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The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant (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

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Page 1: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

The Allo-Transplantation CompanyFocused on better outcomes through personalized transplant surveillanceJune 2020

Allo-transplant (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 · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

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.

2

Safe Harbor Statement

Page 3: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Our MissionWe are committed to improving long-term outcomes by providing innovative solutions throughout the entire transplant patient journey

Our VisionThe leading partner for the transplant ecosystem

Page 4: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Industry Leadership Position and Continued Growth

4

Expanding $10B+ market opportunity

IndustryLeading

Products & Services

LeadingMedicare

Reimbursement

Strong Clinical

Data

RobustEnd-stage Pipeline

Strong Financial Position

Page 5: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

>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

Multiple Touchpoints Along Patient Journey

5New

Pre-Transplant Post-Transplant Surveillance

Page 6: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

6

Acqu

isiti

ons

Leveraging Business Development to Establish Leadership in Transplantation

Part

ners

hips

/

Colla

bora

tions

Pre-transplant HLA testing & international

expansion

Entry into digital

transplant tools

First dd-cfDNA

technology in transplant

First HLA target capture

sequencing technology

Global rights to NGS products in bone marrow &

solid organ transplant

First validated

transplant AI as part of iBox

2014 2015 2016 2017 2018 20202019

First dd-cfDNA

technology in transplant

Expansion of multi-modality

offerings with HistoMap & UroMap

Page 7: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

CareDx’s Growth Story

7

Multi-Product

Platform

Single Product

Heart Transplant• Gene Expression Profiling• TAM: $150M

Solid Organ Transplant• Sequencing based• Multi-modality Testing• US Transplant Centers• TAM: $2.5B

All Transplant• Services, Products & Digital• Global Medical Institutions• Ecosystem Partnerships• Patient Engagement• TAM: $10 bn

Page 8: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

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Clinically validated testing protocol

15 Planned Surveillance Tests Post-Transplant

1 2 3 4 5 6 7 8 9 10 11 12

Year 1

Year 2

Year 3

KIDNEY TRANSPLANT PATIENTS

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

Page 9: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

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Clinically validated / FDA approved

AlloMap Patient Results(in Thousands)

HEART TRANSPLANT PATIENTS

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 8 10 12 13 14 15 1619

20172012 2014 20162009 20152010 20132011 2018 2019

Page 10: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

CareDx is the Leading Partner Across US Transplant Centers

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Note: Center penetration based on UNOS listed transplant centers as of Q1 2020; does not include non-transplant hospitals.

Deep Center Penetration

ClinicalPartnerships

LeadershipIndicators

KIDNEY HEART OTHER ORGANS

70%+Centers Using AlloSure

90%+Centers Using AlloMap

20+Centers Using AlloSure Lung

70+KOAR/OKRA Centers

40+SHORE Centers

20+Investigator Initiated Trials

>40Named Center Protocols Newly Transplanted Patients

50%Publications

High Impact

Page 11: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Adapting to COVID-19 World

11

TransplantCenters

PatientConsent

Patient Care Manager

Mobile Network

Field LabSupport

Broad interest

Rapid uptake

Accelerated structure

Created national phlebotomy

Established customer excellence group

> 150 Centers

> 3K Patients

40+ Hiredin 3 Weeks

> 10K in Network

CombinedPatient Facing

Employees

Home Based Blood Draws for Full Blood Workup/Surveillance

Page 12: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Transplant CoordinatorAssistants

Transplant Account

Manager (TAM)

Medical Science

Liaison (MSL)

Building a MOAT Around Each Center

12

SOLID ORGANTRANSPLANT CENTERS

RemoTraCPhlebotomy

Field LabService Team

EMR Solutions

Community Nephrology Team

Patient Care Management

Team

TRANSPLANT ECO-SYSTEM

1

2

3

4

5

6

“The Only 100% Transplant Focused Company ”

Page 13: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Latest Innovation Transplant Care: Multi-Modality Surveillance

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

Machine learning Transplant Data Analytics

Gene Expression Profiling (GEP)

