Annual Result 2005 and Forecast 2006 of MediGene AG: Significant Increase in Revenues and Improved Result
March 22 2006 - 7:13AM
PR Newswire (US)
* Total revenues increased by 50% to 19.7 million euro (2004: 13.1
million euro) * Operating loss (EBIT) reduced by 22% to -11.5
million euro (2004: -14.7 million euro) * Forecast 2006: further
increase in revenues by 50% to approx. 30 million euro, and
breakeven on EBIT basis * Current cash position more than 50
million euro MARTINSRIED/MUNICH, Germany and SAN DIEGO, March 22
/PRNewswire-FirstCall/ -- The German-American biotech company
MediGene AG (Frankfurt, Prime Standard: MDG) has presented its
annual report 2005 in Frankfurt today. Total revenues increased
from 13.1 million euro to 19.7 million euro. Apart from increasing
sales revenues from the commercialization of the drug Eligard(R),
the conclusion of a license agreement with Glaxo Group Ltd. also
contributed to this. General administration and selling expenses as
well as research and development expenses remained on the previous
year's level. The operating loss (EBIT) was reduced by 22% from
-14.7 million euro to -11.5 million euro. In the annual financial
statements the company depreciated the value of shares of the US
company QLT, Inc., held by MediGene. The value adjustment resulted
in a significant impact of 1.5 million euro on the net result. But
nevertheless the net loss was reduced by 5 % to -12.0 million euro
(2004: - 12.7 million euro). Income statement (abbreviated)
according to IFRS in T euro 2005 2004 Change Total revenues 19,682
13,138 50 % Cost of sales 9,077 5,930 53 % Gross profit 10,605
7,208 47 % General administration and selling expenses 6,123 6,294
-3 % Research and development expenses 15,997 15,627 2 % EBIT
-11,515 -14,713 22 % Net loss -12,045 -12,666 5 % After conclusion
of a US marketing partnership for Polyphenon(R) E with Bradley
Pharmaceuticals, Inc., and the successful completion of a capital
increase the cash position has increased to presently more than 50
million euro. MediGene achieved some major milestones in 2005: *
Eligard(R), MediGene's first approved drug, was launched in nine
other European countries. * MediGene's second drug, the
Polyphenon(R) E Ointment is undergoing the approval process after
acceptance of the marketing authorization application by the US
regulatory authority FDA. * The clinical phase II development
program for the drug candidate EndoTAG(TM)-1 was started with the
initiation of a trial on 200 patients in the pancreatic carcinoma
indication. Outlook & forecast for the financial year 2006
Revenues of 30 million euro and achieving of EBIT breakeven point
During the financial year 2006, total revenues should again
increase by 50%, to approx. 30 million euro then, and the breakeven
point in operating result (EBIT) is expected to be reached at the
same time. Approval of the Polyphenon(R) E Ointment in the USA in
2006, and the market launch of Eligard(R) in the remaining European
countries according to schedule will be crucial factors for
reaching the financial forecast. In addition to the increasing
revenues from Eligard(R) sales, MediGene expects to receive further
milestone payments from its marketing partner Astellas Pharma
Europe Ltd. According to the sales and results forecast, the
year-end 2006 cash position will be over 50 million euro. Regarding
the key projects Polyphenon(R) E Ointment and EndoTAG(TM), MediGene
expects to reach some important milestones * Polyphenon(R) E
Ointment - completion of approval procedure in the USA; submission
of marketing authorization applications in Europe The US regulatory
authority FDA is currently reviewing MediGene's marketing
authorization application for its Polyphenon(R) E Ointment for
commercialization in the indication genital warts. MediGene expects
completion of this procedure before the end of this year. Upon
approval of the ointment in the USA, MediGene will receive another
milestone payment from the marketing and development partner
Bradley Pharmaceuticals, Inc. MediGene is planning to submit the
marketing authorization application for this drug in several
European countries. The further development in other indications
such as actinic keratosis will be agreed with the marketing partner
Bradley Pharmaceuticals, Inc. * EndoTAG(TM)-1 - interim analysis of
the ongoing clinical phase II trial MediGene is currently
conducting a clinical phase II trial of the drug candidate
EndoTAG(TM)-1 for the treatment of pancreatic cancer. An interim
analysis of the results is scheduled for the end of the financial
year 2006. * Extension of the clinical program to other cancer
indications with high sales potential MediGene is preparing the
extension of the EndoTAG(TM)-1 development program in the field of
solid tumor treatment. In the second half of 2006, a clinical phase
II trial in the indication hormone resistant breast cancer is
scheduled to start in Europe. Apart from that, another phase II
trial in another cancer indication is in preparation and should be
initiated in 2007. * Extension of the EndoTAG(TM) research beyond
oncology by means of 1.4 million euro research grant from the
Bavarian Research Foundation The funds granted for this research
program over a period of three years are utilized for the
development of the EndoTAG(TM) technology for the treatment of
diseases other than cancer. The proof of additional applications of
the EndoTAG(TM) technology provides the opportunity for MediGene to
close cooperations beyond the main focus oncology at an early
stage. In addition MediGene expects to reach milestones in the
following projects: * Eligard(R): product launch in Europe
completed by market launch in 14 additional countries * HSV:
interim results of the ongoing phase I/II trial of NV1020 for the
treatment of liver metastases Dr. Peter Heinrich, Chief Executive
Officer of MediGene AG, comments: "Apart from Eligard(R), the
approval and commercialization of the Polyphenon(R) E Ointment will
determine MediGene's development in the short term, whereas the
clinical EndoTAG(TM)-1 development projects as well as the
extension of this technology to other indications will make the
greatest impact on MediGene's growth. In addition we will review
other companies' products in order to add further clinical product
candidates to our drug pipeline, if possible. With our
well-balanced product portfolio and our solid cash position we feel
very well positioned for the future." The annual report 2005 can be
accessed at http://www.medigene.de/deutsch/quartalsberichte.php.
This press release contains forward-looking statements that involve
risks and uncertainties. The forward-looking statements contained
herein represent the judgement of MediGene as of the date of this
release. These forward- looking statements are no guarantees for
future performance, and the forward- looking events discussed in
this press release may not occur. MediGene disclaims any intent or
obligation to update any of these forward-looking statements.
MediGene(TM) and EndoTAG(TM) are trademarks of MediGene AG,
Polyphenon(R) E is a trademark of Mitsui Norin, Eligard(R) is a
trademark of QLT USA, Inc. MediGene AG is a publicly quoted
(Frankfurt: TecDAX), German-American biotechnology company located
in Martinsried, Germany and San Diego, USA. MediGene is the first
German biotech company with a drug on the market. The NDA for a
second drug, Polyphenon(R) E Ointment, has been submitted. In
addition, MediGene has several oncological drug candidates
undergoing clinical development, and possesses innovative platform
technologies for drug development. MediGene's core competence lies
in research into and development of novel approaches for the
treatment of various cancer and tumor diseases. DATASOURCE:
MediGene AG CONTACT: Contact MediGene AG: Dr. Georg Donges, Public
Relations, ++49- 89-8565-3317, Dr. Michael Nettersheim, Investor
Relations, ++49-89-8565-2946, Email: , Fax: ++49-89-8565-2920
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