Castle Biosciences(CSTL)
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Castle Biosciences(CSTL) - 2025 Q2 - Quarterly Results
2025-08-04 20:08
[Financial & Operational Highlights](index=1&type=section&id=Financial%20%26%20Operational%20Highlights) Q2 2025 revenue was $86.2 million, a slight decrease, with core test volume growth and raised full-year guidance [Second Quarter Ended June 30, 2025](index=1&type=section&id=Second%20Quarter%20Ended%20June%2030%2C%202025) Q2 2025 revenues were $86.2 million, a slight decrease, impacted by coverage decisions, with total test reports up 6% Q2 2025 Key Financial Metrics (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $86.2M | $87.0M | -0.9% | | Adjusted Revenues | $86.2M | $86.6M | -0.5% | | Gross Margin | 77% | 81% | -4 pp | | Adjusted Gross Margin | 80% | 83% | -3 pp | | Net Income | $4.5M | $8.9M | -49.2% | | Diluted EPS | $0.15 | $0.31 | -51.6% | | Adjusted EBITDA | $10.4M | $21.5M | -51.8% | Q2 2025 Test Report Volume | Test | Q2 2025 Reports | Q2 2024 Reports | Change | | :--- | :--- | :--- | :--- | | Total Test Reports | 26,574 | 25,102 | +6% | | DecisionDx-Melanoma | 9,981 | 9,585 | +4% | | TissueCypher | 9,170 | 4,782 | +92% | | DecisionDx-SCC | 4,762 | 4,277 | +11% | | IDgenetix | 1,027 | 4,903 | -79% | - Revenue and test volume were **negatively impacted** by the Novitas LCD deeming DecisionDx-SCC noncovered and the discontinuation of the IDgenetix test[4](index=4&type=chunk) [Six Months Ended June 30, 2025](index=2&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025) H1 2025 revenues increased 9% to $174.2 million, with total test reports up 11%, but a net loss of $21.3 million due to amortization H1 2025 Key Financial Metrics (in millions) | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $174.2M | $160.0M | +9% | | Adjusted Revenues | $176.2M | $159.0M | +11% | | Net (Loss) Income | ($21.3M) | $6.4M | N/A | | Diluted (Loss) EPS | ($0.74) | $0.22 | N/A | | Adjusted EBITDA | $23.4M | $32.1M | -27% | H1 2025 Test Report Volume | Test | H1 2025 Reports | H1 2024 Reports | Change | | :--- | :--- | :--- | :--- | | Total Test Reports | 50,976 | 45,990 | +11% | | DecisionDx-Melanoma | 18,602 | 17,969 | +4% | | TissueCypher | 16,602 | 8,211 | +102% | | DecisionDx-SCC | 9,137 | 7,854 | +16% | | IDgenetix | 3,605 | 8,981 | -60% | [Cash Position and 2025 Outlook](index=3&type=section&id=Cash%20Position%20and%202025%20Outlook) The company held **$275.9 million** in cash and raised full-year 2025 revenue guidance to **$310-320 million** - The company held **$275.9 million** in cash, cash equivalents, and marketable investment securities as of June 30, 2025[8](index=8&type=chunk) - Full-year 2025 revenue guidance was raised to **$310-320 million** from the prior range of $287-297 million[1](index=1&type=chunk)[9](index=9&type=chunk) [Business Accomplishments and Highlights](index=3&type=section&id=Second%20Quarter%20and%20Recent%20Accomplishments%20and%20Highlights) The company achieved significant milestones, including FDA Breakthrough Device designation for DecisionDx-Melanoma and the acquisition of Previse [Dermatology](index=3&type=section&id=Dermatology) DecisionDx-Melanoma received FDA Breakthrough Device designation, and DecisionDx-SCC saw new studies and a reconsideration request - DecisionDx-Melanoma was granted **Breakthrough Device designation** by the U.S. FDA[12](index=12&type=chunk) - A real-world study showed DecisionDx-Melanoma was associated with a **32% reduction in mortality risk** compared to untested patients[12](index=12&type=chunk) - A reconsideration request was submitted for the Novitas LCD regarding DecisionDx-SCC, with two new studies supporting its clinical utility[12](index=12&type=chunk)[13](index=13&type=chunk) [Gastroenterology](index=4&type=section&id=Gastroenterology) The acquisition of Previse was completed, expected to expand GI offerings for Barrett's esophagus and other GI diseases - The acquisition of Previse (Capsulomics, Inc.) was completed, expected to **expand Castle's GI offerings** for Barrett's esophagus[14](index=14&type=chunk) [Uveal Melanoma](index=4&type=section&id=Uveal%20Melanoma) New data supports adding PRAME gene expression to DecisionDx-UM to refine metastatic risk prediction for uveal melanoma - New data from an independent validation study supports adding PRAME gene expression to DecisionDx-UM to **refine metastatic risk prediction**[15](index=15&type=chunk) [Pipeline Initiatives](index=4&type=section&id=Pipeline%20Initiatives) A collaboration with SciBase was initiated to develop a diagnostic test for predicting flares in atopic dermatitis patients - A collaboration and license agreement was signed with SciBase to develop a diagnostic test for predicting flares in atopic dermatitis[16](index=16&type=chunk) [Corporate](index=4&type=section&id=Corporate) CEO Derek Maetzold received a Lifetime Achievement Award, and the company earned multiple Top Workplaces awards - CEO Derek Maetzold received a **Lifetime