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 THE
SECURITIESEXCHANGE ACT OF 1934
Forthe month of May 2024
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 ☐
MDXHEALTHSA
On May 1, 2024, 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 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.
| Exhibit No. | Description of Exhibit |
|---|---|
| 99.1 | Press Release, dated May 1, 2024 |
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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:<br> May 1, 2024 | By: | /s/<br> Michael McGarrity | |
| Name: | Michael<br> McGarrity | ||
| Title: | Chief<br> Executive Officer |
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Exhibit 99.1
MDxHealthReports Q1-2024 Results and Announces Growth Capital from OrbiMed
Year-over-yearQ1 revenues increase by 35% to $19.8 million
Increasing2024 revenue guidance to $83-85 million, previously $79-81 million
Conferencecall with Q&A today at 08:30 AM ET / 14:30 CET
IRVINE,CA, and HERSTAL, BELGIUM – May 1, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a commercial-stage precision diagnostics company, today announced its financial results for the first quarter ended March 31, 2024 and the closing of a new debt facility with OrbiMed.
MichaelK. McGarrity, CEO of mdxhealth, commented: “We are pleased to report operating results that demonstrate successful execution of our growth strategy and support our outlook for delivering sustainable growth in revenues, a consistent reduction in cash burn, and adequate runway to achieve adjusted EBITDA profitability in the first half of 2025. Additionally, we have received the first clinical samples from current customers for hereditary germline testing and now expect germline testing to begin contributing to revenue in the second quarter. Based on this continued momentum in our execution and strong demand for our tests, we are increasing our 2024 revenue guidance to $83-85 million from the previous $79-81 million.
“We are excited to partner with OrbiMed in a new debt facility, which provides significant growth capital and balance sheet flexibility, and allows the Company to further support growing demand for our precision diagnostic tests. This investment also reflects the continued progress we are making in attracting leading institutional investors who recognize our Company’s unique positioning within our high growth, urology markets.”
KeyHighlights:
| ● | First<br>quarter revenue of $19.8 million, an increase of 35% over prior year period |
|---|---|
| ● | Prostate<br> test volume of 12,061, an increase of 16% over prior year period |
| --- | --- |
| ● | First<br> clinical samples received for new hereditary germline testing |
| --- | --- |
| ● | Refinanced<br> existing $70 million debt facility with $100 million, 5-year interest-only debt facility<br> with OrbiMed, of which $55 million has been drawn at closing |
| --- | --- |
| ● | Implemented<br> $50M At-The-Market (“ATM”) program to foster long-term shareholder development |
| --- | --- |
Financialreview for the quarter ended March 31, 2024
| Quarter Ended March 31 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| USD in thousands (except per share data) Unaudited | 2024 | 2023 | % Change | ||||||
| Revenue | 19,834 | 14,700 | 35 | % | |||||
| Cost of goods | (7,771 | ) | (5,985 | ) | 30 | % | |||
| Gross Profit | 12,063 | 8,715 | 38 | % | |||||
| Operating expenses | (18,667 | ) | (17,432 | ) | 7 | % | |||
| Operating loss | (6,604 | ) | (8,717 | ) | (24 | )% | |||
| Net loss | (8,511 | ) | (11,709 | ) | (27 | )% | |||
| Basic and diluted loss per share | (0.31 | ) | (0.53 | ) | (42 | )% |
Revenue increased 35% to $19.8 million compared to $14.7 million for the prior year.
Gross margins were 60.8% compared to 59.3% for the prior year, an improvement of 1.5 percentage points.
Operating expenses increased 7% to $18.7 million compared to $17.4 million for the prior year, driven primarily by scale and volume increases through our laboratories.
Net loss decreased 27% to $8.5 million compared to $11.7 million for the prior year, driven by our increases in revenues and gross profit.
Cash and cash equivalents as of March 31, 2024, were $14.5 million.
DebtRefinancing with OrbiMed
On May 1, 2024, mdxhealth closed a $100 million loan and security agreement with funds managed by OrbiMed Advisors LLC (“OrbiMed”). The Company drew down $55 million from this loan, replacing its existing $35 million debt funded by an affiliate of Innovatus Capital Partners, LLC. At the option of the Company, an additional $45 million can be drawn under the OrbiMed facility, consisting of a $25 million delayed draw term loan and a $20 million delayed draw term loan, in 2025 and 2026 respectively, subject to certain conditions. The loans are secured by substantially all assets of the Company, including intellectual property rights. Remaining proceeds of the loans will be used for working capital purposes and to fund general business requirements.
