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]

Revenue Generation - Castle Biosciences primarily generates revenue from its DecisionDx-Melanoma and DecisionDx-SCC tests, with additional contributions from TissueCypher and DecisionDx-UM tests[111]. - The reimbursement rate for DecisionDx-Melanoma is set at $7,193 per test for 2024 and 2025, based on median private payor rates[125]. - DecisionDx-SCC has a list price of $8,500 per test, effective from April 1, 2024, through December 31, 2025[128]. - The rate for TissueCypher is set at $4,950 per test for 2025, based on median private payor rates[130]. - MyPath Melanoma has a reimbursement rate of $1,950 per test for 2024 and 2025[132]. - IDgenetix will be discontinued effective May 2025, with a reimbursement rate of $1,336 per test for 2024[137]. Market Opportunity - The estimated total addressable market (TAM) for invasive cutaneous melanoma (CM) is approximately $540 million, with around 130,000 patients diagnosed annually in the U.S.[114]. - For cutaneous squamous cell carcinoma (SCC), 20% of cases are classified as high-risk, representing an estimated TAM of approximately $820 million[115]. - TissueCypher has an estimated U.S. TAM of approximately $1 billion, aimed at predicting the progression of Barrett's esophagus[117]. Performance Metrics - The number of test reports delivered is a key performance indicator for assessing business performance[139]. - Test report volume increased by 16.8% in Q1 2025 compared to Q1 2024, with dermatologic tests up by 7.4%[140]. - TissueCypher test reports surged by 117% in Q1 2025 compared to the same period in 2024[140]. - Approximately 52% of clinicians ordering DecisionDx-SCC also ordered DecisionDx-Melanoma in Q1 2025[141]. - Total test reports delivered in 2024 reached 96,071, with 36,008 from DecisionDx-Melanoma and 16,348 from DecisionDx-SCC[140]. Financial Performance - Net revenues for the three months ended March 31, 2025, increased by $15.0 million, or 20.6%, to $87.988 million compared to the same period in 2024[166]. - Revenue from non-dermatologic tests increased by $11.4 million, primarily due to a 117% increase in test report volumes for the TissueCypher Barrett's Esophagus test[167]. - Revenue from dermatologic tests increased by $3.6 million, with net revenue from these tests rising from 18.7% to 28.4% of total net revenue[168]. - Total operating expenses increased by $37.471 million, or 47.8%, to $115.916 million, driven by higher amortization of acquired intangible assets and increased personnel costs[169]. - Gross margin percentage decreased to 49.2% for the three months ended March 31, 2025, down from 77.9% in the same period in 2024[171]. Expenses and Investments - The company expects significant increases in expenses due to clinical studies, commercialization strategies, and new product development[146]. - The company anticipates increased research and development expenses as it invests in new product development[154]. - Research and development expenses decreased by $1.2 million, or 8.8%, reflecting lower personnel costs and clinical study expenses[172]. - Selling, general and administrative expenses increased by $10.125 million, or 20.9%, primarily due to higher personnel costs and business development activities[174]. - Stock-based compensation expense totaled $11.2 million for the three months ended March 31, 2025, down from $12.7 million in the same period in 2024[181]. Cash Flow and Debt - As of March 31, 2025, the company had cash and cash equivalents of $89.7 million and marketable investment securities of $185.5 million[182]. - Net cash used in operating activities was $6.0 million for the three months ended March 31, 2025, primarily due to a net loss of $25.8 million[202]. - Net cash used in investing activities was $22.4 million for the three months ended March 31, 2025, mainly from purchases of marketable investment securities totaling $48.4 million[205]. - As of March 31, 2025, the company had long-term debt of $8.9 million, with total long-term debt net of current portion at $10.0 million[189]. - The company has a $25.0 million line of credit available until March 31, 2025, with no draws made as of March 31, 2025[197]. Future Outlook - The company expects to incur additional expenses in the future as it invests in the commercialization of existing products and the development of new product candidates[187]. - The company expects total capital expenditures for the development of its future corporate headquarters to be approximately $43.1 million, with $5.1 million spent as of March 31, 2025[186]. - The 2024 Loan and Security Agreement includes a $10.0 million term loan and a $25.0 million credit line, secured by substantially all assets excluding intellectual property[191]. - A hypothetical 10% change in interest rates would not have a material impact on the company's financial statements[212]. - The company lost Medicare coverage for its DecisionDx-SCC test in April 2025, which is expected to decrease revenues and cash inflows from this test[187]. Economic Factors - Macroeconomic conditions, including geopolitical conflicts and inflation, may materially impact the company's financial condition and operational performance[145]. - Federal NOL carryforwards as of December 31, 2024, totaled $129.4 million, with $52.9 million expiring in 2031 and $76.5 million available indefinitely[162].

