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Kulicke and Soffa Industries, Inc. Message Board

dcxavier 115 posts  |  Last Activity: 21 hours ago Member since: Nov 22, 1999
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  • Reply to

    BAX-855 results distinctly mediocre

    by dcxavier Aug 21, 2014 10:00 PM
    dcxavier dcxavier 21 hours ago Flag

    -- "fend off long acting competition to the Advate franchise"

    Which is great for BAX. The way to look at it from NKTR's point of view is to try to figure out how much money NKTR will collect in royalties. Doberstein already stated that there are escalating royalty rates of 5% to 13%. Let's assume the following... 5% on $0 to $400M, 7% on $400M to $800M, 9% on $800M to $1.2B, 11% on $1.2B to $1.6B, 13% above $1.6B. Then you get the following royalty payments based on sales.

    Sales - Royalties
    $400M...$20M
    $800M...$48M
    $1.2B....$84M
    $1.6B...$128M
    $2B......$180M

    Big money doesn't kick in until sales start to approach that of Advate currently. A ramp of $200M sales per year seems reasonable. That assumption results in BAX-855 sales of $1B in 2020. Great for BAX. But it's a royalty payment of $66M to NKTR. Not chump change, but NKTR won't get rich on it either. To get there faster, doctors and patients need a compelling reason to try patients on BAX-855 rather than Eloctate. I don't see it in the data.

  • Reply to

    BAX-855 results distinctly mediocre

    by dcxavier Aug 21, 2014 10:00 PM
    dcxavier dcxavier Aug 21, 2014 11:25 PM Flag

    Baxter has long noted that factor VIII drugs are very sticky. Once a patient finds a drug that works, they rarely change. For that reason, I expect switchover from Advate to BAX-855 to be a long, drawn out process. Meanwhile, new patients will have Eloctate as a choice. Eloctate is a BIIB product, not exactly brand X pumped out of an Indian or Chinese factory. It also has a two year marketing lead. Advate was the recombinant king to a large extent by being first to market in the class. The shoe is on the other foot now.

    In a positive vein, FDA approval of BAX-855 ought to be a slam dunk.

    Also note, BAX has an active preclinical program for the next generation factor VIII product. I'm not sure how it's progressing, but if it does, figure four years from IND to market.

  • Half life ramped downhill from 2.1 times Advate in preclinicals to 1.4-1.5 in Phase 3. Most recent reported half-life of Advate is 12.4 hours, so we have the following.

    BAX-855: 17.4 to 18.6 hours
    Eloctate: 19 hours
    N8-GP: 18.4 hours (submission delayed by NVO)
    BAY 94-9027: 19 hours (from Phase 1)

    Additional point of comparison. 96% stop bleeding within two doses with BAX-855 compared with 98% with Eloctate. Eloctate will have a two year head start on the market.

    NKTR get paid escalating royalties of 5% to 13%. In an earlier post, I estimated NKTR would receive $66M in royalties with $1B BAX-855 sales.

    Bottom line... these results are not very good.

  • Reply to

    Avastin get approved ...But

    by corona_and_a_cigar Aug 18, 2014 9:43 PM
    dcxavier dcxavier Aug 19, 2014 9:35 AM Flag

    Which post are you talking about? Subject? What did I say?

  • Reply to

    Is movantik a cardio risk?

    by mwalk65 Aug 18, 2014 4:43 PM
    dcxavier dcxavier Aug 19, 2014 7:57 AM Flag

    There are six patients listed as having CV deaths. The narratives supersede the data presented in Table 9. I'm not saying that the FDA won't approve Movantik, but this isn't mother's milk either, like some posters seem to believe.

    1. Study 04 Patient E4068050 was a 73-year-old male in the naloxegol 12.5 mg group.

    2. Study 07 Patient E4073006 was a 54-year-old male in the naloxegol 12.5 mg group.

    3. Study 08 Patient E5228010 was a 30-year-old female in the Usual Care group. She was a rollover patient who had been taking naloxegol 12.5 mg before entering Study 08.

    4. Study 08 Patient E8843004 was a 39-year-old female in the naloxegol 25 mg group.

    5. Patient E4010003 (naloxegol 25 mg)... This death is not captured in the clinical database and is therefore not included in either Study 04 or pooled data presentations. (*This case is not included in the Table above.)

    6. There was 1 death in the Phase I studies of naloxegol. In Study 09, Subject E0001005...

  • dcxavier dcxavier Aug 18, 2014 10:21 PM Flag

    For a quick overview, read the June 14 press release "bluebird bio Reports Rapid Transfusion Independence in Beta-Thalassemia Major Patients Treated with its LentiGlobin Product". If you are familiar with b-thal major, those results will knock your socks off. Any presentation you find will have additional details.

  • Reply to

    Avastin get approved ...But

    by corona_and_a_cigar Aug 18, 2014 9:43 PM
    dcxavier dcxavier Aug 18, 2014 10:03 PM Flag

    It's a quantum leap forward in the treatment of late stage cervical cancer. If NKTR-102 turns in those kind of numbers in the MBC study, the NKTR market cap will increase by billions too. We'd call those results blowout!

