09.11.2010 – 08:46
EANS-News: EPIGENOMICS AG Releases 9-Months Financial Report
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Company Information/9-month report/Molecular diagnostics
Berlin, Germany, November 9, 2010 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX) reports today its third quarter and nine months financials for the period ended September 30, 2010.
| | |Q3/10 |9M/10 | 9M/09 |% change | | | |(unaudited)|(unaudited)|(unaudited)|(9M) | | | | | | | | |Revenue |in mill. |0.36 |1.34 |3.2(1) |-58% | | |EUR | | | | | |EBIT |in mill. |-3.01 |-8.44 |-7.1 |19% | | |EUR | | | | | |Net Loss |in mill. |-3.00 |-8.36 |-7.1 |18% | | |EUR | | | | | |Liquid Assets |in mill. | |29.61(2) |9.5 | | | |EUR | | | | | 1) Includes non-recurrent payments in R&D and licensing partnerships in 2009. 2) Difference due to the raising of gross proceeds of approx. EUR 33.1 million in a capital increase in early 2010 Operational Highlights in the Reporting Period Dual track commercial strategy rolling out in Europe & US and key highlights during the 9 month period included: o Direct sales: Epi proColon kits available nationwide in Germany and Switzerland o Partners´ sales: colorectal cancer blood tests based on Septin9 available in the US through Quest Diagnostics and ARUP Laboratories, and Abbott (EU and Asia/Pacific) o New non-exclusive licensing agreement signed with Warnex for Canadian market, expected launch by the end of 2010 Tests now being shipped to customers internationally Positive clinical data published at leading scientific conferences worldwide including results of the successfully completed prospective PRESEPT Study at the 2010 Digestive Disease Week Launched new lung cancer diagnostic test, Epi proLung BL Reflex Assay, in Europe after successful completion of pivotal performance evaluation study
Post Period End Events
Exclusive distribution deals signed with Pronto Diagnostics, DATEKs and DPC for commercialization of Epi proColon in the entire Middle East region Further positive clinical validation studies o ARUP presented data demonstrating that its Septin9 laboratory- developed test has 90% sensitivity for cancer at 89% specificity at ASCO-NI-EORTC meeting o Epigenomics presented new data generated by an independent laboratory with the PRESEPT Septin9 assay at the UEGW as well as AACR meetings showing sensitivity of 86% at specificity of 93% Briefing booklet submitted to FDA on Epi proColon; Epigenomics expects pre-IDE meeting to take place late 2010 / early 2011 Allocation of US$ 245,000 grant to Epigenomics as a partial reimbursement and co-funding of the clinical trial PRESEPT for the fiscal year 2009 under the Qualifying Therapeutic Discovery Projects (QTDP)
program by the US Internal Revenue Service. The QTDP program is funded through the Patient Protection and Affordable Care Act.
Geert Nygaard, Chief Executive Officer of Epigenomics said: "We are proud of Epigenomics´ extensive operational achievements so far this year. Our dual track commercial strategy is developing well with new partners and distributors on board giving us access to new markets and countries with our test and technology. We are also seeing very positive clinical data which are reinforcing the independent view that blood-based colorectal cancer tests are going to become an essential method of screening for patients in the future."
He added: "Sales growth is taking longer than expected due to slower initial uptake of our test and this is likely going to continue at a gradual pace during 2011. However, we are taking proactive steps to reach out to the medical profession about the benefits of the test to patients. In addition, with the recent funding of EUR33.1m gross proceeds, the Company is in a solid financial position to support the commercial strategy at this early stage and in bringing new partners on board."
The full 9-Months Financial Report 2010 is available for download at www.epigenomics.com/en/investor_relations/Financial_Information/
The Company´s management will be available for analyst and investor meetings at the upcoming Lazard Capital Markets 7th Annual Healthcare Conference in New York, USA, on November 16-17, 2010 and the German Equity Forum 2010 in Frankfurt am Main, Germany, on November 22-23, 2010.
-Ends- Notes to the Editor |Contact Epigenomics AG | |Dr. Achim Plum | |Sen. VP Corporate Development | |Epigenomics AG | |Tel +49 (0) 30 24345 368 | |email@example.com | |www.epigenomics.com | Conference Details
Lazard Capital Markets 7th Annual Healthcare Conference Epigenomics´ presentation on November 16, 2010 at 10:25 am EST The St. Regis Hotel, 22 East 55th Street, New York, USA
German Equity Forum 2010 Epigenomics´ presentation on November 23, 2010 at 12:00 noon CET, Room Madrid, Congress Center, Messe Frankfurt, Ludwig-Erhard-Anlage 1, Frankfurt am Main, Germany
Epigenomics AG 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 for colorectal, lung, and prostate cancer aim at aiding in an earlier and more accurate diagnosis of these diseases thereby potentially increasing the patient´s chances of survival.
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, ARUP Laboratories, Inc., and Warnex 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, USA. 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 by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established.
end of announcement euro adhoc --------------------------------------------------------------------------------
Further inquiry note:
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
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