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 July 2024
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 July 8, 2024, MDxHealth SA (the “Company”) reported preliminary results of revenues for the second quarter and first half
of 2024 of approximately $22.2 and $42.0 million, respectively. The Company also reported that its cash balance as of June 30, 2024, was
$21.3 million. The Company has not completed its quarter end closing procedures and the Company’s independent registered public
accounting firm has not yet reviewed the results. Further commentary on the Company’s actual second quarter and first half of 2024
financial results will be provided as part of its 2024 Interim Report. Accordingly, these preliminary results are subject to change pending
finalization, and actual results could differ materially as the Company finalizes such results.
On July 8, 2024, the Company reported Lieve Verplancke, representative of Qaly-Co Sàrl, resigned from the Company’s Board
of Directors, effective July 7, 2024, and that Sanford J. Siegel, M.D. was appointed to Company’s Board of Directors, effective
July 7, 2024, to fill the vacancy resulting from the resignation.
On
July 8, 2024, the Company issued two press releases related to the above, copies of which are attached hereto as Exhibit 99.1
and Exhibit 99.2.
Information
Incorporated by Reference
This Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Nos.
333-268885 and 333-280606) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents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; provided, however, the information in the attached Exhibit 99.1 and Exhibit 99.2 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.
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.
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MDXHEALTH SA |
|
|
|
Date: July 8, 2024 |
By: |
/s/
Michael McGarrity |
|
|
Name: |
Michael McGarrity |
|
|
Title: |
Chief Executive Officer |
2
Exhibit 99.1
Mdxhealth Appoints Sanford J. Siegel, M.D.
to Board of Directors
IRVINE, CA, and HERSTAL, BELGIUM –
July 8, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”),
a commercial-stage precision diagnostics company, today announced the appointment of Sanford J. Siegel, M.D. to its Board of Directors.
Dr. Siegel will be taking the seat of Lieve Verplancke M.D., who is stepping down from the Board of mdxhealth.
Dr. Siegel has more the 45 years of experience
as a practicing urologist and over 35 years of executive leadership experience. Dr. Siegel currently serves as the Chairman of the Board
of United Urology Group, having previously served as its Chief Executive Officer. United Urology Group, which was acquired by Audax in
2016, was formed under Dr. Siegel’s leadership and is one of the nation’s leading urology networks. Previously, Dr. Siegel
served as the President and Chief Executive Officer of Chesapeake Urology Associates, which he founded in 1999. Dr. Siegel is a founding
member of the Large Urology Group Practice Association (LUGPA), which was formed in 2008. He was a board member of the Urology Care Foundation
(UCF) from 2016 until 2023 and The Urology Times. As a recognized leader in the field of medicine, Dr. Siegel has been honored with official
citations for outstanding commitment and leadership from both the Governor and the General Assembly of Maryland. Dr. Siegel earned his
medical degree from the University of Maryland School of Medicine and completed his specialty training in urology at Temple University
Hospital in Philadelphia. He has been certified by the American Board of Urology and as Fellow of the American College of Surgeons.
Michael K. McGarrity, CEO of mdxhealth, commented:
“We are very happy and honored to welcome Dr. Sanford Siegel onto our Board of Directors. Dr. Siegel is an exceptionally accomplished
individual who has achieved remarkable success as a leading urologist, entrepreneur, and public health advocate. As mdxhealth continues
to grow, Dr. Siegel will provide us with invaluable insights and guidance on how best our leading menu of precision diagnostic solutions
can be fully leveraged by urology practices to ensure patients receive the critical diagnostic information necessary for determining the
most appropriate course of treatment.”
“I am pleased to join the mdxhealth Board
of Directors, which is a company that is helping to shape the future of prostate cancer diagnosis,” said Dr. Siegel. “As
with most areas of cancer, the key to improving treatment outcomes is ensuring that patients have access to the most advanced diagnostics
earlier in the course of their disease so that treatment options can be determined in a more timely and effective manner. As a practicing
urologist who has treated thousands of patients with prostate cancer, I believe mdxhealth is well positioned to deliver this critically
important technology to urologists, which should ultimately lead to improved patient care.”
