Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — Corporate Update (January 2024)
44 slides from Castle Biosciences's corporate update, Jan 8, 2024
Slide 1: Transforming Disease Management
January 8, 2024 Transforming Disease Management
Slide 2: Disclaimers
2 Disclaimers 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
Slide 3: Preliminary Q4 2023 Information
January 8, 2024 Preliminary Q4 2023 Information
Slide 4: Estimated ~$8B U.S. Total Addressable Market for Commercially Available Tests
4 Estimated ~$8B U.S. Total Addressable Market1 for Commercially Available Tests Dermatology Gastroenterology Mental Health Cutaneous melanoma/ risk of metastasis, SLNB positivity risk Patients classified as Stage I, II or III2 ~$540M ~130K Cutaneous squamous cell carcinoma/risk of metastasis Patien
Slide 5: Preliminary Fourth Quarter and Year-end 2023 Performance Results
5 Preliminary Fourth Quarter and Year-end 2023 Performance Results1,2 (unaudited) Expect to report >$210M in revenue for 2023, exceeding the floor of our guidance of at least $200M3 1Castle expects to report its audited consolidated financial statements and complete financial and operational results
Slide 6: 2023 Year-end Cash Expected To Be Approximately $243 million
6 2023 Year-end Cash, Cash Equivalents & Marketable Investment Securities Expected To Be Approximately $243 million1 Cash, Cash Equivalents & Marketable Investment Securities As of 12/31/23 ~$243M (expected) As of 9/30/23 $230M As of 6/30/23 $226M As of 3/31/23 $232M 1This amount is preliminary, una
Slide 7: Third Quarter 2023 As previously reported
Third Quarter 2023 As previously reported Transforming Disease Management
Slide 8: Consistent Execution Of Growth Initiatives Supports Long-Term Growth
8 Consistent Execution Of Growth Initiatives Supports Long-Term Growth 2017-2023 Revenue ($M) 2017-2022 Total Test Report Volume 1 2 *2023 revenue guidance of at least $200 million, as of November 2, 2023 $14 $23 $52 $63 $94 $137 ≥$210* 2017 2018 2019 2020 2021 2022 2023E 10,614 13,445 17,055 18,185
Slide 9: Financial Performance Summary Q3 2023
9 Financial Performance Summary Q3 2023 18,409 12,390 Total test reports Total Dermatology test reports Q3 2023 Q3 2022 1See Non-GAAP reconciliations at the end of this presentation. $61.5M $60.6M Revenues Adj. Revenues1 77.9% 81.3% Gross Margin Adj. Gross Margin1 12,114 9,824 $37.0M $37.3M 69.8% 76
Slide 10: Key Q3 2023 and Recent Accomplishments
10 Raised 2023 revenue guidance to at least $200 million, from at least $180 million Earned a Top Workplaces National Industry Award, ranking third among 84 Top Workplaces in the healthcare industry Key Q3 2023 and Recent Accomplishments Publication of study data showed the addition of drug-drug int
Slide 11: Answering Clinical Questions To Guide Care Along The Patient Journey
11 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 Dermatology Ophthalmology Gastroenterology Mental Health Screening Diagnostic Support Risk Stratification
Slide 12: Significant Scientific Evidence Through Robust Clinical Research Program
12 Significant Scientific Evidence Through Robust Clinical Research Program 237 Committed/contributing clinical research sites as of Q3 2023 ~20,460 Patients enrolled in studies over lifetime of Castle1 ~11,670 Current patients enrolled in studies as of Q3 2023 Data as of September 30, 2023 1Number
Slide 13: First-To-Market Dermatologic Franchise, Additional Growth Opportunities
13 First-To-Market Dermatologic Franchise, Additional Growth Opportunities Diagnostic Support Risk Stratification Therapy Selection 1 New=clinician who ordered a Castle dermatologic test for the first time. Inflammatory Skin Disease Therapy Selection Pipeline Program Strong provider growth and conti
Slide 14: DecisionDx-Melanoma Clinical Validity, ADLT Status and Reimbursement
Demonstrated clinical validity, utility and impact, backed by more than 45 peer-reviewed publications, including two recent publications (Bailey et al. and Dhillon et al.) demonstrating an association with testing and improved patient outcomes Classified as an Advanced Diagnostic Laboratory Test (AD
Slide 15: DecisionDx-Melanoma Provides Answers For Two Critical Clinical Questions
15 DecisionDx- Melanoma Class Result Breslow Thickness Ulceration Mitotic Rate Age Breslow Thickness Ulceration Mitotic Rate SLN Status Age Tumor Location Individual Risk of Sentinel Lymph Node Positivity Individual Risk of Recurrence Whitman et al. JCO PO 2021; Jarell et al. JAAD 2022 Neural networ
Slide 16: DecisionDx-Melanoma Has Consistent And Independent Evidence Of Prognostic Value
16 DecisionDx-Melanoma Has Consistent And Independent Evidence Of Prognostic Value Across Studies Greenhaw et al. JAAD 2020 1086420 100 80 60 40 20 0 Time (Years) % R ec ur re nc e Fr ee 1086420 100 80 60 40 20 0 Time (Years) % D is ta nt M et as ta si s F re e RFS DMFS Breslow thickness (per mm) 1.
