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March 2020 The Transplant Company Focused on better outcomes through personalized transplant surveillance.

The Transplant Company Focused on better outcomes through ... › wp-content › ... · SHORE – Surveillance HeartCare® Outcomes Registry. 14. Multicenter, prospective, observational

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Page 1: The Transplant Company Focused on better outcomes through ... › wp-content › ... · SHORE – Surveillance HeartCare® Outcomes Registry. 14. Multicenter, prospective, observational

March 2020

The Transplant Company

Focused on better outcomes through personalized transplant surveillance.

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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

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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.

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Multiple Touchpoints Along The Entire Patient Journey

ESRD Wait List

End State Disease Post Transplant Surveillance

OTTR EMR Longitudinal Patient Management (60 Transplant Centers)

Clinical Trials / Registry Studies (>50 Transplant Centers)

First in ClassLiquid BxAlloSure

InnovatorTissue GEPHistoMap

First in ClassAI Graft Survival

iBox

Clinical Trials

InnovatorBlood GEPAlloMap

Waitlist Management

Xyn

Best in ClassHLA matching

AlloSeq

5.500 Patients

80%Transplant Labs

8%US Patients

1st FPFVSept ‘19

XynQAPI Quality Management (30+ Transplant Centers)

1st FPFVSept ‘19

InDev

Transplant Surveillance

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Pipeline expansion addresses $4.5B+ market opportunity

5

CareDx Focused on Improving Transplant Patient Outcomes

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Transplantation is a Large and Growing Global Market

(1): https://journals.lww.com/transplantjournal/Abstract/2018/07001/Worldwide_distribution_of_solid_organ.119.aspxhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4889523/

(2): Average survival for US-based transplant patients (kidney, heart, lung, liver)(3): Company estimates

200,000Global transplants per year1 ~10 years

Patient survival post transplant2

>8% growthKidney transplant growth 20193

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$1B+

Business Lines Focused on $4.5B+ TAM Opportunity

*Kidney and Heart; ** Includes Kidney, Heart, HCTSource: company estimates

DIGITAL

U.S.

~300,000 Patients

150 Centers perform 90% of all transplants

Protocols & Surveillance

Global

1.5M Patients

1,000Labs & Centers

HLA Typing & Surveillance

Global

>3M Users

1,000 Centers & Ecosystem

EMR & Patient Engagement

SERVICES* PRODUCTS**

~$2.5B

7

$1B+

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8

Transplant Surveillance

Transplantation

End Stage Disease

Waitlist Management

Heart Transplant Patient Care

Transplant Patient Management & EMR SoftwareTransplant Quality Management Tools

HLA Typing Products

Organ Transplant Surveillance Products

Kidney Transplant Patient Care

Stem Cell Transplant Surveillance Products

Innovative Offerings Along the Transplant Patient Journey

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Multi-Modality Platform Drives Better Outcomes for Patients

Graft survival prognosis

Immune activity

Graft injury

Gene Expression Profiling(GEP)

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

Machine learning transplantdata analytics

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Both Kidney and Heart Services Are Significant Opportunities

1. Includes AlloMap Heart and AlloSure Heart2. Includes AlloSure Kidney, AlloMap Kidney and i-Box3. Based on Q4:19 services revenue

$3.1B

$0.9B

2

$0.5 B

$2.0 B

Total5% Penetration3

1

$2.5 B+

10% Penetration1

4% Penetration2

CareDx has created transplant surveillance market

…with multiple opportunities with new organ types

and entry into stem cell

transplant

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100% Dedicated Transplant Company Based on Clinical Science

14,000+Patients

9+Clinical Studies

25+Peer-reviewed publications

Landmark multi-center, prospective studies

Generated cutting edge & relevant clinical data

First to deliver GEPand cfDNA

First reimbursement with MolDx for transplant

Innovates on clinical experience with registries

Focused on transplant innovation & relationships

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Strategic Investment in Ongoing Large Multi-Center, Prospective Studies to Generate Future Data to Support Adoption

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

>50

>50

14

28

12

13

14

8

Patients

> 3600

> 1000

400

>1,000

629

783

>2000

>700

Samples

> 20,000

> 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

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OKRA – Long-Term Kidney Outcomes

13

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

1,500NEWLY TRANSPLANTED

1,500ENROLLED IN K-OAR

1,000CONTROL

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SHORE – Surveillance HeartCare® Outcomes Registry

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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 HeartCaresurveillance use

Year 3 post-transplant clinical follow-up for outcomeEstimated primary endpoint: 12/2024 | Estimated completion: 12/2027

3,600Patients

2,800NEWLY TRANSPLANTED

800CONTROL

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150Centers perform

90%of all transplants

Concentrated U.S. Market Enables Efficient Addition of New Services and Expansion into New Organs

Efficient commercial strategy

Leverageable model to include future offerings of1. New Organs2. Additional services3. Digital platform

Substantial transplant center overlap between organs

Fully staffed field organization

Further synergy with ecosystem and pre-transplant offerings

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LONG-TERM ( >12mo)MID-TERM (H2)SHORT-TERM (H1)

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Testing Services Drives Adoption and Growth

• > 150 centers• > 50 centers in registries (KOAR and OKRA)• > 30 protocols in Top 50 centers

• NEW reimbursement for additional Organs

• New Service offerings

• New Market (HCT)

• NEW Centers (U.S.)

