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Epigenomics AG

EANS-News: Epigenomics AG Reports First Half 2009 Results

Key Figures
. Revenue: EUR 2.1 million in H1 2009, up by 37% (H1 
2008: EUR 1.5 million) 
 . EBIT: EUR - 4.8 million in H1 2009, 
improved by 19% (H1 2008: EUR -5.9 million) 
 . Net loss: EUR - 4.8 
million in H1 2009, decreased by 15% (H1 2008: EUR -5.6 illion) 
 . 
Liquid assets: EUR 12.1 million as of 30/06/2009 (31/12/2008: EUR 
12.1 million)
Highlights of the First Half 2009
. 
Significantly improved revenue, EBIT and net loss 
 . Progressed 
PRESEPT colorectal cancer clinical study according to plan 
 . First 
diagnostic mSEPT9 blood testing service for colorectal cancer 
launched by Swiss Viollier AG
 . Development of Abbott mSEPT9 IVD 
product on track for European product launch in Q4/2009
 . Awarded 
grant by the German Federal Government for further research into 
colorectal cancer biomarkers
 . Presented mSEPT9 data and reported on
progress of PRESEPT Study at several international conferences 
 . 
Received allowances for key patents in Europe 
 . Obtained ISO 13485 
certification for development, manufacturing and distribution of IVD 
products
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
companies/finances/Molecular diagnostics
Press release, Berlin, Germany, and Seattle, WA, U.S.A., August 11, 
2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
molecular diagnostics company focusing on the development and 
commercialization of in vitro diagnostic products for cancer, today 
reported financial results for the second quarter and first half of 
2009, which ended June 30, 2009.
Commenting on the first six months, Geert Nygaard, the company's 
Chief Executive Officer said: "In the first half of 2009 we have made
significant progress on moving towards becoming a commercial 
molecular diagnostics company. The mSEPT9 colorectal cancer blood 
test is now for the first time available to patients in Europe. 
Further, we obtained ISO 13485 certification for the development, 
manufacturing and distribution of IVD products. Both are important 
milestones on our way to becoming a leading cancer molecular 
diagnostics company."
"The significant progress in our partnerships, product development, 
clinical PRESEPT Study and commercialization efforts are all 
reflected in our first half financials. We are well on track for 
meeting all our financial goals and guidance with an expected revenue
growth to more than EUR 3 million for fiscal 2009", added Oliver 
Schacht, the company's Chief Financial Officer.
First Half 2009 - Financial Review
Epigenomics' revenue in the first half of 2009 amounted to EUR 2.1 
million, an increase of more than 37% compared to EUR 1.5 million 
during the same period in 2008. H1 revenue was generated from 
continued and newly signed collaborations and licensing agreements in
the form of R&D payments, licensing fees, reimbursements as well as 
product sales from Research-Use-Only (RUO) kits.
EBIT for H1 of 2009 of EUR -4.8 million was a 19% improvement 
compared to EBIT for the corresponding period in 2008 of EUR -5.9 
million.
R&D costs dropped from EUR 4.7 million in the first half of 2008 to 
EUR 3.4 million in the reporting period primarily resulting from 
increased resource allocation to Epigenomics' commercial 
collaboration projects i.e. to cost of sales, as well as from 
consolidating all laboratory operations at the Berlin site at the end
of the second quarter of 2008. Costs of sales increased to EUR 1.5 
million compared to EUR 0.5 million in H1 2008, mainly as a result of
increased product development expenses within the collaboration 
projects with Abbott Molecular (Abbott) and Philips.
Net loss for the reporting period amounted to EUR -4.8 million, a 
substantial reduction compared to EUR -5.6 million in H1 2008. Basic 
loss per share improved from EUR -0.22 in H1 2008 to EUR -0.17 in H1 
2009.
In the first half of 2009, Epigenomics' cash flow and its financial 
position were mainly affected by the continued net cash consumption 
from operating activities and the successful PIPE financing 
transaction in February 2009. As of June 30, 2009, liquid assets 
amounted to EUR 12.1 million, virtually unchanged  compared to 
December 31, 2008.
Cash outflow from operating activities in H1 2009 totaled EUR 5.3 
million. Cash inflow from investing activities amounted to EUR 0.4 
million, primarily due to a redemption of marketable securities. Cash
flow from financing activities was positive at EUR 5.1 million, due 
to the capital increase in February 2009. Overall, the net cash flow 
in H1 2009 was positive at EUR 0.2 million.
