Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — FY2019 Earnings Presentation
34 slides from Castle Biosciences's earnings presentation, Jan 9, 2020
Slide 1: The Skin Cancer Diagnostics Company – Company Presentation January 2020
The Skin Cancer Diagnostics Company COMPANY PRESENTATION January 2020 NASDAQ:CSTL
Slide 2: Disclaimers – Forward-Looking Statements
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: Preliminary Fourth Quarter and Year-End 2019 Performance Results
PRELIMINARY FOURTH QUARTER AND YEAR-END 2019 PERFORMANCE RESULTS1 (unaudited) › High volume growth: › 4Q2019 DecisionDx-Melanoma increased by 37% over the same period in 2018 › Full-year 2019 DecisionDx-Melanoma increased by 29% year-over-year from 2018 › New ordering clinicians for DecisionDx-Melan
Slide 4: 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 3270 12,032 24% 37% 9,300 29% 6,295 2,858 4Q18 4Q19 2015 2016 201
Slide 5: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company COMPANY PRESENTATION November 14, 2019 NASDAQ:CSTL The following is the unedited presentation made available on the Company’s website, www.castlebiosciences.com, on November 14, 2019.
Slide 6: Castle Biosciences: Improving Health Outcomes of Patients With Skin Cancer
CASTLE BIOSCIENCES Improving Health Outcomes Of Patients With Skin Cancer Through Innovative, Clinically Actionable, Cost-effective Diagnostics › STRONG FINANCIALS › High volume growth: 3Q2019 = DecisionDx-Melanoma = 32%; 30% total GEP test reports › Strong revenue: 3Q2019 =$14.8 million; YTD2019 =
Slide 7: Recent and Upcoming Expected Milestones
RECENT AND UPCOMING EXPECTED MILESTONES 2018 2019 2020 2021 7
Slide 8: Dermatological Cancer Products and Pipeline Target Estimated $2.0B U.S. TAM
CASTLE’S DERMATOLOGICAL CANCER PRODUCTS & CURRENT PIPELINE TARGET AN ESTIMATED $2.0B U.S. TOTAL ADDRESSABLE MARKET1 SQUAMOUS CELL SUSPICIOUS PIGMENTED MELANOMA CARCINOMA LESIONS TOTAL ANNUAL ~190,000 ~1 Million ~2 Million INCIDENCE Patients Patients Patients INITIAL CASTLE ~130,000 patients classifi
Slide 9: Castle's Products and 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 process
Slide 10: The Skin Cancer Diagnostics Company
The Skin Cancer Diagnostics Company
Slide 11: Two Primary Treatment Decisions Following Diagnosis of Cutaneous Melanoma
TWO PRIMARY TREATMENT DECISIONS ARE REQUIRED FOLLOWING DIAGNOSIS OF CUTANEOUS MELANOMA Diagnosis of localized cutaneous melanoma 1 2 Is the risk of Is the risk of SLN- recurrence high positivity high enough to warrant enough to warrant initiation of imaging, referral for the high frequency SLNB surg
Slide 12: DecisionDx-Melanoma Informs Two Important Clinical Decisions
DECISIONDX-MELANOMA INFORMS THESE TWO IMPORTANT CLINICAL DECISIONS AND IMPACTS TREATMENT PLANS Diagnosis of localized cutaneous LIMITATIONS OF CURRENT melanoma STAGING TO INFORM BOTH DECISIONS 1 SLNB Surgery: • SLNB is prognostic only – no melanoma-specific survival benefit 1 2 • Surgery is often ba
Slide 13: 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 (FFPE) Lowest risk 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 14: 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 low risk for SLN positivity similar to stage Result (n=1065) (n=448) (n=247) (n=370) T1a patien
Slide 15: 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 16: 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 17: Strong 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 18: Product Pipeline
PRODUCT PIPELINE The Skin Cancer Diagnostics Company
Slide 19: Treatment Pathways in Squamous Cell Carcinoma 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 Targeted to 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, Strong Evidence Base
: 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 › 1Q19: Expanded sales territories from 14 to 23 Report › Further expansion from 23 to 32 planned for Dec 2019 Volume › 3Q19 vs 3Q18, DecisionDx-Melanoma report volume up 32% and new ordering clinicians up 26% Revenue › DecisionDx-Melanoma ASP: Significant g
Slide 26: Sales Expansion Supported Strong Test Report Growth
1Q19 SALES EXPANSION SUPPORTED STRONG TEST REPORT GROWTH AND NEW ORDERING PHYSICIANS GROWTH Outside Sales Territories DecisionDx-Melanoma DecisionDx-Melanoma 32 Test Report Growth New Ordering Physicians 4126 23 3136 32% 26% 16 15 15 14 2015 2016 2017 2018 Feb 19 Dec 19 3Q18 3Q19 3Q18 3Q19 Expanded
Slide 27: Pipeline Products Fit Into Existing Commercial Channel
PIPELINE PRODUCTS FIT INTO EXISTING COMMERCIAL CHANNEL DecisionDx-Melanoma Call Points Test Report Growth 13,445 Product Primary Secondary 12,032 Dermatology (including Mohs), Dermatopathology 9,300 Surgeons Medical Oncology 6,295 * Dermatology (including Mohs), Dermatopathology 2,858 Surgeons Medic
Slide 28: Strong Third Quarter 2019 Adjusted Revenue and Adjusted Gross Margin
STRONG THIRD QUARTER 2019 ADJUSTED REVENUE AND ADJUSTED GROSS MARGIN Adj. Net Revenue ($ in millions) Adj. Gross Margin ($ in millions) $14.8 $13.1 $5.91 $4.51 3Q18 3Q19 3Q18 3Q19 Adj. Gross Margin % 77% 1 88% Source: Company financials. Unaudited. 1 See Non-GAAP Reconciliation at end of presentatio
Slide 29: Castle Biosciences: Improving Health Outcomes of Patients With Skin Cancer
CASTLE BIOSCIENCES Improving Health Outcomes Of Patients With Skin Cancer Through Innovative, Clinically Actionable, Cost-effective Diagnostics › STRONG FINANCIALS › High volume growth: 3Q2019 = DecisionDx-Melanoma = 32%; 30% total GEP test reports › Strong revenue: 3Q2019 =$14.8 million; YTD2019 =
Slide 30: Thank You
The Skin Cancer Diagnostics Company THANK YOU
Slide 31: Non-GAAP Financial Measures
NON-GAAP FINANCIAL MEASURES In this presentation, we use the metrics of Adjusted Revenues, Adjusted Gross Margin and Adjusted Gross Margin Percentage, whichare non-GAAP financial measures and are not calculated in accordance with generally acceptance accounting principles in the United States, or GA
Slide 32: Reconciliation of Non-GAAP Financial Measures
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES Three Months Ended September 30, 2019 2018 (in thousands) Adjusted Revenues Adjusted Revenues (Non-GAAP)$ 14,775 $ 5,898 DecisionDx-Melanoma Medicare revenue associated with test reports delivered in 3Q18 not recognizable until 4Q18 - (2,186) Net Revenue
Slide 33: Appendix
Appendix CASTLE | 3 ‘BIOSCIENCES
Slide 34: Leadership Team and Board of Directors
LEADERSHIP TEAM Board of Directors Name Prior Experience Name Derek Maetzold Dan Bradbury, Founder, Director, Castle Chairman, President and CEO Equillium CEO Frank Stokes Derek Maetzold Chief Financial Officer Bernhard Spiess Bonnie Anderson, Chief Business Officer Veracyte CEO Toby Juvenal Mara As