MDxHealth Reports Fourth Quarter and Fiscal Year 2013 Results

MDxHealth Reports Fourth Quarter and Fiscal Year 2013 Results

Sharp increase in ConfirmMDx test volume with 10% penetration among U.S.
urology community and revenue of $7.6 million in 2013

IRVINE, Calif. and HERSTAL, Belgium, Feb. 27, 2014 (GLOBE NEWSWIRE) --
MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company
that develops and commercializes epigenetic tests to improve the diagnosis and
treatment of cancer patients, today announced results for the fourth quarter
and the fiscal year ended December 31, 2013. This year the company has changed
its reporting currency to U.S. Dollars, while keeping its functional currency
in Euros.

Business Highlights

ConfirmMDx for Prostate Cancer

  *Strong commercial uptake of ConfirmMDx^® for Prostate Cancer case volume,
    with approximately 7,000 patients tested in 2013, compared to
    approximately 1,100 in 2012, the year of commercial launch. 
  *ConfirmMDx revenue increased to $3.8 million in 2013 compared to $0.4
    million in 2012.
  *Q4 ConfirmMDx revenue increased from $0.4 million in 2012 to $1.2 million
    in 2013.
  *Published a blinded, multi-center, clinical validation study in the
    Journal of Urology demonstrate the utility of the ConfirmMDx test as a
    powerful tool to address well-documented concerns over false-negative
    biopsy results.
  *Published an economic impact study demonstrating the health care
    cost-savings achievable using ConfirmMDx in American Health and Drug
  *Completed a second U.S. based blinded, multi-center clinical validation
    trial, showing that the ConfirmMDx test met all of the primary endpoints
    (submitted for publication in 2014).
  *Received approval for ConfirmMDx by the New York State Department of
  *Signed co-marketing agreement with Bostwick Laboratories.
  *Executed 10 insurance agreements with preferred provider organization
    (PPO) networks covering over 135 million lives. 

Other Business Activities

  *Signed pharmaceutical related agreement with Summit Pharmaceuticals
    International Corporation (SPI) to gain entrance to the Japanese market. 
  *Signed agreement with HistoGeneX for pharmaceutical testing services for
    the European market. 
  *PredictMDx® for Glioblastoma, based on the MGMT (O6-methylguanine-DNA
    methyl transferase) biomarker, was included in the 2013 National
    Comprehensive Cancer Network (NCCN) Guidelines and awarded with Tier 1
    reimbursement code (81287) by the American Medical Association.

Events after the Reporting Period

  *Signed exclusive distribution agreement with Teva Pharmaceutical Ltd. for
    commercialization of the ConfirmMDx for Prostate Cancer and PredictMDx®
    for Glioblastoma tests in Israel. 
  *Presented a study at the annual ASCO Genitourinary Cancers symposium on
    January 28-31, 2014 in San Francisco, showing the potential prognostic
    value of the ConfirmMDx genes to identify men with a low versus high risk
    for aggressive prostate cancer. 
  *A case study was published in The Journal of OncoPathology describing use
    of the ConfirmMDx for Prostate Cancer test as part of a multidisciplinary
    approach to successfully confirm prostate cancer diagnosis missed by five
    previous biopsies.
  *On February 5, 2014 MDxHealth's licensee, Exact Sciences, reported that
    the U.S. Food and Drug Administration has confirmed by notice in the
    Federal Register that its Molecular and Clinical Genetics Panel of the
    Medical Devices Advisory Committee will review the premarket approval
    application (PMA) for the Cologuard test on March 27, 2014 MDxHealth
    expects to receive milestone payments and royalties from the sale of the
    Cologuard® test.
  *Signed provider agreement with Prime Health Services, Inc. ("Prime
    Health") a Preferred Provider Organization (PPO) network. This insurance
    agreement covers all 50 states, offering patients greater access to
    MDxHealth's ConfirmMDx for Prostate Cancer test. 

"In line with our expectations, we experienced sharp growth in ConfirmMDx case
volume with close  to 7,000 patient  cases reported in  2013. ConfirmMDx  case 
volume in Q4 2013 grew to more than 2,300 patients, compared to  approximately 
660 patients tested in Q4 2012," said Dr. Jan Groen, CEO of MDxHealth.  "Since 
launch, over 1,000 urologists have  ordered the ConfirmMDx test,  representing 
approximately 10% of U.S. practicing urologists."

