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Maxine Moir Kidney Transplant Recipient June 2019 Corporate Presentation 27, 2019

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Page 1: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Maxine MoirKidney Transplant Recipient

June 2019

Corporate Presentation

27, 2019

Page 2: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

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: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

OUR VISIONThe Leading Partner forTransplant Patients andThe Transplant Ecosystem

OUR MISSIONWe are committed toImproving transplant Patient outcomes throughInnovative, non-invasiveTesting solutions throughoutThe entire patient journey.

3

Page 4: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

CareDx Highlights

4

Leader in Transplant Molecular Diagnostics

Revenue Growth Accelerates Path to Profitability

Transformational AlloSure Launch

Products across continuum of transplant diagnostics

AlloMap used in 90% of heart transplant centers

Leadership position in cell free DNA (“Liquid Bx”)

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

Used in +100 centers and on 4% of U.S. kidney transplant patients since launch

Leverage existing AlloMap presence to scale in a highly capital efficient manner

Genomic Information and Artificial Intelligence Drives Future Opportunity Product portfolio expansion with pre- and post-transplant solutions

Building platform for Artificial Intelligence in Transplant Care (AiTraC)

Outcome orientation along the transplant patient journey

85% revenue growth in Q1 2019, FY revenue guidance raised to $113m to $115m

Achieved third consecutive quarter of adjusted EBITDA profitability

Strong, debt free balance sheet

Page 5: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

2019 Highlights

5

• AlloSure Launch Progress >4% TAM Kidney Tx

• KOAR > 1000 patients enrolled

• KidneyCare and HeartCare advanced

• OTTR acquisition, iBox addition

• AlloSeq cfDNA Early Access exUS started

Page 6: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Robert WoodwardVP, Research &

Development

XDx, Gladstone Institute,

UC San Francisco

Mike DonnellVP, Transplant

Software 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, Laboratory

Solutions Business

BioGraph 55, Novartis,

Celera

Ardelyx, AstraZeneca /

Medimmune, Organon

BioSciences, Boehringer

6

Page 7: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Better Matching + Better Surveillance=

Better Outcomes

7

Page 8: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

CareDx – 20 Years of Focus on Transplantation

Evolution during last 5 years to deliver on Vision

2014 2019

AlloMap Business

Building dd-cfDNA technology platform (ImmuMetrix)

Acquired pre-transplant business (Allenex)

Acquired ex-Conexio / Illumina SBT

License NGS Tx- Portfolio (Illumina)

Launched AlloSure first dd-cfDNA

Leader Heart Tx

TODAY

Pre-TxBusiness

LeaderRenal Tx

Pipeline / Platform

Global Operations

TransplantLeader

Launched QTYPE (PCR HLA)

Launched Heartcare (via SHORE)

8

Page 9: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Ongoing Unmet Needs in Transplantation

9

Transplant Post TransplantEnd stage disease

Availability of Organs

Donor identification and qualification

Waitlist management

Lifelong Immunosuppression- Rejection- Infection- Function

Services & Products to ensure personalization and surveillance, partnering with centers and clinicians

Quality of Match

Quality of Care

Typing Products with right resolution and turnaround time in transplant centers

Organ Shortage Organ Matching Precision & Compliance

Longitudinal Data Management

Page 10: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

CareDx Focuses on Long-Term Outcomes

10

10

Source: Team Analysis

Current Survival

Future Survival

Years

13

Complianceand

Adherence

Standardization and

Personalization

ImmunoModulation

Page 11: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Laying Foundation to Lead in Patient Care Management Evolution during next 12 months for longitudinal and long-term patient management

Launched HeartCare and AlloSure Lung

Launch Kidney Care (AlloSure, AlloMap, and i-BOX)

Partner for i-BOX Technology, first step towards Artificial Intelligence

Acquired OTTR with bioinformatics capabilities

Launch AlloSeq BMT- new technology for this field

Launch AlloSeq Tx17- next leap forward in NGS HLA Typing

Leader Heart

Today

LeaderRenal Tx

Leader HLA Typing

Pipeline / Platform

Global Operations

New platform partnerships

New pipeline programs- Tx specific

Expand ex-US offerings (e.g. AlloSeq cfDNA)

