Slides
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Click to edit Master text styles Click to edit Master title style •J A N U A R Y 1 4 , 2 0 2 5 The Transplant Solutions Company Patrick G, Kidney Transplant Recipient
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Safe Harbor Statement 2 These slides and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this presentation, including statements regarding the future financial position of CareDx®, Inc. (together with its subsidiaries, “CareDx” or the “Company”), including financial targets and expectations, business strategy, and plans and objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "target," "contemplate," "predict," "expect," and the negative and plural forms of these words and similar expressions are intended to identify that CareDx has based these forward-looking statements on its own estimates and assumptions and its current expectations and projections about future events. These slides and the accompanying oral presentation include forward-looking statements, including expectations regarding CareDx's fourth quarter and full year 2024 revenue, other fourth quarter and full year 2024 GAAP and non-GAAP results, number of patient results, and cash, cash equivalents, and marketable securities as of December 31, 2024, achievement of its financial and operational goals, its prospects in 2025, and its 2027 revenue and adjusted EBITDA targets. 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 for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (the "SEC") on February 28, 2024, the Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024, filed with the SEC on May 9, 2024, the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024, filed with the SEC on July 31, 2024, and the Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024, filed with the SEC on November 4, 2024. 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 .Further information regarding our non-GAAP financial measures can be found in our filings with the SEC. 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.
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Experienced Executive Leadership to Drive Profitable Growth 3 650 CareDx Employees Globally Headquartered in South San Francisco & Stockholm 110 Scientists & Researchers Building the Next Innovations in Transplant Commercial Employees Supporting our Customers and Patients 80 Software Programmers Building Our Digital Solutions 180 Kashif Rathore Chief Technology Officer Robert Woodward, PhD Chief Scientific Officer Keith Kennedy Chief Operating Officer Stacey Follon Head of Human Resources Marica Grskovic, PhD Chief Strategy Officer John Hanna President & CEO Abhishek Jain Chief Financial Officer Jeff Novack, JD General Counsel Chris Cisar Vice President, Market Access Jing Huang, PhD Chief Data and AI Officer Jessica Meng Chief Commercial Officer Anna Czene Vice President, Corporate Communications
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CareDx is the Established Solutions Provider to Transplant Centers Sources: CareDx Data On File. Transplant Services Market: Bentley, S. 2020 U.S. Organ and Tissue Transplants: Cost Estimates, Discussion, and Emerging Issues. Milliman Research Report; OPTN National Transplant Data. Accessed Oct. 8, 2024. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data 4 ~1M Rejection Monitoring Tests Performed ~200K HLA Typing Kits Sold Annually 70% Centers Use One Or More Software Products 150K Rx Filled Annually by Transplant Pharmacy $50B Transplant Services Market 46K Transplants Annually
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CareDx Q4 2024 Preliminary Financial Highlights 5 REVENUE $85-$86 million ~30% increase TESTING VOLUME ~45,500 14% increase ADJUSTED EBITDA $8-$9 million gain ~$19 million gain CASH BALANCE $261 million +$26 million Q4 2024 YEAR- OVER-YEAR Please refer to GAAP to non-GAAP reconciliation for further details in the Appendix. The preliminary financial information for Q4 2024 is based on CareDx's current expectations and may be adjusted as a result of, among other things, the completion of customary annual audit procedures.
