Castle Biosciences, Inc. · NASDAQ:CSTL
Castle Biosciences — FY2021 Earnings Presentation
45 slides from Castle Biosciences's earnings presentation, Feb 28, 2022
Slide 1: Transforming Disease Management
Tr a n s fo r m i n g D i s e a s e Management February 28, 2022
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: Mission, Vision and Values
MISSION: Improving health through innovative tests that guide patient care VISION: To transform disease management by keeping people first: patients, clinicians, employees and investors VALUES: Trust, Excellence, Collaboration, Integrity, Innovation and 3 Excitement
Slide 4: Castle: A Diagnostic Leader
Improving Health Through Innovative Tests That Guide Patient Care Castle Team A Diagnostic Leader Robust Data Supporting our Tests Peer-reviewed publications 345 Total employees Strong financial position, driven by investments in our growth pillars and commercial excellence 35+ 9 Diversified portfol
Slide 5: Financial Performance Summary 2021
Financial Performance Summary 2021 2021 2020 Revenue $94.1M $62.6M Adj. Revenue1 $90.8M $62.5M Total GEP test reports2 28,118 18,185 Total Derm test reports2 26,500 16,790 Operating Cash Flow $(19.0)M $9.9M Adj. Operating Cash Flow1 $(12.5)M $1.5M Gross Margin 81.1% 84.5% Adj. Gross Margin1 82.6% 84
Slide 6: Castle Remains Focused On Transforming Disease Management
Castle Remains Focused On Transformi ng Disease Management S t ra te g i c p r i n c i p l e s t h a t c re a te v a l u e fo r c u s t o m e rs , p a t i e n t s a n d s t o c k h o l d e rs Address areas Leverage advanced Provide robust data to Accelerate test with unmet technologies for support t
Slide 7: Driving Long-Term Growth Through Derm Foundation, Pipeline and Strategic Opportunities
D r i v i n g L o n g - Te r m G r o w t h T h r o u g h A S t r o n g D e r m F o u n d a t i o n , P i p e l i n e a n d Strategic Opportunities Near-to Mid-term Growth Mid-to Long-term Growth 2022-2023 2024 and beyond (Potential LCD effective in 2023) Pipeline (Potential LCD effective in 2023) Ex
Slide 8: Answering Clinical Questions to Guide Care Along The Patient Journey
Answering Clinical Questions to Guide Care Along The Patient Journey O u r fo c u s i s o n d i a g n o s t i c , r i s k s t ra t i f i c a t i o n a n d t h e ra p y re s p o n s e a re a s o f t h e p a t i e n t c a re c o n t i n u u m Inflammatory Pipeline Test Patient Care Journey Screening D
Slide 9: Pillars Of Our Growth Plan
Pillars Of Our Growth Plan C o n s i s te n t e xe c u t i o n f u r t h e rs o u r l e a d i n g p o s i t i o n i n d e r m a t o l o g y a n d i n t h e D x s p a c e Strong Core Derm Business Pipeline Initiatives Strategic Opportunities • Continuing provider education + • Ability to answer clini
Slide 10: 2021 Key Accomplishments
2021 Key Accomplishments Achieved strong, consistent year-over-year growth, both in our revenue (+50%) and test report volume (+55%), with net cash used in operating activities of $19 million and adjusted operating cash flow use of $13 million Doubled our dermatology-facing commercial team and added
Slide 11: Consistent Execution On Growth Initiatives Supports Long-Term Growth
Consistent Execution On Growth I ni tiatives Supports Long -Term Growth 2017-2021 Total Test Report Volume CAGR 2017-2021 Revenue CAGR $94.1m 62% 28,118 $62.6m 28% $51.9m 17,055 18,185 13,445 10,614 $22.8m $13.8m 1 2 2017 2018 2019 2020 2021 2017 2018 2019 2020 2021 11 1Due to COVID-19, cutaneous me