Launch new global offerings (e.g. AlloSeq BMT)

Leader in Kidney, Heart and Lung Tx

2019+

Leader in 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

11

Page 12: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

MarketGlobal HLA Typing

ProductsUS Heart Transplant Surveillance Services

US Kidney Transplant Surveillance Services

Annual Volume3 million

HLA Typings2,600 Transplants20,000 Patients

18,000 Transplants200,000 Patients

Targets1000 Labs150 (US)

130 Centers(50 centers = 70%)

250 Centers(100 centers = 80%)

Testing5 typings

per transplantYear 1: 6-8 tests*Year >1: 2-4 tests

Year 1: 7 tests** Year >1: 4 tests**

TAM $500 million $150 million > $2 billion

12

*SHORE registry will be monthly testing; **ARTS protocol at time of launch and as part of KOAR registry. Source: Company estimates

Focused on Large Addressable Markets in Transplantation

KidneyCare

Page 13: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

CareDx – Your Dedicated Partner in Transplant Care

Heart

Kidney

Lung

BMT

TestingService

Surveillance Products

TBD

Assign

Score6

TypingProducts

SoftwareSolutions

AlloSeq® Tx 17

AlloSeq® HLA

AlloMap Variability Score

2019 Plan

2019 New

2019 Coming

13

Page 14: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Strategic Advantage From Multi-Center Clinical Studies

Clinical Validity/Utility

Start Study Impact Centers Patients Samples

2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000

2018 K-OAR Long-term Kidney Transplant Outcomes >50 > 1,000 > 8,000

2015 DART Validation AlloSure Kidney Transplant 14 400 2,100

2014 D-OAR Validation of HeartCare 28 >1,000 > 3,000

2005 CARGOII AlloMap validation in Heart (EU) 13 741 7,600

2004 LARGO AlloMap validation in Lung 14 >2000 >8500

2001 CARGO AlloMap validation in Heart (US) 8 >600 >4900

14

Page 15: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

15

Near-Term Opportunities to Expand Addressable Market

• Offer surveillance solutions outside US• Launch in 2019

• Enter global Bone Marrow Transplantation• Launch in 2019

• Includes AlloSure, AlloMap, and iBox• Launch at ATC 2019

• Provide a best in class NGS HLA solution • Launch in 2019AlloSeq® Tx 17

AlloSeq® cfDNA

AlloSeq® BMT

KidneyCare

Page 16: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

AlloSure Launch Metrics

16

Launch MetricsQ4

2017Q1

2018Q2

2018Q3

2018Q4

2018Q1

2019

Patient (Pt) Results (in qtr) 282 1,051 2,300 3,708 4,575 5,710

Unique Pts Tested (in qtr) 250 842 1,723 2,829 3,377 4,284

Ordering Centers cumulative (cum) 32 52 76 96 - -

Ordering Centers (in qtr) - - - - 100 101

KOAR Enrolled Centers (cum) 0 12 27 40 47 50

KOAR Enrolled Pts (cum) 0 63 237 480 748 1,006

Surveillance MetricsQ4

2017Q1

2018Q2

2018Q3

2018At

12/31/18At

3/31/19

New Standing Order Pts (in qtr) 115 568 793 1,260 - -

Current Surveillance Pts - - - - 3,190 3,644

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

Page 17: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Our 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

17

Page 18: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Gene Expression Profiling (GEP)

Immune Activity

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

Graft Injury

Multi-Modality Testing

18

Machine learning algorithm

Graft Survival Prognostic

iBox

Page 19: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Transforming Transplant Patient Care

OTTR

19

Page 20: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

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

Source: Company estimates

20

Growing Global Presence Across Transplant HLA Labs

RegionTransplant HLA Labs

CareDx Penetration

Europe 300 80%

North America 200 79%

Rest of World 475 10%

TOTAL 975 46%

Page 21: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Building a Moat in Transplant Care

AlloSure/AlloMap Customers

HLA Typing Customers

OTTR 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

21

Page 22: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

85% Revenue Growth in Q1 2019

22

3.3

10.614.1

4.4

21.5

26.0

Testing Services TotalProducts

+34%

+103%

+85%

20192018

Test Q1 2018 Q1 2019 YoY%

AlloMap 3,847 4,280 11%

AlloSure 1,051 5,710 NM

Q1 Test Volume

Q1 Revenue ($ millions)

