(MENAFN- GlobeNewsWire - Nasdaq) Delivered Q3 2025 revenue of $83 million Q3 2025 non-dermatologic revenue increased by 67% over Q3 2024
Q3 2025 total test reports for our core revenue drivers (DecisionDx®-Melanoma, TissueCypher®) increased 36% over Q3 2024
Raising full-year 2025 revenue guidance to $327-335 million from $310-320 million
Announced launch of AdvanceAD-TxTM, the Company's test designed to guide systemic treatment decision making in patients ages 12 and older with moderate-to-severe atopic dermatitis (AD)
Conference call and webcast today at 4:30 p.m. ET
FRIENDSWOOD, Texas, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the third quarter and nine months ended Sept. 30, 2025.
“We delivered a strong third quarter, generating $83 million in revenue and 26,841 in total test report volume,” said Derek Maetzold, president and chief executive officer of Castle Biosciences.“These strong results are a testament to the workforce culture we have built at Castle and our unwavering commitment to improving patient care.
“Our momentum this quarter reflects the strength of our core dermatologic and gastrointestinal testing franchises, with DecisionDx-Melanoma and TissueCypher each surpassing 10,000 test reports for the first time in a single quarter, significant milestones that underscore the expanding adoption of our core tests. Based on our strong execution, we are raising our full-year 2025 total revenue guidance to $327-335 million from the previously provided range of $310-320 million.
“Additionally, with the launch of AdvanceAD-Tx, our new test designed to guide systemic treatment decision making in patients with moderate-to-severe atopic dermatitis, we are thrilled to provide an additional innovative, first-in-class, proprietary test addressing a significant unmet need in clinical dermatology.”
Third Quarter Ended Sept. 30, 2025 , Financial and Operational Highlights
Revenues were $83.0 million, compared to $85.8 million in the third quarter of 2024. Affecting third quarter 2025 revenue was the Novitas local coverage determination (LCD), Genetic Testing in Oncology: Specific Tests, that included DecisionDx®-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix® in May 2025. Delivered 26,841 total test reports in the third quarter of 2025, compared to 26,010 in the same period of 2024. Affecting third quarter 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025: DecisionDx-Melanoma test reports delivered in the quarter were 10,459, compared to 9,367 in the third quarter of 2024. TissueCypher Barrett's Esophagus test reports delivered in the quarter were 10,609, compared to 6,073 in the third quarter of 2024. DecisionDx-SCC test reports delivered in the quarter were 4,186, compared to 4,195 in the third quarter of 2024. Affecting third quarter test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025. MyPath® Melanoma test reports delivered in the quarter were 1,151, compared to 933 in the third quarter of 2024. DecisionDx®-UM test reports delivered in the quarter were 436, compared to 397 in the third quarter of 2024.
Gross margin was 75%, and Adjusted Gross Margin was 77%, compared to 79% and 82%, respectively, for the same periods in 2024. Net cash provided by operations was $22.6 million, compared to $23.3 million for the same period in 2024. Net loss, which includes non-cash stock-based compensation expense of $12.1 million, was $0.5 million, compared to net income of $2.3 million for the same period in 2024. Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.02, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.08, for the same period in 2024. Adjusted EBITDA was $9.2 million, compared to $21.6 million for the same period in 2024.
Nine Months Ended Sept. 30, 2025 , Financial and Operational Highlights
Revenues were $257.2 million, compared to $245.8 million during the same period in 2024. Affecting nine months ended September 30, 2025 revenue was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025. Delivered 77,817 total test reports in the nine months ended September 30, 2025, compared to 72,000 in the same period of 2024. Affecting nine months ended September 30, 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025: DecisionDx-Melanoma test reports delivered in the nine months ended September 30, 2025, were 29,061, compared to 27,336 for the same period in 2024. TissueCypher Barrett's Esophagus test reports delivered in the nine months ended September 30, 2025, were 27,211, compared to 14,284 for the same period in 2024. DecisionDx-SCC test reports delivered in the nine months ended September 30, 2025, were 13,323, compared to 12,049 for the same period in 2024. Affecting nine months ended September 30, 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025. MyPath Melanoma test reports delivered in the nine months ended September 30, 2025, were 3,243, compared to 3,030 for the same period in 2024. IDgenetix test reports delivered in the nine months ended September 30, 2025, were 3,605, compared to 14,026 for the same period in 2024. The Company discontinued its IDgenetix test offering effective May 2025. DecisionDx-UM test reports delivered in the nine months ended September 30, 2025, were 1,374, compared to 1,275 for the same period in 2024.
