EANS-News: Epigenomics AG Reports Q3 and Nine Months 2009 Results

Key Figures 9M 2009

Revenue, EBIT and net loss significantly
improved

* Revenue: EUR 3.2 million in 9M 2009, up by 77% (9M
2008: EUR 1.8 million)
* EBIT: EUR - 7.1 million in 9M 2009,
improved by 17% (9M 2008: EUR -8.5 million)
* Net loss: EUR - 7.1
million in 9M 2009, decreased by 13% (9M 2008: EUR -8.1 million)
*
Liquid assets: EUR 9.5 million at end of September 2009 (31/12/2008:
EUR 12.1 million)

Operational Highlights Fiscal Year (FY) 2009 to
Date

* Launched Epi proColon, the first CE-marked IVD kit for
colorectal cancer blood testing
* Colorectal cancer blood test
available to patients through Swiss diagnostic laboratory Viollier AG
and four German laboratories
* Progressed PRESEPT colorectal cancer
clinical study
* Development of Abbott Septin9 product on track for
European launch in Q4/ 2009
* Signed licensing deal with ARUP
Laboratories for non-exclusive U.S. rights to mSEPT9 for
laboratory-developed test (LDT) use
* Finalized clinical evaluation
of mSHOX2 lung cancer biomarker and initiated product development
*
Strengthened intellectual property position by cross license with DxS
Ltd., since then acquired by Qiagen

Epigenomics to present today
at investor conference at the German Equity Forum of the Deutsche
Börse Group in Frankfurt/ Main, Germany

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9-month report/Molecular diagnostics

Subtitle: Key Figures 9M 2009

Revenue, EBIT and net loss significantly improved

* Revenue: EUR 3.2 million in 9M 2009, up by 77% (9M 2008: EUR 1.8
million) * EBIT: EUR - 7.1 million in 9M 2009, improved by 17% (9M
2008: EUR -8.5 million) * Net loss: EUR - 7.1 million in 9M 2009,
decreased by 13% (9M 2008: EUR -8.1 million) * Liquid assets: EUR 9.5
million at end of September 2009 (31/12/2008: EUR 12.1 million)

Operational Highlights Fiscal Year (FY) 2009 to Date

* Launched Epi proColon, the first CE-marked IVD kit for colorectal
cancer blood testing * Colorectal cancer blood test available to
patients through Swiss diagnostic laboratory Viollier AG and four
German laboratories * Progressed PRESEPT colorectal cancer clinical
study * Development of Abbott Septin9 product on track for European
launch in Q4/ 2009

* Signed licensing deal with ARUP Laboratories for non-exclusive U.S.
rights to mSEPT9 for laboratory-developed test (LDT) use * Finalized
clinical evaluation of mSHOX2 lung cancer biomarker and initiated
product development * Strengthened intellectual property position by
cross license with DxS Ltd., since then acquired by Qiagen

Epigenomics to present today at investor conference at the German
Equity Forum of the Deutsche Börse Group in Frankfurt/ Main, Germany

Press release, Berlin, Germany, and Seattle, WA, U.S.A., November 10,
2009 (euro adhoc) - The molecular diagnostics company Epigenomics AG
(Frankfurt Prime Standard: ECX) today reported financial results for
the third quarter and for the first nine months of 2009, which ended
September 30, 2009, and provided a corporate update.

Commenting on the operational progress in the year 2009 to date,
Geert Nygaard, the company's Chief Executive Officer said: "With the
launch of our CE-marked Epi proColon test, we have reached one of the
most significant milestones in Epigenomics' history so far. Septin9
colorectal cancer blood testing is now available to doctors and
patients at several laboratories in Europe. With our partner Abbott
expected to launch their Septin9-based product for the European
market before the end of the year and Quest Diagnostics expected to
launch their Septin9 testing service in the U.S.A. in Q4 2009, we
will further expand the availability of the test to the benefit of
the cancer screening population."

"The significant progress in our licensing partnerships, our IVD
product development, and the excellent progress in our clinical
PRESEPT Study are all reflected in our 9-months financials. As of the
end of Q3 we have already met our goals of growing our revenue for
fiscal 2009 to more than 3 million Euros and to significantly improve
our earnings", added Oliver Schacht, the company's Chief Financial
Officer.

First 9 Months of 2009 - Financial Review

Epigenomics' revenue in 9M 2009 amounted to EUR 3.2 million, an
increase of more than 77% compared to EUR 1.8 million during the same
period in 2008. The revenue during the first nine months was
generated from continued and newly signed collaborations and
licensing agreements in the form of R&D payments, licensing fees,
reimbursements as well as sales of Research-Use-Only products.

EBIT for 9M 2009 of EUR - 7.1 million showed a 17% improvement over
EBIT for the corresponding period in 2008 of EUR - 8.5 million.

