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6-K 1 ea0301975-6k_mdxhealth.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of August 2026

 

Commission File Number 001-40996

 

MDXHEALTH SA

(Translation of registrant’s name into English)

 

CAP Business Center

Zone Industrielle des Hauts-Sarts

4040 Herstal, Belgium

+32 4 257 70 21

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F        Form 40-F

 

 

 

 

 

MDXHEALTH SA

 

On August 13, 2026, MDxHealth SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1.

 

The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the 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 made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

 

Exhibit No.   Description of Exhibit
99.1   Press Release, dated August 13, 2026

 

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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, thereunto duly authorized.

 

  MDXHEALTH SA
     
Date: August 13, 2026 By: /s/ Michael McGarrity
    Name:  Michael McGarrity
    Title: Chief Executive Officer

 

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EX-99.1 2 ea030197501ex99-1.htm PRESS RELEASE, DATED AUGUST 13, 2026

Exhibit 99.1

 

Mdxhealth Reports Second Quarter 2026 Financial Results

 

Second quarter revenue growth of 16% to $27.2 million

Conference call with Q&A today at 4:30 PM EST / 22:30 CET

 

IRVINE, California – August 13, 2026 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a leader in urology-focused precision diagnostics, today announced its financial results for the second quarter ended June 30, 2026.

 

Michael K. McGarrity, CEO of mdxhealth, commented: “We delivered sequential revenue growth of $3.3 million from Q1 to Q2, establishing a clear path toward meeting or exceeding our 2026 revenue guidance of $110-115 million, which represents 20-26% growth over 2025 (excluding Resolve). Importantly, the commercial team’s successful transition of all our Resolve customers by June 30, coupled with the integration of the ExoDx business and our sales force restructuring over the past two quarters, is reflected in the strong recovery of our tissue-based business in Q2.

 

We expect our tissue growth rates to accelerate further throughout the second half of the year, driving a return to positive adjusted EBITDA as we exit 2026. These results underscore our track record of operating discipline and commercial execution. Combined with a strengthened balance sheet, we are well-positioned to drive sustainable revenue growth and profitability.

 

Finally, our recent peer-reviewed publication of the GPS PROMPT results from the Oxford study, alongside our ongoing AI initiatives, provides compelling support for expanding our market conversion and share gains in the active surveillance population ahead of our landmark PROTECT study.”

 

Key Highlights for the second quarter from continuing operations:

 

Revenue of $27.2 million, an increase of 16% over prior year period, and a sequential increase of $3.3 million over Q1

 

Operating loss of $5.1 million compared to $1.5 million for second quarter of 2025, primarily due to increased operating expenses related to the ExoDx acquisition

 

Net loss of $9.5 million, an increase of 36% over prior year period

 

Adjusted EBITDA of $(2.3) million compared to $1.1 million for the same period last year

 

Tissue-based (Confirm mdx and GPS mdx) test volume of 12,525, a decrease of 1% over prior year period, but a 13% sequential increase over Q1

 

Liquid-based (Exo mdx) test volume of 13,578 compared to Select mdx volume of 4,455 for the same period last year

 

Period-end cash and cash equivalents balance of $19.2 million

 

Results exclude Resolve mdx, which has been discontinued and accounted for as a “discontinued operation” for the current and prior year periods.

 

Discontinuation of the Resolve mdx Business

 

As previously announced in our first-quarter update, the Company made the strategic decision to discontinue the Resolve UTI offering to renew our focus on our core prostate cancer business. We successfully completed this wind-down in Q2, with the permanent cessation of operations of our wholly-owned subsidiary Delta Laboratories, LLC (“Delta Lab”) and its Plano, Texas laboratory prior to June 30, 2026. Having met the requisite accounting criteria, the Resolve business is now formally classified as a discontinued operation in accordance with IFRS. As required by these reporting standards, all current and prior-year financial metrics discussed in this release and related financial statements reflect only our continuing core operations, with the historical results of the Resolve business fully excluded.

 

 

 

In connection with the wind-down of Resolve, on August 3, 2026, Delta Lab executed an Assignment for the Benefit of Creditors (“ABC”), assigning all assets and liabilities of Delta Lab to a receiver who will have broad powers and authority to take possession of, and protect and preserve, the assets of Delta Lab, and provide creditors of Delta Lab the opportunity to file proofs of claims. The ABC was executed in order to expedite an orderly sale and disposition of the assets of Delta Lab and pay claims in order of priority, inclusive of the previously disclosed Novitas Solutions’ $10.4 million recoupment claim received by Delta Lab in relation to certain of its historical Resolve mdx claims. The ABC process is limited solely to Delta Lab, which has been independently operated since it was acquired in 2022.

