IRVINE, Calif. & LIEGE, Belgium--()--Regulatory News:
MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today issued its business update for the quarter ended March 31, 2012.
Q1 2012 Highlights
- Continued Year-over-Year improvement of key financial performance indicators:
- Revenue increased by 115% compared to the same period last year
- Operating loss reduced by 3.1%
- Net loss reduced by 4.1%
- Operating cash utilization increased by 2.5%
- Cash position at the end of the Q1 was EUR 9.6 million or (USD 12.8 Million)
- Company’s California diagnostic laboratory obtained CLIA-registration and state licenses for both California and Maryland.
- Received the Frost & Sullivan 2011 European molecular diagnostics for oncology technology leadership award.
- Licensing partner Predictive Biosciences launched its CertNDx™ bladder cancer test based on MDxHealth’s technology and biomarkers.
Material Events after the Reporting Period
Yesterday, MDxHealth announced the launch of ConfirmMDx™ for Prostate Cancer in the United States. The ConfirmMDx for Prostate Cancer test helps urologists distinguish patients who have a true-negative prostate biopsy from those who may have occult cancer. Testing will be performed in MDxHealth’s state-of-the-art Irvine-based CLIA laboratory for physicians submitting prostate tissue samples directly or via its exclusive co-marketing partner PLUS Diagnostics.
On April 26, 2012, MDxHealth and PLUS Diagnostics entered into a marketing agreement for ConfirmMDx™ for Prostate Cancer. PLUS Diagnostics, a leading anatomic pathology laboratory, will promote MDxHealth’s prostate cancer test through its U.S. urology network, complementing the Company’s direct sales efforts.
“MDxHealth Pharmaco Diagnostic revenues have shown two consecutive quarters of growth. The growth trends are encouraging and momentum in this business segment is strong. Epigenetics, the methods to measure changes in genes beyond those in the DNA sequence, is one of the fastest growing fields in cancer and MDxHealth is striving to be the leader in applying epigenetics in cancer diagnostics. We are investing in the commercialization of our brain and prostate tests while continuing to grow our Pharmaco Diagnostic segment,” said Dr. Jan Groen, Chief Executive Officer of MDxHealth. He went on to say: “Yesterday, we announced the launch in the U.S. of ConfirmMDx for Prostate Cancer, the first clinical product offered from our state-of-the-art Irvine-based CLIA laboratory. Epigenetic markers and technology included in ConfirmMDx for Prostate Cancer have been tested on approximately 4,128 patients with over 42 published studies. We have now hired our own sales team in the U.S. and together with the recent marketing agreement with PLUS Diagnostics, we believe we are on track for successful roll-out of this important test to the urology community. These accomplishments demonstrate our commitment to execute aggressively the new commercial strategy we outlined in October 2010.”
Key non-audited financials, as of 31.03.2012
Amounts as at and for the three months ended
|Euro thousands||March 31, 2012 YTD||March 31,2011 YTD|
|EBITDA Income (Loss)||(1,842)||(1,930)|
|EBIT Operating Income (Loss)||(1,953)||(2,015)|
|Net Profit (Loss)||(1,920)||(2,000)|
|Cash and cash equivalents||9,557||9,065|
Q1 Pharmaco Diagnostic business segment revenue was Euros 582K representing over 81% of total Q1 revenue and growing 203% over Q1 of 2011. Growth in royalty income due in part to Predictive Biosciences’ launch of CertNDx contributed meaningfully to Q1 revenue growth. The remaining revenue came from grants, which is expected to decline as a percentage of the company’s overall revenues in 2012.
Overall spending in Q1 was Euros 2.7 million, up 16.5% over the same period last year. The increase in overall expense was primarily due to the continuing buildup of U.S. commercial operations in anticipation of the launch of the Prostate ConfirmMDx test. The rate of increase in spending to support the U.S. launch of this test will be monitored carefully versus overall company revenue growth, so profitability goals are maintained. First quarter operating loss (EBIT) and the net loss of Euros 1.9 million improved by 3.1% and 4.1%, respectively, over the same period in 2011 due to higher revenues. The Company’s cash and cash equivalents as of March 31, 2012 was Euros 9.6 million which was 5.4% higher as compared to the same period last year as a result of our equity financing in April 2011.
Q2 and FY2012 Outlook
As the Company continues to execute its new commercialization strategy by establishing new collaborative partnerships in Pharmaco Diagnostics and launching its ConfirmMDx for Prostate Cancer test, additional sources of revenue are anticipated during the remainder of this year. In Q2, the Company expects revenue to grow over Q1 and show year-over-year growth for FY2012. This guidance is based on management’s assessment of growth prospects in the current business, anticipation of new Pharmaco opportunities, and today’s launch of the Company’s ConfirmMDx for Prostate Cancer test. The Company expects to release data from a blinded European validation study for ConfirmMDx before the end of this quarter.
MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. By applying patented DNA methylation platform and biomarkers, MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. For more information visit http://www.mdxhealth.com and follow us on Twitter at: http://www.twitter.com/mdxhealth.
Dr Jan Groen will make a formal presentation on the Company at the 13th annual meeting BioEquity Europe that is taking place on May 15th-16th in Frankfurt, Germany.
Please visit MDxHealth at the American Urology Association Annual Meeting, May 19-23 2012 in Atlanta, GA, booths #3831 and #3923.
Important information about forward-looking statements
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.