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    DGAP-News  880  0 Kommentare Epigenomics AG: Epigenomics AG Reports Results for the Financial Year Ended December 31, 2014 and Provides Outlook for 2015 - Seite 3


    2015 is expected to be at a lower level than in 2014 at EUR -10.0 to
    -11.0 million. Efforts to develop the U.S. market for the Company's
    lead product will initially hinder the operating result. In addition,
    expenditures in connection with the current ADMIT trial, as well as a
    post-approval study expected to be mandated as part of the FDA approval
    in the second half of 2015, will also be contributing factors.

    - All business projections for 2015 are based on the approval of Epi
    proColon(R) as an IVD product in the U.S. market around mid-year and
    generation of first revenues during Q3 2015, which are initially
    expected to be at a moderate level. Nevertheless, since the overall
    likelihood and timing of such an approval decision is uncertain,
    efforts to provide the capital markets with a reliable prognosis on the
    Company's earnings situation are hampered. Any delay in the approval
    decision might result in a reduction of the revenue estimate on the one
    side, which would then be compensated by lower additional costs on the
    other.

    - Based on the business plans for 2015, Epigenomics expects an increase
    in cash consumption compared to 2014 to a range between EUR 9.5 and
    10.5 million. For 2016 and the years to come, cash utilization is
    expected to decrease in line with revenue growth.

    - At this projected cash consumption for 2015 and considering possible
    additional cash inflows from conversion premiums of the outstanding
    convertible bonds, current financial resources are sufficient to
    support the Company's operations beyond 2015. Epigenomics is convinced
    that a positive FDA decision will open up further financing options on
    the capital markets and is determined to exercise such options in the
    Company's best interest. The Company will also continue to diligently
    explore all further strategic options.


    Summary of Operational Highlights in 2014

    - Final steps towards Premarket Approval (PMA) for Epi proColon(R): In
    the June 2014 response letter from the FDA with respect to the PMA
    application for Epi proColon(R) it was determined that while the
    studies performed so far had established the clinical performance of
    the test, there was a need for additional data demonstrating that
    Epigenomics' convenient blood-based test will increase compliance to
    CRC screening in the intended use population, compared to those being
    offered a stool-based fecal immunochemical test (FIT). As a
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    DGAP-News Epigenomics AG: Epigenomics AG Reports Results for the Financial Year Ended December 31, 2014 and Provides Outlook for 2015 - Seite 3 DGAP-News: Epigenomics AG / Key word(s): Final Results Epigenomics AG: Epigenomics AG Reports Results for the Financial Year Ended December 31, 2014 and Provides Outlook for 2015 25.03.2015 / 07:30 …