This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

Castle Biosciences, Inc.
2/26/2026
Good afternoon and welcome to Castle Biosciences' fourth quarter and full year 2025 conference call. As a reminder, today's call is being recorded. We will begin 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 Sequeira, Vice President, Investor Relations and Corporate Affairs.
Thank you, Operator. Good afternoon, everyone. Welcome to Castle Bioscience's fourth quarter and full year 2025 results conference call. Joining me today are Castle's founder, president, and chief executive officer, Derek Matfield, and chief financial officer, Frank Stokes. Information recorded on this call speaks only as of today, February 26, 2026. 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, including statements about expected addressable markets, statements containing projections regarding future events or our future financial or operational results and performance, including our anticipated 2026 total revenue and the impact of our investments and growth initiatives, including our ability to achieve long-term growth and drive stockholder value. Forward-looking statements are based upon current expectations and involve inherent risks and uncertainties, and there can be no assurances that the results contemplated in these statements will be realized. A number of factors and risks could cause actual results to differ materially from those contained in these forward-looking statements. Please refer to the risk factors in our most recent SEC filings for more information. These forward-looking statements speak only as of today, and we assume no obligation to update or revise these forward-looking statements as circumstances change. In addition, some of the information discussed today includes non-GAAP financial measures such as adjusted revenue, adjusted gross margin, and adjusted EBITDA that have not been calculated in accordance with U.S. GAAP. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted on the investor relations page of the company's website. I will now turn the call over to Derek.
Thank you, Camilla, and good afternoon, everyone. We close out a strong fourth quarter and deliver an outstanding year in 2025. driven by continued momentum across our core revenue drivers, discipline execution, and the dedication of our employees. I'm intentional in mentioning the dedication of our employees. It is through their efforts that we're able to deliver clinically actionable results with our current commercial tests today and tomorrow with the addition of future tests. With fourth quarter revenue of $87.0 million, we delivered revenue of $344.2 million for the full year of 2025. Excluding DecisionDX, SCC, and IDGeneX revenue from both 2025 and 2024, our revenue growth for the year would have been approximately 34%. For the full year, we also delivered total test report volume of 105,053 test reports from our core revenue drivers, increasing 37% compared to 2024, highlighted by continued momentum in tissue cipher report volume, which achieved 86% growth over 2024. As I reflect on our many accomplishments across our gross initiatives, we have succeeded in evolving CASEL considerably. Over the course of 2025, we completed the acquisition of PROVISED, entered into a collaboration and license agreement with Sybase, launched our first-in-class advanced AD TX test, further strengthened our commercial teams, and continued to solidify an already strong balance sheet. At the same time, DecisionDx melanoma reached a significant milestone, surpassing 230,000 test orders since launch. And we continue to build a robust body of clinical evidence across our entire portfolio. And we continue with our unwavering commitment to improving patient care. Everything we do at Castle remains focused on innovative, clinically actionable tests that help clinicians make better informed decisions and improve outcomes for their patients. We can only accomplish this mission because of the people who call Castle home. I sincerely thank our entire team for their hard work, resilience, and commitment throughout the year. None of this progress would be possible without them. As we review 2025 results, I will also outline how we are thinking about our growth story, starting with the drivers of our near-term performance in 2026, then turning to our mid-term opportunities, and finally discussing the longer-term pipeline that we believe positions Castle well for sustained growth and value creation. Frank will then provide additional 2025 financial highlights and insight for 2026 before we turn to your questions. Let's start with our core revenue drivers and what we see as the bulk of our 2026 top-line growth story, decision DX melanoma and tissue ciphering. In 2025, for DecisionDx melanoma, we delivered 39,083 test reports, representing 9% year-over-year growth, achieving our high single-digit volume growth commitment. Importantly, we continue to see new clinicians ordering DecisionDx melanoma for the first time. Specifically in 2025, we had 1,795 clinicians order DecisionDx melanoma for the very first time. This was consistent with our experience in both 2024 and 2023, reflecting continued strong interest in adoption. Additionally, total ordering clinicians over the lifetime of this test is nearing 17,000. Our compelling body of evidence for DecisionDx melanoma also continues to expand, with now 58 peer-reviewed publications supporting the clinical use of the test, which is not only a key driver for test adoption, but also meaningfully differentiates our tests from the competition. We saw an approximately 31% patient penetration exiting 2025, and we believe decision DX melanoma remains a durable growth driver in 2026. Turning to our gastroenterology franchise, TissueCypher delivered 39,014 test reports compared to 20,956 test reports in 2024, representing 86% growth and surpassing 80,000 tests ordered to date. We believe this adoption