2020 Additions

Gene Expression/Urine

• Developed by Cornell• Gene expression for acute

cellular rejection

• 95% NPV• 89% PPV ABMR (AS+DSA)• Only dd-cfDNA to discriminate

ambiguous rejections

• Leveraged FDA cleared panel• Dynamic gene expression

approach

Graft Injury

• Validated Prognostic algorithm• Published validation cohort

(>7k patients)

Graft Prognosis Immune Activity Gene Expression/Tissue

• Developed by Banff• Identify rejection in issue• Improved work-flow,

reproducible

13

Latest Innovation

Page 14: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Strategic Investments in Clinical Development

14

Start Name Impact Centers Patients Samples

2020 c19txr Long-term COVID Transplant Outcomes >30 >1000* N/A

2019 OKRA Long-term Kidney Transplant Outcomes >50 >1500 >8,000

2018 SHORE Long-term Heart Transplant Outcomes >50 >3000 >8,000

2018 K-OAR Long-term Kidney Transplant Outcomes >50 >1500 >8,000

2015 DART Validation AlloSure Kidney Transplant 14 400 2,100

> 40Transplant Centers

> 40Transplant

Investigators

Large Multi-Center Clinical Studies

Investigator Initiated Trial Program

Grant Supportincl. Societies

* Expected final enrollment

Page 15: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

New: Surveillance for Allogeneic Engineered Cell Transplantation

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Cell TherapyPatient Monitoring

Cell TherapyAddressable market

• 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

• > 300,000 patients…• …receiving ~1.2 treatments

annually…• …with ~7 tests per

treatment

$5.5B+

C max

ContractionPersistence

Months/YearsInfusion

% C

ell P

rodu

ct

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.

Expansion

Page 16: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

AlloCell: Improving the Cell Transplant Treatment Paradigm

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• Therapies lack proactive, comprehensive matching and monitoring capabilities

– Opportunity to personalize cell therapy

• Different cell therapy approaches 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 in leading hospitals

– Scale and existing business/service models

• Ability to leverage…

– Existing patient, provider and payor relationships

– Transplant data/digital capabilities

AlloCell: Potential to Set Standard of CareCurrent Short Falls

Page 17: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

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Best-in-Class Sequencing Based Genetic Matching

Coverage includes classical and non-classical HLA

7.0MbDPB2

DPA2DPB1DPA1

DOA

DMADMB

Z

TAP1TAP2DOB

6.5MbDQB2DQA2DQB3

DQB1

DQA1 DRB1

DRB2

DRB3,DRB4,DRB5DRB8

DRB9DRA

6.0Mb

5.5Mb

5.0Mb

MICB

MICASB

C4.0Mb

3.5Mb

0MbHFE

Location unknown

Y

FVP

HG

TKUA

WJ

LN

EGene Resolution Coverage

HLA-A 4th field Full gene

HLA-B 4th field Full gene

HLA-C 4th field Full gene

HLA-E 4th field Full gene

HLA-F 4th field Full gene

HLA-G 4th field Full gene

HLA-H 4th field Full gene

DRB1 3rd field Full exon

DRB3/4/5 3rd field Full exon

DQA1 3rd field Full exon

DQB1 3rd field Full exon

DPA1 3rd field Full exon

DPB1 3rd field Full exon

MICA 2nd field Full exon

MICB 2nd field Full exon

Donor-Recipient 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 Mark May 2020

Page 18: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

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Digital Offerings: Transplant EMR & Patient App

Support EMR integration and testing protocol adherence

Transplant dedicated EMR based on Cerner platform

Growth from OttrSAAS, Ottr Bone Marrow and Cerner/VA implementation

Leading Transplant Patient Engagement

AITraCClinical Decision Support

Ottr 3.xElectronic Medical Records

XynQAPIQuality Management

XynCareWaitlist Management

AlloCarePatient Engagement App

“Tracy”Virtual Transplant Assistant

Transplant Data PlatformFoundational functionality for data exploration and insights creation

Provider Solutions Patient Solutions

Page 19: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Record Growth in FY 2019 with Strong Quarterly Momentum

