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Exelixis, Inc. Message Board

erniewerner 156 posts  |  Last Activity: Jul 28, 2015 4:22 PM Member since: Jan 18, 2000
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  • Reply to

    It's the medicine 'now' stupid

    by snowflakeformationxy Jul 28, 2015 11:52 AM
    erniewerner erniewerner Jul 28, 2015 4:22 PM Flag

    "The management there will do what they do for all the other therapies they offer. Wait for approval and THEN act."

    Yes, and act quickly. The final approval contains the language for the package insert. That's why it takes two weeks from the approval date to make the product available. The Zelboraf. Kadcyla, Perjeta and Erivedge approval press releases all mentioned availability within two weeks. Why would Z/C be any different? It is a rational expectation.

    "Can you even find any evidence that something was near release? No. You see, desperation on the part of EXEL or its shareholders are not being experience by Roche."

    What evidence would there be? A rough draft of a press release? The only desperation I see is that manifested in your insistence on inventing reasons for "failure" and "impending Implosion." You keep raising the issue of credibility of others as if you are in a position to judge.

    Here's a proposal for you. I bet the approval V/C press release will have the same proviso for availability within two weeks. If it doesn't, I won't post on Yahoo until 2016. If it does, your disappear for the same timeframe and actually do it without welching out and whining about it.

  • Reply to

    It's the medicine 'now' stupid

    by snowflakeformationxy Jul 28, 2015 11:52 AM
    erniewerner erniewerner Jul 28, 2015 3:28 PM Flag

    "Of course, like ernie's insistence that Roche is ready to go day 1 after approval on the melenoma therapy, there is no evidence..."

    And there is no evidence that pigs can't fly. Proving a negative can be a bit difficult. Genentech has had three drug approvals since 2012, Perjeta, Kadcyla and Erivedge. All three were available within 2 weeks of the FDA approval announcement. Cobi figures prominently as Zelboraf is rapidly losing market share to the GSK D/T combination. The only way to stop that erosion is to make their own BRAF/MEK combination available. Do you have any evidence that this new drug rollout will be any different than the most recent 3?

  • erniewerner erniewerner Jul 25, 2015 6:10 PM Flag

    You literally spent hours upon hours heaping scorn and derision on the regular posters on this board, including me, remember "they even trotted out the Erniewerner ID." You predicted doom and collapse around every corner. At one point you promised to leave and then made up excuses to come back. Your arguments were mostly trivial, manufactured, and inaccurate. You did your best to shake confidence and encourage long term holders to sell going into an important binary event.

    The odd thing is that you didn't believe your own propaganda. Rather than be wrong, at the last minute you had an awakening. Something magic appeared in the charts in time for you to switch sides and participate on the winning side. Somehow the voodoo medicine worked and the survival analysis didn't cause any problems. Let's switch hats for a minute. For once you do some explaining instead of constantly chipping away with endless distractions. How could you have been so wrong for so long?

  • erniewerner erniewerner Jul 25, 2015 5:40 PM Flag

    "You would have infinitely more credibility if you could comment any of the four points..."

    Speaking of credibility. Before we create the next round of arguments supporting the imminent doom scenario, let's address some of the credibility robbing posts from the recent past.

    'I must honor my agreement. So, its time for me to go."

    'Ditch your shares now before the big dump! You know this is going south just like every other CC.
    DON'T BE A BAG HOLDER!!!'

    "On balance, it is far greater than the reward. There was absolutely no reason for this to rise the way it did from December. Nothing!"

    "There is no reason at all for the run-up. But there are plenty for the impending implosion."

    "How much PROFIT do you think is in the first $200M of sales when they amortize the testing costs?."

    "I say its the start of the long slow drive to oblivion. The daily water torture until the big collapse on bad news of dilution or test failure. Maybe both. You're all gambling and you know it. Get out and find a real investment."

    "Voodoo medicine...They piggie-back on other drugs and hope they catch a statistical anomaly. Where the data says there is an additional benefit but there really isn#$%$ just random chance."

    "I think you're off on this. Meteor is going to crash and burn. "

  • erniewerner erniewerner Jul 25, 2015 4:46 PM Flag

    "1. How likely is a buy out at this level and what would be a reasonable premium?"

