Archives

Epigenomics AG Reports Financial Results for Fiscal Year 2021

• Total revenue of EUR 6.2 million, adjusted EBITDA of EUR -1.8 million
• FDA clinical trial for Epi proColon “Next Gen” expected to start with patient enrollment this summer and to take two years to complete; publication of preliminary data is anticipated
• Company evaluating multiple financing alternatives for the completion of the “Next-Gen” trial

Berlin (Germany) and San Diego, CA (U.S.A.), March 24, 2022 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the “Company”) today reported financial results (according to IFRS) for fiscal year 2021.

OPERATIONAL DEVELOPMENTS

• In 2021, Epigenomics started preparations for the FDA clinical trial for the Company’s Epi proColon “Next-Gen” test. Epigenomics expects to start enrollment this summer. The study will require approximately 16,000 participants and will take about two years to complete. If the test receives FDA approval and meets the criteria for blood-based colorectal cancer screening tests set by the Centers for Medicare and Medicaid Services (CMS) – which Epigenomics is confident of – Epi proColon “Next-Gen” will be automatically reimbursed by CMS. The Company will focus its efforts on the activities required to bring Epi proColon “Next-Gen” to market.
• Until the FDA approval of Epi proColon “Next-Gen”, Epigenomics still has the opportunity to obtain CMS reimbursement for its current test Epi proColon via legislation. Recently President Biden announced a reignition of the Cancer Moonshot, a program launched in 2016 with the mission to accelerate the rate of progress against cancer. The passage of a bill to reimburse a blood test for CRC screening would serve the program’s target as well as two other core goals of the Biden administration: Fighting racial healthcare discrimination and the COVID-19 pandemic, since CRC affects a disproportionate number of People of Color, and the pandemic has significantly reduced CRC screening participation rates in the U.S. As promising as the initiative is, it is currently impossible to make a reliable statement on whether a relevant bill will be passed.
• In 2021, the Company has also focused on maximizing its financial position to enable the development of the Epi proColon “Next-Gen” test. In this context, cost-cutting measures were initiated, the sale of a non-essential portion of the Company’s biobank as well as the issuance of convertible bonds in the amount of EUR 22.0 million have strengthened the balance sheet and given Epigenomics the ability to move forward with the FDA trial in 2022. However, the Company will need to raise additional capital to complete the trial and the subsequent FDA approval. The Company is evaluating numerous financing alternatives including exchanges with more potential access to capital.
• The Executive Board has added two new members. President and Chief Scientific Officer Andrew Lukowiak, Ph.D., started as President and Chief Scientific Officer in December 2021 and Jens Ravens has taken over the CFO position in February 2022. The Executive Board looks forward to working together and is convinced that Epigenomics is well positioned to master the challenges to achieve the Company’s goals.

Greg Hamilton, CEO of Epigenomics AG: “We are excited about the future of Epigenomics and see our improved Epi proColon “Next-Gen” test as a major untapped opportunity in the cancer screening market. We expect to initiate the clinical trial this summer and to publish preliminary data for the “Next-Gen” test. We believe our blood based “Next-Gen” will be a cost-effective solution in the market.”

Financial results 2021

• Total revenue increased to EUR 6.2 million (2020: EUR 0.8 million), mainly due to the sale of the blood sample database (“biobank”) in August 2021. In contrast, revenues from Epigenomics’ test kits remained low both in the U.S.A. and in Europe, amounting in total in the fiscal year to EUR 0.4 million (2020: EUR 0.6 million) in line with the expectations, due to the pandemic-related reduction of patient office visits.
• Selling, general and administrative costs in the amount of EUR 7.5 million remained roughly equivalent to previous year’s level of EUR 7.3 million and is inclusive of the costs related to the biobank sale.
• EBITDA (before share-based payment expenses) improved to EUR -1.8 million (2020: EUR -10.5 million) and exceeded the forecast of EUR -3.0 million adjusted in the third quarter due to currency effects.
• The net loss for the year fell to EUR -2.4 million (2020: EUR -11.7 million); the loss per share also decreased to EUR -0.22 (2020: EUR -2.02).
• Cash consumption improved to EUR -4.2 million in fiscal year 2021 compared to EUR -9.6 million in 2020.

Outlook 2022

Revenue

• As the Company is not currently actively marketing Epi proColon due to the lack of CMS reimbursement, Epigenomics estimates its 2022 revenue between EUR 0.3 million and EUR 0.8 million. If Medicare reimbursement is indeed achieved via legislation in 2022, the Company is likely to amend the revenue forecast.

EBITDA / Cash consumption

• For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR -15.0 million to EUR -17.0 million. This assumes that the Company initiates the Epi proColon “Next-Gen” trial in the summer of 2022. If this trial is delayed or enrollment is slower than anticipated then the forecast for the adjusted EBITDA is likely to improve. The anticipated spend for the clinical trial in 2022 will be aligned with the Company’s ability to raise funds for the remainder of the trial in 2023 and 2024.

