the allo-transplantation company...expanding $10b+ market opportunity industry leading products...
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May 2020
The Allo-Transplantation Company
Focused on better outcomes through personalized transplant surveillance.
Allotransplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues or organs to a recipient from a genetically non-identical donor of the same species
These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical factcontained in this presentation, including statements regarding future financial position of CareDx, Inc. (together with its subsidiaries, “CareDx” orthe “Company”), including financial targets, business strategy, and plans and objectives for future operations, are forward-looking statements.CareDx has based these forward-looking statements on its estimates and assumptions and its current expectations and projections about futureevents. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those contained in the “RiskFactors” section of the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed or maysubsequently file with the U.S. Securities and Exchange Commission (the “SEC”). In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation are inherently uncertain and may not occur, and actual results could differ materiallyand adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-lookingstatements as predictions of future events. CareDx undertakes no obligation to update publicly or revise any forward-looking statements for anyreason after the date of this presentation or to conform these statements to actual results or to changes in CareDx’s expectations.
These slides and the accompanying oral presentation contain certain non-GAAP financial measures, which are provided to assist in an understandingof the business and performance of CareDx. These measures should always be considered only as a supplement to, and not as superior to, financialmeasures prepared in accordance with GAAP. Please refer to the Appendix included in these slides for a reconciliation of the non-GAAP financialmeasures included in these slides and the accompanying oral presentation to the most directly comparable financial measures prepared inaccordance with GAAP.
Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representativeshas verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes anyrepresentations as to the accuracy or completeness of that data or undertakes any obligation to update such data after the date of this presentation.Such data involves risks and uncertainties and is subject to change based on various factors.
The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construedas an endorsement of the products or services of the Company.
Safe Harbor Statement
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Our MissionWe are committed to improving
transplant patient outcomes by providing
innovative and intelligent solutions throughout
the entire patient journey.
Our VisionThe leading partner for transplant patients
and the transplant ecosystem.
Expanding $10B+ market opportunity
INDUSTRY
LEADING
PRODUCTS &
SERVICES
Our Focus Underpins Our Leadership Position and Continued Growth
LEADING
MEDICARE
REIMBURSEMENT
STRONG
CLINICAL
DATA
ROBUST
END-STAGE
PIPELINE
STRONG
FINANCIAL
POSITION
4
Pre-Transplant Post-Transplant Surveillance
>75 Transplant CentersClinical Studies
Quality Management >30 Transplant Centers
Electronic Medical Records >60 Transplant Centers
“Liquid Biopsy”dd-cfDNA
cfDNA Cell Therapy
Augmented Intel Risk Prediction
Gene Expression Profiling
Waitlist Management
High Resolution HLA matching
Note: Illustrative, not an exhaustive representation of CareDx’s portfolio
Multiple Touchpoints Along Patient Journey
5New
OTTR Transplant Electronic Medical Record
Building dd-cfDNA Technology Platform (Stanford/ImmuMetrix)
Building HLA Sequencing Platform (Conexio/Illumina )
Applying AI with Ibox Prediction Scores (Cibiltech)
Partnering with Quest (RemoTraC)
Expanding into StemCell Transplant
Leader in Diagnostics
TODAY
Global Operations
Pipeline / Platform
Digital Offerings
Collaborating on Cellular Therapy
Building Multimodality Testing (Cornell)
Impacting Transplantation Globally
Olerup HLA Typing Technology
XDx AlloMap Heart Transplant
Integrated Service
PrecisionMedicine
20192000
CareDx: 20+ Years of Focus on Transplantation
6
Total TAM
$5.5B+Building a new
business
$10B+
CareDx’s Portfolio has a $10B Total Addressable Market
$5.5B+
$10B+
Testing Services
Cell Therapy Surveillance
$2.5B+
TransplantProducts
$1B+
DigitalSolutions
$1B+
Note: Total addressable market based on internal company analysis.
