MDxHealth Trading Update: January to April 2017

NEWS RELEASE /  REGULATED INFORMATION / INSIDE INFORMATION
                                                                                                                            

IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CEST, May 8, 2017 - MDxHealth SA (Euronext: MDXH.BR) today issued its first trading update for the year summarizing commercial, R&D and financial highlights for the four months ended April 30, 2017.

"With nearly 8,000 patients tested during the first four months of 2017, we experienced strong growth in volume compared to the same period last year," said Dr. Jan Groen, CEO of MDxHealth. "Additionally, we believe our recent US government services agreement, together with 11 new payor contracts, will continue to drive positive momentum through the rest of the year."

Commercial highlights (four months ended April 30, 2017):

  • Nearly 8,000 patients tested, an increase of 25% compared to the same period in 2016. Testing volume was in part driven by the uptake of SelectMDx(TM) for Prostate Cancer.
     
  • Sharp revenue growth of 128%, or $19.4 million, compared to the same period in 2016.
     
  • Exact Sciences acquired MDxHealth patents directed toward colorectal cancer for a total of $15 million, including payments accrued since July 2016.
     
  • Cash and cash equivalents on April 30 2017 of $35.1 million.
     
  • Expanded access to portfolio of prostate cancer tests:
     
    • 11 new US payor contracts for ConfirmMDx® including US Government Services Administration (GSA), Blue Cross Blue Shield plans of New Jersey, Illinois and Montana; Independence Blue Cross; Michigan, Pennsylvania and Wisconsin Medicaid programs; MediNcrease; IPN and AmeriHealth NJ.
       
    • Two new US positive coverage policies for ConfirmMDx, including Blue Cross Blue Shield of Tennessee and Prominence Health Plan.
       
    • New contract with MediNcrease, US payor, for SelectMDx and distribution agreements with Istituto Diagnostico Varelli and Lab21 to make SelectMDx available in Italy and the UK, respectively.
       
  • Euronext included MDxHealth in its Tech 40, which recognized innovative European small and mid-cap companies listed on its markets.

R&D highlights:

  • Data from a prospective study presented at the European Association of Urology (EAU) annual congress demonstrated that biomarkers from ConfirmMDx could help urologists monitor therapy response to improve the personalized treatment of castration resistant prostate cancer. The study is another strategic milestone in MDxHealth's ongoing development of liquid biopsy products.
     
  • SelectMDx adopted by the Michigan Medicine prostate cancer risk clinic at US University of Michigan hospital as a pre-biopsy diagnostic tool to monitor men with previously diagnosed genetic mutations.
     
  • Study demonstrating SelectMDx reduced over-diagnosis and overtreatment of men at risk of prostate cancer versus PSA testing alone published in the Britsh Journal of Urology International.
     
  • Exclusive license agreement with Ghent University in Belgium for its proprietary molecular diagnostic visualization technology (methylation in situ hybridization (MISH)).
     
  • Five-year research collaboration agreement with Exact Sciences in the field of epigenetics.
     
  • Agreement with the Faculty of Health, Medicine and Life Sciences / School for Oncology and Developmental Biology (GROW) at Maastricht University to expand its existing research collaboration to develop next generation (epi)genetic cancer diagnostics for improved diagnosis, staging and treatment of cancer patients.

             
2017 Outlook:

The Company maintains its guidance for the 2017 fiscal year and expects continued revenue growth from increased adoption of ConfirmMDx and SelectMDx in the EU and US markets, driven by increased payor coverage, distribution agreements for SelectMDx and launch of the SelectMDx CE-marked vitro diagnostic (IVD) kit.

The Company maintains the following guidance for 2017:

  • Growth between 55% to 75% on product and service income.
     
  • Increasing utilization of its products in and outside the US, contributing to a continuing reduction in operating losses.
     
  • Increasing private payor adoption and securing favourable reimbursement rates for ConfirmMDx and SelectMDx in the US.
     
  • Continue to expand its product and services offering and leverage its established commercial presence through the launch of AssureMDx(TM) for Bladder Cancer.
     
  • Continue to demonstrate the clinical utility of its product portfolio through peer-review articles.

About MDxHealth

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:

Shalon Roth, EVP Corporate Communications
MDxHealth
UK: +44 (0)7393 906278
@ShalonRoth
info@mdxhealth.com

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 and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.