 

Registered Direct Placement

 

On August 11, 2026, the Company executed a registered direct placement of 44,052,862 ordinary shares of the Company without nominal value (“Ordinary Shares”) at the Nasdaq closing price-per-share of $0.454 on August 10, 2026, for total gross proceeds of $20 million before deducting estimated offering expenses. The shares were sold to institutional investors, including some of the Company’s largest shareholders, and were placed directly by the Company under its shelf registration statement on Form S-3 filed on February 17, 2026.

 

Financial review of continuing operations for the three and six months ended, June 30, 2026 and 2025

 

    Three months ended June 30     Six months ended June 30  
USD in ’000 (except per share data) Unaudited   2026     2025
(re-presented*)
    % Change     2026     2025
(re-presented*)
    % Change  
Revenue     27,209       23,394       16 %     51,106       44,957       14 %
Cost of sales (exclusive of amortization of intangible assets)     (9,320 )     (7,335 )     27 %     (18,547 )     (14,438 )     28 %
Gross Profit     17,889       16,059       11 %     32,559       30,519       7 %
Operating expenses     (22,988 )     (17,578 )     31 %     (45,822 )     (36,735 )     25 %
Operating loss     (5,099 )     (1,519 )     236 %     (13,263 )     (6,216 )     113 %
Net loss     (9,478 )     (6,960 )     36 %     (19,174 )     (16,262 )     18 %
Adjusted EBITDA**     (2,294 )     1,071       n/a       (7,633 )     (530 )     n/a  
Basic and diluted loss per share     (0.18 )     (0.14 )     29 %     (0.37 )     (0.33 )     12 %

 

* Comparative information has been re-presented to reflect the classification of the Resolve business as a discontinued operation

 

** A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading “Non-IFRS Measures

 

Results from continuing operations for the three months ended June 30, 2026

 

Revenue increased 16% to $27.2 million compared to $23.4 million for the prior year. Revenue in the second quarter of 2026 and 2025 was comprised of 73% and 96% from tissue-based tests, respectively.

 

Gross profit increased 11% to $17.9 million compared to $16.1 million for the prior year. Gross margins were 65.7% as compared to 68.6% for the prior year, a reduction of 2.9 percentage points, primarily attributed to test mix.

 

Operating loss increased 236% to $5.1 million compared to $1.5 million for the prior year, driven by increased operating expenses related to the ExoDx acquisition in September 2025.

 

Net loss increased 36% to $9.5 million compared to $7.0 million for the prior year, primarily driven by higher operating expenses related to the ExoDx acquisition in September 2025.

 

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Adjusted EBITDA was ($2.3) million compared to $1.1 million for the same period last year.

 

A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading “Non-IFRS Disclosure.”

 

Results from continuing operations for the six months ended June 30, 2026

 

Revenue increased 14% to $51.1 million compared to $45.0 million for the prior year. Revenue in the first six months of 2026 and 2025 was comprised of 75% and 96% from tissue-based tests, respectively.

 

Gross profit increased 7% to $32.6 million compared to $30.5 million for the prior year. Gross margins were 63.7% as compared to 67.9% for the prior year, a reduction of 4.2 percentage points, primarily attributed to test mix.

 

Operating loss increased 113% to $13.3 million compared to $6.2 million for the prior year, driven by increased operating expenses related to the ExoDx acquisition in September 2025.

 

Net loss increased 18% to $19.2 million compared to $16.3 million for the prior year, primarily driven by higher operating expenses related to the ExoDx acquisition in September 2025.

 

Adjusted EBITDA was ($7.6) million compared to ($0.5) million for the same period last year.

 

A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading “Non-IFRS Disclosure.”

 

Cash and cash equivalents as of June 30, 2026, were $19.2 million. Pro-forma cash balance as of June 30, 2026, including the $20 million in gross proceeds from the registered direct placement discussed above, equals $39.2 million.

 

Conference Call

 

Michael K. McGarrity, Chief Executive Officer, and Ron Kalfus, Interim Chief Financial Officer, will host a conference call and Q&A session today at 4:30 PM EST / 22:30 CET. The call will be conducted in English and a replay will be available for 30 days.

 

To participate in the conference call, please select your phone number below:

 

United States: 1-833-309-3473

Belgium: 0800 72 519

United Kingdom: 0808 101 1183

Conference ID: MDX2Q26

 

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1768432&tp_key=e5dee9dbef

 

To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start time.

