DGAP-News: Epigenomics AG: Epigenomics AG Announces Q1 2013 Financial Results and Reports on Operational Highlights
(firmenpresse) - DGAP-News: Epigenomics AG / Key word(s): Quarter Results
Epigenomics AG: Epigenomics AG Announces Q1 2013 Financial Results and
Reports on Operational Highlights
08.05.2013 / 08:30
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Epigenomics AG Announces Q1 2013 Financial Results and Reports on
Operational Highlights
Berlin, Germany, and, U.S.A., May 8, 2013 - Epigenomics AG (Frankfurt Prime
Standard: ECX), the German-American cancer molecular diagnostics company,
today announced its financial results for the first quarter ending March
31, 2013.
- U.S. Food and Drug Administration (FDA) accepted Premarket Approval
(PMA) submission for Epi proColon(R) and granted priority review status
- Revenue Q1 2013 increased 46% compared to Q1 2012
- New distribution agreement for China signed
- R&D costs decreased 27% compared to Q1 2012
- EBIT in Q1 improved by 26% compared to Q1 2012
- Net cash flow in Q1 2013 positive due to successful capital increase in
January
'During the first quarter of 2013, we continued to make progress on the
regulatory path towards U.S. approval of Epi proColon(R). After completion
of our PMA submission late last year, the FDA notified us of having
accepted the application for review and has granted priority review status
to it. We are very positive about this decision and continue our
constructive discussion with the agency. Several inspections have already
been conducted and we are excited with the progress made so far', said Dr.
Thomas Taapken, CEO/CFO of Epigenomics AG. 'The successful capital raise
earlier this year provides us with the funds to keep working on bringing
the advantages of Epi proColon(R), a convenient blood-based testing for
early detection of colorectal cancer, to the screening eligible
population.'
Q1 2013 Financial Results
- Q1 2013 revenues increased by 46% to EUR 355 thousand (Q1 2012: EUR 243
thousand) due to an increase in product sales (+31%) and R&D service
fees.
- R&D costs decreased by 27% to EUR 1.1 million (Q1 2012: EUR 1.4
million). This was primarily attributable to the comparison study,
which was terminated at the end of 2012 and significantly had affected
the 2012 numbers as well as to the now fully visible effects of the
company restructuring in late 2011, resulting in a reduction in
headcount from 46 employees at the end of Q1 2012 to 33 at the
reporting date.
- As a result of the headcount reduction SG&A costs also declined
significantly by 27% to EUR 1.0 million (Q1 2012: EUR 1.4 million).
- EBIT for Q1 2013 amounted to EUR -1.7 million (Q1 2012: EUR -2.3
million) and net loss to EUR 1.7 million (Q1 2012: EUR 2.3 million) -
an improvement of about 26% each.
- Net cash flow in Q1 2013 was positive at EUR 2.8 million (Q1 2012: EUR
-2.6 million).
A major impact on liquidity resulted from the
successful capital raise, through which Epigenomics recorded a net cash
inflow of EUR 4.6 million. Cash outflow from operating activities was
reduced to EUR 1.8 million (Q1 2012: EUR 2.5 million).
- Liquid assets at the end of the period amounted to EUR 5.5 million
(December 31, 2012: EUR 2.7 million).
Operational highlights
- FDA Approval Process Progresses as Planned: During the first quarter of
2013, the U.S. Food and Drug Administration (FDA) notified the Company
of having accepted the application for U.S. approval of Epi proColon(R)
for review and has granted it priority review status. Several
inspections have already been conducted so far and the progress made is
encouraging. An advisory board panel review meeting is expected to be
called by the FDA as part of the review process. The Company will
continue to update the public on all major developments.
- In parallel, Epigenomics continues to make all necessary efforts in the
U.S. to create awareness for the test and generate support in the
medical and laboratory customer communities to achieve inclusion of the
test in screening guidelines and assure the availability of
reimbursement by insurance carriers once the product is approved.
- Product Sales Increasing: Sales of Epigenomics' products are increasing
gradually. While this demonstrates the growing acceptance for the
Company's products in the market, it also is a result of our maturing
basis of customers and distributors.
- Agreement with BioChain for China: In March 2013, BioChain - a leading
laboratory services provider in Asian markets - has licensed
Epigenomics' methylated Septin9 marker to make a blood-based assay for
the convenient detection of colorectal cancer (CRC) available in China,
where prevalence of CRC is on the rise and growing awareness is
creating a need for early detection.
- Successful Capital Increase: In January 2013, Epigenomics successfully
completed a capital increase by way of a rights issue and a subsequent
private placement, which extended the cash runway of the Company at
least until the end of 2013. A total number of 3,149,430 new shares
were issued at a price of EUR 1.58, resulting in gross proceeds of EUR
5.0 million.
- Changes to the Executive Management: Early April 2013, Epigenomics
announced the appointment of Dr. Uwe Staub to the Executive Board of
the Company as Chief Operating Officer (COO), a position he has held
since September of 2012 in a non-executive function. He joined the
Executive Board as a second member in addition to Dr. Thomas Taapken,
acting CEO and CFO of Epigenomics AG.
Outlook
- The Company confirms its financial prognosis for the current business
year as published in its Group management report for 2012. Prior to the
approval of Epi proColon(R) as an IVD product in the U.S. market,
Epigenomics remains cautious and does not expect revenue to increase
significantly compared to 2012 levels. EBIT and net loss for 2013 are
expected to be significantly lower than in 2012 as the effects of the
2011 restructuring measures now become fully visible as well as due to
significantly reduced R&D expenses. Net loss and cash consumption for
2013 are both expected to be in the range of EUR 6.5 to 7.5 million.
- The most significant milestone for Epigenomics will be the expected
U.S. approval for Epi proColon(R) by the FDA in the second half of
2013, in order to start the commercialization of the product in the
most relevant market of the world. This approval will heavily affect
the future value of the Company and its financial situation.
- Current financial resources are expected to fund the Company's
operations at least until the end of 2013. Since it is not anticipated
that the Company will be able to generate sufficient cash flows from
licensing income or from product sales in the short-term, Epigenomics
will continue to evaluate all strategic options available, including
the possibility of a further capital increase, in order to secure its
business operations beyond this term.
Further Information
The full Q1 Financial Report 2013 can be obtained from Epigenomics' website
at:
http://www.epigenomics.com/en/news-investors/investors/financial-reports/2
013.html
- Ends -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Präsidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir(at)epigenomics.com
www.epigenomics.com
For US press inquiries:
Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr(at)epigenomics.com
About Epigenomics
Epigenomics (www.epigenomics.com) 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(R), is a blood-based test for the
early detection of colorectal cancer, which is currently marketed in Europe
and is in development for the U.S.A. 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 disclaimer
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.
End of Corporate News
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08.05.2013 Dissemination of a Corporate News, transmitted by DGAP - a
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Language: English
Company: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir(at)epigenomics.com
Internet: www.epigenomics.com
ISIN: DE000A1K0516
WKN: A1K051
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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