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Bankleitzahlen - online.de


MediGene Reports First Six Months of 2009: Revenue Increased, Result Improved

Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




* Total revenue increased by 45% to 20.0 million EUR (6M 2008: 13.8
million EUR)
* Improvement of EBITDA by 59% to -6.8 million EUR (6M 2008: -16.5
million EUR)
* Net loss reduced by 50% to -8.3 million EUR (6M 2008: -16.6
million EUR)
* Analyst conference call with webcast (in English) today at 2.30
pm (CEST)

Martinsried/Munich, August 7, 2009. In the first six months of 2009,
the biotech company MediGene AG (Frankfurt: MDG, Prime Standard,
TecDAX) improved both its revenue and operating result compared to
last year's reporting period. These results are reported in
compliance with IFRS (International Financial Reporting Standards).

In the first six months of 2009, total revenue increased by 45% to
20.0 million EUR (6M 2008: 13.8 million EUR) and were mainly
generated from the commercialization of Eligard® in Europe. Revenues
also include income from the first royalties received on sales of
Veregen®, which was recently launched by MediGene's partner Nycomed
in the USA, as well as from research grants. The loss on an EBITDA
basis decreased by 59% to -6.8 million EUR in the first six months of
2009 (6M 2008: -16.5 million EUR). The net loss for the period
decreased by 50% to -8.3 million EUR (6M 2008: -16.6 million EUR).
Cash used by operating activities decreased by 25% to -11.4 million
EUR in the first six months of 2009 (6M 2008: -15.2 million EUR). The
average monthly cash burn rate from operating activities in the first
six months of 2009 was 1.9 million EUR (6M 2008: 2.5 million EUR).
Adjusted by the changes in working capital in early 2009, the net
cash burn rate decreased to approx. 1.0 million EUR in 6M 2009.
Research and development expenses were reduced by 42%, and selling,
general, and administrative expenses by 33%. This decrease results
mainly from reduced expenses for the mTCR technology, as well as the
RhuDexTM and L1 projects.

Total revenue in the second quarter 2009 was 8.4 million EUR (Q2
2008: 8.8 million EUR). The slight decrease in revenue is due to
Eligard® stockpiling effects at MediGene's partner Astellas in Q1
2009 which have been re-balanced in Q2 2009. Astellas' direct sales
of EligardÒ have continued to increase in every quarter since market
launch. The loss on an EBITDA basis decreased by 45% to -4.9 million
EUR in the second quarter (Q2 2008: -8.9 million EUR). The net loss
decreased by 18% from -7.8 million EUR in the second quarter 2008 to
-6.4 million EUR in the second quarter 2009. Cash used by operating
activities decreased by 45% to -3.1 million EUR in the second quarter
2009 (Q2 2008: -5.6 million EUR). The average monthly net cash burn
rate from operating activities was 1.0 million EUR in the second
quarter 2009 (Q2 2008: 1.9 million EUR).

Cash and cash equivalents at June 30, 2009 totalled 13.5 million EUR
(December 31, 2008: 25.1 million EUR). In addition, MediGene has
access to additional cash of up to 25 million EUR from an equity
funding agreement signed with YA Global Investments L.P. in 2008.
With the exception of a test tranche of 0.1 million EUR, this
facility has not been used up to now.

Major events since the beginning of 2009:

* Start of sales promotion and active marketing of Veregen® in the
USA through MediGene's partner Nycomed
* Listing of the MediGene share on the TechDAX index
* Dr. Frank Mathias appointed new Chief Executive Officer of
MediGene AG
* US regulatory authority grants orphan drug designation for
EndoTAG(TM)-1
* Marketing partnership agreement concluded for commercialization
of Veregen® in Spain and Portugal
* Positive assessment on market authorization for Veregen® in the
first European countries




Consolidated income statement (abbreviated)

In TEUR Q2 2009 Q2 2008 Change 6M 2009 6M 2008 Change


Total revenue 8,374 8,778 -5% 19,988 13,767 45%
Cost of sales -6,910 -6,576 5% -14,528 -9,972 46%
Gross profit 1,464 2,202 -34% 5,460 3,795 44%
Selling, general, and
administrative expenses -1,869 -3,194 -41% -3,905 -5,802 -33%
Research and -4,723 -8,258 -43% -8,751 -15,125 -42%
development expenses
Operating result -5,128 -9,250 -45% -7,196 -17,132 -58%
Result before income -6,383 -8,130 -21% -8,316 -17,591 -53%
tax
Net loss for the period -6,383 -7,795 -18% -8,316 -16,591 -50%

Dr. Thomas Klaue, CFO of MediGene AG, commented: "The financial
development and results of the first six months show that MediGene is
on the right track. Product sales are increasing and cost-saving
measures are now making an impact. The conclusion of a partnership
for our cancer drug EndoTAG(TM)-1 will be crucial for MediGene's
further development, and we are pleased to announce that negotiations
for which have now reached an advanced stage."

