MDxHealth Reports Fourth Quarter and Fiscal Year 2012 Results

MDxHealth Reports Fourth Quarter and Fiscal Year 2012 Results 
Regulated Information 
Revenue of EUR 4.6M ($6.0M), an Increase of 71% Versus Fiscal Year
2011 
IRVINE, CA, and LIEGE, BELGIUM -- (Marketwire) -- 02/28/13 -- 
MDxHealth SA (EURONEXT BRUSSELS: MDXH), a leading molecular
diagnostic company that develops and commercializes epigenetic tests
to support cancer treatment, today announced results for the fourth
quarter and the fiscal year ended December 31, 2012.  
Business Highlights
 MDxHealth achieved several major business
milestones, including the accreditation of its CLIA laboratory in
Irvine, California, the launch of ConfirmMDx(TM) for Prostate Cancer
and the publication of the multicenter clinical trial of ConfirmMDx
for Prostate Cancer in the Journal of Urology. Earlier in July 2012
MDxHealth raised EUR 10 million in gross proceeds through a private
placement, to support its ongoing commercial activities and delisted
from the NYSE Euronext in Amsterdam, The Netherlands, while
maintaining its listing on Euronext Brussels, Belgium. In Q4 2012,
the Company established a Center in Pharmaco (Epi)genomics in
collaboration with the Ghent University to further advance its strong
leadership position in the field of epigenomics. In December 2012,
MDxHealth's licensing partner Exact Sciences Corp. (NASDAQ: EXAS)
announced that it has submitted the first module of its premarket
approval application (PMA) to the U.S. Food and Drug Administration
(FDA) for its stool-based DNA colorectal cancer screening test.  
In support of commercialization efforts in 2013, MDxHealth presented
two prostate cancer studies at the annual ASCO Genitourinary Cancers
symposium on February 14-16, 2013 in Florida. The medical dossier for
ConfirmMDx supporting clinical validation and utility in the U.S. was
submitted to the Centers for Medicare & Medicaid Services (CMS)
within the U.S. Department of Health and Human Services.  
"MDxHealth's revenues increased by 71% to more than EUR 4.6 million
in 2012 versus 2011 and we are poised to build upon this strong
momentum in 2013," said Dr. Jan Groen, Chief Executive Officer of
MDxHealth. "During the year, we achieved all of our key milestones in
support of the commercialization of ConfirmMDx for Prostate Cancer
and moving f
orward, we will continue to execute on our licensed
central lab strategy, increasing our market penetration in the
urology community and driving the development and commercialization
of new ClinicalMDx and PharmacoMDx products and services."  
Key Figures (EUR thousands, except number of shares and per share
data): 


 
                                                                            
                                                                            
      As at or for the year ended December 31              2012         2011
Total revenues                                            4,602        2,687
Total operating expenses                                 12,606        9,518
Operating profit (EBIT)                                  -8,907       -7,097
Net loss                                                 -8,976       -6,947
Earnings per share, basic (EUR )                          -0.35        -0.37
Number of outstanding shares                         25,513,440   18,622,327
Cash and cash equivalents                                11,714       11,123