Dr. Groen  continued:  "The  increase  in  market  share  and  revenue  growth 
associated with  ConfirmMDx  sales reflects  the  promising rate  of  adoption 
within the urology community and illustrates  the clinical value of our  test. 
For the  full  year  2013,  we  achieved  exceptional  growth  in  ConfirmMDx 
revenues, of $3.8  million, compared to  $0.4 million in  2012. Total  company 
revenues increased to $7.6 million for 2013, a strong increase of 28% compared
to the previous  year. For  2013, 50% of  revenue came  from ConfirmMDx  test 
sales as compared to  previous years where the  large majority of revenue  was 
derived from PharmacoMDx business and grants. This demonstrates the impact of
our focus  on  diagnostics  and  our  investment in  sales,  as  well  as  our 
reimbursement and  billing efforts  in 2013.  We believe  these efforts  will 
yield even greater revenue growth in 2014."

Key Figures for the full year (thousands of U.S. dollars, except number of
shares and per share data):

As of or for the year ended      4^th quarter Full Year 4^th quarter Full Year
December 31*                     2013*        2013*     2012         2012
Total revenues                   1,576        7,554     2,146        5,913
Total operating expenses         3,685        17,832    4,384        16,196
EBITDA (Loss)                    -4,234       -15,653   -2,942       -10,932
Operating profit (EBIT)          -4,299       -16,071   -2,997       -11,444
Net loss                         -4,387       -16,175   -3,099       -11,533
Earnings per share, basic ($)    -0.13        -0.47     -0.12        -0.45
Number of outstanding shares     34,251,303             25,513,440
Cash and cash equivalents        24,683                 15,455

*Reporting currency  changed  from Euro  to  US Dollar,  effective  with  2013 


Total revenues for the full year ended December 31, 2013, increased by 28%  to 
$7.6 million, compared to total revenues  of $5.9 million for the prior  year. 
Revenue from ConfirmMDx for Prostate Cancer was 75% of the total Q4  revenues 
compared to 20% in the same quarter last year. Total revenues for Q4 2013 were
$1.6 million compared  to $2.1  million during the  same period  in 2012.  The 
decline in Q4  2013 revenues compared  to the  prior period was  due to  lower 
PharmacoMDx revenues resulting from the  timing of the completion of  projects 
and the shift in focus to  ClinicalMDx opportunities. For the full year,  50% 
of company's revenue  came from  ConfirmMDx for Prostate  Cancer, compared  to 
only 8% in 2012.

At the beginning of 2013, certain molecular diagnostics billing codes  adopted 
by Medicare, Medicaid and third-party payors were eliminated or replaced. As a
consequence many  payors  are  requesting additional  information  to  process 
claims, resulting in  payment delays. These  changes have a  larger impact  on 
companies new to the market and those with limited years of reimbursement  and 
billing  history.  Based  on  2013  reported  cases  and  historical   average 
reimbursement amounts, the total  estimated value of  tests performed in  2013 
was $9.2  million. Of  this amount  $3.8 million  was recognized  as  revenue, 
leaving  uncollected  outstanding  unrecognized  revenues  of  $5.4   million, 
consisting of $2.8 million from Medicare and $2.6 million from private payors.
This uncollected amount has  been excluded from  the Company's 2013  revenues, 
but may  still  be  recognized  and  collected  at  a  later  point  in  time. 
MDxHealth's revenue recognition policy evaluates the certainty of payment on a
payor-by-payor basis,  currently  resulting  in a  mixture  of  accrual  based 
revenue recognition and cash based collections depending on our evaluation  of 
certainty of payment. We believe  our conservative revenue recognition  policy 
is appropriate  at this  time. However,  as more  managed care  contracts  are 
secured, and experience with existing payors increases, the Company expects to
transition more payors to an accrual basis and increase revenue recognition in

In Q4 2013,  the Company reported  a net loss  of $4.4 million,  or ($0.13)  a 
share, compared to a net loss of $3.1 million, or ($0.07) a share, in the same
period 2012. The Company's net loss for the year ended December 31, 2013,  was 
$16 million, or ($0.47) a share, compared to $11.5 million loss, or ($0.45)  a 
share, for  the  prior  year.  This  loss  is  attributed  to  the  continued 
investment  in  commercialization  efforts  in  the  U.S.  and  the  delay  in 
recognizing revenues from ConfirmMDx sales.

Operating Expenses

Operating expenses for Q4 2013 were  $3.7 million, a decrease of 16%  compared 
to  $4.4  million  in   Q4  2012.  This  decrease   is  attributable  to   the 
capitalization of internal development costs for products partially offsetting
the ongoing build-up of  U.S. operations to  support the commercialization  of 
the ConfirmMDx for  Prostate Cancer test.   Operating expenses  for the  year 
ended December 31, 2013 increased by  10% to $17.8 million from $16.2  million 
for the prior year. 

