6-K

MDxHealth SA (MDXH)

6-K 2025-05-14 For: 2025-05-14
View Original
Added on April 06, 2026

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549


FORM6-K


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

UNDERTHE SECURITIES EXCHANGE ACT OF 1934

Forthe month of May 2025

CommissionFile Number 001-40996

MDXHEALTHSA

(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 ☐

MDXHEALTHSA

INCORPORATIONBY REFERENCE


Exhibit 99.1 of this report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Statements No. 333-268885 and 333-280606) of MDxHealth SA (the “Company,” “we,” “us” and “our”) (including any prospectuses forming a part of such registration statement) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

On May 14, 2025, the Company issued a press release, a copy of which is attached hereto as Exhibit 99.2.

Theinformation in the attached Exhibit 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of thatSection, 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 Financial Results for the First Quarter and the Three-Month Period Ended March 31, 2025
99.2 Press Release, dated May 14, 2025
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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: May 14, 2025 By: /s/<br> Michael McGarrity
Name: Michael McGarrity
Title: Chief Executive Officer
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Exhibit 99.1

MDxHealth<br> SA and Subsidiaries

UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS


Three Months Ended <br> March 31,
In thousands of $ (except per share amounts) 2025 2024
Revenues $ 24,292 $ 19,834
Cost of sales (exclusive of amortization of intangible assets) (8,788 ) (7,771 )
Gross profit 15,504 12,063
Research and development expenses (2,499 ) (2,164 )
Selling and marketing expenses (9,821 ) (10,028 )
General and administrative expenses (5,842 ) (5,359 )
Amortization of intangible assets (1,322 ) (1,125 )
Other operating (expense) income, net (608 ) 9
Operating loss (4,588 ) (6,604 )
Financial income 692 1,371
Financial expenses (5,176 ) (3,278 )
Loss before income tax (9,072 ) (8,511 )
Income tax (137 )
Loss for the period $ (9,209 ) $ (8,511 )
Loss per share attributable to parent
Basic and diluted $ (0.19 ) $ (0.31 )

UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION


Thousandsof $ March 31, <br> 2025 December 31,<br> 2024
ASSETS
Non-current assets
Goodwill $ 35,926 $ 35,926
Intangible assets 39,270 40,592
Property, plant and equipment 4,328 4,363
Right-of-use assets 8,199 8,617
Financial assets 777 936
Total non-current assets 88,500 90,434
Current assets
Inventories 3,326 3,869
Trade receivables 15,542 14,440
Prepaid expenses and other current assets 1,793 1,788
Cash and cash equivalents 65,672 46,798
Total current assets 86,333 66,895
TOTAL ASSETS $ 174,833 $ 157,329
EQUITY
Share capital $ 214,670 $ 214,670
Issuance premium 153,177 153,177
Accumulated deficit (378,724 ) (369,515 )
Share-based compensation 17,515 17,124
Translation reserve (670 ) (615 )
Total equity 5,968 14,841
LIABILITIES
Non-current liabilities
Loans and borrowings 75,368 50,967
Lease liabilities 7,056 7,413
Other non-current financial liabilities 43,281 41,445
Total non-current liabilities 125,705 99,825
Current liabilities
Loans and borrowings 162 324
Lease liabilities 1,392 1,360
Trade payables 7,552 8,001
Other current liabilities 6,474 6,567
Other current financial liabilities 27,580 26,411
Total current liabilities 43,160 42,663
Total liabilities 168,865 142,488
TOTAL EQUITY AND LIABILITIES $ 174,833 $ 157,329
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UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

Thousands of $ Three Months Ended<br><br> March 31,
For the years ended December 31 2025 2024
CASH FLOWS FROM OPERATING ACTIVITIES
Operating loss $ (4,588 ) $ (6,604 )
Depreciation 925 775
Amortization of intangible assets 1,322 1,125
Share-based compensation 391 168
Other non-cash transactions 619 (1 )
Cash used in operations before working capital changes (1,331 ) (4,537 )
Decrease (+) / increase (-) in inventories 543 (265 )
Increase (-) in receivables (1,107 ) (1,392 )
Decrease (-) / increase (+) in payables (737 ) 679
Net cash outflow from operating activities (2,632 ) (5,515 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment (476 ) (220 )
Acquisition and generation of intangible assets (544 )
Interests received 489 146
Net cash outflow from investing activities 13 (618 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from loan obligation, net of fees 24,250
Repayment of loan obligation (162 ) (160 )
Payment of lease liability (516 ) (475 )
Payment of interest (1,959 ) (947 )
Other financial expenses (127 ) (170 )
Net cash (outflow) / inflow from financing activities 21,486 (1,752 )
Net increase (+) / decrease (-) in cash and cash equivalents 18,867 (7,885 )
Cash and cash equivalents at beginning of period 46,798 22,380
Effect on exchange rate changes 7 (1 )
Cash and cash equivalents at end of period $ 65,672 $ 14,494
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Exhibit99.2

MDxHealthReports Q1-2025 Results

Year-over-yearQ1 revenues increase by 22% to $24.3 million

71%year-over-year improvement in adjusted EBITDA in first quarter

Conferencecall with Q&A today at 4:30 PM ET / 22:30 CET

IRVINE,CA, and HERSTAL, BELGIUM – May 14, 2025 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a leading precision diagnostics company, today announced its financial results for the first quarter ended March 31, 2025.

