- Company confirms preliminary financial results for the fiscal year ending December 31, 2013 announced on February 26, 2014
- Prior to securing U.S. market approval for Epi proColon®, Epigenomics provides an outlook for 2014, expecting revenue and net loss slightly increased compared to 2013
- FDA Advisory Committee provides recommendations for Epigenomics’ colorectal cancer screening blood test
- Company will discuss financial results and positive outcome from committee meeting in more detail in today’s conference for journalists, analysts and investors
Berlin (Germany) and Germantown, MD (U.S.A.), March 28, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced that it has published today the annual report for the fiscal year ending December 31, 2013 and an outlook for the year 2014. The Company already published 2013 preliminary financial results and operational highlights on February 26, 2014.
Epigenomics confirmed that revenue in 2013 increased by 53% to approximately EUR 1.6 million (2012: EUR 1.0 million), operating loss (EBIT) was significantly reduced by 40% to EUR 7.3 million (2012: EUR 12.1 million) and net loss was reduced by 39% to EUR 7.4 million (2012: EUR 12.2 million) which equals a loss per share of EUR 0.62 (2012: EUR 1.38). Cash consumption in 2013 amounted to EUR 6.5 million (2012: EUR 10.9 million) and year-end liquidity including marketable securities to EUR 8.0 million (2012: EUR 2.7 million).
“2013 was a good year for Epigenomics. We were able to successfully establish important strategic partnerships to support the commercialization of our key product Epi proColon® following potential regulatory approval in the U.S. and to develop new markets, for example China. In addition, we significantly improved our financial position and increased our financial flexibility by raising EUR 12.5 million, in a series of transactions,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “We are pleased with the advice of the FDA’s Medical Devices Advisory Committee for our blood-based colorectal cancer screening test that we announced yesterday. This recommendation is a big milestone for the Company and we will discuss results of the meeting in more detail during today’s conference. We will now define an approval path with the FDA to launch Epi proColon® in the U.S. as soon as possible and believe we are best positioned to bring sustainable value to our shareholders through prosperous product launches in major markets.”
Outlook for 2014
Prior to an approval of Epi proColon® as an IVD product in the U.S. market, Epigenomics remains cautious and expects revenue in 2014 to slightly increase from 2013 levels. Net loss for 2014 is expected to be in the range of EUR 7.5 to 8.5 million. In line with the expected net loss range, cash consumption for fiscal 2014 is projected at a slightly increased level compared to 2013 in the range of EUR 7.0 to 8.0 million.
The complete annual report 2013 including an outlook for 2014 can be downloaded from the Company’s website under http://www.epigenomics.com/en/news-investors/investors/financial-reports/2013.html.
Epigenomics AG will host a conference for journalists, analysts and investors today, March 28, 2014 from 1:00 pm to 2:30 pm CET at equinet Bank AG, Gräfstrasse 97, Frankfurt am Main in German language followed by a conference call starting at 3:00 pm CET in English language. Management will discuss the detailed results for the financial year 2013 and provide an update on the FDA Advisory Committee meeting. The conference call will be webcasted and can be accessed on Epigenomics’ website under www.epigenomics.com.
Contact Epigenomics AG
For US press inquiries:
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
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 under regulatory review by the FDA for the U.S.A. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung®, in Europe. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.
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 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.