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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 24, 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 28, 2026, CareDx, Inc. (the “Company”)
entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Naveris, Inc., a Delaware corporation
(“Naveris”), Nautilus Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger
Sub”), and Shareholder Representative Services LLC, solely in its capacity as the representative of the securityholders of
Naveris, pursuant to which, and subject to the terms and conditions set forth therein, Merger Sub will merge with and into Naveris,
with Naveris continuing as the surviving corporation and a wholly owned subsidiary of the Company (the “Transaction”).
Under the terms and subject to the conditions set forth in the Merger Agreement, at the closing of the Transaction (the
“Closing”), the Company will pay to Naveris’ equityholders an aggregate $160.0 million in cash, subject to certain
customary adjustments specified in the Merger Agreement, including for Naveris' cash, indebtedness, transaction expenses and net
working capital. Additionally, under the terms and subject to the conditions set forth in the Merger Agreement,
Naveris’ equityholders will be eligible to receive up to $100.0 million in additional cash consideration contingent upon the
achievement of specified revenue-based milestones in respect of fiscal years ending December 31, 2026 and December 31, 2027. A portion
of the closing consideration equal to $5.0 million will be deposited into an escrow account at the Closing to secure post-closing
purchase price adjustments.
Each party’s obligation to consummate of the Transaction is subject to customary closing conditions, including, among other things,
(i) the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, (ii) the accuracy of the representations and warranties of the other party contained in the Merger Agreement (except,
generally, for any inaccuracies that have not had, or would not reasonably be expected to have, a material adverse effect or, with respect to certain specified representations and warranties, for any inaccuracies in any material or de minimis respect,
as applicable), (iii) performance in all material respects by the other party of its covenants and (iv) with respect to the Company’s
and Merger Sub’s obligations, the absence of a material adverse effect on Naveris.
The Merger Agreement contains representations, warranties and covenants that are customary for a transaction of this nature.
The Merger Agreement also includes customary termination rights, including (i) by mutual written consent of the Company and
Naveris, (ii) by either party if a governmental entity permanently prohibits or makes illegal the consummation of the Transaction, (iii)
by either party if the Transaction has not been consummated by October 28, 2026 (subject to automatic extension under specified circumstances),
(iv) by either party, if the other party is in an uncured material breach of its respective representations and warranties or covenants
under the Merger Agreement such that a closing condition would not be satisfied, and (v) by the Company if Naveris does not
deliver the requisite written stockholder consent within 24 hours after execution of the Merger Agreement.
The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference
to the full text of the Merger Agreement, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
The Merger Agreement is filed to provide investors with information regarding its terms. It is not intended to provide any
other factual information about the Company or Naveris. The representations, warranties and covenants contained in the Merger 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 or Naveris.
Item 2.02 Results of Operations and Financial Condition.
On April 28, 2026, the Company issued
a press release announcing its financial results for the quarter ended March 31, 2026. 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 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.
Item 7.01 Regulation FD Disclosure.
The Company is posting an updated corporate presentation (the “Corporate
Presentation”) on its website. The Corporate Presentation is current as of April 28, 2026, and the Company disclaims any obligation
to update this material in the future.
On April 28, 2026, the Company issued the Press Release announcing the entry into the Merger Agreement and the Transaction
described in Item 1.01 above. A copy of the Press Release is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated
herein by reference.
The information set forth in this Item 7.01 and in the attached 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 of 1933, as amended, or the Exchange
Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On April 24, 2026, the Company’s Board of Directors (the “Board”)
authorized a common stock repurchase program of up to $100 million in shares for up to 24 months from April 30, 2026. Under the repurchase
program, the Company may purchase shares of common stock on a discretionary basis from time to time through open market repurchases, privately
negotiated transactions or other means, including through Rule 10b5-1 trading plans or through the use of other techniques. The timing
and number of shares repurchased, and the price of any repurchases, will depend on a variety of factors, including stock price, trading
volume, and general business and market conditions. The repurchase program does not obligate the Company to acquire a specified number
of shares and may be modified, suspended, or discontinued at any time at the Company’s discretion. Repurchases under this program
will be funded from the Company’s existing cash and cash equivalents or future cash flow.
The Board’s authorization for this program is separate from,
and does not replace or otherwise affect, the prior $50 million stock repurchase program that was authorized by the Board in May 2025.
