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Vrijdag 8 augustus festival friday

247 Posts
Pagina: 1 2 3 4 5 6 ... 13 »» | Laatste | Omlaag ↓
  1. [verwijderd] 7 augustus 2014 21:05
    Het weekend staat weer voor de deur. En dus kunnen we de week weer positief afsluiten.

    Succes iedereen. en maak voor een ieder een gezellig weekend van op het terras of op een gezellig festival of waar dan ook.
  2. [verwijderd] 7 augustus 2014 22:16
    Over the last few months, we achieved a number of important milestones for our business that enhance our competitive position and expand our market opportunities. Our new digestive disease specialty sales force has made significant progress in a short period of time in increasing our prescriber base, particularly with primary care physicians. Regarding our products, on July 1 we announced the statistically significant outcome of TARGET 3 evaluating the efficacy of repeat treatment with XIFAXAN 550 for Irritable Bowel Syndrome with Diarrhea (IBS-D); on July 10 the Food and Drug Administration (FDA) approved our request which was submitted under appeal that RELISTOR Subcutaneous Injection be approved to treat opioid-induced constipation in patients taking opioids for chronic, non-cancer pain on data submitted in our supplemental NDA (sNDA) and on July 16 the FDA approved RUCONEST for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). We view all of these positive events as catalysts for Salix to amplify its growth. In addition, our pending transaction with Cosmo Technologies Limited further strengthens our position as a leading gastrointestinal-focused company, adding highly complementary pipeline products to our portfolio while enhancing our profitability.

    Cijfers salix, niet slecht en zie RUCONEST!
  3. [verwijderd] 7 augustus 2014 22:20
    On July 10, 2014, the FDA Office of Drug Evaluation III approved Salix’s request that the FDA approve the RELISTOR Subcutaneous Injection sNDA for the treatment of OIC in patients with chronic, non-cancer pain. In regard to the sNDA the FDA directed Salix to submit certain information to the Division of Gastroenterology and Inborn Errors Products (DGIEP). On July 25 Salix submitted the requested information to the DGIEP. The Company currently expects a two month review in order to complete the label review and agree upon post-marketing commitments and requirements.
    The Company intends to meet with the FDA as soon as possible to discuss a path forward for RELISTOR Oral for the treatment of OIC in patients with chronic, non-cancer pain.
    OTHER

    RUCONEST® - On July 16, 2014, the FDA approved RUCONEST® (CI Esterase Inhibitor [Recombinant]) 50IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). The Company plans on making RUCONEST® accessible to patients in the fourth quarter of 2014.
    UCERIS (budesonide) Rectal Foam - The FDA has issued a Prescription Drug User Fee Act (PDUFA) Action Date of September 15, 2014.
    SOLESTA® - During the second quarter data demonstrating the long-term safety and efficacy of SOLESTA over three years were published in Neurogastroenterology & Motility and a 3-year cost effectiveness model for SOLESTA was published in Clinical Therapeutics. These publications should help facilitate consistent and improved coverage among commercial payers.
  4. [verwijderd] 7 augustus 2014 22:22
    Financial Outlook

    Adam Derbyshire, Executive Vice President and Chief Financial Officer, stated, “We continue to see considerable momentum in our business, which we expect to accelerate through the second half of the year. We have achieved several key milestones over the last several months, our new sales infrastructure is beginning to gain traction and prescriptions for our key products are growing. Our third quarter outlook reflects our expectation for some adjustments in the supply chain to continue into the quarter as wholesalers more closely manage inventory levels. However, we expect to see a strong fourth quarter, which historically has been our strongest quarter, as the business continues to realize the combined impact of strong prescription growth and rising productivity of our new digestive disease sales force.”

    Current annualized run rates, based on dollarizing June 2014 prescription data, are approximately $712 million for XIFAXAN®; $124 million for UCERIS®; $159 million for APRISO®; $227 million for GLUMETZA®, $108 million for ZEGERID®; $99 million for MOVIPREP®/OSMOPREP®; $45 million for RELISTOR®; and $76 million for Salix’s “other products”.

    For the full year 2014, Salix expects:

    Total net product revenue of approximately $1.6 billion.
    Gross margins of approximately 78%.
    Non-GAAP research and development costs of approximately $165 million.
    Non-GAAP selling, general and administrative expenses of approximately $430 million.
    EBITDA, excluding expenses associated with the acquisition of Santarus and the pending merger with Cosmo Technologies, of approximately $650 million.
    Non-GAAP net income of approximately $475 million, or $6.16 per diluted share. The change in per share amount from prior guidance is due to the effect of the Company’s higher stock price on the fully diluted share calculation.
    Assumes a cash income tax rate of approximately 12%.
    Fully diluted shares of 77.0 million.
    For the third quarter of 2014, Salix expects:

    Total net product revenue of approximately $395.0 million.
    Gross margins of approximately 78%.
    Non-GAAP research and development costs of approximately $45 million.
    Non-GAAP selling, general and administrative expenses of approximately $110 million.
    EBITDA, excluding expenses associated with the acquisition of Santarus and the pending merger with Cosmo Technologies, of approximately $155.0 million.
    Non-GAAP net income of approximately $121.0 million, or $1.53 per diluted share.
    Assumes a cash income tax rate of approximately 6%.
    Fully diluted shares of 79.0 million.
    The following table reconciles future guidance for non-GAAP measures to the most closely related GAAP measures. See “Use of Non-GAAP Financial Measures” below.