reflects growing clinical recognition of tissue ciphers value in determining a patient's individual risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal cancer. Barrett's esophagus is the only known risk factor for the development of esophageal adenocarcinoma, one of the fastest growing cancers in the U.S. Unfortunately, esophageal adenocarcinoma is also one of the most aggressive and difficult cancers to treat with a five-year survival rate of less than 20%. In 2024, the American Gastroenterological Association, or AGA, released a clinical practice guideline for Barrett's esophagus, stating that it can be effectively treated with endoscopic procedures like ablation and noting that identifying high-risk patients is crucial. Importantly, tissue cycle was highlighted as the first prognostic test capable of identifying patients with Barrett's esophagus at risk of progression to high-grade dysplasia or esophageal cancer. We believe this recognition by the AGA reinforces tissue cycle's role in providing personalized and clinically validated risk stratification, which in turn assists clinicians and their patients in making better management decisions, with the end goal of extending the lives of high-risk patients with interventions at the pre-cancerous state. The year ended December 31st, 2025. We had 2,082 new ordering clinicians for the tissue cipher test, up from 1,234 in 2024. We remain highly focused on education and building awareness to drive continued adoption. With roughly 11% patient penetration for TissueCypher exiting 2025, an expanded commercial team, and the compelling clinical actionability with a high clinical need, we continue to believe TissueCypher is still in the early stages of a long runway for significant growth in 2026 and beyond. Let's move on to the midterm phase of planned potential growth, which we view as 2027 and 2028. In addition to the continued contribution of our core revenue drivers, let's discuss our recently launched ADVANCE-AD-TX test. ADVANCE-AD-TX is our first-in-class test designed to guide systemic treatment selection for patients 12 years and older with moderate to severe atopic dermatitis. We clinically launched the test on a limited-access model in late November 2025. The launch of advanced AD significantly expanded our total addressable market and reinforced our commitment to the dermatology community. Early results have exceeded our high expectations. As we announced in early January, we limited access to approximately 150 dermatological counts in the U.S. Through year end, we were pleased to see that more than half of these initial counts had ordered one or more tests in the first five weeks of clinical availability. As mentioned in our third quarter 2025 earnings call, Our market research suggested a high level of clinical need and adoption. The results of the initial five weeks of clinical availability matched those expectations. In fact, through mid-February, we received close to 500 orders continuing to reinforce our expectations for adoption from our mid-2025 market research studies. We expect to expand clinician access in a phased manner based on a number of internal metrics. We expect revenue contribution from advanced AD to be immaterial in 2026, with material revenue contribution expected in 2027 or 2028. Based upon revenue cycle timelines, we would expect to be in a position to communicate more about reimbursement in the second half of 2026. Lastly, moving on to the next phase of our growth strategy, the longer term, which we view as 2028 and beyond, touching our pipeline initiatives and strategic investments. Let's start with our GI pipeline. We acquired a non-endoscopic cell collection device with our acquisition of PROVISE. We plan to use this collection device to gather samples for development of a pipeline test for differential diagnostic and screening support for GI diseases. We expect to initiate and enroll our first patient for the development study in the second quarter of 2026. This test will be upstream from tissue cipher, and we expect preliminary data before the end of 2026. This collection device requires FDA clearance, and we currently expect to both file our submission and potentially receive clearance in 2026. Next is our collaboration with SideBase, where we will evaluate their electrical impedance spectroscopy, or EIS technology for short. We have U.S. and select country rights to a number of possible indications. The first indication we are studying is the ability of the handheld EIS device or PEN to predict flares in patients with atopic dermatitis. We believe there are at least two additional intended uses in the atopic dermatitis population alone should we see promising results from initial flare prediction study. Importantly, this approach could offer a nice synergy with our advanced AD test by extending the ability to support patients across different points in their disease journey. We expect to initiate the EIS Penn study and enroll our first patient for AD flares in the second quarter of 2026 and have preliminary development data before the end of 2026. And to wrap up our near, mid, and long-term growth strategy, we continue to expect M&A to play a role. With our strong balance sheet and history of successful execution in this area, we continue to evaluate cannabis that fit within our strategic opportunities criteria. That is, number one, test near or at market, Number two, test near or at reimbursement. Number three, test that can be promoted within sales teams the size of our current teams or less, that is around 100 or less. And four, test within or complementary to our current customer verticals as a priority. In summary, we believe our financial strength is as well to invest across our growth initiatives for continued value creation. And with that, I'll turn the call over to Frank. Thank you, Derek. Good afternoon, everyone.
You're reading a preview of the CSTL Q4 2025 earnings call.
Free account.