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 Merger 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+* |
|
Agreement and Plan of Merger, dated April 28, 2026 by and among CareDx, Inc., Nautilus Merger Sub, Inc., Naveris, Inc. and Shareholder
Representative Services LLC, solely in its capacity as the representative of the securityholders of Naveris, Inc. |
| 99.1 |
|
Press Release issued by CareDx, Inc., dated April 28, 2026 (earnings release). |
| 99.2 |
|
Press Release issued by CareDx, Inc., dated April 28, 2026 (Naveris acquisition). |
| 104 |
|
Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). |
+ 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 28, 2026 |
CAREDX, INC. |
| |
|
|
| |
By: |
/s/ John W. Hanna |
| |
|
John W. Hanna |
| |
|
Chief Executive Officer |
| |
|
(Principal Executive Officer) |
Exhibit 99.1
CareDx Announces First Quarter 2026 Financial
Results
First Quarter Revenue Growth of 39% Driven by
Strong Performance Across Testing Services and Patient and Digital Solutions
Raises 2026 Revenue Guidance to $447 Million
to $465 Million and Raises 2026 AEBITDA Guidance to $43 Million to $57 Million
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 reported
financial results for the first quarter ended March 31, 2026.
First Quarter 2026 Financial Highlights
| · | Revenue of $118 million, an increase of 39% year-over-year |
| · | Testing services revenue of $91 million, an increase of 48% year-over-year, and testing services volume of approximately 54,900, an
increase of 17% year-over-year |
| · | Patient and digital solutions revenue of $16 million and lab product revenue of $10 million, representing
year-over-year growth of 33% and a decline of 4%, respectively |
| · | Average revenue per test of approximately $1,660 including approximately $14 million in prior period
revenue |
| · | GAAP net income of $3 million, compared to GAAP net loss of $10 million for the first quarter of 2025 |
| · | Adjusted EBITDA of $19 million, compared to $5 million for the first quarter of 2025 |
| · | Cash flow from operations of $4 million |
Recent Business Highlights
| · | Announced definitive agreement to divest the Lab Products business to Eurobio Scientific for $170 million in cash consideration |
| · | Advanced pipeline program with presentation of the AlloHeme clinical trial data at TANDEM Annual Conference |
| · | Launched VANTx™, an AI powered, cloud native clinical data and analytics platform designed to
transform complex transplant data into insights that support clinical research and real-world evidence development |
| · | Achieved a record quarter for cash collections, reflecting disciplined operational execution and focus on high margin Testing Services
growth |
| · | Advanced Epic Aura integrations, with nine transplant centers live and 16 integrations in-process |
| · | Presented more than 50 abstracts at the International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting, reflecting
the breadth of CareDx’s clinical evidence and leadership in transplantation |
| · | In April 2026, the Board of Directors authorized a common stock repurchase program of up to $100 million of shares over a period
of up to 24 months |
“Our team delivered another quarter of record growth, driven
by continued momentum in our Precision Medicine Testing Services and Patient and Digital Solutions businesses,” said John W. Hanna,
President and CEO of CareDx. “And we took important strategic steps advancing our lead pipeline asset, AlloHeme, and agreeing to
divest the Lab Products business to simplify our operating model and create focus, with the goal of expanding our AEBITDA margins.”
First Quarter 2026 Financial Results
Total revenue was $118 million, compared to $85 million in the first
quarter of 2025, an increase of 39% driven primarily by higher Testing Services revenue, reflecting increased testing volumes, continued
execution across core transplant testing programs, and contributions from Patient and Digital Solutions; partially offset by lower Lab
Products revenue as the Company advances its portfolio optimization strategy.
Testing services revenue of $91 million, an increase of 48% year over
year, and testing services volume of approximately 54,900, an increase of 17% year over year, reflecting an increase in average revenue
per test, including the recognition of prior period revenue associated with improved collections, a favorable mix-shift in surveillance
testing, and increased for-cause growth across transplant programs.
Patient and digital solutions revenue was $16 million, compared to
$12 million in the first quarter of 2025, an increase of 33% driven by continued adoption of new transplant centers in the CareDx Pharmacy,
along with increasing adoption of digital solutions.
Lab Product revenue remained relatively flat at $10 million, down 4%
from the first quarter of 2025, while the Company continues to focus on growth in its core Testing Services and Patient and Digital Solutions
businesses.