Slide 12: Full-Year 2022 Guidance
F u l l - Ye a r 2 0 2 2 G u i d a n c e February 28, 2022 Key Drivers Revenue $115 - $120 million Cost of Sales Scaling of Pittsburgh lab; preparation for volume ramp (exclusive of amortization of acquired 65%-75% growth for TissueCypher, DecisionDx-SCC and DiffDx- intangible assets) Melanoma ahead
Slide 13: Estimated ~$6.6B U.S. Total Addressable Market
E s t i m a t e d ~ $ 6 . 6 B U . S . To t a l A d d r e s s a b l e M a r ke t 1 In market and pipeline tests, across dermatologic and gastrointestinal franchises Dermatologic Franchise GI Franchise Cutaneous Cutaneous squamous Suspicious pigmented Pipeline Test - Additional Derm Barrett’s esophagu
Slide 14: 2022 Anticipated Catalysts
2022 Anticipated Catalysts Potential DecisionDx-SCC and DecisionDx DiffDx-Melanoma draft LCD Potential expansion of commercial teams to further accelerate test adoption and volume growth in GI and Derm Continued evidence development, data presentations and peer-reviewed publications to support the v
Slide 15: GI/Cernostics Integration Update
GI/Cernostics Integration Update F u e l i n g m i d - a n d l o n g - te r m g ro w t h w i t h T i s s u e C y p h e r ® p l a t fo r m a n d G I f ra n c h i s e New GI commercial team of ~ 14 outside territories hired, trained and in the field in January 2022, GI focused medical science liaisons
Slide 16: Significant Scientific Evidence Through Robust Clinical Research Program
Significant Scientific Evidence Through Robust Clinical Research P r o g r a m A c r o s s O u r Te s t i n g P o r t f o l i o 16 341 7,800+ ~12,000 20,000+ Ongoing clinical Committed/ Patients enrolled in Patients enrolled in Additional patient’s research studies contributing clinical studies at s
Slide 17: Accelerating Investments In Clinical Development
Accelerating I nvestments I n Cl i nical Development G e n e ra t i n g d a ta t h a t s u p p o r t s t h e c l i n i c a l v a l u e o f o u r te s t s a n d s u p p o r t s p ro v i d e r a n d p aye r a d o p t i o n 4 Ongoing studies 3 Ongoing studies 3 Ongoing studies 3 Ongoing studies 102 144
Slide 18: First To Market Dermatologic Franchise, Additional Growth Opportunities
First To Market Dermatologic Franchise, Additional Growth Opportunities Diagnostic Support Risk-Stratification Therapy Response1 Inflammatory Pipeline 18 1 Target launch anticipated by the end of 2025 .
Slide 19: DecisionDx-Melanoma: Precision Risk Stratification
D ec isio n Dx -M ela noma : Prec ision R isk S t rat if icat ion B ased on Tu mor B io lo gy Info rms Tre at me nt Pla n s Market Snapshot Clinical Questions Clinical Utility Transforming Disease Management (post-melanoma diagnosis) DecisionDx-Melanoma could result in 74% fewer SLNB surgeries7, pot
Slide 20: Current Melanoma Staging Misses Patients With Aggressive Tumor Biology
Current Melanoma Staging Misses Patients With Ag gressive Tumor Biology Stage at Diagnosis Melanoma Deaths by Stage at Diagnosis Stage I Stage I 34% Stage II The majority of 80% 26% melanoma deaths 92% 60% occur in patients who Stage I or II 12% Stage II Stage I or II were diagnosed at 8% Stage I or
Slide 21: DecisionDx-Melanoma Is Supported By Significant Scientific Evidence
DecisionDx-Melanoma Is Supported By Significant Scientific Evidence 6,000+ 35+ 90,000+ Patients with a Patients included in studies including Peer-reviewed, published studies DecisionDx-Melanoma order independent validation including 2 meta-analyses from more than 9,300 clinicians 50% Medicare+ 1A D
