Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — Investor Presentation (May 2023)
47 slides from Castle Biosciences's investor presentation, May 2023
Slide 1: Transforming Disease Management
Transforming Disease Management May 2023
Slide 2: Disclaimers
Disclaimers Forward-Looking Statements 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 sectio
Slide 3: Financial Performance Summary Q1 2023
Financial Performance Summary Q1 2023 Q1 2023 Q1 2022 Total test reports 14,916 8,627 Total Dermatology test reports 10,974 8,115 Revenues $42.0M $26.9M Adj. Revenues1 $43.4M $26.3M Gross Margin 70.5% 71.7% Adj. Gross Margin1 76.5% 77.4% Net Loss $(29.2)M $(24.6)M Adj. EBITDA1 $(15.1)M $(11.4)M Oper
Slide 4: Consistent Execution of Growth Initiatives Supports Long-Term Growth
Consistent Execution of Growth Initiatives Supports Long-Term Growth 2017-2022 Total Test Report Volume 2017-2022 Revenue 44,419 $137.0 58% 46% $94.1 28,145 $62.6 17,055 18,185 $51.9 13,445 10,614 $22.8 $13.8 1 2 2017 2018 2019 2020 2021 2022 2017 2018 2019 2020 2021 2022 1Due to COVID-19, cutaneous
Slide 5: Key Q1 2023 Accomplishments
Key Q1 2023 Accomplishments With continued momentum from Published prospective, multicenter National Society for Cutaneous 2022, delivered a strong start to the study, called DECIDE, 1 showing Medicine endorses DecisionDx- year, with significant test report DecisionDx-Melanoma test results Melanoma
Slide 6: Mission Vision Values
Mission Vision Values Improving health To transform disease ExCIITE: Excitement, through innovative management by keeping Collaboration, tests that guide people first: patients, Integrity, Innovation, patient care clinicians, employees Trust and Excellence and investors 6
Slide 7: Three Strategic Guideposts That Create Value for Customers, Patients and Stockholders
Three Strategic Guideposts That Create Value for Customers, Patients and Stockholders Customer & Solution Centric We value best-in-class customer experience at all points along the testing journey. For each type of customer we serve, we are focused on providing solutions that address multiple clinic
Slide 8: Driving Long-Term Growth through Strong Execution and our Operational Guideposts
Driving Long-Term Growth through Strong Execution and our Operational Guideposts Exceptional Employees, Continuous Evolution & Improvement and Customer & Solution Centric Near- to Mid-term Growth Mid- to Long-term Growth Strategic Mental Health Opportunities Mental Health Gastrointestinal Gastrointe
Slide 9: Answering Clinical Questions to Guide Care Along the Patient Journey
Answering Clinical Questions to Guide Care Along the Patient Journey Our focus is on diagnostic support, risk stratification and therapy response areas of the patient care continuum Therapy Response MRD/Recurrence PATIENT CARE JOURNEY Screening Diagnostic Support Risk Stratification Monitoring Infla
Slide 10: Estimated ~$8B U.S. Total Addressable Market for Commercially Available Tests
Estimated ~$8B U.S. Total Addressable Market1 for Commercially Available Tests Dermatology Gastroenterology Mental Health Cutaneous melanoma/ Cutaneous squamous cell Suspicious pigmented Barrett’s esophagus/risk of progression to risk of metastasis, SLNB Mental health therapy response carcinoma/risk
Slide 11: Well Positioned for Continued Growth with Expected 2023 Catalysts
Well Positioned for Continued Growth with Expected 2023 Catalysts Expected publication of Pittsburgh lab opening in Q2 2023, Further refinement of sales Expect new GI and MyPath collaborative NCI study showing bringing Castle’s total laboratory territories in our Derm, GI and commercial team expansi
Slide 12: Significant Scientific Evidence Through Robust Clinical Research Program
12 Significant Scientific Evidence Through Robust Clinical Research Program Across Our Testing Portfolio 18 323 ~11,800+ ~18,000+ Ongoing clinical Committed/contributing Patients enrolled in Patients enrolled in research studies clinical research sites as of studies as of Q1 studies over lifetime Q1
Slide 13: First-to-Market Dermatologic Franchise, Additional Growth Opportunities
First-to-Market Dermatologic Franchise, Additional Growth Opportunities Diagnostic Support Risk Stratification Therapy Response1 Inflammatory Skin Disease Therapy Response Pipeline Strong provider growth and continued adoption with ~540 new ordering clinicians1 and ~4,500 total ordering clinicians f
Slide 14: Castle Biosciences DecisionDx-Melanoma