R&D costs dropped from EUR 6.8 million in 9M 2008 to EUR 5.1 million
in the reporting period primarily resulting from increased resource
allocation to commercial collaboration projects and a corresponding
shift to cost of sales. Costs of sales increased to EUR 2.1 million
compared to EUR 0.7 million in 9M 2008, mainly as a result of
increased product development expenses associated with collaboration
agreements with Abbott and Philips and costs for the acquisition of
clinical samples under the agreement with Abbott.

Net loss for the reporting period amounted to EUR - 7.1 million, a
substantial reduction compared to EUR - 8.1 million in 9M 2008. Basic
loss per share improved from EUR - 0.32 in 9M 2008 to EUR - 0.24 in
9M 2009.

In 9M 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. Overall, the financial position in 9M 2009 has developed
according to plan with short-term liquidity as of September 30, 2009,
of EUR 9.5 million - a decrease of EUR 2.6 million from EUR 12.1
million at year-end 2008 - mainly due to net cash consumption for
operating activities as well as for investments in tangible and
intangible assets.

Cash outflow from operating activities in 9M 2009 totaled EUR 8.0
million (9M 2008: EUR 6.9 million). Cash inflow from investing
activities amounted to EUR 0.3 million (9M 2008: EUR 1.0 million),
primarily due to a redemption of marketable securities. Cash flow
from financing activities was positive at EUR 5.1 million (9M 2008:
EUR 11.5 million), due to the capital increase in February 2009.

Operational Review and Highlights of FY 2009 to date

In 2009 to date, Epigenomics focused its development and
commercialization on its Septin9 blood test for colorectal cancer.
The test is the first IVD blood test ever offered for colorectal
cancer early detection in Europe. As the first laboratory network,
Swiss Viollier AG, started offering the test to patients, general
practitioners and gastroenterologists in Switzerland in July. Several
German laboratories, including Labor Dr.Limbach & Kollegen
(Heidelberg), Labor Krone (Bad Salzuflen), MVZ Dr. Stein & Kollegen
(Moenchengladbach) and MVZ Dr. Eberhard & Partner (Dortmund) started
offering Septin9 testing as of October 1, 2009.

Epigenomics also successfully completed the development of its
Septin9 in vitro diagnostic (IVD) test kit. The CE-marked IVD product
was launched in Europe under the brand name Epi proColon on October
6, 2009. The test can now be sold to any suitably equipped molecular
diagnostics laboratory in Europe as an aid in the detection of
colorectal cancer.

Throughout the reporting period, Epigenomics also progressed the
PRESEPT colorectal cancer screening study. Enrollment in this
prospective study for the Septin9 biomarker reached 6,376 subjects at
the end of Q3 with more than three quarters of the expected 50
colorectal cancer cases already identified by colonoscopy. By 31st
October enrollment into the PRESEPT Study had reached over 7,000
subjects with almost 90% of CRC cases identified by colonoscopy.
Testing of PRESEPT samples using the Epi proColon test has been
initiated by Epigenomics in three independent clinical laboratories,
namely Quest Diagnostics, ARUP Laboratories, and Charité -
Universitätsmedizin Berlin in October 2009. Testing of the samples
will be completed in late 2009 or early 2010, depending on when the
last of the targeted 50 cancer cases is enrolled into the study. The
laboratories as well as Epigenomics will be completely blinded to any
testing results until the last sample has been tested.

Quest Diagnostics, Inc., made solid progress in the development of
its Septin9 test and announced that it would start offering Septin9
testing to doctors and patients in the U.S. still within 2009.
Moreover, Epigenomics expects its collaboration partner Abbott
Molecular, Inc. to launch their CE-marked Septin9 blood test
optimized for the Abbott m2000 platform as planned towards the end of
2009 in Europe.

During the third quarter Epigenomics has continued to implement its
non-exclusive commercialization strategy by signing a license
agreement for the mSEPT9 biomarker with ARUP Laboratories, Inc., Salt
Lake City, UT, U.S.A. ARUP is the second non-exclusive reference
laboratory licensee for the U.S. market and is expected to launch its
Septin9 testing service in the U.S. in 2010.

In a lung cancer study conducted in cooperation with the Charité -
Universitätsmedizin Berlin, Germany, Epigenomics has demonstrated
that the mSHOX2 biomarker that is at the core of the Company's
bronchial lavage test for lung cancer is also a promising biomarker
for lung cancer blood testing. The study with about 340 patients
demonstrated that in a population of patients undergoing diagnostic
work-up for suspected lung cancer, of which typically about 40%
actually have the cancer, an mSHOX2 test can potentially predict the
presence of the disease with 92% probability (positive predictive
value).

Epigenomics also further strengthened its technology position by
cross-licensing certain technologies with its partner DxS Ltd.
enabling both partners to use DxS' Scorpions® technology for DNA
methylation research and IVD products. DxS has recently been acquired
by Qiagen, also a long-term partner of Epigenomics.

