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Home  /  Forum  /  Pharming  /  SOBI

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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

  • 0,908 23 apr 2024 17:35
  • 0,000 (0,00%) Dagrange 0,905 - 0,923
  • 4.300.077 Gem. (3M) 6,9M

SOBI

3 Posts
| Omlaag ↓
  1. Berdientje 19 februari 2015 09:37
    Sobi publishes its Report for the Fourth Quarter and Full Year 2014
    2015-02-19
    Swedish Orphan Biovitrum AB (publ) (Sobi) today announced its results for the fourth quarter and full year 2014. Revenues for the year totalled SEK 2,607 M (2,177), an increase of 20 per cent. Revenues in the fourth quarter were 15 per cent higher compared to the previous year. All parts of the business contributed to the result with Orfadin® and the Partner Products portfolio delivering strong performance.

    Business Highlights Q4 2014

    Received positive opinion by the CHMP regarding Xiapex for the treatment of Peyronie's disease
    Exercised opt-in right for Elocta(TM)
    Marketing Authorisation Application for Elocta filed and validated for review by EMA
    Orfadin approved in Japan
    Financial Highlights Q4 2014 (Q4 2013)

    Total revenues were SEK 705.3 M (610.8)
    Product revenues were SEK 575.3 M (448.0)
    Gross margin was 60 per cent (59)
    EBITA was SEK 38.2 M (65.2)
    EBITA excluding write-downs (Multiferon) was SEK 63.4 M (65.2)
    Financial Highlights FY 2014 (FY 2013)

    Total revenues were SEK 2,607.0 M (2,176.7)
    Product revenues were SEK 1,988.8 M (1,557.7)
    Gross margin was 59 per cent (59)
    EBITA was SEK -43.4 M (211.0)
    EBITA excluding write-downs (Kiobrina/Multiferon) was SEK 306.7 M (211.0)
    Ended the year with a cash position of SEK 519.1 M (445.1)[1]
    "2014 was a pivotal year for Sobi marked by excellent commercial performance across the portfolio. Total revenues were SEK 2,607 million, an increase of 20 per cent over the prior year and above our estimates. Cash flow increased year over year and gross margin was stable," said Geoffrey McDonough, CEO and President.

    "Looking at our development portfolio, the positive results of the Kids A-LONG study paved the way for the European filing of Elocta in October 2014, making EU approval possible before the end of 2015. As a result we formally exercised our opt-in right to take over final development and commercialisation in our territories. During 2014 we have been focused on building a world class haemophilia organisation to support launch and commercialisation and this will be expanded in 2015."

    Financial Summary
    Q4 Q4 Full year Full year
    Amounts in SEK M 2014 2013 Change 2014 2013 Change
    Total revenues 705.3 610.8 15% 2,607.0 2,176.7 20%
    Gross profit 426.6 358.3 19% 1,547.8 1,284.0 21%
    Gross margin 60% 59% 59% 59%
    EBITA2 38.2 65.2 -41% -43.4 211.0 <-100%
    EBITA excluding write-downs 63.4 65.2 -3% 306.7 211.0 45%
    EBIT (Operating profit/loss) -32.7 -4.9 <-100% -325.0 -66.6 <-100%
    Profit/loss for the period -17.4 -13.4 -30% -267.8 -93.0 <-100%

    2 2014 FY includes write-downs relating to Kiobrina of SEK 324.9 M and Multiferon of SEK 25.2 M. Multiferon is also included in the quarter.
    Outlook 2015

    For 2015, Sobi expects total revenues for the full year to be in the range of SEK 2,800 to 3,000 M, and gross margin to be in the range of 58-60 percent. Operating costs are projected to increase as the company continues to prepare for the planned launch of Elocta. Sobi expects EBITA to be in line with the adjusted 2014 level. The outlook for 2015 is based on current exchange rates, and excludes revenue from the European launch of Elocta.

    - - -

    Sobi's report for the fourth quarter and full year 2014 can be found on www.sobi.com/Investors--Media/Reports/.
  2. Berdientje 19 februari 2015 09:39
    Invitation - Presentation of Sobi's fourth quarter and full year results 2014
    2015-02-12
    On 19 February, at 08:00 CET, Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the fourth quarter and full year 2014.

