Summary of Castle Biosciences Conference Call Company Overview - Castle Biosciences is a diagnostic services company focused on guiding patient care and improving outcomes through a portfolio of tests, including MyPath Melanoma, DecisionDx-Melanoma, DecisionDx-SCC, and TissueCypher for Barrett's esophagus [3][4][5] Key Products and Services - **MyPath Melanoma**: A genomic test for identifying or ruling out melanoma in indeterminate biopsy samples [3] - **DecisionDx-Melanoma and DecisionDx-SCC**: Tests providing risk scores for skin cancers, aiding in treatment decisions [4] - **TissueCypher**: A spatial protein test for assessing the risk of Barrett's esophagus progressing to esophageal cancer, with a five-year mortality rate of 85% for esophageal cancer [4] - **ESOPredict**: Recently acquired test with similar utility to TissueCypher, aimed at identifying Barrett's esophagus [5] - **Atopic Dermatitis Program**: Collaboration with Cybase to identify flares of atopic dermatitis [3][5] Financial Performance - The company reported strong growth in its portfolio and maintained a high gross margin, with approximately $275 million in cash at year-end, positioning it well for future opportunities [5][6] Market Penetration and Growth Potential - Current testing penetration for melanoma is estimated at 30-31% of suitable patients, with significant room for growth as melanoma is underreported [9][10] - Approximately 55-60% of eligible clinicians have used Castle's dermatology tests, indicating potential for increased adoption [10] - Long-term growth is expected to be in the high single digits, with seasonal variations impacting volume [13][15] Reimbursement and Coverage - The company received acceptance for reconsideration requests for its squamous cell carcinoma test from Medicare contractors, which is seen as a positive administrative milestone [20][21] - Significant publications supporting the clinical utility of the SCC test suggest potential cost savings for Medicare, which could influence future coverage decisions [23][24] Strategic Direction - Castle Biosciences aims to identify clinical questions that lack adequate answers and develop tests to address these needs, with a focus on both dermatology and gastroenterology [26][30] - The company has expanded its sales force to enhance market penetration, particularly in the GI space, and is focused on maintaining strong relationships with physicians [36][39] Future Outlook - The company anticipates continued strong growth for its tests, particularly TissueCypher, with an expanding patient pool and positive physician response [40][41] - There is an ongoing emphasis on R&D to enhance existing tests and develop new ones, ensuring the company remains competitive in the diagnostic testing market [7][34] Additional Insights - The company has made strategic acquisitions, such as Previse, to enhance its product offerings and address unmet clinical needs [31][32] - The focus on automation and efficiency in lab processes has contributed to maintaining attractive gross margins despite varying profitability across different test types [34][35]

Core Insights - Castle Biosciences significantly outperformed Wall Street expectations in Q2 2025, reporting GAAP EPS of $0.15 and non-GAAP revenue of $86.2 million, both exceeding analyst estimates [1][2] - The company raised its full-year 2025 revenue guidance to a range of $310 million to $320 million, reflecting stronger-than-expected adoption of key tests [10] Financial Performance - GAAP revenue for Q2 2025 was $86.2 million, nearly flat compared to $87.0 million in Q2 2024, with a year-over-year change of -0.9% [2] - Non-GAAP EPS was $0.16, down 51.6% from $0.31 in Q2 2024 [2] - Adjusted EBITDA fell to $10.4 million, a decrease of 51.6% compared to $21.5 million in Q2 2024 [2] - Gross margin decreased from 80.7% in Q2 2024 to 77.3% in Q2 2025, reflecting rising expenses and a less favorable sales mix [2][9] Business Overview - Castle Biosciences specializes in molecular diagnostics, focusing on tests that provide actionable information for managing skin, gastrointestinal, and mental health diseases [3] - The company aims to expand its test portfolio through launches and acquisitions while ensuring reimbursement coverage to support test adoption [4] Recent Developments - Total test volumes reached 26,574 in Q2 2025, a 6% increase year-over-year, primarily driven by core offerings like DecisionDx-Melanoma and TissueCypher [5] - DecisionDx-Melanoma received FDA's Breakthrough Device designation in Q2 2025, indicating regulatory recognition for its innovation [5] - TissueCypher test report volume increased by 117% year-over-year in Q1 2025, attributed to expanded sales force coverage and rising clinical demand [6] - The company discontinued the IDgenetix test due to reimbursement challenges, aiming to streamline operations and improve profitability [8] Strategic Focus - Management is refocusing commercial efforts towards melanoma tests following the loss of Medicare coverage for DecisionDx-SCC, which has significantly impacted revenue [7] - The acquisition of Previse aims to broaden the gastrointestinal segment's potential, although it is not expected to contribute meaningfully to 2025 financial results [6]

Empowering people, informing care decisions August 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 for continued growth ...

