DGAP-News: Epigenomics AG: Epigenomics AG Announces 2013 Third Quarter and Nine Month Financial Results and Reports on Operational Highlights
(firmenpresse) - DGAP-News: Epigenomics AG / Key word(s): Quarter Results
Epigenomics AG: Epigenomics AG Announces 2013 Third Quarter and Nine
Month Financial Results and Reports on Operational Highlights
06.11.2013 / 08:30
---------------------------------------------------------------------
Berlin, Germany, and U.S.A., November 6, 2013 - Epigenomics AG (Frankfurt
Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular
diagnostics company, today announced its financial results for the third
quarter and the nine months ending September 30, 2013.
- 9M 2013 revenue increased by 43% to EUR 961 thousand
- 9M 2013 operating costs decreased by 40% to EUR 6.6 million
- 9M 2013 EBIT improved by 45% to EUR -5.2 million
- Strategic partnerships with Polymedco for the U.S. and BioChain for
China (after period-end)
- Successful financing of EUR 5,2 million closed (thereof EUR 4,7 million
after period-end)
- Supervisory Board re-appoints Thomas Taapken as CEO/CFO until end of
2015
'In the past weeks we have achieved significant progress as evidenced by
two strategically important collaborations we entered into with Polymedco
and BioChain and by securing a EUR 5.2 million financing for the future
development of our Company. We are especially proud that both of our new
partners, BioChain and Polymedco, have expressed their commitment and trust
in Epigenomics by becoming strategic investors', said Thomas Taapken,
CEO/CFO of Epigenomics AG. 'Investor confidence in Epigenomics finally
seems to be returning; our share price has tripled since the beginning of
this year. We are committed to live up to these high expectations to the
benefit of our shareholders and partners and remain confident to receive
the FDA approval for Epi proColon(R) in the foreseeable future.'
Nine Months 2013 Financial Results
- 9M 2013 revenue increased by 43% to EUR 961 thousand (9M 2012: EUR 672
thousand), mainly driven by product revenue of EUR 438 thousand (+52%)
and R&D service fees of EUR 342 thousand (+242%).
- 9M 2013 operating costs decreased to EUR 6.6 million, down 40% from EUR
11.0 million in 9M 2012. This was primarily attributable to the
clinical trial (i.e. FIT study), which was completed at the end of 2012
and had significantly affected the 2012 costs. Furthermore, the
decrease mirrors the Company's headcount reduction from 45 employees at
the end of Q3 2012 to 34 at the reporting date.
- As a consequence, EBIT for the 9M 2013 improved by 45% to EUR -5.2
million (9M 2012: EUR -9.4 million) and net loss by 44% to EUR 5.2
million (9M 2012: EUR 9.4 million). Net loss per share was
significantly reduced to EUR 0.16 for Q3 2013 (Q3 2012: EUR 0.42) and
to EUR 0.45 for the nine-month period (9M 2012: EUR 1.07).
- Net cash flow in 9M 2013 added up to EUR -0.3 million (9M 2012: EUR
-6.9 million). A major impact on liquidity resulted from the successful
capital raise in Q1 2013 and the convertible bond issuance in Q3 2013
leading to a net cash inflow of EUR 4.9 million for the Company.
- Cash outflow from operating activities was EUR 5.2 million in 9M 2013 -
a significant decrease of EUR 2.3 million compared to 9M 2012 (EUR 7.5
million).
- Liquid assets at the end of the period amounted to EUR 2.6 million
(December 31, 2012:EUR 2.7 million), which does not yet reflect the
recently concluded financings after the end of the reporting period.
Operational highlights
- PMA Registration on Track, Panel Meeting Awaited: Throughout the third
quarter of 2013, Epigenomics completed all required activities in
connection with the premarket approval (PMA) submission of Epi
proColon(R). The review of the PMA submission by the U.S. Food and Drug
Administration (FDA) and resulting activities from this review have
dominated the activities of the Company for most of the year. As a next
step towards the approval decision, the FDA will convene an advisory
board panel meeting, comprising independent medical experts to discuss
the PMA application. As in the past, once a panel meeting date has been
set, the FDA will publicly announce it and Epigenomics will immediately
inform its shareholders.
- Joint Commercialization Agreement with Polymedco for Epi proColon(R) in
North America: On October 2, 2013, after period-end, Epigenomics
announced a joint commercialization agreement for Epi proColon(R) in
North America with Polymedco, Inc., the leading U.S. company in the
field of selling CRC screening products with more than 1,500
established customers in the sector and a CRC-dedicated sales force.