Outlook

In Q4 2009, Epigenomics' focus will remain on driving
commercialization of the colorectal cancer blood test based on the
mSEPT9 biomarker by direct marketing and sales of the Epi proColon
IVD test kit, as well as by supporting the non-exclusive licensees in
their endeavors to develop and launch mSEPT9-based blood tests for
colorectal cancer. Therefore, significant parts of the operational
activities in the last quarter of 2009 will continue to be directed
towards executing the PRESEPT Study and delivering first clinical
results from that trial either in late 2009 or in early 2010.

Cooperation with Abbott to support them in completing the final
phases of their product development will be continued, with the
strategic goal of having Abbott launch a CE-marked IVD blood test for
colorectal cancer detection based on mSEPT9 in Europe by the end of
2009.

The key strategic focus in marketing and business development
activities in late 2009 and 2010 will be on closing additional
non-exclusive licensing deals for colorectal cancer screening and
mSEPT9. The timing of any future mSEPT9 deals with expected results
from the PRESEPT Study as well as the expected Abbott product launch
in Europe will be carefully coordinated. The goal is to maximize
value to Epigenomics in any future licensing deals for mSEPT9.

All R&D activities will be focused on progressing programs in the
current product pipeline in colorectal, lung and prostate cancer.

Full-year revenue for 2009 is expected to be higher than 2008
revenue, as it exceeded the 2008 revenue already as of September 30,
2009. This increase in revenue resulted from existing collaborations,
from the additional partnerships and license agreements that have
been entered into as well as from initial direct product sales.

In Q4 revenue is expected to come from partnering activities in
diagnostics as milestones are expected to be reached (e.g. CE-marked
Septin 9 kit launch by Abbott in Europe and Quest Diagnostics' launch
of a Septin9 testing service in the U.S.). Further, initial sales of
the Epi proColon IVD test kit and a number of biomarker R&D
collaborations with pharmaceutical companies and academic
institutions are expected to also contribute to revenue growth. Due
to continued strict cost discipline EBIT and net loss for the full
year 2009 are expected to show an improvement over the previous year.
Net cash consumption for 2009 is anticipated to be at a very similar
level compared to 2008, i.e. at around EUR 10 million.

Epigenomics' investor conference at the German Equity Forum of the
Deutsche Börse Group today

The German Equity Forum of the Deutschen Börse Group takes place from
November 9th to November 11th, 2009 at the Congress Center Messe
Frankfurt, Ludwig-Erhard-Anlage 1, 60327 Frankfurt/ Main, Germany.

The investor conference for the presentation of Epigenomics' current
financial results takes place today, Tuesday, November 10th, 2009
from 4:30pm to 5:15pm, room Zurich.

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 on the market and in development aim at
diagnosing cancer at an early stage before symptoms occur and thereby
may reduce mortality from this dreaded disease.

Epigenomics' product portfolio contains Epi proColon, a CE-marked IVD
blood test for the early detection of colorectal cancer based on the
validated biomarker mSEPT9, and further proprietary DNA methylation
biomarkers at various stages of development for colorectal, lung and
prostate cancer detection in blood, bronchial lavage, and urine
specimens. Epigenomics' biomarker mSEPT9 for the early detection of
colorectal cancer in a simple blood sample has demonstrated
continuously highest performance in eight clinical case-control
studies with in total more than 3,300 individuals tested. A large
prospective clinical study - PRESEPT - to evaluate the performance
characteristics and the health economic benefit of colorectal cancer
screening with the mSEPT9 biomarker in a representative screening
population is currently under way (www.presept.net). Once completed,
the PRESEPT Study will be one of the largest commercially sponsored
colorectal cancer screening clinical studies ever conducted. The
clinical performance and health economic analysis results are
expected to support future coverage of mSEPT9 testing by public and
private health insurers worldwide. Epigenomics' partners developing
IVD test kits for the mSEPT9 biomarker can co-fund and access the
PRESEPT sample collection to conduct clinical trials for regulatory
filings in the U.S.

For development and global commercialization of IVD test products,
Epigenomics pursues a dual business strategy in which direct
commercialization of proprietary diagnostic test products is combined
with non-exclusive licensing to diagnostic industry players with
broad customer access. Strategic diagnostics industry partners
include Abbott Molecular, Philips, Sysmex Corporation, Quest
Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostic
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 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 HYPERLINK
"http://www.epigenomics.com"www.epigenomics.com.

Epigenomics legal disclaimers. 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.

The information contained in this communication does not constitute
nor imply an offer to sell or transfer any product, and no product
based on this technology is currently available for sale in the
United States. The analytical and clinical performance
characteristics of any product based on this technology which may be
sold at some future time in the U.S. have not been established.

end of announcement euro adhoc
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

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
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