GAAP net income was $3 million, compared to GAAP net loss of $10 million
in the first quarter of 2025. Basic and diluted GAAP net income per share was $0.05, compared to basic and diluted GAAP net loss per share
of $0.19 in the first quarter of 2025, reflecting higher revenue and improved operating leverage.
Non-GAAP net income was $18 million, compared to $5 million in the
first quarter of 2025. Diluted non-GAAP net income per share was $0.34 compared to $0.09 i n the first quarter of 2025.
Adjusted EBITDA was $19 million, compared to $5 million in the first
quarter of 2025, driven by revenue growth and continued focus on operational efficiency and cost discipline.
2026 Guidance
For the full year 2026, CareDx now expects revenue to be in the range
of $447 million to $465 million, compared to the $420 million to $444 million range that was previously disclosed. The Company now expects
full year 2026 adjusted EBITDA to be in the range of $43 million to $57 million.
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.
Forward Looking Statements
This press release includes forward-looking statements, including expectations
regarding the achievement of CareDx’s financial and operational goals and its expectations and prospects for 2026. 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, all of which are difficult to predict and many of which are beyond CareDx’s
control, that could cause the actual results to differ materially from those projected, including 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,
2025 filed by CareDx with the SEC on February 25, 2026, 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.
Use of Non-GAAP Financial Measures
CareDx has presented in this release certain financial information
in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) and also on a non-GAAP basis, including non-GAAP
cost of testing services, non-GAAP cost of product, non-GAAP cost of patient and digital solutions, non-GAAP research and development
expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other income, net, non-GAAP income
tax expense, non-GAAP gross profit, non-GAAP gross margin (%), non-GAAP operating expenses, non-GAAP net income, non-GAAP basic and diluted
net income per share and adjusted EBITDA. These non-GAAP financial measures are not meant to be considered superior to or a substitute
for financial measures calculated in accordance with GAAP, and investors are cautioned that there are material limitations associated
with the use of non-GAAP financial measures as an analytical tool.
We define non-GAAP net income and per share results as the GAAP net
income (loss) and per share results excluding the impacts of stock-based compensation expense; acquisition-related amortization of purchased
intangible assets and related tax effects; changes in estimated fair value of contingent consideration; litigation settlement expense;
business development and portfolio optimization expense; and certain other charges presented in the reconciliation in this release. We
define adjusted EBITDA as non-GAAP net income before interest income, income tax expense, depreciation expense and other (income) expense,
net. We define non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin excluding the impacts of stock-based
compensation expense, and acquisition-related amortization of purchased intangible assets included in cost of sales. Non-GAAP gross margin
is calculated as non-GAAP gross profit divided by total revenue. Corporate free cash flow is defined as Cash from Operations less Capital
Expenditures.
We are presenting these non-GAAP financial measures to assist investors
in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool
for investors to use in comparing our core business operating results over multiple periods where certain items may vary independent of
business performance. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx’s
GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding
of CareDx’s operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from,
or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily
comparable to similarly titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information
is provided immediately following the financial tables. A reconciliation of the forecasted range for adjusted EBITDA for 2026 is not included
in this release due to the number of variables in the projected range and because we are currently unable to quantify accurately certain
amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.
CareDx, Inc.
