MDxHealth SA 6-K, filed Oct 27, 2022
MDxHealth SA (MDXH)
About this 6-K
MDxHealth SA filed this 6-K on October 27, 2022.
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 October 2022
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 October 27, 2022, MDxHealth SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1.
The information in the attached Exhibit 99.1 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 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 October 27, 2022 |
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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: October 27, 2022 | By: | /s/ Michael McGarrity |
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Name: Michael McGarrity Title: Chief Executive Officer | ||
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Exhibit 99.1
NEWS RELEASE - REGULATED INFORMATION
27 OCTOBER 2022, 4:00PM EDT / 22:00 CET
MDxHealth Reports Q3-2022 Results
IRVINE, CA, and HERSTAL, BELGIUM – October 27, 2022 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today announced its financial results for the third quarter ended September 30, 2022.
Michael K. McGarrity, CEO of mdxhealth, commented: “We are pleased to report continued strong operating results for the third quarter 2022. Our focus on operating discipline and commercial execution and 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.”
Highlights for the third quarter ended September 30, 2022
| ● | Q3-2022 revenue of $11.2 million, representing an increase of 103% over Q3-2021; excluding revenues from the recently acquired Oncotype DX Genomic Prostate Score (GPS) test, Q3-2022 revenue increased 42% over Q3-2021, reflecting continued execution by our sales team, expanded coverage of our menu and efficient revenue cycle management |
| ● | Closed our acquisition of the Oncotype DX GPS business from Exact Sciences on August 2, 2022 |
| ● | Continued commercial uptake of our Urinary Tract Infection (UTI) test, newly branded as Resolve mdx |
| ● | Q3-2022 Confirm mdx billable test volume increased 14% to 4,272 versus 3,748 for the same period last year |
| ● | The Company’s guidance for 2022 revenue remains unchanged at $40-42 million |
| ● | Cash and cash equivalents of $27.4 million as of September 30, 2022 |
Summary of Billable Test Volume by Product
| Product | Three months ended September 30, | ||
| 2022 | 2021 | % Change | |
| Confirm mdx | 4,272 | 3,748 | 14% |
| Select mdx | 3,004 | 3,218 | (7%) |
| Product | Nine months ended September 30, | ||
| 2022 | 2021 | % Change | |
| Confirm mdx | 12,681 | 11,726 | 8% |
| Select mdx | 9,558 | 10,269 | (7%) |
Financial review for the three and nine months ended September 30, 2022
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USD in ‘000 (except per share data) |
Three months ended September 30 | Nine months ended September 30 | ||||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | |||
| Services | 11,136 | 5,482 | 103% | 24,111 | 15,944 | 51% | ||
| Licenses and royalties | 18 | 13 | 38% | 52 | 282 | (82%) | ||
| Total Revenue | 11,154 | 5,495 | 103% | 24,163 | 16,226 | 49% | ||
| Cost of goods | (4,931) | (2,933) | 68% | (12,168) | (8,449) | 44% | ||
| Gross Profit | 6,223 | 2,562 | 143% | 11,995 | 7,777 | 54% | ||
| Operating expenses | (14,364) | (9,713) | 48% | (37,159) | (27,371) | 36% | ||
| Operating loss | (8,141) | (7,151) | 14% | (25,164) | (19,594) | 28% | ||
| Net loss | (8,613) | (7,621) | 13% | (26,717) | (20,920) | 28% | ||
| Basic and diluted loss per share | (0.05) | (0.06) | (6%) | (0.17) | (0.18) | (6%) | ||
Total revenue for the three months ended September 30, 2022, was $11.2 million, an increase of 103% as compared to total revenue of $5.5 million for the three months ended September 30, 2021. Excluding the Oncotype DX GPS revenues, total revenues for the quarter were $7.8 million, an increase of 42% compared to the third quarter of 2021.
For the nine months ended September 30, 2022, total revenue was $24.2 million, an increase of 49% as compared to total revenue of $16.2 million for the nine months ended September 30, 2021. Excluding the Oncotype DX GPS revenues, total revenues were $20.8 million, an increase of 28% compared to the first nine months of 2021.
Gross profit for the three months ended September 30, 2022, was $6.2 million, an increase of 143% as compared to $2.6 million for the three months ended September 30, 2021. Gross margins were 55.8% for Q3-2022 as compared to 46.6% for Q3-2021, an improvement of 917 basis points attributed to contribution from Resolve mdx and the addition of initial Oncotype DX GPS revenues.
