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Castle Biosciences, Inc.
5/6/2026
Good afternoon, and welcome to CASEL Biosciences' first quarter 2026 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 Camila Zuccaro, Vice President, Investor Relations and Corporate Affairs. Please go ahead.
Thank you, Operator. Good afternoon, everyone. Welcome to CASEL Biosciences first quarter 2026 results conference call. Joining me today are CASEL's founder, president, and chief executive officer, Derek Manshold, and chief financial officer, Frank Stokes. Information recorded on this call speaks only as of today, May 6, 2026. Therefore, if you're 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 impact 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. There can be no assurances 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 delivered strong first quarter results, building on our momentum from 2025. Thanks to the strong execution by the entire CASEL team, We delivered revenue of $83.7 million. Test report volumes for our core revenue drivers grew 36% compared to the first quarter of 2025. Excluding decision DXSCC and ID genetics revenue, Our revenue growth for the first quarter of 2026 is approximately 42% compared to the first quarter of 2025, highlighted by double-digit year-over-year test report volume growth for both decision DX melanoma and tissue cipher. Throughout the first quarter of 2026, our teams remain focused on executing our growth priorities, and our strong performance gives us confidence to raise our 2026 revenue outlook to between $345 million to $355 million compared to our previous provided guidance of $340 million to $350 million. Now, I will walk you through business highlights from the first quarter, and then Frank will provide additional financial highlights 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, DecisionDx Melanoma and Tissue Cipher. For DecisionDx Melanoma, we delivered 10,021 test reports in the first quarter, representing 16% year-over-year growth. Further, March of 2026 saw an all-time high record month for test reports delivered. We believe DecisionDx melanoma remains a durable growth driver and continue to expect mid to high single-digit volume growth for the full year 2026. Driving test adoption and sustaining our competitive advantage through robust clinical evidence remains a key priority. We recently presented new data at the 2026 American Academy of Dermatology Annual Meeting, demonstrating that our DecisionDx melanoma test can significantly improve risk prediction within American Joint Committee on Cancer or AJCC stages for patients with cutaneous melanoma. These data from 1,868 SEER-linked patients show that DecisionDx melanoma significantly stratifies five-year melanoma-specific survival within AJCC stages and T-categories, identifying patients whose mortality risk is substantially higher or lower than staging alone would predict. What this means is that in this study, decision DX melanoma provided clinically meaningful differences in risk within the same stage, enabling more personalized risk-aligned management decisions by helping clinicians identify patients who may warrant closer monitoring or early intervention, while also recognizing those who may safely be managed less intensively. These great results are in addition to our recently published data from the prospective multicenter study evaluating decision DX melanomas I-31 SLMB test result. Data from this prospective U.S.-based study confirmed again that our test identifies patients with a less than 5% predicted risk consistent with the national comprehensive cancer network guideline thresholds while maintaining favorable outcomes and outperforming traditional staging criteria. Let's turn to our gastroenterology franchise. During the first quarter of 2026, we delivered 11,745 tissue cipher test reports compared to 7,432 in the first quarter of 2025, which is 58% growth. Consistent with our decision DX melanoma test in March, March also represented an all-time record month for tissue cipher. Two studies were recently presented at the Digestive Disease Week by researchers at the Mayo Clinic. The findings demonstrated how molecular risk stratification with a tissue cipher test refined risk assessment and directly informed real-world management decisions for patients with Barrett's esophagus, with one study showing changes in surveillance intervals in more than half of patients compared with recommendations guided by traditional histopathology alone, supporting more personalized, risk-aligned patient management. Look to our news release from earlier this month for more information on these studies. Looking to the full year, we expect to add a similar number of tests in 2026 as it did in 2025, indicating year-over-year growth approaching 50%. Let's move on to what we believe are our midterm, which we view as 2027 and 2028 revenue drivers, which includes our advanced ADTX test in addition to our core revenue drivers. As a reminder, Advanced ADTX is our first-in-class test designed to guide systemic treatment selection for patients 12 years of age and older with moderate to severe atopic dermatitis, or AD. You may recall that we released this test under a limited-access program mid-fourth quarter of 2025. Continuing on our limited access during the first quarter, we received approximately 650 orders. Initial responses indicate that clinicians appreciate that Advanced ADTX integrates into their existing AD care pathway, helping to make more informed systemic therapy choices early in the patient treatment journey. Supporting this claim, during the quarter, we published data from a prospective multicenter clinical validation study in the Journal of the American Academy of Dermatology, demonstrating that advanced ADTX can identify patients with moderate to severe atopic dermatitis who are significantly more likely to achieve greater and faster responses when treated with a JAK inhibitor compared to a Th2 biological therapy. The data show that advanced ADTX can stratify patients by molecular profile, identifying those more likely to achieve near clear skin or EZ90, faster time to response, and meaningful patient-reported benefits when taking a JAK inhibitor. supporting improved outcomes and more biologically informed systemic treatment decisions early in the treatment journey with JAK inhibitor therapy as compared to TH2 targeted biologic therapy. Based on revenue cycle timelines, we expect to be in a position to provide more detail on reimbursement by the end of the third quarter of 2026. And with that, I will now turn the call over to Frank.
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