Media Relations
Natasha Moshirian Wagner
nwagner@CareDx.com
Investor Relations
Caroline Corner
investor@CareDx.com
CareDx, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share data)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Revenue: | |
| | |
| |
| Testing services revenue | |
$ | 91,398 | | |
$ | 61,921 | |
| Product revenue | |
| 10,346 | | |
| 10,810 | |
| Patient and digital solutions revenue | |
| 15,956 | | |
| 11,954 | |
| Total revenue | |
| 117,700 | | |
| 84,685 | |
| Operating expenses: | |
| | | |
| | |
| Cost of testing services | |
| 17,097 | | |
| 15,113 | |
| Cost of product | |
| 4,834 | | |
| 5,586 | |
| Cost of patient and digital solutions | |
| 11,698 | | |
| 7,716 | |
| Research and development | |
| 21,416 | | |
| 18,524 | |
| Sales and marketing | |
| 30,373 | | |
| 22,991 | |
| General and administrative | |
| 30,484 | | |
| 22,769 | |
| Litigation settlement expense | |
| 600 | | |
| 5,360 | |
| Total operating expenses | |
| 116,502 | | |
| 98,059 | |
| Income (loss) from operations | |
| 1,198 | | |
| (13,374 | ) |
| Other income: | |
| | | |
| | |
| Interest income, net | |
| 1,909 | | |
| 2,784 | |
| Other (expense) income, net | |
| (330 | ) | |
| 295 | |
| Total other income | |
| 1,579 | | |
| 3,079 | |
| Income (loss) before income taxes | |
| 2,777 | | |
| (10,295 | ) |
| Income tax benefit (expense) | |
| 32 | | |
| (58 | ) |
| Net income (loss) | |
$ | 2,809 | | |
$ | (10,353 | ) |
| Net income (loss) per share (Note 3): | |
| | | |
| | |
| Basic | |
$ | 0.05 | | |
$ | (0.19 | ) |
| Diluted | |
$ | 0.05 | | |
$ | (0.19 | ) |
| Weighted-average shares used to compute net income (loss) per share: | |
| | | |
| | |
| Basic | |
| 51,151,794 | | |
| 55,262,459 | |
| Diluted | |
| 53,129,928 | | |
| 55,262,459 | |
CareDx, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
| | |
As of | |
| | |
March 31, 2026 | | |
December 31, 2025 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 77,923 | | |
$ | 65,429 | |
| Marketable securities | |
| 109,253 | | |
| 111,779 | |
| Accounts receivable | |
| 44,585 | | |
| 42,628 | |
| Inventory | |
| 26,404 | | |
| 26,705 | |
| Prepaid and other current assets | |
| 11,230 | | |
| 10,591 | |
| Total current assets | |
| 269,395 | | |
| 257,132 | |
| Property and equipment, net | |
| 33,156 | | |
| 32,971 | |
| Operating lease right-of-use assets | |
| 21,206 | | |
| 22,760 | |
| Marketable securities, non-current | |
| 10,901 | | |
| 24,165 | |
| Intangible assets, net | |
| 32,102 | | |
| 31,960 | |
| Goodwill | |
| 40,336 | | |
| 40,336 | |
| Restricted cash | |
| 551 | | |
| 551 | |
| Other assets | |
| 3,415 | | |
| 3,353 | |
| Total assets | |
$ | 411,062 | | |
$ | 413,228 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 9,066 | | |
$ | 9,988 | |
| Accrued compensation | |
| 20,545 | | |
| 38,107 | |
| Accrued and other liabilities | |
| 49,542 | | |
| 41,754 | |
| Total current liabilities | |
| 79,153 | | |
| 89,849 | |
| Deferred tax liability | |
| 130 | | |
| 181 | |
| Operating lease liabilities, less current portion | |
| 17,837 | | |
| 19,679 | |
| Other liabilities | |
| 407 | | |
| 418 | |
| Total liabilities | |
| 97,527 | | |
| 110,127 | |
| Commitments and contingencies | |
| | | |
| | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock | |
| 51 | | |
| 50 | |
| Additional paid-in capital | |
| 1,052,306 | | |
| 1,043,925 | |
| Accumulated other comprehensive loss | |
| (6,272 | ) | |
| (5,515 | ) |
| Accumulated deficit | |
| (732,550 | ) | |
| (735,359 | ) |
| Total stockholders’ equity | |
| 313,535 | | |
| 303,101 | |
| Total liabilities and stockholders’ equity | |
$ | 411,062 | | |
$ | 413,228 | |
CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Financial
Measures
(Unaudited)
(In thousands)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Cost of testing services reconciliation: | |
| | | |
| | |
| GAAP cost of testing services | |
$ | 17,097 | | |
$ | 15,113 | |
| Stock-based compensation expense | |
| (265 | ) | |
| (363 | ) |
| Acquisition related-amortization of purchased intangibles | |
| (311 | ) | |
| (347 | ) |
| Non-GAAP cost of testing services | |
$ | 16,521 | | |
$ | 14,403 | |
| Cost of product reconciliation: | |
