6-K
MDxHealth SA (MDXH)
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 May 2023
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 May 15, 2023, MDxHealth SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1. On May 15, 2023, the Company posted to its website its financial results for the three months ended March 31, 2023, a copy of which is attached hereto as Exhibit 99.2.
The information in the attachedExhibits 99.1 and 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the SecuritiesExchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shallit be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the ExchangeAct, 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 May 15, 2023 |
| 99.2 | Financial Results for the Three Months Ended March 31, 2023 |
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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 15, 2023 | By: | /s/ Michael McGarrity | |
| Name: | Michael McGarrity | ||
| Title: | Chief Executive Officer |
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Exhibit 99.1
NEWS RELEASE - REGULATED INFORMATION
15 MAY 2023, 4:00PM EDT / 22:00 CET
MDxHealth Reports Q1-2023 Results
| § | Year-over-year revenues increase by 141% to $14.7 million; excluding GPS,revenues up 39% |
|---|---|
| § | Gross margin expanded by 1,270 basis points over prior year period |
| --- | --- |
| § | Positive Local Coverage Determination (LCD), extending coverage for Selectmdx test to Medicare population |
| --- | --- |
IRVINE, CA, and HERSTAL, BELGIUM – May 15, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today announced its financial results for the first quarter ended March 31, 2023.
Michael K. McGarrity, CEO of mdxhealth, commented: “We are pleased to report strong operating results for the first quarter of 2023. Our focus on operating discipline and commercial execution, as well as continued implementation of our growth strategy, is building the foundation for sustained growth for mdxhealth as the leading provider of personalized diagnostic solutions focused exclusively into urology.
“I am also pleased to note that after successfully completing a rigorous technical assessment, we announced in April that Select mdx will now be reimbursed throughout the U.S. for Medicare patients who meet coverage conditions under the foundational Local Coverage Determination (LCD) for Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer. With this coverage decision, each of the tests in our prostate cancer menu is now covered by Medicare and included in the NCCN guidelines.”
Highlightsfor the first quarter ended March 31, 2023
| ● | Q1-2023 revenue of $14.7 million, representing<br>an increase of 141% over Q1-2022; excluding GPS, Q1-2023 revenue increased 39% over Q1-2022, reflecting execution by our sales team, broader<br>coverage of our expanded test menu, and efficient revenue cycle management |
|---|---|
| ● | Strengthened our balance sheet with gross proceeds of $43 million through<br>an equity offering of 10.75 million American Depository Shares (ADSs) in February 2023 |
| --- | --- |
| ● | Continued commercial uptake of Resolve mdx, our<br>Urinary Tract Infection (UTI) test, with triple-digit unit growth year-over-year and Q1-2023 revenues of $2.2 million |
| --- | --- |
| ● | Q1-2023 revenues of $14.7 million were comprised<br>of $6.2 million from GPS, $5.7 million from Confirm mdx, $2.2 million from Resolve mdx, with the remaining revenues from Select mdx and<br>other |
| --- | --- |
| ● | Gross margin expansion of 1,270 basis points<br>during the quarter to 59.3% |
| --- | --- |
| ● | Billable test volume for the first quarter ended<br>March 31, 2023, for Confirm mdx increased by 5% to 4,366, and for Select mdx decreased by 4% to 3,181 versus the same period last year |
| --- | --- |
| ● | Cash and cash equivalents of $48.3 million as<br>of March 31, 2023 |
| --- | --- |
Financialreview for the quarter ended March 31, 2023
| USD in thousands (except per share data) Unaudited | Quarter Ended March 31 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022% | Change | |||||||
| Revenue | 14,700 | 6,106 | 141 | % | |||||
| Cost of goods | (5,985 | ) | (3,263 | ) | 83 | % | |||
| Gross Profit | 8,715 | 2,843 | 207 | % | |||||
| Operating expenses | (17,432 | ) | (10,695 | ) | 63 | % | |||
| Operating loss | (8,717 | ) | (7,852 | ) | 11 | % | |||
| Net loss | (11,709 | ) | (8,270 | ) | 42 | % | |||
| Basic and diluted loss per share | (0.05 | ) | (0.05 | ) | - |
Total revenue for the first quarter ended March 31, 2023, was $14.7 million, an increase of 141% as compared to total revenue of $6.1 million for the first quarter of 2022. Excluding the GPS revenues, total revenues for the quarter were $8.5 million, an increase of 39% compared to the first quarter of 2022. Q1-2023 revenues of $14.7 million were comprised of $6.2 million from GPS, $5.7 million from Confirm mdx, $2.2 million from Resolve mdx, with the remaining revenues from Select mdx and other.
Gross profit for Q1-2023 was $8.7 million as compared to $2.8 million for Q1-2022. Gross margins were 59.3% for Q1-2023 as compared to 46.6% for Q1-2022, representing a gross margin improvement of 1,270 basis points, primarily related to our product mix and the addition of GPS to our product menu.
Operating expenses for Q1-2023 were $17.4 million, up 63% from $10.7 million for Q1-2022, primarily related to the additional field sales personnel associated with the GPS business.
