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NEWS RELEASE - REGULATED INFORMATION
21 OCTOBER 2021, 07:00 A.M. CET
MDxHealth Provides Q3-2021 Business Update
IRVINE, CA, and HERSTAL, BELGIUM – October 21, 2021 – MDxHealth SA (Euronext: MDXH.BR) (“MDxHealth” or the “Company”), a commercial-stage precision diagnostics company, today provided a business update for the third quarter ended September 30, 2021.
Michael K. McGarrity, CEO of MDxHealth, commented: “As communicated in our midyear results in August, we remain firmly committed and focused on the execution of our growth strategy, despite the continued challenges presented by the virulent COVID-19 Delta variant. Services revenue in the third quarter of 2021 increased by 23% compared to Q3-2020, and ConfirmMDx units, though still impacted in this quarter by the pandemic, were up 5% from the same period last year. Despite the unavoidable challenges presented by the resurgent pandemic and its impact on screenings and patient flow, MDxHealth’s strong business fundamentals and emphasis on focus and execution remain unchanged.
I would also like to communicate the following evidence of our path forward to sustainable growth and value creation:
Our SelectMDx test has been included in the National Cancer Center Network (NCCN) Guidelines and a draft Local Coverage Determination (LCD) issued by Medicare.
Our commercial sales team has been engaged in driving adoption of and compliance to our diagnostic pathway for prostate cancer.
Our R&D focus on expansion of our menu into Active Surveillance would allow MDxHealth to be the only company in the diagnostic space to take a patient from elevated PSA all the way through the diagnostic and treatment pathway.
We have introduced our first channel opportunity targeted into our urology customer base with a urinary tract infection (UTI) test to provide broad clinically actionable results for both organism identification and drug susceptibility, and are encouraged by our initial introduction.
Finally, we remain committed to prudent financial stewardship and operating discipline.”
Results for the third quarter ended September 30, 2021
Total revenue of $5.5 million, up 23% from $4.5 million in Q3-2020
ConfirmMDx unit growth of 5% compared to Q3-2020
SelectMDx unit decline of 1% compared to Q3-2020
Cash and cash equivalents of $24.7 million as of September 30, 2021
Summary of billable test volume
Quarter Ended September 30
The board of directors appointed Mr. Donnie (Don) M. Hardison as an independent non-executive director. Mr. Hardison was most recently the President and Chief Executive Officer, and served on the board of directors, of Biotheranostics, Inc., a molecular diagnostic company focused on oncology, from February 2017 until it was acquired by Hologic, Inc. in February 2021. From April 2010 to March 2016, Mr. Hardison was the President and Chief Executive Officer of Good Start Genetics, a molecular genetic testing and information company. For more than 20 years prior to that, Mr. Hardison held various executive and senior management positions at companies including Laboratory Corporation of America (LabCorp), Exact Sciences Corporation, Quest Diagnostics Inc., and Smith Kline Beecham Corporation. He currently serves as an independent director on the boards of directors of Stemina Biomarker Discovery, Inc., Seventh Sense Biosystems, BioPorto, Inc. and IQuity, Inc. He also formerly served on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February 2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina, Chapel Hill. Mr. Hardison will continue the mandate of Mr. Timothy Still, who previously stepped down from the board of directors. His appointment as director will be submitted for confirmation to the next general shareholders' meeting of the Company.
Michael K. McGarrity, CEO of MDxHealth commented: “We are very excited to welcome Don Hardison to our board of directors. Don’s breadth of experience and reach into the U.S. and global diagnostic industry will serve MDxHealth well as we go forward. As we have built our operating team, we as a Company, are now stronger with Don on our board of directors.”
Don Hardison commented: “I am thrilled to join MDxHealth and the board of directors in their important mission to drive change in the course of prostate cancer diagnosis and treatment for both patients and providers, and am pleased to have the opportunity to help lead the company forward which I believe has a compelling combination of a strong management team and significant growth prospects.”
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, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
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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, 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.