6-K - MDXH - Equibles

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORM6-K

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

SECURITIESEXCHANGE ACT OF 1934

Forthe month of March 2022

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 ☐

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.

MDXHEALTHSA

On March 2, 2022, MDxHealth SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1. On March 2, 2022, the Company posted to its website its financial results as of December 31, 2021, a copy of which is attached hereto as Exhibit 99.2.

Theinformation in the attached Exhibit 99.1 and Exhibit 99.2 is being furnished and shall not be deemed “filed” for thepurposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwisesubject to the liabilities of that Section, nor shall they be deemed incorporated by reference in any filing made by the Companyunder the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly setforth by specific reference in such a filing.

Exhibit No.	Description of Exhibit
99.1	Press Release, dated March 2, 2022.
99.2	2021 Financial Results, as of December 31, 2021.

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:<br> March 3, 2022	By:	/s/<br> Michael McGarrity
		Name:<br> Michael McGarrity
		Title:<br> Chief Executive Officer

Exhibit 99.1

NEWS RELEASE - REGULATED INFORMATION<br><br> <br>2 MARCH 2022, 4:00 PM EST / 22:00 CET

MDxHealth ReportsFinancial Year 2021 Results

and ProvidesOutlook and Guidance for 2022

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

IRVINE, CA, and HERSTAL, BELGIUM – March 2, 2022 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today announced its financial results for the fourth quarter and year ended December 31, 2021 and provided a business update and outlook for 2022.

2021 Business Highlights

●	Revenues<br> for the fourth quarter ended December 31, 2021, increased by 46% to $6.0 million compared<br> to the same period last year
●	Revenues for full year 2021 increased by 20%<br>to $22.2 million compared to full year 2020
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●	Draft<br> Local Coverage Determination (LCD) for Biomarkers for Prostate Cancer published by Palmetto<br> GBA (under its MolDx program) citing evidence of the clinical utility of SelectMDx^®^
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●	Strengthened balance sheet through successful initial public offering (IPO)<br>on the NASDAQ, raising gross proceeds of $45 million
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Michael K. McGarrity, CEO of MDxHealth, commented: “While 2021 presented continued headwinds related to the pandemic and its continued effect on patient flow for our particular patient population in prostate cancer, we have made significant progress and we believe our results provide evidence that MDxHealth will emerge from this challenging period with strong and sustainable growth.

“We believe this progress is evidenced by the following:

●	Publication of draft 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 SelectMDx® and, when finalized, is expected to support coverage for qualified Medicare<br>patients throughout the United States;
●	Improvement in cash collections and capital allocation,<br>driven by continued focus on operating discipline;
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●	Advancement of development programs to expand<br>our prostate cancer menu into Active Surveillance;
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●	Introduction of novel Urinary Tract Infection<br>(UTI) testing services into our urology channel which we are confident will contribute to our total revenue in 2022.”
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Highlightsfor the fourth quarter and year ended December 31, 2021

●	Revenues for the fourth quarter ended December<br>31, 2021, increased by 46% to $6.0 million versus $4.1 million for the same period last year
●	2021 revenues increased by 20% to $22.2 million<br>versus $18.5 million for 2020
---	---
●	Billable test volume for the fourth quarter ended<br>December 31, 2021 for ConfirmMDx® decreased by 3% to 3,598 versus 3,704, and for Select decreased by 4% to 3,346 versus 3,472, for<br>the same period last year
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●	2021 billable test volume for ConfirmMDx®<br>and SelectMDx increased by 3% to 15,324 and 13,615, respectively, versus 14,945 and 13,201, respectively, for 2020
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●	Successfully completed initial public offering<br>(IPO) in the United States on the NASDAQ, raising gross proceeds of $45 million
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●	Cash balance as of December 31, 2021 of $58.5<br>million
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Financialreview for the year ended December 31, 2021

USD in thousands (except per share data)	Year Ended December 31
Unaudited	2021			2020			% Change
Services		21,937			18,064			21	%
Licenses and royalties		302			396			(24	)%
Total Revenue		22,239			18,460			20	%
Cost of goods		(11,675	)		(10,416	)		12	%
Gross Profit		10,564			8,044			31	%
Operating expenses		(37,405	)		(35,167	)		6	%
Operating loss		(26,841	)		(27,123	)		(1	)%
Net loss		(29,002	)		(28,662	)		1	%
Basic and diluted loss per share		(0.24	)		(0.34	)		(30	)%

Total revenue for 2021 was $22.2 million, an increase of 20% as compared to total revenue of $18.5 million for 2020. Services revenue amounted to $21.9 million, an increase of 21% as compared to $18.1 million a year earlier. Revenue from ConfirmMDx represented over 90% of services revenue for all periods.

Gross profit for 2021 was $10.6 million as compared to $8.0 million for 2020. Gross margins were 47.5% for 2021 as compared to 43.6% for 2020, representing a gross margin improvement of 390 basis points, primarily related to a higher average selling price (ASP).

