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Exelixis, Inc. Message Board

duckduffer 43 posts  |  Last Activity: 20 hours ago Member since: May 29, 2003
  • duckduffer by duckduffer Mar 29, 2015 2:09 PM Flag

    Crashed into the earth and demolished EXEL's valuation, much has happened that might lead one to believe the short interest would be better served covering and moving on.
    *EXEL announces Roche filing of Cobi used in combo w/vemurafenib NDA
    *Meteor RCC Study enrollment completed in November/readout expected in Q2
    *ECOG/ACRIN Study E1512 in 2L or 3L EGFR wild-type NSCLC interim analysis meets primary endpoint
    *Roche Cobi NDA attains priority review/ August 11th PDUFA
    *Vemurafenib plus XL888 in malignant melanoma anti-tumor activity observed in 92% of evaluable patients
    *EXEL announces 2014 YE Cash of $242.8M sufficient to fund operations through year-end 2015
    *45 ongoing or planned studies of EXEL compounds with significant readouts in 2nd half of 2015
    *Comet 1 data release demonstrates greater than 50% OS improvement in CRPC patients with visceral mets
    None of these developments are negative. In fact, one would be hard pressed to find any negative developments for EXEL since the Comets. Pretty clear the short interest is hoping that METEOR doesn't hit endpoints. At this point...is that a bigger gamble than investing at these valuations on the long side? As mentioned by everyone ad nauseam..do your own due diligence...the YMB is a like looking through a landfill for treasures. Gotta sort through so much garbage...there are much better places to look.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Mar 26, 2015 2:02 PM Flag

    Window dressing has to be a factor here, with EXEL increasing for anyone who added in January around 50%. If you were a hedgie, who bought in Dec/Jan, wouldn't you take profits now? Your results for the quarter would be brilliant and you can always buy back in April before METEOR readout (probably) if you believe in the Cabo. At the same time for those looking to add shares, this might be the lowest PPS buying oppty before METEOR reads.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Been watching Exelixis for a long time

    by kahn_boonie Mar 24, 2015 1:26 PM
    duckduffer duckduffer Mar 24, 2015 7:54 PM Flag

    "I like your comment but I disagree that it would displace everolimus. It's a different target"
    Currently Axitinib has $410M in annual 2nd line RCC treatment sales as a VEGFR/KIT inhibitor. The median PFS of patients receiving Axitinib was 6.7 months in their clinical trial on previously treated patients in RCC. Cabo targets VEGFR/KIT/ and MET and is shooting for 7.5 months PFS in their clinical trial for previously treated patients in RCC.
    Whether it's taking share from Afinitor or Inlyta (axinitib), either or both will work for me. Cabosun, the trial vs Sutent is nearing enrollment completion and will read out in 2016.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Been watching Exelixis for a long time

    by kahn_boonie Mar 24, 2015 1:26 PM
    duckduffer duckduffer Mar 24, 2015 6:15 PM Flag

    "The question in my mind is not whether it will meet the 7.5 months median PFS, but how much more? 12 month or 14 month?"
    That really gets to the gist of how much increased valuation we might expect on a successful METEOR. If the Cabo PFS numbers match the earlier trial (12 months) and everolimus performs as expected (5 months), the valuation will be exponentially better than just meeting the trial endpoints. And considering how heavily pretreated the patients were in the earlier trial, who's to say Cabo won't outperform those results? With a 12 month PFS outcome, the assumption would have to be that Cabo will not only assume all of Afinitors (everolimus) marketshare in RCC ($400M per year), but that Cabo would also likely show better results than Sutent in that ongoing head to head trial. That would bring the possibility of Cabo being a $1B drug into the range of reality, and a foregone conclusion with a successful CELESTIAL trial in RCC.
    What is a $1B drug worth in market valuation these days? It's at least $5B. Oh yeah...what about Cobi...:)
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Rationale for Cabo plus immunotherapy

    by wilderguide Mar 18, 2015 11:59 AM
    duckduffer duckduffer Mar 18, 2015 1:31 PM Flag

    Perfect! Prom nite dumpster baby....one of my favorite "Family Guy" diddy's....worthy of a you tube break...thanks Wilder!!

