NEW YORK (GenomeWeb News) – Epigenomics today reported that revenues in the second quarter fell 57 percent year over year.
The molecular diagnostics firm posted €156,000 ($192,992) in revenues during the three months ended June 30, down from €364,000 a year ago as it recognized no R&D revenues in the recently completed quarter while product sales and licensing income fell year over year.
Epigenomics' net loss for the quarter widened to €3.4 million from €3.0 million in Q2 2011.
Its R&D expenses were up 50 percent to €2.1 million from €1.4 million a year ago due primarily to costs associated with a study comparing its Epi proColon colorectal cancer test to fecal immunochemical testing, as well as increased efforts aimed at getting US Food and Drug Administration approval. Its SG&A costs were snipped 17 percent to €1.5 million from €1.8 million, resulting from restructuring measures begun in 2011 in marketing and sales.
In a statement, Epigenomics CEO Geert Nygaard said the company's focus remains on completing efforts to gain US regulatory approval for the Epi proColon test. The FIT study is anticipated to be completed in the fourth quarter and will be an integral part of the fourth and last module of its PMA submission to FDA. The company filed the third module of the submission with the agency in June and expects to complete its regulatory submission documentation with the filing of its final module before the end of 2012.
The company also said that it has started preparation for an FDA advisory panel meeting, anticipated to be part of FDA's review process.
Epigenomics said that it continues to seek licensing partners in the US and distribution partners and key account customers in the rest of the world. "However, our own product-derived revenues are expected to remain at modest levels prior to the US approval of Epi ProColon by the FDA," Epigenomics said.
It added that net loss for full-year 2012 is expected to improve from 2011 due to benefits from the restructuring initiative started last summer. Securing additional resources to support its regulatory submission efforts will be required, it said, and the firm is assessing "all strategic options available, including the possibility [of] a capital markets transaction."
Epigenomics finished the quarter with €9.1 million in liquidity.