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Exelixis, Inc. Message Board

duckduffer 50 posts  |  Last Activity: 19 hours ago Member since: May 29, 2003
  • duckduffer duckduffer 19 hours ago Flag

    "I am going to assume one of the tumor types Roche is looking at with the PDL-1/cobi combo is non small cell lung cancer. They have a pivotal trial underway with PDL-1 as a mono therapy in non small cell lung cancer."

    From Ohad Hammers blog-
    "Roche is conducting additional combination studies with cobimetinib, the most important of which is with its PD-L1 antibody. The trial appears to have reached the expansion stage and is now focusing on melanoma, lung cancer and KRAS-mutant colorectal cancer. Initial data from the trial may be available in 2015."

    Sentiment: Strong Buy

  • duckduffer duckduffer 20 hours ago Flag

    We can only speculate on coBRIM until the data is out. We know it met trial endpoints... Zelboraf was one of the faster sales growth compounds for Roche in 2013 with a 50% increase in sales to $397M, but in the first quarter of 2014 sales declined 11% likely due to increased competition. Roche obviously has a big interest in the coBRIM results. The impact on Zelboraf sales with a less than stellar outcome would be significant. The combination of Cobi/Zelb will command a pricing premium with a strong showing. Cobi/Zelboraf will likely be the SOC for BRAFV600 Melanoma. The shared income projection is somewhere in the $150M PAR range to EXEL.... should be enough to move the stock, as that added to MTC ($60M PAR) would justify an $850M- $1B valuation. RCC, HCC, NSCLC Ret+, combined could add another $200M in risk adjusted valuation. Even comprehending the convertible debt, this would justify a $4-5 PPS. Will Mr. Market see it that way...? Hard to say, but the math works. And should RCC/Meteor reach its PFS trial endpoint, more derisking would occur, estimated PAR's for MTC, Cobi, and RCC combine for over $400M justifying a valuation north of $1.6B. That in turn could move the PPS high enough to trigger the convertibles, which would correspondingly reduce the short interest, removing a significant amount of overhang on the valuation. Post RCC there could also be a monetization of Cabo (outside the US or even a full partner), which would address cash needs. I'm not trying to pump up the prospects as much as outline what impact positive results moving forward could have. There is a path to a $7+ PPS sometime in 2015 with some good results.
    Anticipation...
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Enzalutamide, Abiraterone, and AR--V7

    by wilderguide Sep 19, 2014 2:26 PM
    duckduffer duckduffer Sep 19, 2014 4:59 PM Flag

    The Foundation One NGS test for tumor profiling covering 343 genes is currently only $3500. And competition is moving quickly into that market. Consider the cost of a Phase 3 clinical trial is in the tens if not hundreds of millions - a few hundred thousand to screen the tumor profile of patients is a no brainer. This will not push developmental biotechs out of the market. It will probably pull more of them in. It will certainly maximize the efficiency of clinical trials, reduce overall cost of getting new drugs to market, and obviously create much improved patient outcomes. What are the cons? That earlier stage trials will be more expensive. However, earlier stage trials typically have a fraction of the patient population of later stage trials. The cost efficiency benefit of the overall process with tumor profiling will far outweigh the small increase in upfront expense.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    realize comet 1 failed but is it totally over

    by alsodoglover Sep 18, 2014 5:48 PM
    duckduffer duckduffer Sep 18, 2014 8:54 PM Flag

    " I truly believe that we have not seen the last of Cabo and prostate cancer.....". Certainly a possibility. There is an interesting take from the ORF blog (Ohad Hammer) on personalized medicine and NGS-based (next gen sequencing) products for tumor profiling. He mentions EXEL as a company who may utilize these products in the future. The article is on Foundation Medicine. He states "personalized medicine is becoming a reality in oncology and many drugs will require patient selection on a molecular level". What impact would this testing have had if used on the RDT Phase 2 CRPC patients? Perhaps a significantly more specific patient profile in Comet 1.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Sep 16, 2014 11:11 PM Flag