    Low probability event and not much of a markup from here.

    "2. If there is no buyout eminent {imminent}, a position I believe, what do they do going forward?"

    What they said. Partner Cabo exU.S. fully enroll Celestial and continue CRADA IST trials.

    '3. No one still has a projection of revenue from the Cobi/EXEL agreement, do they?'

    Not sure where he got it, but Wilbiftek sent me a spiffy spreadsheet from some analyst. He might share if you ask.

    4. What if Roche reports a loss from the Cobi/Exel agreement and they have to spend some of that newly printed money to reimburse Roche for the loss?

    Initially cost will exceed revenue, but they should cross into the black soon enough. There are lots of things to worry about, but losing money on Cobi going forward is low on my list. Z/C is the better BRAF/MEK combo and will take away D/T's share pretty quick. We will have to see how the Nivo/Ipi situation works out. Certainly D/T will capture the 2nd line BRAF+ spot and maybe some of the frontline also. If I had melanoma I would go straight to Nivo/Ipi hoping for a durable response.

  • Reply to

    Trametinib monotherapy

    by wilderguide Jul 25, 2015 12:27 AM
    erniewerner erniewerner Jul 25, 2015 4:27 PM Flag

    "...but Roche/Genentech will be prepared for launch hence the market will be delivered the day after approval!... No they won't. As a EXEL hypester that is what you say. But matters of desperation on the part of EXEL and its long hypesters does not necessarily translate to number one priorities for Roche."

    There is no secret about when Z/C will be approved. The PDUFA date is Nov 11. Year over year sales of Zelboraf are flat because Tafinlar/Mekinist is now first line treatment of choice having supplanted Z monotherapy. Are you saying that with all these months to prepare Roche will not be ready to market and deliver commercial product on the day after approval? Get real.

  • Reply to

    Valuation of EXEL post METEOR

    by pvaluens Jul 25, 2015 9:13 AM
    erniewerner erniewerner Jul 25, 2015 12:56 PM Flag

    "( of course if OS cabo data is positive) "

    I don't think many appreciate how close Cabo came to achieving the OS endpoint on the interim. Here are the stats, HR=.67 p=.005 with statsig at p=.0019 or less. I ran some numbers and if the HR had just been a little better at .63 or if the trial had been 100 patients larger with the same HR or the analysis occurred just 1-2 months later to capture more events with the same HR, then this trial would be over without the need to continue to the next analysis. It is almost statistically inconceivable that the final analysis for OS will not reach statistical significance as the requisite p value then will be much more permissive, somewhere in the .03 to .04 range.

    Another interesting observation is that the completed Nivo study had n=822 whereas Meteor had n=650. That additional statistical power could easily be the differentiating factor that caused Nivo to succeed on its interim with an efficacy result no better than Cabo.

    There is an ongoing Nivo+Ipi vs Sutent trial in frontline RCC. It will not read out for a few years. My guess is that it will succeed and the frontline SOC will be Nivo+Ipi. Also ongoing is the CaboSun trial, which is probably not large enough to provide anything other than a proof of concept, but compelling results could still affect the order in which Sutent and Cabo are prescribed. Now recruiting patients we also have the Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors. Not an RCC trial, but one which could have implications for future clinical development if combination synergies are seen.

  • Reply to

    SEC Filing today

    by twodogsfracking Jul 24, 2015 4:48 PM
    erniewerner erniewerner Jul 25, 2015 5:26 AM Flag

    "Clearly the press release was false and there likely was a letter of intent or similar agreement, but until Thursday's agreement, there was no "fully underwritten" offering."

    I tried to tell you. The underwriters in these deals do not actually guarantee anything until there is an agreement on the price and they don't commit to a price until they have a chance to gage the market. Your frustration is with the semantics and what you believe the words should mean instead of what the company's actual intent is. What happened this week is not exceptional, it is the norm.

    "...not to mention the fact that given the strength in the sp (never really came close to $5.40), they might have gotten better execution."

    Actually in the regular session on Friday it got down to $5.44. The opportunity was there for anyone who so desired to purchase shares at less than a 1% markup to the offering. Yesterday's volume was only 19 million with lots of churning. Many of those 25 million shares are still waiting to be traded so the aftermath is not over. Would not surprise me at all to see us trade at or below $5.40 some time soon.