Achievement Award** and was named a 2025 Most Admired CEO[18](index=18&type=chunk)[19](index=19&type=chunk) - The company earned several 2025 Top Workplaces awards for its healthcare industry ranking and culture excellence[18](index=18&type=chunk) [Financial Statements (Unaudited)](index=8&type=section&id=Financial%20Statements%20(Unaudited)) Unaudited financial statements show a H1 2025 net loss of $21.3 million, total assets of $544.7 million, and positive operating cash flow [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) H1 2025 net revenues grew to $174.2 million, but a $30.3 million amortization expense led to a $21.3 million net loss Condensed Consolidated Statements of Operations (in thousands) | | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net Revenues** | **$174,176** | **$159,976** | | Total operating expenses, net | $206,355 | $160,435 | | *Amortization of acquired intangible assets* | *$30,286* | *$4,494* | | Operating (loss) income | ($32,179) | ($459) | | **Net (loss) income** | **($21,325)** | **$6,386** | | **Diluted (loss) earnings per share** | **($0.74)** | **$0.22** | [Condensed Consolidated Balance Sheets](index=10&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets reached $544.7 million, with liabilities at $89.4 million and equity stable at $455.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $82,233 | $119,709 | | Marketable investment securities | $193,697 | $173,421 | | **Total Assets** | **$544,729** | **$531,235** | | **Total Liabilities** | **$89,353** | **$75,400** | | **Total Stockholders' Equity** | **$455,376** | **$455,835** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) H1 2025 operating cash flow was $14.8 million, but investing activities led to a $37.5 million decrease in cash Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $14,785 | $17,163 | | Net cash used in investing activities | ($50,809) | ($41,118) | | Net cash (used in) provided by financing activities | ($1,452) | $10,686 | | **Net Change in Cash and Cash Equivalents** | **($37,476)** | **($13,269)** | [Non-GAAP Financial Measures](index=5&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP metrics show Q2 2025 Adjusted Revenues of $86.2 million and Adjusted EBITDA of $10.4 million [Reconciliation of Adjusted Revenues, Gross Margin, and Net Income Per Share](index=12&type=section&id=Reconciliation%20of%20Adjusted%20Revenues%2C%20Gross%20Margin%2C%20and%20Net%20Income%20Per%20Share) H1 2025 Adjusted Revenues were $176.2 million, with a $20.1 million amortization adjustment leading to a $1.2 million Adjusted Net Loss Reconciliation of Key Non-GAAP Metrics (Q2 2025 vs Q2 2024) (in thousands) | | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net revenues (GAAP) | $86,188 | $87,002 | | **Adjusted Revenues (Non-GAAP)** | **$86,182** | **$86,639** | | Gross Margin percentage (GAAP) | 77.3% | 80.7% | | **Adjusted Gross Margin percentage (Non-GAAP)** | **79.5%** | **83.2%** | - For H1 2025, a **$20.1 million one-time adjustment** for accelerated amortization of IDgenetix significantly impacted GAAP net loss[44](index=44&type=chunk)[45](index=45&type=chunk) [Reconciliation of Adjusted EBITDA](index=13&type=section&id=Reconciliation%20of%20Adjusted%20EBITDA) Q2 2025 Adjusted EBITDA was $10.4 million, a decrease from Q2 2024, with H1 2025 Adjusted EBITDA at $23.4 million Reconciliation of Adjusted EBITDA (in thousands) | | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net income (loss) | $4,523 | $8,920 | ($21,325) | $6,386 | | Adjustments | $5,848 | $12,619 | $44,711 | $25,697 | | **Adjusted EBITDA (Non-GAAP)** | **$10,371** | **$21,539** | **$23,386** | **$32,083** | [Supplementary Information](index=5&type=section&id=Supplementary%20Information) This section provides conference call details, company overview, and forward-looking statements with associated risk factors [Conference Call and Webcast Details](index=5&type=section&id=Conference%20Call%20and%20Webcast%20Details) A conference call and webcast are scheduled for August 4, 2025, at 4:30 p.m. ET to discuss Q2 2025 results - A conference call is scheduled for **August 4, 2025, at 4:30 p.m. ET** to discuss Q2 2025 results[20](index=20&type=chunk) [About Castle Biosciences](index=6&type=section&id=About%20Castle%20Biosciences) Castle Biosciences is a diagnostics company focused on innovative tests for skin cancers, Barrett's esophagus, and uveal melanoma - The company's portfolio includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, with ongoing R&D[29](index=29&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements, including revenue guidance, with a caution that actual results may differ due to risks - The press release includes forward-looking statements concerning 2025 revenue guidance and product developments[31](index=31&type=chunk) - Investors are cautioned that actual results may differ materially due to various risks detailed in SEC filings[32](index=32&type=chunk)
Castle Biosciences Reports Second Quarter 2025 Results