Slide 22: DecisionDx-Melanoma Adoption Since Launch
DecisionDx-Melanoma Adoption Since Launch C o n s i s te n t g ro w t h i n v o l u m e a n d m a r ke t p e n e t ra t i o n d r i v e n b y c l i n i c a l va l u e a n d c o m m e rc i a l e xc e l l e n c e 18% DecisionDx-Melanoma test report volume Estimated market penetration 16% 12% 20,328 9%
Slide 23: NCI/SEER Data Linked with DecisionDx-Melanoma Test Results
NCI/SEER Data L i nked wi th DecisionDx -Melanoma Test Results D a ta a n a l y s i s o f t h e f i rs t c o h o r t o f p a t i e n t s 6 5 ye a rs o r o l d e r 1 Data further strengthens Data provides real world independent, risk- evidence that patients tested stratification value of with Decisio
Slide 24: DecisionDx-SCC: Predicts Metastatic Risk for SCC
D e c isio n Dx -S CC: Predicts Metastatic Ri sk for SCC Pat i ents Wi t h One Or More Ri sk Factors Market Snapshot Clinical Question Clinical Utility Transforming Disease Management (post-SCC diagnosis) Improved accuracy of metastasis risk predictions Predicts metastatic risk for compared to BWH a
Slide 25: DecisionDx-SCC Addresses the Unmet Need In High-Risk SCC Patients
DecisionDx -SCC Addresses t he Unmet Need I n Hi gh -Risk SCC Pat ients W h o i s re a l l y a t l o w r i s k o r h i g h r i s k fo r m e ta s ta s i s ? Deaths from SCC are now estimated to exceed those from melanoma ~20% of SCC patients (200,000 annually) have one or more clinical or pathologica
Slide 26: DecisionDx-SCC Informs Risk-Appropriate Management
D e c i s i o n D x - S C C I n f o r m s R i s k - A p p r o p r i a t e M a n a g e m e n t To G u i d e P a t i e n t Care Validated in 420-patient For high-risk SCC patients 9 peer-reviewed cohort of high-risk SCC from with one or more risk factors publications to date 33 U.S. centers Incorporat
Slide 27: Comprehensive Diagnostic Offering Improves Clinically Actionable Reporting
C o mp re he n sive D ia g n ost i c O ffe r i n g I mp rove s C l i n i ca l l y A c t i o n a bl e Re p o rt in g fo r ~ 9 9 % o f C o n c e r ni n g L e s i o n s Market Clinical Question Clinical Utility Transforming Disease Management Snapshot Annually, ~300,000 difficult-to-diagnose ~$600M Lev
Slide 28: Diagnosing Melanoma, the Clinical Issue: Uncertainty Creates Over- or Under-Treatment Dilemma
Diagnosing Melanoma, the Clinical Issue: Uncertainty Creates An Over - O r U n d e r - Tr e a t m e n t D i l e m m a Histopathologic Staging, surveillance, Clinically evaluated Primary treatment and follow-up options evaluation suspicious pigmented lesions SLNB Definitive melanoma diagnoses (invasi
Slide 29: Inflammatory Pipeline Test
Inflammatory Pipeline Test 29
Slide 30: Targeting the Unmet Need In Moderate To Severe Psoriasis And Atopic Dermatitis
Inflammatory Pipeline Test Targeting the Unmet Need In Moderate To Severe Psoriasis And Atopic Dermatitis C o m m o n s k i n d i s e a s e s w i t h s i g n i f i c a n t p a t i e n t i m p a c t s a n d c o s t s t o h e a l t h c a re sy s te m Psoriasis (PSO) and Atopic Dermatitis (AD) are amon
Slide 31: Inflammatory Skin Disease Pipeline Test Being Developed To Predict Systemic Therapy Response
Inflammatory Pipeline Test Castle’s I nflammatory Skin Di sease Pi peline Test I s Being Developed To Predict Systemic Therapy Response 50 50 4,800 5 Committed Total Target Target Sites Sites PatientEnrolled Target Enrolled Enrollment PatientsPatients Program Milestones Q2-Q32021 Q32021 Q22022 2025
