MDxHealth Nine Month Trading Update
Patient test volume for the first nine months up 43%
SelectMDx test volume in Europe increased nearly 400%
NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION
IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CET, November 2, 2017 - MDxHealth SA (Euronext: MDXH.BR) today issued its interim trading update summarizing commercial, R&D and financial highlights for the nine months ended September 30, 2017.
Financial highlights for the nine months ended September 30, 2017
Total revenue of $30.5 million, up 38% from the same period in 2016, in part driven by $12.1 million net revenue from a one-time buy-out of the Company's patents directed towards colorectal cancer to Exact Sciences;
Product revenue of $18.2 million, up 3% from $17.6 million last year, adversely affected by the impact of hurricanes;
EBITDA improved by 34.1% from $-6.2 million compared to $-9.1 million in 2016;
Cash and cash equivalents on September 30, 2017 of $22.9 million;
Over 23,000 patients tested, an increase of 43% compared to the same period in 2016, with SelectMDx® representing approximately 36% of total;
EU SelectMDx test volume up nearly 400% to over 2,000 patients tested compared to 400 in the same period in 2016.
"Hurricanes Harvey and Irma depressed industry-wide laboratory Q3 testing volumes and reduced ConfirmMDx test volumes in the affected states by an estimated 50%," said Dr. Jan Groen, Chief Executive Officer of MDxHealth. "However, overall growth of patient test volume remains strong. After nine months, we tested nearly as many patients as for the full year in 2016. Our expanded sales force has been fully deployed since early September and is expected to fuel growth in the fourth quarter and beyond."
Business highlights for the three months ended September 30, 2017
Commercial achievements, clinical and business development
Expanded access to portfolio of prostate cancer tests:
o Blue Cross Blue Shield plans of Arizona and Idaho added to payors under contract for ConfirmMDx® for Prostate Cancer test, now totaling 62 payors;
o Healthcare services agreement signed with Southern California Permanente Medical Group to assess the performance of the ConfirmMDx;
o US payor contract for SelectMDx signed with Lakehead Airforce Base, bringing the total number of SelectMDx contracted payors to 15;
o Distribution agreements signed with IDI Hospital in Rome, Italy; MicroDiagnostics in Thessaloniki, Greece and IPS Genomix in the Middle East;
o MVZ Dr. Stein & Kollegen medical laboratory in Mönchengladbach Germany, one of the laboratories within the Limbach Gruppe SE, will perform SelectMDx service testing. To offer this service through its network, the laboratory will purchase SelectMDx CE-marked IVD kits from MDxHealth.
Data from a retrospective study, conducted by the Radboud Medical Center and published in The Prostate, demonstrated that SelectMDx correlated with multiparametric MRI (mpMRI) and outperformed the PCA3 test;
· A US cost-effectiveness study demonstrated that SelectMDx improved patient outcomes while significantly reducing healthcare costs by preventing over-diagnosis and overtreatment of men with clinically insignificant prostate cancer;
· Opening of a new service and research laboratory at the Novio Tech Campus in Nijmegen, the Netherlands, expanding the capacity to perform SelectMDx and support ongoing research, development and commercial activities;
· Continued expansion of executive functions with the appointments of Michael K. Brawer, MD as Chief Medical Officer and Paul Marr as Executive Vice President of Sales for North America in conjunction with the expansion of its US sales force to 50 representatives.
Post-Period Development
Signed three distribution agreements for SelectMDx with Unilabs, in Geneva, Switzerland; Omgen in Istanbul, Turkey and TH Servive in Sofia, Bulgaria;
Two new US positive coverage policies for ConfirmMDx issued by Blue Cross Blue Shield Idaho and Geisinger Health Plan, bringing the total to 33;
The Board of Directors elected Mrs. Hilde Windels, as independent director. Mrs. Windels is an executive director of Biocartis, has 20 years of experience in the biotechnology sector with a track record of building and structuring organizations, fundraising, M&A, public capital markets and corporate strategies. At Biocartis, she was CEO ad interim and Deputy CEO from September 2015 until September 2017 and CFO from 2011 until September 2015. Previously, Mrs. Windels worked as independent CFO for several private biotech companies and from 1999 to 2008 she was CFO of Devgen. Currently, Mrs. Windels also serves as a board member at EryTech, Ablynx and BioCartis. In the past, she also served on the boards of Devgen, MDxHealth and FlandersBio. Mrs. Windels holds a Masters in Economics from the University of Leuven, Belgium;
On October 19th Mark Shaffar, chairman of the board of directors (represented by Shaffar LLC), has informed the Company of his decision to retire from the board of directors. The board of directors has elected Mr. Wally Narajowski to be the new chairman.