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Epigenomics AG. (2/26/14). "Press Release: Epigenomics AG Reports Preliminary Results and Highlights for the Year Ended December 31, 2013". Berlin & Germantown, MD.

Organisations Organisation Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY)
  Group Epigenomics (Group)
  Organisation 2 Team Curis (Group)
Products Product Epi proColon® blood test
  Product 2 Epi proLung BL Reflex Assay
Persons Person Taapken, Thomas (Medigene 201701–201808 CFO before Epigenomics + Biotie/elbion + DVC + Burrill + Hoechst LEFT 8/18)
  Person 2 Zeise, Antje (Epigenomics 201112 Manager IR | PR)

> Revenue improved by 53% to EUR 1.6 million (2012: EUR 1.0 million)

> Net loss reduced by 39% to EUR 7.4 million (2012: EUR 12.2 million) through cost reductions; cash consumption of EUR 6.5 million reduced by 40% (2012: EUR 10.9 million)

> Decisive steps forward in PMA application of Epi proColon®; FDA advisory committee panel meeting scheduled for March 26, 2014

> Key agreements for commercialization in the U.S. and China signed in 2013

> Raised EUR 12.5 million in 2013, liquidity of EUR 8.0 million at year end

Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced preliminary financial results for the fiscal year ending December 31, 2013. The complete annual report including an outlook for 2014 will be released as planned, on March 28, 2014.

Dr. Thomas Taapken, CEO/CFO of Epigenomics, commented: "We are excited to finally be approaching the potential U.S. approval for our key value driver, the innovative and convenient blood-based colorectal cancer (CRC) screening assay, Epi proColon®. Activities towards this goal clearly determined our efforts over the past year. During 2013, we successfully established a framework of partnerships in order to commercialize the product following potential regulatory approval in the U.S. and to develop new markets, for example China. Lastly, we improved our financial position, after raising EUR 12.5 million in 2013. As we stand today, 2014 will become the decisive year for our Company and it is our view that we can bring sustainable value to our shareholders through product launches in major markets."

Summary of Operational Highlights in 2013

> Premarket approval (PMA) review proceeds towards potential U.S. approval of Epi proColon®: PMA submission completed, priority review status granted and Food and Drug Administration (FDA) advisory committee review panel convened to discuss PMA application and to receive expert guidance on Wednesday, March 26, 2014. Committee to provide non-binding recommendation to the FDA immediately at this meeting.

> Joint commercialization agreement signed with Polymedco, the U.S. market leader in the field of CRC screening products: over 1,500 established customers in the CRC screening sector and exclusively CRC-dedicated sales force. Alliance will enable an accelerated commercial roll-out in the U.S. after a potential approval. Efforts underway to achieve inclusion in major cancer screening guidelines and assure favorable reimbursement post approval from key U.S. payors.

> Broad strategic collaboration signed with BioChain, a leading clinical diagnostics company in China. BioChain acquired an exclusive license to develop and commercialize Septin9 tests for CRC screening in China. Major clinical trial initiated to validate Septin9 assay with the goal to gain market approval by the Chinese Food and Drug Administration (CFDA). 5,000 Epi proColon® tests ordered. BioChain and its owners also invested USD 1.3 million into Epigenomics.

> MACSF became the second healthcare provider in France to reimburse Septin9 tests: MACSF is the leading French supplementary insurance provider with about 800,000 policy holders from the medical community and their families. Overall, a moderate but steady uptake of Epi proColon® has been observed in Europe with a clear trend towards centralization of testing by fewer laboratories that are increasingly ordering larger numbers of tests.

> Epi proLung® starting to gain more attention: Licensing and supply agreement for lung cancer diagnostic test Epi proLung® BL assay signed in early 2014 with Kindstar, the largest Chinese company for clinical diagnostics tests.

> Successful 2013 financings: Throughout 2013, Epigenomics raised EUR 12.5 million in gross proceeds through the issuance of shares and convertible securities to finance its operations beyond potential FDA approval of Epi proColon® and to build and strengthen its distribution capacities for the market launch in the U.S.

> Level 1 American Depositary Receipt (ADR) program established to meet growing investor interest in the U.S. and to broaden shareholder base. Epigenomics' ADRs meanwhile trading on OTCQX International (reserved for high quality non-US companies) since January 2014.

Preliminary Financial Review 2013

> In 2013, Epigenomics' revenue rose by 53% to approximately EUR 1.6 million from EUR 1.0 million in 2012. Driven by increased product revenue of EUR 0.6 million (2012: EUR 0.4 million), resulting from the new strategic collaboration with BioChain in China as well as R&D service fees, which also exceeded expectations and rose to EUR 0.5 million in 2013 (2012: EUR 0.2 million).

> The higher proportion of product sales versus licensing income compared to last year was the main reason for a decline in gross margin from 72.0% in 2012 to 69.4% in 2013, as cost of sales increased year on year from EUR 0.3 million to EUR 0.5 million. However, gross profit rose to EUR 1.1 million from EUR 0.7 million in 2012.

> Total operating costs strongly decreased by 33% to EUR 9.5 million (2012: EUR 14.1 million). The decrease was driven by research and development ("R&D") costs, which declined significantly to EUR 4.4 million in 2013 from EUR 8.0 million in 2012, when the execution of the FIT comparison study expanded the Company's operating activities. In the absence of a comparable study in 2013 and with a slightly reduced R&D headcount compared to 2012, costs for materials and consumables, for staff and various external services could be reduced significantly. Furthermore, selling, general and administrative ("SG&A") costs decreased from EUR 5.5 million in 2012 to EUR 4.5 million in 2013, mainly due to a sharp decrease in personnel costs. Pre-commercialization activities prior to the market entry of Epi proColon® in the U.S. were one of the drivers of these costs alongside the various financing measures executed and the fact that headcount reductions in previous years had to be compensated by external services to a greater extent.

> In 2013, operating loss (EBIT) amounted to EUR 7.3 million (2012: EUR 12.1 million). Net loss amounted to EUR 7.4 million - a 39% improvement compared to the previous year (EUR 12.2 million) and in line with the guidance in the range of 6.5-7.5 million provided at the beginning of the year. This equals a loss per share of EUR 0.62 (2012: EUR 1.38).

> Cash consumption in 2013 amounted to EUR 6.5 million (2012: EUR 10.9 million) and was at the lower end of Epigenomics' 2013 prognosis (EUR 6.5-7.5 million). Due to net cash inflows from financing activities of EUR 11.5 million, net cash flow added up to EUR 5.0 million.

> The Company's liquidity including marketable securities at the end of 2013 amounted to EUR 8.0 million (2012: 2.7 million). This should give the Company enough buffer time to be fully operational until the expected FDA approval for Epi proColon®, probably in the second quarter of 2014, and possibly beyond.

Further information

Condensed versions of the preliminary FY 2013 consolidated financial statements can be downloaded from Epigenomics' website at:

The complete Annual Report 2013, which will be released on March 28, 2014, can be obtained from Epigenomics' website at:

On March 28, 2014, Epigenomics will host a conference for journalists, analysts and investors in Frankfurt/Main in German language followed by a conference call in English language. Details of both events will be made available prior to March 28, 2014 on Epigenomics' website at



Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel. +49 (0) 30 24345 368

For US press inquiries:

Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876

About Epigenomics

Epigenomics ( is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company's products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics' lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is under regulatory review by the FDA for the U.S.A. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung®, in Europe. The Company's technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics' legal disclaimers. 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.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.

Record changed: 2017-04-02


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