CASTLE BIOSCIENCES Decision Dx > Melanoma
Slide 15: DecisionDx-Melanoma Provides Answers for Two Critical Clinical Questions
DecisionDx-Melanoma Provides Answers for Two Critical Clinical Questions Individual Breslow Risk of Thickness Sentinel Ulceration Mitotic Rate Lymph Age Node Positivity DecisionDx- Melanoma Neural network Class Result with AI algorithm Breslow Thickness Individual Ulceration Risk of Mitotic Rate Rec
Slide 16: DecisionDx-Melanoma GEP Has Consistent and Independent Evidence of Prognostic Value
DecisionDx-Melanoma GEP Has Consistent and Independent Evidence of Prognostic Value across Studies 100 RFS HR RFS (95% CI) HR DMFS (95% CI) FEATURE p-value p-value 80 % Recurrence Free Breslow thickness (per mm) 1.12 (1.03-1.22), p=0.01 1.14 (1.02-1.26), p=0.02 60 40 Ulceration 1.63 (1.18-2.25), p=0
Slide 17: Direct Evidence Demonstrating Treatment Decisions Guided by DecisionDx-Melanoma Can Improve Outcomes
Direct Evidence Demonstrating Treatment Decisions Guided by DecisionDx-Melanoma Results Can Lead to Improved Patient Outcomes Independent, multi-center study of SLN negative Key findings: patients (n=634) • DecisionDx-Melanoma test directed routine surveillance imaging in SLN-, high-risk patients “U
Slide 18: Collaboration with the National Cancer Institute
Collaboration with the National Cancer Institute Linking DecisionDx-Melanoma clinical testing with patients captured in the NCI-SEER Registry
Slide 19: NCI/SEER Data Linked with DecisionDx-Melanoma Test Results
NCI/SEER Data Linked with DecisionDx-Melanoma Test Results Data analysis of a cohort of real-world, unselected, prospectively tested patients with cutaneous melanoma 3-year OS (95% CI) Deaths, % (n/N) 31-GEP Tested 93.1% (92.0-94.2%) 4.8% (174/3,621) Benefit in Overall Survival (OS) in 21% patients
Slide 20: DecisionDx-Melanoma Disease Specific Survival Outcomes Are Favorable Relative to Other Tests
DecisionDx-Melanoma Disease Specific Survival Outcomes Are Favorable Relative to Other Tests Tumor size P-value 10-yr MSS Sentinel lymph node biopsy (SLNB) Thin (<1.2mm) Not reported Not impacted • SLNB is a risk-stratification surgical procedure “test” in melanoma Intermediate (1.2-3.5mm) not signi
Slide 21: DecisionDx-Melanoma Is Supported by Significant Scientific Evidence
DecisionDx-Melanoma Is Supported by Significant Scientific Evidence 10,000+ 40+ 128,300+ Total patients included in studies Peer-reviewed, published studies Patients with a clinical including independent including prospective studies DecisionDx-Melanoma order validation and 2 meta-analyses from 11,6
Slide 22: Castle DecisionDx-SCC
CASTLE Decision Dx »SCC
Slide 23: DecisionDx-SCC Provides Independent Risk Stratification to Inform SCC Management Decisions
DecisionDx-SCC Provides Independent Risk Stratification to Inform SCC Management Decisions Class 1: Low Biological Risk Less than half the general study population risk • Quantifies expression of 40 genes from primary tumor SCC patients using RT-PCR Class 2A: with one or Moderate Biological Risk mor
Slide 24: 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 <7% risk of metastasis; Metastasis-free survival (MFS) Less than half the general study population risk Class 2A – Moderate Biolog
Slide 25: Castle Biosciences MyPath Melanoma
CASTLE BIOSCIENCES MyPath > Melanoma
Slide 26: Unmet Need in Patients with a Difficult-to-Diagnose Pigmented Lesion
Unmet Need in Patients with a Difficult-to-Diagnose Pigmented Lesion The Clinical Problem These difficult-to-diagnose Of the estimated two million lesions are commonly sent Diagnostic ambiguity can suspicious pigmented lesions for second opinions to lead to clinical management A clinical hurdle for
Slide 27: MyPath for Use in Ambiguous Melanocytic Lesions
MyPath for Use in Ambiguous Melanocytic Lesions Expression of each gene group is calculated and normalized to the control genes. The aggregated score for each gene group is input into a trained logistic regression algorithm which weights each input and calculates a single score and classification of
Slide 28: Castle Biosciences TissueCypher Barrett's Esophagus
CASTLE BIOSCIENCES TissueCypher > Barrett's Esophagus
Slide 29: TissueCypher is a Risk Stratification Tool for Patients with Barrett's Esophagus
TissueCypher is a Risk Stratification Tool for Patients with Barrett's Esophagus Individualize 5-year risk of progression to HGD or EAC • Indicated for NDBE, IND and LGD • High Risk score enables increased surveillance or early intervention to prevent cancer • Low Risk score minimizes over treatment
