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Epigenomics 2014 Revenues Fall 6 Percent

NEW YORK (GenomeWeb) – German molecular diagnostics firm Epigenomics today reported a 6 percent drop in 2014 revenues due primarily to the phasing out of existing licensing agreements ahead of anticipated US commercialization of its Epi proColon blood-based test for the early detection of colorectal cancer.

In 2014, Epigenomics tallied €1.5 million ($1.6 million) in revenues compared to €1.6 million in 2013. Product sales increased to $800,000 in 2014 from $600,000 in 2013.

The Berlin-based company, which also has a US office in Germantown, Md., said that its R&D costs increased 7 percent to €4.7 million from €4.4 million driven by efforts toward garnering US Food and Drug Administration approval for Epi proColon. Meantime, SG&A expenses at the company spiked 9 percent to €4.9 million from €4.5 million.

Epigenomics' net loss in 2014 was €8.9 million, or €0.65 per share, compared to €7.4 million, or €0.62 per share, in 2013.

The company noted that the FDA's anticipated approval decision for Epi proColon remains a key target in 2015. The test is based on detecting aberrantly methylated DNA in the Septin9 gene in blood plasma, which the company has shown is shed into the blood stream by tumor cells.

In June 2014 the company received a response letter from the FDA with respect to its pre-market application for Epi proColon stating that while studies had established the clinical performance of the test, additional data was necessary to demonstrate that the assay will increase compliance to colorectal cancer screening in the intended use population compared to those being offered a stool-based immunochemical test.

As such, in the second half of the year Epigenomics designed and initiated the Adherence to Minimally Invasive Testing (ADMIT) trial in patients that have been historically non-compliant to CRC screening according to current screening guidelines, with the intended primary endpoint of a statistically significant increase in adherence to testing by subjects offered Epi proColon versus the fecal immunoassay.

In a separate announcement today, Epigenomics said that enrollment into this trial has been completed, and that it expects results in the second quarter.

In December Epi proColon received marketing approval from the China Food and Drug Administration. Epigenomics and its partner BioChain are now launching the test into the Chinese market.

Epigenomics said that it expects 2015 revenue to be in the range of €3.0 million to €4.0 million with the bulk of this in the second half of the year, assuming FDA approval of Epi proColon. This revenue growth, the company noted, would almost exclusively be driven by the expected initial product sales in the US and in China.