Full Press Release Details
NEWS RELEASE - REGULATED INFORMATION
15 MAY 2023, 4:00PM EDT / 22:00 CET
MDxHealth Reports Q1-2023 Results
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."
for the first quarter ended March 31, 2023
review 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.
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
The Netherlands: 0800 023 4340
United Kingdom: 0800 756 3429
Conference ID: 13738494
To ensure a timely connection, it is recommended
that users register at least 10 minutes prior to the scheduled start time.
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:
LifeSci Advisors (IR & PR)
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, 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. 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; our ability to obtain and maintain regulatory approvals and comply
with applicable regulations; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the
Oncotype DX GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and
the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk
Factors 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 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
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 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 property of their respective owners.