19

13 14 16

28

49

2015 2016 2017 2018 2019

+77%

1015

Q1 2020

Q1 2019

+50%

$48$28

2015 20172016

$41

$127

$77

2018 2019

+66%

$38$26

Q1 2019

Q1 2020

+48%

Testing Services Patient Results(FYE-December; in Thousands)

Total Revenue(FYE-December; in Millions)

Page 20: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Testing Services Primarily Drives Revenue Growth

20

21.5

4.4

26.031.4

4.7

38.4

TOTALDigital & OtherTesting Services Products2.2

+46%

+6%

+48%

20202019

Q1 Revenue (In $ Millions)

Page 21: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Strong Pathway to Margin Improvement

21

2017 2018 Q1 2020

68%

2019

60%

Q1 2019

67%61%

71%

-$12

-$3

$4

2017 2018 2019

-$14

-$4 -$3

2017 2018 2019

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

Adjusted EBITDA(FYE-December; in Millions)

Net Operating Cash Flow(FYE-December; in Millions)

Page 22: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

CareDx’s Solutions Target Long-Term Outcomes

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Multi-Modality Approach

Current Survival

Future Survival

KIRA trial RemoTraC

AlloCare

AiTraC

Immuno-modulation

Complianceand

Adherence

Standardization and

Personalization

10 Years

13 YearsExamples of “How?”

Trailblazing Innovation• GEP• dd-cfDNA• Target Capture Sequencing• Augmented Intelligence

Fueling Transplant R&D • Multi-modality• Immunomodulation• Cellular Therapies

Defining Standards• dd-cfDNA Cut-off• Surveillance Protocol

Page 23: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Upcoming Growth Drivers Across Segments

Testing Services Transplant Products Digital Business

• “Going deep” in US Centers• Community Nephology Expansion

• Support Testing Services• Start VA Roll-out

• Launch Patient Engagement/App

• Global Launches• Asia Pacific Entry

Continued Adoption and Growth Global AlloSeq Launches Supporting Testing and Growth

23

• Pharma Partnerships

/ /

Page 24: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

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Appendix

Page 25: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Reconciliation of Non-GAAP Gross Margin

Revenue 48.3 76.6 127.1 26.0 38.4

GAAP Cost of Revenue 21.4 33.0 45.5 9.7 12.4 Stock-based compensation expense (0.2) (0.8) (2.2) (0.8) (0.4)

Acquisition related amortization of purchased intangibles (1.5) (2.2) (2.4) (0.5) (0.8)

Acquisition related amortization of inventory valuation adjustment (0.5) - - - -

Non-GAAP Cost of Revenue 19.2 30.0 40.8 8.5 11.2

Non-GAAP Gross Profit 29.1 46.6 86.3 17.5 27.1 Non-GAAP Gross Margin % 60% 61% 68% 67% 71%

in Millions FY 2019FY 2018FY 2017 Q1 2020

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Q1 2019

Page 26: The Allo-Transplantation Company · The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant(allo-meaning

Reconciliation of Adjusted EBITDA

GAAP Net Loss (55.5) (46.8) (22.0)Stock-based compensation expense 1.7 7.1 22.4 Acquisition related amortization of purchased intangibles 2.4 3.0 3.6 Acquisition related amortization of inventory valuation adjustment 0.5 0.3 -Acquisition related fees and expenses - - 0.7 Change in estimated fair value of contingent consideration 1.2 1.0 0.2 Change in estimated fair value of warrant & derivative liabilities 29.6 23.0 (0.3)Amortization of debt discount 2.1 2.1 -Debt extinguishment 0.3 3.0 -Loss on conversion from debt to equity 0.3 2.8 -Accretion of liability - - 0.3 Tax effect related to amortization of purchased intangibles (0.7) (0.8) (0.5)Impairment 2.0 - 0.2

Non–GAAP Net Income (Loss) (16.1) (5.3) 4.6 Interest income 3.8 1.6 (1.0)Income tax benefit (1.0) (0.6) (1.5)Depreciation expense 0.9 1.2 1.6 Other expense, net 0.9 0.2 0.4 Net loss attributable to noncontrolling interest (0.1) (0.0) -

Adjusted EBITDA (11.5) (3.0) 4.2

in Millions FY 2019FY 2018FY 2017

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