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Home  /   Forum   /   BioPharma   /   INSM - Insmed - Deel 16

BioPharma« Terug naar discussie overzicht

INSM - Insmed - Deel 16

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1.439 Posts
Pagina: «« 1 ... 61 62 63 64 65 ... 72 »» | Laatste | Omlaag ↓
  3. [verwijderd] 1 april 2009 00:18
    10k highlights

    investor.insmed.com/secfiling.cfm?fil...

    1. Enough Inventory through 2010.
    2. No outsource manufacturer identified yet.
    3. 12-18 months to get approved once identified.

    The transfer of the Boulder facility to Merck takes away our internal IPLEX™ production capability. We believe, however, that we have sufficient inventory of IPLEX™ to support our ongoing Amyotrophic Lateral Sclerosis Expanded Access Program (“ALSEAP”) in Italy through 2010 together with the IPLEX™ requirement for the clinical trial currently being planned with the FDA for ALS patientsin the US. Any requirements for IPLEX™ beyond 2010 or any significant increase in demand beyond our current commitments either in the Myotonic Muscular Dystrophy (“MMD”) or ALS fields will require that we identify a Contract Manufacturing Organization (“CMO”) to produce the necessary IPLEX™ to meet the demand. We estimate that the tech transfer of our IPLEX™ production process could take 12 to 18 months once a CMO has been identified.

    -12/31/2008 - accumulated deficit - $346 million (ie future tax write offs)
  5. [verwijderd] 1 april 2009 08:18

    Insmed Completes Sale Of Follow-on Biologics Business To Merck For $130 Mln. - Update
    3/31/2009 7:04:40 PM RTT News
    Insmed completes $130 mln sale of its follow-on biologics business to Merck - Quick Facts
    3/31/2009 5:23:18 PM RTT News
    Insmed closes $130 mln sale of its follow-on biologics business to Merck
    3/31/2009 5:07:48 PM RTT News
    Insmed Pens Agreement With IDIS to Manage Expanded Access Programs for IPLEX - Quick Facts
    3/30/2009 6:01:23 PM RTT News
    Insmed signs agreement with IDIS, UK to manage programs for investigational drug IPLEX worldwide, excluding US and Italy
    3/30/2009 5:32:38 PM RTT News
    Insmed says NASDAQ further extends temporary suspension of minimum bid closing price rule
    3/25/2009 8:07:29 AM RTT News
    Insmed Q4 & FY08 Earnings Conference Call At 8:30 AM
    3/11/2009 7:49:48 AM RTT News
    Insmed Q4 loss widens - Quick Facts
    3/11/2009 7:18:32 AM RTT News
    Insmed posts Q4 loss per share of $0.03, same as last year
    3/11/2009 7:06:09 AM RTT News
    FDA to allow patients with Lou Gehrig's disease to access Insmed's drug Iplex - quick facts
    3/10/2009 2:01:24 PM RTT News
    Previous 10 Headlines

    Press Releases
    Insmed Completes Sale of Follow-On Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million
    3/31/2009 5:06:24 PM PR Newswire
    Insmed Announces Agreement With IDIS to Manage Expanded Access Programs for IPLEX(TM)
    3/30/2009 5:30:08 PM PR Newswire
    Insmed Announces That NASDAQ Further Extends Temporary Suspension of Minimum Bid Closing Price Rule
    3/25/2009 8:01:34 AM PR Newswire
    Insmed Announces Fourth Quarter and Full-Year 2008 Financial Results
    3/11/2009 7:01:23 AM PR Newswire
    Insmed Announces FDA Issues Statement Regarding Position on Allowing Patients With ALS Access to IPLEX(TM) Under an IND
    3/10/2009 1:40:35 PM PR Newswire
    Insmed to Host Fourth Quarter and Full-Year 2008 Conference Call
    2/26/2009 8:01:29 AM PR Newswire
    Insmed Sells Follow-on Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million
    2/12/2009 7:01:11 AM PR Newswire
    Merck & Co., Inc. Acquires Biologic Manufacturing Capabilities and Developmental Follow-on Biologics Portfolio from Insmed
    2/12/2009 7:00:14 AM Business Wire
    Insmed and Premacure Announce European Orphan Designation for IPLEX(TM) in Retinopathy of Prematurity in Infants
    1/21/2009 8:02:10 AM PR Newswire


  8. ludwig mack 1 april 2009 10:59
    quote:

    crackedtooth schreef:

    10k highlights

    investor.insmed.com/secfiling.cfm?fil...

    1. Enough Inventory through 2010.
    2. No outsource manufacturer identified yet.
    3. 12-18 months to get approved once identified.

    The transfer of the Boulder facility to Merck takes away our internal IPLEX™ production capability. We believe, however, that we have sufficient inventory of IPLEX™ to support our ongoing Amyotrophic Lateral Sclerosis Expanded Access Program (“ALSEAP”) in Italy through 2010 together with the IPLEX™ requirement for the clinical trial currently being planned with the FDA for ALS patientsin the US. Any requirements for IPLEX™ beyond 2010 or any significant increase in demand beyond our current commitments either in the Myotonic Muscular Dystrophy (“MMD”) or ALS fields will require that we identify a Contract Manufacturing Organization (“CMO”) to produce the necessary IPLEX™ to meet the demand. We estimate that the tech transfer of our IPLEX™ production process could take 12 to 18 months once a CMO has been identified.

    -12/31/2008 - accumulated deficit - $346 million (ie future tax write offs)
    crack, wijkt dit nu af van wat je eerst dacht, dat ze zelf iplex konden maken in hun overgebleven faciliteit? hebben ze nu een voorraad aangelegd, die moet heel wat waarde hebben dan? en hoe vind je nw faciliteit en alles klaar hebben dan ......
    vragen, die ze blijkbaar wel weten op te lossen.
    gr
  16. [verwijderd] 1 april 2009 22:51


    "

    Current situation
    Current state = $123 million in the bank and full loaded there are about 144 million shares outstanding = .85/share

    .96 - .85 = .11/share above cash value = @$15 million

    We are receiving about $10 million in revenue from cost recover program in Italy so $15 million - $10 million = $5 million

    That means that the market is placing a value of $5 million on the following:

    1) Phase II results from MMD trial that was paid for by the MDA - anticipated revenues of more than $300 million if approved
    2) If MMD results are good we could see an opt in from Ipsen or Roche - more cash on hand
    3) ALS expansion in US and Europe - so if only half the number of people actually take advantage of the program in the rest of the world as are using iPlex in Italy that would make up all the $5 million by itself in current revenues
    4) ROP, oncology platform, ins-18 ...

    Really??? Is it logical that people would sell 1 million shares at a .04 loss from yesterdays close and confirmation that we actually have $123 million in the bank???

    I don't think so. Plus Antler is back with some new friends. Things are looking pretty good. Slacker

    "
1.439 Posts
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