EANS-News: Epigenomics AG Epigenomics AG Reports Results for the Financial
Year Ended 31 December 2012
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Subtitle: * PMA application for Epi proColon® accepted and priority review
status granted by the FDA
* Non-inferiority of Epi proColon® to FIT for sensitivity shown in comparison
study
* Significant cost savings implemented; EUR 5.0 million raised at the beginning
of 2013
Financial Figures/Balance Sheet/Molecular Diagnostics
Berlin, Germany and U.S.A. (euro adhoc) - Epigenomics AG (Frankfurt Prime
Standard: ECX), the German-American cancer molecular diagnostics company, today
announced its results for the financial year ended 31 December 2012 and provided
an outlook for 2013.
Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer
of Epigenomics commented: "By the close of 2012 we had completed a very busy
year in which we made significant progress on our regulatory pathway for Epi
proColon® in the U.S. and in the development of our commercialization plans for
this blood-based colorectal cancer screening assay. By submitting our Premarket
Approval (PMA) application to the FDA, including encouraging data from the
recent comparison study, we achieved our primary objective for the year. The
next most significant milestone for us is to be able to start commercialization
of our product in the most relevant market of the world - the United States of
America - and to ultimately transform Epigenomics into a commercially driven
molecular diagnostics company with growing revenue derived from product sales."
2012 Financial Results
* 2012 revenue amounted to EUR 1.0 million (2011: EUR 1.4 million) generated
from product sales of EpiproColon® kits, royalty payments, licensing income and
partnering activities; the decrease compared to 2011 is primarily due to one-off
licensing payments received in 2011 with no comparable effects in 2012. Product
sales prior to a potential approval of EpiproColon® in the US continued on a low
level, though moderately increasing, over the year.
* Other income increased to EUR 1.0 million (2011: EUR 0.5 million) primarily
driven by the reversal of provisions related to the restructuring of the Company
in 2011.
* Net loss improved by 22% to EUR 12.2 million (2011: EUR 15.6 million). The
decline in total revenue and an increase of R&D costs due to the execution of
the comparison study were overcompensated by the absence of extraordinary
effects (i.e. restructuring and goodwill amortization) in 2012 (2011: EUR 5.5
million).
* Epigenomics implemented significant cost savings in 2012. Consequently, cash
consumption was reduced to EUR 10.9 million (2011: EUR 12.2 million) but
contained high cash outflows directly attributable to the study mentioned above
(EUR 2.3 million) and payments related to restructuring measures taken (in total
EUR 1.4 million).
* Cash and cash equivalents at year-end 2012 amounted to EUR 2.7 million (2011:
EUR 14.0 million). The Company raised gross proceeds of EUR 5.0 million in an
equity issue at the beginning of 2013.
Outlook for 2013
* Prior to securing approval of Epi proColon® as an IVD product in the U.S.
market, Epigenomics remains cautious and does not expect revenues to
significantly differ from 2012 levels.
* EBIT and net loss for 2013 are expected to be significantly lower than in 2012
due to the full effect of the 2011 restructuring and significantly reduced R&D
expenses. Net loss for 2013 expected in the range of EUR 6.5 to 7.5 million.
* In line with reduced net loss, cash consumption 2013 is expected to be in the
range of EUR 6.5 to 7.5 million.
* Current financial resources expected to support the Company's operations until
the end of 2013. Epigenomics will continue to diligently explore all strategic
options, including the possibility to raise capital.
Operational Highlights in 2012 and 2013 YTD
Non-inferiority of Epi proColon® against FIT demonstrated: Epigenomics performed
a head-to-head comparative study with the goal to demonstrate non-inferiority of
Epi proColon® to fecal immunochemical testing (FIT) for the detection of CRC.
This clinical trial started in Q2 2012, after having agreed on the study
protocol with the FDA, and was successfully completed before year-end. In
summary, Epi proColon® met the critically important endpoint of non-inferiority
with respect to sensitivity compared to FIT. The sensitivity - or cancer
detection rate - amounted to 71%. The FIT comparator used in the study showed a
sensitivity of 67% and detected less cancer cases than Epi proColon®. The
difference in specificity - or the rate of correctly assessed non-cancer cases
-was determined at 81% for Epi proColon® and at 98% for FIT and is in line with
previous studies performed with Epi proColon® and published data for FIT. The
difference in specificity was anticipated and in our opinion is less vital,
since patients will undergo a colonoscopy - the currently recommended screening
procedure in the U.S. - as a result of a positive test result.