Gross margin for the nine months ended September 30, 2025, was 67%, and Adjusted Gross Margin was 80%, compared to 79% and 82%, respectively, for the same period in 2024. Net cash provided by operations was $37.4 million, compared to $40.5 million for the same period in 2024. Net loss, which includes non-cash stock-based compensation expense of $34.5 million, was $21.8 million, compared to net income of $8.7 million for the same period in 2024. Net loss per share, Basic and Diluted, was $0.76 and Adjusted Net Loss per Share, Basic and Diluted, was $0.06, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.31 and $0.30, respectively, for the same period in 2024. Adjusted EBITDA was $32.5 million, compared to $53.7 million for the same period in 2024.
Cash, Cash Equivalents and Marketable Investment Securities
As of Sept. 30, 2025, the Company's cash, cash equivalents and marketable investment securities totaled $287.5 million.
2025 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2025. The Company now anticipates generating between $327-335 million in total revenue in 2025, compared to the previously provided guidance of between $310-320 million.
Third Quarter and Recent Accomplishments and Highlights
Dermatology- Skin Cancer
DecisionDx-Melanoma: The Company presented new data demonstrating DecisionDx-Melanoma stratifies risk across histological subtypes at the 25th Annual Fall Clinical Dermatology Conference®, which was held Oct. 23–26, 2025, in Las Vegas, Nevada. Specifically, cutaneous melanoma (CM) subtypes, such as superficial spreading and nodular melanoma, vary in how often they occur and in their outcomes. Even among patients with the same subtype, differences in tumor biology can lead to very different prognoses. In a real-world cohort of 13,560 patients with stage I–III CM from Castle's ongoing collaboration with the National Cancer Institute's Surveillance, Epidemiology and End Results (NCI's SEER) Program Registries, DecisionDx-Melanoma stratified melanoma-specific survival (MSS) across different tumor subtypes. For example, five-year MSS in nodular melanoma was 98.5% for patients with Class 1A (lowest risk) test results versus 82.3% for patients with Class 2B (highest risk) test results; similar stratification was observed across superficial spreading, lentigo maligna and unspecified subtypes. These results suggest that DecisionDx-Melanoma provides clarity in overall risk beyond histology, supporting more informed treatment planning and potentially improved outcomes. See the Company's news release from October 24, 2025, for more information. DecisionDx-SCC: Two new studies were published supporting the clinical utility of DecisionDx-SCC in patients with high-risk cutaneous squamous cell carcinoma (SCC). The first study represented a new validation milestone, establishing DecisionDx-SCC as a significant predictor of local recurrence (LR) in patients classified as high-risk by National Comprehensive Cancer Network (NCCN) guidelines, thereby adding a third utility to the test's existing capabilities. The test has now been validated to predict individual risk of metastasis, benefit from adjuvant radiation therapy (ART) and risk of LR, providing comprehensive results to support tailored post-surgical management and treatment pathway recommendations for patients with SCC. The second publication shared results from a clinical impact study, affirming the impact of the test's results in guiding these recommendations, specifically the use of ART and surveillance imaging, by providing actionable decision points based on individual patient risk. See the Company's news release from August 25, 2025, for more information.
Gastroenterology
The Company announced new data demonstrating the personalized risk stratification provided by its TissueCypher Barrett's Esophagus (BE) test at the American Foregut Society's (AFS) 2025 Annual Meeting. Specifically, this study evaluated TissueCypher's ability to stratify risk in 85 patients diagnosed with non-dysplastic Barrett's esophagus (NDBE) who received test results from four surgical practices. Patients with NDBE are generally considered to have the lowest risk of cancer progression, and current guidelines recommend surveillance every three to five years. However, while 85% of patients in the study received low-risk TissueCypher results, 15% were classified as intermediate- or high-risk by the TissueCypher test, indicating a significantly higher likelihood of progressing to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) than their pathology results suggested. Patients with intermediate-risk scores had a median five-year progression probability of 9%, and those with high-risk scores had a 16% probability. Both groups exceeded the 8.5% five-year risk of progression associated with expert-confirmed low-grade dysplasia (LGD) based on population estimates, which is the threshold at which guidelines recommend escalating to endoscopic eradication therapy (EET) or more frequent surveillance every six to twelve months. These findings show that TissueCypher can deliver clinically meaningful risk insights that can help physicians better tailor care for patients with BE. Notably, patients in the study with intermediate- and high-risk scores had similar or greater predicted progression risk than patients diagnosed with LGD, despite having a NDBE diagnosis. By identifying low-risk patients whose care can follow guideline-based surveillance intervals and intermediate- and high-risk patients who may benefit from earlier intervention, TissueCypher can potentially support more precise, risk-aligned management aimed at preventing disease progression. See the Company's news release from September 9, 2025, for more information.
