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Epigenomics AG: Epigenomics AG Announces H1 2014 and Q2 2014 Financial Results and Reports on Operational Highlights - Seite 2
2013: EUR 698 thousand); thereof, product revenue increased
year-on-year by 31% from EUR 327 thousand to EUR 427 thousand.
- Operating costs in Q2 2014 amounted to EUR 2.1 million and remained
nearly unchanged to Q2 2013. H1 2014 operating costs increased to EUR
4.6 million (H1 2013: EUR 4.3 million) mainly due to an increased usage
of materials and higher costs for patent protection.
- Corresponding with this increase in operating costs, Q2 2014 EBIT was
EUR -1.6 million and nearly unchanged to Q2 2013; H1 2014 EBIT amounted
to EUR -3.6 million (H1 2013: EUR -3.3 million). Net loss amounted to
EUR 1.8 million in Q2 2014 (Q2 2013: EUR -1.6 million) and to EUR 4.1
million in H1 2014 (H1 2013: EUR 3.4 million), respectively.
- Net loss per share dropped slightly to EUR 0.13 from EUR 0.14 in Q2
2013 and increased only marginally to EUR 0.30 in H1 2014 from EUR 0.29
in H1 2013.
- Cash outflow from operating activities was EUR 3.1 million in H1 2014 -
a decrease of EUR 0.7 million compared to H1 2013 (EUR 3.8 million)
which was mainly attributable to the changes in current and non-current
liabilities from operations. Cash inflow from financing activities
amounted to EUR 1.9 million and was mainly due to the issuance of
428,000 new shares in context with the conversion of four convertible
notes.
- Liquid assets amounted to EUR 6.8 million at the reporting date (Dec
31, 2013: EUR 8.0 million).
Operational highlights
- Update on Regulatory Status with Epi proColon(R): Following the meeting
of the Molecular and Clinical Genetics Panel of FDA's Medical Devices
Advisory Committee ("Advisory Committee") end of March 2014, in which
the members in their majority voted positively that the benefits of Epi
proColon(R) outweigh the risks of the test for use in screening
eligible patients, the Company continued to diligently collaborate with
FDA. A follow-on meeting with FDA's PMA review team was held in April
2014 to define an approval path to launch Epi proColon(R) in the U.S.A.
This meeting focused on detailed discussions regarding submitted data,
product labeling and design of the proposed post-approval study as well
as on topics raised at the recent Advisory Committee meeting.
- Response Letter from FDA: In June 2014, the Company received the
awaited response letter from the FDA. In this letter, the agency
determined that whilst the studies performed so far have established
2013 and increased only marginally to EUR 0.30 in H1 2014 from EUR 0.29
in H1 2013.
- Cash outflow from operating activities was EUR 3.1 million in H1 2014 -
a decrease of EUR 0.7 million compared to H1 2013 (EUR 3.8 million)
which was mainly attributable to the changes in current and non-current
liabilities from operations. Cash inflow from financing activities
amounted to EUR 1.9 million and was mainly due to the issuance of
428,000 new shares in context with the conversion of four convertible
notes.
- Liquid assets amounted to EUR 6.8 million at the reporting date (Dec
31, 2013: EUR 8.0 million).
Operational highlights
- Update on Regulatory Status with Epi proColon(R): Following the meeting
of the Molecular and Clinical Genetics Panel of FDA's Medical Devices
Advisory Committee ("Advisory Committee") end of March 2014, in which
the members in their majority voted positively that the benefits of Epi
proColon(R) outweigh the risks of the test for use in screening
eligible patients, the Company continued to diligently collaborate with
FDA. A follow-on meeting with FDA's PMA review team was held in April
2014 to define an approval path to launch Epi proColon(R) in the U.S.A.
This meeting focused on detailed discussions regarding submitted data,
product labeling and design of the proposed post-approval study as well
as on topics raised at the recent Advisory Committee meeting.
- Response Letter from FDA: In June 2014, the Company received the
awaited response letter from the FDA. In this letter, the agency
determined that whilst the studies performed so far have established
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