DGAP-News

Epigenomics AG: Epigenomics AG Announces H1 2014 and Q2 2014 Financial Results and Reports on Operational Highlights

DGAP-News: Epigenomics AG / Key word(s): Half Year Results
Epigenomics AG: Epigenomics AG Announces H1 2014 and Q2 2014 Financial
Results and Reports on Operational Highlights

12.08.2014 / 08:30

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Berlin (Germany) and Germantown, MD (U.S.A.), August 12, 2014 - Epigenomics
AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American
cancer molecular diagnostics company, today announced its financial results
for the second quarter and the first half of 2014 ending June 30.

- H1 2014 revenue increased by 16% to EUR 812 thousand compared to H1
2013, mainly driven by an increase in product sales of 31%

- Earnings prognosis for 2014 remains unaltered despite delay in the
expected market approval for Epi proColon(R) in the U.S.A.

- U.S. Food and Drug Administration (FDA) issued response letter
requesting further data

- Results from Epi proColon(R) clinical studies published in renowned
U.S. scientific journals

- Chinese partner BioChain filed Epi proColon(R) for market approval in
China with China Food and Drug Administration (CFDA).

"The first six months of 2014 were characterized by the pending decision of
the FDA in relation to the premarket approval (PMA) application for Epi
proColon(R). Although, FDA's response to our PMA submission was unexpected,
we are now more than ever convinced that finally the approval of our
patient-friendly blood-based test for CRC screening is very likely, and
that it is ultimately a matter of time to complete the additional data
requested by the FDA. Our joint U.S. commercialization partner Polymedco
remains fully committed to begin commercialization once our product is
approved and we are well underway in gearing up manufacturing capabilities,
in order to be able to supply the demand once the product will be on the
market", said Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. "With regard
to the commercialization in China, we are delighted that our partner
BioChain filed the test sooner than anticipated for regulatory approval
with the CFDA. We are proud to contribute to the future of CRC screening
with a convenient blood test that has the potential to significantly
improve uptake and adherence and ultimately reduce CRC incidence and
mortality as well as resulting healthcare cost."


Q2/H1 2014 Financial Results

- Total Q2 2014 revenue was up 18% to EUR 405 thousand (Q2 2013: EUR 343
thousand) and H1 2014 revenue increased by 16% to EUR 812 thousand (H1