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.