2009-11-13 07:36:01 -
London, November , 13, 2009
Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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* Total revenue increased by 12% to 28.6 million EUR (9M
2008: 25.5 million EUR)
* EBITDA improved by 33% to -13.1 million EUR (9M 2008:
-19.5 million EUR)
* Net loss reduced by 37% to 15.9 million EUR (9M 2008: 25.0
million EUR)
* Forecast for the full year clarified
* Analyst conference call with webcast (in English) at 2.30
pm (CET) today
Martinsried/Munich, November 13, 2009. In the first nine months of
2009, the biotech company MediGene AG (Frankfurt: MDG, Prime
Standard, TecDAX) improved its total revenue and EBITDA, and reduced
its net loss compared to last year's reporting period. These results
are reported in compliance with IFRS (International Financial
Reporting Standards).
Total revenue, generated mainly from the commercialization of the
drug EligardÒ in Europe, amounted to 28.6 million EUR in the first
nine months of 2009 (9M 2008: 25.5 million EUR) and to 8.6 million
EUR in the third quarter 2009 (Q3 2008: 11.7 million EUR). The
decrease in total revenue when comparing the third quarters is due to
a one-time revenue item of 4.4 million EUR posted for the sale of the
rights to OraceaÒ to Galderma in 2008. Adjusted for this one-time
effect, revenue for the third quarter increased by 17 % compared to
last year's reporting period.
The loss on an EBITDA basis in the third quarter of 2009 amounted to
6.3 million EUR compared to last year's reporting period (Q3 2008:
3.0 million EUR). Adjusted to the above-mentioned one-time item, the
result was also significantly improved. In the first nine months of
2009, the loss on an EBITDA basis was reduced by 33 % to 13.1 million
EUR (9M 2008: 19.5 million EUR).
The net loss was reduced by 37% to 15.9 million EUR in the first nine
months of 2009 (9M 2008: 25.0 million EUR), and to 7.6 million EUR in
the third quarter 2009 (Q3 2008: 8.4 million EUR). This decrease is
primarily due to increased revenue, reduced R&D expenses, of which
the mTCR technology spin-off contributed significantly, and to
reduced selling, general, and administrative expenses during the
first nine months of 2009. R&D expenses decreased by 37% to 13.6
million EUR in the first nine months of 2009 (9M 2008: 21.7 million
EUR), and by 27% to 4.8 million EUR in the third quarter of 2009 (Q3
2008: 6.6 million EUR).
Cash used by operating activities decreased by 32% to -15.7 million
EUR in the first nine months of 2009 (9M 2008: -23.0 million EUR),
and by 45% to -4.3 million EUR in the third quarter of 2009 (Q3 2008:
-7.8 million EUR). The average monthly net cash burn rate from
operating activities in the first nine months of 2009 was 1.7 million
EUR (9M 2008: 2.6 million EUR), and 1.4 million EUR in the third
quarter of 2009 (Q3 2008: 2.6 million EUR).
As at closing date September 30, 2009, cash and cash equivalents
totalled 9.7 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. In October
2009 MediGene called two tranches from this SEDA program, and the
proceeds collected against issue of 429,553 shares, which totalled
2 million EUR, are not included in the figures herein.
