MediGene Reports First Six Months of 2009: Revenue Increased, Result
Improved
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Total revenue increased by 45% to 20.0 million EUR (6M 2008: 13.8 million EUR) * Improvement of EBITDA by 59% to -6.8 million EUR (6M 2008: -16.5 million EUR) * Net loss reduced by 50% to -8.3 million EUR (6M 2008: -16.6 million EUR) * Analyst conference call with webcast (in English) today at 2.30 pm (CEST)Martinsried/Munich, August 7, 2009. In the first six months of 2009,the biotech company MediGene AG (Frankfurt: MDG, Prime Standard,TecDAX) improved both its revenue and operating result compared tolast year's reporting period. These results are reported incompliance with IFRS (International Financial Reporting Standards).In the first six months of 2009, total revenue increased by 45% to20.0 million EUR (6M 2008: 13.8 million EUR) and were mainlygenerated from the commercialization of Eligard® in Europe. Revenuesalso include income from the first royalties received on sales ofVeregen®, which was recently launched by MediGene's partner Nycomedin the USA, as well as from research grants. The loss on an EBITDAbasis decreased by 59% to -6.8 million EUR in the first six months of2009 (6M 2008: -16.5 million EUR). The net loss for the perioddecreased by 50% to -8.3 million EUR (6M 2008: -16.6 million EUR).Cash used by operating activities decreased by 25% to -11.4 millionEUR in the first six months of 2009 (6M 2008: -15.2 million EUR). Theaverage monthly cash burn rate from operating activities in the firstsix months of 2009 was 1.9 million EUR (6M 2008: 2.5 million EUR).Adjusted by the changes in working capital in early 2009, the netcash burn rate decreased to approx. 1.0 million EUR in 6M 2009.Research and development expenses were reduced by 42%, and selling,general, and administrative expenses by 33%. This decrease resultsmainly from reduced expenses for the mTCR technology, as well as theRhuDexTM and L1 projects.Total revenue in the second quarter 2009 was 8.4 million EUR (Q22008: 8.8 million EUR). The slight decrease in revenue is due toEligard® stockpiling effects at MediGene's partner Astellas in Q12009 which have been re-balanced in Q2 2009. Astellas' direct salesof Eligardÿ have continued to increase in every quarter since marketlaunch. The loss on an EBITDA basis decreased by 45% to -4.9 millionEUR in the second quarter (Q2 2008: -8.9 million EUR). The net lossdecreased by 18% from -7.8 million EUR in the second quarter 2008 to-6.4 million EUR in the second quarter 2009. Cash used by operatingactivities decreased by 45% to -3.1 million EUR in the second quarter2009 (Q2 2008: -5.6 million EUR). The average monthly net cash burnrate from operating activities was 1.0 million EUR in the secondquarter 2009 (Q2 2008: 1.9 million EUR).Cash and cash equivalents at June 30, 2009 totalled 13.5 million EUR(December 31, 2008: 25.1 million EUR). In addition, MediGene hasaccess to additional cash of up to 25 million EUR from an equityfunding agreement signed with YA Global Investments L.P. in 2008.With the exception of a test tranche of 0.1 million EUR, thisfacility has not been used up to now.Major events since the beginning of 2009: * Start of sales promotion and active marketing of Veregen® in the USA through MediGene's partner Nycomed * Listing of the MediGene share on the TechDAX index * Dr. Frank Mathias appointed new Chief Executive Officer of MediGene AG * US regulatory authority grants orphan drug designation for EndoTAG(TM)-1 * Marketing partnership agreement concluded for commercialization of Veregen® in Spain and Portugal * Positive assessment on market authorization for Veregen® in the first European countriesConsolidated income statement (abbreviated)In TEUR Q2 2009 Q2 2008 Change 6M 2009 6M 2008 ChangeTotal revenue 8,374 8,778 -5% 19,988 13,767 45%Cost of sales -6,910 -6,576 5% -14,528 -9,972 46%Gross profit 1,464 2,202 -34% 5,460 3,795 44%Selling, general, andadministrative expenses -1,869 -3,194 -41% -3,905 -5,802 -33%Research and -4,723 -8,258 -43% -8,751 -15,125 -42%development expensesOperating result -5,128 -9,250 -45% -7,196 -17,132 -58%Result before income -6,383 -8,130 -21% -8,316 -17,591 -53%taxNet loss for the period -6,383 -7,795 -18% -8,316 -16,591 -50%Dr. Thomas Klaue, CFO of MediGene AG, commented: "The financialdevelopment and results of the first six months show that MediGene ison the right track. Product sales are