Globenewswire· 2025-08-04 20:05
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]
Castle Biosciences to Present at the Canaccord Genuity 45th Annual Growth Conference
Globenewswire· 2025-07-29 11:00
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 Canaccord Genuity 45 Annual Growth Conference on August 12, 2025, at 12:30 p.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 actively developing tests for diseases with high clinical need, including a test for guiding systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment [4]
Earnings Preview: Castle Biosciences, Inc. (CSTL) Q2 Earnings Expected to Decline
ZACKS· 2025-07-28 15:06
Core Viewpoint - Wall Street anticipates a year-over-year decline in earnings for Castle Biosciences, Inc. due to lower revenues, with a focus on how actual results compare to estimates impacting stock price [1][2]. Earnings Expectations - The upcoming earnings report is expected on August 4, with a consensus estimate of a quarterly loss of $0.51 per share, reflecting a year-over-year change of -264.5% [3]. - Revenues are projected to be $73.89 million, down 15.1% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 26% lower in the last 30 days, indicating a reassessment by analysts [4]. - The Most Accurate Estimate matches the Zacks Consensus Estimate, resulting in an Earnings ESP of 0% [12]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, with a strong predictor for positive readings [9][10]. - Castle Biosciences currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat [12][13]. Historical Performance - In the last reported quarter, Castle Biosciences was expected to post a loss of $0.08 per share but actually reported a loss of -$0.20, resulting in a surprise of -150.00% [14]. - Over the past four quarters, the company has beaten consensus EPS estimates three times [15]. Industry Comparison - Moderna, another player in the Zacks Medical - Biomedical and Genetics industry, is expected to report a loss of $2.99 per share, with revenues projected at $127.17 million, down 47.2% year-over-year [19][20]. - Moderna's consensus EPS estimate has been revised 1.4% lower, but it has a positive Earnings ESP of +7.22% and a Zacks Rank of 3, indicating a likelihood of beating the consensus estimate [20][21].
Castle Biosciences’ Founder, President and CEO Derek Maetzold Named a Most Admired CEO by the Houston Business Journal
GlobeNewswire· 2025-07-25 11:00
Core Insights - Castle Biosciences' CEO Derek Maetzold has been recognized as a 2025 Most Admired CEO by the Houston Business Journal for his exceptional leadership and contributions to the community [3][4] - The award highlights the importance of financial stewardship and fostering inclusive workplace cultures, which are key aspects of Maetzold's leadership approach [3][4] Company Overview - Castle Biosciences (Nasdaq: CSTL) is a diagnostics company focused on improving health through innovative tests that guide patient care [5] - The company aims to transform disease management by prioritizing the needs of patients, clinicians, employees, and investors [5] Product Portfolio - Castle's current portfolio includes diagnostic tests for skin cancers, Barrett's esophagus, and uveal melanoma [6] - The company is also engaged in research and development for additional tests addressing high clinical needs, including a test for guiding systemic therapy selection for patients with moderate-to-severe atopic dermatitis [6]
FDA Grants Breakthrough Device Designation to Castle Biosciences' DecisionDx®-Melanoma Test
Globenewswire· 2025-07-23 11:00
Core Insights - Castle Biosciences, Inc. announced that its DecisionDx-Melanoma test received Breakthrough Device designation from the FDA, aimed at improving patient care for those diagnosed with stage I-III cutaneous melanoma [1][3] Company Overview - Castle Biosciences is a diagnostics company focused on innovative tests that guide patient care, with a mission to transform disease management by prioritizing patients, clinicians, employees, and investors [5] - The company has a portfolio that includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, and is engaged in R&D for additional tests in high clinical need areas [6] Product Details - DecisionDx-Melanoma is a gene expression profile test that assesses a patient's risk of sentinel lymph node positivity and melanoma recurrence/metastasis, integrating tumor biology with clinical factors [4] - The test has been validated through over 10,000 patient samples and is supported by more than 50 peer-reviewed studies, demonstrating its clinical value and association with improved patient survival [4] - As of March 31, 2025, DecisionDx-Melanoma has been ordered over 200,000 times for patients diagnosed with cutaneous melanoma [4]
Castle Biosciences Honored with Multiple Top Workplaces Awards Recognizing the Company's Strong Culture
Globenewswire· 2025-07-17 11:00