Operating loss for Q1-2023 was $8.7 million, an increase of 11% over Q1-2022, primarily related to the additional field sales personnel associated with the GPS acquisition.
Net loss for Q1-2023 of $11.7 million increased by $3.4 million versus $8.3 million for the prior year period, primarily from an increase in financial expenses, of which $1.9 million was non-cash and relates to the fair value adjustment of the GPS contingent consideration, and the remainder was primarily related to an increase in interest expense from our debt facility.
Our cash burn for Q1-2023 was $7.9 million versus $11.9 million for Q4-2022, representing a 34% decline in cash burn and bringing our cash and cash equivalents as of March 31, 2023 to $48.3 million. This amount reflects the receipt of $40.4 million in net proceeds from the equity offering in February 2023.
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: 1-877-407-9716
Belgium: 0800 73904
The Netherlands: 0800 023 4340
United Kingdom: 0800 756 3429
Conference ID: 13738494
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1612703&tp_key=c5b907adf5
To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start time.
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2023Reporting Calendar
| ● | May 25, 2023: Annual general shareholders’ meeting |
|---|---|
| ● | August 23, 2023: Publication of H1-2023 results |
| --- | --- |
| ● | November 8, 2023: Q3-2023 business update |
| --- | --- |
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
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, all of whichinvolve certain 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 well as similar expressions.Forward-looking statements contained in this release include, but are not limited to, statements regarding the acquisition of OncotypeDX® GPS prostate cancer business from Exact Sciences including statements regarding the anticipated benefits of the acquisition; statementsregarding expected future operating results; statements regarding product development efforts; and statements regarding our strategies,positioning, resources, capabilities and expectations for future events or performance. Such statements and estimates are based on assumptionsand 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 materiallydifferent. 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. Importantfactors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statementsinclude, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effectson our operations, and the demand for our products; our ability to successfully and profitably market our products; the acceptance ofour products and services by healthcare providers; the willingness of health insurance companies and other payers to cover our productsand services and adequately reimburse us for such products and services; our ability to obtain and maintain regulatory approvals and complywith applicable regulations; the possibility that the anticipated benefits from our business acquisitions like our acquisition of theOncotype DX® GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; andthe amount and nature of competition for our products and services. Other important risks and uncertainties are described in the RiskFactors 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 itsexpectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless requiredby law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets ofMDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under theU.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securitieslaws.
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 GPStest was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and otherliterature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, amongothers. The Oncotype DX trademark, and all other trademarks and service marks, are the property of their respective owners.
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Exhibit 99.2
| MDxHealth SA and Subsidiaries |
|---|
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSSAND COMPREHENSIVE INCOME
| **** | |||||
|---|---|---|---|---|---|
| In thousands of (except per share<br> amounts) | **** | 2022 | **** | ||
| Services | 14,607 | 6,092 | |||
| Royalties and other revenues | 93 | 14 | |||
| Revenues | 14,700 | 6,106 | |||
| Cost of goods & services sold | (5,985 | ) | (3,263 | ) | |
| Gross profit | 8,715 | 2,843 | |||
| Research and development expenses | (2,106 | ) | (1,784 | ) | |
| Selling and marketing expenses | (9,428 | ) | (4,422 | ) | |
| General and administrative expenses | (5,174 | ) | (4,492 | ) | |
| Other operating income (expense), net | (724 | ) | 3 | ||
| Operating loss | (8,717 | ) | (7,852 | ) | |
| Financial expenses, net | (2,992 | ) | (418 | ) | |
| Loss before income tax | (11,709 | ) | (8,270 | ) | |
| Income tax | 0 | 0 | |||
| Loss for the period | (11,709 | ) | (8,270 | ) | |
| Loss per share attributable to parent | |||||
| Basic and diluted, | (0.05 | ) | (0.05 | ) | |
| Unaudited condensed consolidated statement of comprehensive income | |||||
| Loss for the period | (11,709 | ) | (8,270 | ) | |
| Other comprehensive income (loss) | |||||
| Items that will be reclassified to profit or loss: | |||||
| Exchange differences arising<br> from translation of foreign operations | 287 | 331 | |||
| Total other comprehensive income (loss) | 287 | 331 | |||
| Total comprehensive loss for the period (net of tax) | (11,422 | ) | (7,939 | ) |
All values are in US Dollars.
