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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):
April 15, 2026
CAREDX, INC.
(Exact Name of Registrant as Specified in its
Charter)
| Delaware |
|
001-36536 |
|
94-3316839 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
| |
| 8000 Marina Boulevard, 4th Floor |
| 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) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Exchange
Act:
| (Title of each class) |
|
(Trading
Symbol) |
|
(Name of exchange
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 1.01. |
Entry into a Material Definitive Agreement. |
On April 15, 2026, CareDx, Inc. (the “Company”)
entered into a Purchase Agreement (the “Purchase Agreement”) with Eurobio Scientific S.A. (“Eurobio”), pursuant
to which, and subject to the terms and conditions set forth therein, the Company agreed to sell to Eurobio the shares of CareDx AB, a
wholly-owned Swedish subsidiary of the Company, and certain assets relating to the Company’s kitted laboratory products business
and related software (the “Business”) for $170 million in cash, subject to certain customary adjustments specified in the
Purchase Agreement, including for working capital, cash and indebtedness (the “Transaction”).
Each party’s obligation to consummate the Transaction is subject
to customary closing conditions, including, among other things, (i) subject to certain exceptions, the accuracy of the representations
and warranties of the other party, (ii) performance in all material respects by the other party of its covenants, (iii) the
receipt of a required regulatory approval and (iv) with respect to Eurobio’s obligation, the absence of a material adverse
effect on the Business that is continuing.
The Purchase Agreement contains representations, warranties and covenants
that are customary for a transaction of this nature.
The Purchase Agreement also includes customary termination rights,
including (i) by mutual written consent of Eurobio and the Company, (ii) by either party if a governmental entity permanently
prohibits or makes illegal the consummation of the Transaction, and by Eurobio if a governmental entity imposes certain remedies in connection
with the Transaction that are not required under the Purchase Agreement, (iii) by either party if the Transaction has not been consummated
by October 15, 2026, (iv) by either party, if the other party is in an uncured material breach of its respective
representations and warranties or covenants under the Purchase Agreement such that a closing condition would not be satisfied and (v) by
Eurobio, if there is an uncured material adverse effect on the Business. Pursuant to the Purchase Agreement, the Company and Eurobio will
enter into a transition services agreement at the closing of the Transaction.
The Company is granted the exclusive right to distribute NGS- and PCR-based
post-transplant assays for solid organ or stem cell transplants in the US, Canada and Mexico manufactured by Eurobio, including AlloSeqcfDNA,
AlloSeqHCT, NGStrack, KMRtrack or any other chimerism or cfDNA monitoring product. Eurobio may, however, continue to serve Eurobio’s
existing customers as of the closing of the Transaction with Eurobio’s current existing products. Eurobio retains the exclusive
right in the US, Canada and Mexico to sell the current Company chimerism assay solely to the Company’s existing customers for three
years after the closing of the Transaction, but may not otherwise sell the current Company chimerism assay in North America
The foregoing description of the Purchase Agreement does not purport
to be complete and is qualified in its entirety by reference to the full text of the Purchase Agreement, which is filed as Exhibit 2.1
to this Current Report on Form 8-K and is incorporated herein by reference.
The Purchase Agreement is filed to provide investors with information
regarding its terms. It is not intended to provide any other factual information about the Company, Eurobio or the Business. The representations,
warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the parties thereto, as of specified
dates, and may be subject to limitations agreed upon by the parties, including being qualified by confidential disclosures made for the
purposes of allocating contractual risk between the parties instead of establishing these matters as facts. Accordingly, investors should
not rely on the representations, warranties and covenants, or any description thereof, as characterizations of the actual state of facts
or condition of the Company, Eurobio or the Business.
| Item 2.02. |
Results of Operations and Financial Condition. |
On April 15, 2026, the Company issued a press release (the “Press
Release”), as described further under Item 7.01 below, which included information with respect to the Company’s preliminary
unaudited financial results for the quarter ended March 31, 2026 and certain additional preliminary metrics. A copy of the Press
Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On April 15, 2026, the Company issued the Press Release announcing
the entry into the Purchase Agreement and the Transaction described in Item 1.01 above. A copy of the Press Release is furnished as Exhibit 99.1
to this Current Report on Form 8-K and is incorporated herein by reference.
The information set forth in Item 2.02, this Item 7.01 and in the attached
Exhibit 99.1 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, or the Exchange Act, except as shall be expressly set forth by specific reference
in such a filing.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Transaction, including
the expected timing of completion, anticipated benefits, and other statements that are not historical facts. Forward-looking statements
can be identified by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “should,” “will” and similar
expressions. These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties
that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, including, among
others, the failure to satisfy the closing conditions to the Transaction, the failure to obtain required regulatory approvals or third-party
consents, the occurrence of any event, change or other circumstance that could give rise to the termination of the Purchase Agreement,
delays in completing the Transaction, the risk that the Transaction may not be completed on the anticipated timeline or at all, and other
risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements
in this Current Report on Form 8-K speak only as of the date hereof, and the Company disclaims any obligation to update or revise
any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
| Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit
No. |
Description |
| |
|
| 2.1+* |
Purchase Agreement, dated April 15, 2026 by and between CareDx, Inc. and Eurobio Scientific S.A.. |
| 99.1 |
Press Release issued by CareDx, Inc., dated April 15, 2026 (furnished). |
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
| + |
Portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K because they are both (i) not material and (ii) are the type of information the Registrant customarily and actually treats as private or confidential. |
| * |
Certain schedules and attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to provide, on a supplemental basis, a copy of any omitted schedules and attachments to the Securities and Exchange Commission or its staff upon request. |
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: April 16, 2026 |
CAREDX, INC. |
| |
|
|
| |
By: |
/s/ John W. Hanna |
| |
|
John W. Hanna |
| |
|
Chief Executive Officer |
| |
|
(Principal Executive Officer) |
Exhibit 99.1
Apr 15, 2026 4:30 PM Eastern Daylight Time
CareDx Announces Agreement to Divest Lab Products Business to EuroBio
Scientific for $170 Million and Announces First Quarter Preliminary Financial Results
Transaction Expected to Sharpen CareDx’s Focus on Core Precision
Medicine Testing Services and Patient and Digital Solutions, Improve Financial Flexibility, Simplify Operating Model, and Support AEBITDA
Margin Expansion
Expects First Quarter Testing Services Revenue Growth of Approximately
48% Year Over Year, Testing Volume Growth of Approximately 17% Year-Over-Year
BRISBANE,
Calif. — (BUSINESS WIRE) — CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine
company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions
for transplant patients and caregivers, today announced that it has entered into a definitive agreement to divest its Lab Products business
to EuroBio Scientific for cash consideration of $170 million. The transaction has been approved by the boards of directors of both companies.