PMA application for Epi proColon® completed: Epigenomics initiated the process
of gaining U.S. regulatory approval for its blood-based CRC test early in the
year. Four data modules of the PMA for Epi proColon® were submitted to the FDA
in the course of the year. Through the submission of the fourth module by the
end of 2012, the Company formally completed its PMA application, which has been
filed with the FDA in early 2013 and will be subject to priority review by the
authorities.
Pre-marketing activities in the U.S.: Although reimbursement levels are still to
be determined, a major accomplishment in 2012 has been the inclusion of Septin9
testing with its own defined code into the Current Procedural Terminology (CPT)
coding document issued by the American Medical Association, which is the basis
for reimbursement of laboratory tests by payers in the United States and will be
first applied in 2013. Epigenomics is also undertaking steps to increase
awareness of the test among KOLs and medical experts setting screening
guidelines.
U.S. partnering activities expanded: In June 2012, the Company signed another
LDT agreement with Companion Dx Reference Lab, a strong partner serving the
Texan cancer-testing market. Encouragingly, Epigenomics is seeing a growing
market acceptance for its test in North America with more than 45,000 Septin9
tests performed in 2012 by its license partners compared to 26,000 tests in
2011.
Increasing acceptance from European healthcare bodies: After a far-reaching
restructuring of commercialization activities in Europe, Epigenomics is starting
to see increasing acceptance from players in the healthcare systems to adopt the
patient-friendly blood test for the early detection of CRC. As a measure of
initial success Swiss Life, one of France's largest private health insurance
companies, has decided to recommend and reimburse up to 50% of the costs of the
Septin9 test. This decision clearly confirms Epigenomics' approach in Europe and
the Company will continue on this path.
Organizational changes reducing cost base: At the Company's Annual General
Meeting (AGM) in May 2012, the shareholders voted with vast majority in favor of
a reduction of the Supervisory Board from six to three members. They elected
Heino von Prondzynski as new member and confirmed the former members Ann Clare
Kessler, Ph. D., and Prof. Dr. Günther Reiter for a further term until the AGM
in 2015. In the initial meeting the newly elected Supervisory Board subsequently
elected Heino von Prondzynski as its new Chairman and Ann Clare Kessler as
Vice-Chairwoman. Epigenomics' former CEO Geert Nygaard agreed with the
Supervisory Board of the Company to retire from the Executive Board and to leave
the Company effective September 30, 2012. Simultaneously, the Supervisory Board
appointed the Company's CFO, Dr. Thomas Taapken, to serve as acting CEO in
addition to his responsibilities as CFO, effective October 1, 2012. Epigenomics'
Executive Board was therefore reduced to one person, marking a significant step
in reducing the Company's cost basis.
Successful capital increase: On January 25, 2013, after the reporting period,
Epigenomics announced a capital increase from authorized capital for 3,149,430
new ordinary bearer shares, generating gross proceeds of EUR 5.0 million.
2,811,707 of these shares were taken up by existing shareholders at a
subscription price of EUR 1.58 per share and the remaining 337,723 shares were
sold at the same price in a private placement to institutional investors, which
was significantly oversubscribed.
-Ends-
Conference call for press and analysts
The Annual Report 2012, which was released today, can be obtained from
Epigenomics' website at:
http://www.epigenomics.com/en/news-investors/investors/financial-reports.html.
Epigenomics will host an annual press conference in Frankfurt Main, Germany in
German language at 9.30 am CET today. The Company will also be hosting a
conference call on the same day at 3.00 pm CET today. The presentation can be
followed as a slide show on the website. Details of both events will be
available on Epigenomics' website at
http://www.epigenomics.com/en/news-investors.html.
Contact Epigenomics AG
Antje Zeise
Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
{ir@epigenomics.com}[HYPERLINK: mailto:ir@epigenomics.com]
{www.epigenomics.com}[HYPERLINK: http://www.epigenomics.com/]
For US press inquiries:
Epigenomics, Inc.
9700 Great Seneca Highway
Rockville, Maryland 20850
{pr@epigenomics.com}[HYPERLINK: mailto:pr@epigenomics.com]
About Epigenomics
Epigenomics ({www.epigenomics.com}[HYPERLINK: http://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®, 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 partnerships with leading diagnostic companies and
testing laboratories. Epigenomics is an international company with operations in
Europe and the U.S.A.
Epigenomics' legal disclaimers. 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 of America.
The analytical and clinical performance characteristics of any product based on
this technology which may be sold at some future time in the U.S.A. have not
been established.
Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386
end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English