EANS-News: Epigenomics AG: Financial Results for the Fiscal Year 2009

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Press release, Berlin, Germany, and Seattle, WA, U.S.A., March 12, 2010 (euro
adhoc) - Key Figures and Financial Highlights:

* Full year revenue increased to EUR 4.3 million
* Operational costs reduced by close to EUR 1.5 million to EUR 15.0 million
* EBIT improved by 20% to EUR -10.2 million
* Net loss improved by 17% to EUR -10.2 million
* Liquidity position of EUR 6.1 million as of December 31, 2009
* EUR 5.2 million PIPE placed at 5% premium in early 2009

Operational Highlights:

* Launched first IVD product Epi proColon
* Partner Abbott Molecular launched Septin9 test mS9 in Europe and Asia/Pacific
* Partner Quest Diagnostics introduced laboratory developed Septin9 test
ColoVantage
* Completed PRESEPT Study enrollment in 2009; topline study data published on
March 8, 2010
* Significantly progressed lung cancer program
* Signed collaboration agreements for Septin9 with Sysmex and ARUP Laboratories
* Obtained ISO 13485 certification for quality management system
* Strengthened intellectual property position by cross licensing and portfolio
maturation

Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics
company, today reported its financial results for the fiscal year ending
December 31, 2009. The complete annual report will be released, as planned, on
March 31, 2010.

"The year 2009 marked the start of a new era for Epigenomics as an emerging
player in molecular diagnostics", said Geert Nygaard, CEO of Epigenomics. "The
introduction of our first IVD product, the Epi proColon blood test for
colorectal cancer early detection, was a transforming event for the company.
With first products launched by us and our licensees in Europe, Asia/Pacific and
the U.S. by the end of 2009, the focus now is on demonstrating commercial
success."

Oliver Schacht, CFO of Epigenomics AG commented: "All our 2009 key financials
reflect the clear emphasis on commercial execution. We have delivered strong
revenue growth through multiple partnership deals and kept our costs tightly
managed despite running one of the largest colorectal cancer screening trials."

Financial Review 2009

In 2009, Epigenomics recognized total revenue of EUR 4.3 million, a significant
increase of 65% compared to EUR 2.6 million in 2008. This strong improvement is
mainly due to progress made in the company's collaboration with Abbott, which
also resulted in revenue recognition of certain milestone payments and revenue
recognized for certain aspects related to the PRESEPT Study as well as to
revenue recognition under the collaboration agreements with Philips and Sysmex
and the licensing agreements with Quest, ARUP, OncoMethylome Sciences and
Qiagen/DxS.

Cost of sales increased significantly as expected by 65% from EUR 1.7 million to
EUR 2.8 million as a result of increased collaboration-driven product
development expenses and especially due to the acquisition of clinical samples
under Epigenomics' collaboration with Abbott.

Other income decreased to EUR 0.5 million in 2009 from EUR 1.1 million in 2008,
when high income from a one-time reversal of provisions affected the total
number in profit or loss.

In 2009, R&D costs decreased significantly by approximately EUR 2.7 million from
EUR 10.0 million in 2008 to EUR 7.3 million at the end of 2009. This significant
drop by 27% is mainly due to increased resource allocation to the Company's
commercial collaboration projects and a corresponding shift of such partnered
R&D activities to "cost of sales" as well as from the closing of all laboratory
operations at Epigenomics Inc. in Seattle only at the end of the second quarter
of 2008 with corresponding full-year effects in 2009.

Marketing and business development costs significantly increased by 39% from EUR
0.9 million in 2008 to EUR 1.2 million in 2009, as a result of increased
pre-marketing, sales and technical support activities for the launch of
Epigenomics' Epi proColon colorectal cancer blood test.
General and administrative costs decreased from EUR 3.4 million in 2008 to EUR
3.3 million at the end of 2009, mainly due to decreased staff costs. Other
expenses amounted to EUR 0.4 Mio (2008: EUR 0.4 Mio).

In 2009, EBIT amounted to EUR -10.2 million, a significant improvement by 20%
compared to previous year's EUR -12.8 million as a result of our strict fiscal
discipline coupled with solid revenue growth. Due to the lower average liquidity
of the Company in the past year compared to 2008 and the simultaneously low
interest level on the capital markets worldwide, the financial result decreased
from EUR 0.7 million in 2008 to EUR 0.2 million in the reporting year. Income
tax expenses amounted to EUR 0.2 million.
In the reporting period net loss for the full year 2009 therefore amounted to
EUR 10.2 million (2008: net loss of EUR 12.3 million). Hence, the result could
be improved by 17%.

Net cash flow in 2009 amounted to EUR -5.9 Mio. (2008: EUR 3.2 Mio.). While cash
flow from operating activities and net cash flow from investing activities
amounted to EUR -10.6 Mio. resp. EUR 0.2 Mio. (2008: EUR -9.8 Mio. resp. EUR 1.5
Mio.) in 2009, a net cash inflow of EUR 5.0 Mio. (2008: EUR 11.5 Mio.) was
generated from financing activities.

The balance sheet total of the Company has shortened to EUR 16.4 million as of
December 31, 2009 (Dec 31, 2008: EUR 20.3 million). This effect was mainly
caused by the decrease in current assets from EUR 14.4 million as of the 2008
reporting date to EUR 10.6 million as of December 31, 2009. This decrease again
was due to the net cash flow of EUR -5.9 million and the resulting reduction of
cash and cash equivalents. The increase in trade receivables to EUR 2.0 million
at the reporting date (Dec 31, 2008: EUR 0.7 million) had a compensating effect.

As of December 31, 2009, the company's financial position including marketable
securities showed a total liquidity amounting to EUR 6.1 million (31.12.2008:
EUR 12.1 Mio.).

