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Cymer Inc. Message Board

dcxavier 189 posts  |  Last Activity: Feb 27, 2015 8:49 AM Member since: Nov 22, 1999
  • dcxavier dcxavier Feb 4, 2015 9:40 AM Flag

    If NKTR-102 fails BEACON, where is the $100M+ to run a GBM Phase 3 going to come from?

  • Reply to

    GILD news not good

    by dcxavier Feb 3, 2015 8:13 PM
    dcxavier dcxavier Feb 4, 2015 9:38 AM Flag

    Government and PBM's are trying to take control of pricing. The issue is that if the government negotiates a price of $900K for BT treatment instead of $1M, the $100K difference comes straight off BLUE's bottom line.

  • Sales current quarter with YoY comparison.

    VBS: Coming up
    RNG: $61.9, +37%
    EGHT: $41.4, +26%

  • Price war with ABBV taking its toll. Big picture issue... Drug developers starting to lose control of pricing.

  • Can't argue with that.

  • Reply to

    NCT02312622 Trail

    by corona_and_a_cigar Feb 2, 2015 4:26 PM
    dcxavier dcxavier Feb 2, 2015 4:56 PM Flag

    corona,

    It's not a NKTR trial. It's a 15 patient, investigator initiated trial, led by Dr. Joel Neal, who is an assistant professor at Stanford.

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcx_one Dec 19, 2014 9:09 PM
    dcxavier dcxavier Feb 2, 2015 8:46 AM Flag

    ofjames charity of choice was St. Athnanasius in Philadephia, an inner city church doing a substantial amount of work to help the local people. But in the big picture, we shouldn't let a contest control our charitable giving. There are few better feelings than donating to a worthy cause.

  • dcxavier dcxavier Feb 2, 2015 7:57 AM Flag

    corona,

    You completely miss the point of my post. Name me one approved drug using siRNA technology. Hint... the next one will be the first.

    Meanwhile, yes, pegylation is used everywhere. So why should a drug developer come to NKTR for its expertise, what competitive advantage does NKTR have over what big pharma can do in house? BAX hired NKTR to use pegylation to improve its hemophilia products. As a result, BAX-855 is a year and a half behind Eloctate with no significant difference in performance, and the factor IX program was cancelled.

    HR's not going to luck out and get NKTR bought for its intellectual property. It's all about the actual products.

  • No surprise. Expect the same for SCD if early data is positive.

    ===

    A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. Section 902 of FDASIA requires the following actions, as appropriate:

    •holding meetings with the sponsor and the review team throughout the development of the drug

    •providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable

    •taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment

    •assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager

    •involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review

  • dcxavier dcxavier Feb 1, 2015 3:35 PM Flag

    Expanding on what cow said, siRNA was the hot technology ten years ago. Kind of what gene therapy, and CAR-T in particular, is now.

    But times have changed. Ten years ago, big pharma was willing to write big checks to acquire technology. HR sold Sirna as the company with the best engineers and deepest knowledge in the field. Even though Sirna didn't have a drug, Merck figured it could apply siRNA technology in its R&D. HR's strategy for NKTR has been similar to what he did at Sirna, substitute pegylation for siRNA. Difference is that these days, big pharma buys companies for their drugs, and they partner for technology instead of buying. Pegylation expertise isn't in high demand these days, so the onus is on NKTR to get products into the market.

  • dcxavier dcxavier Feb 1, 2015 11:50 AM Flag

    siRNA - Ha ha!

    I don't believe a single drug ever came out of Sirna Therapeutics when HR ran it, nor during the eight years after the company was bought out by Merck.

    siRNA = Where money goes to die.

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcxavier Dec 19, 2014 9:02 PM
    dcxavier dcxavier Jan 31, 2015 2:12 PM Flag

    St Athanasius parish is so 20th century. The church website isn't set up for online donations, so I called the rectory and spoke with Fr. Okonski. He said it was the first time he was approached by someone donating to his church in that way. He then discussed all of the work the church does at its location. The check is off in the mail.

    Good luck to you and all who participated in the contest.

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcxavier Dec 19, 2014 9:02 PM
    dcxavier dcxavier Jan 30, 2015 11:04 PM Flag

    Waiting for ofjames to name his charity.

    cow, your pick was nowhere near the worst this contest has seen. In 2009, KV-A fell almost 80% after having its manufacturing facility shut down by the FDA.

  • dcxavier by dcxavier Jan 30, 2015 10:32 PM Flag

    Company performance is very sensitive to US dollar strength.

    ===

    "While the impact of foreign exchange on total company sales and earnings in 2014 was very modest, as we enter 2015, the steep depreciation of both the euro and the Japanese yen represent a major financial headwind. Our earnings are exposed to the movement of these 2 currencies versus the dollar. Specifically, on the combined company, we estimate that every $0.01 change in the euro-dollar exchange rate will have an impact of approximately $1.5 million to $2 million EBITDA. And every JPY 1 change in the yen-dollar exchange rate will have an EBITDA impact of approximately $0.5 million to $1 million. To put that in perspective, ranging the euro between $1.12 and $1.18, and the yen to between JPY 117 and JPY 121, we would expect to see a $40 million to $50 million headwind to EBITDA in 2015, or about $0.20 per share."

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcxavier Dec 19, 2014 9:02 PM
    dcxavier dcxavier Jan 30, 2015 6:24 PM Flag

    This is cross-posted on the KLIC board

    Congratulations of ofjames, winner of the 2015 Cr-ppy Stock Picking Contest. It came down to the final day, as the top three stocks finished within four percent of each other. The month had its share of crappiness. There were financial issues with MHR and BTU, and management turmoil at SODI. Even the positive catalyst of a drug approval couldn't move RMTI.

