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EANS-News: Epigenomics AG / Epigenomics AG Reports Financial Results for the Fiscal Year 2008

Geschrieben am 31-03-2009

Successfully delivering on new partnering deals - PRESEPT clinical
trial on track - Product launches expected in 2009 - Financials in
line with latest expectations - Two successful financing transactions


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ots.CorporateNews transmitted by euro adhoc. The issuer is responsible for
the content of this announcement.
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balance/molecular diagnostics

Press Release, Berlin, Germany and Seattle, WA, USA, Tuesday, March
31, 2009 (euro adhoc) - Key Figures and Financial Highlights :


. Full year revenue EUR 2.6 million and other income of EUR 1.1 million
. Operational costs reduced by close to EUR 1 million to EUR 16.5 million
. EBIT improved by 6% to EUR (12.8 million) despite one-time write-off
of in-licensed platform and IP of EUR 1.5 million
. Liquidity position of EUR 12.1 million as of December 31, 2008
. Successfully completed rights issue in early 2008 raising EUR 13.5
million
. EUR 5.2 million PIPE placed at 5% premium in early 2009 secures funding
through end of 2010


Operational Highlights:


. Abbott Molecular on track for European launch of colorectal cancer blood
test in Q4-2009
. Sysmex Corporation second non-exclusive partner for colorectal cancer
blood test
. Licensed GSTP1 prostate cancer biomarker to Quest Diagnostics
. Entered into broad R&D collaboration in cancer molecular diagnostics with
Philips
. Delivered results in biomarker collaborations with Johnson & Johnson,
Pfizer, Centocor and others
. PRESEPT Study now co-funded by Abbott and on track with over 3,000
subjects enrolled
. mSEPT9 research product launched in Europe
. Successfully completed clinical evaluation of lung cancer biomarkers
. Initiated development of IVD test for lung cancer after successful
clinical evaluation
. mPITX2 biomarker successfully validated for prostate cancer prognosis;
test available in early access program in due course
. Strengthened IP position with key patent grants and new licensing
agreements with OncoMethylome Sciences and DxS Ltd.
. Strengthened commercially oriented organization with several key new
hires


Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular
diagnostics company developing tests based on DNA methylation, today
reported its financial results for the fiscal year ending December
31, 2008 and provided an update on strategy and operations.

Geert Nygaard, CEO of Epigenomics, said: "We look back on a very
successful year in which we have continued to focus on our key value
driver, the blood-based colorectal cancer screening test. We have
delivered and expect to continue to deliver on our strategy.
Specifically we have executed several new deals such as the Philips
and Sysmex partnerships, which are in line with our nonexclusive
licensing approach, and we have also expanded both our Abbott
Molecular as well as our Quest Diagnostics deals. In addition, we
have made progress with PRESEPT, our major clinical study, and have
advanced the development of our other cancer products. With the two
successful financing transactions in the past 15 months and the
licensing agreement with Quest Diagnostics on prostate cancer we have
made a very successful start in 2009 and we are now ideally
positioned to bring our key products to the market this year."

Operational Review 2008 and recent highlights

2008 and early 2009 have been characterized by continued execution of
Epigenomics' nonexclusive partnering strategy as well as the
substantial progress made in the Company's product development
pipeline with successful clinical study results in colorectal, lung
and prostate cancer programs.

In early 2008 Epigenomics confirmed the performance of its colorectal
cancer blood test based on the mSEPT9 biomarker in two independent
clinical studies with a total of over 500 patient samples tested.
These studies used a routine- capable and automatable workflow that
has proved to be an excellent model assay and benchmark for the
Company's partners developing tests for mSEPT9.

To maximize diagnostic platform access and ultimately the market
penetration and therefore the value for Epigenomics and its
stakeholders, the Company continued to leverage its biomarkers in a
nonexclusive licensing approach. In line with this business model,
Epigenomics has initiated and expanded several strategic
partnerships. Following the initial licensing of the mSEPT9 biomarker
in the autumn of 2007, Abbott has increased its commitment by
co-funding Epigenomics' PRESEPT clinical study. Obtaining access to
the specimen collected in this study will allow Abbott to conduct its
pivotal clinical trials for FDA approval of its mSEPT9 colorectal
cancer blood test in a timely and cost effective manner.

