MdxHealth (TM) : MDxHealth Reports Fourth Quarter and Fiscal Year 2012 Results

MdxHealth (TM) : MDxHealth Reports Fourth Quarter and Fiscal Year 2012 Results

Regulated Information

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 
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 €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  €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

Revenues
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
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.

Results
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.

Cash Position
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 
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 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.

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

  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.

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, 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'Hôpital 11 -  4000 
Liège; VAT BE 0479.292.440 RPM Liège, Belgium.

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



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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Source: MdxHealth (TM) via Thomson Reuters ONE
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