6-K - MDXH - Equibles

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TORULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

For the month of August 2022

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 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

MDXHEALTH SA

On August 25, 2022, MDxHealth SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1.

The information in the attachedExhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities ExchangeAct of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall they be deemedincorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, exceptas 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 25, 2022.

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 25, 2022	By:	/s/ Michael McGarrity
		Name: Michael McGarrity<br><br> <br>Title: Chief Executive Officer

Exhibit 99.1

NEWS RELEASE - REGULATED INFORMATION<br><br><br><br>25 AUGUST 2022, 4:00PM EDT, 22:00 CET

MDxHealth Reports Half Year 2022 Results

IRVINE, CA, and HERSTAL, BELGIUM – August 25, 2022 – MDxHealth SA (NASDAQ/Euronext: MDXH) (“mdxhealth” or the “Company”), a commercial-stage precision diagnostics company, today announced its financial results for the half year ended June 30, 2022.

Michael K. McGarrity, CEO of mdxhealth, commented: “We are excited to report strong operating results for the first half of 2022, coupled with our recently announced acquisition of the Oncotype DX GPS business from Exact Sciences. Our first half 2022 performance reflects the continued execution of our growth strategy and provides a strong foundation for driving sustained growth for mdxhealth.”

Key Financial and Corporate Highlights forthe half year and quarter ended June 30, 2022:

●	Q2-2022 revenue of $6.9 million, representing<br>an increase of 22% over Q2-2021; H1-2022 revenue of $13.0 million, representing 21% growth over H1-2021
●	Publication of final foundational Local Coverage<br>Determination (LCD) for Biomarkers to Stratify Patients at Increased Risk for Prostate Cancer by Palmetto GBA under its MolDx program,<br>which cites evidence of the clinical utility of Select mdx and is expected to support coverage for qualified Medicare patients throughout<br>the United States and contribute to the Company’s revenue in Q3-2022
---	---
●	Strong evidence supporting our strategy in launching<br>a Urinary Tract Infection (UTI) test, newly branded as Resolve mdx, with over 3,000 tests billed in the first half of 2022
---	---
●	As announced on August 2, 2022, the Company has:
---	---
○	increased its revenue guidance for existing mdxhealth business<br>to $27-29 million for FY 2022, up from previous revenue guidance of $25-27 million, representing anticipated growth of 21%-30% over full<br>year 2021 revenue of $22.2 million
---	---
○	increased<br> its total FY 2022 revenue guidance to $40-42 million, representing anticipated growth of<br> 80%-89% over full year 2021 revenues, inclusive of $13 million in expected revenue for the<br> acquired Oncotype DX GPS business over the August to December 2022 period
---	---

Additional Highlights for the half year andquarter ended June 30, 2022

●	H1-2022 Confirm mdx billable test volume increased<br>5% to 8,409 versus 7,978 for the same period last year; Q2-2022 up 5% from Q2-2021 and up 3% sequentially from Q1-2022
●	Cash and cash equivalents balance as of June<br>30, 2022, was $40.0 million
---	---

Summaryof Billable Test Volume by Product

****	Second Quarter Ended June 30,
Product	2022		2021		% Change
Confirm mdx		4,268		4,065		5	%
Select mdx		3,243		3,792		(14	%)

	Half Year Ended June 30,
Product	2022		2021		% Change
Confirm mdx		8,409		7,978		5	%
Select mdx		6,554		7,051		(7	%)

During the second quarter of 2022, the Company incurred a temporary OEM supply chain issue for our Confirm mdx and Select mdx collection kits that had a negative impact on unit volume, mainly for Select mdx, with no material impact to revenue.

Financial review for the half year endedJune 30, 2022

USD in thousands (except per share data)	Half Year Ended June 30,
Unaudited	2022			2021			% Change
Services		12,975			10,462			24	%
Licenses and royalties		34			269			(87	%)
Total Revenue		13,009			10,731			21	%
Gross Profit		5,772			5,215			11	%
Operating expenses		(22,795	)		(17,658	)		29	%
Operating loss		(17,023	)		(12,443	)		37	%
Net loss		(18,104	)		(13,299	)		36	%
Basic and diluted loss per share		(0.12	)		(0.12	)		0	%

Total revenue for the first half of 2022 was $13.0 million compared to total revenue of $10.7 million for the first half of 2021, an increase of 21%. Services revenue amounted to $13.0 million, an increase of 24% as compared to $10.5 million a year earlier.

