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Epigenomics AG Reports Financial Results for Fiscal Year 2019 and Preliminary Unaudited Financial Results for the First Quarter of 2020

Berlin (Germany) and San Diego, CA (USA), April 29, 2020 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the “Company”) today reported financial results (according to IFRS) for the fiscal year 2019. In addition, the Company announces preliminary unaudited financial results for the first quarter of 2020.
 

HIGHLIGHTS

• At the end of November 2019, a microsimulation model developed by scientists at Harvard Medical School was published in the journal Cancer Medicine. The results show that patient adherence and screening intervals are decisive factors in a successful colorectal cancer (CRC) screening strategy. When these factors are incorporated into the evaluation of various CRC screening measures, blood tests can play a significant role in reducing the incidence and mortality of colorectal cancer.
• On February 28, 2020, the Centers for Medicare and Medicaid Services (CMS) opened the National Coverage Determination (NCD) review of Epi proColon, a further significant milestone for Epigenomics AG on its way to U.S. reimbursement by CMS. With the NCD opening, CMS is required by legal statute to publish a decision on the reimbursement of Epi proColon within a maximum period of nine months, i.e. no later than November 28, 2020. A positive reimbursement decision would be a major breakthrough for the marketing of the blood test in the U.S. market.
• To finance its ongoing operations, Epigenomics successfully completed a capital increase by way of a private placement on March 31, 2020. The new shares were fully subscribed by institutional investors from Germany and the U.S.A. The gross proceeds of the capital increase amount to approximately EUR 4.0 million and, together with cost reduction measures initiated in connection with the Covid-19 pandemic, will ensure that the Company will have sufficient liquid funds well into Q1 2021.
• The US-American National Comprehensive Cancer Network (NCCN) announced on April 23, 2020 that it has included Epi proColon in its updated 2020 NCCN CRC guidelines. Inclusion in the guidelines underscores the potential of Epi proColon to significantly increase screening rates and thereby reach the over 30 million Americans who are at risk for colorectal cancer but do not participate in screening.

Greg Hamilton, CEO of Epigenomics AG: “We have made tremendous progress in the last six months towards Medicare reimbursement, the key prerequisite for full commercialization of Epi proColon. In November, a pivotal microsimulation model was published demonstrating the effectiveness of Epi proColon and in February, CMS initiated its national coverage determination process for the test. In addition, the NCCN CRC screening guidelines were updated to include Epi proColon in a manner consistent with our FDA indications for use as an option for patients who refuse other screening modalities. We believe this positive momentum will culminate in a positive coverage decision later this year.”
 

Financial results 2019

• Total revenue decreased to EUR 1.1 million (2018: EUR 1.5 million), mainly due to the decrease in licensing revenue from China. Product revenue increased to EUR 1.0 million from EUR 0.8 million in 2018.
• Selling, general and administrative costs increased from EUR 8.7 million (2018) to EUR 8.9 million, mainly due to greater expenses for sales and marketing. Research and development costs rose from EUR 6.4 million (2018) to EUR 7.3 million, largely because of external costs that arose in connection with carrying out the post-approval study for Epi proColon and the HCC cross-section study in the U.S.A.
• The decline in EBITDA (before share-based payment expenses) to EUR -13.3 million (2018: EUR -11.4 million) was mainly caused by temporary cost increases in connection with the clinical studies and non-cash expenses.
• The net loss for the year increased to approximately EUR -17.0 million (2018: EUR -12.7 million) and was impacted by a one-off non-cash expense of EUR 2.5 million; the loss per share decreased slightly to EUR -0.46 (2018: EUR -0.47).
• Cash consumption rose to EUR -13.5 million in fiscal year 2019 (2018: EUR -9.6 million) due to higher operating cash outflows. Furthermore, the prior-year figure was buoyed by a stronger effect from working capital that no longer applied in the reporting period.
   

Preliminary financial results Q1 2020

• Based on preliminary unaudited figures, Epigenomics AG generated revenues of EUR 0.2 million in the first quarter of 2020 (Q1 2019: EUR 0.3 million).
• EBITDA (before share-based payment expenses) improved slightly from EUR -3.0 million (Q1 2019) to EUR -2.6 million.
• The net loss for the period also improved slightly from EUR -3.0 million (Q1 2019) to EUR -2.9 million.
• Cash consumption decreased by EUR 1.0 million to EUR -3.3 million (Q1 2019: EUR -4.3 million).
   

