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Margot Duane Stem Cell Transplant Recipient Corporate Presentation November 2019 27, 2019

Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

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Page 1: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Margot Duane Stem Cell Transplant Recipient

Corporate Presentation

November 2019

27, 2019

Page 2: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding future financial position of CareDx, Inc. (together with its subsidiaries, “CareDx” or the “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 future events. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those contained in the “Risk Factors” 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 may subsequently 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 materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. CareDx undertakes no obligation to update publicly or revise any forward-looking statements for any reason 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 understanding of the business and performance of CareDx. These measures should always be considered only as a supplement to, and not as superior to, financial measures prepared in accordance with GAAP. Please refer to the Appendix included in these slides for a reconciliation of the non-GAAP financial measures included in these slides and the accompanying oral presentation to the most directly comparable financial measures prepared in accordance with GAAP.

Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives has verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations 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 construed as an endorsement of the products or services of the Company.

Safe Harbor Statement

2

Page 3: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

OUR VISIONThe Leading Partner forTransplant Patients andThe Transplant Ecosystem

OUR MISSIONWe are committed to improving Transplant Patient Outcomes by providing Innovative and Intelligent Solutions throughoutthe entire Patient Journey

3

Page 4: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

CareDx Highlights

4

Leader in Transplantation

Revenue Growth Accelerates Path to Profitability

Transformational AlloSure Launch in $2bn US Market

− Provider of leading solutions across continuum of transplantation

− Technology leadership position in Molecular Diagnostics with (“Liquid Biopsy”) and Gene Expression profiling

− Leader in continuum of care along the transplant patient journey

− Established Medicare Price of $2,840 per test, coverage of 70-80% of kidney transplant patients

− Used in 120+ centers and on 7% of U.S. kidney transplant patients since launch

− Leveraged existing AlloMap presence to scale in a highly capital efficient manner

Genomic Information and Artificial Intelligence Drives Future Opportunity− Expanding product portfolio with pre- and post-transplant patient management solutions

− Developing a platform for Artificial Intelligence in Transplant Care (AiTraC)

− Outcome orientation along the transplant patient journey

− 60% revenue growth in Q3 2019, FY revenue guidance $124m to $125m

− Achieved fifth consecutive quarter of adjusted EBITDA profitability

− Strong, debt free balance sheet

Page 5: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

YTD 2019 Highlights

5

• AlloSure Launch Progress 7% US Kidney Tx Patients

• KOAR >1,000 patients, SHORE & OKRA initiated

• KidneyCare and HeartCare advanced

• OTTR & Xyn acquisition, iBox addition

• AlloSeq cfDNA and AlloSeq Tx 17 launched

Page 6: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Robert WoodwardVP, Research &

Development

XDx, Gladstone Institute,

UC San Francisco

Mike DonnellVP, Transplant

Digital Business

United Resource Networks,

Baylor and Keck Hospital

Reg SeetoPresident, CBO

Paul CiccolellaSenior Vice President,

Operations

Pacific Biosciences, Affymetrix,

ProtoGene Labs

David SayerVP, Global Transplant

Laboratory Services

Experienced Management Team

Peter MaagChief Executive Officer

McKinsey, Novartis Pharma,

Novartis Diagnostics

Michael BellChief Financial Officer

Novartis Vaccines & Diagnostics,

Ernst & Young, Deloitte

Sham DholakiaSVP, Medical Affairs

& Clinical Operations

University of Oxford,

GE Healthcare

Amitabh ShuklaSVP Technology

Persistent Systems, Life

Technologies, Agilent, IBM

Sasha KingChief Commercial

Officer

Genentech, Ariosa Diagnostics,

Fletcher Spaght

CONFIDENTIAL

Marissa DixonVP, Human

Resources

Metabiota, DuPont Bioscience,

Genencor, WageWorks

Illumina,

Conexio Genomics

Alex JohnsonVP, Transplant

Products Business

BioGraph 55, Novartis,

Celera

Ardelyx, AstraZeneca /

Medimmune, Organon

BioSciences, Boehringer

6

Page 7: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Better Matching + Better Surveillance =

