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Epigenomics AG

EANS-News: Epigenomics Reports on a Successful Year 2009 at Annual Press Conference and Analyst Meeting

Key financials improved significantly in 2009
Important development and commercialization milestones met in 2009
Expect revenue growth and similar earnings in 2010
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Company Information/Molecular diagnostics
Subtitle: Key financials improved significantly in 2009
Important development and commercialization milestones met in 2009
Expect revenue growth and similar earnings in 2010
Press release, Berlin, Germany, and Seattle, WA, USA, April 19, 2010 
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a 
cancer molecular diagnostics company, today hosted its Annual Press 
Conference and Analyst Meeting in Frankfurt/ Main. Geert Nygaard, 
CEO, and Oliver Schacht, CFO, informed on the results of the fiscal 
year 2009, reported on key highlights and provided an outlook on the 
company's business activities and expectations for 2010 and beyond.
Geert Nygaard, CEO of Epigenomics commented:"Delivering on our 
promises and meeting all our key development and commercialization 
milestones in 2009 and early 2010 such as the launches of Epi 
proColon, Abbott's Real Time mS9 Colorectal Cancer Assay, Quest's 
ColoVantage test service as well as the successful completion of our 
PRESEPT study have ideally positioned Epigenomics for the commercial 
phase in our corporate development."
Oliver Schacht, CFO of Epigenomics added: "With the successful 
closing of our oversubscribed public rights offering in Q1-2010 that 
yielded gross proceeds of EUR 33.1 million we are well funded to 
execute our product development programs and drive commercialization 
of our products."
Key Financials 2009
In 2009, Epigenomics grew its total revenue to EUR 4.3 million; a 
significant increase of 65% compared to EUR 2.6 million in 2008.
Cost of sales increased significantly 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 had affected the total number.
In 2009, R&D costs have 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.
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.
In 2009, EBIT amounted to EUR -10.2 million, a significant 
improvement of 20% compared to previous year's EUR -12.8 million as a
result of our strict fiscal discipline coupled with solid revenue 
growth.
Cash flow from operations was EUR -10.6 million for 2009 versus EUR 
-9.8 million for 2008.
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.).
On March 30, 2010, Epigenomics successfully completed the placement 
of 14,697,361 new ordinary bearer shares within a rights offering 
representing the entire authorized capital available. The new shares 
were placed at the subscription price of EUR 2.25 per new share 
resulting in gross proceeds of about EUR 33.1 million. With the 
registration of the capital increase on March 31 2010 the total 
issued share capital of Epigenomics has increased from EUR 
29,394,724.00 to EUR 44,092,085.00. ICF Kursmakler AG (Frankfurt, 
Germany) acted as sole lead manager and sole underwriter and Trout 
Capital LLC (New York, NY, U.S.A.) acted as placement agent to 
Epigenomics in the U.S.
Key Highlights 2009/2010
Following the launch of Epi proColon as a CE-marked IVD product in 
Europe in October 2009 Epigenomics has grown its laboratory customer 
base from a handful in Q4-2009 to 18 customer laboratories in Germany
and Switzerland as of today, including synlab with its 55 German 
sites, one of Europe's largest laboratory networks.
2009 and early 2010 have been characterized by continued focus on 
Epigenomics' commercialization of the lead product Epi proColon. 
Enrollment into the PRESEPT Study was completed successfully and 
substantial progress has been made in the company's product 
development pipeline especially the lung cancer program.
During 2009 and into 2010, Epigenomics' R&D activities have continued
to focus on executing the PRESEPT Study. 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%.
During 2009 Epigenomics continued executing its non-exclusive 
partnering and commercialization strategy by entering into new 
collaboration agreements 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. 
Further deals were signed with Quest Diagnostics and Predictive 
Biosciences for a laboratory-developed prostate cancer test.
Moving forward in transforming the company into a fully integrated 
molecular diagnostics company Epigenomics has made significant 
progress. The company obtained ISO 13485 certification in 2009 
enabling it to develop, manufacture and market IVD products. 
Throughout 2009 Epigenomics has made substantial progress in its lung
cancer product development program. 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.
Outlook for 2010 and beyond
Epigenomics intends to build on the successful year 2009 as well as 
