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quarterly report/molecular diagnostics
Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Press release
Epigenomics AG Announces Nine Months 2012 Financial Results
Berlin, Germany, and Seattle, WA, U.S.A., November 7, 2012 - Epigenomics AG
(Frankfurt Prime Standard: ECX), the German-American cancer molecular
diagnostics company, today announced its financial results for the first nine
months and third quarter ending September 30, 2012.
"During the third quarter of 2012, we made decisive steps forward towards the
completion of our ongoing head-to-head comparison study between Epi proColon®
and fecal immunochemical testing (FIT). The results of this study should become
available soon and thus allow us to complete the Premarket Approval (PMA)
application of our blood-based colorectal cancer (CRC) screening test", said Dr.
Thomas Taapken, CEO/CFO of Epigenomics AG. "At this point, already ahead of
potential regulatory approval of our product, around 1,000 laboratory developed
Septin9 tests are being performed by our laboratory partners every week in the
United States. We expect these partners to become future customers of Epi
proColon®, once we potentially receive regulatory approval for our test. At that
time we also expect to be able to expand the market significantly. Furthermore,
we are making all efforts necessary to create the awareness for the test and
generate the support in the medical and laboratory customer communities in order
to achieve the inclusion of the test in screening guidelines and assure the
availability of reimbursement by insurance carriers."
9M/Q3 2012 Financial Results
* Revenue in Q3 2012 of EUR 272 thousand was slightly higher than the comparable
number for the previous year (Q3 2011: EUR 257 thousand) due to an increase of
R&D service fees which offsets a decrease in licensing income. In the nine-month
period, the decrease in revenue compared to the same period in 2011 amounts to
EUR 570 thousand and is mainly attributable to a reduction in licensing income.
* Like in previous quarters of 2012 and in line with guidance, R&D costs
increased notably in Q3 2012 to EUR 2.3 million from EUR 1.1 million in Q3 2011.
This is mainly due to the ongoing FIT comparison study and activities in
connection with the FDA approval process. Moreover, no capitalization of R&D
expenses was recorded in 2012, compared to EUR 0.8 million of capitalized
development costs in Q3 2012.
* SG&A costs in Q3 2012 amounted to EUR 1.8 million. This significant increase
compared to EUR 1.4 million in Q3 2011 was mainly attributable to the
termination of the contract of Epigenomics' former CEO Geert Walther Nygaard as
of September 30, 2012. On a nine month basis, SG&A costs were still slightly
lower than in the comparable period of 2011 (EUR 4.7 million vs. EUR 4.8
* EBIT for Q3 2012 amounted to EUR -3.7 million - an improvement of 26.7%
compared to Q3 2011 (EUR -5.0 million). EBIT for the first nine months of 2012
was EUR 9.4 million (2011: EUR -10.7 million).
* Net loss for Q3 2012 amounted to EUR 3.7 million (Q3 2011: EUR 4.8 million)
and for 9M 2012 to EUR 9.4 million (9M 2011: EUR 10.7 million).
* Cash consumption in 9M 2012 was EUR 7.6 million (9M 2011: EUR 8.8 million).
* Liquidity at the end of the period amounted to EUR 6.2 million (December 31,
2011: EUR 14.0 million).
* FIT Comparison Study: The ongoing head-to-head comparison study between Epi
proColon® and FIT is on track since patient enrollment is almost completed.
Headline data from the study is expected to be announced within weeks, allowing
the company to complete the PMA submission to the FDA before the end of the
* Changes to the Executive Management: On September 25, 2012, Epigenomics
announced the appointment of Dr. Thomas Taapken as sole member of the Executive
Board of the company, effective October 1, 2012. Geert Walther Nygaard,
previously CEO of Epigenomics, left the company, effective September 30, 2012.
* The responsibilities of Dr. Uwe Staub, former Senior Vice President Research &
Development, were expanded by promoting him to Chief Operating Officer (COO) and
granting him "Prokura" (power of attorney). Among other duties, Dr. Staub is
responsible and oversees all activities in connection with the development and
the approval process for Epi proColon®.
* Epigenomics actively continues to seek licensing and distribution partners as
well as key account customers for its products. Since European marketing and
sales efforts have been scaled down significantly, an increase in
product-derived revenues is not expected prior to FDA approval of Epi proColon®
(FDA decision on the PMA application expected in the second half of 2013) and
the ability to sell Epi proColon® directly into the U.S. market.
* The necessity to invest into further clinical trials ahead of completion of
the PMA submission to the FDA, which arose earlier in 2012 as well as additional
one-time costs in connection with restructuring measures will lead to higher
full year costs in comparison to originally announced plans for 2012.
Nevertheless, operational costs are still expected to be significantly below
2011 numbers. The company still anticipates an improved EBIT and a narrowed net
loss for 2012 compared to last year.
* Going forward, Epigenomics strives to significantly reduce the cash needs for
2013. Detailed financial guidance for 2013 will be provided latest with the
announcement of full year 2012 results.
* Epigenomics' current financial resources are not sufficient to support the
company's operations beyond the first quarter of 2013 and will force management
to secure additional funds in the near future to remain operational in 2013 and
beyond. 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 is evaluating its options to raise capital in the markets
before the end of 2012 using all means it has at its disposition, including
issuance of shares and convertible bonds.
The full Nine Months Financial Report 2012 can be obtained from Epigenomics'
- Ends -
Contact Epigenomics AG
Manager IR | PR
Tel +49 (0) 30 24345 368
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®, 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 including Abbott, QIAGEN, Sysmex, and Quest
Diagnostics. 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.
Further inquiry note:
Antje Zeise | CIRO
Tel: +49 30 24345 386
end of announcement euro adhoc
company: Epigenomics AG
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