increasing and cost-savingmeasures are now making an impact. The conclusion of a partnershipfor our cancer drug EndoTAG(TM)-1 will be crucial for MediGene'sfurther development, and we are pleased to announce that negotiationsfor which have now reached an advanced stage."Forecast:Financial forecast 2009: MediGene confirms the forecast for thefinancial year 2009 to increase revenues, and to reduce the loss onEBITDA basis compared to 2008 (2008: total revenue 40 million EUR,EBITDA -25 million EUR). This financial forecast does not take intoaccount the planned partnership for the cancer drug EndoTAGTM-1.Eligard®: The six-month depot formulation of Eligard® (Eligard® 45mg), which was launched in Germany at the beginning of March 2007 andwhich is now available in 16 other European countries, will also belaunched by Astellas Pharma in additional European countries.MediGene anticipates a continuous rise in the Eligard® market share,driving further increases in European sales revenues from Eligard®.Veregen® (Polyphenon E® Ointment): In February 2009, MediGene'smarketing partner Nycomed started active marketing of Veregen® in theUSA. Therefore MediGene expects increasing sales revenues from thecommercialization of the ointment on the US market.Following the conclusion of a marketing partnership for Veregen® forSpain and Portugal, MediGene expects at least one more marketingpartnership to be concluded before the end of this year.EndoTAG®-1: In October 2008, MediGene presented the results obtainedin a clinical phase II trial of the drug candidate EndoTAGTM-1 forthe treatment of pancreatic carcinoma. Since April 2007, MediGene hasbeen conducting a phase II trial of EndoTAGTM-1 for the treatment oftriple receptor-negative breast cancer. Patient recruitment is to becompleted in 2009, and final evaluation of the trial is expected forthe first six months of 2010. The negotiations for the conclusion ofa global partnership for EndoTAGTM-1 have reached an advanced stage.RhuDex(TM): MediGene has conducted in-vitro tests with RhuDexTM, withthe goal of ruling out any potential connection between the activeingredient and an increased cardiovascular risk. The results obtainedin these studies are now submitted to the regulatory authorities forassessment. Upon approval of the authorities, clinical development ofthe drug candidate may be resumed before the end of this year.oHSV: MediGene is not planning to continue development of oncolyticviruses, and intends to spin off or to sell a license for thistechnology.Analyst conference call with webcast:An analyst conference call in English will take place in Frankfurt at2.30 pm (CEST) today, and will be webcast live. Access to the webcastincluding synchronized slides is possible at the MediGene website atwww.medigene.de. A replay will also be available.The detailed 6-months report is available athttp://www.medigene.de/englisch/quartalsberichte.phpThis press release contains forward-looking statements representingthe opinion of MediGene as of the date of this release. The actualresults achieved by MediGene may differ significantly from thestatements made herein. MediGene is not bound to update any of theseforward-looking statements. MediGene®, EndoTAG(TM), EndoTAG(TM)-1 andVergen® are registered trademarks of MediGene AG. Eligard® is aregistered trademark of QLT USA, Inc. RhuDex(TM) is a trademark ofMediGene Ltd. These trademarks may be owned or licensed in selectlocations 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 thefirst German biotech company to have drugs on the market, which arebeing distributed by partner companies. MediGene has several drugcandidates in clinical development, including EndoTAG(TM)-1, whichcould offer substantial sales returns. In addition, the company hasnumerous projects in research and pre-clinical development andpossesses innovative platform technologies. MediGene focuses on theresearch and development of novel drugs for the treatment of cancerand autoimmune diseases.Contact MediGene AGE-mail: investor(at)medigene.comFax:+49 - 89 - 85 65 - 2920Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 8565 - 3324Dr. Georg Dönges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946 --- End of Message ---MediGene AGLochhamer Strasse 11 Martinsried / München GermanyWKN: 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;
Datum: 07.08.2009 - 07:31 Uhr
Sprache: Deutsch
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