 
Revenues 
Total revenues for Q4 2012 increased 84% to EUR 1.7 million from EUR
0.9 million during the same period in 2011. The revenue increase was
attributable to both the Company's ClinicalMDx and PharmacoMDx
products and services. Total revenues for the full year ended
December 31, 2012, increased by 71% to EUR 4.6 million, compared to
total revenues of EUR 2.7 million for the prior year.  
In 2012, the Company began recognizing revenue for its ClinicalMDx
products and services, based on the ConfirmMDx for Prostate Cancer
test launched in May 2012. The Company initiated billing to U.S.
third party private insurance payors in Q3 2012 for tests performed
in 2012. MDxHealth has held claims to Medicare and will pursue
payment once Medicare has reviewed and approved the company's medical
dossier and finalizes reimbursement for the test, expected in 2013.
The Company's revenue recognition policy at this time is primarily
based on cash collections. Uncollected outstanding billable cases
have therefore generally been excluded from the Company's 2012
revenues. However, as billing and reimbursement trends are
established with each payor, the Company is transitioning to an
accrual-based revenue recognition policy.  
Operating Expenses
 Operating expenses for Q4 2012 were EUR 3.4
million, increasing 53% compared to EUR 2.2 in Q4 2011. This increase
is attributable to the build-up of the U.S. operations to support the
commercialization of the ConfirmMDx for Prostate Cancer test, as well
as potential future tests in the U.S. market. Q4 2012 operating
expenses were also higher than in each of the preceding three
quarters of 2012 due to the continuing build-up of the U.S.
operations through the year. Operating expenses for the year ended
December 31, 2012 increased by 32% to EUR 12.6 million from EUR 9.5
million for the prior year.  
Results
 In Q4 2012, the Company
reported a net loss of EUR 2.4 million, or (EUR 0.09) a share,
compared to a net loss of EUR 1.3 million, or (EUR 0.07) a share, in
the same period 2011. The Company's net loss for the year ended
December 31, 2012, was EUR 9.0 million, or (EUR 0.35) a share,
compared to EUR 6.9 million loss, or (EUR 0.37) a share, for the
prior year. This loss is attributed to the expanded development and
commercialization efforts. 
Cash Position
 The Company ended the year with cash and cash
equivalents of EUR 11.7 million, compared to EUR 11.1 million on
December 31, 2011. The Company raised net proceeds of EUR 9.7 million
in a private placement in July 2012. Excluding the proceeds of the
2012 private placement, the Company had a net cash burn of EUR 9.0
million in 2012 compared to a net cash burn of EUR 6.8 million in
2011. This 32% increase in the cash used by the Company resulted from
the expansion of its U.S. operations, commercialization of the
ConfirmMDx for Prostate Cancer test, and support of the development
PharmacoMDx assays for use in clinical trials.  
Outlook
 The Company
is accelerating the sales efforts of ConfirmMDx for Prostate Cancer.
In its Irvine, CA facility, the Company will continue to focus on the
development and validation of its own tests to support its
ClinicalMDx service offerings through its CLIA laboratory. In 2013
the Company continues with the development of epigenetic assays for
it's CLIA Lab. In Belgium, the Company will focus on assay
development and service activities for its pharmaceutical partners.  
For the fiscal year 2013, the Company expects strong revenue growth,
and is expecting the majority of revenues to come from its
ClinicalMDx products and services. In the course of 2013 the Company
expects to receive Medicare coverage for its ConfirmMDx test.
Operating expenses are expected to increase primarily from the
expansion of sales and marketing efforts in the U.S. Accordingly,
2013 net loss and cash burn are expected to increase versus 2012,
while R&D expenses are expected to be remain at current levels. The
projections provided herein should be considered forward looki
ng
statements and are subject to the risks summarized in the safe harbor
statement at the end of this press release. 
Post closing events
 In January 2012, our licensing partner Exact
Sciences Corp. (NASDAQ: EXAS) announced that it has submitted the
second module of its premarket approval application (PMA) to the U.S.
Food and Drug Administration (FDA) for its stool DNA colorectal
cancer screening test, Cologuard(TM), which includes an MDxHealth
epigenetic biomarker together with MDxHealth's methylation-specific
PCR (MSP) platform.  
In February 2012, a pivotal health economics study for the ConfirmMDx
for Prostate Cancer test was published in the American Health & Drug
Benefits journal. This budget impact analysis demonstrated achievable
cost savings of MDxHealth's ConfirmMDx for Prostate Cancer test,
which is used by urologists to identify men who may avoid unnecessary
repeat prostate biopsies, thereby reducing overall healthcare
spending. 
Our partner Merck KGaA announced earlier this week that its Phase III
clinical study with cilengitide in newly diagnosed glioblastoma did
not meet its primary endpoints. MDxHealth has been providing an MGMT
(methylguanine-DNA methyltransferase) diagnostic test, PredictMDx for
Glioblastoma, that was used in the clinical study to identify and
stratify those glioblastoma patients who may be more likely to
benefit from cilengitide treatment.  
Other Announcements
 In November 2012, the Company appointed Dr.
Ming-Chou Lee as Vice President of Product Development, who is based
at the Company's U.S. headquarters in Irvine. Dr. Lee has over 25
years of experience in molecular diagnostic product development for
CLIA labs and in vitro diagnostic companies. In his previous position
he was the Senior Director of Assay Development at Roka Biosciences
in San Diego. Prior to that he was the Vice President of Assay
development at PrimeraDx in Boston. He also held senior R&D positions
at Focus Diagnostics and Beckman Coulter. Dr. Lee holds a Ph.D. in
Molecular Biology from the University of Alabama in Birmingham and a
M.S. in Microbiology from Texas Tech.  
Reporting Calendar 


 
--  Publication of 2012 FY results: February 28, 2013
--  Publication Q1 results: May 7, 2013
--  Publication H1 results: August 22, 2013
--  Publication Q3 results: November 6, 2013

  
Financial Statements and Auditors' Opinion
 The Company's 2012
consolidated IFRS financial statements have been audited by its
auditors, BDO Reviseurs d'Entreprises. The auditors have issued an
unqualified audit opinion.  
The condensed Consolidated Statement of Comprehensive Income,
Statement of Financial Position, Cash Flow Statement, and Statement
of Changes in Shareholders' Equity can be found on the Company's
website at www.mdxhealth.com. The full Annual Report is expected to
be made available to the public via the Company's website during
April 2013.  
About MDxHealth(R) 
 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, ConfirmMDx for Prostate Cancer, has been
shown to help distinguish patients who have a true-negative biopsy
from those who may have undetected 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 prostate, brain and lung cancers. The company is based
in Irvine, California with a European headquarters in Liege, Belgium.
For more information visit MDxHealth's website at www.mdxhealth.com. 
MDxHealth SA Coordinates: Address: Tour 5 GIGA - Av. de l'Hopital 11
- 4000 Liege; VAT BE 0479.292.440 RPM Liege, Belgium. 
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. 
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.  
FY RESULTS ENG http://hugin.info/137314/R/1681767/549890.pdf  
Contacts  
Dr Jan Groen
CEO 
MDxHealth 
US: +1 949 812 6979 
BE: +32 4 364 20 70 
info@mdxhealth.com  
Mike Sinclair 
Halsin Partners 
UK: +44 20 7318 2955 
Cell: +44 7968 022075 
msinclair@halsin.com  
Seth Lewis 
Trout Group 
US: +1 646 378 2952
slewis@troutgroup.com 
 
 
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