    Salix Pharmaceuticals, Ltd.
    Reconciliation of GAAP Guidance to Non-GAAP Guidance
    (In millions, except per share data)
  5. [verwijderd] 7 augustus 2014 22:53
    RUCONEST® - On July 16, 2014, the FDA approved RUCONEST® (CI Esterase Inhibitor [Recombinant]) 50IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). The Company plans on making RUCONEST® accessible to patients in the fourth quarter of 2014

    Read more: www.nasdaq.com/press-release/salix-ph...
  6. [verwijderd] 7 augustus 2014 22:58
    quote:

    tb alrac schreef op 7 augustus 2014 22:53:

    RUCONEST® - On July 16, 2014, the FDA approved RUCONEST® (CI Esterase Inhibitor [Recombinant]) 50IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). The Company plans on making RUCONEST® accessible to patients in the fourth quarter of 2014

    Read more: www.nasdaq.com/press-release/salix-ph...
    Nog even geduld hebben dus! Of zou PH voor die tijd toch overgenomen zijn?
  7. [verwijderd] 7 augustus 2014 23:14
    quote:

    surveyor schreef op 7 augustus 2014 22:58:

    [...]

    Nog even geduld hebben dus! Of zou PH voor die tijd toch overgenomen zijn?
    Mijn gevoel zegt overname om dan meteen meer druk op ontwikkeling van ruconest tbv pancreatitis te zetten.
  8. [verwijderd] 7 augustus 2014 23:21
    quote:

    tb alrac schreef op 7 augustus 2014 23:14:

    [...]Mijn gevoel zegt overname om dan meteen meer druk op ontwikkeling van ruconest tbv pancreatitis te zetten.
    Of, goedkoper, research subsidieren zoals intel, samsung etc bij asml doen. Zou druk in een keer van de ketel nemen bij Pha
  9. [verwijderd] 7 augustus 2014 23:28
    Sorry,maar kpn forum is minder actief op dit moment, svp hulp, via google - fd kpn - zie ik na 17:30 uur bij de omzet een uitschieter, wat kan hier aan de hand zijn?
  10. [verwijderd] 7 augustus 2014 23:30
    quote:

    tb alrac schreef op 7 augustus 2014 23:14:

    [...]Mijn gevoel zegt overname om dan meteen meer druk op ontwikkeling van ruconest tbv pancreatitis te zetten.
    Waarom zou daar een overname voor nodig zijn dan? Het huidige Ruconest contract is het meest voordelig voor Salix aangezien zij niet de onkosten van Pharming erbij krijgen. Salix regelt nu al de trials van Ruconest mbt. Pancreatitis, daar hebben ze geen overname voor nodig.

    Zolang de Pancreatitis behandeling nog niet goedgekeurd is zie ik geen voordelen voor Salix (of een andere partij) om Pharming over te nemen. Het zou in ieder geval geheel tegen de trend in gaan als een biotech overname voorbarig plaatsvindt.

    Ik ben toch bang dat geduld de sleutel blijft :) Wat ook niet erg is, want dan kun je nog lekker traden en voor hetzelfde geld meer aandeeltjes oprapen. Genoeg mensen die de market makers achterna lopen.
  11. [verwijderd] 7 augustus 2014 23:36
    quote:

    Puber schreef op 7 augustus 2014 23:28:

    Sorry,maar kpn forum is minder actief op dit moment, svp hulp, via google - fd kpn - zie ik na 17:30 uur bij de omzet een uitschieter, wat kan hier aan de hand zijn?
    170k stuks in de eindveiling? Wat hoger dan gemiddeld maar verder niks bijzonders zou ik zeggen. De echte uitschieters waren tussen 9 & 10.
  12. [verwijderd] 7 augustus 2014 23:47
    quote:

    Puber schreef op 7 augustus 2014 23:43:

    Ik kan denk ik geen printscreen toevoegen, maar er staat toch echt iets van dik 2 miljoen ofzo, of kijk ik verkeerd?
    Misschien gaat er ergens wat fout ja, dit zie ik.
  13. [verwijderd] 7 augustus 2014 23:52
    quote:

    Puber schreef op 7 augustus 2014 23:49:

    Het ging niet over pharming, maar over kpn.

    O haha excuus soms lees ik iets te selectief laat op de avond, even kijken :) Daar zijn inderdaad bijna 4 miljoen stuks verhandeld in de eindveiling. Heel apart, want het heeft geen mega stijging veroorzaakt. Ik vermoed 2 grote aandeelhouders (of partijen) die van positie wilde wisselen, de 1 eruit de ander erin.
  14. greenways 8 augustus 2014 07:06
    quote:

    Puber schreef op 7 augustus 2014 23:58:

    Bedankt voor het antwoord en het uitzoeken, de achterliggende reden zal wel onbekend blijven.
    Bij Kpn zijn dit normale eindveilingen.
    Mvg
247 Posts
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