practice days in offices. And Q2 just has the most office days of any of the quarters. You know, Q1 has big physician meetings, two of them. Q3, you've got summer holidays. Q4, you've got the summer holidays. So Q2 has the most days of kind of physician encounters of any quarter, and that's what drives that very predictable, very regular seasonality. So not much of a surprise to see the pattern this year, and, yeah, we think we'll continue to grow our melanoma tests. Of course, it's on a bigger base, so the percentage is lower, but we'll continue to see that grow as we increase penetration.

Perfect. Thank you, Frank.

Thank you, Situ. We now have Mark Marasso with BTID. You may proceed.

Hey, guys. Thanks for taking the questions. Yeah, I guess my first one is on just, you know, maybe a question that you don't get very often in years, perhaps, is, On the commercial payer side, you guys have still relatively immature commercial pay covered lives even on your flagship core melanoma test. So can you just speak about the frequency with which you try to get in front of these commercial payers? Do you have meetings scheduled perhaps later this year? Or how are you thinking about getting in front of these? Because I see a potential for another leg higher in terms of recognizing revenue and pricing from payers that are giving you denials today. So how should we think about commercial pay both for melanoma and for SEC?

So, Mark, the the commercial and payer environment is not much different for capsule than it is for other high value molecular diagnostic testing companies. And the reality is the decision to cover tests significantly lags the development of clinical utility evidence. Said another way, there is ample evidence to support coverage long before that coverage comes. It would be supposition on my part to offer why that is. You can talk to payers or we can all think about it and probably come up with our own views, but that's pretty typical in the sector and across the industry. What's changed in recent years is the growing number of payers who have outsourced their own technical assessments to lab benefit managers or technical third-party tech assessment groups. And so when that happens, you're unable to access medical directors and director teams and individual payers because they direct you to the LBMs, the third parties. And those groups tend to have fairly regular cycles of review And they follow them pretty clearly. There is occasionally the opportunity for off-cycle review with those groups, but if you just think it through, there's not much benefit to them to offer an off-cycle review. And so, even in the case of tests that have significant cost savings to the healthcare system, in many cases, the companies are already providing test results to patients whose payers are declining claims. And so if you think that through, you're going to a payer and saying, you know, we think you should cover this test because it's going to save you, you know, 50 or 70% of the cycles of adjuvant radiation therapy you would pay for otherwise. But they understand in many cases that they're already getting that benefit because we are providing the test report. to patients anyway. So it's a, how we think about commercial coverage, we're in favor of it. We certainly agree it would be a positive. We were able to get to that view and we spend a lot of time and a lot of money working on that process, but it is unfortunately fairly opaque and not necessarily one we can directly have, you know, significant influence over from a quarterly basis.

Okay, got it. And you guys put up a really terrific quarter. And so congrats on that. And, you know, you're baking in SEC Medicare revenue through the end of September. I guess, you know, questions we get from investors are, you know, how should we handicap the extra time that Novitas might need to render their final decision? So, You guys seem perhaps to have some visibility into the end of September. That's more visibility than I have, quite frankly. So just curious if you can give us a sense for, you know, is there any chance that they could be, you know, might need six months, nine months, 12 months? And then second part of this question is not for Palmetto on your SEC directly, but generally speaking, because I don't see a ton of reconsideration requests to Palmetto. What is the typical timeline for reconsideration requests and claim appeals? Because I recognize that Palmetto did not include a lot of really solid evidence that you submitted to them. So I'm just curious if you have a sense, based on your conversations with consultants, what type of timeline a reconsideration request or claim appeal is with Palmetto.

Yeah, so Mark, as it relates to the guide and 1st of October versus any other date, you and I have the same visibility there, and that is, as we've said in other quarters when we've updated our guidance, if a contractor follows Medicare's published policies, when a new LCD is finalized, there's a 45-day period before it becomes effective. I am told that is to allow the computer programmers to make the changes that are necessary and to make the edits in the systems. I don't know if that's completely full story or not because I'm not an expert there. And so, as we said before, we are currently a covered test service following a full medical review that was performed in 2022. And so all I'm doing is saying, you know, I'm taking 45 days from today, and I'm not trying to do it by the week. I'm just doing it by the month, and I get to October 1st. So that's the visibility there, which has been the same as each quarter. On a reconsideration request, my understanding is the only timeline that's required is to notify you if the reconsideration is going to be granted, I think, correct? And then there's no one-year clock, like from a draft LCD, on a reconsideration. To your point, there aren't a whole lot of precedents there. So it would be difficult to say, you know, here's a sample pool and we can kind of get to a standard deviation of what we expect it to be. Given the cadence of other processes at Medicare, you feel like it's sort of a one-year, maybe a two-year process. But that would be, again, it's not, there's nothing in the manual that directs them there. So that's the... I guess that's the negative, right? That's the negative to the reconsider process.

Yeah. The only, so yeah, so the history is limited, doesn't tell us what we can do. One would expect that if they had certainly seen or read our submissions last summer, they would have seen the ART in pre-publication form. And that should be, and as you noted earlier, Mark, there's been significant I think extremely clear publications in the last four, five or six months regarding the use of our tests in that matter for ART guidance. They know about our SCC test because it just finalized the LCD. Does one think that if a reconsideration request goes in fairly soon because it's top of mind, They realized there was a lot of data that's come out that was not included in the review because of timing periods from Medicare standpoint. Does that say it should be reviewed quicker rather than later? I have no idea how to gauge that, except that's an interesting possibility.

Thank you. I would now like to hand it back to Derek for some final closing remarks.

Thank you, Operator. This concludes our second quarter 2024 earnings call. Thank you again for joining us today and for your continued interest in Castle Biosciences.

Thank you all for joining. I can confirm that does conclude Castle Biosciences' second call to 2024 conference call. Please enjoy the rest of your day, and you may now disconnect from the call.