Slide 17: DecisionDx-Melanoma Results Guided Treatment Decisions And Led To Improved Outcomes
17 DecisionDx-Melanoma Results Guided Treatment Decisions And Led To Improved Patient Outcomes Key Findings: • Routine surveillance imaging in SLN-, high-risk patients detected melanoma recurrence ~10 months earlier than those without routine imaging. • Tumor burden at detection was significantly lo
Slide 18: 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 19: NCI/SEER Data Linked With DecisionDx-Melanoma Test Results
19 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 Bailey et al. JCO PO, 2023. ‡Hazar
Slide 20: Favorable Outcomes Compared To Other Standard Of Care Prognostic Tests
20 97.4%DecisionDx-Melanoma 96.1%Match Untested Absolute Mortality Difference 99.6%Oncotype DX - Breast 99.1%Match Untested Absolute Mortality Difference Clinical Use Of DecisionDx-Melanoma Shows Favorable Outcomes When Compared To Other Standard Of Care Prognostic Tests 1. Morton et al. N Engl J Me
Slide 21: DecisionDx-Melanoma Is Supported By Significant Scientific Evidence
21 DecisionDx-Melanoma Is Supported By Significant Scientific Evidence 10,000+ Total patients included in studies including independent validation 45+ Peer-reviewed, published studies including prospective studies and 2 meta-analyses ~146,000 Patients with a clinical DecisionDx-Melanoma order from 1
Slide 22: DecisionDx-SCC Clinical Validity and ADLT Status
Demonstrated validity, utility and impact, backed by 14 peer-reviewed publications, including data showing that DecisionDx-SCC can significantly impact patient management plans in a risk- appropriate manner within established guidelines1 Classified as an Advanced Diagnostic Laboratory Test (ADLT) by
Slide 23: DecisionDx-SCC Provides Independent Risk Stratification
23 DecisionDx-SCC Provides Independent Risk Stratification To Inform SCC Management Decisions Wysong et al. JAAD 2021; Ibrahim et al. Future Oncology 2021 Class 1: Low Biological Risk Less than half the general study population risk • Quantifies expression of 40 genes from primary tumor using RT-PCR
Slide 24: DecisionDx-SCC is Validated to Predict Metastatic Risk
24 DecisionDx-SCC is Validated to Predict Metastatic Risk for Individual SCC Patients with One or More Risk Factors Wysong et al. JAAD 2021; Ibrahim et al. Future Oncology 2021 M et as ta si s- fr ee s ur vi va l ( M FS ) Years n = 420 p < 0.0001 Cohort Distribution: Class 1 Class 2A Class 2B Kaplan
Slide 25: Class 2A And Class 2B are Strong, Independent Predictors of Metastasis
25 Class 2A And Class 2B are Strong, Independent Predictors of Metastasis Class 2B multivariate HR of 6.9 is 3x that of the strongest prognostic risk factors Class 2A multivariate HR of 2.3 is independent and similar to deep invasion and poor differentiation Class 2B univariate HR of 11.6 is ~3x tha
Slide 26: Who is eligible for Adjuvant Radiation Therapy (ART)?