Gross profit on products and services for the first half of 2022 was $5.8 million as compared to $5.2 million for the first half of 2021. Gross margins on products and services declined to 44.4% for the first half of 2022 as compared to 48.6% for the same period in 2021, primarily due to timing of cash receipts for our UTI test, which is expected to reverse in the second half of 2022. In addition, we expect coverage of our Select mdx test, as well as our recently acquired Oncotype GPS business, to contribute further to gross margin growth in the second half of 2022.

Operating expenses in the first half of 2022 were $22.8 million versus $17.7 million for the first half of 2021, primarily due to additional public company expenses as a result of the dual listing.

Operating loss and net loss for the first half of 2022 were $17.0 million and $18.1 million, respectively, with losses increasing compared to $12.4 million and $13.3 million, respectively, over the same period in 2021, for the reasons stated above.

Cash and cash equivalents as of June 30, 2022, were $40.0 million. Total cash collections amounted to $12.5 million in H1-2022, an increase of 22% compared to the same period last year, as a result of increased Confirm mdx volume as well as improved average selling prices. Cash use for H1-2022 was $18.6 million compared to $13.1 million in the prior year period.

Outlook

The Company maintains its outlook, as provided in its press release on August 2, 2022, as follows:

●	Revenue guidance for existing mdxhealth business<br>of $27-29 million, representing anticipated growth of 21%-30% over full year 2021 revenue of $22.2 million
●	Revenue guidance for acquired Oncotype DX GPS<br>business of $13 million for the period August to December 2022
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●	Combined full year guidance of $40-42 million,<br>representing anticipated growth of 80%-89% over full year 2021 revenue of $22.2 million
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SubsequentEvents

On August 2, 2022, mdxhealth announced that it entered into an asset purchase agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation (“Exact Sciences”), to acquire the Oncotype DX^®^ GPS (Genomic Prostate Score^®^) test from Exact Sciences along with most of its team of urology sales and marketing professionals. Following the acquisition, the Company’s commercial field organization has expanded to over 70 sales representatives, strategic account managers, and medical science liaisons.

In addition, on August 2, 2022, the Company announced that it obtained debt financing of $35 million under a new loan and security facility with an affiliate of Innovatus Capital Partners, LLC, which replaces the Company’s existing EUR 9 million debt facility with Kreos Capital.

For complete details of the Oncotype DX GPS acquisition as well as the Innovatus debt facility, please refer to the press release issued by the Company on August 2, 2022, which is available on the Company’s website at https://mdxhealth.com/press-releases-events.

About mdxhealth^®^

Mdxhealth is a commercial-stage precision diagnostics company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The Company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers and prognosis of recurrence risk. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and U.S. headquarters and laboratory operations based in Irvine, California, with additional laboratory operations in Plano, Texas. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

Financial statements and auditor review

The Company’s statutory auditor, BDO Bedrijfsrevisoren BV, has confirmed that its review procedures with respect to the Company’s condensed consolidated financial statements as of and for the six-month period ended 30 June 2022, prepared in accordance with the International Financial Reporting Standards as issued by the International Accounting Standards Board (IASB) and as adopted by the EU, have been substantially completed. The aforementioned condensed consolidated financial statements may be found on the Company’s website at www.mdxhealth.com.

For more information:

mdxhealth

info@mdxhealth.com

LifeSci Advisors (IR & PR)

US: +1-949-271-9223

ir@mdxhealth.com

Important information

This press release includes forward-lookingstatements with respect to the anticipated future performance of mdxhealth and the market in which it operates, all of which involvecertain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases suchas “potential,” “expect,” “will,” “goal,” “next,” “potential,”“aim,” “explore,” “forward,” “future,” and “believes” as wellas similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding theacquisition of Oncotype DX^®^ GPS prostate cancer business from Exact Sciences including statements regarding the anticipatedbenefits of the acquisition; statements regarding expected future operating results; statements regarding product development efforts;and statements regarding our strategies, positioning, resources, capabilities and expectations for future events or performance. Suchstatements 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. Important factors that could cause actual results, conditionsand events to differ materially from those indicated in the forward-looking statements include, but are not limited to, risks relatedto potential disruptions in our operations due to the conflict between Russia and Ukraine; risks and uncertainties associated with thecoronavirus (COVID-19) pandemic, including its possible effects on our operations, and the demand for our products; risks related tothe acquisition of the Oncotype DX^®^ GPS prostate cancer business; risks related to our ability to successfully and profitablymarket our products; risks and uncertainties related to the acceptance of our products and services by healthcare providers; risks anduncertainties related to the willingness of health insurance companies and other payers to cover our products and services and adequatelyreimburse us for such products and services; and risks and uncertainties related to the amount and nature of competition for our productsand services. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.In addition, even if our results, performance or achievements are consistent with such forward-looking statements, they may not be predictiveof results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publicationof this release. mdxhealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflectany change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement isbased unless required by law or regulation.