| | | |
| | |
| GAAP cost of product | |
$ | 4,834 | | |
$ | 5,586 | |
| Stock-based compensation expense | |
| (89 | ) | |
| (231 | ) |
| Acquisition related-amortization of purchased intangibles | |
| (512 | ) | |
| (412 | ) |
| Non-GAAP cost of product | |
$ | 4,233 | | |
$ | 4,943 | |
| Cost of patient and digital solutions reconciliation: | |
| | | |
| | |
| GAAP cost of patient and digital solutions | |
$ | 11,698 | | |
$ | 7,716 | |
| Stock-based compensation expense | |
| (134 | ) | |
| (220 | ) |
| Acquisition related-amortization of purchased intangibles | |
| (152 | ) | |
| (152 | ) |
| Non-GAAP cost of patient and digital solutions | |
$ | 11,412 | | |
$ | 7,344 | |
| Research and development expenses reconciliation: | |
| | | |
| | |
| GAAP research and development expenses | |
$ | 21,416 | | |
$ | 18,524 | |
| Stock-based compensation expense | |
| (1,323 | ) | |
| (1,359 | ) |
| Non-GAAP research and development expenses | |
$ | 20,093 | | |
$ | 17,165 | |
| Sales and marketing expenses reconciliation: | |
| | | |
| | |
| GAAP sales and marketing expenses | |
$ | 30,373 | | |
$ | 22,991 | |
| Stock-based compensation expense | |
| (1,835 | ) | |
| (2,584 | ) |
| Acquisition related-amortization of purchased intangibles | |
| (643 | ) | |
| (628 | ) |
| Non-GAAP sales and marketing expenses | |
$ | 27,895 | | |
$ | 19,779 | |
| General and administrative expenses reconciliation: | |
| | | |
| | |
| GAAP general and administrative expenses | |
$ | 31,084 | | |
$ | 28,129 | |
| Business development and portfolio optimization expense* | |
| (3,357 | ) | |
| — | |
| Stock-based compensation expense | |
| (6,157 | ) | |
| (4,174 | ) |
| Change in estimated fair value of contingent consideration | |
| — | | |
| (46 | ) |
| Litigation settlement expense | |
| (600 | ) | |
| (5,360 | ) |
| Non-GAAP general and administrative expenses | |
$ | 20,970 | | |
$ | 18,549 | |
| Total other income reconciliation: | |
| | | |
| | |
| GAAP other income | |
$ | 1,579 | | |
$ | 3,079 | |
| Non-GAAP other income | |
$ | 1,579 | | |
$ | 3,079 | |
| Income tax benefit (expense) reconciliation: | |
| | | |
| | |
| GAAP income tax expense | |
$ | 32 | | |
$ | (58 | ) |
| Tax effect related to amortization of purchased intangibles | |
| (126 | ) | |
| (99 | ) |
| Non-GAAP income tax expense | |
$ | (94 | ) | |
$ | (157 | ) |
* Business development and portfolio optimization expense primarily
includes legal, consulting, financial advisory, due diligence, and other transaction-related costs incurred in connection with business
development activities and the sale of our lab product business.
CareDx, Inc.
GAAP and Non-GAAP Operating Expenses
(Unaudited)
(In thousands)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| GAAP operating expenses: | |
| | | |
| | |
| Research and development | |
$ | 21,416 | | |
$ | 18,524 | |
| Sales and marketing | |
| 30,373 | | |
| 22,991 | |
| General and administrative | |
| 31,084 | | |
| 28,129 | |
| Total GAAP operating expenses | |
$ | 82,873 | | |
$ | 69,644 | |
| | |
| | | |
| | |
| Non-GAAP operating expenses: | |
| | | |
| | |
| Research and development | |
$ | 20,093 | | |
$ | 17,165 | |
| Sales and marketing | |
| 27,895 | | |
| 19,779 | |
| General and administrative | |
| 20,970 | | |
| 18,549 | |
| Total Non-GAAP operating expenses | |
$ | 68,958 | | |
$ | 55,493 | |
CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Gross Profit
and Gross Margin
(Unaudited)
(In thousands, except percentages)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| GAAP total revenue | |
$ | 117,700 | | |
$ | 84,685 | |
| GAAP cost of sales | |
| 33,629 | | |
| 28,415 | |
| GAAP gross profit | |
| 84,071 | | |
| 56,270 | |
| GAAP gross margin % | |
| 71 | % | |
| 66 | % |
| Stock-based compensation expense | |
| 488 | | |
| 814 | |
| Acquisition related-amortization of purchased intangibles | |
| 975 | | |
| 911 | |
| Non-GAAP gross profit | |
$ | 85,534 | | |
$ | 57,995 | |
| Non-GAAP gross margin % | |
| 73 | % | |
| 68 | % |
CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Financial
Measures
(Unaudited)
(In thousands, except share and per share data)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| GAAP net income (loss) | |
