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11.05.2011 | 110511_Press_release_Q1_Results_

Berlin, Germany, May 11, 2011 – Epigenomics AG (Frankfurt Prime Standard: ECX) today reports its Q1 financials for the period ended 31 March 2011.

Key Financials

Q1/11 (unaudited) Q1/10 (unaudited) % change
Revenue in mill. € 0.62 0.62
EBIT in mill. € (2.74) (2.61) 5%
Net Loss in mill. € (2.89) (2.59) 12%
At Mar 31, 2011 At Dec 31, 2010
Liquid Assets in mill. € 23.49 26.37

Financial Highlights
• Revenue for the period of EUR 0.6 million were equal to revenues in the comparative period (Q1 2010: EUR 0.6 million).
• Operational costs remained at similar levels at EUR 3.4 million (Q1 2010: EUR 3.4 million).
• Reflecting the increasing focus on commercial activities, R&D costs decreased significantly by 15% while SG&A costs increased by around 21% relative to the comparative period.
• EBIT (operating loss) increased by 5% to EUR 2.7 million (Q1 2010: EUR 2.6 million).
• Net loss for the period amounted to EUR 2.9 million (Q1 2010: EUR 2.6 million)
• Cash and cash equivalents amounted to EUR 21.5 million as at 31 March 2011 compared to EUR 24.6 at the year end 2010.
• 2011 guidance remains unchanged:
o Revenues should be similar or marginally higher level in 2011, with key drivers coming from license payments, R&D funding, sales in Europe with growing royalty income coming from partner Septin9-based tests sales worldwide. Main cost drivers are sales and marketing activities and the development of Epi proColon 2.0.
o Cash consumption is expected to remain around EUR 10 million – 12 million and should decrease gradually going forward as it is countered by positive cash flow from operations.

Operational highlights
• Epigenomics’ major focus for the period was furthering the pre-launch and operational efforts in advance of a potential FDA approval of Epi proColon 2.0 in the U.S.
• In Q1 2011, the Company completed the feasibility phase of its second-generation test, Epi proColon® 2.0 being developed simultaneously for the U.S. market and as a second-generation product for the European and ROW markets. Epigenomics has now entered into the development and verification phase. Clinical validation studies are planned for H2 2011.
• In February 2011, Epigenomics met the FDA to discuss the improved product concept, its intended use and clinical data required to support an application for its commercialisation. Epigenomics’ application for Pre-market Approval is on track for submission by year-end.
• Also in February 2011, Epigenomics has signed a collaboration agreement with QIAGEN for the development and commercialization of a colorectal cancer blood test. QIAGEN received a 2-year option on a worldwide non-exclusive commercial license and a research license for the mSEPT9 biomarker and certain DNA methylation technologies for the colorectal cancer detection in blood.
• In March 2011, Epigenomics’ partner Quest Diagnostics Inc received approval for its Septin9 colorectal cancer blood test ColoVantage™ from the New York State’s Department of Health. This increases the market availability of ColoVantage™ to the whole of the USA.

Post reporting period events
• In April 2011, Dr. Thomas Taapken was appointed as Epigenomics’ new CFO Dr. Taapken joined from publicly listed Biotie Therapies, Turku, Finland. He has significant experience in transactions including acquisitions, mergers, divestitures and public offerings.
• Also in April 2011, Noel Doheny was appointed as Chief Executive Officer of Epigenomics’ US subsidiary and will spearhead the activities around the Company’s US commercial strategy. Mr. Doheny has 30+ years of experience in the field of diagnostics, with over 20 years in senior management of companies including Affymetrix and QIAGEN.
• In May 2011, Life Technologies agreed to supply Dynabeads® MyOne™ SILANE and associated reagents for Epigenomics’ second generation colorectal cancer blood test Epi proColon® 2.0. These magnetic particles for DNA capture together with further modifications of the test, lead to a substantially improved clinical performance of the Epi proColon® 2.0 assay with 91% sensitivity at 87% specificity in a recent feasibility study.
• Also in May 2011, a health economic analysis performed by Dr. Uri Ladabaum of Stanford University and further scientists was presented at Digestive Disease Week 2011. In the study, the group comes to the conclusion that screening for colorectal cancer using Septin9 tests is a medically beneficial and health economically cost-effective strategy when it addresses the currently unscreened population in the U.S.. Patient behavior studies are underway at the University of Utah and the Huntsman Cancer Institutes in collaboration with ARUP Laboratories, Salt Lake City, UT, U.S.A., that investigate the impact of blood tests on patient acceptance of colorectal cancer screening and their potential to increase overall screening compliance. First results of the study indicated that the majority of the currently unscreened patients would take a Septin9 test for screening.
• In May 2011, Quest Diagnostics reported royalty-bearing sales of approximately 1,500 ColoVantage™ tests in Q1 2011. With approximately 4,000 tests performed in 2011 by the end of April, ColoVantage™ shows rapidly increasing adoption by physicians and robust performance in the clinical routine in the U.S.A.

Geert Nygaard, Chief Executive Officer of Epigenomics said: “As discussed at time of publication of our Full Year results, our primary focus in 2011 is to further establish the marketing and sales operations of the business and to emphasize the positioning of Epigenomics as a commercially-driven cancer molecular diagnostics company. We are also looking forward to the launch of our second generation Epi proColon® 2.0 test in Europe later this year and, as a key focus of our activities, to complete all necessary steps allowing us to submit the product for FDA review before the end of the year. Before a potential US approval in 2012, our 2011 revenues will be similar to last year’s and we will continue to keep a strong control of costs, as we focus on our commercialization efforts.”
The full 3-Months Financial Report 2011 is available for download at
www.epigenomics.com/en/news-investors/investors/financial-reports.html

The Company’s management will be available for investor meetings at the upcoming BioEquity 2011 meeting in Paris on 23-24 May 2011.
-Ends-
Notes to the Editor
Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

Conference Details

BioEquity Europe 2011
May 23–24, 2011 • Paris, France
www.ebdgroup.com/bee
About Epigenomics
Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal 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.

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 by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.