Archives

CMS Still Actively Working on Proposed Decision Memo with Goal to Publish As Soon As Possible

Berlin (Germany) and San Diego, CA (USA), August 31, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the Centers for Medicare & Medicaid Services (CMS) did not issue the proposed decision memo for its National Coverage Analysis (NCA) for Screening for Colorectal Cancer with Blood-Based Biomarker Tests by the statutory due date of August 28, 2020. CMS is actively working on the decision, and its goal is to publish the decision as soon as possible.

“While we are disappointed CMS did not meet its statutory timeline, we recognize the agency’s resources are stretched because of the pandemic,” said Greg Hamilton CEO of Epigenomics. “We remain confident that CMS will issue a positive proposed decision based upon the clinical evidence and are hopeful the agency will publish it as quickly as possible.”
 

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, and HCCBloodTest, a blood-based test for liver cancer detection in cirrohtic patients, 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

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.

Epigenomics AG presents operational highlights and reports financial results for first six months of 2020

Berlin (Germany) and San Diego, CA (U.S.A.), August 13, 2020 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the “Company”) today reported operational highlights and financial results for the second quarter and first half of 2020.

Operational highlights

• In late February 2020, the Centers for Medicare and Medicaid Services (CMS) initiated the National Coverage Determination (NCD) review process on Epi proColon. This milestone will result in a proposed NCD by August 28 and a final reimbursement decision by the end of November. The public response during the initial 30-day public comment period in March was overwhelmingly positive. Epigenomics’ management is confident that the public support combined with the results of the microsimulation model and the major FDA approval studies will lead to a positive reimbursement decision.
• Moreover, the National Comprehensive Cancer Network (NCCN) – a major medical society in the U.S.A. – included Epi proColon in April 2020 in its colorectal cancer (CRC) guidelines. The inclusion of Epi proColon in accordance with FDA-approved indications underlines the blood test’s potential to significantly increase CRC screening rates in the U.S.A.
• A study published last week in the Journal of the National Cancer Institute (JNCI) concluded that Epi proColon(R) is the test of choice for the millions of individuals not willing to participate in FIT or colonoscopy screening. Annual mSEPT9 screening resulted in more Quality-adjusted-life-years gained (QALYG), CRC cases averted and CRC deaths averted than both annual FIT screening and Cologuard(R) every three years, albeit at a higher colonoscopy referral rate.
• As a result of the capital increase successfully completed at the end of March and the cost-cutting measures taken in connection with the ongoing Covid-19 pandemic – including reduction in Executive Board and Supervisory Board compensation – the Company had sufficient cash and cash equivalents at the end of June 2020 to finance the Company well into the first quarter of 2021.

Greg Hamilton, CEO of Epigenomics AG commented: “With the recent JNCI study publication adding the robust body of evidence supporting Epi proColon we are eagerly anticipating the upcoming NCD publication within the next two weeks. CMS has indicated they are on track to issue the decisions on time despite the Covid 19 pandemic. With the upcoming reimbursement proposal at the end of August and the final decision by the end of November 2020, we are closer than ever to our major goal of CMS reimbursing Epi proColon. A positive reimbursement decision would be the breakthrough for our Company and we are confident that CMS will recognize the contribution that Epi proColon can make to the fight against colorectal cancer and thus will decide in the best interest of patients.”

6M 2020 financial results

• Total revenue in the first six months of 2020 decreased by 53% to EUR 322 thousand (6M 2019: EUR 679 thousand) compared to the same period of the previous year, due to the effects of Covid-19 in the second quarter. Epigenomics experienced significant decline in April and May but has seen a recovery in June and July. Product revenue fell from EUR 660 thousand in the first half of 2019 to EUR 293 thousand in the reporting period.
• Research & development costs declined from EUR 3,867 thousand in the prior year to EUR 2,754 thousand. The decrease was mainly driven by the Covid-19 interruption of almost all clinical studies in the U.S.A., specifically the post-approval study for Epi proColon.
• Selling, general and administrative costs also decreased by EUR 958 thousand to EUR 3,901 thousand (6M 2019: EUR 4,859 thousand) in the reporting period, due to the reduction in sales and marketing activities, as virtually all relevant events such as conferences and trade fairs were cancelled due to the pandemic.
• Overall, operating costs fell from EUR 9.4 million to EUR 7.4 million compared to the first half of the previous year due to the impact of Covid-19 and the Company’s subsequent cost reduction measures.
• Adjusted EBITDA (before share-based payment expenses) for the first six months of 2020 was EUR -5.7 million (6M 2019: EUR -7.2 million).
• The net loss for the period improved to EUR 6.4 million (6M 2019: EUR 7.4 million); the loss per share was EUR 0.14 (6M 2019: EUR 0.21). This was also impacted by the increased number of shares resulting from the capital increases executed in the second half of 2019 and in March 2020.
• The cash outflow from operating activities fell significantly in the first half of 2020 by EUR 2.3 million to EUR 5.5 million (6M 2019: 7.8 million). This is due to both the improved operating result (EBIT) and changes in current assets.
• As of June 30, 2020, the Company had cash and cash equivalents of EUR 8.7 million (including marketable securities) compared to EUR 11.0 million at the end of 2019.

