Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — Q4 2019 Earnings Presentation
30 slides from Castle Biosciences's earnings presentation, Mar 10, 2020
Slide 1: The Skin Cancer Diagnostics Company - Company Presentation
The Skin Cancer Diagnostics Company COMPANY PRESENTATION March 10, 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 the
Slide 3: Castle Biosciences
CASTLE BIOSCIENCES Improving Health Outcomes Of Patients With Skin Cancer Through Innovative, Clinically Actionable, Cost-Effective Diagnostics › INNOVATIVE PRODUCTS › Two commercialized products that improve treatment decisions for patients with melanoma › 95% of commercial emphasis currently on sk
Slide 4: Dermatological cancer products and pipeline target an estimated $2.0B U.S. total addressable market
CASTLE’S DERMATOLOGICAL CANCER PRODUCTS & CURRENT PIPELINE 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
Slide 5: Castle's Products & Product Pipeline
CASTLE’S PRODUCTS & PRODUCT PIPELINE DEVELOPMENT VALIDATION COMMERCIALIZATION Secure Assay Algorithm Analytical Clinical Clinical Physician Commercial Guideline Medicare1 Samples Development Development Validation Validation Utility Adoption Payors Inclusion LCD effective Dec 2018 In
Slide 6: Significant Achievements and Expected Future Milestones
SIGNIFICANT ACHEIVEMENTS AND EXPECTED FUTURE MILESTONES Continued evidence development for all commercialized products 2H2020: Anticipate LCD expansion for DecisionDx-Melanoma 2022: Potential effective effective LCD for Aug 2019: Expanded DecisionDx-SCC Dec 2018: Initial LCD draft LCD for 2H2020: Ex
Slide 7: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 8: 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 9: DecisionDx-Melanoma Workflow: After Diagnosis for 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 10: Decision 1: SLNB Surgery Rule Out in T1-T2 Melanomas
DECISION 1 : SLNB SURGERY RULE OUT IN 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 stage T1a patien
Slide 11: 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 12: DecisionDx-Melanoma Further Stratifies Risk of Recurrence Beyond AJCC Staging
2 DECISIONDX-MELANOMA FURTHER 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 I
Slide 13: Decision 2: 50% of Patients Had a Change in Management
DECISION 2 : 50% OF PATIENTS HAD 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 man
Slide 14: DecisionDx-Melanoma Informs Both Primary Treatment Decisions
DECISIONDX-MELANOMA INFORMS BOTH PRIMARY TREATMENT DECISIONS, ADDRESSING THE ISSUES OF OVER- AND UNDER-TREATMENT 1 Rule-out SLNB for T1-T2 melanoma Class 1A: <5% SLN positivity and favorable prognosis patients, including T1a with adverse Class 1B-2B: ≥5% SLN positivity and higher rates of metastasis
Slide 15: 22 Peer-Reviewed Publications Since 2015 for DecisionDx-Melanoma
22 STRONG PEER-REVIEWED PUBLICATIONS SINCE 2015 FOR DECISIONDX-MELANOMA Validation & Validation & Prospective Studies Clinical Impact Studies Performance Studies Performance Studies • Vetto et al. Future Oncol 2019 • Keller et al. Cancer Med 2019 • Marks et al. SKIN 2019 • Gastman et al. JAAD 2019 •
Slide 16: DecisionDx-Melanoma Increased 29% in 2019 Year-over-Year
CASTLE’S LEAD PRODUCT, DECISIONDX-MELANOMA, INCREASED 29% IN 2019 YEAR-OVER-YEAR FROM 2018 DecisionDx-Melanoma DecisionDx-Melanoma Test DecisionDx-Melanoma Test Report Growth 4Q19 Report Growth New Ordering Clinicians 2019 4480 15,529 12,032 3270 24% 37% 29% 9,300 6,295 2,858 4Q18 4Q19 2015 2016 201
