News

MediGene Reports First Six Months of 2009: Revenue Increased, Result Improved

     

     

    • 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 to last year's reporting period. These results are reported in compliance with IFRS (International Financial Reporting Standards).

     

     

     

    In the first six months of 2009, total revenue increased by 45% to 20.0 million EUR (6M 2008: 13.8 million EUR) and were mainly generated from the commercialization of Eligard® in Europe. Revenues also include income from the first royalties received on sales of Veregen®, which was recently launched by MediGene's partner Nycomed in the USA, as well as from research grants. The loss on an EBITDA basis decreased by 59% to -6.8 million EUR in the first six months of 2009 (6M 2008: -16.5 million EUR). The net loss for the period decreased by 50% to -8.3 million EUR (6M 2008: -16.6 million EUR). Cash used by operating activities decreased by 25% to -11.4 million EUR in the first six months of 2009 (6M 2008: -15.2 million EUR). The average monthly cash burn rate from operating activities in the first six 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 net cash 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 results mainly from reduced expenses for the mTCR technology, as well as the RhuDexTM and L1 projects.

     

     

     

    Total revenue in the second quarter 2009 was 8.4 million EUR (Q2 2008: 8.8 million EUR). The slight decrease in revenue is due to Eligard® stockpiling effects at MediGene's partner Astellas in Q1 2009 which have been re-balanced in Q2 2009. Astellas' direct sales of EligardÒ have continued to increase in every quarter since market launch. The loss on an EBITDA basis decreased by 45% to -4.9 million EUR in the second quarter (Q2 2008: -8.9 million EUR). The net loss decreased 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 operating activities decreased by 45% to -3.1 million EUR in the second quarter 2009 (Q2 2008: -5.6 million EUR). The average monthly net cash burn rate from operating activities was 1.0 million EUR in the second quarter 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 has access to additional cash of up to 25 million EUR from an equity funding agreement signed with YA Global Investments L.P. in 2008. With the exception of a test tranche of 0.1 million EUR, this facility 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 countries

     

     

     

     

     

     

     
    Consolidated income statement (abbreviated)
     
    In TEUR
     
     
     
    Q2 2009
     
     
     
     
     
    Q2 2008
     
     
     
    Change
     
     
     
    6M 2009
     
     
     
     
     
    6M 2008
     
     
     
    Change
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
    Total 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, and administrative expenses
     
    -1,869
     
     
     
    -3,194
     
    -41%
     
    -3,905
     
     
     
    -5,802
     
    -33%
     
    Research and development expenses
     
    -4,723
     
    -8,258
     
    -43%
     
    -8,751
     
    -15,125
     
    -42%
     
    Operating result
     
    -5,128
     
    -9,250
     
    -45%
     
    -7,196
     
    -17,132
     
    -58%
     
    Result before income tax
     
    -6,383
     
    -8,130
     
    -21%
     
    -8,316
     
    -17,591
     
    -53%
     
    Net loss for the period
     
    -6,383
     
    -7,795
     
    -18%
     
    -8,316
     
    -16,591
     
    -50%

     


    Dr. Thomas Klaue, CFO of MediGene AG,
    commented: "The financial development and results of the first six months show that MediGene is on the right track. Product sales are increasing and cost-saving measures are now making an impact. The conclusion of a partnership for our cancer drug EndoTAG(TM)-1 will be crucial for MediGene's further development, and we are pleased to announce that negotiations for which have now reached an advanced stage."

     

     

     

    Forecast:

     


    Financial forecast 2009: MediGene confirms the forecast for the financial year 2009 to increase revenues, and to reduce the loss on EBITDA basis compared to 2008 (2008: total revenue 40 million EUR, EBITDA -25 million EUR). This financial forecast does not take into account the planned partnership for the cancer drug EndoTAGTM-1.

     

     

     

    Eligard®: The six-month depot formulation of Eligard® (Eligard® 45 mg), which was launched in Germany at the beginning of March 2007 and which is now available in 16 other European countries, will also be launched 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's marketing partner Nycomed started active marketing of Veregen® in the USA. Therefore MediGene expects increasing sales revenues from the commercialization of the ointment on the US market.

     

     

     

    Following the conclusion of a marketing partnership for Veregen® for Spain and Portugal, MediGene expects at least one more marketing partnership to be concluded before the end of this year.

     

     

     

    EndoTAG®-1: In October 2008, MediGene presented the results obtained in a clinical phase II trial of the drug candidate EndoTAGTM-1 for the treatment of pancreatic carcinoma. Since April 2007, MediGene has been conducting a phase II trial of EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer. Patient recruitment is to be completed in 2009, and final evaluation of the trial is expected for the first six months of 2010. The negotiations for the conclusion of a global partnership for EndoTAGTM-1 have reached an advanced stage.

     

     

     

    RhuDex(TM): MediGene has conducted in-vitro tests with RhuDexTM, with the goal of ruling out any potential connection between the active ingredient and an increased cardiovascular risk. The results obtained in these studies are now submitted to the regulatory authorities for assessment. Upon approval of the authorities, clinical development of the drug candidate may be resumed before the end of this year.

     

     

     

    oHSV: MediGene is not planning to continue development of oncolytic viruses, and intends to spin off or to sell a license for this technology.

     

     

     

    Analyst conference call with webcast:

     

    An analyst conference call in English will take place in Frankfurt at 2.30 pm (CEST) today, and will be webcast live. Access to the webcast including synchronized slides is possible at the MediGene website at  www.medigene.de. A replay will also be available.

     


    The detailed 6-months report is available at www.medigene.de/englisch/quartalsberichte.php

     

     

     

     

     

    This press release contains forward-looking statements representing the opinion of MediGene as of the date of this release. The actual results achieved by MediGene may differ significantly from the statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene®, EndoTAG(TM), EndoTAG(TM)-1 and Vergen® are registered trademarks of MediGene AG. Eligard® is a registered trademark of QLT USA, Inc. RhuDex(TM) is a trademark of MediGene Ltd. These trademarks may be owned or licensed in select locations 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 the first German biotech company to have drugs on the market, which are being distributed by partner companies. MediGene has several drug candidates in clinical development, including EndoTAG(TM)-1, which could offer substantial sales returns. In addition, the company has numerous projects in research and pre-clinical development and possesses innovative platform technologies. MediGene focuses on the research and development of novel drugs for the treatment of cancer and autoimmune diseases.

     

     

     

    Contact MediGene AG

     

    E-mail: investor@medigene.com

     

    Fax:+49 - 89 - 85 65 - 2920

     

    Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 85 65 - 3324

     

    Dr. Georg Dönges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946