Archives

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: https://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.

Press release

Epigenomics AG: Liquid Biopsy Test for Liver Cancer Detection to obtain CE Mark

– Epigenomics plans to CE Mark mSEPT9 blood test for liver cancer by year-end 2018, enabling commercialization in Europe

– Prospective U.S. trial for FDA submission to be initiated in 2019

– Investigating optimal path for CFDA approval in China

Berlin (Germany) and San Diego, CA (U.S.A.), July 2, 2018 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced it’s plan to CE Mark mSEPT9 blood test by year-end 2018 to 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.

In a recently reported clinical study, the mSEPT9 blood test demonstrated high sensitivity of 90.6 percent at a specificity of 87.2 percent for the indication of liver cancer. Furthermore, the mSEPT9 blood test exhibited higher diagnostic accuracy compared to alpha-fetoprotein (AFP), a widely used serum diagnostic marker for liver cancer.

According to the World Health Organization (WHO), liver cancer is the second most common cause of death from cancer worldwide with Hepatocellular carcinoma (HCC) accounting for 70-90 percent of primary liver cancers (PLC)*. A major risk-factor for developing HCC is liver cirrhosis. Globally, 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.

In Europe, liver cirrhosis is responsible for over 170,000 deaths per year* and Epigenomics estimates approximately three million patients per year in Western Europe are eligible for liver surveillance resulting in a total available market of over one billion Euros per year. Epigenomics is currently evaluating the best potential commercial partnership opportunities for the distribution of the product.

“We are very excited about the opportunity to launch the first liquid biopsy test for liver cancer”, said Greg Hamilton, CEO of Epigenomics AG. “Based on the initial performance data of the test, we are moving forward with CE Marking and prospective clinical studies to capitalize on the opportunity to address this deadly disease.”

*Journal of Hepatology Volume 58, Issue 3 March 2013, Blachier et.al.

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(R), 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.

Press release

Centers for Medicare & Medicaid Services publish preliminary rate for Epigenomics’ colorectal cancer screening test Epi proColon(R)

Medicare Administrative Contractors determine rate of $192 per test

Berlin (Germany) and Germantown, MD (U.S.A.), June 11, 2018 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), announced that the Centers for Medicare & Medicaid Services (CMS) published a preliminary rate of $192 per Epi proColon test. Epi proColon is the first and only FDA-approved blood-based test for colorectal cancer screening.

“The new rate published by CMS is a significant milestone for the company as it appropriately values our innovative blood-based colorectal cancer screening test,” said Greg Hamilton, CEO of Epigenomics AG. “Medicare pricing sets a benchmark for value and is an important component of successful commercialization.”

The publication of the preliminary rate as developed by the Medicare Administrative Contractors is part of the “gapfilling” method to determine the rate for novel tests when no comparable, existing test is available.

Based on the proposed preliminary rate, CMS will determine the final rate. The publication of the final rate to be included in the 2019 Clinical Laboratory Fee Schedule is expected in November 2018.

Parallel to the CMS payment determination process, Epigenomics continues its efforts to gain coverage for Epi proColon either through a National Coverage Determination (NCD) or through legislative action by the U.S. congress.

In March 2018, Senators Shelley Moore-Capito (R -WV) and Martin Heinrich (D – NM), introduced the “Colorectal Cancer Detection Bill” to the United States Senate in Washington D.C. This Senate Bill is parallel to House Bill (H.R. 1578) ”Donald Payne Sr. Colorectal Cancer Detection Act” introduced by Congressman Donald M. Payne, Jr. (D – NJ). These bipartisan initiatives aim to provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests.

About colorectal cancer (CRC)

Colorectal cancer remains the second-leading cause of cancer death in the United States with over 140,000 new diagnosed cases and over 50,000 deaths, annually. Regular screening and early detection of colorectal cancer can save lives: The American Cancer Society projects increasing screening rates from 65% to 80% would prevent 277,000 new cases of colorectal cancer and 203,000 deaths within 20 years.

About Epi proColon

Epi proColon is the first and only FDA-approved blood-based test indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

For more information on Epi proColon, visit www.epiprocolon.com.

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(R), 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 in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

Contact Epigenomics AG
Peter Vogt
Vice President Corporate Communication & Investor Relations
Phone +49 (0) 30 24345 386
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.

Publication of Inside Information according to Article 17 MAR

Centers for Medicare & Medicaid Services publish preliminary rate of $192 for Epigenomics’ colorectal cancer screening test Epi proColon(R)

June 9, 2018 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), announced today that the Centers for Medicare & Medicaid Services (CMS) published a preliminary rate of $192 per Epi proColon test. Epi proColon is the first and only FDA-approved blood-based test for colorectal cancer screening. A press release with further details will be published on Monday, June 11, 2018.

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

Forward-Looking Statements

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.

Publication of Inside Information according to Article 17 MAR

Epigenomics AG: American Cancer Society published its updated colorectal cancer screening guidelines

May 30, 2018 – Epigenomics AG announces that the Company’s blood-based colorectal cancer test Epi proColon(R) is not included in the updated colorectal cancer screening guidelines of the American Cancer Society published today.

The Company will continue to pursue its goal to provide the significant unscreened patient population in the United States access to this innovative, FDA-approved blood-based test for the detection of colorectal cancer.

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

Forward-Looking Statements

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 future 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.