MARTINSRIED/MUNICH, Germany and SAN DIEGO, May 4 /PRNewswire-FirstCall/ -- The German-American biotech company MediGene AG (Frankfurt, Prime Standard: MDG) has again significantly improved its results in the first quarter 2005.
In the first three months 2005, MediGene's net loss decreased by 37 % to -0.9 million EUR (Q1-2004: -1.5 million EUR). This improvement mainly results from the successful completion of the clinical phase III trial of the Polyphenon(R) E Ointment end of 2004 which declined the R&D expenses by 13 % to 3.3 million EUR in the first quarter 2005 (Q1-2004: 3.8 million EUR). Earnings before interest and tax (EBIT) was -1.3 million EUR (Q1-2004: -1.3 million EUR). The loss per share was reduced by 50 % to -0.05 EUR (number of shares approx. 18.5 million), compared with -0.10 EUR in the first quarter 2004 (number of shares approx. 12.3 million).
Total revenues amounted to 3.8 million EUR in the first three month of 2005 (Q1-2004: 3.9 million EUR), comprising milestone payments as well as proceeds from product sales and royalties for the company's first drug on the market, i.e. Eligard(R). The cancer drug Eligard(R) has been available on the German market since May 2004 and is sold by MediGene's marketing partner, Astellas Pharma Europe Ltd. (previously Yamanouchi Ltd.). The sales revenues in last year's reporting period were generated mainly by an upfront payment upon conclusion of the partnership with Astellas Pharma (Yamanouchi at that time).
MediGene's average monthly net cash burn rate during the first three months 2005 was 1.3 million EUR. MediGene's cash position as at March 31, 2005 was 44.7 million EUR (Q1-2004: 38.0 million EUR). The quarterly financial statement of MediGene was compiled in accordance with the International Financial Reporting Standards (IFRS) instead of US GAAP for the first time. However, this did not have any major effect on the results for the period.
Alexander Dexne, MediGene's Chief Financial Officer, comments: "The excellent quarterly results are clear evidence that MediGene succeeds in continuously improving its operating results. In our opinion, this is an important intermediate result in our strategy of implementing our ambitious goals regarding growth and result for the ongoing financial year successfully."
Outlook: MediGene confirms the company's forecast for the year 2005. The company expects total revenues of approx. 20 million EUR and a reduction of its net loss to less than 10 million EUR. As major milestones for 2005, the company anticipates the completion of the clinical phase II trial of the Polyphenon(R) E Ointment in the indication actinic keratosis (precursor of skin cancer), the submission of the marketing authorization application for Polyphenon(R) E Ointment to the American regulatory authority FDA, the conclusion of a marketing partnership for Polyphenon(R) E Ointment, the initiation of a phase II clinical trial for the drug candidate EndoTAG-1, as well as the market launch of Eligard(R) in additional European countries.
Consolidated Income Statement (Abbreviated)
Q1-2005 Q1-2004 Change
(in thousands of euros)
Total revenues 3,824 3,910 -2 %
Cost of sales 372 28 >200 %
Gross profit 3,452 3,882 -11 %
General, administrative and
selling expenses 1,414 1,398 1 %
Research and development
expenses 3,298 3,795 13 %
EBIT -1,260 -1,311 4 %
Net loss from continued
operations -947 -1,222 23 %
Result from discontinued
operations -1 -281 100 %
Net loss -948 -1,503 37 %
The complete 3-Months Report 2005 is available at http://www.medigene.de/englisch/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) is a trademark of MediGene AG. Eligard(R) is a trademark of QLT USA, Inc. Polyphenon(R) E is a trademark of Mitsui Norin.
MediGene AG is a publicly quoted (Frankfurt: TecDAX), 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 company has the most mature drug development pipeline in the German biotech industry with oncological drug candidates undergoing clinical phase I - III trials (phase III completed). In addition, MediGene possesses innovative platform technologies with its HSV technology and the newly acquired EndoTAG technology. MediGene's core competence lies in research and development of novel approaches for the treatment of various tumor diseases.