Slide 30: TissueCypher Is the Strongest Independent Predictor of Progression
TissueCypher Is the Strongest Independent Predictor of Progression Original Pathologic Diagnosis TissueCypher HR = 7.7 (high- vs. low- risk) p<0.0001 HR = 2.8 (inter- vs. low-risk) p<0.0001 n=699 patients1-5 (ND n=567, IND n=50, LGD n=82) 152 incident progressors, 38 prevalent cases, 509 non-progres
Slide 31: IDgenetix: Precision Medicine Designed to Streamline Medication Selection for Mental Health
IDgenetix: Precision Medicine Designed to Streamline Medication Selection for Mental Health Next Generation PGx Unrivaled Efficacy Easy to Use • Eliminate trial and error • 2x improved chance of • 10 mental health and pain prescribing medication response vs. conditions in one report • 3 in 1 test: c
Slide 32: 2.5x Increase in Remission Rates for Severe Depression
2.5x Increase in Remission Rates for Severe Depression Demonstrated Enhanced Clinical Outcomes vs. Standard of Care >2.5x Response Rate Remission Rate increase in remission rate vs. control ≥ 50% Reduction from Baseline Patients Achieving Remission 73% 2x 35% increase in response rate vs. control 55
Slide 33: Castle DecisionDx-UM
CASTLE Decision Dx >UM
Slide 34: DecisionDx-UM: the Standard of Care in the Management of Newly Diagnosed Uveal Melanoma
DecisionDx-UM: the Standard of Care in the Management of Newly Diagnosed Uveal Melanoma Uveal Melanoma Facts – A Melanoma About Uveal Rare Eye Cancer Strong Evidence Base • 24 peer-reviewed publications with 3,600+ patients ~2,000 patients diagnosed in the U.S. annually ~97% of patients – no evidenc
Slide 35: Inflammatory Skin Disease
Inflammatory Skin Disease Pipeline test to predict response to systemic therapies with target launch by the end of 2025
Slide 36: Castle Has Started Two Studies to Aid in Treatment of Inflammatory Skin Diseases
Inflammatory Pipeline Test Castle Has Started Two Studies to Aid in Treatment of Inflammatory Skin Diseases IDENTITY SIGNAL-MF • Help guide therapy selection for atopic • Identify mycosis fungoides (MF) 1 – a type dermatitis and psoriasis of cutaneous T-cell lymphoma that can mimic atopic dermatitis
Slide 37: IDENTITY Study
Inflammatory Pipeline Test IDENTITY Study Castle’s inflammatory skin disease pipeline test is being developed to predict systemic therapy response Committed Sites Patients Enrolled1 2021 2022 2023 2025 Q2-Q3 Q3 Q2 2H 2023 2025 Steering committee First patient enrolled Proof of RNA extraction Early d
Slide 38: Thank you
CASTLE BIOSCIENCES Thank you
Slide 39: Use Of Non-GAAP Financial Measures (Unaudited)
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 (GAAP
Slide 40: Reconciliation of Non-GAAP Financial Measures (Unaudited)
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. 40
Slide 41: Reconciliation of Non-GAAP Financial Measures (Unaudited)
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 39 for further information regarding the Company’s use of non-GAAP financial measures. 41
Slide 42: Appendix
Appendix
Slide 43: Our Giving Philosophy
Our Giving Philosophy Patient Care Education Community Engagement 43
Slide 44: Employee Engagement is Part of our Core Strategy for Success
Employee Engagement is Part of our Core Strategy for Success Based on the results of Castle’s annual employee survey1 Castle employee 81% Healthcare benchmark 53% 2 2022 89% engagement score: average engagement score: Response Rate 40% 41% 17% 2% Enthusiastically engaged Engaged Disengaged Deeply di
Slide 45: Commitment to Diversity
Commitment to Diversity ETHNICITY/RACE GENDER 0.7% 2.9% 3.1% AMERICAN INDIAN OR ALASKA NATIVE 7.2% ALL EMPLOYEES BLACK OR AFRICAN AMERCIAN 11.6% 34.3% FEMALE TWO OR MORE RACES (NOT HISPANIC OR LATINO) MALE ASIAN 65.7% 74.2% HISPANIC WHITE 3.2% 3.2% TOTAL EMPLOYEES = 543 6.5% ASIAN 6.5% EXECUTIVES BL
Slide 46: Award-Winning Company
Award-Winning Company Committed to cultivating a culture of innovation, continuous growth and advancement 2019 Technology Innovation in Melanoma Award Winner 46
Slide 47: Leadership Team Overview
Leadership Team Overview Derek Maetzold © SCHERING Dan Bradbury Eauillium Founder, Director, President and CEO SSXSINE a am S, SANDOZ —, Frank Stokes LEERINK” nd fz] Derek Maetzold CASTLE Chief Financial Officer Suan Mara Aspinall Toby Juvenal Bi eccove seneucs Gy Ese Pharmaceuticals Chief Commercia
Castle Biosciences — Investor Presentation (May 2023) on 6ix