Both parties will work jointly on the marketing, launch and development
strategies and with key payers to obtain favorable reimbursement
coverage for Epi proColon(R). Epigenomics will retain the
responsibility to manufacture the product and to support it from the
medical and regulatory point of view, including activities necessary to
achieve inclusion in major cancer screening guidelines post approval.
The significant know-how and established position of Polymedco in the
CRC screening space will ensure a successful market introduction of Epi
proColon(R) and accelerate the commercial roll-out once the test has
received FDA approval.
- Broad Strategic Collaboration with BioChain in China: On October 27,
2013, after the end of the reporting period, Epigenomics signed another
strategically important agreement with BioChain, a leading clinical
diagnostics company in cancer and genetic diagnostics in China and the
U.S.A. BioChain acquired an exclusive license to develop and
commercialize Septin9 in vitro diagnostic (IVD) tests for CRC screening
in the large Chinese market, where more than 290 million people are CRC
screening eligible. BioChain will initiate a major clinical trial to
validate the Septin9 assay with the goal to gain market approval for
the blood-based test by the Chinese Food and Drug Administration
(CFDA). In October, BioChain has placed an order for 5,000 Epi
proColon(R) tests for this clinical study, which is expected to start
immediately.
- Successful Financing of EUR 5,2 Million though Private Placement,
Convertible Bond Issuance and Strategic Investment of BioChain: Over
the last weeks, Epigenomics has raised a gross amount of EUR 5,2
million to finance its current operations and to build and strengthen
the distribution capacities for Epi proColon(R). In the context of the
aforementioned agreement, BioChain and its owners invested
approximately EUR 1 million into Epigenomics. In addition, at the end
of October, the Company successfully raised EUR 3.3 million in a
private placement to institutional investors in Europe and the U.S.
Among others, the owners of its strategic partner Polymedco
participated in the financing. Earlier in August, Epigenomics had
entered into an agreement with Yorkville, securing a convertible bond
financing for up to EUR 5 million. The agreement allows management to
access funds with great flexibility to improve the Company's financial
position. The first two tranches of EUR 0.5 million each were issued in
August and after the end of the reporting period.
- Supervisory Board Re-appoints Dr. Thomas Taapken: In Q3 2013, the
Supervisory Board of the Company unanimously re-appointed Dr. Thomas
Taapken as CEO/CFO of Epigenomics until the end of 2015.
- First Berlin Increases Price Target: Based on the recent operational
and financing successes, research analysts of First Berlin Equity
Research have increased the price target for Epigenomics shares to EUR
8.20 per share.
Outlook
- The most significant milestone for Epigenomics over the next months
will be the approval decision for Epi proColon(R) by the FDA. The
transformation of Epigenomics into a commercially driven molecular
diagnostics company with growing revenue from product sales remains the
goal for the medium and long term.
- With regard to the financial prognosis for the current business year,
there are no significant changes compared to the statements in
Epigenomics' consolidated management report for 2012. Based on the
nine-month results, Epigenomics expects to see a noticeable increase of
its full year revenue compared to the previous year, driven by higher
product sales and R&D income. 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, significantly improved over 2012 through the successful
reduction of costs. The expected net loss per share will likely be in
the range of EUR 0.54 to EUR 0.64 (2012: EUR 1.38). Cash consumption
for 2013 is expected to be approximately EUR 7 million (2012: EUR 10.9
million).
- Following the successful financing of Epigenomics during the recent
weeks, current financial resources are expected to fund the Company's
operations well into 2014. However, Epigenomics will continue to
evaluate all financing options available to secure its business
operations beyond this term.
Further Information
Conference call for press and analysts
The full 2013 Third Quarter and Nine Month Financial Report 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, November 6th, 2013. The conference call
will be held in English.
The dial-in numbers for the conference call are:
Dial-in number (within Germany): +49 30 232 531 490
Dial-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 and China. 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
---------------------------------------------------------------------
06.11.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
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
---------------------------------------------------------------------
238101 06.11.2013
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 06.11.2013 - 08:30 Uhr
Sprache: Deutsch
News-ID 313175
Anzahl Zeichen: 4444
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 250 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: Epigenomics AG: Epigenomics AG Announces 2013 Third Quarter and Nine Month Financial Results and Reports on Operational Highlights"
steht unter der journalistisch-redaktionellen Verantwortung von
Epigenomics AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
