6-K
MDxHealth SA (MDXH)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,D.C. 20549
FORM6-K
REPORTOF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THESECURITIES EXCHANGE ACT OF 1934
Forthe month of April 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 April 27, 2022, MDxHealth SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1.
Theinformation in the attached Exhibit 99.1 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 they 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 April 27, 2022. |
1
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: April 27, 2022 | By: | /s/ Michael McGarrity | |
| Name: | Michael McGarrity | ||
| Title: | Chief Executive Officer |
2
Exhibit99.1
| NEWS RELEASE - REGULATED INFORMATION |
|---|
| 27 APRIL 2022, 4:00PM EDT / 22:00 CET |
MDxHealthReports Q1-2022 Results
IRVINE,CA, and HERSTAL, BELGIUM – April 27, 2022 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today announced its financial results for the first quarter ended March 31, 2022.
MichaelMcGarrity, CEO of MDxHealth, commented: “We are excited to report greater than 20% revenue growth for Q1 as well as the resumption of year-over-year unit growth for SelectMDx® and ConfirmMDx® tests. While patient flow remains inconsistent by geography, we are beginning to see the normalization of historical urology patient visit patterns, and we expect these trends to continue to improve as effects of the pandemic wane.
“We are also encouraged by the initial introduction of novel molecular Urinary Tract Infection (UTI) testing into our focused urology channel. The market for UTI testing is well-defined, with urologists accounting for approximately 20% of the 10 million tests ordered annually in the U.S.
“As we noted at the beginning of the year, we look forward to providing greater visibility to our 2021 guidance with our mid-year update. We are pleased with the execution of our team, and the strong underlying momentum in our business and new product initiatives.”
Highlightsfor the first quarter ended March 31, 2022
| ● | Revenues<br> for the first quarter ended March 31, 2022, increased by 21% to $6.1 million versus $5.1<br> million for the same period last year |
|---|---|
| ● | Billable<br> test volume for the first quarter ended March 31, 2022, for ConfirmMDx increased by 6% to<br> 4,141 versus 3,913, and for Select by 2% to 3,311 versus 3,259, for the same period last<br> year |
| --- | --- |
| ● | Cash<br> and cash equivalents of $48.0 million as of March 31, 2022 |
| --- | --- |
Financialreview for the quarter ended March 31, 2022
| USD<br> in thousands (except per share data) Unaudited | Quarter<br> Ended March 31 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | % Change | |||||||
| Services | 6,092 | 4,800 | 27 | % | |||||
| Licenses and royalties | 14 | 258 | (95 | )% | |||||
| Total Revenue | 6,106 | 5,058 | 21 | % | |||||
| Cost of goods | (3,263 | ) | (2,683 | ) | 22 | % | |||
| Gross Profit | 2,843 | 2,375 | 20 | % | |||||
| Operating expenses | (10,695 | ) | (8,135 | ) | 31 | % | |||
| Operating loss | (7,852 | ) | (5,760 | ) | 36 | % | |||
| Net loss | (8,270 | ) | (6,183 | ) | 34 | % | |||
| Basic and diluted loss per<br> share | (0.05 | ) | (0.06 | ) | (5 | )% |
Total revenue for the first quarter ended March 31, 2022, was $6.1 million, an increase of 21% as compared to total revenue of $5.1 million for the first quarter of 2021. Services revenue amounted to $6.1 million for Q1-2022, an increase of 27% as compared to $4.8 million for Q1-2021.
Gross profit for the first quarter ended March 31, 2022, was $2.8 million as compared to $2.4 million for the first quarter of 2021. Gross margins were 46.6% for Q1-2022 as compared to 47.0% for Q1-2021.
Operating expenses for the first quarter ended March 31, 2022, were $10.7 million, up 31% from $8.1 million for the first quarter of 2021, primarily driven by an increase in our public company expenses, following our initial public offering on the NASDAQ in the fourth quarter of 2021.
Operating loss and net loss for the first quarter ended March 31, 2022, were $7.9 million and $8.3 million, respectively, compared to $5.8 million and $6.2 million, respectively, for Q1-2021.
Cash and cash equivalents as of March 31, 2022, were $48.0 million.
AboutMDxHealth
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.
Formore information:
MDxHealth
info@mdxhealth.com
LifeSci Advisors (IR & PR)
US: +1 949 271 9223
ir@mdxhealth.com
Thispress release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and themarket in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertaintiesand other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend uponfactors that are beyond the company’s control, and may turn out to be materially different. Examples of forward-looking statementsinclude, 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, conditionsand events to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertaintiesassociated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations, and the demand for our products;our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers;the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for suchproducts and services; and the amount and nature of competition for our products and services. MDxHealth expressly disclaims any obligationto update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any changein events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press releasedoes not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securitiesof 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, ConfirmMDx, SelectMDx, ResolveMDx, AS-MDx and MonitorMDx are trademarks or registered trademarksof MDxHealth SA. All other trademarks and service marks are the property of their respective owners.