Exhibit 99.1 Castle Biosciences Reports First Quarter 2025 Results Q1 2025 revenue increased 21% over Q1 2024 to $88 million ® ® Q1 2025 total test reports for our core revenue drivers (DecisionDx -Melanoma, DecisionDx -SCC, TissueCypher ) increased 33% over Q1 2024 ® Raising full-year 2025 revenue guidance to $287-297 million from $280-295 million Conference call and webcast today at 4:30 p.m. ET FRIENDSWOOD, Texas - May 5, 2025--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through i ...

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]

Core Insights - Castle Biosciences, Inc. is presenting new data on its TissueCypher Barrett's Esophagus test at the Digestive Disease Week® (DDW 2025) Annual Meeting, emphasizing its role in improving risk stratification and management of Barrett's esophagus patients [1][2][9] Company Overview - Castle Biosciences is a diagnostics company focused on innovative tests that guide patient care, with a portfolio that includes tests for skin cancers, Barrett's esophagus, and mental health conditions [10][11] - The TissueCypher Barrett's Esophagus test is designed to predict the future development of high-grade dysplasia and/or esophageal cancer in patients with Barrett's esophagus [9] Event Highlights - The company will showcase two posters at DDW 2025, including findings on the detection of missed neoplasia and risk stratification for Barrett's esophagus patients [3][2] - A product theater titled "The Time is Now: A Clinical Practice Model to Help Prevent Progression from Barrett's to EAC" will be hosted by an expert physician panel [1][6] Educational Collaborations - Castle is collaborating with the American Society for Gastrointestinal Endoscopy (ASGE) and other GI experts to conduct educational sessions on the use of TissueCypher [1][2]

Core Insights - Castle Biosciences, Inc. announced that its DecisionDx-Melanoma test significantly outperforms traditional methods in identifying low-risk melanoma patients who may avoid sentinel lymph node biopsy (SLNB) surgery, with a sentinel lymph node positivity rate of 2.8%, well below the NCCN's 5% threshold [1][2][3] Company Overview - Castle Biosciences is a diagnostics company focused on innovative tests that enhance patient care, with a portfolio that includes tests for skin cancers and other conditions [6][8] - The DecisionDx-Melanoma test has been ordered over 200,000 times for patients diagnosed with cutaneous melanoma, demonstrating its widespread adoption and clinical relevance [5] Study Findings - The study published in Cancer Diagnosis & Prognosis indicates that DecisionDx-Melanoma provides better risk stratification compared to the American Joint Committee on Cancer (AJCC) staging and the CP-GEP test, confirming its clinical utility [2][3] - Patients identified as low risk by CP-GEP had a sentinel lymph node positivity rate of 6.2%, while those identified by DecisionDx-Melanoma had a significantly lower rate of 2.8%, highlighting the latter's superior accuracy [3] Clinical Implications - The findings support the use of DecisionDx-Melanoma in clinical decision-making, allowing clinicians to confidently recommend forgoing SLNB for patients with low-risk results, thereby improving patient outcomes and reducing unnecessary procedures [4][5] - The test integrates tumor biology with clinical factors, providing personalized risk assessments for sentinel lymph node positivity and melanoma recurrence [5]

Core Insights - GSK reported quarterly earnings of $1.13 per share, exceeding the Zacks Consensus Estimate of $1.08 per share, and showing an increase from $1.09 per share a year ago, resulting in an earnings surprise of 4.63% [1] - The company posted revenues of $9.46 billion for the quarter ended March 2025, slightly missing the Zacks Consensus Estimate by 0.85%, but showing growth from $9.34 billion year-over-year [2] - GSK's stock has increased by approximately 15.2% since the beginning of the year, contrasting with a -5.5% decline in the S&P 500 [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $1.05, with projected revenues of $10.04 billion, and for the current fiscal year, the EPS estimate is $4.24 on revenues of $40.62 billion [7] - The estimate revisions trend for GSK is mixed, leading to a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which GSK belongs, is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]