    "Can you remind of the choices MMM had did COMET 1 need to be that difficult?"
    They tried for an easier shot on goal, working with the FDA for an SPA. But they couldn't make it happen. It's immaterial now. If we had been sitting on only the Comet trials earlier this year, I would guess many longs would have sold out of EXEL. Way too much riding on one pivotal trial. But the facts are over the last 1-2 years all these other shots on goal have materialized. CoBRIM Phase 3 trial, RCC Phase 3 trial , HCC Phase 3 trial, NSCLC Ret Phase 2 trial.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Sep 16, 2014 9:01 PM Flag

    enabler,
    The investment thesis on EXEL has been discussed here ad nauseam by regular posters. Multiple shots on goal. MTC, COBI, CRPC, RCC, HCC, NSCLC, etc. The first missed goal, CRPC, was unfortunately the least likely to score. Many, many regular posters here speculated on a fairly low likelihood of success. Many blogs like Ohad Hammers, which many posters regularly referred too, had the chances of success at 30%. The most optimistic post I can recall from an informed poster was no more than 60% chance of success. Better than 30%, but a long way from a sure thing. CRPC was a long shot. As MMM said many times, the data was "provocative". Provocative means suggestive, but not definite. The facts are that Cabo performed as expected. The control group did not. Many physicians and biotech analysts will tell you that Cabo has good activity in CRPC. But at the end of the day, EXEL needs to score their other shots on goal. That's how it works. All the FUD being thrown around isn't going to change the investment thesis. If CoBRIM data is good, Cobi/Zelboraff become the standard of care in BRAFV600 melanoma. That is a significant shot on goal. We'll see how it goes from there. Don't lose your perspective or you walk right into the FUDsters fog emporium.
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Sep 15, 2014 1:24 PM Flag

    For those watching the ticker on EXEL minute by minute, let me suggest one thought. With revenues that are in the tens of millions and expenses that are in the hundreds of millions due to clinical trials, this is a playground for shortsellers. The financial uncertainty is what allows them to do FUD gymnastics. In addition, there are still convertible holders who have an arbitrage play that continues to go short, cover, buy long, sell, sell short....etc. This will also continue until such time as a meaningful binary event produces true market optimism for EXEL's long term prospects. The CoBRIM topline data at ESMO may be one of those events. Certainly Comet 2 topline and Meteor RCC topline are those types of events. But in the interim, if you wish to live longer, perhaps a slightly less reactive view towards the daily PPS would help.
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Sep 12, 2014 5:06 PM Flag

    Very telling exchange from the Morgan Stanley conf-

    Unidentified Analyst

    "And in light of the recent news, have you looked at changing your call-through relationship with Roche as a potential way to perhaps increase your cash balance?"

    Michael Morrissey - President and Chief Executive Officer
    "We like our current collaboration with Roche and the framework for that. We think the asset has a lot of value now and could have more value going forward if the other trials that are ongoing are successful and lead to additional pivotal trials of the other combination. So, we are not looking at ways of monetizing that asset right now to be able to increase our cash position now."

    So for all those critical thinkers spewing FUD about BK as a near term possibility.... EXEL has a number of options for monetizing assets that would bypass seeking funds from the capital markets. EXEL has been fairly consistent in expressing they have the cash to operate through the Meteor topline readout...and with those results in hand...what would the monetization opportunity be for partnering Cabo outside the US?? It's certainly a number in the hundreds of millions considering MTC and RCC revenue opportunities. A monetization could occur within days of RCC topline results. Cobi has the same oppty for monetization, but as MMM clearly indicates, they project even more value with additional trials. We shall see what direction EXEL chooses. For today raising cash isn't a concern, but when it is there will likely be excellent options outside of capital markets.

    Sentiment: Strong Buy

  • Reply to

    Morgan Stanley Transcript

    by duckduffer Sep 9, 2014 7:07 PM
    duckduffer duckduffer Sep 10, 2014 12:05 PM Flag

    Thanks for the read Wilder. There's a statement in the article that addresses the possibility of drug approvals in mCRPC for PFS, despite other approved compounds having been granted based on OS. I would bet that after the Comet 2 topline data, anticipating good pain palliation and a positive OS trend, there will be much more discussion regarding this possibility. And deservedly so. It would be a crime not to allow physicians to utilize a compound that has proven efficacy on bone mets, pain, and soft tissue. OS will improve as better sequencing and biomarker understanding evolves. But in the near term, how about just putting patients in salvation therapy on Cabo for an initial 6 week interval. If bone scans improve, CTC levels decline, and pain palliation occurs...continue therapy...the data suggests you will live longer and with a better QOL. Seems almost too simple...:)
    GLTA

    Sentiment: Strong Buy

  • Reply to

    CFO

    by csanderson1805 Sep 9, 2014 12:18 PM
    duckduffer duckduffer Sep 9, 2014 9:23 PM Flag

    "So in summary they need a good ESMO to get the momentum going"
    Agree that good ESMO data would enhance the value of Cobi and help the PPS of EXEL. But don't forget that Roche announced that CoBrim met the trial endpoints. Cobi is already a success. The question now is how big.