First Half 2009 - Operational Review and Highlights
During the first half of 2009, Epigenomics' R&D activities continued 
to focus on executing the PRESEPT Study. PRESEPT is a multicenter 
study to characterize the clinical performance of Epigenomics' mSEPT9
biomarker and the potential health economic benefit of colorectal 
cancer screening with mSEPT9 in a U.S. colorectal cancer 
screening-guideline-eligible population. It enrolls individuals with 
an average or increased disease risk according to U.S. screening 
guidelines who undergo a screening colonoscopy. In line with 
expectations, the 22 participating clinical sites in the U.S. and 
Germany by the end of H1 2009 had enrolled a total of 4,906 subjects 
that have yielded about two thirds of the target number of 50 cancer 
cases. Overall, the study is expected to enroll 7,500 individuals. 
First study results are expected to be available by the end of 2009.
In particular in the second quarter of 2009, Epigenomics further 
advanced the commercialization of the mSEPT9 blood test for 
colorectal cancer. On June 22, the company announced, that one of 
Switzerland's largest diagnostics laboratory networks, Viollier AG, 
launched mSEPT9 testing service on July 1, 2009. This makes the 
mSEPT9 test the first blood test for colorectal cancer detection ever
offered in Europe to patients, general practitioners and 
gastroenterologists. Epigenomics further expects several German 
laboratories to start offering mSEPT9 testing by year-end and Quest 
to launch a laboratory developed test (LDT) in the U.S. in due 
course. For broad commercialization, Epigenomics' collaboration 
partner Abbott is developing an IVD test kit for mSEPT9. With the 
development progressing as expected, Epigenomics expects Abbott to 
launch a CE- marked IVD product for mSEPT9 testing in Europe in Q4 
2009.
In May 2009, Epigenomics received notice that the German Federal 
Ministry of Education and Research (BMBF - Bundesministerium für 
Bildung und Forschung) will fund a clinical research project to be 
realized in an alliance with scientists from the 2nd Medical Clinic 
of the University Hospital rechts der Isar of the Munich Technical 
University and the Association of Statutory Health Insurance Doctors 
in Bavaria (KVB - Kassenärztliche Vereinigung Bayerns). The project 
aims at identifying further biomarkers that in combination with 
mSEPT9 have a utility in early stage cancer and potentially polyp 
detection. The total project budget is expected to be around EUR 1.3 
million and has been successfully started in July.
To further support the adoption of colorectal cancer blood testing 
with mSEPT9, Epigenomics during the second quarter of 2009 presented 
mSEPT9 data and reported on the progress of the PRESEPT Study at 
several scientific and medical conferences in the U.S. and Europe 
including the Digestive Disease Week (DDW) in Chicago, IL, U.S.A., 
and the 11th World Congress on Gastrointestinal Cancer in Barcelona, 
Spain.
Epigenomics IP position was further strengthened by two Rule 71 (3) 
notifications stating that the European Patent Office intends to 
grant patents protecting the company's PITX2 DNA methylation 
biomarker (mPITX2), a biomarker with prognostic utility in prostate 
and breast cancer. These notifications are equivalent to "Notices of 
Allowance" by the United States Patent and Trademark Office.
Epigenomics obtained ISO 13485 certification for its quality 
management system in June 2009. This certification was granted for 
both the headquarters in Berlin, Germany, and the wholly owned 
subsidiary Epigenomics, Inc. in Seattle, U.S.A., and is an important 
prerequisite for the design, development, manufacture and 
distribution of in vitro diagnostic (IVD) products in compliance with
regulatory requirements.
Outlook H2 2009
In the second half of 2009, Epigenomics' focus will continue to be 
driving the mSEPT9 blood test through the final stages of clinical 
validation and product development. Therefore, a significant part of 
the operational activities will continue to be directed towards 
executing the PRESEPT Study and delivering clinical results from that
trial. Also, the company will continue working with Abbott to support
them in completing the final phases of their product development with
the strategic goal of having Abbott launch a CE-marked IVD test kit 
based on mSEPT9 in Europe in Q4 2009. Independently, the company will
work on broadening the number of laboratories in Europe and the 
U.S.A. that offer mSEPT9 testing. The first launch of the mSEPT9 test
in July 2009 by Viollier AG is expected to considerably support the 
sales and marketing activities in this area.