Dermatology- Atopic Dermatitis
AdvanceAD-TxTM: The Company announced the launch of AdvanceAD-Tx, a gene expression profile (GEP) test designed to guide systemic treatment decision making in patients ages 12 and older with moderate-to-severe atopic dermatitis (AD). This innovative 487-GEP test is designed to identify patients with a Janus kinase (JAK) inhibitor responder profile who are more likely to achieve an Eczema Area and Severity Index improvement of 90% (EASI-90), more quickly and with reduction of flares and itch by three months, when treated with a JAK inhibitor than those treated with a T helper type 2 (Th2)-targeted therapy. See the Company's news release from November 3, 2025, for more information.
Corporate
The Company announced that its founder, president and chief executive officer Derek Maetzold was named CEO of the Year by The CEO Magazine. The Executive of the Year Awards program recognizes senior executives driving measurable impact, innovation and inspiration. See the Company's news release from October 1, 2025, for more information. The Company announced it was recognized as a Greater Pittsburgh Top Workplace by The Pittsburgh Post-Gazette. The designation is based exclusively on anonymous employee feedback gathered through a third-party survey. The confidential survey measures several aspects of workplace culture designed to be indicative of employee satisfaction and engagement, including feeling respected and supported, enabled to grow and empowered to execute. Castle was among just 89 companies honored with a Greater Pittsburgh Top Workplaces award in 2025. See the Company's news release from September 23, 2025, for more information. The Company announced it was included in the inaugural 2025 America's Greatest Companies list, published by Newsweek. The ranking honors 650 U.S. companies demonstrating strong performance across four key pillars: financial strength, workforce dedication, innovation, and commitment to environmental sustainability and corporate ethics. Evaluations were based on company reviews, filings with the U.S. Securities and Exchange Commission (SEC) and Patent and Trademark Office (USPTO), and third-party data sources to provide an objective measure of corporate performance. See the Company's news release from September 17, 2025, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, November 3, 2025, at 4:30 p.m. Eastern time to discuss its third quarter 2025 results and provide a corporate update.
A live webcast of the conference call can be accessed here: or via the webcast link on the Investor Relations page of the Company's website, . Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company's website until November 24, 2025.
To access the live conference call via phone, please dial 833-470-1428 from the United States, or global dial-in numbers are available here: , at least 10 minutes prior to the start of the call, using the conference ID 735311.
There will be a brief Question & Answer session following management commentary.
Use of Non-GAAP Financial Measures (UNAUDITED)
In this release, we use the metrics of Adjusted Revenues, Adjusted Gross Margin, Adjusted EBITDA and Adjusted Net Income (Loss) per Share, Basic and Diluted, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). Adjusted Revenues and Adjusted Gross Margin reflect adjustments to GAAP net revenues to exclude net positive and/or net negative revenue adjustments recorded in the current period associated with changes in estimated variable consideration related to test reports delivered in previous periods. Adjusted Gross Margin further excludes acquisition-related intangible asset amortization. Adjusted EBITDA excludes from net income (loss): interest income, interest expense, income tax benefit or expense, depreciation and amortization expense, stock-based compensation expense and changes in fair value of equity securities. Adjusted Net Income (Loss) per Share, Basic and Diluted, excludes a one-time adjustment of an acceleration of amortization expense for our IDgenetix test from net income (loss).
We use Adjusted Revenues, Adjusted Gross Margin, Adjusted EBITDA and Adjusted Net Income (Loss) per Share, Basic and Diluted, internally because we believe these metrics provide useful supplemental information in assessing our revenue and operating performance reported in accordance with GAAP, respectively. We believe that Adjusted Revenues, when used in conjunction with our test report volume information, facilitates investors' analysis of our current-period revenue performance and average selling price performance by excluding the effects of revenue adjustments related to test reports delivered in prior periods, since these adjustments may not be indicative of the current or future performance of our business. We believe that providing Adjusted Revenues may also help facilitate comparisons to our historical periods. Adjusted Gross Margin is calculated using Adjusted Revenues and therefore excludes the impact of revenue adjustments related to test reports delivered in prior periods, which we believe is useful to investors as described above. We further exclude acquisition-related intangible asset amortization in the calculation of Adjusted Gross Margin. We believe that excluding acquisition-related intangible asset amortization may facilitate gross margin comparisons to historical periods and may be useful in assessing current-period performance without regard to the historical accounting valuations of intangible assets, which are applicable only to tests we acquired rather than internally developed. Adjusted Net Income (Loss) per Share, Basic and Diluted, is calculated by excluding a one-time adjustment of an acceleration of amortization expense for our IDgenetix test from net loss. We believe that providing Adjusted Net Income (Loss) per Share, Basic and Diluted, may also help facilitate comparisons to our historical periods. We believe Adjusted EBITDA may enhance an evaluation of our operating performance because it excludes the impact of prior decisions made about capital investment, financing, investing and certain expenses we believe are not indicative of our ongoing performance. However, these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes.