    Sentiment: Strong Buy

  • Reply to

    New 8K-Deerfield

    by neers87 Mar 9, 2015 7:01 PM
    duckduffer duckduffer Mar 9, 2015 8:46 PM Flag

    They are not picking up $100M. They are exercising the option to extend the notes until 2018, as they discussed previously. This is nothing new.

    Sentiment: Strong Buy

  • duckduffer duckduffer Mar 4, 2015 3:56 PM Flag

    "The visceral mets data is at best informative "
    To further your point made in the post. This is still much much better than the alternative, data which indicates less efficacy than the Phase 2's. As MMM pointed out in the last CC, all the data, CTC's, bone scan response, OS, PFS, and even OS was similar to the phase 2 trials. Cabo performed exactly as expected, which is what many feared wasn't the case. Many took the Comet failure as an indictment that Cabo was simply another drug that didn't have the same efficacy in a larger trial population than the Phase 2. The data, the article, EXEL's recent comments, have obviously had a profound effect on reversing this sentiment.
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Mar 3, 2015 12:59 PM Flag

    As much as I can't stop thinking about the Comet 1 visceral mets OS data, it's apparently outside the lines of what MMM was willing to address in an investor call that is open to the public. Who knows what additional questions he fielded in the investor sessions. All in all a good call, continues to show a very high level of confidence going into Meteor results. We all know that the small Phase 1B RCC study produced exciting data. In addition to covering all the previously discussed positives around the primary endpoint being PFS, another somewhat newer data point demonstrating positive is the median age/health of the patients in study. Second line RCC patients are generally healthier than 3rd line CRPC patients. The average age in Comet 1 was 69. In a similar to METEOR (RECORD-1) study for RCC the age was 60. This clearly was bad for Comet OS results, but will apparently be good for Meteor. So in sum, combine a PFS study (Cabo's history of success in PFS and a trial with no confounding agents) with a younger more tolerant patient group and the prospects for a successful METEOR look even better.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Can't get it out of my mind....

    by duckduffer Mar 2, 2015 4:35 PM
    duckduffer duckduffer Mar 2, 2015 7:32 PM Flag

    "we may have to wait."
    You may be right. What gets me wondering is that the Cedars Sinai study is a Phase 2 that is targeted to enroll only 40 patients. And the primary endpoint is "clinical benefit as defined by RECIST". This Comet 1 data is more significant and compelling as it shows OS, an already established approvable endpoint for mCRPC on a much larger group of patients with a control. Keeping my ears up and in the open position.
    GLTA

    Sentiment: Strong Buy

  • "For 191 pts with visceral disease median OS was 7.1 months for Cabo vs 4.8 months for Pred (HR 0.65; P = 0.0215"
    Quite possibly we'll hear more on this provocative data manana.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    ASCO-Comet 1

    by neers87 Feb 26, 2015 6:07 PM
    duckduffer duckduffer Feb 26, 2015 6:21 PM Flag

    It certainly appears there could be something coming in regards to CRPC. As pointed out when the abstracts hit, the data for patients with bone mets and visceral disease very compelling, almost a 50% increase in OS in that subset of patients. Fast forward to today and the commentary on twitter is quite "provocative" (couldn't resist). I fully expect them to discuss in much more detail on Tuesday at Cowen. MMM had his tongue tied on the earnings call in waiting for today's presentations. On Tuesday he can spill the beans. Could very well be they are very seriously considering a NDA filing for Cabo in mCRPC. And with today's price action...there are many who are thinking the same way.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Any arguments against +Meteor results

    by alexp1112 Feb 26, 2015 3:04 PM
    duckduffer duckduffer Feb 26, 2015 6:13 PM Flag

    Gisela's dosing rationalization-
    "we are conducting all our Phase 3 studies and also the Phase 2 program that I've mentioned through RFPs in detail at the 60 mg dose and that dose was based upon the median average dose received by patients in earlier study, including the RCC study, where patients dose reduced and ultimately received 75 mg per day as a median average dose, which is close for the 60 mg."

    Sentiment: Strong Buy

  • Reply to

    Whats going on with EXEL

    by ac585517 Feb 26, 2015 2:57 PM
    duckduffer duckduffer Feb 26, 2015 4:32 PM Flag

    Something like..."Hey this $#@%& works pretty well on later line CRPC patients with bone mets and visceral disease"..."somebody really ought to think about that"..."seriously"..."I'm not kidding, this is my job"..