Page 23: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Third Consecutive Profitable Quarter in Q1 2019

23

Non-GAAP*Q1

2018 Q2

2018Q3

2018Q4

2018Q1

2019

Total Revenue 14.1 17.8 21.2 23.5 26.0

Gross Margin 60% 63% 61% 59% 67%

Adjusted EBITDA (3.2) (0.8) 0.2 0.8 1.8

Adjusted EBITDA Margin -23% -4% 1% 3% 7%

$ millions

* See Appendix for non-GAAP reconciliation

Page 24: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Significant Operating Leverage Potential at Scale

24

$ millions

Non-GAAP Targets*Q1 2019

Annualized Run Rate

Target “At Scale”

Total Revenue 104 200

Gross Margin 67% 70%

Adjusted EBITDA 7 50

Adjusted EBITDA Margin 7% 25%

* See Appendix for non-GAAP reconciliation

Page 25: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Strong, Debt-Free Balance Sheet

25

Cash & Debt$ millions

At 3/31/19*

Cash & Cash Equivalents 57.4

Debt -

Common Stock at 3/31/19# millions

Outstanding Common Stock 41.9

Stock Options / RSUs 3.6

Warrants 0.5

Fully Diluted Common Stock 46.0

*Excludes ~$16m cash paid for OTTR acquisition on 5/7/19

Page 26: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Revised 2019 Revenue Guidance

26

2018

$113m-$115m

>100%

Mid-singledigit

>20%

• 50 Center Penetration• KOAR Registry

• HeartCare Protocol• SHORE Registry

• NGS Launches• QTYPE adoption

2019

$77m AlloSure

AlloMap

Products

Growth Drivers

Software $4m - $6m • OTTR Acquisition

Revenue

Page 27: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

OUR VISIONThe Leading Partner forTransplant Patients andThe Transplant Ecosystem

OUR MISSIONWe are committed toImproving transplant Patient outcomes throughInnovative, non-invasiveTesting solutions throughoutThe entire patient journey.

27

Page 28: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Appendix

28

Page 29: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Use of Non-GAAP Financial Measures

29

$ millionCareDx has presented in this presentation certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including adjusted EBITDA and adjusted EBITDA margin. 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 define adjusted EBITDA margin as adjusted EBITDA as a percentage of total revenue. 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’soperating 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 this slide.

Page 30: Jefferies - Corporate Presentation...Utility Start Study Impact Centers Patients Samples 2018 SHORE Long-term Heart Transplant Outcomes >30 > 1000 > 8,000 2018 K-OAR Long-term Kidney

Reconciliation of Non-GAAP Financial Measures

30

Q1 2018

Q2 2018

Q32018

Q42018

Q12019

GAAP Net Loss (9.0) (4.1) (20.0) (3.8) (7.5)

Stock-based compensation expenseAcquisition-related amortization of purchased intangiblesChange in estimated fair value of contingent considerationAmortization of debt discountDebt financing related fees and expensesLoss on conversion from debt to equityChange in estimated fair value of warrant & derivative liabilitiesTax effect related to amortization of purchased intangiblesAcquisition-related amortization of inventory valuation adjustment

0.70.80.11.9-

2.8(1.3)(0.2)0.2

2.50.70.90.1

--

8.8-

0.0

1.90.7-

0.1--

17.1(0.4)0.0

2.10.7

-0.03.0

-(1.6)(0.2)0.0

6.10.7

----

3.0(0.1)(0.0)

Non–GAAP Net Income (Loss) (4.0) (1.1) (0.6) 0.3 2.2

Interest (income) expenseIncome tax (benefit) expenseDepreciation expenseOther expenseNet loss attributable to noncontrolling interest

0.8(0.2)0.30.0

-0.0

0.4(0.4)0.30.0-

0.30.10.30.1

-

0.1(0.1)0.40.1

-

(0.3)(0.5)0.40.1

-

Adjusted EBITDA (3.2) (0.8) 0.2 0.8 1.8

$ million