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Achieved Sixth Consecutive Quarter of Testing Services Volume Growth Across All Organs 1. Drop in Testing Services volume from Q1 2023 to Q2 2023 due to the impact of Billing Article introduced in March 2023. 6 49.9k Q1 20231 37.5k Q2 2023 38.4k Q3 2023 39.9k Q4 2023 42.1k Q1 2024 43.7k Q2 2024 44.6k Q3 2024 45.5k Q4 2024 +14%+14%
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Building Blocks of Growth 7 PRODUCT PIPELINE PATIENT ADHERENCE CUSTOMER ADOPTION 4 3 2 TRANSPLANT VOLUME1
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Forces Driving Transplant Volume Growth 1 T RANS P L ANT VO LU ME 8 IOTA Model Increasing Organ Transplant Access Growing government efforts are working to expand transplantation access Technological advances are improving organ viability 12% Lung Transplant Annual Growth 11% Heart Transplant Annual Growth 7% Kidney Transplant Annual Growth Sources: OPTN National Transplant Data. Annual Growth from 2022 to 2023. Accessed October 8, 2024. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
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ORGAN MATCHING/WAIT LISTING LAB PRODUCTS TRANSPLANT CENTER PATIENT DX & SOLUTIONS ▪ HLA Typing ▪ Lab Management Software ▪ Waitlist Management ▪ Transplant EMR ▪ Quality Reporting ▪ Staff Augmentation ▪ Remote Monitoring ▪ Graft Health Assessment ▪ Tissue Diagnosis SOLUTIONS ACROSS PATIENT JOURNEY CARE QUALITY/SYSTEM EFFICACY GRAFT HEALTH Synergistic Portfolio Drives Customer Adoption 2 CU STO M ER A DO P TI O N 9
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Multi-Solution Accounts Generate 2x Testing Services Revenue 29% Average new transplant patient acquisitionfor testing $600K Average transplant center revenue from testing Accounts that have 3or more CareDx solutions have higher average patient acquisition, 2x the absolute testing volume increase and, ultimately, 2x the testing services revenue <3 SOLUTIONS 44% Average new transplant patient acquisition for testing $1.2M Average transplant center revenue from testing 3+ SOLUTIONS 2x 2 CU STO M ER A DO P TI O N Source: CareDx internal data estimates. 10
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K I D N E Y S L U N G S H E A R T 7 10 CURRENT number of tests/patient in first 3 years 24 15 20 PROTOCOL-DRIVEN number of tests/patient in first 3 years 38 Opportunity to Improve Patient Adherence 3 PAT I EN T AD H ER ENC E Sources: Protocol calculations based on: Heart HARTS protocol is11, 4, 4; Kidney ARTS protocol is 7, 4, 4; and Lung ALRTS protocol is 12, 4, 4; Testing frequency is always subject to the treating physician’s individualized determination of medical necessity; CareDx internal data estimates. 11
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Pipeline Fuels Additional Growth for Testing Services 4 P RO D UC T PIP EL INE 12 Launch New Dx for use with AlloSure Kidney AlloSure Heart PEDS AlloSure SPK 2 0 2 5 2 0 2 6 HistoMap Kidney Diagnoses rejection subtype in patients with elevated AlloSure UroMap Complements AlloSure in the management of BK virus AlloMap Kidney Gene-expression profiling combined with AlloSure enhances risk stratification Expanded Indications
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H I G H M A R K BLU E S POLICY: Positive coverage for AlloSure Kidney STUDY: AlloSure Kidney Nature Medicine Launched 2006 / Medicare Coverage 2006 Launched 2018 / Medicare Coverage 2020 Launched 2017 / Medicare Coverage 2017 Launched 2021 / Medicare Coverage 2023 Evidence Strategy Drives Coverage Growth Sources: Percent of CareDx submitted claimsthat are covered by Medicare and Commercial medical policy. Data on file; Khush et al., J Heart Lung Transplant. 2024. doi:10.1016/j.healun.2024.05.003; Aubert et al., Nat Med. 2024. doi:10.1038/s41591-024- 03087-3. ~90% AlloMap Heart Covered Lives ~40% AlloSure Heart Covered Lives ~60% AlloSure Kidney Covered Lives ~30% AlloSure Lung Covered Lives B C BS F E D E R A L E M P LO Y E E S POLICY: Positive coverage for AlloSure Heart STUDY: HeartCare SHORE data, J Heart Lung Transplant 13
