Epigenomics AG: Full Year Results for the Year Ended 31 December 2010

Focus 2010/2011 on U.S. product development and FDA submission

12-Apr-2011 - Germany

Epigenomics AG announced its full year results for the year ended 31 December 2010 and gave an outlook on the priorities for 2011.

Key Financials 2010 and Prognosis 2011:

Revenue for the full year of EUR 1.8 million (2009: EUR 4.3 million) generated from product sales of Epi proColon® kits and out-licensing and partnering activities; Decrease in revenues is due to recognition of non-recurring revenue from R&D support for partners in 2009;
Costs of sales accordingly significantly dropped to EUR 0.5 million (2009: EUR 2.8 million)
Overall operating costs decreased by 5% in 2010 due to further streamlining operations and commercially focused strategy execution.
Costs for external R&D and for biological samples decreased significantly due to the finalization of the academic PRESEPT study in Q1/2010;
Operating (EBIT) loss increased by 12% to EUR 11.5 million (2009: EUR 10.2 million);
Net loss for the year amounted to EUR 11.5 million (2009: EUR 10.2 million);
Cash consumption improved with EUR 10.3 million in 2010 compared to EUR 11.3 million in 2009;
Financial position substantially strengthened by capital increase in Q1/2010 resulting in gross proceeds of EUR 33.1 million;
Cash and cash equivalents at year end 2010 amounted to EUR 24.6 million in (2009: EUR 4.0 million);
2011 financial guidance: EBIT, net loss and cash consumption for 2011 expected to be at similar levels compared to 2010;
Accrued losses expected to surpass 50% of share capital in German statutory accounts (HGB) in H2 2011 and if so, will require an extraordinary shareholder meeting pursuant to Sec. 92 para 1 AktG (German Stock Corporation Act).

Geert Nygaard, Chief Executive Officer of Epigenomics commented: “In 2010 we have continued evolving Epigenomics into a commercially-oriented, product-driven company, and this will continue to be the primary aim of our strategy going forward. We have continued to pursue a successful dual strategy with our own product, Epi proColon®, and with our partners and their colorectal cancer blood tests using our mSEPT9 biomarker available around the world. After about a year in the market, we and our partners have started seeing the first commercial traction with these products and, most importantly, success stories of cancer cases detected by our test that otherwise might have gone unnoticed - with potential fatal consequences for the patients affected. Our main focus in 2011 will be on the strategically most important U.S. market. Great progress is being made with the development of our U.S. product and we believe we are still on plan for filing with the FDA within 2011. We align our activites here closely with our partner Abbott. As we are progressing with the development of our second generation product for the U.S. market, we have also made progress in building a commercial core team for the U.S. and will announce a new head of our Seattle-based U.S. operations shortly. In parallel we have initiated a project focused on U.S. reimbursement and screening guideline recognition.”

https://www.bionity.com/en/news/131856/epigenomics-ag-full-year-results-for-the-year-ended-31-december-2010.html