Operating expenses for 2021 were $37.4 million, up 6% from $35.2 million for 2020. Excluding non-cash expenses such as depreciation, amortization and stock-based compensation, operating expenses for 2021 were $33.1 million, an increase of 10% over 2020, primarily driven by R&D expenses related to our future product pipeline.

Operating loss and net loss for 2021 were $26.8 million and $29.0 million, respectively, substantially flat compared to $27.1 million and $28.7 million, respectively, for 2020.

Cash and cash equivalents as of December 31, 2021 were $58.5 million, strengthened by gross proceeds from the January equity raise of €25 million (approximately $30 million) and the November NASDAQ IPO of $45 million. Total cash collections amounted to $21.5 million during 2021, an increase of 1% compared to 2020. Cash burn for 2021 was $26.8 million compared to $21.9 million in the prior year period.

Outlookfor 2022

Michael K. McGarrity, CEO of MDxHealth, commented: “Even amidst the dynamics of the pandemic’s impact on patient visits, we anticipate a return of patient flow and continued adoption of SelectMDx and ConfirmMDx, which are emerging as the standard of care in the diagnostic pathway of patients at risk for prostate cancer. We believe that these tests will take hold and drive growth into and beyond 2022.

In addition, we are developing solutions for active surveillance (AS) of prostate cancer with our AS-MDx and Monitor-MDx tests. These menu additions would provide clinically actionable results for urologists evaluating cancer patients considered for active surveillance, as well as regular monitoring of these patients where the current standard of care is an invasive and costly annual biopsy. This is a well-characterized market where urologist are seeking a less invasive actionable solution.

We believe these initiatives, coupled with our current menu, will position MDxHealth to be the market leader in providing urologists with advanced diagnostics to support a patient from an elevated PSA through the diagnostic continuum of care with increased clinical insight and confidence.

Finally, we are encouraged by the initial introduction of novel molecular UTI testing services into our focused urology channel. The market for UTI testing is well-defined, with urologists accounting for approximately 20% of the 10 million UTI tests ordered annually in the U.S.”

Based on these catalysts for growth, MDxHealth is providing the following guidance, with growth in 2022 driven by:

●	Issuance of a final LCD for the SelectMDx test,<br>supporting additional coverage from commercial payers and contributing to both revenue and gross margin growth in the second half of 2022;
●	Achieving full year 2022 revenue of $25 million<br>to $27 million, representing growth of 13%-21% over full year 2021 revenue of $22.2 million.
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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 and use the Conference ID: 2329214.

International: +1-323-994-2093

United Kingdom: 0800 358 6377

Belgium: 0800 58228

The Netherlands: 0800 023 1436

United States: +1-888-204-4368

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1529679&tp_key=255b0ee24b

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

2022Reporting Calendar

●	April 20, 2022: Q1-2022 business update
●	May 25, 2022: Annual general shareholders’<br>meeting
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●	August 25, 2022: Publication of H1-2022 results
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●	October 20, 2022: Q3-2022 business update
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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. 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 audit procedures with respect to the Company’s consolidated financial statements, 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, that the procedures completed to date have not revealed any material adjustments that would have to be made to the accounting information derived from the Company’s consolidated financial information that is included in this press release.

The condensed Consolidated Statement of Comprehensive Income may be found on the Company’s website at www.mdxhealth.com. The full Annual Report is expected to be made available to the public via the Company’s website in April 2022.

For more information:

MDxHealth

info@mdxhealth.com

LifeSci Advisors (IR & PR)

US: +1 949 271 9223

ir@mdxhealth.com

This press release contains forward-lookingstatements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statementsand estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemedreasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’scontrol, and may turn out to be materially different. Examples of forward-looking statements include, among others, statements we makeregarding expected future operating results; product development efforts, our strategies, positioning, resources, capabilities and expectationsfor future events or performance. Important factors that could cause actual results, conditions and events to differ materially from thoseindicated in the forward-looking statements include, among others, the following: uncertainties associated with the coronavirus (COVID-19)pandemic, including its possible effects on our operations, and the demand for our products; our ability to successfully and profitablymarket our products; the acceptance of our products and services by healthcare providers; the willingness of health insurance companiesand other payers to cover our products and services and adequately reimburse us for such products and services; and the amount and natureof competition for our products and services. MDxHealth expressly disclaims any obligation to update any such forward-looking statementsin this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances onwhich any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitationfor the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold withinthe 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,ConfirmMDx, SelectMDx, AS-MDx and MonitorMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and servicemarks are the property of their respective owners.

Exhibit 99.2

MDxHealth SA and Subsidiaries<br><br> <br>2021 Financial Results<br><br> <br>as of December 31, 2021

Unaudited consolidated statement of profit and loss

Thousands of (except per share amounts) For the years ended December 31
Services	21,937		18,064
Licenses	250		250
Royalties and other revenues	52		146
Revenues	22,239		18,460
Cost of goods & services sold	(11,675	)	(10,416	)
Gross profit	10,564		8,044
Research and development expenses	(6,673	)	(4,543	)
Selling and marketing expenses	(17,744	)	(16,752	)
General and administrative expenses	(14,149	)	(13,990	)
Other operating income, net	1,161		118
Operating loss	(26,841	)	(27,123	)
Financial income	11		4
Financial expenses	(2,172	)	(1,543	)
Loss before income tax	(29,002	)	(28,662	)
Income tax	0		0
Loss for the year	(29,002	)	(28,662	)
Earnings per share attributable to parent (EPS)
Basic and diluted,	(0.24	)	(0.34	)

All values are in US Dollars.