    Let me know what charity I should direct the donation to, ofjames.

    Hope everyone enjoyed it. Good luck to all!

    Entrant..................... Stock.... 12/31/14... Today... Change

    cow_4_beans............MHR..........3.14........1.94....-38.2%
    lonerunner_99...........BTU...........7.74........6.23....-19.5%
    flyktning....................BOBE.......51.18......56.37...+10.1%
    dcxavier....................SODI..........4.28........4.19......-2.1%
    bugsisdog.................RMTI........10.28......10.79.....+5.0%
    gladpick....................VRTX.....118.80.....110.14.....-7.3%
    ofjames.....................GILD........94.26.....104.83..+11.2%
    mwalk65...................GALE.........1.51........1.63.....+8.0%
    rbtears10..................NKTR.......15.50......14.64......-5.6%

    Total.......................................................................-4.3%

  • Eloctate sales in Q4 were $37M. Probably mostly North America since it received EMA approval in October. Next quarter will include all major markets. The Eloctate ramp is probably a good model for what to expect from BAX-855.

    It appears that these pegged factor 8's are a stopgap as companies try for a cure via gene therapy. BIIB has thrown its hat into the gene therapy ring.

    ===

    • In January 2015, Biogen Idec and San Raffaele Hospital announced they entered into a worldwide collaboration to jointly develop gene therapies for the treatment of both hemophilia A and B. The agreement will combine San Raffaele Hospital’s extensive expertise in creating vectors that deliver genetic material to cells with Biogen Idec’s deep understanding of hemophilia biology to potentially treat the underlying causes of hemophilia A and B.

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcxavier Dec 19, 2014 9:02 PM
    dcxavier dcxavier Jan 29, 2015 8:30 PM Flag

    This is cross-posted on the KLIC board

    The group was barely up on a strong market day. VRTX fell nearly 6% as it received analyst downgrades. VRTX is generally considered fully valued at this price point. With only one day remaining, BOBE continues to hold a slight lead.

    Good luck to all!

    Entrant..................... Stock.... 12/31/14... Today... Change

    cow_4_beans............MHR..........3.14........1.99....-36.6%
    lonerunner_99...........BTU...........7.74........6.12....-20.9%
    flyktning....................BOBE.......51.18......57.29...+11.9%
    dcxavier....................SODI..........4.28........4.19......-2.1%
    bugsisdog.................RMTI........10.28......10.41.....+1.3%
    gladpick....................VRTX.....118.80.....114.14.....-3.9%
    ofjames.....................GILD........94.26.....104.18..+10.5%
    mwalk65...................GALE.........1.51........1.63.....+8.0%
    rbtears10..................NKTR.......15.50......15.06......-2.8%

    Total.......................................................................-3.9%

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcxavier Dec 19, 2014 9:02 PM
    dcxavier dcxavier Jan 28, 2015 11:15 PM Flag

    This is cross-posted on the KLIC board

    We didn't do well today, losing 2.8%. VRTX reported AH, beating on the top and bottom line (at least non-GAAP). United Health selected GILD's Harvoni as its preferred Hep C drug. BOBE hit a 52 week high and BTU a 52 week low. BOBE is now in the lead with two days to go.

    Good luck to all!

    Entrant..................... Stock.... 12/31/14... Today... Change

    cow_4_beans............MHR..........3.14........1.92....-38.9%
    lonerunner_99...........BTU...........7.74........6.10....-21.2%
    flyktning....................BOBE.......51.18......56.61...+10.6%
    dcxavier....................SODI..........4.28........4.21......-1.6%
    bugsisdog.................RMTI........10.28......10.53.....+2.4%
    gladpick....................VRTX.....118.80.....121.26....+2.1%
    ofjames.....................GILD........94.26.....102.45....+8.7%
    mwalk65...................GALE.........1.51........1.65.....+9.3% rbtears10..................NKTR.......15.50......14.52......-6.3%

    Total.......................................................................-3.9%

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcxavier Dec 19, 2014 9:02 PM
    dcxavier dcxavier Jan 27, 2015 4:49 PM Flag

    This is cross-posted on the KLIC board

    We did very well today, up 0.2% on a day that the market took a hit. This is despite the fact that BTU hit a trifecta of crappiness. The company missed earnings, lowered guidance and reduced the dividend. The competition remains very close. GALE snuck into the lead.

    Good luck to all!

    Entrant..................... Stock.... 12/31/14... Today... Change

    cow_4_beans............MHR..........3.14........2.14....-31.9%
    lonerunner_99...........BTU...........7.74........6.24....-19.4%
    flyktning....................BOBE.......51.18......56.97...+11.3%
    dcxavier....................SODI..........4.28........4.15......-3.0%
    bugsisdog.................RMTI........10.28......11.07.....+7.7%
    gladpick....................VRTX.....118.80.....123.67....+4.1%
    ofjames.....................GILD........94.26.....105.03..+11.4%
    mwalk65...................GALE.........1.51........1.71...+13.3% rbtears10..................NKTR.......15.50......14.97......-3.4%

    Total.......................................................................-1.1%

  • Reply to

    Perez interview- Better Irinotecan is here

    by pettitmb Jan 27, 2015 10:02 AM
    dcxavier dcxavier Jan 27, 2015 10:26 AM Flag

    But, then again, Dr. Perez was quite surprised when Kadcyla failed its Phase 3 in advanced Her2+ breast cancer. That was despite stellar Phase 2 results. So we wait for BEACON completion.

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