Core Insights - Castle Biosciences reported Q2 2025 revenue of $86 million, a slight decrease from $87 million in Q2 2024, while total test reports for core revenue drivers increased by 33% year-over-year [1][4] - The company raised its full-year 2025 revenue guidance to a range of $310-320 million from the previous range of $287-297 million, reflecting strong performance in its core tests [7] Financial Highlights - Q2 2025 revenues were $86.2 million, compared to $87.0 million in Q2 2024, with adjusted revenues of $86.2 million, slightly down from $86.6 million in the same period last year [4] - Total test reports delivered in Q2 2025 were 26,574, a 6% increase from 25,102 in Q2 2024 [4] - Gross margin for Q2 2025 was 77%, with an adjusted gross margin of 80%, compared to 81% and 83% in Q2 2024, respectively [4] - Net cash provided by operations was $20.8 million, down from $24.0 million in Q2 2024 [4] Operational Highlights - The company delivered 9,981 DecisionDx-Melanoma test reports in Q2 2025, up from 9,585 in Q2 2024, and 9,170 TissueCypher Barrett's Esophagus test reports, significantly up from 4,782 in the same period last year [4] - The DecisionDx-SCC test reports delivered were 4,762, compared to 4,277 in Q2 2024, despite the impact of the Novitas local coverage determination [4] - The company discontinued its IDgenetix test offering in May 2025, which affected test report volumes [4] Strategic Developments - Castle Biosciences completed the acquisition of Previse and announced a collaboration with SciBase, aimed at enhancing its gastrointestinal offerings and developing new diagnostic tests [3][10] - The company is focused on executing its current test portfolio while investing in future growth initiatives [3] Market Position and Future Outlook - The company anticipates continued growth in test volumes and revenue, supported by the clinical value of its tests [2] - The DecisionDx-Melanoma test has received Breakthrough Device designation from the FDA, which may enhance its market position [13] - The company aims to create a multiomics approach for improved patient care in Barrett's esophagus through its acquisition of Previse [10]

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 ...

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]

Core Insights - Castle Biosciences, Inc. reported a 21% increase in Q1 2025 revenue to $88 million compared to Q1 2024 [1] - The company raised its full-year 2025 revenue guidance to $287-297 million from the previous range of $280-295 million [1][6] - The total test reports for core revenue drivers increased by 33% over Q1 2024 [1] Financial Performance - Revenues for Q1 2025 were $88 million, up from $73 million in Q1 2024, representing a 21% increase [4] - Adjusted revenues, excluding prior period adjustments, were $87.2 million, a 22% increase from $71.3 million in the same period last year [4] - The gross margin was 49%, while the adjusted gross margin remained at 81% [4] - The net loss for Q1 2025 was $25.8 million, compared to a net loss of $2.5 million in Q1 2024 [4][8] Operational Highlights - The company delivered 24,402 total test reports in Q1 2025, a 17% increase from 20,888 in Q1 2024 [4] - DecisionDx-Melanoma surpassed 200,000 test orders since its launch, indicating strong demand and clinical value [3][9] - The company decided to discontinue the IDgenetix test offering effective May 2025 [4][12] Cash Position - As of March 31, 2025, the company's cash, cash equivalents, and marketable investment securities totaled $275.2 million [5] Future Outlook - The company anticipates total revenue in 2025 to be between $287-297 million, reflecting confidence in continued growth [6] - Castle Biosciences is focused on expanding its proprietary test portfolio and enhancing patient outcomes [4][22]

Core Insights - Castle Biosciences has signed a definitive agreement to acquire Capsulomics, Inc., also known as Previse, which focuses on gastrointestinal health, particularly chronic acid reflux diseases and esophageal cancer [2][3] - The acquisition aims to enhance Castle's existing gastroenterology franchise by integrating Previse's methylation technology and other developmental technologies, thereby expanding its testing options [3][4] - The transaction is expected to close in the coming weeks, pending customary closing conditions [3] Company Overview - Castle Biosciences is a diagnostics company listed on Nasdaq (CSTL) that develops innovative tests to guide patient care and improve health outcomes [5] - The company's current portfolio includes tests for skin cancers, Barrett's esophagus, mental health conditions, and uveal melanoma, with ongoing research in other high clinical need areas [6] Previse Overview - Previse, established in 2018, specializes in gastrointestinal health and aims to improve patient outcomes through early detection and prevention of diseases like esophageal cancer [4] - The company utilizes advanced biomarker technology developed at Johns Hopkins University, which is exclusively licensed to Previse, to support its mission [4]