EX-99.2 3 d909876dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

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The Transplant Solutions Company•J A N U A R Y 1 3 , 2 0 2 5 Patrick G, Kidney Transplant Recipient


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Safe Harbor Statement 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.2


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Experienced Executive Lea o fi650 180CareDx Employees Globally Commercial Employees Headquartered in South Supporting our San Francisco & Stockholm Customers and Patients110 80Scientists & Researchers Software Programmers Building the Next Building Our Digital Innovations in Transplant SolutionsAnna CzeneVice President, Corporate Communications3


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CareDx is the Established Solutions Provider to Transplant Centers$50B ~1M 70%Rejection Monitoring Centers Use One Or More Tests Performed Software ProductsTransplant Services Market46K ~200K 150KHLA Typing Rx Filled Annually by Kits Sold Annually Transplant Pharmacy Transplants AnnuallySources: 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-data4


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CareDx Q4 2024 Preliminary Financial HighlightsREVENUE TESTING VOLUME ADJUSTED EBITDA CASH BALANCEQ4 2024 $85-$86 ~45,500 $8-$9 $261million million gain millionYEAR- ~30% 14% ~$19 +$26OVER-YEAR increase increase million gain millionPlease 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.5


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Achieved Sixth Consecutive Quarter of Testing Services Volume Growth Across All Organs+14% +1 %49.9k42.1k 43.7k 44.6k 45.5k38.4k 39.9k37.5kQ1 20231 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 20241. Drop in Testing Services volume from Q1 2023 to Q2 2023 due to the impact of Billing Article introduced in March 2023.6


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Building Blocks of Growth4 PRODUCT PIPELINE3 PATIENT ADHERENCE2 CUSTOMER ADOPTION 1 TRANSPLANT VOLUME7


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1 TRANSPLANT VOLU MEForces Driving Transplant Volume Growth11%Heart Transplant Annual Growth7%Kidney Transplant Annual Growth12%Lung Transplant Annual GrowthGrowing government effortsare working to expand transplantation accessIOTA ModelIncreasing Organ Transplant AccessTechnological advances are improving organ viabilitySources: 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/8


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2 CU STOMER A DOPTIONSynergistic Portfolio Drives Customer AdoptionORGAN MATCHING/WAIT LISTING CARE QUALITY/SYSTEM EFFICACY GRAFT HEALTHSOLUTIONS ACROSS PATIENT JOURNEYLAB PRODUCTSâ–ª HLA Typingâ–ª Lab Management Softwareâ–ª Waitlist Management TRANSPLANT CENTERâ–ª Transplant EMRâ–ª Quality Reportingâ–ª Staff AugmentationPATIENT DX & SOLUTIONSâ–ª Remote Monitoring â–ª Graft Health Assessmentâ–ª Tissue Diagnosis9


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2 CU STOMER A DOPTIONMulti-Solution Accounts Generate 2x Testing Services Revenue <3 SOLUTIONS29% $600KAverage new transplant Average transplant center patient acquisition for testing revenue from testing3+ SOLUTIONS44% $1.2MAverage new transplant Average transplant center patient acquisition for testing revenue from testingAccounts that have 3 or more CareDx solutions have higher 2x average patient acquisition, 2x the absolute testing volume increase and, ultimately, 2x the testing services revenueSource: CareDx internal data estimates. 10


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3 PATIENT ADHER ENC EOpportunity to Improve Patient AdherenceCURRENT PROTOCOL-DRIVEN number of tests/patient number of tests/patient in first 3 years in first 3 years7 15 K I D N E Y S24 38 H E A R T10 20 L U N G SSources: 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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4 PRODUC T PIPELINEPipeline Fuels Additional Growth for Testing Services2 02 5 2 02 6Expanded IndicationsAlloSure SPK AlloSure Heart PEDSAlloMap Kidney HistoMap Kidney UroMap Launch New Dx for use with Gene-expression profiling Diagnoses rejection Complements AlloSure AlloSure Kidney combined with AlloSure subtype in patients with in the management enhances risk stratification elevated AlloSure of BK virus12


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Evidence Strategy Drives Coverage Growth~90% ~40%AlloMap Heart AlloSure HeartCovered Lives Covered LivesLaunched 2006 / Medicare Coverage 2006 Launched 2018 / Medicare Coverage 2020~60% ~30%AlloSure Kidney AlloSure LungCovered Lives Covered LivesLaunched 2017 / Medicare Coverage 2017 Launched 2021 / Medicare Coverage 2023B C BS FEDER A L EMP LOY EESPOLICY: Positive coverage for AlloSure Heart STUDY: HeartCare SHORE data, J Heart Lung TransplantHI GHMA R K BLU ESPOLICY: Positive coverage for AlloSure Kidney STUDY: AlloSure Kidney Nature MedicineSources: Percent of CareDx submitted claims that 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. 13


