Full Press Release Details
MDxHealth Reports Half Year 2022 Results
IRVINE, CA, and HERSTAL, BELGIUM -
August 25, 2022 - MDxHealth SA (NASDAQ/Euronext: MDXH) ("mdxhealth" or the "Company"), a commercial-stage
precision diagnostics company, today announced its financial results for the half year ended
Michael K. McGarrity, CEO of mdxhealth, commented:
"We are excited to report strong operating results for the first half of 2022, coupled with our recently announced acquisition of
the Oncotype DX GPS business from Exact Sciences. Our first half 2022 performance reflects the continued execution of our growth strategy
and provides a strong foundation for driving sustained growth for mdxhealth."
Key Financial and Corporate Highlights for
the half year and quarter ended June 30, 2022:
Additional Highlights for the half year and
quarter ended June 30, 2022
of Billable Test Volume by Product
| Second Quarter Ended June 30, | ||||||||||||
| Product | 2022 | 2021 | % Change | |||||||||
| Confirm mdx | 4,268 | 4,065 | 5 | % | ||||||||
| Select mdx | 3,243 | 3,792 | (14 | %) |
| Half Year Ended June 30, | ||||||||||||
| Product | 2022 | 2021 | % Change | |||||||||
| Confirm mdx | 8,409 | 7,978 | 5 | % | ||||||||
| Select mdx | 6,554 | 7,051 | (7 | %) |
the second quarter of 2022, the Company incurred a temporary OEM supply chain issue for our Confirm mdx and Select mdx collection kits
that had a negative impact on unit volume, mainly for Select mdx, with no material impact to revenue.
Financial review for the half year ended
| USD in thousands (except per share data) | Half Year Ended June 30, | |||||||||||
| Unaudited | 2022 | 2021 | % Change | |||||||||
| Services | 12,975 | 10,462 | 24 | % | ||||||||
| Licenses and royalties | 34 | 269 | (87 | %) | ||||||||
| Total Revenue | 13,009 | 10,731 | 21 | % | ||||||||
| Gross Profit | 5,772 | 5,215 | 11 | % | ||||||||
| Operating expenses | (22,795 | ) | (17,658 | ) | 29 | % | ||||||
| Operating loss | (17,023 | ) | (12,443 | ) | 37 | % | ||||||
| Net loss | (18,104 | ) | (13,299 | ) | 36 | % | ||||||
| Basic and diluted loss per share | (0.12 | ) | (0.12 | ) | 0 | % |
Total revenue for the first half of 2022 was $13.0
million compared to total revenue of $10.7 million for the first half of 2021, an increase of 21%. Services revenue amounted to $13.0
million, an increase of 24% as compared to $10.5 million a year earlier.
Gross profit on products and services for the
first half of 2022 was $5.8 million as compared to $5.2 million for the first half of 2021. Gross margins on products and services declined
to 44.4% for the first half of 2022 as compared to 48.6% for the same period in 2021, primarily due to timing of cash receipts for our
UTI test, which is expected to reverse in the second half of 2022. In addition, we expect coverage of our Select mdx test, as well as
our recently acquired Oncotype GPS business, to contribute further to gross margin growth in the second half of 2022.
Operating expenses in the first half of 2022 were
$22.8 million versus $17.7 million for the first half of 2021, primarily due to additional public company expenses as a result of the
Operating loss and net loss for the first half
of 2022 were $17.0 million and $18.1 million, respectively, with losses increasing compared to $12.4 million and $13.3 million, respectively,
over the same period in 2021, for the reasons stated above.
Cash and cash equivalents as of June 30, 2022,
were $40.0 million. Total cash collections amounted to $12.5 million in H1-2022, an increase of 22% compared to the same period last year,
as a result of increased Confirm mdx volume as well as improved average selling prices. Cash use for H1-2022 was $18.6 million compared
to $13.1 million in the prior year period.
The Company maintains its outlook, as provided
in its press release on August 2, 2022, as follows:
On August 2, 2022, mdxhealth announced that it
entered into an asset purchase agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation ("Exact Sciences"),
to acquire the Oncotype DX GPS (Genomic Prostate Score ) test from Exact Sciences along with most of its
team of urology sales and marketing professionals. Following the acquisition, the Company's commercial field organization has expanded
to over 70 sales representatives, strategic account managers, and medical science liaisons.
In addition, on August 2, 2022, the Company announced
that it obtained debt financing of $35 million under a new loan and security facility with an affiliate of Innovatus Capital Partners,
LLC, which replaces the Company's existing EUR 9 million debt facility with Kreos Capital.
For complete details of the Oncotype DX GPS acquisition
as well as the Innovatus debt facility, please refer to the press release issued by the Company on August 2, 2022, which is available
on the Company's website at https://mdxhealth.com/press-releases-events.
Mdxhealth is a commercial-stage precision diagnostics
company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The Company's
tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis
of urologic cancers and prognosis of recurrence risk. The Company's European headquarters are in Herstal, Belgium, with laboratory
operations in Nijmegen, The Netherlands, and U.S. headquarters and laboratory operations based in Irvine, California, with additional
facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
Financial statements and auditor review
The Company's statutory auditor, BDO Bedrijfsrevisoren
BV, has confirmed that its review procedures with respect to the Company's condensed consolidated financial statements as of and for the
six-month period ended 30 June 2022, prepared in accordance with the International Financial Reporting Standards as issued by the International
Accounting Standards Board (IASB) and as adopted by the EU, have been substantially completed. The aforementioned condensed consolidated
financial statements may be found on the Company's website at www.mdxhealth.com.
For more information:
LifeSci Advisors (IR & PR)
Important information
This press release includes forward-looking
statements 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 the
acquisition of Oncotype DX GPS prostate cancer business from Exact Sciences including statements regarding the anticipated
benefits of the acquisition; statements regarding 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 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. Important factors that could cause actual results, conditions
and events to differ materially from those indicated in the forward-looking statements include, but are not limited to, risks related
to potential disruptions in our operations due to the conflict between Russia and Ukraine; risks and uncertainties associated with the
coronavirus (COVID-19) pandemic, including its possible effects on our operations, and the demand for our products; risks related to
the acquisition of the Oncotype DX GPS prostate cancer business; risks related to our ability to successfully and profitably
market our products; risks and uncertainties related to the acceptance of our products and services by healthcare providers; risks and
uncertainties related to 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 risks and uncertainties related to the amount and nature of competition for our products
and services. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.
In addition, even if our results, performance or achievements are consistent with such forward-looking statements, they may not be predictive
of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication
of this release. 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, and Genomic Prostate Score are trademarks or registered trademarks of MDxHealth SA. Oncotype DX and
Exact Sciences are trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective
For the six months ended June 30, 2022
CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND
OTHER COMPREHENSIVE INCOME
In thousands of USD (except per share data)