* Total revenues increased by 50% to 19.7 million euro (2004: 13.1 million euro) * Operating loss (EBIT) reduced by 22% to -11.5 million euro (2004: -14.7 million euro) * Forecast 2006: further increase in revenues by 50% to approx. 30 million euro, and breakeven on EBIT basis * Current cash position more than 50 million euro
MARTINSRIED/MUNICH, Germany and SAN DIEGO, March 22 /PRNewswire-FirstCall/ -- The German-American biotech company MediGene AG has presented its annual report 2005 in Frankfurt today. Total revenues increased from 13.1 million euro to 19.7 million euro. Apart from increasing sales revenues from the commercialization of the drug Eligard(R), the conclusion of a license agreement with Glaxo Group Ltd. also contributed to this. General administration and selling expenses as well as research and development expenses remained on the previous year’s level.
The operating loss (EBIT) was reduced by 22% from -14.7 million euro to -11.5 million euro.
In the annual financial statements the company depreciated the value of shares of the US company QLT, Inc., held by MediGene. The value adjustment resulted in a significant impact of 1.5 million euro on the net result. But nevertheless the net loss was reduced by 5 % to -12.0 million euro (2004: - 12.7 million euro).
Income statement (abbreviated) according to IFRS in T euro 2005 2004 Change Total revenues 19,682 13,138 50 % Cost of sales 9,077 5,930 53 % Gross profit 10,605 7,208 47 % General administration and selling expenses 6,123 6,294 -3 % Research and development expenses 15,997 15,627 2 % EBIT -11,515 -14,713 22 % Net loss -12,045 -12,666 5 %
After conclusion of a US marketing partnership for Polyphenon(R) E with Bradley Pharmaceuticals, Inc., and the successful completion of a capital increase the cash position has increased to presently more than 50 million euro.
MediGene achieved some major milestones in 2005: * Eligard(R), MediGene’s first approved drug, was launched in nine other European countries. * MediGene’s second drug, the Polyphenon(R) E Ointment is undergoing the approval process after acceptance of the marketing authorization application by the US regulatory authority FDA. * The clinical phase II development program for the drug candidate EndoTAG(TM)-1 was started with the initiation of a trial on 200 patients in the pancreatic carcinoma indication. Outlook & forecast for the financial year 2006 Revenues of 30 million euro and achieving of EBIT breakeven point
During the financial year 2006, total revenues should again increase by 50%, to approx. 30 million euro then, and the breakeven point in operating result (EBIT) is expected to be reached at the same time. Approval of the Polyphenon(R) E Ointment in the USA in 2006, and the market launch of Eligard(R) in the remaining European countries according to schedule will be crucial factors for reaching the financial forecast. In addition to the increasing revenues from Eligard(R) sales, MediGene expects to receive further milestone payments from its marketing partner Astellas Pharma Europe Ltd. According to the sales and results forecast, the year-end 2006 cash position will be over 50 million euro.
Regarding the key projects Polyphenon(R) E Ointment and EndoTAG(TM), MediGene expects to reach some important milestones
* Polyphenon(R) E Ointment - completion of approval procedure in the USA;
submission of marketing authorization applications in Europe
The US regulatory authority FDA is currently reviewing MediGene’s marketing authorization application for its Polyphenon(R) E Ointment for commercialization in the indication genital warts. MediGene expects completion of this procedure before the end of this year. Upon approval of the ointment in the USA, MediGene will receive another milestone payment from the marketing and development partner Bradley Pharmaceuticals, Inc.
MediGene is planning to submit the marketing authorization application for this drug in several European countries. The further development in other indications such as actinic keratosis will be agreed with the marketing partner Bradley Pharmaceuticals, Inc.
* EndoTAG(TM)-1 - interim analysis of the ongoing clinical phase II trial
MediGene is currently conducting a clinical phase II trial of the drug candidate EndoTAG(TM)-1 for the treatment of pancreatic cancer. An interim analysis of the results is scheduled for the end of the financial year 2006.
* Extension of the clinical program to other cancer indications with high
sales potential
MediGene is preparing the extension of the EndoTAG(TM)-1 development program in the field of solid tumor treatment. In the second half of 2006, a clinical phase II trial in the indication hormone resistant breast cancer is scheduled to start in Europe. Apart from that, another phase II trial in another cancer indication is in preparation and should be initiated in 2007.
* Extension of the EndoTAG(TM) research beyond oncology by means of 1.4
million euro research grant from the Bavarian Research Foundation
The funds granted for this research program over a period of three years are utilized for the development of the EndoTAG(TM) technology for the treatment of diseases other than cancer. The proof of additional applications of the EndoTAG(TM) technology provides the opportunity for MediGene to close cooperations beyond the main focus oncology at an early stage.
In addition MediGene expects to reach milestones in the following projects:
* Eligard(R): product launch in Europe completed by market launch in 14 additional countries * HSV: interim results of the ongoing phase I/II trial of NV1020 for the treatment of liver metastases
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: “Apart from Eligard(R), the approval and commercialization of the Polyphenon(R) E Ointment will determine MediGene’s development in the short term, whereas the clinical EndoTAG(TM)-1 development projects as well as the extension of this technology to other indications will make the greatest impact on MediGene’s growth. In addition we will review other companies’ products in order to add further clinical product candidates to our drug pipeline, if possible. With our well-balanced product portfolio and our solid cash position we feel very well positioned for the future.”
The annual report 2005 can be accessed at http://www.medigene.de/deutsch/quartalsberichte.php.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgement 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) and EndoTAG(TM) are trademarks of MediGene AG, Polyphenon(R) E is a trademark of Mitsui Norin, Eligard(R) is a trademark of QLT USA, Inc.
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 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: Contact MediGene AG: Dr. Georg Donges, Public Relations, ++49-89-8565-3317, Dr. Michael Nettersheim, Investor Relations,++49-89-8565-2946, Email: investor@medigene.com, Fax: ++49-89-8565-2920