the very promising start into 2010 with EUR 33.1 million gross 
proceeds from the recently completed financing transaction to 
complete the transformation into an integrated molecular diagnostics 
industry player. Focus will be on the commercial execution together 
with partners and licensees as well as driving direct product sales 
in the home markets. To that end Epigenomics expects to grow the 
marketing and sales team in Europe by a handful of key additions and 
new hires.
The company anticipates commercial traction of all Septin9-based 
tests that are commercially available to increase gradually during 
2010 and to accelerate in 2011 and beyond. The management expects 
direct product sales of the Epi proColon test in Germany, Switzerland
and Austria as well as distributor sales in other key European 
markets to add to revenue growth. Furthermore Epigenomics expects to 
maintain a solid base of R&D collaboration, licensing and partnering 
based revenue generation at similar levels to the previous years, 
which assumes the closing of one additional IVD partnership in 2010. 
Royalty income from sales of Abbott's RealTime mS9 Colorectal Cancer 
product and Quest's ColoVantage? testing service should also 
gradually start to contribute in 2010 with accelerated growth 
expected in 2011 and beyond. The expected launch of ARUP's Septin9 
testing service in 2010 should add to the royalty income going 
forward.
On the product development and pipeline progress Epigenomics' 
management awaits the launch of the CE marked Epi proLung BL Reflex 
Assays by midyear 2010. In line with the commercial strategy in 
colorectal cancer the company intends to market and sell directly in 
home markets and work with distributors in other countries. It also 
plans to initiate  a clinical trial for regulatory approval of the 
Epi proColon test using the PRESEPT cohort in 2010 with a view to 
obtaining such regulatory approval in the USA ideally still in 2011. 
Epigenomics also expect its partner Abbott to complete its clinical 
trial for regulatory approval of the Abbott RealTime mS9 Colorectal 
Cancer test and to seek such regulatory approval for the U.S. by 
2011.
R&D going forward will focus on enhancement and expansion of Epi 
proColon product. As an example, the company has recently launched an
updated version of the product which can now be used on two real-time
PCR devices, the Roche LightCycler? 480 and AB7500 Fast Real Time PCR
System. Further R&D in the colorectal cancer program focuses on 
enhanced clinical characteristics for colorectal cancer early 
detection as well as expansion of the clinical utility into disease 
monitoring and adenoma detection. Lung cancer test development will 
take second priority with prostate cancer taking third priority and 
requiring current and future partners to commercialization.
Financials for the fiscal year 2010 are expected to be characterized 
by continued fiscal discipline and focus on commercialization. 
Epigenomics anticipates 2010 revenue of at least EUR 5 million, with 
the potential to double in each of the following two years towards 
achieving profitability by the end of 2012 at the earliest. This will
depend on successful commercialization of own products as well as 
current and new partners being successful in their test 
commercialization. 2010 EBIT is expected to be similar to 2009 with a
target of around EUR -10 million for the fiscal year 2010. Cash burn 
will be closely monitored and is expected remain around EUR 10 
million for 2010 despite the completion of PRESEPT and the lung 
cancer IVD development, as marketing and sales spending will 
increase. Further, the Company expects to fund a clinical trial and a
filing for regulatory approval in the U.S. in 2010 and 2011 before 
eventually commercializing a regulatory approved Epi proColon product
in the U.S.
Further Information
The annual report 2009 is available at Epigenomics' website at: http:
//www.epigenomics.com/en/investor_relations/Financial_Information/
An Analyst Conference Call will be hosted by Epigenomics' management 
today at 3 pm (CET)/ 9 am (EST). The conference call will be 
conducted in English.
Dial-in number (within Germany.): +49 (0) 69 247 501 899
Dial-in number (outside Germany): +1 212 444 0297
Please dial-in at least 10 minutes prior to the start of the call.
To follow the presentation, we kindly ask all participants of the 
call to download the slide set from the company website prior to the 
call where it will be made available as a PDF file today at 12 pm CET
(5 am EST) on the same day via: 
www.epigenomics.com/en/down_loads/corporate_material/
The conference call will be recorded and also made available on the 
company website web as a audio file after the call. Please go to: 
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 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

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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