DGAP-News: Epigenomics AG Announces 2018 Second Quarter and Six Month Financial Results

Press release

Epigenomics AG Announces 2018 Second Quarter and Six Month Financial Results

Berlin (Germany) and San Diego, CA (U.S.A.), August 8, 2018 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) today announced its financial results for the second quarter and the first six months 2018 ending June 30.

"While we continue to pursue our objective of Medicare coverage for Epi proColon(R) in the U.S., we are moving forward with our innovative liver cancer surveillance test", said Greg Hamilton, CEO of Epigenomics AG. "Based on the recently published excellent clinical data, this new blood-test could provide the next major opportunity for our company. Obtaining CE mark by year-end will be a key milestone for the product."

Q2/6M 2018 Financial Results

- Total Q2 2018 revenue increased to EUR 0.5 million (Q2 2017: EUR 0.2 million) and 6M 2018 revenue grew to EUR 0.8 million (6M 2017: EUR 0.5 million) due to higher revenue in the United States and license payments made by our partner in China.

- Product revenue in Q2 2018 increased by 65% to EUR 0.3 million (Q2 2017: EUR 0.2 million). In the six month period 2018, product revenue increased by 56% to EUR 0.4 million (6M 2017: EUR 0.2 million).

- Adjusted for non-cash expenses related to share-based payment expenses, EBITDA in Q2 2018 was at EUR -2.2 million (Q2 2017: EUR -3.4 million); adjusted EBITDA for 6M 2018 amounted to EUR -5.4 million (6M 2017: EUR -5.8 million). The lower EBITDA loss is mainly due to increased revenue and lower SG&A expenses.

- Net loss amounted to EUR 2.6 million in Q2 2018 compared to EUR 4.1 million in Q2 2017, and EUR 5.8 million for 6M 2018 (6M 2017: EUR 6.5 million). Net loss per share for Q2 2018 decreased to EUR 0.11 (Q2 2017: EUR 0.18) and for 6M 2018 to EUR 0.24 (6M 2017: EUR 0.28).

- Cash consumption (cash outflow from operating and investing activities) was EUR 4.2 million in 6M 2018 compared to EUR 4.7 million in 6M 2017.

- Liquid assets (including marketable securities) amounted to EUR 9.4 million at the reporting date (December 31, 2017: EUR 13.7 million).

Operational highlights

- Centers for Medicare & Medicaid Services published preliminary rate for Epigenomics' colorectal cancer screening test Epi proColon: The Centers for Medicare & Medicaid Services (CMS) published a preliminary reimbursement rate of $192 per Epi proColon test. Based on the proposed preliminary rate, CMS will determine the final rate. The publication of the final rate is expected in November 2018.

- Blood test shows promise in the detection of liver cancer: Results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrated high accuracy of Epigenomics' proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis. In the studies, the mSEPT9 test exhibited higher diagnostic accuracy than the currently established diagnostic marker. A further independent, prospective clinical study with 440 patients was initiated.

- Liquid biopsy test for liver cancer detection to obtain CE mark: Epigenomics announced it's plan to CE mark the mSEPT9 blood test by year-end 2018 as an aid in detecting liver cancer among patients with cirrhosis. In 2019, the Company also plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China. Epigenomics estimates the liver cirrhosis surveillance market to be in excess of 10 million tests per year making it more than a three billion Euro market opportunity globally.

Outlook 2018 confirmed

- The Company confirms the outlook for the financial year 2018 as provided in its Annual Report 2017.

- Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

- We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.

Further Information

The interim report for the first six months 2018 can be downloaded from Epigenomics' website at: http://www.epigenomics.com/news-investors/financial-reports/

Conference call for analysts and investors

The Company will host a conference call and webcast at 2.30 pm CET / 8.30 am EDT, today. The presentation can be followed on the Company's website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531428
UK: +44 1635 598060
USA: +1 516-269-8983

The webcast will be made available on: https://em-tn.meetyoo.de/?token=0lRCiuCDGsI%3D&lang=en

An audio replay of the conference call will be provided on Epigenomics' website subsequently.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics' lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R), a blood-based test for lung cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact:
Epigenomics AG, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, E-Mail: ir@epigenomics.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any expected results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.