DGAP-News: Epigenomics AG: Epigenomics AG Announces H1 2013 and Q2 2013 Financial Results and Reports on Operational Highlights
(firmenpresse) - DGAP-News: Epigenomics AG / Key word(s): Half Year Results
Epigenomics AG: Epigenomics AG Announces H1 2013 and Q2 2013 Financial
Results and Reports on Operational Highlights
07.08.2013 / 08:30
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Berlin, Germany, and U.S.A., August 7, 2013 - Epigenomics AG (Frankfurt
Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular
diagnostics company, today announced its financial results for the first
half and second quarter of 2013 ending June 30.
- Revenue in Q2 2013 increased by 120% to EUR 343 thousand compared to Q2
2012
- Operating costs decreased by 44% to EUR 2,098 thousand over Q2 2012
- EBIT in Q2 improved by 53% to EUR -1,607 thousand compared to Q2 2012
- Net cash flow in H1 2013 positive due to successful capital increase in
January
- Level 1 ADR program established
'In the first half of 2013, we were pleased to see growing sales of our
blood-based colorectal cancer (CRC) test, Epi proColon(R) in the European
and Asian markets, demonstrating growing acceptance of this product. At the
same time, we have continued to focus on the approval process at the U.S.
Food and Drug Administration (FDA). A series of facility inspections by the
FDA have been conducted and we are currently in a constructive dialogue
with the agency, awaiting additional feedback on the review process and
news regarding the expected advisory board panel meeting date in the near
future. We remain confident and anticipate the approval decision regarding
our lead product within the second half of this year', said Dr. Thomas
Taapken, CEO/CFO of Epigenomics AG.
H1 2013 Financial Results
- Revenue in H1 2013 significantly increased by 75% to EUR 698 thousand
(H1 2012: EUR 399 thousand) driven by strong product sales of EUR 327
thousand and R&D service fees of EUR 246 thousand (Q2 2013: EUR 343
thousand; Q2 2012: EUR 156 thousand; +120%)
- Operating costs decreased by 37% in H1 2013 compared to H1 2012 to EUR
4.3 million (H1 2012: EUR 6.8 million; Q2 2013: EUR 2.1 million; Q2
2012: EUR 3.8 million; -45%).This was primarily attributable to the
completed clinical trial (i.e. FIT study) in 2012, which had
significantly impacted the 2012 numbers. In addition, it mirrors the
Company's reduction in headcount from 44 employees at the end of H1
2012 to 32 at the reporting date.
- As a consequence of cost reductions, EBIT for H1 2013 improved by 42%
to EUR -3.3 million (H1 2012: EUR -5.7 million) and net loss by 42% to
EUR 3.3 million (H1 2012: EUR 5.7 million).
- Loss per share in H1 2013 amounted to EUR 0.29 compared to EUR 0.65 in
H1 2012 (Q2 2013: EUR 0.14; Q2 2012: EUR 0.38).
- Net cash flow in H1 2013 was positive at EUR 0.8 million (H1 2012: EUR
-5.0 million). A major impact on liquidity resulted from the successful
capital raise in Q1 2013, through which Epigenomics recorded
a net cash inflow of EUR 4.6 million.
- Cash outflow from operating activities was reduced to EUR 3.8 million
(H1 2012: EUR 4.8 million). This outflow included payments in
connection with the FIT comparison study completed in 2012 and payments
for consulting and regulatory services during the ongoing FDA approval
process.
- Liquid assets at the end of the period amounted to EUR 3.6million
(December 31, 2012: EUR 2.7 million).
Operational highlights
- FDA Approval Process Progresses as Planned: In the second quarter of
2013, Epigenomics continued to focus on the U.S. approval of its
blood-based CRC test, Epi proColon(R), and proceeded on the regulatory
path according to plan. A series of facility inspections by the FDA
have been conducted and open topics have been addressed. The Company
now awaits feedback from the agency on the review process and an
advisory board panel review meeting is expected to be called in by the
FDA. Epigenomics remains confident and anticipates the approval
decision within the second half of this year. The Company will continue
to update the public on all major developments.
- Data of FIT Comparison Study Presented at DDW Conference: In May 2013,
results of the head-to-head comparative study between Epi proColon(R)
and fecal immunochemical testing (FIT) were presented at a workshop of
the World Endoscopy Organization (WEO) during the Digestive Disease
Week (DDW) Conference in Orlando, Florida, U.S.A.
- Product Sales Increasing: Sales of Epigenomics' products have further
gained ground, demonstrating the growing acceptance of the Company's
products in the market. Sales through some of the Epigenomics' largest
established laboratory customers have strengthened and especially the
recent collaboration with the Chinese partner BioChain got off to a
good start.
- Level 1 ADR Program Established: In July 2013, after the reporting
period, Epigenomics announced the establishment of a Level 1 American
Depositary Receipt (ADR) program. Epigenomics' ADRs can now be traded
on the OTC (over-the-counter) market under the ticker symbol EPGNY.
- Analysts Coverage Broadened: Research analysts from Kempen&Co.,
Nomura Code Securities and First Berlin Equity Research have initiated
coverage of Epigenomics with 'buy' recommendations and valuations
ranging between EUR 2.80 and EUR 4.30 per share.
- Changes to the Executive Board: In 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 already since
September 2012 in a non-executive function.
Outlook
- Based on the half-year results, Epigenomics is now confident to see an
increase of revenue for 2013 compared to the previous year. The
successful reduction of costs will enable the Company to reach its
forecasted financial targets for 2013. In line with previous guidance,
EBIT and net loss are expected to be in a range between EUR -6.5
million and EUR -7.5 million respectively for the full year. The
expected net loss per share for 2013 will likely be in the range of EUR
-0.54 to EUR -0.64, a significant reduction compared to 2012 (EUR
-1.38). Cash consumption for 2013 is expected to be approximately EUR 7
million (2012: EUR 10.9 million).
- The most significant milestone for Epigenomics remains the expected
U.S. approval for Epi proColon(R) by the FDA in the second half of
2013. This approval will heavily affect the future value of the Company
and its ability to improve its financial situation going forward.
- Current financial resources are expected to fund the Company's
operations into early 2014. Since it is not anticipated that the
Company will be able to generate sufficient cash flows from licensing
income or product sales in the short-term, Epigenomics is intensively
evaluating all financing options available, including the possibility
of a further capital increase, in order to secure its business
operations beyond this term.
Further Information
Conference call for press and analysts
The full 6-Months Financial Report 2013 can be obtained from Epigenomics'
website at:
http://www.epigenomics.com/en/news-investors/investors/financial-reports/2
013.html
Epigenomics' management will host a conference call with web presentation
at 3pm CET/9am ET today, Wednesday, August 7th, 2013. The conference call
will be held in English.
The dial-in numbers for the conference call are:
Dial-in number (within Germany): + 49 69 247 501 895Dial-in number (within
the UK): +44 203 367 9216
Dial-in number (within the U.S.): +1 408 916 9838
Participants are kindly requested to dial in 10 minutes prior to the start
of the call.
The presentation accompanying the conference call and dial-in details for
the web presentation will be available on Epigenomics' website:
http://www.epigenomics.com/en/news-investors.html
Both an audio replay of the conference call and a transcript of the
conference call will be provided on Epigenomics' website subsequently:
http://www.epigenomics.com/en/news-investors.html
- Ends -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 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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07.08.2013 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: DE000A1K0516WKN: A1K051
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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