Forecast:
Financial forecast 2009: MediGene confirms the forecast for the
financial year 2009 to increase revenues, and to reduce the loss on
EBITDA basis compared to 2008 (2008: total revenue 40 million EUR,
EBITDA -25 million EUR). This financial forecast does not take into
account the planned partnership for the cancer drug EndoTAGTM-1.

Eligard®: The six-month depot formulation of Eligard® (Eligard® 45
mg), which was launched in Germany at the beginning of March 2007 and
which is now available in 16 other European countries, will also be
launched by Astellas Pharma in additional European countries.
MediGene anticipates a continuous rise in the Eligard® market share,
driving further increases in European sales revenues from Eligard®.

Veregen® (Polyphenon E® Ointment): In February 2009, MediGene's
marketing partner Nycomed started active marketing of Veregen® in the
USA. Therefore MediGene expects increasing sales revenues from the
commercialization of the ointment on the US market.

Following the conclusion of a marketing partnership for Veregen® for
Spain and Portugal, MediGene expects at least one more marketing
partnership to be concluded before the end of this year.

EndoTAG®-1: In October 2008, MediGene presented the results obtained
in a clinical phase II trial of the drug candidate EndoTAGTM-1 for
the treatment of pancreatic carcinoma. Since April 2007, MediGene has
been conducting a phase II trial of EndoTAGTM-1 for the treatment of
triple receptor-negative breast cancer. Patient recruitment is to be
completed in 2009, and final evaluation of the trial is expected for
the first six months of 2010. The negotiations for the conclusion of
a global partnership for EndoTAGTM-1 have reached an advanced stage.

RhuDex(TM): MediGene has conducted in-vitro tests with RhuDexTM, with
the goal of ruling out any potential connection between the active
ingredient and an increased cardiovascular risk. The results obtained
in these studies are now submitted to the regulatory authorities for
assessment. Upon approval of the authorities, clinical development of
the drug candidate may be resumed before the end of this year.

oHSV: MediGene is not planning to continue development of oncolytic
viruses, and intends to spin off or to sell a license for this
technology.

Analyst conference call with webcast:
An analyst conference call in English will take place in Frankfurt at
2.30 pm (CEST) today, and will be webcast live. Access to the webcast
including synchronized slides is possible at the MediGene website at
www.medigene.de. A replay will also be available.
The detailed 6-months report is available at
http://www.medigene.de/englisch/quartalsberichte.php


This press release contains forward-looking statements representing
the opinion of MediGene as of the date of this release. The actual
results achieved by MediGene may differ significantly from the
statements made herein. MediGene is not bound to update any of these
forward-looking statements. MediGene®, EndoTAG(TM), EndoTAG(TM)-1 and
Vergen® are registered trademarks of MediGene AG. Eligard® is a
registered trademark of QLT USA, Inc. RhuDex(TM) is a trademark of
MediGene Ltd. These trademarks may be owned or licensed in select
locations only.

- ends -


MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG,
TecDAX) biotechnology company located in Martinsried/Munich, Germany,
with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the
first German biotech company to have drugs on the market, which are
being distributed by partner companies. MediGene has several drug
candidates in clinical development, including EndoTAG(TM)-1, which
could offer substantial sales returns. In addition, the company has
numerous projects in research and pre-clinical development and
possesses innovative platform technologies. MediGene focuses on the
research and development of novel drugs for the treatment of cancer
and autoimmune diseases.

Contact MediGene AG
E-mail: investor@medigene.com
Fax:+49 - 89 - 85 65 - 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 85
65 - 3324
Dr. Georg Dönges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946



--- End of Message ---

MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany

WKN:
502090; ISIN: DE0005020903 ;
Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in
Bayerische Börse München,
Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr
in Niedersächsische Börse zu Hannover,
Regulierter Markt in Frankfurter Wertpapierbörse;
Copyright © Hugin AS 2009. All rights reserved.



 
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