Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — Q3 2023 Earnings Presentation
42 slides from Castle Biosciences's earnings presentation, Nov 2, 2023
Slide 1: Transforming Disease Management
Transforming Disease Management November 2023
Slide 2: Disclaimers
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 sectio
Slide 3: Castle Biosciences – Transforming Disease Management
Castle Biosciences – Transforming Disease Management Steadfast commitment to improving patient care Portfolio of through our innovative, actionable tests Innovative Tests Leader in the field of molecular diagnostics by Dermatology challenging the status quo with deep scientific expertise, unique va
Slide 4: Financial Performance Summary Q3 2023
Financial Performance Summary Q3 2023 Q3 2023 Q3 2022 Total test reports 18,409 12,114 Total Dermatology test reports 12,390 9,824 Revenues $61.5M $37.0M Adj. Revenues1 $60.6M $37.3M Gross Margin 77.9% 69.8% Adj. Gross Margin1 81.3% 76.2% Net Loss $(6.9)M $(20.2)M Adj. EBITDA1 $6.6M $(9.6)M Operatin
Slide 5: Consistent Execution Of Growth Initiatives Supports Long-Term Growth
Consistent Execution Of Growth Initiatives Supports Long-Term Growth 2017-2022 Total Test Report Volume 2017-2023 Revenue ($M) 44,419 ≥$200* 45%+ 28,145 $137 $94 17,055 18,185 13,445 $63 10,614 $52 $23 $14 1 2 2017 2018 2019 2020 2021 2022 2017 2018 2019 2020 2021 2022 2023E * 2023 revenue guidance
Slide 6: Key Q3 2023 and Recent Accomplishments
Key Q3 2023 and Recent Accomplishments Delivered excellent Q3 results, Raised 2023 revenue guidance to at Earned a Top Workplaces National highlighted by $5 million in cash flow least $200 million, from at least $180 Industry Award, ranking third among 84 from operations and strong year-over- millio
Slide 7: Driving Long-Term Growth Through Strong Execution And Our Operational Guideposts
Driving Long-Term Growth Through Strong Execution And Our Operational Guideposts Exceptional Employees, Continuous Evolution & Improvement and Customer & Solution Centric Near- to Mid-term Growth Mid- to Long-term Growth Mental Health Strategic Mental Health Opportunities Gastrointestinal Strategic
Slide 8: Answering Clinical Questions To Guide Care Along The Patient Journey
Answering Clinical Questions To Guide Care Along The Patient Journey Our focus is on diagnostic support, risk stratification and therapy selection/response areas of the patient care continuum Therapy MRD/Recurrence PATIENT CARE JOURNEY Screening Diagnostic Support Risk Stratification Selection/Respo
Slide 9: Estimated ~$8B U.S. Total Addressable Market for Commercially Available Tests
Estimated ~$8B U.S. Total Addressable Market1 for Commercially Available Tests Dermatology Gastroenterology Mental Health Cutaneous melanoma/ Cutaneous squamous cell Suspicious pigmented Barrett’s esophagus/risk of progression to Guide mental health therapy risk of metastasis, SLNB carcinoma/risk of
Slide 10: Significant Scientific Evidence Through Robust Clinical Research Program
10 Significant Scientific Evidence Through Robust Clinical Research Program 14 237 ~11,670 ~20,460 Ongoing clinical Committed/contributing Current patients Patients enrolled in research studies clinical research sites as of enrolled in studies over lifetime Q3 2023 studies as of Q3 2023 of Castle1 O
Slide 11: First-To-Market Dermatologic Franchise, Additional Growth Opportunities
First-To-Market Dermatologic Franchise, Additional Growth Opportunities Diagnostic Support Risk Stratification Therapy Selection Inflammatory Skin Disease Therapy Selection Pipeline Program Strong provider growth and continued adoption with approximately 1,600 new1 ordering clinicians and approximat
Slide 12: Clinical Validity, Utility and ADLT Status Reimbursement
Clinical Validity, Utility and ADLT Status Demonstrated Patient Outcomes Reimbursement Demonstrated clinical validity, Classified as an Advanced Reimbursement coverage through utility and impact, backed by more Diagnostic Laboratory Test (ADLT) Medicare Administrative Contractor than 45 peer-reviewe
Slide 13: DecisionDx-Melanoma Provides Answers For Two Critical Clinical Questions