7
8
CLINICALLY VALIDATED TESTING PROTOCOL
8
Leading science with the lowest limit of detection, now at 0.12%
$2,840 CMS reimbursement coverage for 70% - 80% of patients
Stratifies patients with T-cell mediated rejection
Efficient care with only one tube of blood required
YEAR 1
15 Planned Surveillance Tests Post-Transplant
1 2 3 4 5 6 7 8 9 10 11 12
YEAR 2
YEAR 3
Kidney Transplant Patients
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CLINICALLY VALIDATED
Non-invasive gene expression profile test of peripheral blood
Detects changes in gene expression associated with acute rejection
Used by over 90% of US transplant centers
$3,240 CMS reimbursement / covered by most private payers
6 7 8 810
12 13 14 15 16
19
2015 201720142012 20182011 20132010 2016 20192009
AlloMap Patient Results(in Thousands)
Heart Transplant Patients
CareDx is the Leading Partner Across US Transplant Centers
10
Kidney Heart Other Organs
Deep Center Penetration
ClinicalPartnership
Leadership Indicators
Centers Using AlloSure Centers Using AlloMap Centers Using AlloSure Lung
KOAR/OKRA Centers SHORE Centers Investigator Initiated Trials
Named Center Protocols Named Center Protocols
70%+ 90%+ 20+
70+ 40+ 20+
>40 >90 Currently indevelopment
Note: Center penetration based on UNOS listed transplant centers as of Q1 2020; does not include non-transplant hospitals.
Focused Building of the MOAT Around Each Center
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Medical ScienceLiaison (MSL)
Transplant Account Manager (TAM)
RemoTraCPhlebotomy
Field LabService Team
Community Nephrology Team
EMR Solutions
Patient Care Management Team
SOLID ORGAN
TRANSPLANT
CENTERS
1
2
3
4
5
6
“The Only Company 100% Transplant Focused”
Transplant CoordinatorAssistants
> 150 Centers
TransplantCenters
PatientConsent
Patient Care
Manager
Mobile Network
Field LabSupport
RemoTraC: Adapting to COVID-19 World
12
BROAD
INTEREST
RAPID
UPTAKE
ACCELERATED
STRUCTURE
CREATED
NATIONAL
PHLEBOTOMY
ESTABLISHED
CUSTOMER
EXCELLENCE
GROUP
> 2K Patients40+ Hired
in 3 Weeks> 10K in Network
CombinedPatient Facing
Employees
• Surveillance Standard• Multi-Center Trials
• Decision Support• Individualized Care
• Clinical Validation• Reimbursement
CareDx’s Approach to Precision Medicine in Transplantation
GenomicBiomarkers
TransplantCare
Artificial IntelligenceTransplant Care
✓ High value ✓ Proprietary
✓ Multi-modality✓ Protocolized
Surveillance✓ Prognostic
✓ Comprehensive✓ Actionable Care
Pathways✓ Integrated into
Electronic Medical Records
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Multi-Modality Surveillance: Latest Innovation Transplant Care
14
Gene Expression/Urine Biomarker
Gene Expression/Tissue Biomarker
✓ Developed by Cornell✓ Gene expression for
acute cellular rejection
✓ Developed by Banff✓ Identify rejection in issue✓ Best in-class (work-flow,
reproducible, FFPE)
Q2 2020 Additions
Significant Investigator Initiated Trial Program
Advancing Transplant Science
> 40Transplant Centers
Strategic Investments in Clinical Development
15
> 40Transplant Investigators
Large Multi-Center, Prospective Studies
Generating Cutting EdgeData to Support Adoption
Leading Grant Support with Investigators and
Transplant Societies
Driving Transplant Innovation
1
2
3
Multicenter, prospective, observational registry, designed to measure outcomes of kidney
transplant recipients managed with KidneyCare
Planned renal surveillance biopsies at 12 months post-transplantation managed with and without donor-derived cfDNA
(AlloSure®) or KidneyCare
• First OKRA patient enrolled 9/2019• Estimated primary endpoint: 12/2021 • Estimated completion: 12/2025
4,000Patients
1,500 NEWLY TRANSPLANTED
1,500ENROLLED IN K-OAR
1,000CONTROL
Multicenter, prospective, observational registry of patients receiving HeartCare surveillance
A historical control group will be matched to the HeartCare group
patients who complete at least two years of HeartCare surveillance use
• Clinical follow-up for outcome (year 3 post-Tx)• Estimated primary endpoint: 12/2024 • Estimated completion: 12/2027
3,600Patients
2,800NEWLY TRANSPLATED
800CONTROL
Multicenter, prospective, observational registry of patients receiving AlloSure Lung surveillance
300Patients
200NEWLY TRANSPLATED
100CONTROL
A cohort study with newly transplanted and > 1 year post-transplant using AS
and RemoTraC surveillance to monitor adverse events
• Clinical follow-up for outcome• Estimated primary endpoint: 6/2022 • Estimated completion: 12/2022
Kidney (OKRA Study) Heart (SHORE Study)
Overview of Ongoing Clinical Trials
Lung (ALARM Study)
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Cell TherapyPatient Monitoring
AlloCell: New Surveillance Solution for Allogeneic Engineered Cell Transplants and Therapies
CELL THERAPYADDRESSABLE
MARKET
$5.5B+
✓ Measures the amount of cell product relative to patient cells
✓ High sensitivity and reproducibility with minimal DNA amount
✓ Fast lab turn-around time
✓ Based on analytically and clinically validated workflow
✓ Monitors the level of engraftment and persistence of allogeneic cells
✓ Five years in-house development and experience with technology
Note: Cell Therapy addressable markets assumes ~180,000 hematological cancer patients, 160,000 solid tumor patients (10% penetration, and reimbursement set at current AlloSure levels; excludes upside from clinical trial partnerships.