Better Outcomes

7

Page 8: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

CareDx – 20 Years of Focus on Transplantation

Evolution during last 5 years to deliver on vision

2014 2018

AlloMap Business

Building dd-cfDNA technology platform (ImmuMetrix)

Acquired pre-transplant business (Allenex)

Acquired ex-Conexio / Illumina SBT

Licensed NGS Tx- Portfolio (Illumina)

Launched AlloSure first dd-cfDNA

Leader Heart Tx

2019

Pre-TxBusiness

LeaderRenal Tx

Pipeline / Platform

Global Operations

TransplantLeader

Launched QTYPE (PCR HLA)

Launched Heartcare (via SHORE)

8

Page 9: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

CareDx’s Solutions Target Long-Term Outcomes

10

Conceptual

Current Survival

Future Survival

Years

13

Complianceand

Adherence

Standardization and

Personalization

ImmunoModulation

Page 10: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Building a Moat in Transplantation Evolution during next 12 months for longitudinal and long-term patient management

Launched HeartCare and AlloSure Lung

Partnered for iBox Technology (prognostic algorithm)

Launched KidneyCare (AlloSure, AlloMap, and iBox)

Acquired OTTR (Transplant EMR) & Xyn with AI capabilities

Launched AlloSeq cfDNA - expanded OUS offerings

Launched AlloSeq Tx17 - next leap forward in NGS HLA Typing

Leader Heart

Today

LeaderRenal Tx

Leader HLA Typing

Pipeline / Platform

Global Operations

Launch AlloSeq BMT - new technology for this field

New platform partnerships (e.g., HistoMap)

New pipeline programs - Tx specific

Launch new global offerings

Leader in Kidney, Heart and Lung Tx

2019+

Leader in Digital Solutions/ Artificial Intelligence

Leader in Disruptive Innovation

Leader Along the Transplant Patient Journey

Global Leader in the Field of Transplantation

Leader in Long-Term Patient Outcomes

10

Page 11: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

11

Business Lines Focused On +$4bn TAM Opportunity

Market US Transplant Global Transplant Global Transplant IT

Annual Volume300,000 Patients700,000 Waitlists

1.5 M Patients> 3 M Patients,

Donors, Caregivers

Targets250 Centers

>7,000 Caregivers1,000 Global Labs &

Centers1,000 Global Centers

Tx Population

OfferingSurveillance Protocol

>15 per patientHLA Typing,Surveillance

EMR,Patient Engagement

TAM +$2bn +$1bn +$1bn

ProductsOpportunity

DigitalOpportunity

Testing ServicesOpportunity

Source: company estimates

Page 12: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

CareDx In Market Products

12

• Capitalize on first mover with AlloSure

• Build on existing legacy of AlloMap

• Provide fastest turnaround typing with QType

• Deep sequencing information with NGS

• Build on existing relationship in Solid Organ

• Grow presence in Bone Marrow Transplant

SolutionApproach

Testing Services84%*

Digital4%

Products12%

Business

* % of Q3 2019 revenues

Page 13: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

CareDx Transplant Solutions Pipeline

13

• Increase menu by multi-modality testing

• Provide AlloSure for other organs

• Anchor with best in class typing products

• Grow globally with cfDNA technology

• Expand transplant EMR with Cerner & EPIC

• Revolutionize Engagement & Decision Making

SolutionApproachBusiness

Testing Services

Digital

Products

Page 14: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

14

Strategic Advantage From Large Multi-Center Clinical Studies

Impact

Long-term Heart Transplant Outcomes

Long-term Kidney Transplant Outcomes

Validation AlloSure Kidney Transplant

Validation of HeartCare

Clinical Utility of AlloMap – NEJM publication

AlloMap validation in Heart (EU)