DecisionDx-Melanoma Provides Answers For Two Critical Clinical Questions Individual Risk of Breslow Thickness Sentinel Ulceration Lymph Mitotic Rate Node Age Positivity DecisionDx- Melanoma Neural network Class Result with AI algorithm Breslow Thickness Ulceration Individual Mitotic Rate Risk of SLN
Slide 14: DecisionDx-Melanoma Has Consistent And Independent Evidence Of Prognostic Value
DecisionDx-Melanoma Has Consistent And Independent Evidence Of Prognostic Value Across Studies 100 RFS HR RFS (95% CI) HR DMFS (95% CI) FEATURE p-value p-value 80 % Recurrence Free Breslow thickness (per mm) 1.12 (1.03-1.22), p=0.01 1.14 (1.02-1.26), p=0.02 60 40 Ulceration 1.63 (1.18-2.25), p=0.003
Slide 15: DecisionDx-Melanoma Results Guided Treatment Decisions And Led To Improved Patient Outcomes
DecisionDx-Melanoma Results Guided Treatment Decisions And Led To Improved Patient Outcomes Key Findings: Independent, multi-center study of SLN negative • Routine surveillance imaging in SLN-, high-risk patients (n=634) patients detected melanoma recurrence ~10 months earlier than those without rou
Slide 16: Collaboration with the National Cancer Institute
Collaboration with the National Cancer Institute Linking DecisionDx-Melanoma clinical testing with patients captured in the National Cancer Institute’s SEER Program Registries
Slide 17: NCI/SEER Data Linked With DecisionDx-Melanoma Test Results
NCI/SEER Data Linked With DecisionDx-Melanoma Test Results Data analysis of real-world, unselected, clinically tested patients showed that DecisionDx-Melanoma testing was associated with lower melanoma-specific and overall mortality relative to untested patients Group 3-year MSS (95% Cl) Deaths, % (
Slide 18: Clinical Use Of DecisionDx-Melanoma Shows Favorable Outcomes Versus Standard Of Care
Clinical Use Of DecisionDx-Melanoma Shows Favorable Outcomes When Compared To Other Standard Of Care Prognostic Tests Sentinel Lymph Node Biopsy (SLNB) Tumor size P-value 10-yr MSS Thin (<1.2mm) Not reported Not impacted • MSLT-I found that SLN biopsy had no impact on 10-year melanoma specific survi
Slide 19: DecisionDx-Melanoma Is Supported By Significant Scientific Evidence
DecisionDx-Melanoma Is Supported By Significant Scientific Evidence 10,000+ 45+ ~146,000 Total patients included in studies Peer-reviewed, published studies Patients with a clinical including independent including prospective studies DecisionDx-Melanoma order validation and 2 meta-analyses from 12,6
Slide 20: Clinical Validity and Utility, ADLT Status, Real-World Use Framework
Clinical Validity and Utility ADLT Status Real-World Use Framework Demonstrated validity, utility and Classified as an Advanced Study in Clinical, Cosmetic and impact, backed by 14 peer-reviewed Diagnostic Laboratory Test (ADLT) Investigational Dermatology publications, including data showing by the
Slide 21: DecisionDx-SCC Provides Independent Risk Stratification To Inform SCC Management Decisions
DecisionDx-SCC Provides Independent Risk Stratification To Inform SCC Management Decisions Class 1: Low Biological Risk Less than half the general study population risk • Quantifies expression of 40 genes from primary tumor SCC patients using RT-PCR Class 2A: with one or Moderate Biological Risk mor
Slide 22: DecisionDx-SCC is Validated to Predict Metastatic Risk
DecisionDx-SCC is Validated to Predict Metastatic Risk for Individual SCC Patients with One or More Risk Factors Kaplan-Meier Estimated MFS Class 1 – Low Biological Risk <7% risk of metastasis; Metastasis-free survival (MFS) Less than half the general study population risk Class 2A – Moderate Biolog
Slide 23: Class 2A And Class 2B are Strong, Independent Predictors of Metastasis
Class 2A And Class 2B are Strong, Independent Predictors of Metastasis Univariate Analysis Multivariate Analysis Class 2A univariate HR of 3.2 is similar to deep Class 2A multivariate HR of 2.3 is independent and invasion, poor differentiation or PNI similar to deep invasion and poor differentiation
Slide 24: Who is eligible for Adjuvant Radiation Therapy (ART)?
