Full Press Release Details
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."
for the third quarter ended September 30, 2022
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%) |
review for the three and nine months ended September 30, 2022
| USD in 000 (except per share data) Unaudited | 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
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
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
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."
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,
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-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.
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 | ) |