  • Reply to

    Is movantik a cardio risk?

    by mwalk65 Aug 18, 2014 4:43 PM
    dcxavier dcxavier Aug 18, 2014 9:51 PM Flag

    Corona,

    Read the ADCOM briefing material before you post again, please!

    It's all on the FDA website. Go to the document "FDA Briefing Information for the June 11-12, 2014 Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (PDF - 16.9MB)". Pages 34-35 have a section entitled "Narratives of MACE in the naloxegol clinical program/Narratives of patients with CV death". Each of the patient deaths during NKTR-118 development is described in detail, including contributing factors.

    Please!

  • Cashing in while he still can.

  • dcxavier dcxavier Aug 18, 2014 7:56 PM Flag

    RTRX director Jeffrey Paley sells 20,000 shares. Cashing in while he still can, I suppose.

  • Reply to

    Is movantik a cardio risk?

    by mwalk65 Aug 18, 2014 4:43 PM
    dcxavier dcxavier Aug 18, 2014 7:51 PM Flag

    There were six CV deaths among NKTR-118 study participants. All had taken Movantik at some point. There were no CV deaths among placebo/usual care only participants. Five of the six were high CV risk patients. There appears to be a trend that Movantik adds to the risk of death in susceptible patients. Although the Adcom panel didn't find an overt signal, they didn't ring the all-clear bell either. Thus, a post marketing study. There is a chance that Movantik could end up with a black box warning against use in high risk CV patients, pending further study.

  • Reply to

    China stuff

    by billyteex1 Aug 18, 2014 8:51 AM
    dcxavier dcxavier Aug 18, 2014 9:10 AM Flag

    Also heard that company got an agreement with Office Max to negotiate a deal for a case of pens.

  • dcxavier by dcxavier Aug 15, 2014 1:36 PM Flag

    Cash out and buy jeans instead.

  • Here's what I think I heard. Please correct me if I got it wrong.

    The reason patients need hospitalization during the transplant procedures is that they have to be preconditioned. That is, after extracting marrow cells to be treated, the remaining bad cells need to be eliminated as completely as possible before the treated cells are reinserted. If the preconditioning isn't necessary, the treatment could be done as an outpatient procedure. This would make it much more feasible in second and third world countries. Sickle cell treatment requires a much lower percentage of good hemoglobin than b-thal to be successful. Although much further research is necessary, treating sickle cell as outpatient is a possibility.

  • Reply to

    AZN Will buy Out NKTR

    by acctboating1 Aug 11, 2014 11:20 AM
    dcxavier dcxavier Aug 12, 2014 11:34 AM Flag

    -- "20, 30 or ever 50 day effectiveness"

    181 doesn't hang out in the body like some of the other pegged drugs. And it definitely shouldn't, otherwise there would be toxic buildup over time.

  • dcxavier dcxavier Aug 12, 2014 11:30 AM Flag

    $10.52? One day later it's 7forallMannkind.

  • Reply to

    AZN Will buy Out NKTR

    by acctboating1 Aug 11, 2014 11:20 AM
    dcxavier dcxavier Aug 12, 2014 9:10 AM Flag

    I owned NKTR for several years for the potential of 181 and the other pain meds, then sold when the Phase 2 failed. There may be a lot more about 181 that we don't know. 181 Phase 3 is getting pushed back. The 181 Phase 2 and 192 Phase 1 failures got Medve fired. Make no mistake, 192 was a blunder of the highest order. It failed early in Phase 1 due to elevated liver enzymes, and it's hard to believe that this problem wasn't seen in the preclinicals. Yet HR made the commitment to move forward with 192 as the company's highest priority. Are there potential problems with 181 that haven't been revealed? To be successful in the market, 181 has to be better at pain relief than the cox-2 inhibitors. If not it's a niche product only.

  • Reply to

    DNDN turning the corner

    by marketmakerx Aug 5, 2013 10:25 AM
    dcxavier dcxavier Aug 12, 2014 7:59 AM Flag

    DNDN is turning the corner and heading for a cliff. Bankruptcy or massive dilution is in their future. This is from yesterday's 10-Q.

    ===

    "we are currently considering alternatives to the repayment of the 2016 Notes in cash, including alternatives that could result in leaving our current stockholders with little or no financial ownership of Dendreon."

  • Reply to

    MNKD hits paydirt

    by marketmakerx Aug 11, 2014 8:57 AM
    dcxavier dcxavier Aug 11, 2014 9:50 AM Flag

    HR got better terms from AZN for NKTR-118 as an investigational drug than Al Mann got out of SNY for an approved drug.

    I'm convinced that mm intentionally posts idiocy to this board just to get a rise out of everyone. His day job is probably a free lance comedy writer.

  • Reply to

    Two New Data Releases from NWBO

    by bioduedil Aug 11, 2014 8:58 AM
    dcxavier dcxavier Aug 11, 2014 9:08 AM Flag

    My God! Here's what really happened.

    NWBO came up with the new entry condition... high white cell count. That retroactively eliminated 55 patients who were already enrolled in the Phase III study. Those 55 patients are now considered compassionate use "information arm". But most importantly -- Their results were UNBLINDED. Guess what? There appears to be a slight increase in OS in the DCVax-L arm, but nowhere near the statistical significance needed for approval. This isn't good news at all.

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