The key strategic focus in Epigenomics' marketing and business 
development activities in 2009 and 2010 will be on closing additional
non-exclusive licensing deals for mSEPT9 similar to the partnership 
with Sysmex Corporation initiated in the first quarter of 2009. 
However, to maximize value in any future arrangement, the company 
will carefully coordinate the timing of mSEPT9 licensing agreements 
with expected results from the PRESEPT Study as well as the expected 
Abbott product launch in Europe.
The company's further research and development activities will be 
focused on progressing pipeline programs in colorectal, lung and 
prostate cancer.
Management expects solid growth in revenue to more than EUR 3 million
for fiscal year 2009 to come from current partnering activities in 
diagnostics as milestones are expected to be reached including the 
launch of a CE-marked mSEPT9 test kit by Abbott in Europe and the 
launch of an LDT by Quest Diagnostics in the U.S., as RUO kit sales 
for our mSEPT9, mPITX2 and mGSTP1 kits gain some traction, and as 
revenue from new partnerships  is introduced. As the bulk of the 
PRESEPT expenses will influence 2009 operating expenses, Epigenomics 
expects EBIT and net loss for 2009 to correspond to 2008 actuals 
despite the increased revenue. Cash burn for fiscal 2009 should be at
a very similar level compared to 2008, i.e. around EUR 10 million.
Further Information
The full 6-Months Report 2009 can be obtained from Epigenomics' 
website at:
http://www.epigenomics.com/en/investor_relations/Financial_Informatio
n/
Epigenomics' management will host a conference call on the second 
quarter and half year 2009 results at 3pm CET today, Tuesday 11th 
August.
The dial-in numbers for the conference call are:
Dial-in number (within Germany):  +49 (0)69 247 501 899
Dial-in number (within the US):   +1 212 444 0297
Participants are kindly requested to dial in 10 minutes prior to the 
start of the call.
The presentation accompanying the conference call will be available 
for download on the Epigenomics website:
http://www.epigenomics.com/en/down_loads/corporate_material/
A recording of the conference call will be provided on Epigenomics' 
website subsequently:
http://www.epigenomics.com/en/down_loads/corporate_material/
About Epigenomics
Epigenomics is a molecular diagnostics company with a focus on the 
development of novel products for cancer. Using DNA methylation 
biomarkers, Epigenomics' tests in development aim at diagnosing 
cancer at an early stage before symptoms occur and thereby may reduce
mortality from this dreaded disease.
Epigenomics' product pipeline contains a validated biomarker for the 
early detection of colorectal cancer in blood plasma, and further 
proprietary DNA methylation biomarkers at various stages of 
development for prostate and lung cancer detection in urine, blood 
and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the
early detection of colorectal cancer in a simple blood sample has 
demonstrated continuously highest performance in multiple clinical 
studies with in total more than 3,000 individuals tested. A large 
prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a 
screening population is currently under way (www.presept.net).
For development and global commercialization of in vitro diagnostic 
test products, Epigenomics pursues a non-exclusive partnering 
strategy. Strategic diagnostics industry partners include Abbott 
Molecular, Philips, Sysmex Corporation and Quest Diagnostics 
Incorporated, for diagnostics test products and services, and QIAGEN 
N.V. for sample preparation solutions and research products.
Partners in the health care industry and the biomedical research 
community can access Epigenomics' portfolio of proprietary DNA 
methylation technologies and biomarkers protected by more than 150 
patent families through research products, Biomarker Services, IVD 
Development Collaborations, and Licensing. The company is 
headquartered in Berlin, Germany, and has a wholly owned subsidiary 
in Seattle, WA, U.S.A. For more information, please visit 
Epigenomics' website at www.epigenomics.com.
Epigenomics' Disclaimer. This communication expressly or implicitly 
contains certain forward-looking statements concerning Epigenomics AG
and its business. Such statements involve certain known and unknown 
risks, uncertainties and other factors which could cause the actual 
results, financial condition, performance or achievements of 
Epigenomics AG to be materially different from any future results, 
performance or achievements expressed or implied by such 
forward-looking statements. Epigenomics AG is providing this 
communication as of this date and does not undertake to update any 
forward-looking statements contained herein as a result of new 
information, future events or otherwise.
end of announcement                               euro adhoc

Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

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