Summary of Castle Biosciences Conference Call Company Overview - Castle Biosciences focuses on improving patient health through innovative diagnostic test services, either developed internally or acquired [2][6] - The company aims to impact the patient journey through diagnostic support, risk stratification, and therapy selection [3][4] Key Products and Services - **MyPath Melanoma**: Aids dermatopathologists in determining if a melanoma biopsy is positive [3] - **DecisionDx SCC**: A test for high-risk squamous cell carcinoma patients, predicting responsiveness to radiation therapy [4][28] - **DecisionDx Melanoma**: Developed to answer clinical questions regarding melanoma progression and recurrence [7][16] - **TissueCipher**: For patients with Barrett's esophagus, identifying those at risk of progression to esophageal adenocarcinoma [5][11] Clinical Evidence and Impact - The **DECIDE study** showed that patients who avoided sentinel lymph node biopsy due to low-risk results had 100% recurrence-free survival at two years [8] - The use of DecisionDx tests led to a **29% improvement** in three-year melanoma-specific survival compared to matched patients not tested [18] - The DecisionDx SCC test demonstrated a **50% reduction** in metastasis rates for patients receiving adjuvant radiation therapy [29] Financial Performance - The company reported a strong balance sheet with **$275 million** in cash at the end of Q1 2025 [32][40] - Adjusted gross margins maintained at approximately **80-81%** over the last five quarters [37] - Operating cash flow showed a trend of growth, with **$23 million** in operating cash flow in the last three quarters of the previous year [38] Strategic Goals - Continue to drive robust test volume growth and maintain industry-leading gross margins [31][32] - Focus on optimizing commercialization investments, particularly in dermatology and gastroenterology [40][42] - Explore potential acquisitions to enhance value in existing markets [43][44] Market Dynamics - Seasonal trends affect revenue, with expectations of increased melanoma detection in warmer months [33][34] - The decision to discontinue the iGenics test was made due to reimbursement challenges, impacting overall test volume [35][36] Conclusion - Castle Biosciences is positioned for growth with a strong product pipeline and strategic focus on enhancing patient care through advanced diagnostic testing. The company aims to maintain financial stability while expanding its market presence in dermatology and gastroenterology.

Group 1 - Castle Biosciences, Inc. has been recognized for its innovative tests that guide patient care, with its CEO Derek Maetzold receiving a Lifetime Achievement Award in the Management: Business Products Industries category at the 2025 American Business Awards [3][4] - The Stevie Awards, which honor outstanding business performances in the U.S., received over 3,600 nominations this year, with gold awards representing the highest level of achievement [4][7] - Under Derek Maetzold's leadership, Castle Biosciences has evolved from a startup to an industry leader, significantly impacting how clinicians care for patients [5][12] Group 2 - The company focuses on molecular diagnostics and precision medicine, aiming to transform disease management by prioritizing patients, clinicians, employees, and investors [9][10] - Castle Biosciences' current portfolio includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, with ongoing R&D for additional tests in high clinical need areas [10] - The company has been recognized as a Top Workplace USA for four consecutive years, reflecting its strong organizational culture [6][12]

Core Insights - Castle Biosciences, Inc. is presenting research at the 2025 ASCO Annual Meeting that highlights the effectiveness of the DecisionDx-Melanoma test in reducing mortality risk for melanoma patients by 32% compared to untested patients [1][2][3] Group 1: DecisionDx-Melanoma Test - The DecisionDx-Melanoma test is a 31-gene expression profile that provides independent risk stratification for cutaneous melanoma patients, demonstrating significant mortality risk predictions [2][4] - In a study involving over 13,500 patients, the DecisionDx-Melanoma test showed a Class 2B hazard ratio of 4.59 and a Class 1B/2A hazard ratio of 3.42, indicating its strong predictive capability for melanoma-specific mortality [2][3] - The test has been ordered more than 200,000 times for patients diagnosed with cutaneous melanoma, supporting its clinical value through over 50 peer-reviewed studies [4][6] Group 2: DecisionDx-UM Test - The DecisionDx-UM test is a 15-gene expression profile that predicts the risk of metastasis in uveal melanoma patients and is widely used in ocular oncology practices in the U.S. [5] - The test is recognized in AJCC staging and NCCN guidelines as a prognostic factor, with nearly 80% of uveal melanoma patients in the U.S. receiving it as part of their diagnostic workup [5][6] Group 3: Research and Development - Castle Biosciences is actively engaged in research and development for tests addressing high clinical needs, including a test for guiding systemic therapy selection for atopic dermatitis [7] - The company aims to transform disease management through innovative tests that prioritize patient care [6][7]

