On August 10, 2021 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the second quarter and first half of 2021 (Press release, Epigenomics, AUG 10, 2021, View Source [SID1234586280]).

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OPERATIONAL DEVELOPMENTS

Epigenomics AG has two options to obtain reimbursement for Epi proColon after the disappointing negative NCD reimbursement decision by the Centers for Medicare & Medicaid Services (CMS) earlier this year: via legislation and by appealing the NCD decision. In the legislative process, the Donald Payne, Sr. Colorectal Cancer Detection Act of 2021 (H.R. 1655) was reintroduced in the new session of Congress and currently has 63 co-sponsors.
Epigenomic’s management is confident that the company’s new Next-Gen version of Epi proColon will meet the new CMS reimbursement criteria. The critical factor for the commercialization of the new test is the clinical study required to apply for marketing approval, which will take at least two years, and the subsequent duration of the FDA review. Epigenomics plan to initiate this trial in the first half of 2022.
As a result of the two capital measures carried out in the first half of 2021, Epigenomics AG received gross proceeds of approximately EUR 7.5 million, which will provide the Company with liquidity well into 2022. In addition, Epigenomics recently announced a further capital measure to raise up to EUR 18 million (gross proceeds) through the issuance of a convertible bond. The placement is back-stopped by the largest shareholder, Deutsche Balaton, and is expected to be issued in the third quarter of the year.
Greg Hamilton, CEO of Epigenomics AG: "We are determined to increase shareholder value. A prerequisite for this is that we continue to move the business forward. 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 Epi proColon "Next-Gen". If we make discernible progress in this regard, we will move decisively closer to the goal of maximizing shareholder value."

6M 2021 FINANCIAL RESULTS

In the first six months of 2021, total revenue decreased from EUR 322 thousand in the first half of 2020 to EUR 223 thousand, with product revenue declining from EUR 293 thousand to EUR 210 thousand. In the current pandemic situation, many patients eligible for screening continue to postpone their screenings.
Research and development costs decreased from EUR 2,754 thousand in the prior year to EUR 1,545 thousand in the first half of 2021. The sharp decrease is mainly due to the fact that almost all clinical trials in the U.S.A. are continuing slowly or remain dormant.
Selling, general and administrative expenses decreased from EUR 3,901 thousand to EUR 3,021 thousand.
EBITDA before share-based payment expenses improved to EUR -3,165 thousand in the reporting period, compared with EUR -5,659 thousand in the same period of the previous year.
The net loss for the period was EUR -3,528 thousand (6M 2020: EUR -6,403 thousand); the loss per share decreased significantly from EUR 1.21 to EUR 0.41 compared to the same period of the previous year.
Cash consumption decreased to EUR 4,214 thousand in the first half of 2021 (6M 2020: EUR 5,510 thousand).
As of June 30, 2021, the Company had cash and cash equivalents of EUR 6,949 thousand (December 31, 2020: EUR 3,566 thousand).

OUTLOOK 2021

Revenue

The Company confirms its outlook for fiscal year 2021 and continues to expect revenue within the range of EUR 0.4 million to EUR 1.0 million.
EBITDA / Cash consumption

For EBITDA before share-based payment expenses, Epigenomics forecasts a range of EUR -7.0 million to EUR -9.0 million for full year 2021. Based on the Company’s 2021 business plan, cash consumption is expected to be in line with the EBITDA forecast (before share-based payment expenses).
Further information

The financial report for the first six months of 2021 is available on the Epigenomics’ website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Company’s website following the call.