MediGene AG Reports Financial Results for the 2009 Fiscal Year
(Thomson Reuters ONE) -
MediGene AG / MediGene AG Reports Financial Results for the 2009 Fiscal Year processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Total revenue EUR 39.5 million (2008: EUR 39.6 million)
* EBITDA loss EUR 18.8 million (2008: EUR 24.6 million)
* Net loss for the year EUR 22.0 million (2008: EUR 30.8 million)
* Average monthly net cash burn rate EUR 1.6 million (2008: EUR 2.3 million)
* Cash and cash equivalents EUR 12.3 million (2008: EUR 25.1 million)
Press conference today in Frankfurt at 11.00 a.m. (CET); Analyst conference call
in English today at 2.30 p.m. (CET) which will be webcast live
Martinsried/Munich, March 26, 2010. Today the biotech company MediGene AG
(Frankfurt: MDG, Prime Standard, TecDAX) reported its results for the fiscal
year 2009, and gave an outlook for the fiscal year 2010. According to the
forecast, MediGene reduced the loss on an EBITDA basis in 2009, from
approximately 25 million euros to approximately 19 million euros, with unchanged
revenue of approximately 40 million euros. The net loss also improved
significantly in 2009, from approximately 31 million euros in 2008 to 22 million
euros this year.
In 2010 MediGene expects increasing revenue and is planning to conclude one or
more partnerships which will probably have a significant impact on the result of
the ongoing year. These results are reported pursuant to IFRS (International
Financial Reporting Standards).
Major events in 2009:
Company:
* Admission to the TecDAX stock index
* Dr. Frank Mathias appointed Chief Executive Officer
* Focus on clinical oncology R&D with an emphasis on liposome technology
* In-house reorganization, including downsizing of the Executive Board
* Revision of development plans for EndoTAG(TM)-1 and RhuDex(®)
EndoTAG(TM)-1:
* Successful conclusion of recruitment for clinical phase II trial for the
treatment of patients with triple receptor-negative breast cancer
* US regulatory authority granted orphan drug designation
* Further European patent coverage granted
* Preparation underway for change in manufacturing process
Veregen(®):
* Market approval in Germany
* Positive assessment of market approval for Austria and Spain
* Conclusion of a marketing partnership with Solvay Arzneimittel GmbH
(acquired by Abbott on February 15, 2010) for commercialization in Germany,
Austria, and Switzerland
* Conclusion of a marketing partnership with Juste S.A.Q.S. for
commercialization in Spain and Portugal
* Extension of a US patent coverage
RhuDex(®):
* Successful conclusion of preclinical tests required by the regulatory
authority
Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: "Following
my taking office in May 2009, we have analyzed MediGene's assets, opportunities
and risks, defined the company's core competence and focused our efforts
accordingly. We prepared concrete business and development plans for the next
five years, in order to reach our corporate objectives. In 2009 we also made
significant progress with our drug development projects: for Veregen(®) we
obtained the first market approval in Europe, and concluded partnerships for the
commercialization of the drug in key European markets. The clinical development
of EndoTAG(TM)-1 made progress, and we initiated the optimization of the
manufacturing process. We are delighted about the increase in sales of our two
marketed drugs, Eligard(®) and Veregen(®), and expect this trend to continue in
2010. Our major goal for 2010 is the conclusion of a partnership for
EndoTAG(TM)-1 in Europe and the USA to ensure the uninterrupted development of
this drug candidate."
Consolidated income statement (abbreviated)
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In euro thousand 2009 2008 Change
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Total revenue 39,466 39,606 0 %
Cost of sales -31,482 -26,926 17 %
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Gross profit 7,984 12,680 -37 %
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Selling, general & administrative expenses -9,124 -10,484 -13 %
Research & development expenses -18,499 -27,465 -33 %
Loss resulting from spin-off 0 -6,431 - %
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Operating result -19,639 -31,700 -38 %
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Result before income tax -21,935 -33,146 -34 %
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Taxes -27 2,356 -101 %
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Net loss for the year -21,962 -30,790 -29 %
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Financial report 2009:
Revenues in the current reporting period totalled EUR 39.5 million (2008: EUR
39.6 million). Whereas total revenue remained unchanged in 2009 compared to the
previous year, its composition changed in favour of product sales. As in
preceding years, the rise in proceeds from product sales and license payments
was mainly generated by increasing Eligard(®) sales, but towards the end of the
year, noteworthy US Veregen(®) sales were posted for the first time. All in all,
product sales and proceeds from license agreements increased by 23% to EUR 37.7
million (2008: EUR 30.1 million). Other income in 2009 was reduced to EUR 1.6
million (2008: EUR 6.1 million), due mainly to a one-time receipt in 2008 in
connection with the return of the European marketing rights to Oracea(®).
Compared to last year, selling, general and administrative expenses decreased by
13% from EUR 10.5 million (2008) to EUR 9.1 million (2009). This amount is
comprised EUR 2.2 million (2008: EUR 2.8 million) selling expenses and EUR 6.9
million (2008: EUR 7.7 million) general and administrative expenses.
Total research and development (R&D) expenses decreased by 33% to EUR 18.5
million (2008: EUR 27.5 million). Most of the R&D expenses were driven by
clinical trials with the drug candidate EndoTAG(TM)-1 in triple
receptor-negative breast cancer. Remaining R&D expenses are allocated to the
other development projects.