26 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 primary cSCC if: • Extensive PNI • Large caliber nerve invasion (LCNI) • Positive margins following surgery ART recommen
Slide 27: Matched Control Analysis Supports Use Of DecisionDx-SCC To Inform ART Decisions
27 No significant impact of ART in cohort as a whole or within Class 1 Matched Control Analysis Supports Use Of DecisionDx-SCC To Inform Adjuvant Radiation Therapy (ART) Treatment Decisions (n=920) Castle Biosciences data on file; manuscript in preparation; *Class 2B p<0.001 CLASS 1 CLASS 2A CLASS 2
Slide 28: MyPath Melanoma Clinical Validity, ADLT Status and Guideline Support
Clinical Validity and Utility ADLT Status Guideline Support Demonstrated validity, utility and impact, backed by 16 peer- reviewed publications demonstrating the performance and utility of the test in providing objective information to aid in diagnosis in ambiguous melanocytic lesions Classified as
Slide 29: Unmet Need In Patients With A Difficult-To-Diagnose Pigmented Lesion
29 A clinical hurdle for dermatopathology is the accurate diagnosis of difficult-to-diagnose melanocytic neoplasms Unmet Need In Patients With A Difficult-To-Diagnose Pigmented Lesion Of the estimated two million suspicious pigmented lesions biopsied annually in the U.S., approximately 300,000 of th
Slide 30: MyPath Melanoma For Use In Ambiguous Melanocytic Lesions
30 MyPath Melanoma For Use In Ambiguous Melanocytic Lesions Cell Signaling Cell Differentiation Immune Signaling LOGISTIC REGRESSION ALGORITHM -16.7 -2.1 0 +11 Benign Intermediate Malignant MyPath score Expression of each gene group is calculated and normalized to the control genes. The aggregated s
Slide 31: TissueCypher Clinical Validity, ADLT Status and AGA Update
Demonstrated validity, utility and impact, backed by 15 peer- reviewed publications demonstrating the ability and performance of the test in risk- stratifying patients with Barrett’s esophagus to guide risk- appropriate treatment decisions Classified as an Advanced Diagnostic Laboratory Test (ADLT)
Slide 32: TissueCypher Is The Strongest Independent Predictor Of Progression
32 TissueCypher Is The Strongest Independent Predictor Of Progression HR = Hazard ratio. Pooled analysis completed by Castle Biosciences. 1Critchley-Thorne et al. Cancer Epidemiol Biomarkers Prev 2016; 2Critchley-Thorne et al. Cancer Epidemiol Biomarkers Prev 2017; 3Davison et al. Am J Gastroenterol
Slide 33: IDgenetix Advanced PGx, Efficacy and Ease of Use
• Demonstrated clinical validity, utility and impact, backed by 19 peer-reviewed publications • Eliminate trial and error prescribing • 3 in 1 test: Drug-gene interactions Drug-drug interactions Lifestyle factors • 2x improved chance of medication response vs. control • >2.5x improved chance o
Slide 34: 2.5x Increase In Remission Rates For Severe Depression
34 2.5x Increase In Remission Rates For Severe Depression Demonstrated Enhanced Clinical Outcomes vs. Standard Of Care Standard of Care IDgenetix Response Rate ≥ 50% Reduction from Baseline Remission Rate Patients Achieving Remission 0.020.05p-value0.0010.01p-value >2.5x increase in remission rate v
Slide 35: DecisionDx-UM Clinical Validity, ADLT Status and Guideline Inclusion
Clinical Validity and Utility ADLT Status Guideline Inclusion Demonstrated validity, utility and impact, backed by 25 peer-reviewed publications demonstrating the performance and utility of the test in predicting individual risk of metastasis in patients with uveal melanoma Classified as an Advanced
Slide 36: DecisionDx-UM: The Standard Of Care In Newly Diagnosed Uveal Melanoma
36 Strong Evidence Base • 25 peer-reviewed publications with 3,600+ patients Widespread Adoption • Nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup • 1,711 reports issued in 2022 Broad Reimbursement • In 2022, more th
Slide 37: Inflammatory Skin Disease Pipeline
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 38: Early Discovery Data for Inflammatory Skin Disease Pipeline Program
38 Early Discovery Data for Inflammatory Skin Disease Pipeline Program Inflammatory Pipeline Test New data showing the ability of pipeline program to distinguish between responders and non-responders to AD therapy; and to distinguish between AD, PSO and mycosis fungoides (MF) skin lesions presented
Slide 39: IDENTITY Study and Program Milestones
39 IDENTITY Study Study for Castle’s inflammatory skin disease pipeline program to develop a genomic test aimed at guiding systemic therapy selection Q2-Q3 Steering committee formed with top KOLs Q3 First patient enrolled Q2 Proof of RNA extraction method concept Q4 Early discovery data presented By
Slide 40: Thank you
CASTLE BIOSCIENCES Thank you
Slide 41: Use Of Non-GAAP Financial Measures (Unaudited)
41 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 (G
Slide 42: Reconciliation of Non-GAAP Financial Measures (Unaudited)
42 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.
Slide 43: Reconciliation of Non-GAAP Financial Measures (Unaudited)
43 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 41 for further information regarding the Company’s use of non-GAAP financial measures.
Slide 44: Leadership Team Overview
Leadership Team Overview MANAGEMENT TEAM Derek Maetzold oe \SCHERING ss m....| SANDOZ Founder, Director, President and CEO SOSYSINE " 7 7 LEERINK™ ~~ E BE cccooe genetics Frank Stokes Chief Financial Officer Toby Juvenal Chief Commercial Officer o encvsive gerzyme ies... mts a St Lake's Medical Cent