ConfirmMDx Test Volume Increases 257% over First Quarter 2013
IRVINE, CA, and HERSTAL, BELGIUM – May 6, 2014 – MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today issued its business update for the quarter ended March 31, 2014.
“ConfirmMDx® for Prostate Cancer sales volume continued to increase sharply, with 257% growth in Q1 2014, over the same period last year. This sharp increase in volume shows continued rapid adoption of our test by the urology community. Also, growing insurance payor coverage continues to provide strong evidence of the clinical utility of ConfirmMDx.” said Dr. Jan Groen, CEO of MDxHealth. “The success of the ConfirmMDx test in the U.S. market, and the recent positive recommendation by the FDA panel to approve Exact Sciences’ Cologuard(TM) test, illustrate the value of new molecular diagnostics in the fast growing field of cancer epigenetics.”
Q1 2014 Highlights
Strong revenue increase of 31% in Q1 2014, over the same period last year
ConfirmMDx for Prostate Cancer case volume showed continued rapid growth, with approximately 2,300 cases in Q1 2014, compared to about 900 cases in Q1 2013
Q1 2014 ConfirmMDx revenue increased to $1.4 million from $0.3 million in Q1 2013
Signed exclusive distribution agreement for MDxHealth service products with Teva Pharmaceutical Ltd. in Israel
ConfirmMDx prognostic data presented at ASCO Genitourinary Cancers Symposium
ConfirmMDx case study published in the Journal of OncoPathology
Signed agreement with PPO provider Prime Health Services, Inc. covering 6 million lives
Data confirming the clinical utility of PredictMDx® for Glioblastoma test published in the New England Journal of Medicine
MDxHealth licensee Exact Sciences published the results of its 10,000 patient DeeP-C pivotal clinical validation study for its CologuardTM test in the New England Journal of Medicine and received an FDA panel unanimous recommendation supporting approval of its Cologuard Test
Events After the Reporting Period
Signed a co-marketing agreement for ConfirmMDx with Long Island Pathology, Inc., an anatomic and clinical pathology laboratory that serves the New York City metropolitan area.
Signed an insurance agreement with Galaxy Health Network, a Preferred Provider Organization (PPO) covering 3.5 million lives, bringing the total of covered lives to 147 million.
Published interactive 2013 annual report (mdxhealth.annual-report.be)
Key Non-audited Financials, as of 31.03.2014
Amounts in Dollars as at and for the three months ended
|Dollars thousands||March 31, 2014 YTD||March 31, 2013 YTD|
|EBITDA Income (Loss)||(4,252)||(3,747)|
|EBIT Operating Income (Loss)||(4,326)||(3,837)|
|Net Profit (Loss)||(4,024)||(3,836)|
|Cash and cash equivalents||19,713||12,122|
Q1 2014 revenue was $1.9 million, growing 31% over Q1 of 2013. Overall spending in Q1 was $6.2 million, up $0.9 million over the same period last year. The increase in overall expense was primarily due to expansion of the company’s commercial operations to accelerate the sales of the ConfirmMDx for Prostate Cancer test. First quarter operating loss (EBIT) and net loss were respectively $4.3 million and $4.0 million, which were modest increases over the same period in 2013, again primarily due to investment in commercialization. The Company’s cash and cash equivalents as of March 31, 2014 was $19.7 million, which was $7.6 million higher as compared to Q1 2013. The Company completed a $24 million equity placement in June 2013.
Q1 and FY2014 Outlook
In Q1 2014, MDxHealth expanded its sales force to 20 sales representatives and is on track with the expansion of its billing and collection department to cope with demand. In Q2, the company expects continued growth in ConfirmMDx test volume over the same period in 2013. Executing upon its managed care strategy to accelerate reimbursement of its ConfirmMDx testing service, the Company continues to pursue insurance agreements, such as the recent insurance agreements with Prime Health Services and Galaxy Health Network. As demand and collections continue to increase, the company expects to recognize more accrual based revenue. However, the company anticipates a growing number of new payors, thus increasing the group of non-contracted private 3rd party payors. This will lead to continued delays in collection and revenue recognition. Any projections provided herein should be considered forward looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.
MDxHealth is a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment. The company’s tests are based on proprietary gene methylation (epigenetics) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
For more information:
|Dr. Jan Groen, CEO||Mike Sinclair (media)|| Len Hall
|MDxHealth||Halsin Partners||Allen & Caron, Inc.|
|US: +1 949 812 6979||UK: +44 20 7318 2955||US: +1 949 474 4300|
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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. 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 and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.