NEW YORK (GenomeWeb) — German molecular diagnostics firm Epigenomics today reported a 21 percent drop in revenues for 2018, resulting from a drop in licensing revenue.
For 2018, Epigenomics revenues fell to €1.5 million ($1.7 million) from €1.9 million in 2017, reflecting the impact of a one-time patent out-licensing in 2017 that led to a €600,000 reduction in 2018 licensing revenue. Revenues from the sale of products — primarily the company's flagship Epi proColon blood-based colorectal cancer screening test — grew to €808,000 from €548,000 year-over-year.
Epigenomics net loss for 2018 climbed to €12.7 million, or €.47 per share, from €10.2 million, or €.44 per share, the year before. Driving the higher loss was a 49 percent jump in R&D spending to €6.4 million from €4.3 million, primarily due to the costs associated with a post-approval study of Epi proColon. Meanwhile, SG&A expenses edged up about 9 percent to €8.7 million from €8.0 million in 2017.
For the fourth quarter of 2018, the company reported €218,000 in revenue and a net loss of €.11 per share.
At the end of 2018, Epigenomics had cash, cash equivalents, and marketable securities totaling €17.1 million, which the firm said is sufficient to fund its operations into 2020.
"In the past fiscal year, we achieved some critical milestones including the reimbursement rate for Epi proColon of $192 per test [in the US], completion of the microsimulation model [evaluating the test], CE marking of our HCCBloodTest for liver cancer, and a successful [€13.7 million] capital raise" in late 2017, Epigenomics CEO Greg Hamilton said in a statement.
"While we did not receive Medicare coverage in 2018, we made progress on both the legislative and [national coverage determination] paths," he added. "We believe we are positioned to receive a positive coverage decision in 2019, which will be a turning point for Epigenomics."
Since Epi proColon was approved by US regulators in 2016, Epigenomics has struggled with pushing the test into wider adoption. It has taken a number of steps to address this issue including launching clinical utility studies focused on specific patient populations.
Looking ahead, Epigenomics said that it expects US test volumes for Epi proColon to increase in 2019 based on the test's new reimbursement rate, and is projecting full-year revenues in the range of €3 million to €6 million even without Medicare coverage.