Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — Q3 2020 Earnings Presentation
39 slides from Castle Biosciences's earnings presentation, Nov 9, 2020
Slide 1: The Skin Cancer Diagnostics Company - Company Presentation
The Skin Cancer Diagnostics Company COMPANY PRESENTATION November 9, 2020 NASDAQ: CSTL
Slide 2: Disclaimers
DISCLAIMERS › Forward-Looking Statements › The information in this presentation contains forward-looking statements and information 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 th
Slide 3: Castle Biosciences
Castle Biosciences Innovators in Proprietary Gene Expression Profile Tests for Dermatologic Cancers Innovative Evidence Strong Products Development Financials Improving Health Outcomes Of Patients With Skin Cancer Through Innovative, Clinically Actionable, Cost-Effective Diagnostics 3
Slide 4: 3Q2020: Strong Financials
3Q2020: Strong Financials Nine months Nine months 3Q20 3Q19 ended 9/30/20 ended 9/30/19 Revenue $15.2M $14.8M $45.4 $34.2M DecisionDx-Melanoma reports 4,404 4,126 11,986 11,049 DecisionDx-UM reports 318 356 985 1,092 Operating Cash Flow $(3.0)M $0.8M $10.3M $2.5M Adj. Operating Cash Flow1 $(3.0)M $0
Slide 5: Castle's in-market products target an estimated $2.0B U.S. total addressable market
Castle’s in-market dermatological cancer products target an estimated $2.0B U.S. total addressable market1 SQUAMOUS CELL SUSPICIOUS PIGMENTED MELANOMA CARCINOMA LESIONS INITIAL CASTLE ~130,000 patients classified ~200,000 patients present ~300,000 patients with an ADDRESSABLE as Stage I, II or III w
Slide 6: Our main focus is serving the skin cancer market
Our main focus is serving the skin cancer market DecisionDx-SCC and DiffDx-Melanoma are utilizing existing relationships Indication / Trade Commercial Reimbursement Peer-Reviewed Primary Initial Launch Test outcome Name Status Status Publications Customers Targets Derms (including Cutaneous Melanoma
Slide 7: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 8: DecisionDx-Melanoma: well studied, informs cancer management decisions
DecisionDx-Melanoma: well studied, informs cancer management decisions >5,700 Patients included in studies including 26 Peer-reviewed, published studies 1A Category IA evidence* an independent validation including 2 meta-analyses 50% Medicare+ Covered by Medicare and multiple private 59,000+ Patient
Slide 9: DecisionDx-Melanoma informs two important clinical decisions and impacts treatment plans
DecisionDx-Melanoma informs these two important clinical decisions and impacts treatment plans Diagnosis of localized cutaneous melanoma 1 LIMITATIONS OF CURRENT STAGING 2 RISK OF RECURRENCE TO INFORM SLNB SURGERY MANAGEMENT 1 2 $20-24k 18% Is the risk of 12% Deaths from Melanoma: Is the risk of SLN
Slide 10: DecisionDx-Melanoma workflow: more accurate prediction of risk
DecisionDx-Melanoma workflow: after diagnosis for more accurate prediction of risk Primary CM Tissue Class 1: 1A Lowest risk (FFPE) Low risk of SLN positivity (eligible T1-T2) Castle CAP/CLIA 1B Low risk of melanoma Low risk Patients with Certified Lab recurrence (T1-T4) Stage I – III Melanoma RNA I
Slide 11: DecisionDx-Melanoma enables rule-out and rule-in for T1-T2 melanomas
1 DecisionDx-Melanoma enables rule-out and rule-in for T1-T2 melanomas Probability of a Positive Sentinel Lymph Node1 DecisionDx- DecisionDx-Melanoma Class 1A identifies a Melanoma All Ages ≥65 years 55-64 years <55 years Result (n=1065) (n=448) (n=247) (n=370) low risk for SLN positivity similar to
Slide 12: DecisionDx-Melanoma is a significant independent predictor of outcomes
2 DecisionDx-Melanoma is a significant independent predictor of outcomes Archival, Multi-center1 Archival, Multi-center2 Prospective, Multi-center3 Prospective, Multi-center4 Disease-Free Survival Melanoma Specific Survival Recurrence-Free Survival Recurrence-Free Survival Stage I-II Stage I-III Sta
Slide 13: DecisionDx-Melanoma stratifies risk of recurrence beyond AJCC staging