Outlook 2020

Revenue

• The Company expects revenue for the fiscal year 2020 within the range of EUR 1.0 million to EUR 2.0 million.

EBITDA / Cash consumption

• Epigenomics’ EBITDA (before share-based payment expenses) is expected to range from EUR -10.5 million to EUR -12.5 million. Based on the Company’s business plan 2020, cash burn is expected to be in line with EBITDA guidance (before share-based payment expenses).
   

Further Information

The Annual Report 2019 is available on the Epigenomics website:
https://www.epigenomics.com/news-investors/financial-reports/. The Interim Statement for the first quarter 2020 will be published on May 7, 2020 on the Company’s website.
 

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 3.00 pm (CET) / 9.00 am (EDT). The webcast can be accessed on the Company’s website: https://www.epigenomics.com/news-investors/financial-reports/

The dial-in numbers for the conference call are:

Dial-in number Germany: +49 30 8687 1428
Dial-in number UK: : +44 1635 598061
Dial-in number U.S.A.: +1 516 269 8974

Participants are kindly asked to dial in 10 minutes prior to the start of the call.

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

About Epigenomics
Epigenomics AG is a molecular diagnostics company focused on blood testing for the early detection of cancer. Based on its proprietary biomarker technology for the detection of methylated DNA, Epigenomics develops and markets blood tests for various cancer indications with high unmet medical need. Epigenomics’ lead product is the blood test Epi proColon(R) for the early detection of colorectal cancer. Epi proColon is approved by the U.S. Food and Drug Administration (FDA) and is marketed in the United States, Europe, China and other selected countries. Epi proLung(R), a blood test for the detection of lung cancer, and HCCBloodTest, a blood test for the detection of liver cancer, have received the CE Mark for marketing in Europe.

For further information please visit www.epigenomics.com.
 

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 BerlinTel
+49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: ir@epigenomics.com.

Note on forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.

Epigenomics AG: Epi proColon included in 2020 National Comprehensive Cancer Network Colorectal Cancer Screening Guidelines

Berlin (Germany), April 24, 2020 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”) announced that Epi proColon, the first and only FDA-approved blood-test for colorectal cancer (CRC) screening, has been included in the 2020 National Comprehensive Cancer Network (NCCN) CRC Guidelines.

NCCN updated their 2020 CRC guidelines in a manner consistent with Epi proColon’s (Septin9) FDA-approved indications. The new NCCN guidelines state that although the mSEPT9 blood test is “not recommended for routine screening”, it however “can be considered for patients who refuse other screening modalities”. Epi proColon’s FDA approved indications for use are the following:

The Epi proColon test is indicated to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined prior to offering the Epi proColon test. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results should be used in combination with physician’s assessment and individual risk factors in guiding patient management.

“We are pleased with the inclusion of Epi proColon in the 2020 NCCN guidelines in close alignment with the blood test’s FDA-approved intended use,” stated Epigenomics CEO Greg Hamilton. “NCCN’s latest guideline update further highlights the significant opportunity to address the over 30 million Americans who currently do not participate in CRC screening. We believe Epi proColon has the potential to significantly increase the screening rates and most importantly save lives.”

Epigenomics AG looks forward to future NCCN guidelines to include key data such as an annual recommendation for the test interval, which could be based on outcomes from the recently published microsimulation paper (D’Andrea et.al. epub – Nov. 2019 – Cancer Medicine. 2020; 9:824.), which was not referenced by the 2020 NCCN guidelines. These data demonstrate that annual Septin9 screening results in comparable long-term benefits and less harms as compared to the “gold standard” colonoscopy every ten years. The Cancer Medicine publication was not included as part of this latest 2020 NCCN guideline as it was published shortly after their literature review cut-off date and subsequent panel review meeting.

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 selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, have received CE mark in Europe.

For more information, visit www.epigenomics.com.
 

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin

Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: ir@epigenomics.com

Note on forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.