8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 13, 2025

CAREDX, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-36536	94-3316839
(State or Other Jurisdiction<br> <br>of Incorporation)	(Commission<br> <br>File Number)	(IRS Employer<br> <br>Identification No.)
8000 Marina Boulevard, 4^th^ Floor
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Brisbane, California 94005
(Address of Principal Executive Offices) (Zip Code)

(415) 287-2300

Registrant’s telephone number, including area code

N/A

(Former Name, or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Exchange Act:

(Title of each class)	(Trading<br>Symbol)	(Name of exchange<br>on which registered)
Common Stock, $0.001 Par Value	CDNA	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02.	Results of Operations and Financial Condition.

On January 13, 2025, CareDx, Inc. (the “Company”) issued a press release announcing its preliminary financial results for the quarter and year ended December 31, 2024, as well as its 2025 revenue guidance. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 2.02, including the press release attached hereto as Exhibit 99.1, is intended to be furnished under Item 2.02 and Item 9.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 7.01	Regulation FD Disclosure.

The Company is furnishing a corporate presentation, attached as Exhibit 99.2 to this Current Report on Form 8-K (the “Corporate Presentation”), which the Company intends to post on the Company’s website. The Corporate Presentation is current as of January 13, 2025, and the Company disclaims any obligation to update this material in the future.

The information in this Item 7.01, including the Corporate Presentation attached hereto as Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01.	Financial Statements and Exhibits.

(d) Exhibits.

Exhibit<br>No.	Description
99.1	Press Release issued by CareDx, Inc., dated January 13, 2025.
99.2	Corporate Presentation of CareDx, Inc., dated January 13, 2025.
104	Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 13, 2025	CAREDX, INC.
	By:	/s/ John W. Hanna
		John W. Hanna
		President and Chief Executive Officer

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EX-99.1

Exhibit 99.1

CareDx Announces Preliminary Fourth Quarter and Full Year 2024 Results

Fourth Quarter Revenue is Expected to Increase 30% Year-Over-Year

Expects Full Year 2024 Revenue of $332 Million to $333 Million

BRISBANE, Calif. — (BUSINESS WIRE)—January 13, 2025, CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company^™^ – today reported preliminary, unaudited financial results for the fourth quarter and full year ended December 31, 2024.

Preliminary Fourth Quarter 2024 Financial Results

•	Revenue is expected to be between $85 million and $86 million, an increase of approximately 30%<br>year-over-year.
•	Testing services revenue is expected to be between $62.5 million and $63.5 million, an increase of<br>approximately 35% year-over-year.
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•	Testing Services volume of approximately 45,500 increased 14% year-over-year.
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•	Revenue is expected to be $11.4 million for Digital Solutions and $11.4 million for Products.<br>
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•	GAAP loss is expected to be approximately $32 million to $34 million and adjusted EBITDA is expected to<br>be a gain of between $8 million and $9 million.
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Preliminary Full Year 2024 Financial Results

•	2024 revenue is expected to be between $332 million to $333 million.
•	2024 GAAP loss is expected to be between $58 million and $60 million and adjusted EBITDA is expected to<br>be a gain of between $25 million to $26 million.
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•	Cash, cash equivalents, and marketable securities as of December 31, 2024, is expected to be approximately<br>$261 million, an increase of approximately $26 million year-over-year.
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2025 Revenue Guidance

•	CareDx anticipates revenue of $370 million during 2025.

“Continuing our mission to serve transplant patients, we achieved our sixth consecutive quarter of testing services volume growth in the fourth quarter. Momentum continued to build for kidney surveillance testing throughout the quarter, and we completed our sales and marketing expansion by about 30 professionals. We are well-positioned for another successful year of growth in 2025 and on pace to achieve our targets of $500 million in revenue and 20% adjusted EBITDA in 2027,” said John W. Hanna, CareDx President and CEO.

The preliminary financial information presented in this press release 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. CareDx will report on the fourth quarter and full year 2024 financial results and anticipates providing 2025 financial guidance on its February 2025 earnings call.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

Forward Looking Statements

This press release includes 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, its 2027 revenue and adjusted EBITDA targets, and its anticipation to report 2024 financial results and provide 2025 financial guidance on its February 2025 earnings call. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties that could cause the actual results to differ materially from those projected, including the completion of the audit of CareDx’s 2024 financial statements, general economic and market factors, and global economic and marketplace uncertainties, among others discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the quarterly report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024, the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

CareDx, Inc.

Media Relations

Anna Czene

818-731-2203

aczene@caredx.com

Investor Relations<br> <br>Caroline Corner<br><br><br>investor@caredx.com

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited and Preliminary)

(In thousands)

	2024
	Three Months EndedDecember 31			Twelve Months EndedDecember 31
GAAP net loss	$	(33,300	)	$	(58,800	)
Stock-based compensation expense		39,600			79,800
Restructuring costs and charges		1,700			1,800
Acquisition related-amortization of purchased intangibles		1,500			6,300
Non-GAAP net income	$	9,500		$	29,100

CareDx, Inc.

Reconciliation of Non-GAAP to Adjusted EBITDA

(Unaudited and Preliminary)

(In thousands)

	2024
	Three Months EndedDecember 31			Twelve Months EndedDecember 31
Non-GAAP net income	$	9,500		$	29,100
Interest income		(2,900	)		(11,600	)
Income tax expense		100			100
Depreciation expense		1,900			7,900
Other income, net		(100	)		—
Adjusted EBITDA	$	8,500		$	25,500

EX-99.2

Exhibit 99.2

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Appendix21

Preliminary Reconciliation –Estimated GAAP Net Loss to Adjusted EBIDTA Profit22

The Transplant Solutions CompanyC O NTAC T U SINVESTOR RELATIONS CORPORATE HQ Caroline Corner 8000 Marina Blvd, investor@caredx.com Brisbane, CA 94005MEDIA RELATIONS Anna Czene aczene@caredx.comKristin J, Stem Cell and Double Lung Recipient