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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

The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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Page 1: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

Page 2: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

2

Page 3: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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.

Page 4: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

Page 5: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

End-State Disease 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

Page 6: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

OTTR Transplant Electronic Medical Record (Omaha)

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 (Stockholm)

XDx AlloMap Heart Transplant (South San Francisco)

Integrated Service

PrecisionMedicine

20192000

CareDx: 20+ Years of Focus on Transplantation

6

Page 7: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Total TAM

$5.5B+Building a new

business

$10B+

1% penetration

CareDx’s Portfolio has a $10B+ Total Addressable Market

Buildinga New

Business

$5.5B+

$10B+

Testing Services

Cell Therapy Surveillance

$2.5B+

TransplantProducts

$1B+

DigitalSolutions

$1B+

Note: Total addressable market based on internal company analysis.

7

Page 8: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

Page 9: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

9

Page 10: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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 Protocols Named 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.

Page 11: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Focused Building of the MOAT Around Each Center

11

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

Page 12: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

> 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

Page 13: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

• 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

13

Page 14: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Multi-Modality Surveillance: Latest Innovation in Transplant Care

14

Page 15: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

Page 16: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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)

16

Page 17: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

Page 18: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

Page 19: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Partnering Based Approach Drives Industry Innovation

19

First Validated Transplant

AI as part of iBox

First Target Capture Sequencing Technology

1st 1st

First dd-cfDNA Technology in TransplantationFirst dd-cfDNA Technology in

Transplantation

1st

Page 20: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

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

20

Page 21: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

OttrElectronic Medical

Records

XynQAPI AlloCarePatient

Engagement App

“Tracy”Virtual Transplant

AssistantWaitlist

Management

XynCareAITraCClinical Decision

Support

Provider Solutions

Digital Solutions Provide Insights to Patients and Providers

21

Patient Solutions

QualityManagement

Transplant Data PlatformFoundational functionality for

data exploration and insights creation

Page 22: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Record Growth in FY 2019 with Strong Quarterly Momentum

22

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%

Page 23: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Testing Services Primarily Drives Revenue Growth

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

23

Page 24: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Non-GAAP Gross Margin(FYE-December; % of Revenue)

Strong Pathway to Margin Improvement

24

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

Page 25: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

$10B+

CareDx’s Solutions Target Long-Term Outcomes

Current Survival

KIRA trial

Standardization and

Personalization

Complianceand

AdherenceImmuno-

modulation

13 Years

10 Years

25

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?”✓

Page 26: The Allo-Transplantation Company€¦ · Global Operations Pipeline / Platform Digital Offerings Collaborating on Cellular Therapy Building Multimodality Testing (Cornell) Impacting

Focused on Driving Adoption and Growth

Testing Services Transplant Products

Upcoming Growth Drivers Across Segments

Digital Business

26

✓ ✓ ✓

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 MolDxSubmission

• Supporting 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