In February 2009, Epigenomics successfully completed a PIPE transaction and
capital increase at a 5% premium to the prevailing market price at that time for
its stock. Epigenomics issued 2,671,088 new shares at a price of EUR 1.94 per
share for gross proceeds of EUR 5.2 million. Therebythe total number of shares
outstanding has increased to 29,394,724. The transaction was lead by a fund of
the BB MEDTECH Group (Schaffhausen/Switzerland), now Bellevue Funds (Lux) SICAV,
Luxemburg, which thereby at the time became Epigenomics' second largest investor
after Federated Investors (Pittsburgh, PA, U.S.A.).

Hence, total equity as reported as of balance sheet date dropped despite a net
loss for the year of EUR 10.2 million only to EUR 12.1 million (Dec 31, 2008:
EUR 16.6 million), corresponding to an equity ratio of 73.9% (Dec 31, 2008:
81.7%).

Operational Review 2009 and Recent Highlights

2009 and early 2010 have been characterized by continued focusing on
Epigenomics' commercialization of the lead product Epi proColon, on the
enrollment completion into the PRESEPT Study as well as the substantial progress
made in the company's product development pipeline.
In October 2009 and as the most important milestone in Epigenomics' history the
company launched its first IVD product in Europe. The Epi proColon test, which
is based on Epigenomics' proprietary biomarker Septin9, is the world's first
ever CE-marked test for the early detection of colorectal cancer in a simple
blood draw. Epi proColon is marketed directly by Epigenomics to molecular
diagnostics laboratories in Europe. As of today, the test is offered by 16
laboratories in Germany and Switzerland making it available to doctors and
patients nationwide in both countries.

During 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' Septin9 biomarker and the potential health economic
benefit of colorectal cancer screening with Septin9 in a U.S. colorectal cancer
screening-guideline-eligible population. In December 2009 enrollment into the
PRESEPT Study was completed reaching a number of 7,941 subjects at 32 clinical
sites in the U.S.A. and Germany. After the release of preliminary data in
January 2010, Epigenomics reported updated top-line PRESEPT Study data on March
8, 2010 showing that the Septin9 biomarker in this academic medicine study
detected colorectal cancer cases with a sensitivity of approximately 63% and a
specificity of around 89%. The Clinical Study Steering Committee overseeing the
Study will submit detailed and final results of the PRESEPT Study for
publication in a peer-reviewed journal and presentation on major medical
conferences in due course.

In December 2009 Abbott launched its blood test for colorectal cancer in Europe
and Asia/Pacific under the brand name Abbott RealTime mS9. Also in late 2009
Quest Diagnostics introduced its laboratory developed blood test ColoVantage?
for aiding in the detection of colorectal cancer in the United States. Both
tests are based on Epigenomics' proprietary Septin9 biomarker and certain
proprietary technologies entitling Epigenomics to significant royalties on its
partners' future test sales. Therefore, Septin9 tests have been commercially
available since late 2009 in the U.S.A., Europe and in the Asia/Pacific region.

During 2009 Epigenomics continued executing its non-exclusive partnering and
commercialization strategy by entering into new collaborations regarding the
Septin9 biomarker for colorectal cancer with the Japanese IVD company Sysmex
Corp. and the U.S. Reference Laboratory ARUP Laboratories in Salt Lake City, UT.

Moving forward in transforming the company into a fully integrated molecular
diagnostics company Epigenomics has made significant progress in its lung cancer
program throughout 2009. After the successful clinical evaluation of the mSHOX2
biomarker in bronchial lavage specimen from patients with suspected lung cancer
in Q1-2009, Epigenomics initiated the formal product development of an IVD test
for lung cancer. The diagnostic test is currently being developed as an aid in
diagnosis for lung cancer and may help pathologists to confirm the diagnosis of
malignant lung disease when current diagnostic procedures fail to establish the
presence of malignancy in patients with suspected lung cancer. Under the brand
name Epi proLung BL Reflex Assay, the Company's second in vitro diagnostic
product, is expected to be launched as a CE-marked diagnostic test kit in
Europe. Epigenomics intends to market the test directly to molecular pathology
laboratories in the home market - Germany, Austria and Switzerland - and address
further European markets through distributors.

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,
and is an important prerequisite for the design, development, manufacture and
distribution of in vitro diagnostic (IVD) products in compliance with regulatory
requirements.

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 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. In
2009 DxS has been acquired by Qiagen, also a long-term partner of Epigenomics.

Further Information

Shortened versions of the FY 2009 consolidated financial statements can be found
at Epigenomics' website at:
http://www.epigenomics.com/en/investor_relations/Financial_Information/

The complete Annual Report 2009, which will be released on March 31, 2010, can
be obtained from Epigenomics' website at:
http://www.epigenomics.com/en/investor_relations/Financial_Information/

Epigenomics will host a press conference in Frankfurt/ Main, Germany in German
language on March 31, 2010. On the same day the management will host a
conference call for analysts in English language. Details of both events will be
made available prior to March 31, 2010 in a note to the press and on
Epigenomics' website.

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 the CE-marked IVD test Epi proColon, the
world's first regulatory cleared molecular diagnostic test for the detection of
colorectal cancer in blood that is based on the biomarker Septin9, and further
proprietary DNA methylation biomarkers and IVD products at various stages of
development for colorectal, lung and prostate cancer. 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, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP
Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V.
for sample preparation solutions and research products. The company is
headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics
Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics'
website at 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.

Further inquiry note:
Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
[email protected]
end of announcement euro adhoc
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issuer: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: [email protected]
WWW: www.epigenomics.com
sector: Biotechnology
ISIN: DE000A0BVT96, DE000A0XFWF2
indexes: Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, München
language: English

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