2 DecisionDx-Melanoma stratifies risk of recurrence beyond AJCC (8th ed.) staging Stage NCCN I II III Risk Category 100 99.6% 98% >99% 94.8% Low Risk ≈AJCC IA ≈AJCC IA ≈AJCC IIA Stage I-IIA Melanoma-Specific Survival (MSS) (%) 90 89.5% 90% ≈AJCC IIIA 84.7% ≈AJCC IIIB 80 High Risk 77% Stage IIB-III A
Slide 14: 50% of patients have a change in management
2 50% of patients have a change in management % Change in Study Design # of Patients Management 4 consecutive clinical impact studies have Prospectively tested cohort, Berger1 multi-center. Retrospective pre 156 53% shown 47-53% change in risk of test / post test management. recurrence management Pr
Slide 15: DecisionDx-Melanoma informs both primary treatment decisions
DecisionDx-Melanoma informs both primary treatment decisions, addressing the issues of over- and under-treatment All eligible T1-T2 Any T ≥0.3 mm T1a with adverse features Consider for any patient and T1b-T2 interested in risk information Informs use of SLNB Informs clinical follow- What’s the risk
Slide 16: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 17: Designed to predict individual metastatic risk for high-risk SCC patients
Designed to predict individual metastatic risk to inform risk-appropriate management ~200,000 patients 4 peer-reviewed Utilizing existing present with high- Validated in 420- publications to date; For high-risk SCC sales channels: risk features patient cohort of patients with one or dermatologists a
Slide 18: DecisionDx-SCC: Addressing the Clinical Problem
DecisionDx-SCC: Designed to predict metastatic risk for high-risk SCC patients Addressing the Clinical Problem DecisionDx-SCC is validated to predict metastatic risk for individual SCC patients with one or more risk factors. DecisionDx-SCC is a validated predictor of risk in uni- and multivariate an
Slide 19: 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 Less than half the general study population risk Metastasis-free survival (MFS) Class 2A – Moderate Biological Risk Similar to the
Slide 20: DecisionDx-SCC Class 2A and 2B are strong independent predictors of metastasis
DecisionDx-SCC Class 2A and Class 2B are strong independent predictors of metastasis Univariate Analysis Multivariate Analysis Immunosuppression 1.5 (ns) NA Tumor diameter (per cm) 1.2 (p<0.001) 1.1 (ns) Perineural invasion 3.3 (p<0.001) 1.2 (ns) Deep invasion 3.1 (p<0.001) 2.1 (p<0.001) Poor differ
Slide 21: DecisionDx-SCC is designed to predict metastatic risk for high-risk SCC patients
DecisionDx-SCC is designed to predict metastatic risk for high-risk SCC patients Treatment plans may include: Follow-up plans may include: SCC patients Low • Surgery, if feasible • Clinical follow-up: 1-2x per year with one or Intensity • Clinical nodal exam more risk • Clinical nodal exam factors •
Slide 22: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 23: Improving diagnostic resolution for the benefit of patient care
Improving diagnostic resolution for the benefit of patient care In most cases, A definitive result Includes multiple after melanoma from DecisionDx subtypes of lesions Demonstrated 5-7 day turn around diagnosis, clinicians DiffDx-Melanoma with uncertain technical success time/ similar to other can o
Slide 24: The unmet need in patients with a difficult-to-diagnose melanocytic lesion
The unmet need in patients with a difficult-to-diagnose melanocytic lesion The Clinical Problem A clinical hurdle for dermatopathology is the accurate diagnosis of difficult-to-diagnose melanocytic neoplasms. Of the estimated 2 million suspicious pigmented lesions biopsied annually in the U.S., appr
Slide 25: Dermatopathologists and dermatologists work together to diagnose melanoma
Dermatopathologists and dermatologists work together to diagnose melanoma Dermatologist Dermatopathologist Dermatologist A suspicious pigmented Lesion is examined via If warranted, the lesion is If the lesion contains a lesion is examined by a microscope by a biopsied. malignant melanocytic doctor o
Slide 26: The Clinical Issue: Uncertainty creates an over- or under-treatment dilemma