Slide 32: Gastrointestinal
G a s t ro i n t e s t i n a l
Slide 33: TissueCypher: Designed to Predict Future Development Of Esophageal Cancer
Tissu eC y p her : Designed to Predict Fut ure Development Of Esophageal Cancer I n Pat ients Wi th Barrett ’s Esophagus Market Snapshot Clinical Decision Point Clinical Utility Transforming Disease Management Provides a 5-year individual risk of TissueCypher high risk score independently progressio
Slide 34: The Standard of Care for Evaluating Metastatic Risk in Uveal Melanoma
The Standard of Care for Evaluating Metastatic Risk in Uveal Melanoma
Slide 35: DecisionDx-UM: The Standard Of Care In 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 • 21 peer-reviewed publications, 3,000+ patients ~2,000 patients diagnosed in the U.S. annually ~97% of patients – no evidence o
Slide 36: Commitment To Diversity
Commitment To Diversity E T H N I C I T Y/ R A C E GENDER 20.4% CAUCASIAN HISPANIC OR LATINO All Employees 3.5% ASIAN 35.4% FEMALE 4.6% 64.3% MALE BLACK OR AFRICAN- 64.6% AMERICAN 7.2% TWO OR MORE RACES (NOT HISPANIC OR LATINO) 3.6% TOTAL EMPLOYEES = 345 Executives CAUCASIAN 21.4% 35.7% FEMALE OTHER
Slide 37: Award-Winning Company
Award-Winning Company C o mmitted to c u lt ivat in g a c u lt u re o f in n ovat io n, co nt in u ous g rowt h a n d a d va n ce me nt 2019 Technology Innovation in Melanoma Award Winner 37
Slide 38: Castle Biosciences Is Improving Health Through Innovative Tests That Guide Patient Care
Castle Biosciences I s I mproving Health Through I nnovati ve Tests That Gui de Pat ient Care SQUAMOUS CELL BARRETT’S CUTANEOUS MELANOMA1,2 UVEAL MELANOMA3 CARCINOMA ESOPHAGUS4 PROGNOSTIC DIAGNOSTIC PROGNOSTIC PROGNOSTIC PROGNOSTIC Predicting Individual Risk Highly Accurate and Better Identifies Ris
Slide 39: Thank You
THANK YOU
Slide 40: Use Of Non-GAAP Financial Measures (Unaudited)
Use Of Non-GAAP Financial Measures (Unaudited) In this presentation, we use the metrics of Adjusted Revenue, Adjusted Gross Margin and Adjusted Operating Cash Flow, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United
Slide 41: Reconciliation Of Non-GAAP Financial Measures (Unaudited)
Reconciliation Of Non -GAAP Financial Measures (Unaudited) The table below presents the reconciliation of adjusted revenue and adjusted gross margin, which are non-GAAP measures. See "Use of Non-GAAP Financial Measures (UNAUDITED)" on the previous slide for further information regarding the Company'
Slide 42: 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)" on the previous slide for further information regarding the Company's use of non-G
Slide 43: Appendix
APPENDIX
Slide 44: Leadership Team Overview
L e a d e r s h i p Te a m O v e r v i e w BOARD OF DIRECTORS MANAGEMENT TEAM Dan Bradbury Derek Maetzold Founder, Director, President and CEO Derek Maetzold Frank Stokes Mara Aspinall Chief Financial Officer Stuart Brad Cole Toby Juvenal Pharmaceuticals Chief Commercial Officer Tiffany Olson Kriste
Slide 45: Recent Achievements And Expected Future Milestones
Recent Achievements And Expected Future Milestones 2021+: Continued evidence development for all 3Q2020: Launch of commercialized products DecisionDx-SCC 2021+: Continued development of July 2019: IPO dermatologic pipeline products; Dec. 2018: 3Q2020: Dermatologic potential launches in 2025 Initial