Who is eligible for Adjuvant Radiation Therapy (ART)? ART is a recommended treatment plan option for high-risk SCC patients by all relevant guideline groups ART recommended for cSCC ART recommended for primary ART recommended/considered for ART recommended for SCC if: with: cSCC if: primary cSCC if:
Slide 25: Matched Control Analysis Supports Use Of DecisionDx-SCC To Inform ART Decisions
Matched Control Analysis Supports Use Of DecisionDx-SCC To Inform Adjuvant Radiation Therapy (ART) Treatment Decisions (n=920) CLASS 1 CLASS 2A CLASS 2B 1.0 1.0 1.0 Cumulative Probability of Metastasis Cumulative Probability of Metastasis Cumulative Probability of Metastasis 0.8 0.8 0.8 0.6 0.6 0.6
Slide 26: Clinical Validity and Utility, ADLT Status, Guideline Support
Clinical Validity and Utility ADLT Status Guideline Support 1. National Comprehensive Cancer Demonstrated validity, utility and Classified as an Advanced Network guidelines for cutaneous impact, backed by 16 peer- Diagnostic Laboratory Test (ADLT) melanoma in the principles for reviewed publications
Slide 27: Unmet Need In Patients With A Difficult-To-Diagnose Pigmented Lesion
Unmet Need In Patients With A Difficult-To-Diagnose Pigmented Lesion The Clinical Problem These difficult-to-diagnose Of the estimated two million lesions are commonly sent Diagnostic ambiguity can suspicious pigmented lesions for second opinions to lead to clinical management A clinical hurdle for
Slide 28: MyPath Melanoma For Use In Ambiguous Melanocytic Lesions
MyPath Melanoma For Use In Ambiguous Melanocytic Lesions Expression of each gene group is calculated and normalized to the control genes. The aggregated score for each gene group is input into a trained logistic regression algorithm which weights each input and calculates a single score and classifi
Slide 29: Clinical Validity and Utility, ADLT Status, AGA Clinical Practice Update
Clinical Validity and Utility ADLT Status AGA Clinical Practice Update Demonstrated validity, utility and Classified as an Advanced Recognized by the American impact, backed by 15 peer- Diagnostic Laboratory Test (ADLT) Gastroenterological Association in reviewed publications by the Centers for Medi
Slide 30: TissueCypher Is The Strongest Independent Predictor Of Progression
TissueCypher Is The Strongest Independent Predictor Of Progression Original Pathologic Diagnosis TissueCypher HR = 7.7 (high- vs. low- risk) p<0.0001 HR = 2.8 (inter- vs. low-risk) p<0.0001 n=699 patients1-5 (ND n=567, IND n=50, LGD n=82) 152 incident progressors, 38 prevalent cases, 509 non-progres
Slide 31: Advanced PGx, Unrivaled Efficacy, Easy to Use
Advanced PGx Unrivaled Efficacy Easy to Use • Demonstrated clinical validity, • 2x improved chance of medication • 10 mental health and pain utility and impact, backed by 19 response vs. control conditions in one report peer-reviewed publications • >2.5x improved chance of • <1 minute to collect DNA
Slide 32: 2.5x Increase In Remission Rates For Severe Depression
2.5x Increase In Remission Rates For Severe Depression Demonstrated Enhanced Clinical Outcomes vs. Standard Of Care >2.5x Response Rate Remission Rate increase in remission rate vs. control ≥ 50% Reduction from Baseline Patients Achieving Remission 73% 2x 35% increase in response rate vs. control 55
