DGAP-News: Epigenomics AG: Epigenomics AG Announces Q1 2014 Financial Results
and Reports on Operational Highlights
DGAP-News: Epigenomics AG / Key word(s): Quarter Results
Epigenomics AG: Epigenomics AG Announces Q1 2014 Financial Results and
Reports on Operational Highlights
13.05.2014 / 08:30
Berlin (Germany) and Germantown, MD (U.S.A.), May 13, 2014 - Epigenomics AG
(Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
molecular diagnostics company, today announced its financial results for
the first quarter ending March 31, 2014.
- Q1 2014 revenue increased by 14% compared to Q1 2013 to EUR 407
thousand driven by increased product sales
- Liquid assets at period-end increased to EUR 8.4 million due to
proceeds from conversion of convertible notes
- FDA Advisory Committee provides recommendations for Epi proColon(R) in
- Chinese partner BioChain completed major clinical validation study and
submitted an application to the CFDA for the approval of Epi
proColon(R) in China
"Over the last weeks, additional progress was made in the regulatory
process for our blood-based screening assay for the early detection of
colorectal cancer (CRC) Epi proColon(R), since the FDA Medical Devices
Advisory Committee voted positively that the test's benefits outweigh its
risks for use in patients who meet the criteria. Subsequently, we met again
with the agency to discuss topics raised in the Advisory Committee meeting,
including the design of the proposed post-approval study", said Dr. Thomas
Taapken, CEO/CFO of Epigenomics AG. "Another important step towards
commercialization of our key value driver was taken by our Chinese partner
BioChain with the earlier than expected completion of a major clinical
validation study with Epi proColon(R) and the official start of the market
approval process with the Chinese Food and Drug Administration (CFDA) in
China. We are expecting the test could enter the Chinese market in 2015.
Overall, we are very pleased with the excellent progress we made with our
test in many regions of the world and strongly believe that the launches of
Epi proColon(R) will help to increase the number of people being tested
early for CRC."
Q1 2014 Financial Results
- Q1 2014 revenue increased by 14% to EUR 407 thousand (Q1 2013: EUR 355
thousand); thereof, product revenue in Q1 2014 increased by more than
30% year-on-year (from EUR 163 thousand to EUR 215 thousand).
- Q1 2014 operating costs increased to EUR 2.5 million, up 14% from EUR
2.2 million in Q1 2013. This increase was primarily attributable to
higher R&D cost of EUR 1.3 million (Q1 2013: EUR 1.1 million) due to
higher costs for international patent protection. SG&A costs of EUR 1.0
million remained almost at last year's level.
- EBIT for Q1 2014 amounted to EUR -2.0 million (Q1 2013: EUR -1.7
million) and net loss to EUR 2.2 million (Q1 2013: EUR 1.7 million),
including interest expenses in the amount of EUR 0.2 million (Q1 2013:
EUR 0) incurred in connection with the issued convertible notes. Due to
the increased number of shares outstanding at the end of Q1 2014, net
loss per share increased only slightly from EUR 0.16 to EUR 0.17
compared to Q1 2013.
- Net cash flow in Q1 2014 was EUR 0.4 million. Cash inflow from
financing activities amounted to EUR 1.9 million and was mainly
attributable to the issuance of 428,000 new shares in context with the
conversion of convertible notes. Cash outflow from operating activities
was EUR 1.5 million - a decrease of EUR 0.3 million compared to Q1 2013
(EUR 1.8 million) - mainly attributable to changes in current and
non-current liabilities from operations.
- Liquid assets at the end of the period amounted to EUR 8.4 million
(December 31, 2013: EUR 8.0 million). Four of the 25 convertible bonds
issued in December 2013 have been converted and EUR 2.1 million was
raised this way during Q1 2014. These conversions have not only given
more financial leeway but as well reduced the redemption amount in a
- Final Phase of U.S. Market Approval Process, Expert Panel Recommends
Epi proColon(R): On March 26, the meeting of the Molecular and Clinical
Genetics Panel of FDA's Medical Devices Advisory Committee ("Advisory
Committee") was held in conjunction with the premarket approval (PMA)
for Epigenomics' blood-based CRC screening test Epi proColon(R) in the
U.S.A. The Advisory Committee reviewed the Company's clinical data and
the performance of Epi proColon(R), discussed data and questions
presented by the FDA as well as testimonies shared during the open
public hearing. After deliberations, the Advisory Committee members in
their majority voted positively that the benefits of Epi proColon(R)
outweigh the risks for use in patients who meet the criteria.