 

About mdxhealth

 

Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests, based on proprietary genomic, epigenomic, exosomal and other molecular technologies, assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

 

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Non-IFRS disclosure

 

In addition to the Company’s financial results determined in accordance with IFRS, the Company provides adjusted EBITDA and adjusted EBITDA margin, non-IFRS measures that the Company determines to be useful in evaluating its operating performance. The Company defines adjusted EBITDA as net loss from continuing operations less interest expense, depreciation and amortization of intangible assets, impairment, share-based compensation, fair-value adjustments, provision for inventory obsolescence, reduction in force severance costs, ExoDx acquisition expenses, amendments related to the Exact Sciences earnout, income tax benefit (expense), and other financial and non-cash expenses. Management believes that presentation of non-IFRS financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Adjusted EBITDA margin is calculated as adjusted EBITDA divided by total revenue. The Company uses this non-IFRS financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. However, non-IFRS financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with IFRS. For example, non-IFRS adjusted EBITDA excludes a number of expense items that are included in net loss. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. The Company’s presentation of expected non-IFRS adjusted EBITDA is a forward-looking statement about the Company’s future financial performance. This non-IFRS measure includes adjustments like share-based compensation, debt extinguishment costs, fair-value adjustments related to contingent considerations that are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. Additionally, management does not forecast many of the excluded items for internal use. Information reconciling forward-looking non-IFRS measures to IFRS measures is therefore not available without unreasonable effort and is not provided. The occurrence, timing, and amount of any of the items excluded from IFRS to calculate non-IFRS could significantly impact the Company’s IFRS results.

 

Forward-Looking Statement: This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “potential,” “expect,” “will,” “goal,” “next,” “potential,” “aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding expected future operating results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated timing and benefits of our acquisitions, including estimated synergies and other financial impacts. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, product development efforts, our strategies, positioning, resources, capabilities and expectations for future events or performance. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; changes in payer claims reimbursement practices and MDxHealth estimates regarding collection amounts for tests; the results of recoupment decisions and related appeals; the impacts and effectiveness of exiting from discontinued operations; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and results of our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements; our ability to remain in compliance with financial covenants made to and make scheduled payments to our creditors; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the ExoDx and GPS prostate cancer businesses will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.

 

NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS mdx, Exosome Diagnostics, ExosomeDx, Exo mdx, ExoDx, ExoDx Prostate Intelliscore (EPI), and Monitor mdx are trademarks or registered trademarks of MDxHealth SA and its affiliates. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others. The Oncotype DX trademark and all other trademarks and service marks, are the property of their respective owners.

 

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CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS

 

    Three months ended     Six months ended  
    June 30,     June 30,  
          2025           2025  
Thousands of $ (except per share data)   2026     (re- presented*)     2026     (re- presented*)  
–Continuing operations–                        
Revenues     27,209       23,394       51,106       44,957  
Cost of sales (exclusive of amortization of intangible assets)     (9,320 )     (7,335 )     (18,547 )     (14,438 )
Gross profit     17,889       16,059       32,559       30,519  
Research and development expenses     (1,995 )     (1,859 )     (4,129 )     (4,347 )
Selling and marketing expenses     (11,412 )     (8,824 )     (22,804 )     (17,816 )
General and administrative expenses     (8,186 )     (6,144 )     (16,235 )     (11,899 )
Amortization of intangible assets     (1,256 )     (1,312 )     (2,513 )     (2,626 )
Other operating (expense) income, net     (139 )     561       (141 )     (47 )
Operating loss     (5,099 )     (1,519 )     (13,263 )     (6,216 )
Financial income     1,701       501       2,855       1,108  
Financial expenses     (6,080 )     (6,358 )     (8,766 )     (11,433 )
Loss before income tax     (9,478 )     (7,376 )     (19,174 )     (16,541 )
Income tax benefit     0       416       0       279  
Loss from continuing operations     (9,478 )     (6,960 )     (19,174 )     (16,262 )
–Discontinued operations–                                
Loss from discontinued operations, net of tax     (2,054 )     (412 )     (1,225 )     (319 )
Loss for the period attributable to owners of the parent     (11,532 )     (7,372 )     (20,399 )     (16,581 )
                                 
Loss per share attributable to owners of the parent                                
Basic and diluted loss per share from continuing operations     (0.18 )     (0.14 )     (0.37 )     (0.33 )
Basic and diluted loss per share from discontinued operations     (0.04 )     (0.01 )     (0.03 )     0.00  
Total basic and diluted loss per share     (0.22 )     (0.15 )     (0.40 )     (0.33 )

 

* Comparative information has been re-presented to reflect the classification of the Resolve business as a discontinued operation.

