MediGene AG Announces Nine-Months Result And Confirms Forecast For The Year

MARTINSRIED/MUNICH, Germany and SAN DIEGO, Nov. 2 /PRNewswire-FirstCall/ - - Today the German-American biotech company MediGene AG presents its results for the first nine months of 2005, and confirms its forecast for the year.

MediGene will hold a conference call today, Wednesday, November 2, 2005 at 9 a.m. ET to discuss its third quarter 2005 earnings results.

You may access the call by dialing: Toll Free US Number: 1-866.271.5140 International Dial in Number: 1-617.213.8893 Passcode: MediGene

A replay of the call will be available until November 9 2005. The call replay can be accessed by calling:

Dial In: 1-888-286-8010 International Dial In: 1-617-801-6888 Passcode 63531423

Total revenues in the third quarter of 2005 amounted to 3,693 T euro (Q3-2004: 2,642 T euro), and to 8,635 T euro in the first nine months (9M-2004: 11,472 T euro). These revenues were generated almost solely by the commercialization of the drug Eligard(R), and are made up of proceeds from product sales, license fees, and milestone payments that MediGene received from its marketing partner Astellas Pharma Europe Ltd. The higher revenues in the first nine months of 2004 resulted from one-time upfront and milestone payments posted after conclusion of the Eligard(R) marketing partnership.

In the third quarter of 2005, gross profit increased to 919 T euro (Q3-2004: 844 T euro), whereas in the first nine months of the year gross profit decreased to 4,585 T euro (9M-2004: 6,421 T euro). This results from higher one-time payments received in the first six months of 2004. In the third quarter of 2005, no milestone payment was posted, just as in the third quarter of last year. The gross profit amount is determined by milestone payments, the release of deferred income, and the ratio of revenues from products sales to license payments. It is subject to substantial fluctuations comparing individual reporting periods.

The increase of general, administrative, and selling expenses to 1,693 Teuro (Q3-2004: 1,375 T euro), and to 4,741 T euro (9M-2004: 4,254 T euro), respectively, is mainly due to the first-time adoption of International Financial Reporting Standards (IFRS), according to which stock options issued to employees are now recognized as expenses of 372 Teuro in the first nine months of 2005.

Consolidated Income Statement (Abbreviated) in T euro Q3-2005 Q3-2004 Change 9M-2005 9M-2004 Change Total revenues 3,693 2,642 40% 8,635 11,472 -25% Cost of sales 2,774 1,798 54% 4,050 5,051 -20% Gross profit 919 844 9% 4,585 6,421 -29% General, administrative, and selling expenses 1,693 1,375 23% 4,741 4,254 11% Research and development expenses 4,242 3,903 9% 11,799 10,723 10% Operating result (EBIT) -5,016 -4,434 -13% -11,955 -8,556 -40% Net loss from continued operations -4,846 -4,294 -13% -11,175 -8,189 -36% Result from discontinued operations -1 5 -120% 3 -295 101% Net loss for the period -4,847 -4,289 -13% -11,172 -8,484 -32%

Comparing this year's and last year's reporting periods, total R&D expenses slightly increased to 4,242 T euro (Q3-2004: 3,903 T euro), and to 11,799 T euro (9M-2004: 10,723 T euro), respectively.

Compared to last year's reporting periods, the net loss increased to -4,847 Teuro (Q3-2004: -4,289 T euro), and to -11,172 T euro (9M-2004: -8,484 T euro), respectively, since last year the company received higher milestone payments for the drug Eligard(R).

Milestones reached in the third quarter: * An NDA for MediGene's second drug candidate, i.e. Polyphenon E(R) Ointment for the treatment of genital warts, was submitted to the US regulatory authority FDA. * A clinical phase II trial of EndoTAG(TM)-1 for the treatment of advanced pancreatic cancer was initiated in Europe; interim analysis of the results scheduled for the end of the year 2006.

Outlook: Based on the current order backlog for Eligard(R), and the progress of our licensing activities, MediGene confirms the forecast for the year 2005, according to which the company expects total revenues of approximately 20 million euro, and a reduction of the net loss to less than 10 million euro. Major milestones expected to be reached are the conclusion of a marketing partnership for the Polyphenon(R) E Ointment, as well as the launch of Eligard(R) in other European countries.

The complete 9-Months Report 2005 is available at

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGene(TM) is a trademark of MediGene AG, Polyphenon(R) E is a trademark of Mitsui Norin.

MediGene AG is a publicly quoted , German- American biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The NDA for a second drug, Polyphenon(R) E Ointment, has now been submitted. In addition, MediGene has several oncological drug candidates undergoing clinical development, and possesses innovative platform technologies for drug development. MediGene's core competence lies in research into and development of novel approaches for the treatment of various cancer and tumor diseases.

MediGene AG

CONTACT: Dr. Georg Donges, Public Relations, +49-89-85-65-3317, or Dr.Michael Nettersheim, Investor Relations, +49-89-85-65-2946,, Fax: +49-89-85-65-2920, all of MediGene AG

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