MediGene AG Reports Three Month 2009 Results:Revenue and Result Significantly Improved

Friday, 15. May 2009 08:30
Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




* Total revenue increased by 133% to 11.6 million EUR (Q1-2008: 5.0
million EUR)
* EBITDA improved by 75% to -1.9 million EUR (Q1-2008: -7.6 million
EUR)
* Net result improved by 78 % to -1.9 million EUR (Q1-2008: -8.8
million EUR)
* Financial forecast 2009 confirmed: further increase in revenue
and reduction of operating loss
* Analyst conference in Frankfurt with webcast (in English) today
at 2.30pm CEST

Martinsried/Munich, May 15, 2009. MediGene AG (Frankfurt: MDG, Prime
Standard, TecDAX) today reports financial results for the first three
months of 2009, with significantly increased total revenue and
improved operating result. The results are reported in compliance
with IFRS (International Financial Reporting Standards).

In the first quarter of 2009, MediGene increased total revenue by 133
% to 11.6 million euros.(Q1-2008: 5.0 million euros), and reduced the
loss on EBITDA basis by 75 % to 1.9 million euros. (Q1-2008:
7.6 million euros). The net loss decreased by 78 % to -1.9 million
euros (Q1-2008: -8.8 million euros). Cash used by operating
activities decreased by 12 % to -8.4 million euros in the first
quarter of 2009 (Q1-2008: -9.6 million euros). A large portion of
this reduction in cash results from the payment of liabilities
originating in the previous year and from a milestone payment made to
QLT. When these items are deducted the average monthly cash burn rate
in the first three months of 2009 totals 1.1 million euros. As at
closing date March 31, 2009, cash and cash equivalents totalled 16.6
million euros (Q1-2008: 25.1 million euros). In addition, MediGene
has access to additional cash of up to 25 million euros from an
equity funding agreement signed with YA Global Investments L.P. in
2008.

Major events since the beginning of 2009:

* Dr. Frank Mathias appointed as new Chief Executive Officer of
MediGene AG
* Start of sales promotion and active marketing of Veregen® in the
USA through MediGene's partner Nycomed
* MediGene share listed on the TecDAX index




Consolidated income statement (abbreviated)

In T¤ Q1-2009 Q1-2008 Change


Total revenue 11,614 4,990 133 %
Cost of sales -7,618 -3,397 124 %
Gross profit 3,996 1,593 151 %
Selling, general and administrative expenses -2,036 -2,608 -22 %
Research and development expenses -4,028 -6,866 -41 %
EBITDA -1,860 -7,553 -75 %
Operating result -2,068 -7,881 -74 %
Result before income tax -1,933 -9,461 -80 %
Net loss for the period -1,933 -8,796 -78 %


Dr. Frank Mathias, Chief Executive Officer of MediGene AG, comments:
"The results of the first quarter 2009 show that MediGene operates
successfully and meets its goals of increasing revenue and improving
its operating result. In our partnering process for the cancer drug
EndoTAG(TM)-1, the negotiations have already reached an advanced
stage. We will now devote time to thoroughly weigh up different
alternatives, in order to opt for the most favorable deal structure,
for the optimum partner, and the most valuable contract. In addition,
the executive and supervisory boards of MediGene are revising
MediGene's business plan and budget, with the objective of sharpening
the profile of MediGene and precisely defining the company's road to
sustained profitability."

Forecast:

Financial forecast: MediGene confirms its forecast for the full year
2009 to increase total revenue compared to 2008, and to reduce loss
on EBITDA basis (2008: total revenue 39.6 million euros, EBITDA -24.6
million euros). The average monthly net cash burn rate from operating
activities is to be reduced to approx. 1.5 million euros in the
remaining nine months of this year. This forecast does not take into
account the conclusion of a partnership for the cancer drug
EndoTAG(TM)-1. Based on the current business planning and the
scenarios derived from it, the management assumes corporate financing
to be secured beyond 2010.

Eligard®: The six-month depot formulation of Eligard® is to be
launched by MediGene's partner Astellas Pharma in additional European
countries. MediGene anticipates a further rise in the Eligard®
market share in 2009, as well as a further increase in sales revenues
from Eligard® in Europe.