    Sentiment: Strong Buy

  • Reply to

    read the transcript on totays ccand have question

    by mj525252 Sep 9, 2014 7:06 PM
    duckduffer duckduffer Sep 9, 2014 7:33 PM Flag

    Always a chance. When EXEL was $12 and investors were ecstatic about Cabo bone scans and waiting anxiously for ASCO in 2011, Cobi was quietly moving through BRIM7 with very little attention from EXEL investors. Cobi hasn't moved the stock much higher yet....but ESMO could change that.

    Sentiment: Strong Buy

  • Here is a statement by MMM that resonates-
    "The PFS endpoint was an exploratory endpoint and it was investigator-generated, but that was significantly favoring cabozantinib. We had a hazard ratio there of 0.5. So, that’s the second trial now where we have seen a pretty dramatic PFS benefits for cabozantinib first in the MTC trial EXAM where we saw a hazard ratio of 0.28 and now in the second trial COMET-1 where we saw hazard ratio of 0.5 for PFS, so somewhat interesting connection there between those two trials. Again, the METEOR trial is looking at PFS as the primary endpoint for RCC. So, that’s actually I think a very good point to kind of underscore"
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Conference with Morgan Stanley

    by laoxao855 Sep 8, 2014 4:14 PM
    duckduffer duckduffer Sep 8, 2014 8:49 PM Flag

    Wilder,
    This statement from a PR regarding OS data in the NRE cohort of the RDT certainly supports your opinion- "In univariate analyses, longer OS was associated with bone scan response at week 6, CTC response at week 6, and pain response." If Comet 2 demonstrates this association as well, it makes a pretty compelling argument.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Sep 8, 2014 4:57 PM Flag

    I wouldn't recommend anyone forming theories on valuation based upon todays trading. I can't imagine there will be much movement in the PPS until ESMO. Right now IMO we are valued for MTC and perhaps a highly risk discounted Cobi. If Roche provides excellent results from CoBrim at ESMO, that would move the needle. IMO with CoBrim results anywhere near the BRIM7 data we would see a gradual improvement in the valuation to somewhere in the 5-600M range. If you believe with good data Cobi has a PAR opportunity to EXEL of $150M (conservative) then the fully realized valuation for that partnership is $600-750M. Cabo in MTC has a projected PAR of $60M. The full valuation of that is $240-300M. Add the two and your looking at $850M-$1.05B. IMO that is the direction the stock will go, although it won't be a straight line up as there are still tricky waters to be navigated with cash raising looming in the background. Positive RCC and we see significantly more blue sky. At that point, EXEL could sell Cobi for a bunch of cash (see above valuation) to Roche and go the distance with Cabo. With RCC/HCC/NSSLC/MTC and what is bound to be other indications from over 30 clinical trials on going....Cabo is still a valuable asset. Is it the 5-10X opportunity it was with a homerun in CRPC...no. But it's not hard to make a compelling case for it being a 3-5X opportunity from here. There is also the possibility with additional indications that Cobi becomes the "franchise". If EXEL had a Cobi cash machine being expanded by one of the worlds best operators in Roche, that might not be a bad scenario either....All eyes on ESMO....
    GLTA

    Sentiment: Strong Buy

  • Reply to

    RCC PFS Approvable Endpoint

    by duckduffer Sep 5, 2014 1:14 PM
    duckduffer duckduffer Sep 5, 2014 5:11 PM Flag

    There are key differences Clem. In CRPC with Cabo there was no OS data prior to Comet 1/2 trial design/launch (May'12). It wasn't until well after the launch that OS data from the RDT NRE cohort readout (June'13). The OS from the NRE was 10.8 months which is almost identical to the Comet 1 results of 11.0 months. Also from the NRE was data that suggested patients showing bone scan response at week 6 and pain reduction from Cabo therapy had a direct correlation to increased OS times. Perhaps with that information in hand and available for consideration/feedback from the FDA, the Comet/s could have been better designed prior to launch. Of lesser significance, but also potentially problematic, OS is susceptible to the confounding impact of subsequent therapies after disease progression.