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| In thousands of $ | March 31, 2023 | December 31, 2022 | ||
|---|---|---|---|---|
| ASSETS | ||||
| Goodwill | 35,926 | 35,926 | ||
| Intangible assets | 45,504 | 46,166 | ||
| Property, plant and equipment | 4,331 | 3,791 | ||
| Right-of-use assets | 3,774 | 4,103 | ||
| Non-current assets | 89,536 | 89,986 | ||
| Inventories | 2,030 | 2,327 | ||
| Trade receivables | 9,002 | 9,357 | ||
| Prepaid expenses and other current assets | 1,971 | 1,962 | ||
| Cash and cash equivalents | 48,254 | 15,503 | ||
| Current assets | 61,257 | 29,149 | ||
| TOTAL ASSETS | 150,793 | 119,135 | ||
| EQUITY | ||||
| --- | --- | --- | --- | --- |
| Share capital | 173,053 | 133,454 | ||
| Issuance premium | 153,177 | 153,177 | ||
| Accumulated deficit | (300,055 | ) | (288,346 | ) |
| Share-based compensation | 11,632 | 11,474 | ||
| Translation reserve | (157 | ) | (444 | ) |
| Total equity | 37,650 | 9,315 | ||
| LIABILITIES | ||||
| Loans and borrowings | 35,015 | 34,914 | ||
| Lease liabilities | 2,813 | 3,091 | ||
| Other non-current financial liabilities | 56,590 | 53,537 | ||
| Non-current liabilities | 94,418 | 91,542 | ||
| Loans and borrowings | 618 | 616 | ||
| Lease liabilities | 1,137 | 1,172 | ||
| Trade payables | 11,277 | 10,178 | ||
| Other current liabilities | 4,104 | 3,985 | ||
| Other current financial liabilities | 1,589 | 2,327 | ||
| Current liabilities | 18,725 | 18,278 | ||
| Total liabilities | 113,143 | 109,820 | ||
| TOTAL EQUITY AND LIABILITIES | 150,793 | 119,135 |
2
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
Attributable to owners of MDxHealth SA
| In thousands of $, except number of shares | Number of<br> shares | Share<br> capital and<br> issuance<br> premium | Accumulated<br> Deficit | Share-based<br> compensation | Foreign<br> Currency<br> Trans-lation<br> reserves | Total<br> equity | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance at January 1, 2022 | 155,969,226 | 281,631 | (244,302 | ) | 10,607 | (1,037 | ) | 46,899 | |||||||
| Loss for the period | (8,270 | ) | (8,270 | ) | |||||||||||
| Other comprehensive income | 331 | 331 | |||||||||||||
| Total comprehensive income for the period | (8,270 | ) | 331 | (7,939 | ) | ||||||||||
| Transactions with owners in their capacity as owners: | |||||||||||||||
| Issuance of shares, net of transaction costs | |||||||||||||||
| Share-based compensation | 132 | 132 | |||||||||||||
| Balance at March 31, 2022 | 155,969,226 | 281,631 | (252,572 | ) | 10,739 | (706 | ) | 39,092 | |||||||
| Balance at January 1, 2023 | 162,880,936 | 286,631 | (288,346 | ) | 11,474 | (444 | ) | 9,315 | |||||||
| Loss for the period | (11,709 | ) | (11,709 | ) | |||||||||||
| Other comprehensive income | 287 | 287 | |||||||||||||
| Total comprehensive income for the period | (11,709 | ) | 287 | (11,422 | ) | ||||||||||
| Transactions with owners in their capacity as owners: | |||||||||||||||
| Issuance of shares, net of transaction costs | 107,500,000 | 39,599 | 39,599 | ||||||||||||
| Share-based compensation | 158 | 158 | |||||||||||||
| Balance at March 31, 2023 | 270,380,936 | 326,230 | (300,055 | ) | 11,632 | (157 | ) | 37,650 |
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UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
| **** | Three months ended March 31, | **** | ||||
|---|---|---|---|---|---|---|
| In thousands of $ | 2023 | **** | 2022 | **** | ||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||
| Operating loss | (8,717 | ) | (7,852 | ) | ||
| Depreciation and amortization | 1,636 | 787 | ||||
| Share-based compensation | 158 | 132 | ||||
| Other non-cash transactions | 815 | 0 | ||||
| Cash used in operations before working capital changes | (6,108 | ) | (6,933 | ) | ||
| Decrease in inventories | 297 | 137 | ||||
| Decrease / (increase) in receivables | 346 | (479 | ) | |||
| Increase / (decrease) in payables | 1,197 | (1,374 | ) | |||
| Net cash outflow from operating activities | (4,268 | ) | (8,649 | ) | ||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||
| Purchase of property, plant and equipment | (787 | ) | (568 | ) | ||
| Acquisition and generation of intangible assets | (455 | ) | (350 | ) | ||
| Net cash outflow from investing activities | (1,242 | ) | (918 | ) | ||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||
| Proceeds from issuance of shares, net of transaction costs | 39,599 | 0 | ||||
| Repayment of loan obligation and debt extinguishment costs | (158 | ) | (253 | ) | ||
| Payment of lease liability | (348 | ) | (332 | ) | ||
| Payment of interest | (831 | ) | (240 | ) | ||
| Interests received | 4 | 11 | ||||
| Net cash inflow from financing activities | 38,266 | (814 | ) | |||
| Net increase / (decrease) in cash and cash equivalents | 32,756 | (10,381 | ) | |||
| Cash and cash equivalents at beginning of the period | 15,503 | 58,498 | ||||
| Effect of exchange rates | (5 | ) | (119 | ) | ||
| Cash and cash equivalents at end of the period | 48,254 | 47,998 |
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