Company Overview - Castle Biosciences, Inc. is a diagnostics company focused on improving health through innovative tests that guide patient care [3] - The company aims to transform disease management by prioritizing patients, clinicians, employees, and investors [3] Upcoming Presentation - The executive management of Castle Biosciences is scheduled to present a company overview at the 2025 Jefferies Global Healthcare Conference on June 4, 2025, at 7:35 a.m. Eastern time [1] - A live audio webcast of the presentation will be available on the company's website, with a replay accessible after the live broadcast [2] Product Portfolio - Castle's current portfolio includes tests for skin cancers, Barrett's esophagus, and uveal melanoma [4] - The company is engaged in research and development for tests addressing high clinical needs, including a test for guiding systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment [4]

FRIENDSWOOD, Texas, May 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data from the first independent validation of the recently published Collaborative Ocular Oncology Group Study No. 2 (COOG2.1) by Harbour et al.1 The data, from a real-world cohort of 1,297 patients with uveal melanoma (UM), was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Mee ...

At just 26 years old, Leah Adams heard the words no one wants to hear: malignant melanoma. In this powerful and emotional story, Leah shares how a routine skin check —prompted by her mother's intuition—led to a life-altering diagnosis. As a runner and only child, Leah's journey through surgery, recovery, and her father's parallel battle with stage 4 metastatic melanoma sheds light on how deeply this disease can impact families. Watch as Leah explains how the DecisionDx® Melanoma test helped guide her next s ...

Empowering people, informing care decisions First Quarter 2025 May 5, 2025 ©2025 Castle Biosciences 1 Disclaimers Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. These forward-looking statements include, but are not limited to, statements concerning: our positioning f ...

Castle Biosciences, Inc. (CSTL) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -150%. A quarter ago, it was expected that this company would post earnings of $0.11 per share when it actually produced earnings of $0.32, delivering a surprise of 190.91%.Over the last four quarters, the company ...

Financial Data and Key Metrics Changes - Revenue grew by 21% to $88 million in Q1 2025 compared to Q1 2024, driven by strong test volume growth [7][25] - Adjusted revenue was $87.2 million, reflecting a 22% increase year-over-year [25] - Gross margin for Q1 2025 was 49.2%, down from 77.9% in Q1 2024, primarily due to a one-time amortization expense of approximately $20.1 million [25][26] - Adjusted gross margin was 81.2%, compared to 80.5% in the same period in 2024 [26] - Net loss for Q1 2025 was $25.8 million, compared to $2.5 million in Q1 2024 [30] - Adjusted EBITDA for Q1 was $13 million, up from $10.5 million in Q1 2024 [31] Business Line Data and Key Metrics Changes - DecisionDx Melanoma test reports increased by 3% to 8,621 in Q1 2025 compared to Q1 2024 [12] - DecisionDx SCC test reports delivered were 4,375 in Q1 2025, with ongoing studies supporting its clinical utility [16][18] - TissueCypher test reports grew by 117% year-over-year, with 7,432 reports delivered in Q1 2025 [21] Market Data and Key Metrics Changes - The company raised its total revenue guidance for 2025 to between $287 million and $297 million, up from a previous range of $280 million to $295 million [26] - The company anticipates high single-digit volume growth for DecisionDx Melanoma for the full year 2025 compared to 2024 [12] Company Strategy and Development Direction - The company signed an agreement to acquire ProVise, enhancing its position in the gastrointestinal space [7][23] - The acquisition aims to expand offerings within the GI vertical and address unmet clinical needs [23] - The company plans to discontinue the iGenx test effective May 2025 to focus resources on more profitable growth areas [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining financial discipline while executing growth initiatives [7] - The company expects to deliver positive net cash flow from operations for the full year of 2025 [31] - Management highlighted the importance of the DecisionDx tests in improving patient outcomes and reducing unnecessary healthcare costs [80] Other Important Information - The company is pursuing reconsideration requests for DecisionDx SCC reimbursement following a local coverage determination [18] - The company continues to assess opportunities for strategic acquisitions that align with its growth criteria [23] Q&A Session Summary Question: Clarification on gross margin guidance - The mid-seventy percent gross margin guidance is adjusted and includes the impact of DecisionDx SCC reimbursement [35][36] Question: Details on ProVise's technology - ProVise offers a tissue-based methylation technology and a non-endoscopic sponge-based technology, with expectations for future integration [37][38] Question: Impact of ID Genetics discontinuation - The discontinuation will have a modest impact on revenue but will positively benefit EBITDA performance [46][47] Question: Volume growth expectations for DecisionDx tests - High single-digit volume growth is expected for DecisionDx Melanoma, with consistent growth anticipated for TissueCypher [49][50] Question: Sales force distribution and hiring expectations - The company currently has around 65 sales territories and is assessing the need for further expansion based on market response [51][52] Question: Timing of reconsideration requests - Timing for the reconsideration requests is uncertain, and management will provide updates as more information becomes available [57][58] Question: Acquisition details and revenue impact - The acquisition of ProVise was cash-based, and its revenue contribution is not material to Castle [83][84]