$ | 2,809 | | |
$ | (10,353 | ) |
| Stock-based compensation expense | |
| 9,803 | | |
| 8,931 | |
| Business development and portfolio optimization expense* | |
| 3,357 | | |
| — | |
| Acquisition related-amortization of purchased intangibles | |
| 1,618 | | |
| 1,539 | |
| Change in estimated fair value of contingent consideration | |
| — | | |
| 46 | |
| Tax effect related to amortization of purchased intangibles | |
| (126 | ) | |
| (99 | ) |
| Litigation settlement expense | |
| 600 | | |
| 5,360 | |
| Non-GAAP net income | |
$ | 18,061 | | |
$ | 5,424 | |
| | |
| | | |
| | |
| GAAP basic net income (loss) per share | |
$ | 0.05 | | |
$ | (0.19 | ) |
| GAAP diluted net income (loss) per share | |
$ | 0.05 | | |
$ | (0.19 | ) |
| | |
| | | |
| | |
| Non-GAAP basic net income per share | |
$ | 0.35 | | |
$ | 0.10 | |
| Non-GAAP diluted net income per share | |
$ | 0.34 | | |
$ | 0.09 | |
| | |
| | | |
| | |
| Shares used in computing non-GAAP basic net income per share | |
| 51,151,794 | | |
| 55,262,459 | |
| Shares used in computing non-GAAP diluted net income per share | |
| 53,129,928 | | |
| 58,315,877 | |
* Business development and portfolio optimization expense primarily
includes legal, consulting, financial advisory, due diligence, and other transaction-related costs incurred in connection with business
development activities and the sale of our lab product business.
CareDx, Inc.
Reconciliation of Non-GAAP to Adjusted EBITDA
(Unaudited)
(In thousands)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| GAAP net income (loss) | |
$ | 2,809 | | |
$ | (10,353 | ) |
| Stock-based compensation expense | |
| 9,803 | | |
| 8,931 | |
| Business development and portfolio optimization expense* | |
| 3,357 | | |
| — | |
| Acquisition related-amortization of purchased intangibles | |
| 1,618 | | |
| 1,539 | |
| Change in estimated fair value of contingent consideration | |
| — | | |
| 46 | |
| Tax effect related to amortization of purchased intangibles | |
| (126 | ) | |
| (99 | ) |
| Litigation settlement expense | |
| 600 | | |
| 5,360 | |
| Non-GAAP net income | |
| 18,061 | | |
| 5,424 | |
| Interest income | |
| (1,909 | ) | |
| (2,784 | ) |
| Income tax expense | |
| 94 | | |
| 157 | |
| Depreciation expense | |
| 2,279 | | |
| 2,061 | |
| Other expense (income), net | |
| 330 | | |
| (295 | ) |
| Adjusted EBITDA | |
$ | 18,855 | | |
$ | 4,563 | |
* Business development and portfolio optimization expense primarily
includes legal, consulting, financial advisory, due diligence, and other transaction-related costs incurred in connection with business
development activities and the sale of our lab product business.
CareDx, Inc.
Net Cash Provided by Operating Activities Reconciliation
to Free Cash Flow
(Unaudited)
(In thousands)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Net cash provided by operating activities (GAAP) | |
$ | 4,333 | | |
$ | (26,584 | ) |
| Less: item not included in free cash flows | |
| | | |
| | |
| Capital expenditures (GAAP) | |
$ | (3,819 | ) | |
$ | (1,630 | ) |
| Free cash flow (non-GAAP) | |
$ | 514 | | |
$ | (28,214 | ) |
Exhibit 99.2
CareDx Announces Agreement to Acquire Naveris, A Leader in Viral-Mediated
Cancer MRD Surveillance Testing
Transaction extends CareDx’s Precision Medicine Testing
Services strategy into specialty oncology with a Medicare-reimbursed commercial-stage MRD test and platform addressing a $4.5
Billion TAM
Estimated 2025 Revenue of $34 Million is expected to grow 30-40%
annually for the next three years and neutral to CareDx’s FY2026 Adjusted EBITDA guidance
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 it has entered into a definitive agreement to acquire Naveris, a commercial stage precision oncology
diagnostics company with a highly differentiated and Medicare-reimbursed, blood-based
monitoring solution for viral-mediated cancers. The transaction is an extension of
CareDx’s strategy to focus on its U.S. Precision Medicine Testing Services and Patient and Digital Solutions. The definitive
agreement provides for an up-front cash consideration of $160 million with up to an additional $100 million based on the achievement
of revenue milestones.