Slide 17: Pipeline Products Leverage Our Existing Commercial Channel
PIPELINE PRODUCTS LEVERAGE OUR EXISTING COMMERCIAL CHANNEL Outside Sales Territories Call Points Product Primary Secondary 40 1 32 Dermatology (including Mohs), Dermatopathology Surgeons Medical Oncology 23 15 16 15 14 2 Dermatology (including Mohs), Dermatopathology Surgeons Medical Oncology Suspic
Slide 18: Product Pipeline
PRODUCT PIPELINE The Skin Cancer Diagnostics Company
Slide 19: Treatment Pathways in Squamous Cell Carcinoma of the Skin Are Based Upon Risk of Metastasis
TREATMENT PATHWAYS IN SQUAMOUS CELL CARCINOMA OF THE SKIN (SCC) ARE BASED UPON RISK OF METASTASIS “Low” Risk Treatment plans may include: 80% of › Curettage and electrodesiccation patients or Mohs or WLE Clinicopathologic factors determine Biopsy high vs low-risk based diagnosis of SCC high-risk is
Slide 20: DecisionDx-SCC Appropriate Use Is Targeted to the High-Risk Patient
DECISIONDX-SCC APPROPRIATE USE IS TARGETED TO THE HIGH-RISK PATIENT AND PROVIDES FOR DIFFERENTIAL ACTIONS “Low” Risk Treatment plans may include: 80% of › Curettage and electrodesiccation patients or Mohs or WLE Clinicopathologic factors determine Biopsy high vs low risk based diagnosis of SCC High-
Slide 21: Suspicious Pigmented Lesions: Product Candidate
SUSPICIOUS PIGMENTED LESIONS: PRODUCT CANDIDATE ADJUNCT DIAGNOSTIC SUPPORT FOR HISTOPATHOLOGICALLY CHALLENGING LESIONS Attractive Market Implications of Over- and Undercalling Melanoma ~2 million suspicious pigmented Overcalling can lead to: lesions biopsied annually › Unnecessary surgery potentiall
Slide 22: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 23: DecisionDx-UM: Standard of Care
: STANDARD OF CARE Strong Evidence Base Uveal Melanoma – A Rare Eye Cancer › 14+ 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 th
Slide 24: Financial Overview
FINANCIAL OVERVIEW The Skin Cancer Diagnostics Company
Slide 25: Key Performance Indicators Driving Growth
KEY PERFORMANCE INDICATORS DRIVING GROWTH › 2019: Expanded sales territories from 14 to 32 Report › Further expansion planned for 2H20 from 32 to at least ~40 Volume › 4Q19 vs 4Q18, DecisionDx-Melanoma report volume up 37%. New ordering clinicians up Revenue 24% in 2019 vs 2018 › DecisionDx-Melanoma
Slide 26: Strong 2019 Revenue and Gross Margin
STRONG 2019 REVENUE AND GROSS MARGIN Net Revenue ($ in millions) Gross Margin ($ in millions) $52 $45 $23 $17 2018 2019 2018 2019 Gross Margin % 77% 86% 26 Source: Company financials.
Slide 27: Castle Biosciences
CASTLE BIOSCIENCES Improving Health Outcomes Of Patients With Skin Cancer Through Innovative, Clinically Actionable, Cost-Effective Diagnostics › INNOVATIVE PRODUCTS › Two commercialized products that improve treatment decisions for patients with melanoma › 95% of commercial emphasis currently on sk
Slide 28: Thank You
The Skin Cancer Diagnostics Company THANK YOU
Slide 29: Appendix
Appendix CASTLE BIOSCIENCES
Slide 30: Leadership Team
LEADERSHIP TEAM Board of Directors Name Prior Experience Name Derek Maetzold Founder, Director, Dan Bradbury President and CEO Frank Stokes Derek Maetzold Chief Financial Officer Bernhard Spiess Bonnie Anderson Chief Operating Officer Toby Juvenal Stuart Senior Vice President, Pharmaceuticals Mara A