Veregen® (Polyphenon E® Ointment): In February 2009 MediGene's
partner Nycomed started active marketing of the drug Veregen® in the
USA. Therefore MediGene expects increasing sales revenues from the
commercialization of the ointment on the US market. Following the
market approval of Veregen® in Germany, Spain, and Austria which are
expected in the next two or three months, MediGene is planning to
conclude marketing partnerships for the first European countries in
2009.

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

RhuDex(TM): MediGene is currently conducting in-vitro tests with
RhuDex(TM), with the goal of ruling out any potential connection
between the active ingredient and an increased cardiovascular risk.
Upon successful completion of these tests, and with the authorities'
consent, clinical development of this drug candidate could be resumed
in the second half of 2009.

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

Financial results Q1-2009 in detail:

Total revenue increased to 11.6 million euros in the first quarter of
2009, (Q1-2008: 5.0 million euros). It was generated mainly from the
commercialization of the drug Eligard® in Europe. Revenue in the
reporting period also includes income from royalties on sales of
Veregen® in the USA and research grants. In addition, MediGene
received a payment of more than one million euros from the company
TNO, resulting from a dispute about the quality of preclinical
studies within the YourDex(TM) development program.

Cost of sales of 7.6 million euros (Q1-2008: 3.4 million euros) arose
primarily within the scope of the commercialization of the drug
Eligard®, and to a small extent, in connection with Veregen®.

Gross profit increased to 4.0 million euros (Q1-2008: 1.6 million
euros). The gross profit amount is determined by milestone payments,
and the ratio of revenues from product sales to license payments.

Compared to last year's reporting period, selling, general and
administrative expenses decreased by 22 % to 2.0 million euros
(Q1-2008: 2.6 million euros). This decrease is primarily a
consequence of reduced selling, general and administrative resulting
from the decision implemented in 2008 not to establish a sales force
for dermatological products.

R&D expenses decreased by 41 % to 4.0 million euros (Q1-2008: 6.9
million euros). The major part of this cost reduction results from
the mTCR technology spin-off.

The loss on EBITDA basis totalled 1.9 million euros. This represents
a 75 % reduction compared to the loss of 7.6 million euros in last
year's reporting period. MediGene uses the term EBITDA as earnings
before interest, tax, foreign currency gains/losses, and depreciation
of fixed and intangible assets.

Depreciation decreased by 37 % to 0.2 million euros in the first
quarter of 2009 (Q1-2008: 0.3 million euros).

As a result of gains from a derivative financial instrument, the
financial result increased to 0.4 million euros in the reporting
period (Q1-2008: -1.6 million euros). The contract for the
commercialization of Eligard® concluded with Astellas Pharma includes
an embedded derivative, since it is processed in US dollars and not
in the functional currency of one of the two contracting parties.
Foreign currency losses result from the translation of US dollar and
British pound into euro.

In the first three months of 2009, the loss for the period decreased
by 78 % to -1.9 million euros (Q1-2008: -8.8 million euros). This
decrease is primarily due to increased revenue, reduced R&D expenses
resulting from the mTR technology spin-off, and to gains from a
derivative financial instrument.

The loss per share decreased to 0.06 euro (weighted average number of
shares: 34,028,561), compared to 0.26 euro loss per share in last
year's reporting period (Q1-2008: weighted average number of shares:
33,967,496).

Cash used by operating activities decreased by 12 % to -8.4 million
euros in the first quarter of 2009 (Q1-2008: -9.6 million euros). The
significant difference of 6.5 million euros between the net loss for
the period and the cash used in the first quarter of 2009 mainly
results from changes in the net working capital, in particular from
the payment of liabilities originating from the previous year, and
from a milestone payment made to QLT. When these items are deducted
the monthly cash burn rate in the first three months of 2009 totals
1.1 million euros.

During the first quarter of 2009, cash used by investing activities
amounted to approx. 0.1 million euros, just as in last year's
reporting period.
As at closing date March 31, 2009, cash and cash equivalents totalled
16.6 million euros. Due to an equity funding agreement closed with
Global Investments L.P. in December 2008, MediGene has secured access
to additionally 25 million euros during a period of 36 months.
Analyst conference with webcast: An analyst conference will be held
in Frankfurt at 2.30 p.m. (CEST) today. The conference will be held
in English 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 3-months report is available at:
http://www.medigene.de/deutsch/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;
Related Links: Medigene AG
Author:
Hugin
Copyright GlobeNewswire, Inc. 2016. All rights reserved.
You can register yourself on the website to receive press releases directly via e-mail to your own e-mail account.