For the nine months ended September 30, 2022, gross profit was $12.0 million, an increase of 54% as compared to $7.8 million for the first nine months of 2021. Gross margins were 49.6% for the first nine months of 2022 as compared to 47.9% for the first nine months of 2021.
Operating expenses for the three months ended September 30, 2022, were $14.4 million, up 48% from $9.7 million for the three months ended September 30, 2021, primarily driven by acquisition-related expenses as well as additional field sales personnel associated with the Oncotype DX GPS business.
For the nine months ended September 30, 2022, operating expenses were $37.2 million, up 36% from $27.4 million for the nine months ended September 30, 2021, primarily due to additional public company expenses as a result of the dual listing as well as expenses related to the acquisition of the Oncotype DX GPS business in August 2022.
Operating loss and net loss for the three months ended September 30, 2022, were $8.1 million and $8.6 million, respectively, compared to $7.1 million and $7.6 million, respectively, for the three months ended September 30, 2021.
For the nine months ended September 30, 2022, operating loss and net loss were $25.2 million and $26.7 million, respectively, compared to $19.6 million and $20.9 million, respectively, for the nine months ended September 30, 2021.
Cash and cash equivalents as of September 30, 2022, were $27.4 million.
Mr. McGarrity concluded, “Today’s results reflect our previously communicated view that mdxhealth is fast becoming a leading precision diagnostics company that can deliver sustainable growth. We anticipate coverage for our Select mdx test, coupled with the addition of our UTI and GPS test revenue, will further support gross margin accretion. While we are still at the beginning stages of our integration plan for the Oncotype DX GPS business, our field sales organization is now fully restructured and in place to support our growth, and we look forward to providing a view forward of 2023 as we enter the new year.”
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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:
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mdxhealth info@mdxhealth.com
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LifeSci Advisors (IR & PR) US: +1 949 271 9223 ir@mdxhealth.com
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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. 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 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 such products and services; and the amount and nature of competition for our products and services. 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. All other trademarks and service marks are the property of their respective owners.
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CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS
For the three months ended September 30, 2022
| In thousands of USD (except per share data) | Jul-Sep 2022 | Jul-Sep 2021 | ||||||
| Services | 11,136 | 5,482 | ||||||
| Licenses | 0 | 0 | ||||||
| Royalties and other revenues | 18 | 13 | ||||||
| Revenues | 11,154 | 5,495 | ||||||
| Cost of goods & services sold | (4,931 | ) | (2,933 | ) | ||||
| Gross Profit | 6,223 | 2,562 | ||||||
| Research and development expenses | (1,672 | ) | (1,504 | ) | ||||
| Selling and marketing expenses | (7,771 | ) | (4,325 | ) | ||||
| General and administrative expenses | (4,932 | ) | (3,813 | ) | ||||
| Other operating income, net | 11 | (71 | ) | |||||
| Operating loss | (8,141 | ) | (7,151 | ) | ||||
| Financial expenses, net | (472 | ) | (470 | ) | ||||
| Loss before income tax | (8,613 | ) | (7,621 | ) | ||||
| Income tax | 0 | 0 | ||||||
| Loss for the period | (8,613 | ) | (7,621 | ) | ||||
| Basic and diluted loss per share | (0.05 | ) | (0.06 | ) | ||||
For the nine months ended September 30, 2022
| In thousands of USD (except per share data) | Jan-Sep 2022 | Jan-Sep 2021 | ||||||
| Services | 24,111 | 15,944 | ||||||
| Licenses | 0 | 250 | ||||||
| Royalties and other revenues | 52 | 32 | ||||||
| Revenues | 24,163 | 16,226 | ||||||
| Cost of goods & services sold | (12,168 | ) | (8,449 | ) | ||||
| Gross Profit | 11,995 | 7,777 | ||||||
| Research and development expenses | (5,257 | ) | (4,327 | ) | ||||
| Selling and marketing expenses | (17,619 | ) | (12,572 | ) | ||||
| General and administrative expenses | (14,568 | ) | (10,552 | ) | ||||
| Other operating income, net | 285 | 80 | ||||||
| Operating loss | (25,164 | ) | (19,594 | ) | ||||
| Financial expenses, net | (1,552 | ) | (1,326 | ) | ||||
| Loss before income tax | (26,716 | ) | (20,920 | ) | ||||
| Income tax | (1 | ) | 0 | |||||
| Loss for the period | (26,717 | ) | (20,920 | ) | ||||
| Basic and diluted loss per share | (0.17 | ) | (0.18 | ) | ||||
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