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Epigenomics H1 Revenues Down 31 Percent

NEW YORK — Epigenomics on Wednesday reported a 31 percent year-over-year drop in revenues for the first half of 2021, which the German molecular diagnostics firm attributed to the effects of the SARS-CoV-2 pandemic.

For the six-month period ended June 30, Epigenomics' revenues fell to €223,000 ($261,920) from €322,000 the year before. Epigenomics said that the decline in part reflected patients eligible for its Epi proColon blood-based colorectal cancer test continuing to postpone screenings during the pandemic.

At the same time, Epigenomics continues to face reimbursement troubles after the US Centers for Medicare and Medicaid Services, or CMS, recently issued a negative National Coverage Determination for Epi proColon.

The firm said that it could obtain reimbursement for Epi proColon either via legislation or by appealing the NCD decision, but that it is confident a next-generation version of the test will meet CMS' reimbursement criteria. Securing this coverage, however, will require a clinical study that is expected to take two years to complete. Epigenomics said it intends to start this trial in the first half of 2022.

Berlin-based Epigenomics' net loss for the first half of 2021 dropped to €3.5 million, or €1.21 per share, from €6.4 million, or €.41 per share, in the year-ago period.

R&D spending in H1 2021 dropped 46 percent year over year to €1.5 million from €2.8 million, while SG&A costs fell 23 percent to €3.0 from €3.9 million.

As of June 30, Epigenomics had cash and cash equivalents totaling €6.9 million.

The company confirmed its prior revenue outlook for full-year 2021 for a range of between €400,000 and €1.0 million.

"We are determined to increase shareholder value … [and] a prerequisite for this is that we continue to move the business forward," Epigenomics CEO Greg Hamilton said in a statement. "Therefore, our strategy at this point is to focus on both achieving CMS reimbursement of Epi proColon, possibly via legislation, while at the same time advancing the development of [the next-generation version of] Epi proColon."

Earlier this year, Epigenomics had said it was considering selling itself and that it was in discussions with several potential buyers.

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