This press release does not constitute an offeror invitation for the sale or purchase of securities or assets of mdxhealth in any jurisdiction. No securities of mdxhealth may be offeredor sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemptiontherefrom, and in accordance with any applicable U.S. securities laws.

NOTE: The mdxhealth logo, mdxhealth,Confirm mdx, Select mdx, Resolve mdx, and Genomic Prostate Score are trademarks or registered trademarks of MDxHealth SA. Oncotype DX andExact Sciences are trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respectiveowners.

For the six months ended June 30, 2022

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS ANDOTHER COMPREHENSIVE INCOME

In thousands of USD (except per share data)

Condensed unaudited consolidated statement of profit or loss


Services	12,975		10,462
Licenses	0		250
Royalties and other revenues	34		19
Revenues	13,009		10,731
Cost of goods & services sold	(7,237	)	(5,516	)
Gross Profit	5,772		5,215
Research and development expenses	(3,585	)	(2,823	)
Selling and marketing expenses	(9,848	)	(8,247	)
General and administrative expenses	(9,636	)	(6,739	)
Other operating income, net	274		151
Operating loss	(17,023	)	(12,443	)
Financial income	27		0
Financial expenses	(1,107	)	(856	)
Loss before income tax	(18,103	)	(13,299	)
Income tax	(1	)	0
Loss for the period	(18,104	)	(13,299	)
Loss for the period attributable to the parent	(18,104	)	(13,299	)
Loss per share attributable to parent
Basic and diluted	(0.12	)	(0.12	)
Condensed unaudited consolidated statement of other comprehensive income
Loss for the period	(18,104	)	(13,299	)
Other comprehensive income
Items that will be reclassified to profit or loss:<br> <br>Exchange differences arising from translation of foreign operations	588		122
Total other comprehensive income	588		122
Total comprehensive loss for the period (net of tax)	(17,516	)	(13,177	)

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

In thousands of USD


ASSETS
Intangible assets	3,104		3,448
Property, plant and equipment	2,364		1,671
Right-of-use assets	3,168		3,347
Non-current assets	8,636		8,466
Inventories	2,089		1,911
Trade receivables	5,036		4,582
Prepaid expenses and other current assets	2,724		1,615
Cash and cash equivalents	40,025		58,498
Current assets	49,874		66,606
Total assets	58,510		75,072
EQUITY
Share capital	128,454		128,454
Issuance premium	153,177		153,177
Accumulated deficit	(262,406	)	(244,302	)
Share-based compensation	10,986		10,607
Foreign currency translation reserves	(449	)	(1,037	)
Total equity	29,762		46,899
LIABILITIES
Deferred tax liability	129		0
Loans and borrowings	3,291		7,651
Lease liabilities	2,454		2,624
Other non-current financial liabilities	1,934		1,466
Non-current liabilities	7,808		11,741
Loans and borrowings	7,760		4,441
Lease liabilities	870		840
Trade payables	9,836		7,455
Other current liabilities	2,062		2,735
Other current financial liabilities	412		961
Current liabilities	20,940		16,432
Total liabilities	28,748		28,173
Total equity and liabilities	58,510		75,072

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS

In thousands of USD


CASH FLOWS FROM OPERATING ACTIVITIES
Operating loss	(17,023	)	(12,443	)
Depreciation and amortization	1,576		1,514
Share-based compensation	379		486
Non-cash fair value change	(20	)	(195	)
Non-cash foreign exchange rate change	30		(339	)
Cash generated from operations before working capital changes	(15,058	)	(10,977	)
Changes in operating assets and liabilities
(Increase)/decrease in inventories	(178	)	205
Increase in receivables	(1,563	)	(474	)
Increase/(decrease) in payables	1,708		(396	)
Net cash outflow from operating activities	(15,091	)	(11,642	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment	(925	)	(411	)
Purchase of intangible assets	(451	)	0
Interests received	27		0
Net cash outflow from investing activities	(1,349	)	(411	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of shares, net of transaction costs	0		28,336
Payment of loan obligation	(439	)	0
Payment of lease liability	(663	)	(536	)
Payment of interest	(511	)	(515	)
Net cash inflow from financing activities	(1,613	)	27,285
Net increase in cash and cash equivalents	(18,053	)	15,232
Cash and cash equivalents at beginning of the period	58,498		15,953
Effect of exchange rates	(420	)	133
Cash and cash equivalents at end of the period	40,025		31,318