Further information

The Annual Report 2021 is available on the Epigenomics website at: 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) / 11.00 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 69 6677 38007
Dial-in number UK: +44 20 3872 0883
Dial-in number U.S.A.: +1 516-269-8979

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 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 and Europe as well as other selected countries. 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 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.

Supervisory Board of Epigenomics AG Retains Greg Hamilton as Chief Executive Officer Through Development of Epi proColon “Next-Gen” Colorectal Cancer Screening Test

• Greg Hamilton retained as CEO through 2025
• Appointment underscores Epigenomics’ commitment to the company’s enhanced blood-based colorectal cancer screening test, Epi proColon “Next-Gen”, which provides a large untapped opportunity in the cancer screening market

Berlin (Germany) and San Diego, CA (U.S.A.), January 24, 2022 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced today that the Supervisory Board retained Greg Hamilton as Chief Executive Officer through December 31, 2025. Mr. Hamilton has been CEO of Epigenomics AG since mid-2016 and will continue to lead the company through the development, FDA approval and commercialization of the company’s Epi proColon “Next-Gen” Colorectal Cancer (CRC) screening test.

Mr. Hamilton, (51), has been instrumental in working with Centers for Medicare and Medicaid Services (CMS) to establish clear reimbursement requirements for future blood-based CRC tests. Based upon the efforts of Epigenomics, CMS has issued a National Coverage Determination (NCD) for blood-based CRC screening that gives Epigenomics a clear path to develop a commercially successful next generation product. Prior to joining Epigenomics, Mr. Hamilton was Chief Executive Officer & Director of AltheaDx Inc., Chief Operating Officer and Chief Financial Officer of Enigma Diagnostics Inc., Vice President of Operations and Finance at Third Wave Technologies Inc. and Vice President of Operations at Hologic Inc. He has been responsible for multiple FDA-approved products including a Human Papillomavirus (HPV) High Risk Screening assay and the first ever cleared HPV genotyping assay. Mr. Hamilton received his MBA from the University of Chicago and his Bachelor of Science in Finance from Purdue University.

“Securing Greg’s leadership through the development, clinical trial, FDA approval and commercialization of Epi proColon’s “Next-Gen” CRC test, which has already advanced substantially since mid of last year, was a priority for the Supervisory Board,” said Heino von Prondzynski, Chairman of the Supervisory Board. “His experience and strategic vision make him ideally suited to grow the company into a cancer diagnostics leader.”

“I’m thrilled and honored to continue to lead Epigenomics toward our goal of becoming a leader in blood-based CRC screening,” said Mr. Hamilton. “Epigenomics has always been a pioneer in liquid biopsy and now we get the chance to use all of our experience to deliver a product that will immediately receive reimbursement upon FDA approval.”
 

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 and Europe as well as other selected countries. 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 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.

Supervisory Board of Epigenomics AG appoints Jens Ravens as Chief Financial Officer

• Jens Ravens is an internationally experienced leader with in-depth experience in Controlling, Finance, M&A, IT, Legal, and Human Resources
• New Chief Financial Officer to join Epigenomics on February 1, 2022

Berlin (Germany) and San Diego, CA (U.S.A.), December 14, 2021 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”), an oncology focused molecular diagnostics company, announced today that the Supervisory Board appointed Jens Ravens as Chief Financial Officer with effect from February 1, 2022. Jens Ravens, who has extensive financial executive experience will become a member of the Executive Board of Epigenomics and oversee the company’s financial and administrative functions.

Jens Ravens (52) has over 20 years of management experience in finance in various European companies. Prior to joining Epigenomics, Jens held several positions at the Hermes Group, Hamburg, part of the OTTO Group, predominantly as Vice President Controlling & Finance as well as Compliance & Risk Management Officer. There he had the financial responsibility for subsidiaries and national companies as well as cost responsibility and profit control responsibility. Previously, he was CFO and Managing Director at Pleon Germany in Düsseldorf and concurrently also served as CFO of Pleon Europe in London. Prior to that Jens worked as Finance Director and Member of the Executive Board at Interseroh CDI S.A. in Paris, France. He started his career at Deutsche Bank, where he worked in Equity Sales / Investment Banking. Jens Ravens holds a bilingual business degree (lic.rer.pol.) with distinction from University of Fribourg, Switzerland, and completed the advanced management programme at INSEAD, Fontainebleau, France.

Heino von Prondzynski, Chairman of the Supervisory Board: “We are very pleased to have Jens join Epigenomics AG as CFO with his in-depth management experience as well as his extensive expertise in finance. We are confident Jens will provide the financial leadership necessary to execute the company’s strategic vision.”

“I am looking forward to becoming part of the Epigenomics team,” said Jens Ravens. “Epigenomics has a tremendous opportunity ahead and I’m excited to play a leadership role in such an innovative organization.”

During the transition period, the current EVP Finance, Albert Weber, will continue to support the company as an advisor, as announced.
 

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 and Europe as well as other selected countries. 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 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.