MediGene reports positive results for the first half of 2011 and confirms forecast for the year

MediGene reports positive results for the first half of 2011 and confirms forecast for the year

ID: 56891

(Thomson Reuters ONE) -
MediGene AG /
MediGene reports positive results for the first half of 2011 and confirms
forecast for the year
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.

Analyst call and webcast (in English) today, 3:30 p.m. (CEST)

* Increase in total revenue (from continued operations and discontinued
operations) by 18% to EUR 29.6 million (6M 2010: EUR 25.2 million)


* Veregen® revenue from product sales and royalties increased by 43%


* Positive EBITDA result of EUR 17.0 million (6M 2010: EUR -5.4 million)


* Net profit of EUR 14.4 million (6M 2010: Net loss EUR -3.3 million)


* Cash and cash equivalents of EUR 15.9 million as of June 30, 2011
(Dec. 31, 2010: EUR 4.8 million)


* Confirmation of forecast for the year


Martinsried/Munich, Germany, August 2, 2011. The biotechnology company MediGene
AG (Frankfurt, Prime Standard) generated total revenue (from continued
operations and discontinued operations) of EUR 29.6 million in the first half of
the 2011 fiscal year (6M 2010: EUR 25.2 million). This revenue consists
primarily of product sales from the commercialization of the drugs Eligard(®)
and Veregen(®) and milestone payments of EUR 20.0 million from the transfer of
European rights for Eligard(®) to Astellas. The EBITDA result was positive and
totaled EUR 17.0 million (6M 2010: EUR -5.4 million). Net profit for the period
was EUR 14.4 million (6M 2010: EUR -3.3 million). Cash and cash equivalents at
the end of the reporting period totaled EUR 15.9 million. These results have
been prepared under IFRS (International Financial Reporting Standards).

Key events of the first half of 2011:

* Conclusion of further partnership agreements for the commercialization of




Veregen®:

* Laboratoires Expanscience for France
* Meditrina for Romania and Bulgaria
* Pierre Fabre for Mexico, Central America, Venezuela, and Colombia
* Will-Pharma for the Benelux countries
* Triton Pharma for Canada
* SynCore Bio for Taiwan


* Veregen® market approval granted in Spain


* Veregen® eligible for insurance reimbursement in Austria since June 2011


* Eligard® rights for EU countries transferred to Astellas, payment of EUR 15
million received


* AAVLP development partnership agreed with The Johns Hopkins University


Arnd Christ, Chief Financial Officer of MediGene AG commented: "The first half
2011 results presented today reinforce our commitment to and belief in our
overall corporate strategy. With the company's financing secured beyond 2012 and
our expenses optimized, we will continue to work on strengthening our pipeline
both through internal progress and business development activities."

Results of the first half of 2011:

Product sales and other income
MediGene increased total revenue from continued operations by 49% in the first
half of 2011 to EUR 1.9 million (6M 2010: EUR 1.3 million). This revenue was
generated from Veregen® product sales and royalties in the USA, Germany, and
Austria, which increased by 43% to EUR 0.8 million (6M 2010: EUR 0.5 million),
and from milestone payments for Veregen® of EUR 0.1 million (6M 2010: EUR 0.7
million). In addition, since March 1, 2011, MediGene has recorded a 2%
participation in net sales of Eligard® in continued operations under other
income. This line item amounted to EUR 0.9 million.

Revenue from discontinued operations totaled EUR 27.7 million (6M 2010: EUR
23.9 million). Revenue from discontinued operations was generated from European
Eligard® product sales, royalties and milestone payments.

EBITDA and net results
In the first half of 2011, MediGene recorded a positive EBITDA result of
EUR 17.0 million, compared to EUR -5.4 million for the same period the previous
year. Net profit was EUR 14.4 million (6M 2010: EUR -3.3 million). This
significant improvement is due primarily to higher revenue. The company has
continued to significantly reduce operating expenses compared to the same period
of the previous year.

Cash and cash equivalents and average monthly cash flow from operating
activities
Cash and cash equivalents totaled EUR 15.9 million as of June 30, 2011 (December
31, 2010: EUR 4.8 million). At the beginning of March, MediGene received a
payment of EUR 15 million from the sale of distribution and marketing rights for
the cancer drug Eligard® to Astellas.

In the first six months of 2011, the average monthly net cash inflow rate from
operating activities amounted to EUR 1.9 million (6M 2010: EUR -1.4 million).
Adjusted for the non-recurring items of the milestone payments received from
Astellas, the average monthly operating cash burn rate was EUR -0.6 million in
the first half of 2011.