Naveris’ highly
differentiated liquid biopsy platform is based on Tumor Tissue Modified Viral (TTMV®) DNA. The platform measures
fragments of viral DNA released from tumor tissue into the bloodstream, serving as a highly accurate biomarker in human
papillomavirus HPV-driven cancers. This tumor-naïve
testing is designed to support the management of patients from diagnosis through post-treatment
molecular residual disease (MRD) surveillance.
Naveris reported unaudited revenue of $34 million in 2025, which we forecast to grow 30-40% annually for the next three years. For the
first quarter of 2026, Naveris reported unaudited revenue of approximately $12 million, gross margins of 65% and net operating loss of
$0.2 million. CareDx estimates the transaction will not impact its 2026 AEBITDA guidance and plans to provide further guidance following
the close of the transaction.
“Today’s announcement accelerates our growth strategy in
Precision Medicine Testing Services and Patient & Digital Solutions. We are focused on being a leader in concentrated specialty markets
where a high burden of disease drives repeat testing. Naveris fits that profile with a differentiated technology that is early in its
adoption,” said John Hanna, President & CEO of CareDx. “Naveris is poised for strong growth, leveraging our core
capabilities—building belief in molecular testing, simplifying clinical workflow, and generating evidence for coverage
and reimbursement.”
Naveris employs approximately 100 individuals and has performed more
than 130,000 commercial NavDx® tests to-date. The test received Medicare coverage in 2023 and is a leading
solution in Head & Neck and Anal cancer MRD surveillance.
“Naveris has developed and commercialized a liquid biopsy monitoring
platform proven to detect cancer earlier and with greater accuracy than conventional approaches,” said James McNally, Chief Executive
Officer of Naveris. “We are thrilled to be combining forces with CareDx to fulfill our mission of improving patient outcomes by
delivering disruptive technology that transforms cancer care and expanding patient access to precision medicine.”
The parties anticipate the transaction to close in the third quarter
of 2026, subject to customary closing conditions.
Goldman Sachs is acting as the exclusive financial advisor to
CareDx in connection with the transaction. Fenwick and West is acting as legal advisor to CareDx. J.P. Morgan Securities LLC is
acting as the exclusive financial advisor to Naveris in connection with the transaction. Skadden, Arps, Slate, Meagher & Flom
LLP is acting as legal advisor to Naveris.
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 Naveris
A portfolio company of B-FLEXION Life Sciences, Naveris is a
privately held, commercial-stage precision oncology diagnostics company focused on improving outcomes for patients with viral-driven
cancers. Founded in 2017, the Company develops and commercializes novel molecular diagnostics designed to enable earlier cancer
detection and more personalized disease management. Naveris’ proprietary NavDx® test is a clinically validated circulating
tumor DNA blood test that detects tumor tissue–modified viral (TTMV®) HPV DNA to support post-treatment surveillance and
molecular residual disease (MRD) assessment in HPV-driven cancers. The Company operates high-complexity clinical laboratories in
Massachusetts and North Carolina that are accredited by the College of American Pathologists and the New York State Department of
Health Wadsworth Center and certified under CLIA. For more information, please visit www.naveris.com and www.NavDx.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx
including statements regarding the expected completion and timing of the acquisition, the anticipated impact of the transaction on CareDx’s
business, financial profile, and operating results, the benefits of the Naveris product, reimbursement coverage for the Naveris product,
the achievement of CareDx’s financial and operational goals and its expectations and prospects for 2026, the
ability of CareDx to advance Naveris’ platform technologies on a timely basis, if at all, the ability to satisfy all closing conditions
and complete the transaction, difficulties or unanticipated expenses in connection with integrating the companies, 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.