Since this expansion of the Abbott partnership, Epigenomics has
entered into new R&D and licensing collaborations with Philips and
Sysmex as second and third IVD partners. Under the agreement with
Philips announced in late 2008, both companies collaborate in R&D for
DNA methylation analysis on a fully integrated IVD platform. This is
an alliance that, if successful, could potentially cover multiple
cancer molecular diagnostic tests. The R&D agreement with Sysmex
closed in early 2009 is targeted at the development of a colorectal
cancer blood test based on mSEPT9, initially for the Japanese market.
Further, Epigenomics expanded its licensing alliance with Quest
Diagnostics to also include the rights to commercialize a prostate
cancer test based on the GSTP1 DNA methylation biomarker. This is in
addition to the mSEPT9 colorectal cancer blood test which we continue
to expect Quest to launch in due course.

Throughout 2008 and during 2009 to date Abbott and Epigenomics have
made excellent progress in the development of the mSEPT9 test (which
will be run on the Abbott m2000 platform) leading to the approval and
freeze of the assay design for the final stages of development and
clinical validation. Market launch for Abbott's colorectal cancer
blood test based on mSEPT9 is on track for Q4-2009 in Europe followed
by the filing for US approval that is planned for 2010. For the
necessary pivotal clinical trial in the U.S., Abbott will make use of
specimen collected by Epigenomics in the PRESEPT Study.

The PRESEPT Study is a multi-center clinical study to characterize
mSEPT9 performance and health economic benefit in a US colorectal
cancer screening guideline-eligible population. The study, which is
expected to enroll approximately 7,500 subjects (the target is to
include 50 previously undetected cancer cases), has progressed
according to plan and expectations. A total of 21 clinical sites (17
in the USA and 4 in Germany) have enrolled more than 3,000 subjects
to date. Reporting of the first study results continues to be
expected by late 2009. Epigenomics has established a high-profile
Medical Advisory Board as well as a fully independent clinical study
steering committee under the chairmanship of Prof. David Ransohoff
(University of North Carolina School of Medicine and with Prof.
Timothy R. Church (University of Minnesota) as Principal
Investigator. Details on the PRESEPT Study and its progress can be
found on at www.clinicaltrials.gov as well as www.presept.net.

In early 2008 Quest Diagnostics obtained the rights to commercialize
Epigenomics' mSEPT9 biomarker as a laboratory-developed test (LDT) to
aid in the early detection of colorectal cancer in the US. Quest is
expected to launch this LDT in due course, making Epigenomics' mSEPT9
biomarker commercially available for the first time to patients and
doctors in the US. In Europe an mSEPT9 research kit has been
successfully developed, manufactured and released and is currently
being used by several clinical laboratories to establish and launch
laboratory developed tests.

Epigenomics' further programs in lung cancer and prostate cancer have
made very good progress over the last year, with advanced product
opportunities in both indications. In lung cancer the Company
completed the clinical evaluation of its proprietary biomarkers in an
application to aid in the diagnosis of lung cancer using bronchial
lavage samples and entered the product development phase for a CE
marked IVD test. This is expected to be ready for commercial launch
in Europe in H1-2010. Data from the clinical evaluation will be
presented by Prof. John Field (University of Liverpool/UK), one of
the collaborators in the clinical evaluation, at the 100th Annual
Meeting of the American Association for Cancer Research in Denver,
Colorado, USA, on April 21, 2009.

In its prostate cancer program the Company has confirmed in an
independent population that its mPITX2 biomarker is an independent
prognostic factor in prostate cancer and can be utilized to assess
the risk of recurrence after radical prostatectomy. Through an Early
Access Program mPITX2 will be made available in several clinical
laboratories in Germany in H1-2009 while the Company is in
negotiation with potential industry partners to commercialize IVD
tests based on this biomarker.

In its R&D collaborations with pharma and biotech companies including
Centocor, Johnson & Johnson, Pfizer, and Merck & Co., Epigenomics has
delivered high quality results and has signed new R&D collaboration
agreements with undisclosed industry and academic research partners.

As part our drive towards the goal of establishing a unified
technology standard for DNA methylation-based diagnostics, during
2008 Epigenomics licensed the non-exclusive rights to several
proprietary core technologies for body fluid and tissue testing to
OncoMethylome Sciences and entered into a strategic cross-licensing
agreement with DxS for DxS' proprietary Scorpions® technology. Along
with the granting of key patents such as the mSEPT9 biomarker patent
issuing in Europe, the IP position of Epigenomics has been further
improved and broadened. Epigenomics continues to leverage its IP
portfolio in DNA methylation via licensing deals such as the
agreements with QIAGEN for preanalytics and our MethyLight real-time
PCR technology.