    On the other hand, in RCC the data for PFS was in hand when they designed the trial. I don't know if the small sample size is going to be perfect as it relates to trial design, but at the end of the day, the data was there and the trial was based on that real data. PFS is also much less likely to confounding factors in the data as there is no "subsequent therapy". Once the disease progresses, the data is locked.

    You have to admit those are pretty significant differences between the trials and IMO their prospects for success.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    RCC PFS Approvable Endpoint

    by duckduffer Sep 5, 2014 1:14 PM
    duckduffer duckduffer Sep 5, 2014 2:55 PM Flag

    As pointed out by wildbiftek, the confounding concerns are less regarding the control arm with PFS. And if you were to draw comparisons to the Comet trial, you would note that PFS was also quite good and stat sig.

    Sentiment: Strong Buy

  • Here is what we know. Cabo in RCC demonstrated a 14.7 month PFS in a Phase 1b study that included heavily pretreated patients (88% having received prior anti-VEGF therapy, 60% having received prior mTOR inhibitor therapy, and 52% having received ≥1 anti-VEGF and 1 mTOR therapy). While that is based on a single arm small sample size study, the results are compelling. Not only is the PFS quite good, the efficacy with patients who are refractory to other treatments is very significant. Let hope the statements made by MM, and Debra Burke relating to having sufficient cash until after the RCC topline readout is solid. If Meteor delivers these type of results combined with what could be very compelling data from CoBrim.....to the moon Alice. For the record, these indications were the primary reason why holding through Comet 1 readout wasn't as big a gamble as many have indicated. The gamble was on hitting a major out of the park homerun in the shorter term. But as for EXEL and still seeing a good return on investment, Meteor and CoBrim have been the hole card all along.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Sonnier's comments

    by wildbiftek Sep 3, 2014 10:50 PM
    duckduffer duckduffer Sep 4, 2014 9:22 PM Flag

    This is from the Tuesday morning call-
    Michael M. Morrissey
    "This workforce reduction will enable us to focus our financial resources on our METEOR and CELESTIAL clinical trials and ensure that we have sufficient cash to take us through the topline results of METEOR next year. "
    and then later in the call during Q&A
    Jonathan Chang - Leerink Partners LLC
    "Thanks and just one last question. In terms of the current cash guidance, taking into account the workforce reduction you have guided to have enough cash to support operations through the release of topline METEOR results next year. Is this new cash guidance different from the past cash guidance?"
    Michael M. Morrissey
    "Yes, it’s Mike. So we've consistently talked about having the ability to get through the METEOR readout and that holds for today."
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Sonnier's comments

    by wildbiftek Sep 3, 2014 10:50 PM
    duckduffer duckduffer Sep 4, 2014 6:12 PM Flag

    This is what I posted after the Q2 con call. It sure sounds like they had the post Comet failure actions dialed in already.
    "I don't think anything is ever in stone when it comes to raising cash, but here is the most compelling statement in the CC from my perspective. It's from Debbie Burke-
    "We continue to expect total cost and expenses in the range of $250 million to $280 million and we anticipate to end the year with greater than $200 million in cash. Our outlook for the length of our financial runway also has not changed and we continue to be confident that our runway extends through the readout of METEOR trial for RCC."
    IMO this is a declaration that the plan is to not raise equity until after RCC topline data which should be early 2015. That would explain the $80M fundraising they did in March. I'm optimistic about COMET, but let's face it, the single most likely trial to show overwhelmingly positive data is METEOR. I like the plan. Let's hope they stick to it."

    Sentiment: Strong Buy

  • Reply to

    Sonnier's comments

    by wildbiftek Sep 3, 2014 10:50 PM
    duckduffer duckduffer Sep 4, 2014 2:01 PM Flag

    Just to clarify, that is 5X PAR, at least $750M just for Cobi. That's if...if...they want to even sell Cobi. With positive RCC who knows....might just want to keep that cash machine.

    Sentiment: Strong Buy

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