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Home  /   Forum   /   Pharming   /   Week 12 - Release Annual Report 2014

Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) Verschil Volume
0,893   +0,020   (+2,23%) Dagrange 0,884 - 0,901 3.728.995   Gem. (3M) 6,5M

Week 12 - Release Annual Report 2014

Volgen
634 Posts
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  13. [verwijderd] 19 maart 2015 10:08
    quote:

    DickMat schreef op 19 maart 2015 10:03:

    Kan die slijmen nou nooit met een positieve toelichting komen zodat er weer vertrouwen komt. Wel weer 2 opvreters toevoegen
    Nou... Hier mag je best vrolijk van worden hoor... :-)

    CEO’S STATEMENT

    For Pharming, 2014 was a long-awaited year of
    important transitions:

    After starting the year with a significant positive
    correction in valuation, the Company was able to solidify
    its balance sheet by means of a private equity
    placement in April that yielded net proceeds of €14.0
    million.
    In July, the FDA approved Ruconest for acute attacks of
    angioedema in patients with Hereditary Angioedema
    (HAE). The approval is a major milestone for Pharming.
    Until now, there has not been an FDA approved
    recombinant C1 esterase inhibitor option to treat
    symptoms of HAE.

    For many years we have strived to make Ruconest available to the HAE patient community in the US, because we
    are aware of the great value and benefit this product adds to patients’ lives. The unpredictability of HAE can make
    patients feel uncertain about when their next attack might strike, which is why it is important to have a medicine that
    can be administered by the patient themselves. The US market for acute and prophylaxis HAE continued to expand
    during 2014 and is now estimated at almost US$1 billion.
    Ruconest was subsequently launched by US commercialisation partner Salix Pharmaceuticals, in November. In the
    same month the receipt of a US$20.0 million milestone payment was triggered from Salix for the first commercial sale
    of Ruconest in the US.

    In September, the Company acquired certain assets from TRM SASU for €0.5 million in cash, including product leads
    for the development of Enzyme Replacement Therapies (ERT) for Pompe, Fabry’s and Gaucher’s disease and Factor
    VIII for the treatment of Haemophilia A. To facilitate optimisation of these products and to broaden the pipeline
    beyond the Ruconest franchise, we have set up an in-house Paris-based research group for the creation of new
    product leads from our biologics technology platform and for the subsequent development of the product leads to
    approvable products. This will be done either through the strategic collaboration with SIPI for products of mutual
    interest to SIPI and Pharming, such as Factor VIII for Haemophilia A or through Pharming’s in-house new product
    development group (NPD), based in Boston. The NPD group was initiated early in 2015. Dr. Perry Calias, our newly
    appointed Chief Scientific Officer (CSO), will have overall responsibility for the development of these ERT
    programmes and will be based in Boston.

    In October, we announced the initiation of direct commercialisation of Ruconest in Austria, Germany and the
    Netherlands. We have hired a small European team of experienced HAE commercialisation and medical affairs
    specialists to lead the direct commercialisation activities in these countries. This step forward into direct
    commercialisation of Ruconest became possible as result of our improved balance sheet and opens up new
    opportunities for Pharming to not only grow revenues, but also, as those revenues build, to put in place the right size
    of specialist commercial infrastructure which could, over time, be leveraged through the marketing of other products.
    Another potential driver of such transition is the ongoing Phase II study for Ruconest in the additional indication of
    prophylaxis of HAE. This study is the first step of a 50/50 shared cost development programme with our US partner
    Salix. The study was started in September and is being conducted at sites in Europe and the United States.

    The first patient was enrolled in early January 2015, patient enrollment for the study continues. Pharming and Salix
    will equally share the development costs for Ruconest for HAE prophylaxis and Pharming will receive an undisclosed
    milestone payment from Salix at FDA approval for this additional indication.
    All of this means that we have now established a platform from which we can confidently build a financially
    sustainable enterprise with a pipeline beyond the Ruconest franchise.
    To effectuate the transition into a financially sustainable enterprise we depend on revenues from Ruconest sales
    from:
    ? Salix launched Ruconest in November 2014 in the US. Ruconest is made available to eligible HAE patients in the
    US under a full service patient support programme; Ruconest Solutions.
    ? Swedish Orphan Biovitrum AB (Sobi) continues to be the distributor for the EU countries and former CIS
    countries.
    ? Pharming’s direct commercialisation activities in Austria, Germany and the Netherlands. Early 2015, Pharming
    developed RucoVitae™; a full service support programme for the treatment of acute attacks of HAE with
    Ruconest for eligible HAE patients in Austria, Germany and the Netherlands.
    ? MegaPharm Ltd. launched Ruconest during the 2nd
    half of 2014 in Israel.
    As a result of our achievements in 2014 and the ongoing development projects, we look forward with confidence to an
    exciting 2015, with potentially significant value-inflexion points and again increasing Ruconest sales, both from our
    partners and as a result of our own commercialisation activities.
    I would like to thank all of our employees, investors and partners for their ongoing commitment and support during
    2014 and for keeping faith in Pharming’s potential to be unlocked. I look forward to the continued delivery on our
    challenging objectives during what promises to be yet another very busy year in the continuing transition of Pharming.

    Leiden, 18 March 2015

    Sijmen de Vries
    Chief Executive Officer and Chairman o
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