2012-11-15 08:06:54 -
IRVINE, CA, and LIEGE, BELGIUM, November 15, 2012 - MDxHealth SA (NYSE Euronext:
MDXH), a leading molecular diagnostic company that develops and commercializes
epigenetic tests to support cancer treatment, today published a business update
for the third quarter ending September 30, 2012.
Highlights
In Q3 2012, MDxHealth made significant progress across all facets of its
business. On July 4, 2012, the company raised €10 million in new equity funding
via a private placement. As of September 30, 2012, the company had €13.9
million of cash on hand. Commercial product and service revenues in Q3
increased 142% compared to the
same period last year, with total revenues of
€2.9 million in the first nine months of 2012, an increase of 90% versus the
same period in 2011.
The commercial roll-out of ConfirmMDx(TM) for Prostate Cancer, launched at the
end of May of this year, is advancing according to expectations. In July,
MDxHealth signed a collaboration agreement with Merck KGaA for the development
and worldwide commercialization of MDxHealth's MGMT diagnostic test,
PredictMDx(TM) for Glioblastoma.
In August, the company received CAP (College of American Pathologists)
accreditation, as well as licenses from Florida and Pennsylvania, for its CLIA
reference laboratory in Irvine, CA.
"We are very pleased with the acceptance of the ConfirmMDx for Prostate Cancer
test among the US urology community as evidenced by our sales growth. The rising
market awareness and adoption of the ConfirmMDx test reflect increasing momentum
of our sales and marketing efforts," said Dr. Jan Groen CEO of MDxHealth. "Based
on the favorable market reception, it is clear that our epigenetic test provides
urologists with valuable information to help address false-negative biopsy
concerns with their patients. This early success gives me confidence that
ConfirmMDx will also deliver value for the company and its shareholders."
Key non-audited financials as of September 30, 2012
Amounts as at and for the three months ended
+------------------------------+---------------+---------------+
| Euro thousands | Sept 30, 2012 | Sept 30, 2011 |
+------------------------------+---------------+---------------+
| Commercial Revenues | 644 | 267 |
+------------------------------+---------------+---------------+
| Total Revenues | 925 | 378 |
+------------------------------+---------------+---------------+
| EBITDA (Loss) | (2,244) | (1,760) |
+------------------------------+---------------+---------------+
| EBIT Operating Income (Loss) | (2,330) | (1,862) |
+------------------------------+---------------+---------------+
| Net Profit (Loss) | (2,321) | (1,879) |
+------------------------------+---------------+---------------+
| Cash and cash equivalents | 13,899 | 12,916 |
+------------------------------+---------------+---------------+
Amounts as at and for the nine months ended
+------------------------------+----------------+---------------+
| Euro thousands | Sept. 30, 2012 | Sept 30, 2011 |
+------------------------------+----------------+---------------+
| Commercial Revenues | 2,100 | 1,086 |
+------------------------------+----------------+---------------+
| Total Revenues | 2,939 | 1,785 |
+------------------------------+----------------+---------------+
| EBITDA Income (Loss) | (6,293) | (5,444) |
+------------------------------+----------------+---------------+
| EBIT Operating Income (Loss) | (6,590) | (5,713) |
+------------------------------+----------------+---------------+
| Net Profit (Loss) | (6,580) | (5,692) |
+------------------------------+----------------+---------------+
| Cash and cash equivalents | 13,899 | 12,916 |
+------------------------------+----------------+---------------+
Commercial revenues up 90% for the first 9 months
Revenues
The total revenues for the first nine months of the year amounted to €2.9
million, of which €2.1 million represent commercial revenues, up 90% compared to
the same period last year.
Operating Expenses
The company's operating expenses were €9.2 million in the first nine months of
2012, versus €7.3 million in the same period in 2011, as the company continued
to invest in the development of its product pipeline and sales and marketing
activities in the US.
Cash Position
As of September 30, 2012, MDxHealth had €13.9 million in cash, compared to €12.9
million on September 30, 2011, €1.0 million higher than the same period last
year.
Outlook for fourth quarter and FY 2012
In Q4 2012, the company expects to report an increase in commercial product and
service revenues compared to previous quarters, primarily due to continuing
growth in sales of our ConfirmMDx for Prostate Cancer test in the US and
commercial service revenues from our ongoing PharmacoMDx collaborations with
Merck Serono, GSK Biologicals and other partners. The health economic study for
the ConfirmMDx for Prostate Cancer test, providing healthcare providers with
important cost comparison data, is scheduled to be submitted for publication.
Total operating costs in Q4 are expected to increase due to higher sales and
marketing and other operating activities.
About MDxHealth
MDxHealth is a molecular diagnostics company that develops and commercializes
advanced epigenetic tests for cancer assessment and the personalized treatment
of patients. The company's first commercial product, the ConfirmMDx(TM) for
Prostate Cancer test, has been shown to help distinguish patients who have a
true-negative biopsy from those who may have occult cancer.MDxHealth helps to
address a large and growing unmet medical need for better cancer diagnosis and
treatment information. The company has a proprietary platform and a strong
epigenetic product pipeline focused on the development of products for brain and
lung cancers. The company is based in Irvine, California with a European
headquarters in Liege, Belgium. For more information visit MDxHealth website at
www.mdxhealth.com.
For more information:
Dr. Jan Groen, CEO Mike Sinclair
MDxHealth Halsin Partners
US: +1 949 812 6979 UK: +44 20 7318 2955
BE: +32 4 364 20 70 Cell: +44 7968 022075
info@mdxhealth.com msinclair@halsin.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.
Q3 2012 ENG:
hugin.info/137314/R/1657741/536263.pdf
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Source: MdxHealth via Thomson Reuters ONE
[HUG#1657741]