 

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CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

 

Thousands of $   As of
June 30,
2026
    As of
December 31,
2025
 
ASSETS            
Non-current assets            
Goodwill     39,252       38,948  
Intangible assets     36,709       39,424  
Property, plant and equipment     3,608       4,855  
Right-of-use assets     8,290       9,821  
Financial assets     1,199       1,496  
Total non-current assets     89,058       94,544  
                 
Current assets                
Assets held-for-sale     0       940  
Inventories     6,433       6,741  
Trade receivables     14,926       14,675  
Prepaid expenses and other current assets     2,462       2,021  
Cash and cash equivalents     19,207       29,032  
Total current assets     43,028       53,409  
TOTAL ASSETS     132,086       147,953  
                 
EQUITY                
Share capital     219,209       219,209  
Issuance premium     153,177       153,177  
Accumulated deficit     (423,433 )     (403,034 )
Share-based compensation     21,297       19,335  
Translation reserve     (654 )     (781 )
Total equity     (30,404 )     (12,094 )
                 
LIABILITIES                
Non-current liabilities                
Loans and borrowings     96,408       76,197  
Lease liabilities     7,634       8,509  
Other non-current financial liabilities     21,046       25,807  
Total non-current liabilities     125,088       110,513  
                 
Current liabilities                
Loans and borrowings     0       0  
Lease liabilities     1,804       1,898  
Trade payables     10,569       10,330  
Other current liabilities     6,945       6,741  
Other current financial liabilities     18,084       30,565  
Total current liabilities     37,402       49,534  
Total liabilities     162,490       160,047  
TOTAL EQUITY AND LIABILITIES     132,086       147,953  

 

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CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS

 

Thousands of $            
For the six months ended June 30,   2026     2025  
CASH FLOWS FROM OPERATING ACTIVITIES            
Operating loss     (14,425 )     (6,504 )
Depreciation     2,253       1,871  
Amortization of intangible assets     2,529       2,642  
Impairment     914       0  
Provision for inventory obsolescence     901       528  
Share-based compensation     1,167       1,071  
Other non-cash transactions     (47 )     70  
Cash used in operations before working capital changes     (6,708 )     (322 )
                 
Changes in operating assets and liabilities                
Increase (-) in inventories     (594 )     (317 )
Increase (-) in receivables     (692 )     (1,083 )
Increase (+) decrease (-) in payables     654       (2,507 )
Net cash outflow from operating activities     (7,340 )     (4,229 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES                
Purchase of property, plant and equipment     (401 )     (840 )
ExoDx acquisition-related working capital adjustment     (304 )     0  
Payment for Innovation Platform     (329 )     0  
Earnout payment (GPS acquisition)     (7,479 )     (19,658 )
Interest received     354       922  
Net cash outflow from investing activities     (8,159 )     (19,576 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from loan obligation     19,400       24,250  
Earnout payment (GPS acquisition)     (6,521 )     (8,313 )
Repayment of loan obligations, loan modifications, and debt extinguishment costs     0       (324 )
Payment of lease liability     (1,393 )     (1,032 )
Payment of interest     (5,520 )     (4,554 )
Other financial expense     (290 )     (227 )
Net cash inflow from financing activities     5,676       9,800  
                 
Net decrease in cash and cash equivalents     (9,823 )     (14,005 )
                 
Cash and cash equivalents at beginning of the period     29,032       46,798  
Effect of exchange rates     (2 )     18  
Cash and cash equivalents at end of the period     19,207       32,811  

 

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UNAUDITED RECONCILIATION OF IFRS TO NON-IFRS FINANCIAL MEASURES

 

    Three months ended     Six months ended  
    June 30,     June 30,  
          2025           2025  
Thousands of $   2026     (re-presented*)     2026     (re-presented*)  
                         
IFRS net loss from continuing operations     (9,478 )     (6,960 )     (19,174 )     (16,262 )
Amortization of intangible assets     1,256       1,312       2,513       2,626  
Depreciation expense     998       796       1,992       1,568  
Impairment     0       0       0       0  
Interest expense, net     3,538       2,640       6,351       4,483  
Share-based compensation expense     605       680       1,167       1,071  
Reduction in force severance costs     0       351       0       351  
Income tax expense     0       (416 )     0       (279 )
Fair value adjustments (1)     686       3,088       (711 )     5,635  
Other adjustments (2)     101       (420 )     229       277  
Adjusted EBITDA     (2,294 )     1,071       (7,633 )     (530 )

 

* Comparative information has been re-presented to reflect the classification of the Resolve business as a discontinued operation.

 

1) Primarily related to GPS and ExoDx contingent considerations, option to pay Bio-Techne and Exact Sciences earnout in shares, and Exact Sciences 5-year warrants

 

2) Bank fees and other non-cash expenses

 

For more information:

 

info@mdxhealth.com

 

LifeSci Advisors (IR & PR)

 

John Fraunces

Managing Director

Tel: +1 917 355 2395

Jfraunces@lifesciadvisors.com

 

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