Outlook 2020:
Revenue / EBITDA / Cash consumption

• Due to the continued uncertainty surrounding the effects of Covid-19, and like many publicly traded companies, Epigenomics AG is pulling its revenue guidance for 2020, however, the Company maintains its previous, adjusted EBITDA (before share-based payment expenses) guidance of between EUR -10.5 million to EUR -12.5 million and cash consumption guidance in a range of EUR 10.5 million to EUR 12.5 million.

Further Information

The financial report for the first six months of 2020 is available on the Epigenomics website: https://www.epigenomics.com/news-investors/financial-reports/.

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 presentation 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 30 232 531 366
Dial-in number UK: +44 1635 598 061
Dial-in number U.S.A.: +1 516-269-8983

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 Company’s 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, Phone +49 221 9140 970, e-mail: ir@epigenomics.com

Note on future-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.

New study published in the Journal of the National Cancer Institute concludes that Epi proColon(R) is the test of choice for the millions of individuals not willing to participate in FIT or colonoscopy screening

• Under the primary base case analysis, annual mSEPT9 screening resulted in more Quality-adjusted-life-years gained (QALYG), CRC cases averted and CRC deaths averted than both annual FIT screening and Cologuard(R) every three years, albeit at a higher colonoscopy referral rate
• Annual Epi proColon was found to be more cost-effective than Cologuard under all five modeling scenarios analyzed

Berlin (Germany) and San Diego, CA (U.S.A.), August 10, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that a study published by the NCI-sponsored cancer intervention and surveillance modeling network (CISNET) in the Journal of the National Cancer Institute reported that by comparing the incremental cost-effectiveness of CTC, PillCam, mtSDNA (Cologuard) and mSEPT9 (Epi proColon), the study revealed that of these CRC screening alternatives annual screening with Epi proColon is cost-effective. Annual screening with Epi proColon had an incremental cost-effectiveness ratio (ICER) of $63,253 per QALYG. Other efficient strategies were CTC screening every 5 years (ICER: $1,092 per QALYG) and annual (but not every three years) mtSDNA screening (ICER: $214,974 per QALYG), which were not optimal given the willingness-to-pay threshold ($100,000 per QALYG).

Jorge Garces, President and CSO of Epigenomics AG: “CISNET microsimulation models are the gold-standard by which the American Cancer Society (ACS), United States Preventative Services Task Force (USPSTF), and other clinical societies base their guideline recommendations for CRC screening. This study supports the findings from another recent study published in Cancer Medicine and adds to the mounting evidence indicating that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer as effectively or better than other approved methods and most importantly highlights the opportunity for the Epi proColon blood test to serve as the test of choice for those currently resistant to colonoscopy and stool-based screening methods.”

The JNCI publication analyzed the clinical effectiveness and performance of various screening strategies under five different scenarios:

1. Screening from age 50 through 75 years in an-average risk population, with perfect adherence to screening, diagnostic follow-up and surveillance recommendations.

2. Assuming screening from age 45 to age 75 with outcomes presented per 1,000 45-year olds at 100% adherence.

3. Using the model version that was used to inform the 2016 USPSTF screening guidelines, in which screening starts at 50 years of age and does not account for the increasing incidence. 100% adherence assumed.

4. Assuming that 90% of the people that participated in a previous round would participate in a subsequent round, and 15% of the people that did not participate in the previous round would participate in the subsequent round. An 80% adherence to diagnostic follow-up and surveillance was assumed.

5. Assuming 12% of advanced adenomas and 18% of colorectal cancers are systematically missed by the mSEPT9.

Under all scenarios examined, annual Epi proColon was more cost-effective than Cologuard. The authors also conclude that ultimately, the best test is the “one that gets done”.

Greg Hamilton, CEO of Epigenomics AG: “This is an important publication as it further validates the clinical and cost-effectiveness of Epi proColon. It is also timely as we await the preliminary National Coverage Determination (NCD) from CMS later this month”.

As the JNCI authors clearly state: “A well-established microsimulation model demonstrates that for people who are unwilling to be screened with FIT or colonoscopy, annual screening with the mSEPT9 is the test of choice given its cost-effectiveness profile compared to CTC, PillCam and mtSDNA.”

Epigenomics will hold a conference call on Tuesday August 11, 2020 at 9:30am ET (3:30pm CET) to discuss the publication in more detail and answer questions. Please use the link in the Financial Calendar on the Epigenomics.com website to join the conference call.
 

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, and HCCBloodTest, a blood-based test for liver cancer detection in cirrohtic patients, 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

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.