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Continuing to Build Evidence for Transplant Monitoring Assays 14 SHORE ALAMO KOAR OKRA LU NG HEA RT K IDNEY PRIMARY STUDYGENERATING EVIDENCE ▪ Surveillance Outcomes ▪ Subclinical Rejection ▪ All Transplant Coverage ▪ Procedure Decision Making ▪ Treating Subclinical Rejection ▪ 3-year Survival ▪ Pediatrics Validation ▪ 5-year Survival ▪ Directing Therapeutic Treatment ▪ >2,700 patients ▪ 5-year follow-up ▪ 67 sites, HARTS protocol ▪ >3,600 patients ▪ 3-year follow-up ▪ 56 sites, ARTS protocol ▪ 500 patients ▪ 5-year follow-up ▪ 19 sites, ALRTS protocol STUDY COMPOSITION ACROBAT ▪ 307 patients ▪ 2-year follow-up ▪ 11 sites ▪ Predict Post-Transplant Relapse ▪ Surveillance Outcomes ▪ Treatment ResponseC ELL THERA PY
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Capital Allocation ▪ M&A ▪ Invest in Core ▪ Share Buyback Profitable Growth Profits And Cash 15% 3-Year Revenue CAGR T arget >70% 2027 Gross Margin Target 20% 2027 Adjusted EBITDA Target +$100M 3-Year Incremental Cash Target $500M 2027 Revenue Target Charting aPath to Profitable Growth and Strategic Capital Allocation 15 2027 FINANCIAL TARGETS Revenue 2025 GUIDANCE $370M
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Building Blocks for Growth 16 Net Revenue$332 - $333M $500M ~5% ~7% ~3% ~1% TRANSPLANT PROCEDURES CUSTOMER ADOPTION & PATIENT ADHERENCE PIPELINE AVERAGE SELLING PRICE (ASP) 2024 TOTAL REVENUE 2027 TOTAL REVENUE Source: 2024 preliminary financial results; CareDx internal targets. Data on file. Testing frequency per patient is always subject to the treating physician’s individualized determination of medical necessity.
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Opportunities in Transplant-Adjacent Areas 17 Autoimmune Disorders Cardiovascular Disease Lung Disease Hematology Disorders PRE -TRANSPLANT Infectious Disease Cancer Therapeutic Selection POST -TRANSPLANT Solid Organ Transplant Cell Therapy
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Expanding Into Cell Therapy Monitoring 18 220 Hematopoietic and bone marrow transplant centers 5,600 Autologous and allogeneic cell therapy registered clinical trials globally Cell Transplant: Hematopoietic Stem Cell and Bone Marrow Transplants Immune Cell Therapy: Engineered (CAR-T, CAR-NK) and Non-Engineered (TCR-T, NK) 70% Cancer (Blood and Solid Tumors) 148 Accredited cell therapy centers 10% Autoimmune Disorders 20% Other (e.g., Diabetes, Viral) Sources: Estimated numbers. www.nmdp.org/what-we-do/partnerships/global-transplant-network/transplant-center-directory. https://accredited.factglobal.org/?_sft_category=cellular-therapy&_sft_country=usa&_sft_clinical=immune-effector-cellular- therapy. Nature Reviews May 2024 doi.org/10.1038/d41573-024-00094-4. Accessed online November 15, 2024.
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Two Products Addressing Critical Unmet Need 19 Time After Hematopoietic Stem Cell Transplantation SOC Relapse Detection Earlier Relapse Prediction Standard of Care AlloHeme No Relapse Number of Cancer Cells ALLOHEME DETECTS CANCER RELAPSE POST-CELL TRANSPLANT Analyzes cells in blood % Cell Product Standardized Pharmacokinetics (PK) Assessment Infusion 2 weeks Months/years Expansion Contraction Persistence ALLOCELL MONITORS IMMUNE CELL THERAPY PHARMACOKINETICS Universal assay based on DNA differences between cell therapy product and patient Sources: The Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting poster presentation. Tandem Meetings. Transplantation and Cellular Therapy Meeting 2024. Oral Presentation.
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PUT IN PLACE THE RIGHT TEAM IDENTIFIED THE MARKET OPPORTUNITIES LAUNCHING INNOVATIVE SOLUTIONS TO RESOLVE UNMET MEDICAL NEEDS Activating Our Strategy 20
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Click to edit Master text styles Click to edit Master title style INVESTOR RELATIONS Caroline Corner investor@caredx.com MEDIA RELATIONS Anna Czene aczene@caredx.com CORPORATE HQ 8000 Marina Blvd, Brisbane, CA 94005 C O N TA C T U S The Transplant Solutions Company Kristin J, Stem Cell and Double Lung Recipient
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Appendix 22
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Preliminary Reconciliation – Estimated GAAP Net Loss to Adjusted EBITDA Profit 23