These non-GAAP financial measures are not meant to be considered in isolation or used as substitutes for net revenues, gross margin, net income (loss) or net income (loss) per share reported in accordance with GAAP; should be considered in conjunction with our financial information presented in accordance with GAAP; have no standardized meaning prescribed by GAAP; are unaudited; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of these non-GAAP financial measures, and we may in the future cease to exclude items that we have historically excluded for purposes of these non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at these non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by us in this press release and the accompanying reconciliation tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Accordingly, investors should not place undue reliance on non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of this release.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. With a primary focus in dermatologic and gastroenterological disease, we develop personalized, clinically actionable solutions that help improve disease management and patient outcomes.
We put people first-empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit and connect with us on LinkedIn, Instagram, Facebook and X.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.
Forward-Looking Statements
This press release 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 expectations regarding: Castle's 2025 total revenue guidance of $327-335 million; continued top-line performance and growth of test volumes; the ability of DecisionDx-Melanoma, DecisionDx-SCC, TissueCypher and AdvanceAD-Tx to bring substantial added value to clinicians and their patients; the ability of DecisionDx-Melanoma to (i) reduce mortality risk compared to untested patients, (ii) improve patient survival; and (iii) provide clarity in overall risk beyond histology; the ability of DecisionDx-SCC to (i) predict individual risk of metastasis, benefit from ART and risk of LR, (ii) provide comprehensive results to support tailored post-surgical management and treatment pathway recommendations and (iii) provide actionable decision points based on individual patient risk; the anticipated success of our launch of AdvanceAD-Tx; and Castle's ability to achieve near- and long-term success and the continued growth of our portfolio. The words“anticipate,”“can,”“could,”“expect,”“goal,”“guidance,”“may,”“plan,”“potentially,”“providing,”“upcoming” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: our assumptions or expectations regarding reimbursement for our products and subsequent coverage decisions; our estimated total addressable markets for our products and product candidates and the related expenses, capital requirements and potential needs for additional financing; the anticipated cost, timing and success of our product candidates; our plans to research, develop and commercialize new tests; our ability to successfully integrate new businesses, assets, products or technologies acquired through acquisitions; the effects of macroeconomic events and conditions, including inflation and monetary supply shifts, labor shortages, liquidity concerns at, and failures of, banks and other financial institutions or other disruptions in the banking system or financing markets, recession risks, supply chain disruptions, tariffs, outbreaks of contagious diseases and geopolitical events (such as the ongoing conflicts in the Middle East and Ukraine-Russia conflict), among others, on our business and our efforts to address any impact on our business; the possibility that subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results discussed in this press release, including with respect to the tests discussed in this press release; our planned installation of additional equipment and supporting technology infrastructures and implementation of certain process efficiencies may not enable us to increase the future scalability of our TissueCypher Test; the possibility that actual application of our tests may not provide the aforementioned benefits to patients; the possibility that our newer gastroenterology franchise may not contribute to the achievement of our long-term financial targets as anticipated; and the risks set forth under the heading“Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each filed or to be filed with the SEC, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.
Investor Relations Contact:
Camilla Zuckero
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281-906-3868
Media Contact:
Allison Marshall
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Stock-based compensation expense is included in the condensed consolidated statements of operations as follows (in thousands):
The table below presents the reconciliation of Adjusted Revenues, Adjusted Gross Margin and Adjusted Net Income (Loss) Per Share, Basic and Diluted, which are non-GAAP financial measures. See "Use of Non-GAAP Financial Measures (UNAUDITED)" above for further information regarding the Company's use of non-GAAP financial measures.
The table below presents the reconciliation of Adjusted EBITDA, which is a non-GAAP financial measure. See "Use of Non-GAAP Financial Measures (UNAUDITED)" above for further information regarding the Company's use of non-GAAP financial measures.
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