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

Geschrieben am 12-03-2010


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Financial Figures/Balance Sheet/Molecular diagnostics

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/e
n/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.epigen
omics.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.


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, Technology 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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