MediGene AG Reports First Nine Months of 2009: Increase in Revenue
and Reduction of Loss
(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 12% to 28.6 million EUR (9M 2008: 25.5 million EUR)* EBITDA improved by 33% to -13.1 million EUR (9M 2008: -19.5 million EUR)* Net loss reduced by 37% to 15.9 million EUR (9M 2008: 25.0 million EUR)* Forecast for the full year clarified* Analyst conference call with webcast (in English) at 2.30 pm (CET) todayMartinsried/Munich, November 13, 2009. In the first nine months of2009, the biotech company MediGene AG (Frankfurt: MDG, PrimeStandard, TecDAX) improved its total revenue and EBITDA, and reducedits net loss compared to last year's reporting period. These resultsare reported in compliance with IFRS (International FinancialReporting Standards).Total revenue, generated mainly from the commercialization of thedrug Eligardÿ in Europe, amounted to 28.6 million EUR in the firstnine months of 2009 (9M 2008: 25.5 million EUR) and to 8.6 millionEUR in the third quarter 2009 (Q3 2008: 11.7 million EUR). Thedecrease in total revenue when comparing the third quarters is due toa one-time revenue item of 4.4 million EUR posted for the sale of therights to Oraceaÿ to Galderma in 2008. Adjusted for this one-timeeffect, revenue for the third quarter increased by 17 % compared tolast year's reporting period.The loss on an EBITDA basis in the third quarter of 2009 amounted to6.3 million EUR compared to last year's reporting period (Q3 2008:3.0 million EUR). Adjusted to the above-mentioned one-time item, theresult was also significantly improved. In the first nine months of2009, the loss on an EBITDA basis was reduced by 33 % to 13.1 millionEUR (9M 2008: 19.5 million EUR).The net loss was reduced by 37% to 15.9 million EUR in the first ninemonths of 2009 (9M 2008: 25.0 million EUR), and to 7.6 million EUR inthe third quarter 2009 (Q3 2008: 8.4 million EUR). This decrease isprimarily due to increased revenue, reduced R&D expenses, of whichthe mTCR technology spin-off contributed significantly, and toreduced selling, general, and administrative expenses during thefirst nine months of 2009. R&D expenses decreased by 37% to 13.6million EUR in the first nine months of 2009 (9M 2008: 21.7 millionEUR), and by 27% to 4.8 million EUR in the third quarter of 2009 (Q32008: 6.6 million EUR).Cash used by operating activities decreased by 32% to -15.7 millionEUR in the first nine months of 2009 (9M 2008: -23.0 million EUR),and by 45% to -4.3 million EUR in the third quarter of 2009 (Q3 2008:-7.8 million EUR). The average monthly net cash burn rate fromoperating activities in the first nine months of 2009 was 1.7 millionEUR (9M 2008: 2.6 million EUR), and 1.4 million EUR in the thirdquarter of 2009 (Q3 2008: 2.6 million EUR).As at closing date September 30, 2009, cash and cash equivalentstotalled 9.7 million EUR. In addition MediGene has access toadditional cash of up to 25 million EUR from an equity fundingagreement signed with YA Global Investments L.P. in 2008. In October2009 MediGene called two tranches from this SEDA program, and theproceeds collected against issue of 429,553 shares, which totalled2 million EUR, are not included in the figures herein.Major events in the first nine months of 2009: * MediGene shares admitted to the TecDAX stock index * Dr. Frank Mathias appointed new Chief Executive Officer of MediGene AG * Reorganization initiated: shift of employees and financial resources to clinical development * Start of sales promotion and active marketing of Veregen® in the USA through MediGene's partner Nycomed * Positive assessment on market authorization for Veregen® in the first European countries, marketing authorization granted in Germany * Marketing partnership agreements concluded for commercialization of Veregen® in Spain and Portugal, and in Germany, Austria, and Switzerland * US regulatory authority grants orphan drug designation for EndoTAGTM-1Consolidated income statement (abbreviated)In T? Q3 2009 Q3 2008 Change 9M 2009 9M 2008 Change unaudited unaudited unaudited unauditedProduct sales 8,403 6,837 23% 26,988 19,706 37%Other operating 176 4,905 -96% 1,580 5,804 -73%incomeTotal revenue 8,579 11,742 -27% 28,568 25,510 12%Cost of sales -7,321 -6,039 21% -21,850 -16,012 36%Gross profit 1,258 5,703 -78% 6,718 9,498 -29%Selling,general, andadministrativeexpenses -2,971 -2,378 25% -6,876 -8,180 -16%Research anddevelopmentexpenses -4,809 -6,559 -27% -13,560 -21,684 -37%Loss resulting 0 -6,384 -% 0 -6,384 -%from spin-offOperating -6,522 -9,618 -32% -13,718 -26,750 -49%resultResult before -7,522 -9,058 -17% -15,838 -26,650 -41%income taxNet loss for -7,550 -8,402 -10% -15,866 -24,994 -37%the