Cash Position

The Company  ended 2013  with  cash and  cash  equivalents of  $24.7  million, 
compared to  $15.5 million  on  December 31,  2012.  The Company  raised  net 
proceeds of $24.3  million in a  private placement in  June 2013.  Collections 
from ConfirmMDx reimbursements were $2.4 million  in 2013 vs. $0.3 million  in 
2012. Collections  which  are  an  important variable  in  net  cash  burn  is 
improving and will  be an important  factor in the  strength of the  company's 
cash position.  Excluding the  proceeds  of the  2013 private  placement,  the 
Company had a net cash  burn of $15.3 million in  2013 compared to a net  cash 
burn of $11.4  million in 2012.  This 33% increase  in the cash  used by  the 
Company  resulted   from  the   expansion  of   it's  U.S.   operations,   and 
commercialization of the ConfirmMDx for Prostate Cancer test. 


The Company  is expanding  the sales  and support  effort for  ConfirmMDx  for 
Prostate Cancer, with plans  to increase its  U.S. sales force  from 15 to  20 
sales representatives and double its billing and collections department in  Q1 
2014 to accelerate its revenue cycle and reimbursement.

In early 2014,  MDxHealth reported on  the potential prognostic  value of  its 
current ConfirmMDx test. If  further studies confirm  the prognostic value  of 
the genes used in ConfirmMDx, this would add significant value to the test and
open expanded labeling. Consistent with its  focus on the urology market,  the 
company  is   also   investigating  the   possibility   to  fast   track   the 
commercialization of its previously reported bladder cancer test. The test  is 
designed to rule-out bladder cancer in patients diagnosed with hematuria,  who 
are traditionally followed with cytology  and cystoscopy. In 2010,  MDxHealth 
published the results of a validation study of the two-gene epigenetic bladder
cancer test, with strong  positive results, in  the journal European  Urology. 
Based on these data the Company is accelerating the development of this  test 
in 2014. The Company will also  continue to pursue its development efforts  on 
next generation  sequencing  (NGS)-based  assays  for  both  its  own  service 
offerings, as well as for its pharmaceutical partners. NGS offers the prospect
for reducing cost and increasing throughput of molecular assays.

For fiscal year 2014, the Company expects a significant increase in ConfirmMDx
test volume,  with  the majority  of  revenues  generated from  sales  of  the 
ConfirmMDx for Prostate  Cancer test.  Building upon  our continued  positive 
interactions with the Medicare contractor responsible for molecular diagnostic
test reimbursement,  MDxHealth  expects  to  receive  coverage  with  evidence 
development (CED)  for its  ConfirmMDx test  by Medicare.  Additionally,  the 
company will  continue  its  focus  on capturing  managed  care  contracts  to 
accelerate the billing and reimbursement  cycle with insurance companies.  In 
2014 the growth rate in operating expenses are expected to moderately increase
from the  rate  in  2013,  primarily from  the  expansion  of  infrastructure, 
including sales force and billing  department expansion, to improve the  order 
to cash cycle. R&D spending in 2014 is expected to modestly decline. In  2014, 
collections from private  third party payors  and volume increases  previously 
noted are expected to improve revenue recognition and cash  inflow.Therefore 
the 2014 net loss and net cash burn are expected to improve compared to  2013. 
The projections  provided  herein  should be  considered  as  forward  looking 
statements and  are  subject  to  the risks  summarized  in  the  safe  harbor 
statement at the end of this press release.

2014 Reporting Calendar

  *Publication of 2013 FY results: February 27, 2014
  *Publication Q1 results: May 6, 2014
  *Publication H1 results: August 21, 2014
  *Publication Q3 results: November 4, 2014

Financial Statements and Auditors' Opinion

The Company's 2013 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   may   be   found   on   the   Company's   website   at The full Annual Report is expected to be made available  to 
the public via the Company's website during April 2014. 

About MDxHealth

MDxHealth  is  a  leading  molecular  diagnostic  company  that  develops  and 
commercializes epigenetic  tests to  support cancer  treatment. The  company's 
tests are based on proprietary  gene methylation (epigenetics) technology  and 
assist physicians with the diagnosis of cancer, prognosis of recurrence  risk, 
and prediction of response to a  specific therapy. For more information  visit and follow us on Twitter at:

For more information:

Dr Jan Groen, CEO    Mike Sinclair (media) Len Hall (investors)
MDxHealth            Halsin Partners       Allen & Caron, Inc
US: +1 949 812 6979 UK: +44 20 7318 2955 US: +1 949 474 4300
BE: +32 4 364 20 70  Cell: +44 7968 022075

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. This  press release  does  not 
constitute an offer or  invitation for the sale  or purchase of securities  or 
assets of MDxHealth  in any jurisdiction.  No securities of  MDxHealth may  be 
offered or sold within the United  States without registration under the  U.S. 
Securities Act  of  1933, as  amended,  or  in compliance  with  an  exemption 
therefrom, and in accordance with any applicable U.S. securities laws.

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.

To access the PDF version, please click here

Press spacebar to pause and continue. Press esc to stop.