MichaelK. McGarrity, CEO of mdxhealth, commented: “mdxhealth delivered a strong first quarter, marked by our 16^th^ consecutive quarter of 20% or greater revenue growth, fueled by continued execution by our team and strong demand for our precision diagnostics. Our expanded test menu continues to gain traction, and our commercial team is successfully increasing penetration in the urology market we serve. Based on the strength of our business and our solid execution, we are reiterating our 2025 revenue guidance of $108-110 million, and expect to reach adjusted EBITDA profitability in the second quarter of 2025.”

Keyhighlights for the first quarter of 2025:

Revenue<br> of $24.3 million, an increase of 22% over prior year period
Adjusted<br> EBITDA of ($1.3) million, a 71% improvement over prior year period
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Tissue-based<br> (Confirm mdx and GPS) test volume of 12,677, an increase of 41% over prior year period
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Liquid-based<br> (Select mdx, Resolve mdx, Germline) test volume of 11,530, an increase of 9% over prior year<br> period
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Quarter-end<br> cash and cash equivalents balance of $65.7 million
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Financialreview for the quarter ended March 31, 2025


Quarter Ended March 31
USD in thousands (except per share data) Unaudited 2025 2024 % Change
Revenue 24,292 19,834 22 %
Cost of goods (8,788 ) (7,771 ) 13 %
Gross Profit 15,504 12,063 29 %
Operating expenses (20,092 ) (18,667 ) 8 %
Operating loss (4,588 ) (6,604 ) (31 )%
Net loss (9,209 ) (8,511 ) 8 %
Adjusted EBITDA* (1,331 ) (4,537 ) (71 )%
Basic and diluted loss per share (0.19 ) (0.31 ) (39 )%

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

Revenue increased 22% to $24.3 million compared to $19.8 million for the prior year period. Tissue-based tests accounted for 85% and 79% of total first quarter 2025 and 2024 revenue, respectively.

Gross profit increased 29% to $15.5 million compared to $12.1 million for the prior year period. Gross margins were 63.8% compared to 60.8% for the prior year period, an improvement of 3.0 percentage points primarily attributed to our test mix.

Operating expenses increased 8% to $20.1 million compared to $18.7 million for the prior year period, primarily driven by increases in clinical trials expenses, stock-based compensation, and overall scale.

Net loss increased 8% to $9.2 million compared to $8.5 million for the year period, primarily driven by non-cash fair value adjustments of $2.5 million. Excluding these non-cash fair value adjustments, our net loss would have decreased 17% to $6.7 million.

Adjusted EBITDA was ($1.3) million, an improvement of 71% compared to ($4.5) 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 March 31, 2025, were $65.7 million.

SubsequentEvents

On April 29, 2025, mdxhealth made its 2024 earnout payment to Exact Sciences in the amount of $28.0 million. After taking into account this earnout payment, our pro-forma cash balance as of March 31, 2025, would have been $37.7 million.


ConferenceCall


Michael K. McGarrity, Chief Executive Officer and Ron Kalfus, 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- 844-825-9789


Belgium: 0800 38 961


The Netherlands: 0800 94 94 506


United Kingdom: 0808 238 9064


Conference ID: 10199102


Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1716341&tp_key=092e4b795e

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

Aboutmdxhealth


Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis and prognosis of urologic cancers and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Plano, Texas. European headquarters are in Herstal, Belgium. 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-IFRSDisclosure


In addition to the Company’s financial results determined in accordance with IFRS, the Company provides adjusted EBITDA, a non-IFRS measure that the Company determines to be useful in evaluating its operating performance. The Company defines adjusted EBITDA as net loss less interest expense, depreciation and amortization of intangible assets, share-based compensation, fair-value adjustments, debt extinguishment costs, 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. 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-LookingStatement: This press release contains forward-looking statements and estimates with respect to the anticipated future performanceof MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, butare 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 limitedto, statements regarding expected future operating results; our strategies, positioning, resources, capabilities and expectations forfuture events or performance; and the anticipated 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, whichwere deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyondthe 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 eventsto differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfullyand profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintainadequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; thewillingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such productsand services; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and resultsof our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operatingexpenses and capital expenditure requirements; our ability to remain in compliance with financial covenants made to and make scheduledpayments to our creditors; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the OncotypeDX® GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and the amountand nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sectionsof our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expresslydisclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations withregard 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 and Monitor mdx are trademarks or registeredtrademarks of MDxHealth SA. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursementdecisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and OncotypeDx Prostate Cancer Assay, among others. The Oncotype DX trademark, and all other trademarks and service marks, are the property of theirrespective owners.