Core Insights - Castle Biosciences, Inc. has received multiple awards in the 2025 Top Workplaces program, including a third consecutive national Healthcare Industry Top Workplaces award, ranking third in its size category, and a fourth consecutive regional Arizona Top Workplaces award [1][2] - The company has also been recognized for its Culture Excellence in various categories such as Innovation, Work-Life Flexibility, Compensation & Benefits, Leadership, and Purpose & Values [1][2] Company Overview - Castle Biosciences is a leading diagnostics company focused on improving health through innovative tests that guide patient care, with a mission to transform disease management by prioritizing patients, clinicians, employees, and investors [3] - The company's current portfolio includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, along with ongoing research and development for additional tests addressing high clinical needs [4] Awards and Recognition - The Top Workplaces awards are based on anonymous employee feedback collected through a third-party survey, which evaluates workplace experience and culture themes indicative of successful organizations [2] - Castle's awards in specific categories highlight its commitment to fostering a people-first culture, which is seen as a catalyst for innovation and impact [2][5]
Castle Biosciences to Release Second Quarter 2025 Financial Results and Host Conference Call on Monday, Aug. 4, 2025
GlobeNewswire News Room· 2025-07-14 11:00
Core Insights - Castle Biosciences, Inc. will release its financial results for Q2 2025 on August 4, 2025, after market close [1] - A conference call and webcast will be held at 4:30 p.m. Eastern time on the same day to discuss the financial results [1] Company Overview - Castle Biosciences is a leading diagnostics company focused on innovative tests that guide patient care [4] - The company aims to transform disease management by prioritizing patients, clinicians, employees, and investors [4] Product Portfolio - Castle's current portfolio includes tests for skin cancers, Barrett's esophagus, and uveal melanoma [5] - The company is also engaged in R&D for tests addressing high clinical needs, including a test for guiding systemic therapy selection for moderate-to-severe atopic dermatitis patients [5] Conference Call Details - A live webcast of the conference call can be accessed through the company's Investor Relations page [2] - For phone access, dial 1 833 470 1428 in the U.S. with access code 638217, and international numbers are available online [3] - A Q&A session will follow the management commentary during the conference call [3]
Castle Biosciences Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-06-19 11:00
Core Points - Castle Biosciences, Inc. granted restricted stock units (RSUs) to 66 employees, covering a total of 135,978 shares of common stock as part of their employment inducement [1] - The RSUs will vest over a four-year period, with 25% vesting on the first anniversary and the remaining shares vesting annually in three equal installments, contingent on continued service [2] - Castle Biosciences focuses on innovative diagnostic tests that guide patient care, with a portfolio that includes tests for skin cancers, Barrett's esophagus, and uveal melanoma [3][4] Company Overview - Castle Biosciences aims to transform disease management by prioritizing patients, clinicians, employees, and investors [3] - The company is actively 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 [4]
Castle Biosciences Enters Collaboration and License Agreement with SciBase to Develop Diagnostic Tests for Dermatologic Diseases
Globenewswire· 2025-06-16 20:30
Core Insights - Castle Biosciences has entered a collaboration and license agreement with SciBase to develop a diagnostic test aimed at predicting flares in patients with atopic dermatitis [1][2][3] - The collaboration targets a potential market of up to 24 million patients in the United States suffering from atopic dermatitis, many of whom experience flares while on maintenance treatment [2][3] - SciBase's technology will be utilized to enhance patient care in dermatology, complementing Castle's existing portfolio of tests for skin cancers and other dermatological conditions [3][5] Company Overview - Castle Biosciences is a diagnostics company focused on innovative tests that guide patient care, with a mission to transform disease management [4] - The company's current portfolio includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, along with ongoing research for additional tests in high clinical need areas [5] Collaboration Details - Under the agreement, both companies will explore various clinical indications related to dermatologic diseases, with SciBase focusing on the EU, Switzerland, UAE, Japan, and South Korea, while Castle will target North America [3] - SciBase will receive a single-digit royalty on Castle's gross margin and a low double-digit percentage markup on product sales, along with a milestone payment of 5 million USD when Castle's sales reach 50 million USD annually [3]