HERSTAL, BELGIUM and IRVINE, CA - December 28, 2017 - MDxHealth SA (Euronext: MDXH.BR, "MDxHealth", or the "Company"), a world leader in molecular diagnostic prostate cancer testing, today announced that, based on preliminary results for the fourth quarter, the Company will not meet earlier guidance for revenue growth in 2017. In line with prior calendar years, the Company had anticipated an increase in volumes during the fourth quarter. However, the Company has faced timing issues in obtaining billable cases from contracted ConfirmMDx customers and from post-marketing studies that support continuation of Medicare coverage. These delayed contracted cases are expected to partly spill over into 2018. As a result, the Company will fall short of its year-over-year product-and services revenue growth target of 45-55%, expecting to instead end the year at growth of around 10-15%.Total revenue for 2017, including the revenue from the one-time buy-out of the Company's colorectal patents by Exact Sciences, is expected to grow by approximately 32-37% compared to 2016.
"Although we are disappointed with these preliminary Q4 results, we remain confident that the fundamentals of our Company are in place for healthy future growth and bottom line results," said Dr. Jan Groen, CEO of MDxHealth. "We have a leading and growing position in urological diagnostics in the US with both ConfirmMDx and SelectMDx, as well as a strong growth position in Europe with our SelectMDx liquid biopsy test."
The next update will be provided on February 22, 2018 together with the full year financial results for 2017.
ConfirmMDx for Prostate Cancer is the first epigenetic, and only tissue-based test in the 2016 NCCN Guidelines for early detection of prostate cancer which addresses false negative biopsy concerns. It is the only molecular diagnostic test that provides a very high negative predictive value (NPV) of 96% for clinically significant prostate cancers, and 90% NPV for all prostate cancers, as well as prostate mapping of the test results to help guide repeat biopsies. Each year, more than 1 million American men undergo an invasive prostate biopsy with a negative result, however approximately 30% of those men have prostate cancer. The current standard of care for prostate biopsy procedures samples less than 1% of the prostate, leaving men at risk for undetected cancer and leading to a high rate of repeat biopsies, even on cancer-free men. ConfirmMDx for Prostate Cancer helps urologists identify low-risk men who may forego an unnecessary repeat biopsy and high-risk men who may benefit from intervention. ConfirmMDx has qualified for Medicare reimbursement and covered by numerous private health insurance plans.
Of the nearly 2 million prostate biopsies performed each year, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive 'liquid biopsy' method to assess a man's risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce the need for MRI procedures and invasive prostate biopsies by up to 50%, thereby reducing healthcare costs.
MDxHealth is a multinational healthcare 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, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company's European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, the Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
For more information:
Dr. Jan Groen, CEO Jean-Marc Roelandt, CFO
US: +1 949 812 6979 BE:+32 4 364 20 70
BE: +32 4 364 20 70 IR@mdxhealth.com
LifeSpring LifeSciences Communication, Amsterdam, The Netherlands
+31 6 538 16 427
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. 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, AssureMDx, PredictMDx and UrNCollect are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.