the allo transplantation company

The Allo-Transplantation Company Focused on better outcomes - PowerPoint PPT Presentation

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

  1. 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

  2. Safe Harbor Statement 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

  3. Our Vision The le Th lead adin ing par artner for the tran ansplan lant ecosystem Our Mission We are committed to improving long-te We term ou outcom omes by providing innovative sol olution ons throughout th t th the enti tire tr transplant t pati tient t journey

  4. Industry Leadership Position and Continued Growth Industry Leading Strong Robust Strong Leading Medicare Clinical End-stage Financial Products & Services Reimbursement Data Pipeline Position Expanding $10B+ market opportunity 4

  5. Multiple Touchpoints Along Patient Journey Pre-Transplant Post-Transplant Surveillance Waitlist High Resolution “Liquid Biopsy” Augmented Intel Gene Expression cfDNA Management HLA matching dd-cfDNA Risk Prediction Profiling Cell Therapy Electronic Medical Records >60 Transplant Centers >30 Transplant Centers Quality Management Clinical Studies >75 Transplant Centers New 5

  6. Leveraging Business Development to Establish Leadership in Transplantation Acquisitions First Pre-transplant First HLA target Entry into dd-cfDNA HLA testing & capture digital technology in international sequencing transplant transplant expansion technology tools 2014 2018 2019 2015 2016 2017 2020 Partnerships / Collaborations First Global rights to First Expansion dd-cfDNA NGS products in validated of multi-modality technology in bone marrow & transplant AI offerings with transplant solid organ as part of iBox HistoMap & UroMap transplant 6

  7. CareDx’s Growth Story Platform Multi-Product Single Product All Transplant Services, Products & Digital • Solid Organ Transplant Global Medical Institutions • Sequencing based • Ecosystem Partnerships • Multi-modality Testing • Heart Transplant Patient Engagement • US Transplant Centers • Gene Expression Profiling • TAM: $10 bn • TAM: $2.5B • TAM: $150M • 7

  8. KIDNEY TRANSPLANT PATIENTS Leading science with the lowest Clinically validated testing protocol limit of detection, now at 0.12% 15 Planned Surveillance Tests Post-Transplant $2,840 CMS reimbursement 1 2 3 4 5 6 7 8 9 10 11 12 coverage for 70% - 80% of patients Year 1 Stratifies patients with T-cell mediated rejection Year 2 Efficient care with only one tube of Year 3 blood required 8

  9. HEART TRANSPLANT PATIENTS Non-invasive gene expression Clinically validated / FDA approved profile test of peripheral blood AlloMap Patient Results (in Thousands) Detects changes in gene expression associated with acute rejection Used by over 90% of US transplant centers 19 16 15 14 13 12 10 8 8 7 $3,240 CMS reimbursement/ 6 covered by most private payers 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 9

  10. CareDx is the Leading Partner Across US Transplant Centers KIDNEY HEART OTHER ORGANS Deep 70%+ 90%+ 20+ Center Centers Using AlloSure Centers Using AlloMap Centers Using AlloSure Lung Penetration 70+ 40+ 20+ Clinical Partnerships KOAR/OKRA Centers SHORE Centers Investigator Initiated Trials >40 50% High Impact Leadership Indicators Named Center Protocols Newly Transplanted Patients Publications Note: Center penetration based on UNOS listed transplant centers as of Q1 2020; does not include non-transplant hospitals. 10

  11. Adapting to COVID-19 World Home Based Blood Draws for Full Blood Workup/Surveillance Transplant Patient Patient Care Mobile Field Lab Centers Consent Manager Network Support Broad Accelerated Rapid Created national Established customer interest structure uptake phlebotomy excellence group > 150 > 3K 40+ Hired > 10K in Combined Patient Facing Centers Patients in 3 Weeks Network Employees 11

  12. Building a MOAT Around Each Center “The Only 100% Transplant Focused Company ” Transplant Medical Community Account Science 1 4 SOLID ORGAN Nephrology Team Manager (TAM) Liaison (MSL) TRANSPLANT CENTERS EMR Solutions RemoTraC 2 5 Phlebotomy Transplant Patient Care TRANSPLANT Field Lab 3 6 Coordinator Management ECO-SYSTEM Service Team Assistants Team 12

  13. Latest Innovation Transplant Care: Multi-Modality Surveillance Latest Innovation 2020 Additions Gene Expression/Urine • Developed by Cornell • Gene expression for acute cellular rejection Machine learning Gene Expression Donor-derived Cell-free DNA Profiling (GEP) Transplant Data Analytics (dd-cfDNA) Graft Injury Graft Prognosis Immune Activity Gene Expression/Tissue • 95% NPV • Validated Prognostic algorithm • Developed by Banff • Leveraged FDA cleared panel • 89% PPV ABMR (AS+DSA) • Published validation cohort • Identify rejection in issue • Dynamic gene expression • Only dd-cfDNA to discriminate (>7k patients) • Improved work-flow, approach ambiguous rejections reproducible 13

  14. Strategic Investments in Clinical Development Start Name Impact Centers Patients Samples 2020 c19txr Long-term COVID Transplant Outcomes >30 >1000* N/A Large 2019 OKRA Long-term Kidney Transplant Outcomes >50 >1500 >8,000 Multi-Center 2018 SHORE Long-term Heart Transplant Outcomes >50 >3000 >8,000 Clinical Studies 2018 K-OAR Long-term Kidney Transplant Outcomes >50 >1500 >8,000 2015 DART Validation AlloSure Kidney Transplant 14 400 2,100 > 40 Investigator Initiated Trial Program Transplant Centers > 40 Grant Support incl. Societies Transplant Investigators 14 * Expected final enrollment

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