To further strengthen the IVD development and commercialization
capabilities of the Company, Epigenomics hired Dr. Uwe Staub as a SVP
Product Development and Dr. Friederike Gerdes as Head of Marketing &
Sales. Both of these new hires come with substantial track records in
the diagnostics industry. Financial Review 2008 & Successful
Financing Transactions

Oliver Schacht, CFO of Epigenomics AG, commented: "We have
successfully closed two financing transactions since January 2008,
raising gross proceeds of EUR 13.5 million in early 2008 and another
EUR 5.2 million in February this year. We were able to complete these
capital increases in the midst of what arguably is the worst global
financial crisis in decades. This is testament to our solid
fundamentals, strategic execution, excellent operational progress and
our fiscal discipline. Last year we successfully managed to further
reduce operational costs by EUR 1 million despite a one-time
write-off of certain in-licensed IP and platform assets. As promised,
we successfully achieved our primary goal of reducing cash-burn in
2008 to less than EUR 10 million, and are now very well placed to
drive the business forward".

In 2008, Epigenomics recognized total revenue of EUR 2.6 million, a
small increase of 1% from the previous year. Revenues from our
biomarker services business contributed EUR 0.9 million and licensing
revenues were EUR 1.2 million. Neither the Philips deal nor the
expansion of the Abbott Molecular deal have yet contributed
significantly to 2008 revenues. Other income amounted to an
additional EUR 1.1 million in 2008.

Cost of sales from the execution of partnered programs increased by
EUR 0.8 million to EUR 1.7 million compared to EUR 0.9 million in
2007 as Epigenomics' diagnostic co-development with Abbott shifted
some costs from 'R&D' to 'Cost of Sales'. R&D costs consequently
decreased from EUR 10.5 million in 2007 to EUR 10.0 million.

Stringent financial discipline and the implementation of our "Epi
2010" initiative have led to a further reduction of the operating
cost basis by EUR 1.0 million. Marketing and business development
costs fell from EUR 1.3 million in 2007 to EUR 0.9 million. This
decrease was partly attributable to a more focused utilization of
external services and the build-up of Epigenomics' in- house
marketing & sales team in late 2008. General and administrative costs
amounted to EUR 3.4 million - significantly below the previous year's
figure (EUR 4.3 million).

In 2008, EBIT amounted to EUR (12.8 million), a significant 6%
improvement compared to previous year's EUR (13.5 million). At EUR
12.3 million, net loss for the full year 2008 also showed a
substantial improvement over the previous year's figure (EUR 13.2
million). These losses include a one-time non-cash related
depreciation of EUR 1.5 million of some of Epigenomics' in-licensed
IP and diagnostic platform assets that are no longer part of our core
strategy, illustrating an even stronger underlying improvement over
last year.

Net cash inflow from financing activities amounted to EUR 11.5
million. This was due to the rights issue financing in Q1 of 2008,
compared to EUR 4.5 million in 2007, which was mainly the result of a
PIPE transaction in Q2 2007. Liquid assets including marketable
securities on December 31, 2008 totaled EUR 12.1 million compared
with EUR 10.0 million at the end of the previous year. The liquidity
position was mainly affected by the continued cash consumption by
operations, especially for Epigenomics' product development.

In Q1 2008 Epigenomics successfully completed a capital increase
despite a very difficult market environment. Epigenomics successfully
placed 8,458,062 new shares at a price of EUR 1.60 each resulting in
gross proceeds of about EUR 13.5 million. Primarily driven by this
capital increase the total issued share capital of Epigenomics
increased from EUR 18,252,824 as of December 31, 2007 to EUR
26,723,636 as of December 31, 2008.

In February 2009 Epigenomics successfully completed a PIPE
transaction and capital increase at a 5% premium to then prevailing
market prices for its stock. Epigenomics issued 2,671,088 new shares
at a price of EUR 1.94 per share for gross proceeds of EUR 5.2
million. Thereby, as of February 27, 2009 the total number of shares
outstanding has increased to 29,394,724. The transaction was lead by
a fund of the BB MEDTECH group (Schaffhausen/Switzerland) which
thereby became Epigenomics' second largest investor after Federated
Investors (Pittsburgh, PA, USA).

Future Outlook

Epigenomics will build on last year's successes and will continue to
focus on driving forward the clinical development and
commercialization of its colorectal cancer test. The Company expects
to complete the PRESEPT study to demonstrate clinical performance and
health economic benefit in a US colorectal cancer screening
guideline-eligible population by the end of 2009 and expects Quest
Diagnostics to launch a laboratory-developed blood test to aid in the
early detection of colorectal cancer in due course. This will mark an
important milestone in Epigenomics' commercialization strategy, as
patients and doctors in the U.S. will for the first time be given
access to a commercial test based on Epigenomics' proprietary mSEPT9
biomarker.

