MdxHealth (TM) : MDxHealth Reports Fourth Quarter and Fiscal Year 2012 Results
Revenue of €4.6M ($6.0M), an increase of 71% versus fiscal year 2011
IRVINE, CA, and LIEGE, BELGIUM - 8:00 AM, February 28, 2013 - MDxHealth SA
(NYSE Euronext: 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
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 €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
"MDxHealth's revenues increased by 71% to more than €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 forward, 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 (€) -0.35 -0.37
Number of outstanding shares 25,513,440 18,622,327
Cash and cash equivalents 11,714 11,123
Total revenues for Q4 2012 increased 84% to €1.7 million from €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 €4.6
million, compared to total revenues of €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 for Q4 2012 were €3.4 million, increasing 53% compared to
€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 €12.6 million from €9.5 million for the prior year.
In Q4 2012, the Company reported a net loss of €2.4 million, or (€0.09) a
share, compared to a net loss of €1.3 million, or (€0.07) a share, in the same
period 2011. The Company's net loss for the year ended December 31, 2012, was
€9.0 million, or (€0.35) a share, compared to €6.9 million loss, or (€0.37) a
share, for the prior year. This loss is attributed to the expanded
development and commercialization efforts.
The Company ended the year with cash and cash equivalents of €11.7 million,
compared to €11.1 million on December 31, 2011. The Company raised net
proceeds of €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
€9.0 million in 2012 compared to a net cash burn of €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
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
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 looking 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.
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.
oPublication of 2012 FY results: February 28, 2013
oPublication Q1 results: May 7, 2013
oPublication H1 results: August 22, 2013
oPublication 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 Réviseurs 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.
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
MDxHealth SA Coordinates: Address: Tour 5 GIGA - Av. de l'Hôpital 11 - 4000
Liège; VAT BE 0479.292.440 RPM Liège, Belgium.
Dr Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
UK: +44 20 7318 2955
Cell: +44 7968 022075
US: +1 646 378 2952
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: TheMDxHealth logo, MDxHealth, ConfirmMDx and PredictMDx are trademarks
or registered trademarks ofMDxHealth SA.All other trademarks and service
marks are the property of their respective owners.
FY RESULTS ENG
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information contained therein.
Source: MdxHealth (TM) via Thomson Reuters ONE
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