NEW YORK (GenomeWeb) – German molecular diagnostics firm Epigenomics today reported a 38 percent increase in revenues for the fiscal year 2015.
Total revenues rose to €2.1 million ($2.4 million) from €1.5 million for 2014. Product revenue increased 88 percent year over year to €1.6 million from €800,000, which the company attributed to the approval of the Epi proColon test in China and inclusion of the test in that country's colorectal cancer screening guidelines.
"The most important achievement of our work in 2015 is the progress we made with the Pre-Market Approval application for our lead product Epi proColon," Epigenomics CEO and CFO Thomas Taapken said in a statement. "We are now in advanced talks with the [US Food and Drug Administration] on the outstanding topics, with the main topics being resolved. We are very confident that the approval process of Epi proColon can be completed in the near future."
In November, the FDA asked the firm for more data before making a decision on whether to approve the test.
The firm reported its net loss widened slightly to €9 million from a net loss of €8.9 million in 2014. However, the loss per share decreased to €.52 from €.65 in 2014 due to an increase in the number of shares outstanding, the firm said.
Epigenomics' R&D spending increased 23 percent to €5.8 million from €4.7 million a year ago, driven by costs related to the application for FDA approval of the Epi proColon test. And the firm's SG&A spending increased 4 percent to €5.1 million from €4.9 million in 2014, attributable to increased legal expenses and auditing, the firm said.
Epigenomics ended the year with €8.6 million in cash and cash equivalents.
For 2016, the firm said it anticipates the successful introduction of Epi proColon to the US market, and total revenues of €3 million to €7 million.