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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
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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