    Financial analysts and media are invited to participate in a telephone conference, which will include a presentation of the results, at 12:30 CET. The event will be hosted by Sobi's CEO and President, Geoffrey McDonough, and the presentation will be held in English.

    The presentation can be followed live, or afterwards on www.sobi.com. Slides used in the presentation will be made available on our website prior to the telephone conference.

    To participate in the telephone conference, please call:

    SE: +46 8 566 426 69
    UK: +44 203 428 1413
    US: +1 855 831 5944

    Live audience URL: event.onlineseminarsolutions.com/r.ht...

    (The recording will be made available via the audience URL three hours after the live broadcast using the same link.)

    - - -
  3. Berdientje 19 februari 2015 09:41
    New long-term data to be presented on Elocta(TM) at annual EAHAD meeting
    2015-02-05
    Swedish Orphan Biovitrum AB (publ) (Sobi) in collaboration with Biogen Idec will present new data from their haemophilia clinical development programmes at the 8th European Association for Haemophilia and Allied Disorders (EAHAD), taking place in Helsinki, Finland, February 11 - 13, 2015. Six abstracts will be presented, including new, interim results from the ASPIRE long-term extension study. Results from the Kids A-LONG, A-LONG, and B-LONG Phase 3 studies will also be presented.

    "We are pleased to continuously share emerging evidence generated from the pivotal clinical programs for the product candidates Elocta and rFIXFc. The new interim results from the ASPIRE study, presented in collaboration with Biogen Idec, discuss the longer term use of Elocta in people with severe haemophilia A, followed in an open label extension from the pivotal A-LONG study, and further establishes the efficacy and safety of Elocta", says Birgitte Volck, MD, PhD, Senior Vice President, Chief Medical Officer at Sobi.

    The titles of the poster presentations are as follows:

    Elocta (rFVIIIFc):

    Long-term safety and efficacy of recombinant factor VIII Fc (rFVIIIFc) in adults and adolescents with severe haemophilia A: an interim analysis of the ASPIRE study; PP066

    Interim analysis of the ASPIRE study evaluating long-term safety and efficacy of recombinant factor VIII Fc (rFVIIIFc) in children with severe haemophilia A; PP076

    Perioperative management of subjects with haemophilia A in the ASPIRE study with long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc); PP116

    Safety, efficacy, and pharmacokinetics of recombinant factor VIII Fc fusion protein (rFVIIIFc) in previously treated paediatric subjects with severe haemophilia A (Kids A-LONG); PP032

    Subject-reported changes in physical activity during the A-LONG study of recombinant factor VIII Fc fusion protein (rFVIIIFc) for severe haemophilia A; PP035
    Alprolix® (rFIXFc):

    Subject-reported changes in physical activity during the B-LONG study of recombinant factor IX Fc fusion protein (rFIXFc) for severe haemophilia B; PP028
    ---

    About Elocta (rFVIIIFc)
    Elocta is a long-acting recombinant factor VIII Fc fusion protein product candidate for people with haemophilia A. Elocta is the trade name in Europe for rFVIIIFc, also known as Eloctate®[Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the US, Canada, Australia, and Japan, where it is approved for the treatment of haemophilia A. A Marketing Authorisation Application for Elocta is currently under review by the European Medicines Agency.

    About Alprolix (rFIXFc)
    rFIXFc is a long-acting recombinant factor IX Fc fusion protein product candidate for people with haemophilia B. Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is approved for the treatment of haemophilia B in the US, Canada, Australia, and Japan.

    About the Sobi and Biogen Idec collaboration
    Sobi and Biogen Idec are partners in the development and commercialisation of Elocta/Eloctate/rFVIIIFc for haemophilia A and Alprolix/rFIXFc for haemophilia B. Sobi has final development and commercialisation rights for rFVIIIFc in the Sobi territories (Europe, North Africa, Russia and certain Middle Eastern markets), as well as an opt-in right to take over final development and commercialisation of Alprolix/rFIXFc in the Sobi territories. Biogen Idec leads development for Elocta/Eloctate/rFVIIIFc and Alprolix/rFIXFc, has manufacturing rights, and has commercialisation rights in North America and all other regions in the world excluding the Sobi territories.
3 Posts
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