• NEW Community Program

• > 100 centers• > 90 centers with protocol• > 50 centers in SHORE

• NEW Centers (U.S.)

• NEW AlloSure Heart reimbursement

• NEW Comprehensive service solutions (Xyn/OTTR/ Services)

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2020 AlloSeq Portfolio

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Products Business is Focused on Global Launches

• Ex-US launch (Sept 2019)• Achieved CE marking (Jan 2020) addressing the need of EU labs• Sales started/ Partnerships in new markets (e.g. China)

• Global Launch (Sept 2019), New and upgraded distributors • Sales started in all markets US, Europe and Asia• Expanded team for launch/ Partnerships in new markets (e.g. China)

• US Launch (Dec 2019) with global launch in Q1, 2020• Leverage of current field team and distributors• Service offerings in the future

Launch Execution

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2020 FocusDigital Portfolio

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Digital Business Focused on Support Testing Services and Growth

• Integrate & support Testing Services EMR with EPIC / Cerner• Leverage XynCare (Waitlist Management team) for Services business• Implement AlloSure - OTTR offering

• Increase accounts for XynQAPI and OTTR Products (SAAS)• Grow patients being managed on the waitlist• Comprehensive Services offerings

• AiTrac / decision support tools• Direct to patient engagement / patient support tools• Transplant data platform

Support Testing Services

IncreaseDigital Growth

Introduce New Offerings

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Fourth Quarter 2019 Non-GAAP* Financials

Q4 2019 Q4 2018

Total Revenue $35.8m $23.5m

Gross Margin 68% 59%

Operating Expense $23.1m $13.5m

Adjusted EBITDA $1.5m $0.8m

Earnings per Share $0.04 $0.01

Net Operating Cash Flow $(1.1)m $2.0m

Ending Cash Balance $38.2m $64.6m

* See Appendix for non-GAAP reconciliation

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52% Revenue Growth in Q4 2019

20

Q4 Revenue (in Millions)

$1.6

$18.9

TOTAL

$29.1

$4.6 $5.1

$23.5

$35.8

+55%

+10%

+52%2018 2019

DIGITAL & OTHERPRODUCTSTESTING SERVICES

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Record Growth in FY 2019

21

2016

$77

$41$28

20182015

$48

2017

$127

2019

+66%

Total Revenue(in Millions)

13 14 16

28

49

20162015 2017 2018 2019

+77%

Testing Services Patient Results(in Thousands)

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2018 2019

+30%

2019A 2020E

Total Revenue(in Millions)

FY 2020 Revenue Guidance

127

165to

168

Testing Services• AlloSure adoption/penetration• HeartCare surveillance protocol• AlloSure Heart reimbursement

Products• AlloSeq Tx & AlloSeq cfDNA launch• Global expansion• Stem cell & cell therapy

Digital• Full year revenue of acquisitions• AlloCare launch• Center adoption of solutions

Growth Opportunities

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The Transplant CompanyFocused on better outcomes through personalized transplant surveillance.

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Appendix

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Robert WoodwardVP, Research &Development

XDx, Gladstone Institute, UC San Francisco

Mike DonnellVP, TransplantDigital Business

United Resource Networks,Baylor and Keck Hospital

Reg SeetoPresident, CBO

Paul CiccolellaSenior Vice President,Operations

Pacific Biosciences, Affymetrix, ProtoGene Labs

David SayerVP, Global TransplantLaboratory Services

Experienced Management Team

Peter MaagChairman & CEO

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 CommercialOfficer

Genentech, Ariosa Diagnostics,Fletcher Spaght

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

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Reconciliation of Non-GAAP Financial Measures

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GAAP Net Loss (4.8) (3.8)Stock-based compensation expense 5.4 2.1Acquisition-related amortization of purchased intangibles 1.2 0.8Change in estimated fair value of contingent consideration 0.2 -Change in estimated fair value of warrant & derivative liabilities (0.3) (1.6)Amortization of debt discount - 0.0Debt extinguishment - 3.0Accretion of Liability 0.1 -Tax effect related to amortization of purchased intangibles (0.1) (0.2)

Non–GAAP Net Income (Loss) 1.6 0.3Interest income (0.3) 0.1Income tax benefit (0.0) (0.1)Depreciation expense 0.4 0.4Other income (expense), net (0.2) 0.1

Adjusted EBITDA 1.5 0.8

in Millions Q4 2019 Q4 2018