    Sentiment: Strong Buy

  • Reply to

    Comet 1

    by trufflesdrive Feb 25, 2015 9:08 AM
    duckduffer duckduffer Feb 25, 2015 12:30 PM Flag

    Post Cabo treatment with Xofigo being a huge factor in the failure of Comet 1 absolutely makes sense when you consider the group with the biggest OS advantage for Cabo of almost 50%...was the group that would have been ineligible for Xofigo therapy (those with visceral disease) post Cabo treatment. Lends even more credence to that specific indication being one with few remaining treatment options and perhaps a spot in the CRPC treatment landscape for Cabo.

    Sentiment: Strong Buy

  • Reply to

    New Flash for semanrasu

    by lagatik Feb 24, 2015 5:31 PM
    duckduffer duckduffer Feb 24, 2015 8:13 PM Flag

    I'm going to surmise this thread involves someone putting a ridiculous spin on the development costs of Cobi. The development costs of the Phase 2 and 3 trials are not EXEL's responsibility. They gave up 50% of the profits on a drug they developed up thru the initial Phase 1 trial in order to NOT be responsible for the cost of further developing the drug, and yet still be able to participate should the promise of the drug be fulfilled.

    Sentiment: Strong Buy

  • duckduffer by duckduffer Feb 24, 2015 6:59 PM Flag

    Exelixis discovered CS-3150 (XL550) and out-licensed the compound to Daiichi-Sankyo. Two phase 2a clinical trials, one in hypertensive patients and the other in type 2 diabetes with albuminuria, are currently being conducted in Japan by Daiichi-Sankyo. Potential milestone payments and licensing revenue from this MR antagonist.

    Sentiment: Strong Buy

  • EXEL finished the year with $242M, which was significantly better than their guidance of $200+M. It's apparent at the current pace of MTC growth, they will earn at least $30M from this indication in 2015. After an FDA approval in July/August for Cobi, expect another $15-20M in 2015 for MM. So the net cash consideration for 2015 is $242M plus $45M= $287M. Better than expected. Next several days should be interesting as it sounds like the Comet data is going to get vetted out pretty thoroughly. Abstract to be presented by Matthew Smith on Thursday at 1:00 EST.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Feb 24, 2015 4:09 PM Flag

    Perhaps the last investor CC was a tell on what the future holds for EXEL in CRPC. MMM stated they are looking for an ex-US partner and we have assumed it would be primarily for RCC post Meteor. But with this new look at the Comet data, perhaps the thinking is to find a partner who likes what they see in the CRPC data set. Either way, I'm encouraged that Cabo may have found another source of revenue in a subset of patients who have an unmet need.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Feb 24, 2015 2:17 PM Flag

    "The significant downside to a compendium listing (if you view it as a downside) is that the indication cannot be advertised".
    I wonder if that carries over to company disclosures and investor conferences, etc. Would certainly explain why they haven't discussed it beyond just the normal conservative expectation setting. Let's face it, if you pitched it during an investor conference, it could definitely be construed as promotion.

    Sentiment: Strong Buy

  • duckduffer duckduffer Feb 24, 2015 1:00 PM Flag

    " it's possible that the circumstances are different enough and the chances are small enough that Exelixis may not want to risk wasting additional time and money going down this route"
    Call me an optimist, but is cost or time really a deterrent? What if it's just an option that is yet to play out. Couldn't EXEL submit a NCCN compendium application at very little expense? And doesn't the NCCN prostate cancer committee meet in June? While it's not an FDA approval, for physicians with patients who have run out of options, wouldn't Cabo becomes a viable option (50% OS improvement is meaningful even in salvage therapy)? Wouldn't insurers reimburse an NCCN recommendation and don't most physicians treat them as near equivalent to FDA approval? What would a salvage application of this type mean to EXEL? If the market thought Comet 1 was a $400M opportunity, would this be 25% of that? Wouldn't it be nice to see at least $100M PAR in the CRPC market after spending a bundle on the clinical trials. What I would expect from EXEL is that we won't get much information about this until it's been completely vetted and perhaps even submitted. Experience has taught MMM about speculative disclosures to the market. Better to not say anything than to disappoint.
    GLTA

    Sentiment: Strong Buy

EXEL
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