Most importantly and unchanged from our previous guidance, the
Company expects Abbott, its first non-exclusive IVD partner for
mSEPT9, to launch a blood test for colorectal cancer as a CE-marked
IVD product in Europe towards the end of 2009.

Epigenomics will continue to execute on its non-exclusive licensing
strategy and is seeking further diagnostic industry partners for the
commercialization of its cancer screening programs. Management will
carefully weigh the benefit of adding a partner ahead of PRESEPT data
versus the incremental value that would be created and captured
following a successful PRESEPT Study and an Abbott product launch in
Europe in Q4-2009.

In its product development program for a lung cancer diagnostic test,
Epigenomics anticipates generating additional clinical data through
2009 and to be ready for the launch of a CE marked IVD kit in Europe
in H1-2010.

Financials for the fiscal year 2009 are expected to be characterized
by continued fiscal discipline and focus on the colorectal and lung
cancer programs. Epigenomics anticipates 2009 revenue of at least EUR
3 million, and to be above 2008 revenue. This will depend on current
R&D collaborations and partnerships as well as potential new
partnerships as outlined above. EBIT loss is expected to continue to
improve over 2008, with a target to no greater than EUR 11 million
for the fiscal year 2009. Cash burn will be closely monitored and is
expected remain below EUR 10 million for 2009 despite the investments
being made in PRESEPT, the lung cancer IVD development, ongoing
clinical studies and the pre-launch marketing activities.

Further Information

The complete Annual Report 2008 published today can be downloaded
from Epigenomics' website.

Internet link:

http://www.epigenomics.com/en/investor_relations/Financial_Informatio
n/

Epigenomics will host a press conference and analyst meeting in
German today at 10 am CET at the premises of the Villa Bonn -
Frankfurter Gesellschaft für Handel Industrie und Wirtschaft in
Frankfurt am Main:

Villa Bonn
Frankfurter Gesellschaft für Handel Industrie und Wirtschaft
Siesmayerstrasse 12
60323 Frankfurt am Main
Room: Vortragsraum (OG)

Epigenomics' management will also host a conference call at 3 pm CET
/ 9 am EST today to discuss 2008 financial results and outlook for
2009. The conference call will be conducted in English.

Dial-in number (within Germany.): +49 (0) 30 868 71 790
Dial-in number (outside Germany): +1 212 444 0297

Please note that the dial-in details changed since the invitation to
the conference call was first posted on March 11, 2009.

Please dial-in at least 10 minutes prior to commencement of the
conference call.

To follow the presentation, Epigenomics kindly ask all participants
of the call to download the slide set from the Company website prior
to the call where it will be made available as a PDF file at 10 am
CET (4 am EST) on the same day.

Internet link:
http://www.epigenomics.com/en/down_loads/corporate_material/

The conference call will be recorded and also made available on the
Company website web as an audio file after the call. Internet link:
http://www.epigenomics.com/en/down_loads/corporate_material/

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation
biomarkers, Epigenomics' tests in development aim at diagnosing
cancer at earlier stage or more accurately and thereby may reduce
mortality from this dreaded disease.

Epigenomics' product pipeline contains a validated biomarker for the
early detection of colorectal cancer in blood plasma, and further
proprietary DNA methylation biomarkers at various stages of
development for prostate and lung cancer detection in urine, blood
and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the
early detection of colorectal cancer in a simple blood sample has
repeatedly demonstrated excellent performance in multiple clinical
studies with in total about 3,500 individuals tested. A large
prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a
screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic
test products, Epigenomics pursues a non-exclusive partnering
strategy. Strategic diagnostics industry partners include Abbott
Molecular, Philips, Sysmex Corporation and Quest Diagnostics for
diagnostics test products, and QIAGEN N.V. for sample preparation
solutions and research products.

Partners in the health care industry and the biomedical research
community can access Epigenomics' portfolio of proprietary DNA
methylation technologies and biomarkers protected by more than 150
patent families through research products, biomarker services, IVD
development collaborations, and licensing. The Company is
headquartered in Berlin, Germany, and has a wholly owned subsidiary
in Seattle, WA, USA. For more information, please visit Epigenomics'
website at www.epigenomics.com.

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.


end of announcement euro adhoc
--------------------------------------------------------------------------------


ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Epigenomics AG

Dr. Achim Plum

Sen. VP Corporate Development

Tel: +49 30 24345 368

achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technologie All Share
Börsen: Börse Frankfurt / regulated dealing/prime standard
Börse Berlin / free trade
Börse Hamburg / free trade
Börse Stuttgart / free trade
Börse Düsseldorf / free trade
Börse München / free trade


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