Slide 33: Clinical Validity and Utility, ADLT Status, Guideline Inclusion
Clinical Validity and Utility ADLT Status Guideline Inclusion Demonstrated validity, utility and Classified as an Advanced Diagnostic Included in the National impact, backed by 25 peer-reviewed Laboratory Test (ADLT) by the Centers Comprehensive Cancer Network publications demonstrating the for Medi
Slide 34: DecisionDx-UM: The Standard Of Care In The Management Of Newly Diagnosed Uveal Melanoma
DecisionDx-UM: The Standard Of Care In The Management Of Newly Diagnosed Uveal Melanoma Uveal Melanoma – A Rare Eye Cancer Strong Evidence Base Facts About Uveal Melanoma • 25 peer-reviewed publications with 3,600+ patients ~2,000 patients diagnosed in the U.S. annually ~97% of patients – no evidenc
Slide 35: Inflammatory Skin Disease
Inflammatory Skin Disease Pipeline program to develop a genomic test aimed at guiding systemic therapy selection for patients with moderate-to-severe atopic dermatitis (AD), psoriasis (PSO) and related conditions
Slide 36: Early Discovery Data for Inflammatory Skin Disease Pipeline Program
Inflammatory Pipeline Test Early Discovery Data for Inflammatory Skin Disease Pipeline Program Goal is to develop a genomic test aimed Test results could empower clinicians to New data showing the ability of pipeline tailor therapy choices for patients by at guiding systemic therapy selection for pr
Slide 37: IDENTITY Study
Inflammatory Pipeline Program IDENTITY Study Study for Castle’s inflammatory skin disease pipeline program to develop a genomic test aimed at guiding systemic therapy selection Committed Sites Patients Enrolled1 2021 2022 2023 2024 2025 Q2-Q3 Q3 Q2 Q4 By end of 2024 By end of 2025 Steering committee
Slide 38: Thank you
CASTLE BIOSCIENCES Thank you
Slide 39: Use Of Non-GAAP Financial Measures (Unaudited)
Use Of Non-GAAP Financial Measures (Unaudited) In this presentation, we use the metrics of Adjusted Revenues, Adjusted Gross Margin and Adjusted EBITDA, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United States (GAAP
Slide 40: Reconciliation of Non-GAAP Financial Measures (Unaudited)
Reconciliation of Non-GAAP Financial Measures (Unaudited) The table below presents the reconciliation of adjusted revenues and adjusted gross margin, which are non-GAAP financial measures. See previous slide for further information regarding the Company’s use of non-GAAP financial measures. 40
Slide 41: Reconciliation of Non-GAAP Financial Measures (Unaudited)
Reconciliation of Non-GAAP Financial Measures (Unaudited) The table below presents the reconciliation of adjusted EBITDA, which is a non-GAAP financial measure. See slide 39 for further information regarding the Company’s use of non-GAAP financial measures. 41
Slide 42: Leadership Team Overview
Leadership Team Overview MANAGEMENT TEAM Derek Maetzold © SCHERING Founder, Director, President and CEO SMSYSME WF mnrenaes L. S. SANDOZ es Frank Stokes LEERINK ~ & Chief Financial Officer Stuart Toby Juvenal BE accove senetes ere Pharmaceuticals Chief Commercial Officer mite gerzyme Kristen Oelschl