The Clinical Issue: Uncertainty creates an over- or under-treatment dilemma Clinically evaluated Histopathologic Primary Staging, surveillance, suspicious pigmented / evaluation treatment and follow-up options melanocytic lesions SLNB Definitive melanoma diagnoses (invasive or Wide Local Excision Im
Slide 27: DecisionDx DiffDx-Melanoma: Addressing the Clinical Problem
DecisionDx DiffDx-Melanoma Designed to improve diagnostic resolution for the benefit of patient care Addressing the Clinical Problem DecisionDx DiffDx-Melanoma is designed to provide a highly accurate, object result in order to aid dermatopathologists in characterizing difficult-to-diagnose melanocy
Slide 28: DiffDx-Melanoma is designed and validated to improve diagnostic resolution
DecisionDx DiffDx-Melanoma is designed and validated to improve diagnostic resolution for the benefit of patient care All ages Age > 65 years N=503 N=178 DecisionDx DiffDx-Melanoma 95% CI DecisionDx DiffDx- 95% CI Melanoma Sensitivity 99.1% 97.9-100 99.2% 97.6-100 Specificity 94.3% 91.5-97.1 100% 10
Slide 29: Improving diagnostic resolution for the benefit of patient care
Improving diagnostic resolution for the benefit of patient care To aid ~300,000 suspicious Utilizing existing dermatopathologists pigmented lesions 2 peer-reviewed relationships within Technical success in characterizing annually; publications2 to date the dermatologic suspicious pigmented rate of 9
Slide 30: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 31: DecisionDx-UM: Standard of Care
: STANDARD OF CARE Strong Evidence Base Uveal Melanoma – A Rare Eye Cancer › 17 peer-reviewed publications, 2,000+ patients ~1,600 patients diagnosed in the U.S. annually Widespread adoption ~97% of patients – no evidence of metastatic › 90%+ of U.S. ocular oncology institutions order disease at the
Slide 32: Financial Overview
FINANCIAL OVERVIEW The Skin Cancer Diagnostics Company
Slide 33: Factors driving near- and long-term growth
Factors driving near-and long-term growth Test Report Volume Commercial sales team expansion in 2H20, further expansion Revenue expected in 2021 Reimbursement Strong ASP growth DecisionDx-Melanoma $7,193 PAMA rate through 2021 Gross Margins Profitability 84% in Q320 Continued margin expansion of exi
Slide 34: Continued revenue growth, driven by test report and ASP growth
Continued revenue growth, driven by test report and ASP growth* Revenue Report Volume Growth 17,055 DecisionDx-UM DecisionDx-Melanoma 13,445 10,614 $14.8m $15.2m 7,490 $3.7m 3,956 2015 2016 2017 2018 2019 3Q 2018 3Q 2019 3Q 2020 34 *3Q2020 ASP growth over 3Q2019 and 3Q2018
Slide 35: Recent achievements and expected future milestones
Recent achievements and expected future milestones 2020 milestones on track Continued evidence development for all commercialized products Sept 2020: Launch of DecisionDx-SCC 2021: Potential draft 2022: Potential LCD for DecisionDx-SCC effective LCD for 3Q2020: Commercial and DecisionDx DiffDx- Deci
Slide 36: Castle's in-market products target an estimated $2.0B U.S. total addressable market
Castle’s in-market dermatological cancer products target an estimated $2.0B U.S. total addressable market1 SQUAMOUS CELL SUSPICIOUS PIGMENTED MELANOMA CARCINOMA LESIONS INITIAL CASTLE ~130,000 patients classified ~200,000 patients present ~300,000 patients with an ADDRESSABLE as Stage I, II or III w
Slide 37: Thank You
THANK YOU The Skin Cancer Diagnostics Company
Slide 38: Use of Non-GAAP Financial Measures (Unaudited)
Use of Non-GAAP Financial Measures (UNAUDITED) › In this presentation, we use the metric of Adjusted Operating Cash Flow, which is a non-GAAP financial measure and is not calculated in accordance with generally accepted accounting principles in the United States (GAAP). This non-GAAP financial measu
Slide 39: Reconciliation of Non-GAAP Financial Measures (Unaudited)
Reconciliation of Non-GAAP Financial Measures (UNAUDITED) The table below presents the reconciliation of adjusted operating cash flow, which is a non-GAAP measure. See "Use of Non-GAAP Financial Measures (UNAUDITED)" above for further information regarding the Company's use of non-GAAP financial mea