The loss on an EBITDA basis was reduced to EUR 18.8 million in 2009, compared to
EUR 24.6 million in 2008. MediGene uses the term EBITDA as earnings before
interest, tax, foreign currency gains/losses, and depreciation of fixed and
intangible assets. The use of this cash-flow-related parameter instead of EBIT
provides comparability of actual operating results before depreciation in the
individual reporting periods.
Total depreciation decreased from EUR 7.1 million (2008) to EUR 0.8 million
(2009). Planned depreciation is related to intangible assets such as patents and
product licenses, and property, plant & equipment. In last year's reporting
period, impairment of intangible assets pursuant to IAS 36 totalling EUR 6
million accrued in the course of the spin-off of the mTCR program into an
independent company.
The financial result, which is mainly composed of foreign currency losses and
interest income, amounted to EUR -0.7 million (2008: EUR -1.2 million).
The net loss per share decreased from last year's EUR 0.91 (weighted average
number of shares: 34,008,289) to EUR 0.64 in fiscal year 2009 (weighted average
number of shares: 34,231,294).
Taking into account the exchange rate fluctuations, net cash decreased by EUR
12.9 million in the period under review (2008: EUR 21.4 million). Cash and cash
equivalents at the end of the 2009 totalled EUR 12.3 million (2008: EUR 25.1
million). Liquidity cover ratio, calculated as the share of cash in the balance
sheet total, was 19% at the reporting date (2008: 31%).
From the consolidated cash flow statements, net cash used by operating
activities was EUR 18.9 million in 2009 (2008: EUR 27.4 million), yielding an
average monthly cash burn rate of EUR 1.6 million (2008: EUR 2.3 million).
Financial forecast for 2010:
MediGene expects to sign one or more development and marketing partnerships for
EndoTAG(TM)-1 in 2010 which are expected to have a significant impact on the
result for the year. However the financial effects of these are difficult to
assess ahead of their conclusion. Irrespective of any payments received under
the terms of these potential agreements, MediGene still expects revenue to
increase to more than EUR 40 million in 2010, mainly generated by product sales
of Eligard(®) and Veregen(®). Crucial for the achievement of this forecast will
be a continuing increase in revenue from Eligard(®), the successful
commercialization of Veregen(®) in the USA, and a successful market launch in
Europe.
A more detailed financial outlook for the year 2010 can be given only after
conclusion of the partnering process for EndoTAG(TM)-1, since both proceeds as
well as composition and amount of the development expenses will largely depend
on the structuring of these partnerships.
The future financing of the company also depends on the structuring of the
intended partnerships. On current planning, the company will be financed by the
proceeds from sales of marketed drugs, as well as payments received under the
terms of the partnership agreements for EndoTAG(TM)-1. In addition, MediGene has
secured access to additional cash from an equity funding agreement signed with
YA Global Investments. Based on present business planning and the scenarios
derived thereof, the company has again obtained an unqualified opinion from the
auditor.
Project objectives for 2010:
· Conclusion of one global or several regional development and marketing
partnerships for EndoTAG(TM)-1 in Europe and the USA
· Publication of the results obtained in the clinical phase II trial of
EndoTAG(TM)-1 in triple receptor-negative breast cancer
· Start of manufacture of EndoTAG(TM)-1 trial medication by new
spray-drying process
· Further European market launches of Veregen(®)
· Conclusion of additional marketing partnerships for Veregen(®), and
submission of further applications for market approval in Europe
· Execution of a preclinical test program to prepare the resumption of
clinical development of RhuDex(® )
· Spin-off or licensing of the oHSV program
· Continuous increase in Eligard(®) and Veregen(® )product sales
Press and analyst conference:
A press conference covering the Annual Report 2009 and forecast for 2010 will
take place in Frankfurt today at 11.00 a.m. (CET).
An analyst conference call in English will takeplace today at 2.30 p.m. (CET),
and will be webcast live. The webcast and synchronized presentation slides can
be accessed at www.medigene.com
live presentation will also be available thereafter.
The detailed Annual Report 2009 may be accessed at
http://www.medigene.de/reports
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 forward-looking statements made
herein. MediGene is not bound to update any of these forward-looking statements.
MediGene(®), EndoTAG(TM)( )and Veregen(®) are registered trademarks of MediGene
AG. RhuDex(®) is a trademark of MediGene Ltd.. Eligard(®) is a registered
trademark of Tolmar Therapeutics, Inc. Oracea(® )is a registered trademark of
CollaGenex Pharmaceuticals, Inc. 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 distributed by partner companies. It has
several drug candidates in clinical development and possesses innovative
platform technologies. MediGene focuses on clinical research and development of
novel drugs with focus on oncology.
Contact MediGene AG
Email: investor(at)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
[HUG#1398064]
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MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN: 502090;ISIN: DE0005020903 ;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg,
Freiverkehr in Börse Düsseldorf,
Freiverkehr in Bayerische Börse München,
Freiverkehr in Niedersächsische Börse zu Hannover,
Prime Standard in Frankfurter Wertpapierbörse,
Regulierter Markt in Frankfurter Wertpapierbörse;
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Datum: 26.03.2010 - 02:30 Uhr
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