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Author: hiddenflem Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 73120  
Subject: exel call Date: 11/7/2012 5:18 PM
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listening to the exel call now. they are reporting slight delays in getting IRB approvals for the Comet trials: they are "widening the window of time" and expecting top line results in 2014 (working towards early but...).
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Author: hiddenflem Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65407 of 73120
Subject: Re: exel call Date: 11/7/2012 5:39 PM
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Analysts seem [rightly] concerned about the timeline issue-seems like every analyst has asked about it.

Gisella said the delay is due to summer months in europe...admin processes. They are activating sites, delay of a "couple weeks or a month".

Again: Working towards delivering first half of 2014 but could slide to second half...

Comet2 all sites up and going by end of year, Comet1 about half up and running by end of year.

Roche call post ESMO apparently has info on the timelines re: the partnered Roche melanoma drug.

Regarding cash from the Aug offering- they expect should be sufficient to complete comet trials and run one or more other phase 3 trials...usage of this $ depends on revenues from Comet.

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Author: projectchris Big red star, 1000 posts Old School Fool Global Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65408 of 73120
Subject: Re: exel call Date: 11/7/2012 5:58 PM
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Roche call post ESMO apparently has info on the timelines re: the partnered Roche melanoma drug.

My vague recollection of that Roche conference call stated they expected top line results in 2nd half 2014 and launch in 2015. Roche stated they would eventually try to update on clinicaltrials.gov site. I will post again after I listen to the call again.

More details on profit share arrangement on MEK inhibitor as follows

50% profit share up to $200 million in sales and 30% profit share after $400 million.

In Q&A, a question arose about using existing salesforce in MTC upon hopeful approval to use towards Exel 25% commercial salesforce team to apply for co commercialization of MEK inhibitor in Roche collaboration. Exelixis conceded it was possible but couldn't get into details until the appropriate time.

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Author: projectchris Big red star, 1000 posts Old School Fool Global Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65409 of 73120
Subject: Re: exel call Date: 11/7/2012 6:02 PM
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Again: Working towards delivering first half of 2014 but could slide to second half...

Exelixis guided for approx. 140 sites initiated for COMET 1 by years end, and near all 50 sites initiated by years end for COMET 2.

Exelixis also is planning pivotal phase 3 trials vs comparator in 2nd line renal, and vs placebo in 2nd line HCC.---First half of 2013. More pivotal trials planned, but no specifics at this time.

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Author: hiddenflem Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65410 of 73120
Subject: Re: exel call Date: 11/7/2012 6:22 PM
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I am not optimistic about the timeline for these trials- if they say that they 'might' slide to 2nd half of 2014 for readout, experience suggests it probably will slide until then. at least.

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Author: projectchris Big red star, 1000 posts Old School Fool Global Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65411 of 73120
Subject: Re: exel call Date: 11/7/2012 6:24 PM
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I am not optimistic about the timeline for these trials- if they say that they 'might' slide to 2nd half of 2014 for readout, experience suggests it probably will slide until then. at least.

I'm with you. Exelixis generally overpromises and underdelivers. If management is already stating timeline issues, you can bet results will be available later rather than sooner.

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Author: projectchris Big red star, 1000 posts Old School Fool Global Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65412 of 73120
Subject: Re: exel call Date: 11/7/2012 8:25 PM
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My vague recollection of that Roche conference call stated they expected top line results in 2nd half 2014 and launch in 2015. Roche stated they would eventually try to update on clinicaltrials.gov site. I will post again after I listen to the call again.

Briefly mentioned in Q&A. It was said that clinicaltrials.gov site has an error with completion date of 2017. Roche said it would be corrected and certainly sooner than that. I probably got my timeline specifics from this link. http://seekingalpha.com/article/901801-exelixis-first-partne...

Short timelines - The phase III trial will start next month with progression-free survival as the primary endpoint. Enrollment should be very quick, given Roche's experience in the indication (Zelboraf was the 1st approved drug for BRAF-mutated melanoma) and the fact that melanoma patients are routinely screened for BRAF status and treated with Zelboraf. Top line results could be available in mid-2014, and Roche expects to submit the combination for approval in 2014.

Don't know where Ohad got his timeline info. Maybe an educated guess?

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Author: TMFCandyMountain Big gold star, 5000 posts Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65424 of 73120
Subject: Re: exel call Date: 11/8/2012 10:24 AM
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Short timelines - The phase III trial will start next month with progression-free survival as the primary endpoint. Enrollment should be very quick, given Roche's experience in the indication (Zelboraf was the 1st approved drug for BRAF-mutated melanoma) and the fact that melanoma patients are routinely screened for BRAF status and treated with Zelboraf. Top line results could be available in mid-2014, and Roche expects to submit the combination for approval in 2014.

Don't know where Ohad got his timeline info. Maybe an educated guess?



Roche Q3 slide deck, slide 48:

http://www.roche.com/investors/ir_agenda/q3-2012.htm

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Author: projectchris Big red star, 1000 posts Old School Fool Global Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 65435 of 73120
Subject: Re: exel call Date: 11/8/2012 3:23 PM
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Aha thanks, I was thumbing those pages and still missed it.

Hoping those pivotal trials can start without a hitch. After looking at transcript, apparently Exelixis didn't commit to a timeline on start of pivotal HCC, and RCC trials

http://seekingalpha.com/article/989151-exelixis-ceo-discusse...

There was a question about whether the notes due in 2019 could be pre paid with cash rather than stock. 10Q shown here http://biz.yahoo.com/e/121107/exel10-q.html describes potential pre payment with cash after Aug 15, 2016.

I am still happy Exelixis chose this path rather than diluting the asset. Some smart folks out there disagree, I know, but it will be fun to see how this all works out 5 years from now.

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