AlloSure validation in Lung*

AlloMap validation in Heart (US)

Start

2018

2018

2015

2014

2005

2005

2004

2001

Study

SHORE

K-OAR

DART

D-OAR

IMAGE

CARGOII

LARGO

CARGO

Centers

>40

>50

14

28

12

13

14

8

Patients

> 1000

> 1000

400

>1,000

629

741

>2000

>600

Samples

> 8,000

> 8,000

2,100

> 3,000

2292

7,600

>8500

>4900

* Based on previously existing CareDx sample repository

Long-Term Kidney Outcomes2019 OKRA >50 > 4000 > 10,000

Page 15: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

15

* Surveillance Patient = KOAR patient or non-KOAR patient managed by CareDx on a predefined transplant center protocol

AlloSure Metrics - Continued Momentum

Launch Metrics Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019

Patient Results (in qtr) 3,708 4,575 5,710 7,355

Unique Patients Tested (in qtr) 2,829 3,377 4,284 5,548

Ordering Centers (in qtr) 86 100 101 117

KOAR Enrolled Centers (cum) 40 47 50 51

KOAR Enrolled Patients (cum) 480 748 1,006 1,204

3,644 4,618 5,738Current Surveillance Patients

At 3/31/19

At6/30/19

At 9/30/19

8,524

124

53

1,390

6,597

Page 16: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

CareDx’s Approach to Precision Medicine in Transplantation

AlloMapAlloSure- High Value - Proprietary

HeartCareKidneyCare- Multimodality- Protocolized Surveillance- Prognostic

GenomicBiomarkers

TransplantCare

ArtificialIntelligenceTransplant

Care

• Surveillance Standard• Multi-Center Trials

• Decision Support• Individualized Care

AiTraC- Comprehensive

- Actionable Care Pathways

- Integrated into EMR

• Clinical Validation• Reimbursement

16

Page 17: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Gene Expression Profiling (GEP)

Donor-derived Cell-free DNA (dd-cfDNA)

17

Machine learning transplant data analytics

Graft Injury Immune Activity Graft Prognosis

The Latest Innovation in Transplant Surveillance

Page 18: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Digital Transformation in Transplant Care

Chronic Condition Wait List

SurgeryEvaluation Post Op Lab Visit Office Visit

End State Disease Life-Long Immunosuppression

Adherence▪ Interventions

▪ Rx personalization

Organ Matching▪ Donor identification

▪ Timely organ

qualification

▪ Wait list management

Care PathwaysData aggregation to allow for decision support

Surveillance▪ Observations

▪ Biomarkers

EMR LISRegistry Studies

Page 19: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Strategy

▪ Patient Dedication

▪ Clinical & Premium Positioning

▪ Pre-Post Transplant Continuum

▪ Multi-Product Offerings

Assets

▪ Strong Reputation & Brands

▪ Broad Channel Access

▪ Latest Technology and Innovation

▪ Passionate and Dedicated People

19

Growing Global Presence Across Transplantation Labs

RegionTransplant HLA Labs

CareDx Penetration

Europe 300 80%

North America 200 79%

Rest of World 475 10%

TOTAL 975 46%

Page 20: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Building a Moat in Transplant Care

AlloSure/AlloMap Customers

Product Customers

Digital Customers

Total US Transplant Centers

K-OARCenters

Source: OPTN database, internal analyses

Strategy

▪ Transplant Center Focused

▪ Multiple Touch Points (Village Concept)

▪ Pan-Organ Offerings

Approach

▪ Based on Clinical Evidence

▪ Tailored to Center Workflow

▪ Improving Patient Care

▪ Advancing Science

20

Page 21: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

60% Revenue Growth in Q3 2019

21

16.8

4.2

21.228.2

4.2

33.8

Total

1.4

Testing Services Products Digital & Other

+68%

-1%

+60%2018A 2019A

Test 2018A 2019A YoY%

Heart 4,080 4,726 16%

Kidney 3,708 8,524 130%

Q3 Patient Results

Q3 Revenue ($ millions)