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Continuing to Build Evidence for Transplant Monitoring AssaysGENERATING EVIDENCE â–ª Pediatrics Validationâ–ª 5-year SurvivalHEA RT â–ª Directing Therapeutic Treatmentâ–ª Procedure Decision Making â–ª Treating Subclinical Rejection KIDNEY â–ª 3-year Survivalâ–ª Surveillance Outcomesâ–ª Subclinical Rejection LU NG â–ª All Transplant Coverageâ–ª Predict Post-Transplant Relapseâ–ª Surveillance Outcomes CELL THERA PY â–ª Treatment ResponsePRIMARY STUDYSHOREKOAROKRAALAMOACROBATSTUDY COMPOSITIONâ–ª >2,700 patientsâ–ª 5-year follow-upâ–ª 67 sites, HARTS protocolâ–ª >3,600 patientsâ–ª 3-year follow-upâ–ª 56 sites, ARTS protocolâ–ª 500 patientsâ–ª 5-year follow-upâ–ª 19 sites, ALRTS protocolâ–ª 307 patientsâ–ª 2-year follow-upâ–ª 11 sites14


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Charting a Path to Profitable Growth and Strategic Capital Allocation2027 FINANCIAL TARGETS Profitable Growth Profits And Cash$500M 20%2027 Adjusted 2027 Revenue Target EBITDA Target+$100M15% 3-Year Incremental 3-Year Revenue CAGR Target Cash TargetCapital Allocation>70% â–ª M&A2027 Gross Margin Target â–ª Invest in Coreâ–ª Share Buyback2025 GUIDANCERevenue$370M15


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Building Blocks for Growth~1% $500M~3% PIPELINEAVERAGE 2027 ~7% SELLINGPRICE (ASP) TOTAL CUSTOMER REVENUE ADOPTION & PATIENT evenue ~5% ADHERENCERTRANSPLANTNet $332—$333M PROCEDURES 2024TOTAL REVENUESource: 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 ne cessity.16


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Opportunities in Transplant-Adjacent AreasPRE-TRANSPLANTAutoimmune Disorders Cardiovascular Disease Lung Disease Hematology DisordersSolid Organ Transplant Cell TherapyPOST-TRANSPLANTInfectious Disease Cancer Therapeutic Selection17


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Expanding Into Cell Therapy Monitoring5,600Autologous and allogeneic cell therapy registered clinical trials globally 220 Hematopoietic and bone marrow transplant centers148 Accredited cell therapy centers70% Cancer (Blood and Solid Tumors) 10% Autoimmune Disorders 20% Other (e.g., Diabetes, Viral)Cell Transplant: Hematopoietic Stem Cell and Bone Marrow TransplantsImmune Cell Therapy: Engineered (CAR-T, CAR-NK) and Non-Engineered (TCR-T, NK)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, 2024.18


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Two Products Addressing Critical Unmet NeedALLOCELL MONITORS IMMUNE CELL THERAPY PHARMACOKINETICSAnalyzes cells in bloodContractionProduct ExpansionCell Persistence%Infusion 2 weeks Months/yearsStandardized Pharmacokinetics (PK) AssessmentUniversal assay based on DNA differences between cell therapy product and patientALLOHEME DETECTS CANCER RELAPSE POST-CELL TRANSPLANTStandard of Care SOC Relapse DetectionCells Cancer ofNumber AlloHeme Earlier Relapse PredictionNo RelapseTime After Hematopoietic Stem Cell TransplantationSources: The Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting poster presentation.Tandem Meetings. Transplantation and Cellular Therapy Meeting 2024. Oral Presentation.19


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Activating Our StrategyPUT IN PLACE THE RIGHT TEAMIDENTIFIED THE MARKET OPPORTUNITIESLAUNCHING INNOVATIVE SOLUTIONS TO RESOLVE UNMET MEDICAL NEEDS20


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Appendix21


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Preliminary Reconciliation –Estimated GAAP Net Loss to Adjusted EBIDTA Profit22


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The Transplant Solutions CompanyC O NTAC T U SINVESTOR RELATIONS CORPORATE HQ Caroline Corner 8000 Marina Blvd, [email protected] Brisbane, CA 94005MEDIA RELATIONS Anna Czene [email protected] J, Stem Cell and Double Lung Recipient