Major events in the first nine months of 2009:
* MediGene shares admitted to the TecDAX stock index
* Dr. Frank Mathias appointed new Chief Executive Officer of
MediGene AG
* Reorganization initiated: shift of employees and financial
resources to clinical development
* Start of sales promotion and active marketing of Veregen® in the
USA through MediGene's partner Nycomed
* Positive assessment on market authorization for Veregen® in the
first European countries, marketing authorization granted in
Germany
* Marketing partnership agreements concluded for commercialization
of Veregen® in Spain and Portugal, and in Germany, Austria, and
Switzerland
* US regulatory authority grants orphan drug designation for
EndoTAGTM-1
Consolidated income statement (abbreviated)
In T€ Q3 2009 Q3 2008 Change 9M 2009 9M 2008 Change
unaudited unaudited unaudited unaudited
Product sales 8,403 6,837 23% 26,988 19,706 37%
Other operating 176 4,905 -96% 1,580 5,804 -73%
income
Total revenue 8,579 11,742 -27% 28,568 25,510 12%
Cost of sales -7,321 -6,039 21% -21,850 -16,012 36%
Gross profit 1,258 5,703 -78% 6,718 9,498 -29%
Selling,
general, and
administrative
expenses -2,971 -2,378 25% -6,876 -8,180 -16%
Research and
development
expenses -4,809 -6,559 -27% -13,560 -21,684 -37%
Loss resulting 0 -6,384 -% 0 -6,384 -%
from spin-off
Operating -6,522 -9,618 -32% -13,718 -26,750 -49%
result
Result before -7,522 -9,058 -17% -15,838 -26,650 -41%
income tax
Net loss for -7,550 -8,402 -10% -15,866 -24,994 -37%
the period
Dr. Thomas Klaue, Chief Financial Officer of MediGene AG, commented:
"During the first nine months of 2009 MediGene further increased
revenue and significantly reduced loss. Moreover the equity funding
agreement closed with YA Global Investments L.P. allows us to collect
a total of 25 million euros additional cash. This enables us to
stabilize MediGene's financial cushion, thus strengthening our
negotiating position for the conclusion of a partnership for our
cancer drug EndoTAGTM-1. We drew the first tranches of cash in the
fourth quarter of 2009. It remains our goal to reach the most
favourable, and not necessarily the fastest achievable, partnership
agreement for EndoTAGTM-1."
Forecast 2009:
Financial forecast: MediGene today clarifies its forecast for the
full year 2009 as originally published in March 2009. MediGene
expects to increase sales by approximately 13% to approximately 38
million EUR and to generate total revenue of approximately 40 million
EUR (2008: total revenue 39.6 million EUR, sales revenue 33.5 million
EUR). MediGene's previous forecast for 2009 was for increased total
revenue compared to 2008, and this increase in total revenue will not
be achieved because certain milestone payments from existing Veregen®
partnerships which were planned for 2009 will now be posted in 2010.
However, MediGene confirms the forecast published in March 2009 which
was to reduce the loss on EBITDA basis compared to last year.
Depending on the date of allocation of a certain cost pool related to
EndoTAGTM-1, MediGene expects the result on an EBITDA basis to be in
the range of -20 to -23 million EUR (2008: EBITDA -24.6 million EUR).
This financial forecast does not take into account any proceeds from
the intended partnership on EndoTAGTM-1.
Eligard®: MediGene anticipates a continuous rise in the Eligard®
market share, as well as a further increase in European sales
revenues achieved with Eligard®, driven particularly by the six-month
depot formulation of Eligard® (Eligard® 45 mg).
Veregen® (Polyphenon E®-Salbe): In February 2009, MediGene's
marketing partner Nycomed started active marketing of the drug
Veregen® in the USA. Therefore MediGene expects increasing sales
revenues for the financial year 2009 from the commercialization of
the ointment on the US market. The launch of the drug on the first
European markets is expected in 2010.
EndoTAGTM-1: The final evaluation of the ongoing clinical phase II
trial of EndoTAGTM-1 for the treatment of triple receptor-negative
breast cancer is expected during the first half of 2010. In 2009
MediGene expects either the conclusion of a partnership or further
progress in the partnering process.
RhuDexTM: Since the UK regulatory authority MHRA consented in October
2009 to the continuation of the clinical development of the drug
candidate in coordination with the authorities, MediGene is now
preparing the further development plan..
oHSV and AAV: MediGene is not planning to continue development of
oncolytic viruses, and intends to spin off or to sell a license for
this technology, similar to that achieved in the successful mTCR
spin-off. In addition MediGene is also planning to spin off the AAV
research program into an independent company.
Analyst conference call with webcast: An analyst conference call in
English will take place at 2.30 pm (CET) 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 9-months report is available at:
www.medigene.de/englisch/quartalsberichte.php
Advance notice: On December 15, 2009, MediGene's annual analyst
conference will take place in Frankfurt. This event will also be
webcast live. MediGene's management will report on its strategy, the
status and design of the development programs, as well as the status
of the partnering and spin-off processes. In addition MediGene will
present its future business and finance plan. Time and agenda of the
conference as well as the webcast link will be communicated in good
time.
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.
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MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard,
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 and has several drug
candidates in clinical development, two of which provide significant
sales potential. 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
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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;