Unaudited consolidated statement of comprehensive income

Thousands of $<br> <br>For the years ended December 31
Loss for the year	(29,002	)	(28,662	)
Other comprehensive income
Items that will be reclassified to profit or loss:
Exchange differences arising from translation of foreign operations	264		(383	)
Total comprehensive loss for the year (net of tax)	(28,738	)	(29,045	)
MDxHealth SA and Subsidiaries<br><br> <br>2021 Financial Results<br><br> <br>as of December 31, 2021
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Unaudited consolidated statement of financial position

Thousandsof $ For the years ended December 31
ASSETS
Non-current assets
Intangible assets	3,448		5,058
Property, plant and equipment	1,671		973
Right-of-use assets	3,347		2,734
Total non-current assets	8,466		8,765
Current assets
Inventories	1,911		2,324
Trade receivables	4,582		3,771
Prepaid expenses and other current assets	1,615		1,043
Cash and cash equivalents	58,498		15,953
Total current assets	66,606		23,091
TOTAL ASSETS	75,072		31,856
EQUITY
Share capital	128,454		76,716
Issuance premium	153,177		136,349
Retained earnings	(244,302	)	(215,300	)
Share-based compensation	10,607		9,385
Translation reserve	(1,037	)	(1,301	)
Total equity	46,899		5,849
LIABILITIES
Non-current liabilities
Loans and borrowings	7,651		10,279
Lease liabilities	2,624		2,017
Other non-current financial liabilities	1,466		690
Total non-current liabilities	11,741		12,986
Current liabilities
Loans and borrowings	4,441		2,818
Lease liabilities	840		757
Trade payables	7,455		5,320
Other current liabilities	2,735		3,217
Other current financial liabilities	961		909
Total current liabilities	16,432		13,021
Total liabilities	28,173		26,007
TOTAL EQUITY AND LIABILITIES	75,072		31,856

MDxHealth SA and Subsidiaries<br><br> <br>2021 Financial Results<br><br> <br>as of December 31, 2021

Unaudited consolidated statement of cash flow

Thousands of $<br> <br>Forthe years ended December 31
CASH FLOWSFROM OPERATING ACTIVITIES
Operating loss	(26,841	)	(27,123	)
Depreciation and amortization	3,036		3,332
Impairment	0		273
Share-based compensation	1,222		1,295
Other non-cash transactions	(325	)	26
Cash used in operations before working capital changes	(22,908	)	(22,197	)
Decrease / (increase) in inventories	413		(1,132	)
(Increase) / decrease in receivables	(1,383	)	2,851
Increase in payables	1,653		234
Net cash outflow from OPERATING ACTIVITIES	(22,225	)	(20,244	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment	(1,219	)	(537	)
Interests received	11		0
Net cash outflow from investing activities	(1,208	)	(537	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of shares (net of transaction costs)	68,566		13,875
Proceeds from the issuance of long-term debt	0		2,316
Payment of lease liability	(1,057	)	(831	)
Payment of interest	(1,011	)	(1,070	)
Net cash inflow from financing activities	66,498		14,290
Net increase / (decrease) in cash and cash equivalents	43,065		(6,491	)
Cash and cash equivalents at beginning of the financial year	15,953		22,050
Effect on exchange rate changes	(520	)	394
Cash and cash equivalents at end of the financial year	58,498		15,953

MDxHealth SA and Subsidiaries<br><br> <br>2021 Financial Results<br><br> <br>as of December 31, 2021

Unaudited consolidated statement of changes in equity

	Attributable to owners of mdxhealth sa
Thousandsof $	Share capital <br> & issuance premium			Retained earnings			Share-based compen-sation		Trans-lation reserve			Totalequity
Balance at January 1, 2020		199,190			(186,638	)		8,090		(918	)		19,724
Loss for the year					(28,662	)							(28,662	)
Other comprehensive income										(383	)		(383	)
Total comprehensive income for the year					(28,662	)				(383	)		(29,045	)
Transactions with owners in their capacity as owners:
Issuance of shares		14,186											14,186
Deduction of transaction costs		(311	)										(311	)
Share-based compensation costs								1,295					1,295
Balance at December 31, 2020		213,065			(215,300	)		9,385		(1,301	)		5,849
Balance at January 1, 2021		213,065			(215,300	)		9,385		(1,301	)		5,849
Loss for the year					(29,002	)							(29,002	)
Other comprehensive income										264			264
Total comprehensive income for the year					(29,002	)				264			(28,738	)
Transactions with owners in their capacity as owners:
Issuance of shares		75,339											75,339
Deduction of transaction costs		(6,773	)										(6,773	)
Share-based compensation costs								1,222					1,222
Balance at December 31, 2021		281,631			(244,302	)		10,607		(1,037	)		46,899