Financial Data and Key Metrics Changes - Revenue grew by 21% to $88 million in Q1 2025 compared to Q1 2024, driven by a 33% increase in total test report volume for core revenue drivers [6][23] - Adjusted revenue was $87.2 million for Q1 2025, reflecting a 22% increase year-over-year [23] - Gross margin for Q1 2025 was 49.2%, down from 77.9% in Q1 2024, primarily due to a one-time amortization expense of approximately $20.1 million [24][25] - Adjusted gross margin was 81.2% for Q1 2025, compared to 80.5% in the same period in 2024 [24] - Net loss for Q1 2025 was $25.8 million, compared to $2.5 million in Q1 2024, with adjusted net loss per share at $0.20 [28][29] Business Line Data and Key Metrics Changes - DecisionDx Melanoma test reports increased by 3% to 8,621 in Q1 2025, with expectations of high single-digit volume growth for the full year [11][12] - DecisionDx SCC test reports totaled 4,375 in Q1 2025, with ongoing efforts to enhance risk stratification [15] - TissueCypher test reports grew by 117% year-over-year, reaching 7,432 in Q1 2025 [19][20] Market Data and Key Metrics Changes - The company raised its total revenue guidance for 2025 to a range of $287 million to $297 million, up from the previous range of $280 million to $295 million [24] - The gross margin for the remaining quarters of 2025 is expected to be in the mid-70s range [25] Company Strategy and Development Direction - The company signed an agreement to acquire ProVise, enhancing its position in the gastrointestinal space and expanding its offerings [6][21] - The focus remains on driving both near and long-term stockholder value through strategic growth initiatives [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining financial discipline while executing growth initiatives, supported by a strong balance sheet with $275 million in cash and equivalents [6] - The company anticipates continued adoption of its tests, bolstered by recent publications validating their clinical utility [12][14] Other Important Information - The company plans to discontinue the iGenx test effective May 2025 to reallocate resources to other areas with unmet clinical needs [22] - The reimbursement landscape for DecisionDx SCC is under review, with ongoing reconsideration requests submitted [17][53] Q&A Session Summary Question: Clarification on gross margin guidance - The mid-seventy percent gross margin guidance is adjusted and includes the impact of DecisionDx SCC reimbursement [32] Question: Details on ProVise's technology - ProVise offers tissue-based methylation technology and a non-endoscopic sponge-based technology, with expected downstream impacts on revenue [33][38] Question: Competition between EsoPredict and TissueCypher - EsoPredict is a methylation-based assay for Barrett's Esophagus, similar to TissueCypher, but the latter has a more robust dataset [41] Question: Discontinuation of ID Genetics and reinvestment plans - The discontinuation will have a modest impact on revenue but is expected to positively benefit EBITDA [42][44] Question: Volume growth expectations for DecisionDx Melanoma - High single-digit volume growth is expected for DecisionDx Melanoma, with continued improvement in average selling price [46][47] Question: Sales force distribution and hiring expectations - The company currently has around 65 sales territories and is assessing the need for further expansion based on market response [48] Question: Update on Medicare reimbursement for DecisionDx SCC - The timing for the reconsideration request is uncertain, and the company will provide updates as more information becomes available [53][75]