Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — Q1 2020 Earnings Presentation
31 slides from Castle Biosciences's earnings presentation, May 11, 2020
Slide 1: Company Presentation
The Skin Cancer Diagnostics Company COMPANY PRESENTATION May 11, 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: COVID-19 Response
CASTLE BIOSCIENCES COVID-19 RESPONSE › At Castle Biosciences, we recognize that this is a challenging time, perhaps more so for those who are diagnosed with cancer. As the COVID-19 pandemic evolves, we remain committed to serving patients who have been diagnosed with melanoma and the clinicians who
Slide 4: Castle Biosciences
CASTLE BIOSCIENCES Improving Health Outcomes Of Patients With Skin Cancer Through Innovative, Clinically Actionable, Cost-Effective Diagnostics › INNOVATIVE PRODUCTS $2.0B › Two commercialized products that improve treatment decisions for patients with melanoma U.S. TAM › 95% of commercial emphasis
Slide 5: Strong Financial Position and Growth Trajectory
STRONG FINANCIAL POSITION AND GROWTH TRAJECTORY Revenue (M) Report Volume Growth $51.9 17,055 DecisionDx-UM DecisionDx-Melanoma 13,445 $22.8 $17.6 $17.4 $14.8 10,614 $10.7 $11.4 $8.7 $4.0 $3.7 7,490 2Q18 2Q19 3Q18 3Q19 4Q18 4Q19 2018 2019 1Q19 1Q20 3,956 2015 2016 2017 2018 2019 4Q 2019 1Q 2020 Gros
Slide 6: 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 7: Significant Achievements and Expected Future Milestones
SIGNIFICANT ACHIEVEMENTS AND EXPECTED FUTURE MILESTONES Continued evidence development for all commercialized products 3Q2020: Expected launch of DecisionDx- SCC 2022: Potential effective LCD for 2H2020: Anticipate DecisionDx-SCC Aug 2019: Expanded Dec 2018: Initial LCD LCD expansion for and suspici
Slide 8: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 9: DecisionDx-Melanoma Informs These Two Important Clinical Decisions
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: 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 11: DecisionDx-Melanoma: 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 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 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 14: DecisionDx-Melanoma: 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 15: 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 16: 23 Strong Peer-Reviewed Publications Since 2015 for DecisionDx-Melanoma
23 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 17: Strong DecisionDx-Melanoma Clinical Adoption
STRONG DECISIONDX-MELANOMA CLINICAL ADOPTION DecisionDx-Melanoma DecisionDx-Melanoma DecisionDx-Melanoma Test Report Volume Test Report Volume New Ordering Clinicians +37% +42% +32% 4,480 4,574 15,529 +27% 4,126 3,691 12,032 3,270 3,232 2,899 3,136 9,300 29% 43% 6,295 2,858 2015 2016 2017 2018 2019
Slide 18: 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 19: Product Pipeline
PRODUCT PIPELINE The Skin Cancer Diagnostics Company
Slide 20: Treatment Pathways in Squamous Cell Carcinoma of the Skin (SCC)
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 21: 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 22: 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 23: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 24: DecisionDx-UM: Standard of Care
: STANDARD OF CARE Strong Evidence Base Uveal Melanoma – A Rare Eye Cancer › 15+ 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 25: Financial Overview
FINANCIAL OVERVIEW The Skin Cancer Diagnostics Company
Slide 26: 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 › 1Q20 vs 1Q19, DecisionDx-Melanoma report volume up 42% › New ordering clinicians up 43% in 1Q20 vs 1Q19 Revenue › DecisionDx-Melanom
Slide 27: Revenue Increased 100% in 1Q2020 vs. 1Q2019
REVENUE INCREASED 100% IN 1Q2020 VS. 1Q2019 Net Revenue ($ in millions) Gross Margin ($ in millions) $17.4 $15.0 $8.7 $7.1 1Q2019 1Q2020 1Q2019 1Q2020 Gross Margin % 82% 86% 27 Source: Company financials.
Slide 28: Castle Biosciences
CASTLE BIOSCIENCES Improving Health Outcomes Of Patients With Skin Cancer Through Innovative, Clinically Actionable, Cost-Effective Diagnostics › INNOVATIVE PRODUCTS $2.0B › Two commercialized products that improve treatment decisions for patients with melanoma U.S. TAM › 95% of commercial emphasis
Slide 29: Thank You
The Skin Cancer Diagnostics Company THANK YOU
Slide 30: Appendix
Appendix CASTLE 2 BIOSCIENCES
Slide 31: 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 Business Officer Toby Juvenal Stuart Mara Aspinall Senior Vice President, Pharmaceu