Q2 2011 results
Total revenue from continued operations rose by 136% in the second quarter of
2011 to EUR 1.2 million (Q2 2010: EUR 0.5 million). This revenue was generated
from Veregen(®) product sales, royalties and milestone payments. It also
includes other operating income, generated mainly from Eligard(®) product sales
since March 2011. Revenue from discontinued operations (Eligard(®)) in the same
period totaled EUR 0.4 million (Q2 2010: EUR 12.6 million). The EBITDA result
improved to EUR -2.2 million in the second quarter (Q2 2010:
EUR -3.0 million). The net loss for the second quarter was EUR -2.6 million (Q2
2010: EUR -1.0 million). The increase in the net loss for the period is due to
lower revenue sharing for Eligard(®) as a result of the transfer of rights to
Astellas. Cash used by operating activities totaled EUR -3.0 million for the
second quarter (Q2 2010: EUR -2.2 million). This corresponds to an average
monthly cash burn rate of EUR -1.0 million (Q2 2010: EUR -0.7 million).

Key figures:
In EUR thousand Q2 2011 Q2 2010 Change 6M 2011 6M 2010 Change
--------------------------------------------------------------------------------
Product sales 529 493 7% 909 1,222 -26%

-        thereof Veregen® 497 366 36% 774 542 43%
product revenue and royalties

-         thereof Veregen® 32 127 -75% 135 680 -80%
milestones

Other operating income 704 30 >200% 973 43 >200%

Total revenue 1,233 523 136% 1,882 1,265 49%

Total operating expenses -3,658 -6,086 -40% -7,411 -12,193 -39%

Operating result from continued -2,425 -5,563 -56% -5,529 -10,928 -49%
operations

Result from continued operations -2,699 -4,760 -43% -5,803 -10,794 -46%

Product sales from discontinued 406 12,629 -97% 27,702 23,906 16%
operations

Result from discontinued 81 3,801 -98% 20,170 7,500 169%
operations

Net result for the period -2,618 -959 173% 14,367 -3,294 >-200%

EBITDA -2,211 -2,957 -25% 17,000 -5,393 >-200%


Outlook:


Financial Forecast 2011:
MediGene today confirms its financial outlook for the 2011 fiscal year. Based on
its present product portfolio, MediGene expects a positive EBITDA result of EUR
10 to 16 million for fiscal year 2011. This result includes non-recurring one-
time effects in the form of milestone payments totalling EUR 20 to 25 million
for Eligard®, which will also contribute to the total revenue (from continued
and discontinued operations) guidance for 2011 of EUR 32 to 38 million.

Eligard®
Since March 1, 2011, MediGene has received a 2% share of net sales revenue from
Eligard® generated by Astellas in Europe. The transfer of the rights for non-EU
countries is expected to be completed by the end of 2011 or early in 2012, and
will lead to a EUR 5 million milestone payment.

Veregen®
MediGene is planning to submit further applications for market approval of
Veregen® in additional European countries in 2011. The German market approval
will serve as the reference within the scope of the mutual recognition
procedure. MediGene also plans to conclude further marketing partnership
agreements within and outside of Europe, and has already signed several
agreements in the first half of 2011. MediGene expects continued growth in both
Veregen® in-market sales and revenue in 2011.

EndoTAG®-1
MediGene intends to enter into one or more partnerships for EndoTAG®-1 with
pharmaceutical or biotech companies, and envisages the partner or partners
taking over further development and future commercialization of the drug
candidate.

RhuDex®
MediGene is preparing to resume clinical development of RhuDex®. The objective
is to initiate a phase I clinical trial in 2011, in which a new formulation
customized for treatment of chronic conditions will be tested and optimized.

AAVLP technology
As part of its collaboration with The Johns Hopkins University, additional pre-
clinical trials will be carried out in 2011 in order to test the first vaccine
candidates of the AAVLP platform for the prevention of HPV-associated cancers.

Analyst call:
An analyst call (in English) and webcast will be held today at 3:30 p.m CEST.
The webcast with synchronized slide presentation can be accessed via MediGene's
website:www.medigene.com. A recording of the presentation will be made available
following the live webcast.

The complete quarterly report is available online 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®, RhuDex®, and Veregen® are registered trademarks of
MediGene AG. Eligard® is a registered trademark of Tolmar Therapeutics, Inc.
These trademarks may be owned or licensed in select locations only.

- ends -

MediGene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology
company headquartered in Martinsried/Munich, Germany. MediGene is the first
German biotech company to have revenues from marketed products. It has various
drug candidates in clinical development and possesses innovative platform
technologies. MediGene focuses on clinical research and development of novel
drugs against cancer and autoimmune diseases.

Contact MediGene AG

Julia Hofmann
(analysts, institutional investors, press)
Kerstin Langlotz
(retail investors, press)

Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20
Email: investor(at)medigene.com

--- End of Message ---

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;


pdf of press release:
http://hugin.info/132073/R/1535422/468205.pdf




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Source: MediGene AG via Thomson Reuters ONE

[HUG#1535422]


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Bereitgestellt von Benutzer: hugin
Datum: 02.08.2011 - 07:31 Uhr
Sprache: Deutsch
News-ID 56891
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