Epigenomics is diligently preparing itself, together with its U.S.
commercial partner Polymedco, for the planned U.S. commercialization in
order to ensure the optimum market introduction and roll-out of Epi
proColon(R) in North America.
- Major Progress with Epi proColon(R) in China (after the End of the
Reporting Period), Commercialization Expected for 2015: In April,
Epigenomics announced that its Chinese partner BioChain has completed a
major clinical study to validate Epi proColon(R) for the early
detection of CRC with the goal to gain market approval for the test in
China. In addition, BioChain has officially submitted an application to
the CFDA in April for such approval. The commercialization of Epi
proColon(R) in China is expected to start in 2015.
- Argentina Becomes First Country outside of Europe to Launch Epi
proColon(R): In March, Epigenomics' local partner in Buenos Aires, VSA
Alta Complejidad S.A. ("VSA"), received approval to market the Epi
proColon(R) kit for the blood-based detection of CRC in Argentina, a
country where CRC mortality rates are still among the highest for males
and females. The test was made available by VSA in the same month on
the occasion of the international "Colon Cancer Awareness Month"
- Clinical Study with Epi proColon(R) Completed with Excellent Results in
the Czech Republic: A study conducted by MU Dr. Zdenek BeneÅ, CSc.,
Head, Medical Department of Thomayer Hospital, Prague, confirmed that
blood-based Septin9 testing could be an attractive screening
alternative to established methods for a population that would
otherwise be non-compliant to CRC screening. In this case control study
comprising 57 patients, Epi proColon(R) 2.0 CE showed a sensitivity of
92% and a specificity of 97%.
- Intellectual Property Coverage for Epi proColon(R) Strengthened in the
U.S. and in China: The Company was granted patent protection for the
method used in Epi proColon(R) to analyze Septin9 DNA methylation by
the United States Patent and Trademark Office (USPTO). In addition,
Epigenomics received a "Notice of Allowance" from the Chinese Patent
and Trademark Office for a patent covering Epigenomics' Septin9 DNA
methylation biomarker (mSEPT9) for use in the diagnosis of CRC.
- The most significant milestone for Epigenomics over the next weeks
remains the approval decision for Epi proColon(R) by the FDA.
- With regard to the earnings prognosis for the current business year,
there are no significant changes compared to our statements in the
consolidated management report for 2013. However, Epigenomics might
adjust its product revenue prognosis upwards for 2014, if market
approval for Epi proColon(R) in the U.S.A. would be granted in due
course. According to the 2013 management report, Epigenomics expects
revenue in 2014 to slightly increase from 2013 levels. Net loss for
2014 is expected to be in the range of EUR 7.5 to 8.5 million. In line
with the expected net loss range, cash consumption for fiscal 2014 is
projected at a slightly increased level compared to 2013 in the range
of EUR 7.0 to 8.0 million.
- The financial prognosis might be adjusted upon further conversions of
issued convertible notes. However, the Company will continue to
diligently explore and potentially execute all strategic options
available to further strengthen its liquidity position. These options
explicitly include further capital market transactions.
Conference call for press and analysts
The full Q1 2014 Financial Report can be obtained from Epigenomics' website
- Ends -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Kleine Praesidentenstrasse 1
Tel +49 (0) 30 24345 386
For U.S. press inquiries:
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
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 under regulatory review by the FDA for the U.S.A. and the Chinese
Food and Drug Administration for China. Additionally, the company markets
its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in
Europe. 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
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.A. have not been established.
End of Corporate News
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Company: Epigenomics AG
Kleine Präsidentenstraße 1
Phone: +49 30 24345-0
Fax: +49 30 24345-555
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
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