  • Reply to

    What's the technical message...

    by wilderguide Jul 24, 2015 11:15 AM
    erniewerner erniewerner Jul 24, 2015 7:19 PM Flag

    " ...if this bad boy closes in the green, never having visited the offering price on the open market?"

    1, In the past, it has always traded below the offering within a few weeks, even if only briefly.

    2. In the past, offerings have resulted in an increase in short interest. Not sure of the exact mechanics, but that is what has occurred.

    3. It does put a big chunk of stock into some opportunistic and weak hands. I'm sure some went to mutual funds and venture capitalists, but face it, it will take longer to work upwards to a fair value that reflects the opportunity. Even I used the last week to offload into strength and then reload on Friday.

    4. There is still good news coming, The EMA Cobi approval will happen soon and then the Nov 11 PDUFA date approaches. Meteor will be presented and I'm sure way may see a significant partnership announcement. Past practice would indicate an announcement when Celestial reached full enrolment and that will start a countdown to data release in the minds of the analyst community.

    5. FWIW here is my valuation. EXEL should be a $6.50 stock now. Cobi approval and a partnership are pretty much baked in, but should make the stock worth $7. Leading into Celestial, the binary event rally will carry the stock to $10. Then after Celestial topline. it's back to $4 or up to $14. All BOE scribbling and things can go wrong. More dilution, revenue disappointment, recession, are all plausible possibilities, and though I like can make a good argument for the Celestial bull thesis, there are never any guarantees.

  • erniewerner erniewerner Jul 24, 2015 8:34 AM Flag

    "What's Up Loser...Remember Me....Who's Losing Now?...Not this guy..."

    Of course not. And your version of how well your doing is going to be just as honest and reliable as your arguments for the bear thesis yesterday. We are soooo lucky to have you here to share your greatness with us.

  • Reply to

    Shares allocated

    by erniewerner Jul 24, 2015 7:56 AM
    erniewerner erniewerner Jul 24, 2015 8:14 AM Flag

    "Can I ask you how you were notified."

    A general email just saying the allocation took place. Then you need to check your account ad it will be posted there. It's pretty haphazard, you'd think there would be an actual confirmation one way or the other, but that's not how they do it.

  • erniewerner by erniewerner Jul 24, 2015 7:56 AM Flag

    I got a tiny fraction of what I asked for. Premarket is holding up pretty good, but trading is thin. The real dump, if it materializes, will come when the market opens at 9:30.

  • Reply to

    What could stop EXEL now?

    by scrotum_harden Jul 23, 2015 10:32 PM
    erniewerner erniewerner Jul 24, 2015 3:38 AM Flag

    "Does anyone expect to see a SEC filing for 5% ownership soon?"

    I've been through a few mergers, Genentech, Chiron, Abgenix, Medarex, Onyx, Amylin.... I have yet to see any acquirer go into the open market to purchase the shares of a target. I've seen direct equity investments negotiated between companies, tender offers and then top off agreements whereby the target issues treasury shares to the suitor to cross an ownership threshold. I'm not saying it never happens, but I think it is a pretty rare animal.

  • Reply to

    Insider Buying by CEO

    by jhsudds Jul 23, 2015 7:11 PM
    erniewerner erniewerner Jul 23, 2015 9:00 PM Flag

    "Do you think recent positive Meteor top line reporting will have an impact on Celestial recruiting?"

    Yes it should. We have no idea where they are wrt enrolment. Meteor filled up incredibly fast, but remember Comet 2, I think it only reached about 1/2 of the planned cohort. So, when they deemphasize a trial it obviously slows and likewise when they prioritize it, it makes a difference. Not sure of the mechanics on how they accomplish this, but we've seen it.

    "Does EXEL have any commitment to share interim analysis?"

    No, but my guess is that they will. Comet had an interim and I remember Dr M saying he considered it material and would release that result. Realize that if the interim fails, no specifics other than the trial continuing are passed to EXEL.

    "What tell-tales might we be looking for wrt a successful early interim assessment?"