periodDr. Thomas Klaue, Chief Financial Officer of MediGene AG, commented:"During the first nine months of 2009 MediGene further increasedrevenue and significantly reduced loss. Moreover the equity fundingagreement closed with YA Global Investments L.P. allows us to collecta total of 25 million euros additional cash. This enables us tostabilize MediGene's financial cushion, thus strengthening ournegotiating position for the conclusion of a partnership for ourcancer drug EndoTAGTM-1. We drew the first tranches of cash in thefourth quarter of 2009. It remains our goal to reach the mostfavourable, and not necessarily the fastest achievable, partnershipagreement for EndoTAGTM-1."Forecast 2009:Financial forecast: MediGene today clarifies its forecast for thefull year 2009 as originally published in March 2009. MediGeneexpects to increase sales by approximately 13% to approximately 38million EUR and to generate total revenue of approximately 40 millionEUR (2008: total revenue 39.6 million EUR, sales revenue 33.5 millionEUR). MediGene's previous forecast for 2009 was for increased totalrevenue compared to 2008, and this increase in total revenue will notbe achieved because certain milestone payments from existing Veregen®partnerships which were planned for 2009 will now be posted in 2010.However, MediGene confirms the forecast published in March 2009 whichwas to reduce the loss on EBITDA basis compared to last year.Depending on the date of allocation of a certain cost pool related toEndoTAGTM-1, MediGene expects the result on an EBITDA basis to be inthe range of -20 to -23 million EUR (2008: EBITDA -24.6 million EUR).This financial forecast does not take into account any proceeds fromthe intended partnership on EndoTAGTM-1.Eligard®: MediGene anticipates a continuous rise in the Eligard®market share, as well as a further increase in European salesrevenues achieved with Eligard®, driven particularly by the six-monthdepot formulation of Eligard® (Eligard® 45 mg).Veregen® (Polyphenon E®-Salbe): In February 2009, MediGene'smarketing partner Nycomed started active marketing of the drugVeregen® in the USA. Therefore MediGene expects increasing salesrevenues for the financial year 2009 from the commercialization ofthe ointment on the US market. The launch of the drug on the firstEuropean markets is expected in 2010.EndoTAGTM-1: The final evaluation of the ongoing clinical phase IItrial of EndoTAGTM-1 for the treatment of triple receptor-negativebreast cancer is expected during the first half of 2010. In 2009MediGene expects either the conclusion of a partnership or furtherprogress in the partnering process.RhuDexTM: Since the UK regulatory authority MHRA consented in October2009 to the continuation of the clinical development of the drugcandidate in coordination with the authorities, MediGene is nowpreparing the further development plan..oHSV and AAV: MediGene is not planning to continue development ofoncolytic viruses, and intends to spin off or to sell a license forthis technology, similar to that achieved in the successful mTCRspin-off. In addition MediGene is also planning to spin off the AAVresearch program into an independent company.Analyst conference call with webcast: An analyst conference call inEnglish will take place at 2.30 pm (CET) today, and will be webcastlive. Access to the webcast including synchronized slides is possibleat the MediGene website at www.medigene.de. A replay will also beavailable.The detailed 9-months report is available at:http://www.medigene.de/englisch/quartalsberichte.phpAdvance notice: On December 15, 2009, MediGene's annual analystconference will take place in Frankfurt. This event will also bewebcast live. MediGene's management will report on its strategy, thestatus and design of the development programs, as well as the statusof the partnering and spin-off processes. In addition MediGene willpresent its future business and finance plan. Time and agenda of theconference as well as the webcast link will be communicated in goodtime.This 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: MDG, Prime Standard,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 and has several drugcandidates in clinical development, two of which provide significantsales potential. In addition, the company has numerous projects inresearch and pre-clinical development and possesses innovativeplatform technologies. MediGene focuses on the research anddevelopment of novel drugs for the treatment of cancer and autoimmunediseasesContact 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;
Bereitgestellt von Benutzer: hugin
Datum: 13.11.2009 - 07:30 Uhr
Sprache: Deutsch
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