CareDx also announced today preliminary financial results for the first quarter of 2026.
CareDx’s Lab Products business consists of IVD (in vitro diagnostic)
PCR kits for rapid deceased donor HLA (human leukocyte antigen) typing, IVD NGS-based (next-generation sequencing) kits for transplant
recipient HLA typing globally, and IVD NGS-based monitoring assays for solid organ and stem cell transplant recipients outside of North
America. As a global IVD kit business with distinct manufacturing, regulatory, and commercial requirements, Lab Products operates under
a different model than CareDx’s core U.S.-based Precision Medicine Testing Services and its Patient and Digital Solutions. The divestiture
is intended to simplify CareDx’s operating model and support disciplined capital redeployment toward opportunities aligned with
its Precision Medicine Testing Services model.
“This divestiture allows us to strategically focus on our core Testing Services and Patient
and Digital Solutions, where our solutions-selling strategy is working. In the first quarter, these segments delivered 48% and 33% year-over-year
revenue growth, respectively,” said John Hanna, President and CEO of CareDx. “Having partnered with EuroBio Scientific since
2014, we believe their global scale and broad IVD capabilities positions them well to execute the Lab Products business and continue providing
the highest quality service to our IVD customers and patients worldwide.”
Highlighted Terms of the Agreement
| · | CareDx to divest its Lab Products business to EuroBio Scientific |
| · | Total consideration of $170 million in cash at closing |
| · | CareDx
to provide transition services to EuroBio Scientific for at least 6-months at EuroBio Scientific’s expense |
| · | EuroBio Scientific grants to CareDx the sole and exclusive perpetual right to distribute post-transplant monitoring IVD tests in North
America, including AlloSeq cfDNA, CareDx’s IVD kit version of its market-leading AlloSure dd-cfDNA CLIA test |
The company
expects to apply a disciplined approach to capital allocation consistent with its track record. Proceeds from the transaction are expected
to be prioritized toward investments that support CareDx’s long-term growth strategy, including potential inorganic investments
that fit its Precision Diagnostics Solutions model, and may also include the return of capital to shareholders.
The transaction, including the sale of CareDx’s Swedish entity,
requires Swedish regulatory review. The parties anticipate the transaction to close by the end of CareDx’s third quarter, 2026.
Separately, CareDx is providing the following preliminary results for
the first quarter of 2026 in advance of its scheduled quarterly reporting process.
Preliminary First Quarter 2026 Financial Results
| · | Revenue of approximately $118 million, growth of 39% year-over-year |
| · | Testing Service Volume of approximately 54,900, growth of 17% year–over-year |
| · | Testing Service revenue of approximately $91 million, growth of 48% year–over-year, |
| · | Average revenue per test of approximately $1,660 including approximately $14 million in prior period revenue |
| · | Patient and Digital Solutions revenue of approximately $16 million, growth of 33% year-over-year |
| · | Lab Products revenue of approximately $10 million, decline of 4% year-over-year |
| · | Cash, cash equivalents, and marketable securities of approximately $198 million as of March 31, 2026 |
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 procedures.
The company anticipates providing further guidance during its first quarter 2026 earnings call on April 28, 2026.
About CareDx
CareDx is
a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s
integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital
health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based
information for transplant patients. For more information, please visit www.caredx.com.
About EuroBio Scientific
Eurobio Scientific
is a major player in the field of specialty in vitro diagnostics. It is involved in everything from research to the marketing of diagnostic
tests in the fields of transplantation, immunology, and infectious diseases, and offers reagents for research laboratories, including
pharmaceutical and biotechnology companies. With its numerous partnerships and strong hospital presence, Eurobio Scientific has its own
extensive distribution network and a portfolio of proprietary products. For further information, visit: www.eurobio-scientific.com
Forward Looking Statements
This press
release includes forward-looking statements related to CareDx including statements regarding the expected completion and timing of the
divestiture, the anticipated impact of the transaction on CareDx’s business, financial profile, and operating results, the expected
use of proceeds, the achievement of CareDx’s financial and operational goals and its expectations and prospects for 2026, and other
statements that are not historical facts. These forward-looking statements are based on information currently available to CareDx
and its current expectations, and are subject to risks and uncertainties that could cause actual results to differ materially from those
expressed or implied by such statements. These risks and uncertainties include, among others, the failure to obtain required regulatory
approvals or satisfy closing conditions, delays in completing the transaction, general economic and market factors, and other risks 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, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that
CareDx has filed with the SEC. Any of these risks 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.