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MDxHealth<br> SA and Subsidiaries

UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS


Three Months Ended <br> March 31,
In thousands of $ (except per share amounts) 2025 2024
Revenues $ 24,292 $ 19,834
Cost of sales (exclusive of amortization of intangible assets) (8,788 ) (7,771 )
Gross profit 15,504 12,063
Research and development expenses (2,499 ) (2,164 )
Selling and marketing expenses (9,821 ) (10,028 )
General and administrative expenses (5,842 ) (5,359 )
Amortization of intangible assets (1,322 ) (1,125 )
Other operating (expense) income, net (608 ) 9
Operating loss (4,588 ) (6,604 )
Financial income 692 1,371
Financial expenses (5,176 ) (3,278 )
Loss before income tax (9,072 ) (8,511 )
Income tax (137 )
Loss for the period $ (9,209 ) $ (8,511 )
Loss per share attributable to parent
Basic and diluted $ (0.19 ) $ (0.31 )
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UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION


Thousands of $ March 31, <br> 2025 December 31,<br> 2024
ASSETS
Non-current assets
Goodwill $ 35,926 $ 35,926
Intangible assets 39,270 40,592
Property, plant and equipment 4,328 4,363
Right-of-use assets 8,199 8,617
Financial assets 777 936
Total non-current assets 88,500 90,434
Current assets
Inventories 3,326 3,869
Trade receivables 15,542 14,440
Prepaid expenses and other current assets 1,793 1,788
Cash and cash equivalents 65,672 46,798
Total current assets 86,333 66,895
TOTAL ASSETS $ 174,833 $ 157,329
EQUITY
Share capital $ 214,670 $ 214,670
Issuance premium 153,177 153,177
Accumulated deficit (378,724 ) (369,515 )
Share-based compensation 17,515 17,124
Translation reserve (670 ) (615 )
Total equity 5,968 14,841
LIABILITIES
Non-current liabilities
Loans and borrowings 75,368 50,967
Lease liabilities 7,056 7,413
Other non-current financial liabilities 43,281 41,445
Total non-current liabilities 125,705 99,825
Current liabilities
Loans and borrowings 162 324
Lease liabilities 1,392 1,360
Trade payables 7,552 8,001
Other current liabilities 6,474 6,567
Other current financial liabilities 27,580 26,411
Total current liabilities 43,160 42,663
Total liabilities 168,865 142,488
TOTAL EQUITY AND LIABILITIES $ 174,833 $ 157,329
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UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

Thousands of $ Three Months Ended<br><br> March 31,
For the years ended<br>December 31 2025 2024
CASH FLOWS FROM OPERATING ACTIVITIES
Operating loss $ (4,588 ) $ (6,604 )
Depreciation 925 775
Amortization of intangible assets 1,322 1,125
Share-based compensation 391 168
Other non-cash transactions 619 (1 )
Cash used in operations before working capital changes (1,331 ) (4,537 )
Decrease (+) / increase (-) in inventories 543 (265 )
Increase (-) in receivables (1,107 ) (1,392 )
Decrease (-) / increase (+) in payables (737 ) 679
Net cash outflow from operating activities (2,632 ) (5,515 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment (476 ) (220 )
Acquisition and generation of intangible assets (544 )
Interests received 489 146
Net cash outflow from investing activities 13 (618 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from loan obligation, net of fees 24,250
Repayment of loan obligation (162 ) (160 )
Payment of lease liability (516 ) (475 )
Payment of interest (1,959 ) (947 )
Other financial expenses (127 ) (170 )
Net cash (outflow) / inflow from financing activities 21,486 (1,752 )
Net increase (+) / decrease (-) in cash and cash equivalents 18,867 (7,885 )
Cash and cash equivalents at beginning of period 46,798 22,380
Effect on exchange rate changes 7 (1 )
Cash and cash equivalents at end of period $ 65,672 $ 14,494
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UNAUDITEDRECONCILIATION OF IFRS TO NON-IFRS FINANCIAL MEASURES


Three Months Ended <br> March 31,
In thousands of $ (except per share amounts) 2025 2024
IFRS net loss $ (9,209 ) $ (8,511 )
Amortization of intangible assets 1,322 1,125
Depreciation expense 925 775
Share-based compensation expense 391 168
Interest expense, net 1,859 1,218
Income tax expense 137
Fair value adjustments (1) 2,547 519
Other adjustments (2) 697 169
Adjusted EBITDA $ (1,331 ) $ (4,537 )

1) Primarily<br>related to GPS contingent consideration, Exact Sciences 5-year warrants, and option to pay Exact Sciences earnout in shares
2) Bank<br>fees and other non-cash expenses
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Formore information:

info@mdxhealth.com

LifeSciAdvisors (IR & PR)

JohnFraunces

ManagingDirector

Tel: +1 917 355 2395

Jfraunces@lifesciadvisors.com

ir@mdxhealth.com


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