    None I know of. EXEL does track events so they will know if an interim is underway, but that's about it. Statsif on the first interim is not a reasonable expectation. Requisite p value will be too small and not enough events to generate statistical power. Perhaps on the second.

    Confirmed my order with Fidelity and I'll find out in the morning how many cheap shares I get (if any). Interesting how they waited til the aftermarket closed before pricing it. Now it will all happen in the morning.

  • Reply to

    Insider Buying by CEO

    by jhsudds Jul 23, 2015 7:11 PM
    erniewerner erniewerner Jul 23, 2015 7:54 PM Flag

    "On 7/20/2015 the CEO exercised the right to buy 1,0027,500 , 240,000 of which were purchased at $5.51 as reported on Form 4....I'd say that's a vote of confidence. This stock should be trading in the 8-10 minimum range right now based on recent data and pipeline."

    That's not what happened. Those options were previously awarded in 3 different tranches as part of his performance based compensation. They became fully vested when he attained a specific goal, namely achieving the primary endpoint for Meteor. Vesting means that they are now his to do with as he pleases with no restrictions. He can hold them, sell them or convert them into stock all at once or piecemeal. They are all in the money and have various expiration dates. There was no vote of confidence aside from that given by the Board's Compensation Committee to the senior executives.

  • erniewerner erniewerner Jul 23, 2015 3:59 PM Flag

    "The registration statement for Exelixis, Inc. Common Stock Follow-On is expected to be declared effective and the offering to be priced this evening, July 23, 2015. The confirmation is expected to occur [between 7:00 pm ET and 12:00 am ET this evening]. Allocation [will not occur prior to 12:00 am ET tonight]. We will send you a separate notice of effectiveness/pricing and a request for confirmation of indication of interest. "

    If this goes the way follow ons typically do, then after the close, it will be priced at a discount to the close. Flippers who are expecting an allocation will immediately start pushing the aftermarket price down to the offering price. A touch of panic may even briefly cause it to trade at or less than the offering. In the morning the stock will open near the offering price and start a measured recovery to pre-offering trading levels. Little about this whole evolution has been typical, so traders get ready and be nimble.

  • Reply to

    4PM Offering Price...Dump AH...

    by cbdthchelp Jul 23, 2015 9:27 AM
    erniewerner erniewerner Jul 23, 2015 12:38 PM Flag

    'The offering was 5.88 you moron, Great trading skills here I see.'

    The offering has not priced yet. Look for it after the close today.

  • Reply to

    CELESTIAL HAS A (WEAK) CHANCE

    by kwasmis Jul 23, 2015 12:55 AM
    erniewerner erniewerner Jul 23, 2015 12:31 PM Flag

    "Do you have an estimate for the time of 1st interim analysis in CELESTIAL (I think it is after 50% of events)"

    Planned enrolment is 760 2:1 Cabo vs Placebo. Analyses at 311, 466 and 621 events. 90% power to detect HR=.76. Large trial and will probably reach all the way to HR=.84 at the final analysis if it is required. Without knowing anything about enrolment other than it started September 2013, it is really impossible to make a reasonable guess as to when the 311th mortality might occur.

  • Reply to

    4PM Offering Price...Dump AH...

    by cbdthchelp Jul 23, 2015 9:27 AM
    erniewerner erniewerner Jul 23, 2015 9:53 AM Flag

    "Oh Boy...I can't wait to see that $5 offering...20 Million Share Dump Coming...."

    I do agree that there will be significant short term volatility and opportunity to make money from both sides over the next few days.

  • Reply to

    Offering Just made available on Fidelity

    by erniewerner Jul 22, 2015 1:07 PM
    erniewerner erniewerner Jul 23, 2015 9:17 AM Flag

    "Ernie, could you please tell if you had to set a maximum price you are willing to pay for the new shares offered with the secondary? Or is the price open to the upside?"

    There is no price attached to the indications of interest. Once the issue is priced (expected at market close), subscribers will receive notice with a deadline to reaffirm their indication of interest. I will obviously check the aftermarket and only confirm my request if the issue is at a discount. Then before the next regular session subscribers will receive notice of their allocation (if any). I'm guessing the issue will be priced at a modest discount to the price at the close (25-50 cents).

EXEL
5.73+0.19(+3.43%)Jul 31 4:00 PMEDT