Page 22: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

22

Non-GAAP* Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019

* See Appendix for non-GAAP reconciliation

($ millions)

Fifth Consecutive Profitable Quarter in Q3 2019

Total Revenue 21.2 23.5 26.0 31.5

Gross Margin % 61% 59% 67% 67%

Operating Expense 13.0 13.5 16.1 21.3

Adjusted EBITDA 0.2 0.8 1.8 0.1

Operating Cash Flow 0.4 2.0 (5.9) 3.6

33.8

69%

23.2

0.8

0.6

Page 23: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Strong, Debt-Free Balance Sheet

23

Cash & Debt at 9/30/19$ millions

Cash & Cash Equivalents 40.9

Debt -

Common Stock at 9/30/19# millions

Outstanding Common Stock 42.4

Stock Options / RSUs 4.2

Warrants 0.4

Fully Diluted Common Stock 47.0

Page 24: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

FY 2019 Revenue Guidance

24

2018

$124m-$125m

>100%

>10%

~20%

• 50 Center Penetration• KOAR Registry• OKRA Registry

• HeartCare Protocol• SHORE Registry

• NGS Launches• QTYPE adoption

2019

$77m AlloSureKidney

AlloMapHeart

Products

Growth Drivers

Digital $4m - $5m• OTTR Acquisition• Xyn Acquisition

Revenue

Page 25: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

OUR VISIONThe Leading Partner forTransplant Patients andThe Transplant Ecosystem

OUR MISSIONWe are committed to improving Transplant Patient Outcomes by providing Innovative and Intelligent Solutions throughoutthe entire Patient Journey

25

Page 26: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Appendix

26

Page 27: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Use of Non-GAAP Financial Measures

27

$ millionCareDx has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP net income, non-GAAP net loss, non-GAAP basic and diluted net income and net loss per share and adjusted EBITDA. We define non-GAAP net income and non-GAAP net loss and per share results as the GAAP net income or loss and per share results excluding the impacts of stock-based compensation; changes in estimated fair value of warrants, derivative liabilities and contingent consideration; acquisition related impairment charges and amortization of intangible assets, purchase accounting adjustments and related tax effects; costs involved with completing an acquisition; amortization of debt discount; and certain other financing charges. We define adjusted EBITDA as non-GAAP net income/(loss) before net interest expense, income tax expense, depreciation and amortization, other expense, and net loss attributable to noncontrolling interest. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx's operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly-titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables.

Page 28: Corporate Presentation - CareDx · Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives

Reconciliation of Non-GAAP Financial Measures

28

Q32018

Q42018

Q12019

Q22019

Q32019

GAAP Net Loss (20.0) (3.8) (7.5) (7.8) (1.8)

Stock-based compensation expense 1.9 2.1 6.1 5.0 6.0Acquisition-related amortization of purchased intangibles 0.8 0.7 0.7 0.8 0.9Acquisition related fees and expenses - - - 0.6 0.1Change in estimated fair value of contingent consideration - - - - -Amortization of debt discount 0.1 0.0 - - -Debt financing related fees and expenses - 3.0 - - -Change in estimated fair value of warrant & derivative liabilities 17.1 (1.6) 3.0 1.4 (4.3)Other financing charges - - - - 0.2Tax effect related to amortization of purchased intangibles (0.4) (0.2) (0.1) (0.1) (0.1)Impairment - - - 0.2 -

Non–GAAP Net Income (Loss) (0.6) 0.3 2.2 (0.1) 0.9

Interest (income) expenseIncome tax (benefit) expenseDepreciation expenseOther expense

0.30.10.30.0

0.1(0.1)0.40.1

(0.3)(0.5)0.40.1

(0.3)(0.1)0.40.2

(0.0)(0.8)0.40.4

Adjusted EBITDA 0.2 0.8 1.8 0.1 0.8

$ million