Koen Hoffman, Chairman of mdxhealth, commented:
“On behalf of the Board of Directors, I would like to welcome Sandy Siegel and thank Lieve Verplancke for her valued service to
mdxhealth. Over the years she has contributed to our progress with the utmost professionalism and expertise.”
About mdxhealth
Mdxhealth is a commercial-stage 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. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth,
facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
For more information:
info@mdxhealth.com
LifeSci Advisors (IR & PR)
US: +1 949 271 9223
ir@mdxhealth.com
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;
and our strategies, positioning, resources, capabilities and expectations for future events or performance. 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: uncertainties associated with global macroeconomic conditions;
our ability to successfully and profitably market our products; the acceptance and reimbursement of our products and services by healthcare
providers and payers; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; the possibility
that the anticipated benefits from our business acquisitions like our acquisition of the Oncotype DX® GPS prostate cancer business
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 and Monitor mdx are trademarks or registered trademarks of MDxHealth
SA. 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.
Exhibit 99.2
![](https://www.sec.gov/Archives/edgar/data/1872529/000121390024059810/ex99-2_001.jpg)
MDxHealth Reports Preliminary Q2 and Half Year
2024 Revenues
and Raises 2024 Revenue Guidance
IRVINE, CA, and HERSTAL, BELGIUM –
July 8, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH), a commercial-stage precision diagnostics
company, today reported preliminary Q2 and half year 2024 revenues and cash. The Company expects to report Q2 and half year 2024
revenues of approximately $22.2 and $42.0 million, respectively, representing year-over-year growth of 32% and 34%, respectively, and
representing sequential growth from Q1 of 12%. The Company is raising its full-year 2024 revenue guidance from $83-85 million to $85-87
million.
The Company’s cash balance as of June 30,
2024, was $21.3 million.
Michael K. McGarrity, CEO of mdxhealth, commented:
“We believe these preliminary results for mdxhealth reflect our stated and firm commitment to deliver consistent and sustainable
growth in our business, driven by our broad menu, sales execution and operating discipline. We are quite confident that this execution
is now fundamentally built in across our operating teams and provide a unique profile of top line growth trajectory and operating leverage
to meet our expected turn to adjusted EBITDA profitability in the first half of 2025.
Based on our visibility to sustainable growth,
we are taking our 2024 revenue guidance up from $83-85 million to $85-87 million, representing 23% year-over-year revenue growth at the
midpoint of our guidance. We look forward to providing our full financial results and update on August 21st.”
About mdxhealth®
Mdxhealth is a commercial-stage 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, with laboratory operations in Nijmegen,
The Netherlands. 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 information and auditor review
The preliminary unaudited financial data for the
second quarter and six-month period ended June 30, 2024, and the updated 2024 revenue guidance set forth above were derived from preliminary
internal financial reports. The Company has not yet finalized its complete results of operations for the period ended June 30, 2024. The
Company and its auditors may identify items that would require the Company to make adjustments, some of which could be material, to the
preliminary unaudited financial data and guidance set forth above.
For more information:
info@mdxhealth.com
LifeSci Advisors (IR & PR)
US: +1 949 271 9223
ir@mdxhealth.com
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 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; 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; the possibility
that the anticipated benefits from our business acquisitions like our acquisition of the Oncotype DX® GPS prostate cancer business
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.
Non-IFRS Measures. The Company’s
reference to adjusted EBITDA is a forward-looking statement about the Company’s future financial performance, and is a non-IFRS
measure that excludes a number of expense items that are included in net loss, including adjustments for items like stock-based compensation,
acquisition and integration costs, impairment of long-lived assets, fair-value adjustment, loan extinguishment costs, as well as other
non-operating, non-recurring expenses that are difficult to predict for future periods because the nature of the adjustments pertain to
events that have not yet occurred. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. Non-IFRS
financial information 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, and such information is referenced for supplemental information purposes only. Management
does not forecast many of the excluded items for internal use, as these are difficult to predict for future periods because the nature
of the adjustments pertain to events that have not yet occurred. 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 measures could significantly impact the Company's IFRS results.
NOTE: The mdxhealth logo, mdxhealth,
Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS and Monitor mdx are trademarks or registered trademarks of MDxHealth
SA. 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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