Full Press Release Details
Financial Year 2021 Results
Outlook and Guidance for 2022
Conference call with Q&A today at 4:30
IRVINE, CA, and HERSTAL, BELGIUM -
March 2, 2022 - MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics
company, today announced its financial results for the fourth quarter and year ended December 31, 2021 and provided a business
update and outlook for 2022.
2021 Business Highlights
Michael K. McGarrity, CEO of MDxHealth, commented:
"While 2021 presented continued headwinds related to the pandemic and its continued effect on patient flow for our particular patient
population in prostate cancer, we have made significant progress and we believe our results provide evidence that MDxHealth will emerge
from this challenging period with strong and sustainable growth.
"We believe this progress is evidenced by
for the fourth quarter and year ended December 31, 2021
review for the year ended December 31, 2021
| USD in thousands (except per share data) | Year Ended December 31 | |||||||||||
| Unaudited | 2021 | 2020 | % Change | |||||||||
| Services | 21,937 | 18,064 | 21 | % | ||||||||
| Licenses and royalties | 302 | 396 | (24 | )% | ||||||||
| Total Revenue | 22,239 | 18,460 | 20 | % | ||||||||
| Cost of goods | (11,675 | ) | (10,416 | ) | 12 | % | ||||||
| Gross Profit | 10,564 | 8,044 | 31 | % | ||||||||
| Operating expenses | (37,405 | ) | (35,167 | ) | 6 | % | ||||||
| Operating loss | (26,841 | ) | (27,123 | ) | (1 | )% | ||||||
| Net loss | (29,002 | ) | (28,662 | ) | 1 | % | ||||||
| Basic and diluted loss per share | (0.24 | ) | (0.34 | ) | (30 | )% |
Total revenue for 2021 was $22.2 million, an increase
of 20% as compared to total revenue of $18.5 million for 2020. Services revenue amounted to $21.9 million, an increase of 21% as compared
to $18.1 million a year earlier. Revenue from ConfirmMDx represented over 90% of services revenue for all periods.
Gross profit for 2021 was $10.6 million as compared
to $8.0 million for 2020. Gross margins were 47.5% for 2021 as compared to 43.6% for 2020, representing a gross margin improvement of
390 basis points, primarily related to a higher average selling price (ASP).
Operating expenses for 2021 were $37.4 million,
up 6% from $35.2 million for 2020. Excluding non-cash expenses such as depreciation, amortization and stock-based compensation, operating
expenses for 2021 were $33.1 million, an increase of 10% over 2020, primarily driven by R&D expenses related to our future product
Operating loss and net loss for 2021 were $26.8
million and $29.0 million, respectively, substantially flat compared to $27.1 million and $28.7 million, respectively, for 2020.
Cash and cash equivalents as of December 31, 2021
were $58.5 million, strengthened by gross proceeds from the January equity raise of 25 million (approximately $30 million) and the
November NASDAQ IPO of $45 million. Total cash collections amounted to $21.5 million during 2021, an increase of 1% compared to 2020.
Cash burn for 2021 was $26.8 million compared to $21.9 million in the prior year period.
Michael K. McGarrity, CEO of MDxHealth, commented:
"Even amidst the dynamics of the pandemic's impact on patient visits, we anticipate a return of patient flow and continued
adoption of SelectMDx and ConfirmMDx, which are emerging as the standard of care in the diagnostic pathway of patients at risk for prostate
cancer. We believe that these tests will take hold and drive growth into and beyond 2022.
In addition, we are developing solutions for active
surveillance (AS) of prostate cancer with our AS-MDx and Monitor-MDx tests. These menu additions would provide clinically actionable results
for urologists evaluating cancer patients considered for active surveillance, as well as regular monitoring of these patients where the
current standard of care is an invasive and costly annual biopsy. This is a well-characterized market where urologist are seeking a less
invasive actionable solution.
We believe these initiatives, coupled with our
current menu, will position MDxHealth to be the market leader in providing urologists with advanced diagnostics to support a patient from
an elevated PSA through the diagnostic continuum of care with increased clinical insight and confidence.
Finally, we are encouraged by the initial introduction
of novel molecular UTI testing services into our focused urology channel. The market for UTI testing is well-defined, with urologists
accounting for approximately 20% of the 10 million UTI tests ordered annually in the U.S."
Based on these catalysts for growth, MDxHealth
is providing the following guidance, with growth in 2022 driven by:
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 and use the Conference ID: 2329214.
International: +1-323-994-2093
United Kingdom: 0800 358 6377
The Netherlands: 0800 023 1436
United States: +1-888-204-4368
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 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. For more information,
Financial statements and auditor review
The Company's statutory auditor, BDO Bedrijfsrevisoren
BV, has confirmed that its audit procedures with respect to the Company's consolidated financial statements, 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, that the procedures completed to date have not revealed any material adjustments that would have
to be made to the accounting information derived from the Company's consolidated financial information that is included in this press
The condensed Consolidated Statement of Comprehensive
Income may be found on the Company's website at www.mdxhealth.com. The full Annual Report is expected to be made available to the public
via the Company's website in April 2022.
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. 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,
ConfirmMDx, SelectMDx, AS-MDx and MonitorMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service
marks are the property of their respective owners.