ConferenceCall
Michael K. McGarrity, Chief Executive Officer and Ron Kalfus, Chief Financial Officer, will host a conference call and Q&A session today at 08:30 AM ET / 14:30 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: 1-800-717-1738
Belgium: +32 2 290 46 34
The Netherlands: +31 20 795 2682
United Kingdom: +44 800 279 7040
Conference ID: 26604
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1668863&tp_key=f2f820a92d
To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start time.
Aboutmdxhealth
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.
Formore information:
info@mdxhealth.com
LifeSciAdvisors (IR & PR)
US: +1 949 271 9223
ir@mdxhealth.com
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Thispress release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and themarket in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, madethrough 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 regardingexpected future operating results; expectations for development of new or improved products and services and their impact on patients;our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated benefitsof our acquisitions, including estimated synergies and other financial impacts. 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.Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-lookingstatements include, among others, the following: uncertainties associated with global macroeconomic conditions; our ability to successfullyand 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 anticipatedbenefits from our business acquisitions like our acquisition of the Oncotype DX^®^ GPS prostate cancer business will notbe realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our productsand services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report onForm 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation toupdate 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.
Non-IFRSMeasures. The Company’s reference to adjusted EBITDA is a forward-looking statement about the Company’s futurefinancial performance, and is a non-IFRS measure that excludes a number of expense items that are included in net loss, including adjustmentsfor items like stock-based compensation, acquisition and integration costs, impairment of long-lived assets, fair-value adjustment, loanextinguishment costs, as well as other non-operating, non-recurring expenses that are difficult to predict for future periods becausethe nature of the adjustments pertain to events that have not yet occurred. As a result, positive adjusted EBITDA may be achieved whilea significant net loss persists. Non-IFRS financial information has limitations as an analytical tool and should not be considered inisolation or as a substitute for financial information presented in accordance with IFRS, and such information is referenced for supplementalinformation purposes only. Management does not forecast many of the excluded items for internal use, as these are difficult to predictfor future periods because the nature of the adjustments pertain to events that have not yet occurred. Information reconciling forward-lookingnon-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 trademarksor 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 propertyof their respective owners.
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| MDxHealth<br> SA and Subsidiaries |
|---|
UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS
| Three Months Ended <br> March 31, | ||||||
|---|---|---|---|---|---|---|
| In thousands of $ (except per share amounts) | 2024 | 2023 | ||||
| Revenues | $ | 19,834 | $ | 14,700 | ||
| Cost of sales (exclusive of amortization of intangible assets) | (7,771 | ) | (5,985 | ) | ||
| Gross profit | 12,063 | 8,715 | ||||
| Research and development expenses | (2,164 | ) | (1,316 | ) | ||
| Selling and marketing expenses | (10,028 | ) | (9,099 | ) | ||
| General and administrative expenses | (5,359 | ) | (5,169 | ) | ||
| Amortization of intangible assets | (1,125 | ) | (1,124 | ) | ||
| Other operating income (expense), net | 9 | (724 | ) | |||
| Operating loss | (6,604 | ) | (8,717 | ) | ||
| Financial expenses, net | (1,907 | ) | (2,992 | ) | ||
| Loss before income tax | (8,511 | ) | (11,709 | ) | ||
| Income tax | – | – | ||||