✓ > 300,000 patients…
✓…receiving ~1.2 treatments annually…
✓…with ~7 tests per treatment
17
Infusion Months/years
% C
ell
Pro
du
ct
Expansion
Contraction
Persistence
C max
AlloCell: Improving the Cell Transplant Treatment Paradigm
18
Focused on Driving Adoption and GrowthCurrent Short FallsAlloCell has the Ability to Change the Standard of Care ✓
• Currently therapies lack proactive, comprehensive matching and monitoring capabilities
✓ Opportunity to personalize cell therapy
• Many different cell therapy constructs expected and variability in patients’ responses to therapy
✓ Need standardized measurement of cellular kinetics and persistence
• CareDx uniquely brings together all components necessary to serve the cell therapy ecosystem…
✓ … deep basic science and clinical expertise
✓ … infrastructure
✓ …scale and existing business models
• Ability to leverage…
✓ …existing patient, provider and payor relationships
✓ …transplant data to provide lessons learned and real-time insights
BEST-IN-CLASS GENETIC MATCHING
17 genes enables more matching points for solid organ and stem cell transplant recipients
Hybrid Capture Technology enables addition of future gene content without workflow changes
Data analysis in less than 30 minutes per run
CE Approval May 2020
Coverage includes classical and non-classical HLA
Donor-Recipient Matching
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Digital Solutions Provide Insights to Patients and Providers
Support EMR integration and testing protocol adherence
Transplant dedicated EMR based on Cerner platform
Growth from OttrSAAS, Bone Marrow and VA implementation
Leading Transplant Patient Engagement
Transplant EMR & Patient App
20
Record Growth in FY 2019 with Strong Quarterly Momentum
21
Testing Services Patient Results(FYE-December; in Thousands)
Total Revenue(FYE-December; in Millions)
2017
13 14 16
28
49
201920182015
+77%
2016
1015
Q1 2020
Q1 2019
+50%
$77
$41
2016 2018
$28
20192017
$48
2015
$127
+66%
Q1 2020
Q1 2019
$26$38
+48%
Testing Services Primarily Drives Revenue Growth
22
Q1 Revenue (in $ Millions)
21.5
4.4
26.031.4
4.72.2
38.4
TOTAL
+46%
+6%
+48%2019 2020
DIGITAL & OTHERPRODUCTSTESTING SERVICES
Non-GAAP Gross Margin(FYE-December; % of Revenue)
Strong Pathway to Margin Improvement
23
Adjusted EBITDA(FYE-December; in Millions)
Net Operating Cash Flow(FYE-December; in Millions)
60% 61%
68% 67%
71%
2017 2018 2019 Q12019
Q12020
-$12 -$3
$4
2017 2018 2019
-$14 -$4 -$3
2017 2018 2019
$10B+
CareDx’s Solutions Target Long-Term Outcomes
Current Survival
KIRA trial
Standardization and
Personalization
Complianceand
AdherenceImmuno-
modulation
13 Years
10 Years
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Future Survival
RemoTraC AiTraC
AlloCare
Multi-Modality Approach
Defining Standards
• dd-cfDNA cut-off
• Surveillance Protocol
Trailblazing Innovation
• GEP
• dd-cfDNA
• Target Capture Sequencing
• Augmented Intelligence
Fueling Transplant R&D
• Multi-modality
• Immunomodulation
• Cellular Therapies
Examples for “How?”✓
Focused on Driving Adoption and Growth
Testing Services Transplant Products
Upcoming Growth Drivers Across Segments
Digital Business
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✓ ✓ ✓
Focused on GlobalAlloSeq Launches
Focused on Supporting Testing and Growth
• “Going deep” in U.S. Centers
• AlloSure Heart Reimbursement
• Community Nephro Program
• Comprehensive Service Solutions (Xyn/OTTR/ Services)
• AlloSure Lung MolDx Submission
• Support Testing Services
• Increase Digital Growth
• Introduce Provider and Patient Offerings (AlloCare)
• EU Expansion
• Asia Pacific Entry
• US Share Gains
• EU CE Mark
• Software/Service Upgrades
• Leverage Existing Network
• Enhance Service Offerings
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