| Loss for the period | $ | (8,511 | ) | $ | (11,709 | ) |
| Loss per share attributable to parent* | ||||||
| Basic and diluted | $ | (0.31 | ) | $ | (0.53 | ) |
| * | The<br>company completed a share consolidation with respect to all its outstanding shares by means of a 1-for-10 reverse stock split as of November<br>13, 2023. All share amounts and the EPS were adjusted retroactively to reflect the reverse stock-split. | |||||
| --- | --- |
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UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| Thousands of $ | March 31, <br> 2024 | December 31,<br> 2023 | ||||
|---|---|---|---|---|---|---|
| ASSETS | ||||||
| Non-current assets | ||||||
| Goodwill | $ | 35,926 | $ | 35,926 | ||
| Intangible assets | 43,757 | 44,337 | ||||
| Property, plant and equipment | 4,758 | 4,956 | ||||
| Right-of-use assets | 4,625 | 4,989 | ||||
| Financial assets | 693 | 763 | ||||
| Total non-current assets | 89,759 | 90,971 | ||||
| Current assets | ||||||
| Inventories | 3,044 | 2,779 | ||||
| Trade receivables | 12,669 | 11,088 | ||||
| Prepaid expenses and other current assets | 1,779 | 1,914 | ||||
| Cash and cash equivalents | 14,494 | 22,380 | ||||
| Total current assets | 31,986 | 38,161 | ||||
| TOTAL ASSETS | $ | 121,745 | $ | 129,132 | ||
| EQUITY | ||||||
| Share capital | $ | 173,931 | $ | 173,931 | ||
| Issuance premium | 153,177 | 153,177 | ||||
| Accumulated deficit | (339,957 | ) | (331,446 | ) | ||
| Share-based compensation | 12,307 | 12,139 | ||||
| Translation reserve | (431 | ) | (593 | ) | ||
| Total equity | (973 | ) | 7,208 | |||
| LIABILITIES | ||||||
| Non-current liabilities | ||||||
| Loans and borrowings | 35,775 | 35,564 | ||||
| Lease liabilities | 3,115 | 3,578 | ||||
| Other non-current financial liabilities | 64,878 | 63,259 | ||||
| Total non-current liabilities | 103,768 | 102,401 | ||||
| Current liabilities | ||||||
| Loans and borrowings | 645 | 643 | ||||
| Lease liabilities | 1,564 | 1,480 | ||||
| Trade payables | 8,759 | 8,811 | ||||
| Other current liabilities | 6,258 | 5,694 | ||||
| Other current financial liabilities | 1,724 | 2,895 | ||||
| Total current liabilities | 18,950 | 19,523 | ||||
| Total liabilities | 122,718 | 121,924 | ||||
| TOTAL EQUITY AND LIABILITIES | $ | 121,745 | $ | 129,132 |
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UNAUDITEDCONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
| Three Months Ended<br><br>March 31, | ||||||
|---|---|---|---|---|---|---|
| Thousands of $ | 2024 | 2023 | ||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||
| Operating loss | $ | (6,604 | ) | $ | (8,717 | ) |
| Depreciation | 775 | 512 | ||||
| Amortization of intangible assets | 1,125 | 1,124 | ||||
| Share-based compensation | 168 | 158 | ||||
| Other non-cash transactions | (1 | ) | 815 | |||
| Cash used in operations before working capital changes | (4,537 | ) | (6,108 | ) | ||
| Increase (-) / decrease (+) in inventories | (265 | ) | 297 | |||
| Increase (-) / decrease (+) in receivables | (1,392 | ) | 346 | |||
| Increase (+) in payables | 679 | 1,197 | ||||
| Net cash outflow from operating activities | (5,515 | ) | (4,268 | ) | ||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||
| Purchase of property, plant and equipment | (220 | ) | (787 | ) | ||
| Acquisition and generation of intangible assets | (544 | ) | (455 | ) | ||
| Interests received | 146 | 4 | ||||
| Net cash outflow from investing activities | (618 | ) | (1,238 | ) | ||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||
| Proceeds from issuance of shares, net of transaction costs | - | 39,599 | ||||
| Repayment of loan obligation | (160 | ) | (158 | ) | ||
| Payment of lease liability | (475 | ) | (348 | ) | ||
| Payment of interest | (947 | ) | (831 | ) | ||
| Other financial expenses | (170 | ) | - | |||
| Net cash (outflow) / inflow from financing activities | (1,752 | ) | 38,262 | |||
| Net decrease (-) / increase (+) in cash and cash equivalents | (7,885 | ) | 32,756 | |||
| Cash and cash equivalents at beginning of period | 22,380 | 15,503 | ||||
| Effect on exchange rate changes | (1 | ) | (5 | ) | ||
| Cash and cash equivalents at end of period | $ | 14,494 | $ | 48,254 |
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