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Mike Morrissey - Chief Executive Officer


Terence Flynn - Goldman Sachs

Exelixis, Inc. (EXEL) Goldman Sachs Healthcare Conference June 6, 2012 12:20 PM ET

[No presentation session for this event]

Question-and-Answer Session

Terence Flynn - Goldman Sachs

Thank you very much everyone. Good morning. I’m Terence Flynn, one of the biotech analysts here at Goldman. We are very pleased this morning to have Exelixis with us and today from the company we have Mike Morrissey, CEO. Mike, thanks for taking the trip out here and right after ASCO, we appreciate the time and maybe given we’re right out of ASCO, you can just start off by providing us some of the key takeaways from the conference.

Mike Morrissey

Yes, for sure. Good morning and thanks for inviting us here and before I start let me just read a quick FLS. During the course of this presentation we will be making forward-looking statements regarding future events or the future performance of the company. Actual events or results of course could differ materially.

We refer you to the risk factors section of our most recent form 10-Q filed with the Securities and Exchange Commission on May 3, 2012, for a description of factors that could cause actual results to differ materially from those contained in any forward-looking statements, including risks related to the potential failure of cabozantinib, to demonstrate efficacy and safety in clinical trials, Exelixis’ ability to conduct clinical trials for cabozantinib sufficient to achieve a positive completion and is essentially of Exelixis’ capital and other resources and the uncertainty of the FDA review and approval process.

So with that, the first question again was ASCO, right.

Terence Flynn - Goldman Sachs


Mike Morrissey

So I believe we had a pretty interesting ASCO this year. We had nine different abstracts that were presented at the meeting. We had four oral presentations covering some I think relatively new data in terms of thyroid indication, prostate indication, as well as updates in liver cancer and renal cancer and we had four-poster presentations that were also discussed, as well as one fiscal report.

So it was a pretty deep dive into the data for cabozantinib, cabo for short, that allows us to I think really bring people up to date with the latest data and I think the take-home messages from the meeting were really three fold.

First is again, MTC looks like a viable indication for cabo that finally has been now completely submitted with the FDA, we announced that last week. So that coupled with the exam data where we again showed pretty strong benefit for PFS looks like a good start in terms of our first potential indication where we could seek approval. So that’s ongoing right now. So that’s I think a good start for us.

Secondly, the second big message is around prostate cancer. Again, we had two different discreet updates; one -- actually both by the MGH group. First was, on Monday we had a poster by Dr. Wigley (ph) who works with Matthew Smith at MGH, talking about the low dose work.

The 40 mg starting dose was again confirmed and expanded upon the data we had last fall, showing the overall rates of bone response, showing good reductions of CTCs, either in terms of absolute reduction or conversions from plus five to minus five, and then good tolerability. Some notations and post reductions or interruptions. So it’s a good data set in terms of handing lower dose cabo in CRPC with good maintenance of that efficacy and then we had his updated yesterday, kind of in the last session, looking at the 100 mg cohort in the NRE.

So that data combined continues to highlight the novelty, the unique nature of cabo in that space and certainly one that is dynamic right now, lots is going on, lots of success in prostrate cancer over the last year or so, but you know we are not curing anybody, lots of patients are progressing on some of the newer therapies. So I think it will outline the opportunity for cabo.

So cabo is certainly positioned for prostate cancer in a very strong sense. We have two pivotal trails going, COMET-1 and COMET-2, so together that totality of information around the ASCO data, as well as, as the COMET’s up and running, I think shows our commitment and progress in prostate cancer.

So there is MTC, there is prostate cancer and then I think the third big message for us was just the activity of cabo outside of those indications. We talked about cabo being more than a bone drug, being more than a prostate cancer drug and I think year’s ASCO really reinforced that kind of information.

We have very early but interesting data in liver cancer. Our overall survival was about 15 months. Again, all the caveats there, single arm study, 41 patients but I think that information in terms of both PFS, which is in the four to five month rage, as well as OS in the 15 month range certainly caught peoples attention and also investigated enthusiasm for both during second line and first line randomized trials in the study and in Phase 2.

RCC, again relatively congested space with a lot of, I would say similar activity would digest and implore inhibitors our PFS there in a highly refractory line of patients. Lots of third, fourth, fifth line patients was about 15 months as well and our survival median has not been reached in that, against, small cohorts.

So we were seeing signs and hints of activity in these either single arm or cohorts from the RDP study that really reinforced the idea that cabo has the depth and breadth of activity, which is unique amongst TKIs in many other conferences. So ASCO is very unique for us and we certainly have a lot of momentum going forward in terms of what we now look forward to in the rest of ‘12 and into ‘13.

Terence Flynn - Goldman Sachs

Great. That was a great recap Mike. I appreciate it. Maybe to dig into a couple of pieces of data, so maybe we could just start of in terms of the low dose data. So just remind us the does that you guys explored and some of the Phase 2 work and what you saw in terms of tolerability and efficacy and them may be why the decision was made, to go down to the corridor and then how that translates into your Phase 3 program, that does you are using there and just kind of frame those pieces…

Mike Morrissey

Yes. So we studied for the most part in the Phase 2 prostate cancer experience now with how they had about 350 patients overall, and again the first patient being found a couple of years ago and describe at ASCO in 2010. So a lot of progress and a lot of experience in terms of the last couple of years, trying to really understand the profile, the reproducibility, the consistency of these different, really unprecedented effects with cabo that we are seeing in the bone and CTCs, other components of that activity.

So the work then was done at 100 mg and the majority of those patients have been started at 100 mg with liberal gross reductions in the case of without all TKIs, most patients at 100 are dose fairly rapidly to 60. That seems to be a pretty stable dose looking at the historical dataset, pushing of those to under 40.

Second, part of the rational for looking at a lower dose was to really do very exhaustive dose range finding and the tumor type then for us was (a) very relevant both medically and commercially; (b) had a lot of patients and that we could rapidly access in getting at most men with prostate cancer and bone disease and then third, using as well established biomaker, in this case a bone scan response, to be able to really ask the question about what’s the optimal dose for both activity, durability and tolerability in that Phase 2 setting, so we could go into Phase 3 with what would optimally be the best dose.

Now with TKIs in general, what’s been seen is most dose optimization takes place actually post Phase 3 in Phase 4. You look at Gleevec, you look at the dasatinib, you look at even (inaudible) a list of examples. The challenge is to find a sense of the population with an asset dose question and we are fortunate to have that opportunity in Phase 2 with prostrate cancer. Lots of patients, they all have for the most part bone meds and most men respond very rapidly and certainly very dramatically to bone with the bone scan response to top it.

So we use the IST format with Matthew Smith to be able to ask that question very, very cleanly and quickly and within a matter of months we’ve been able to really bracket the 40 mg dose and the 20 mg dose to understand and look at a bone scan response perspective and CTCs and intolerability.

That 40 is actually kind of a low end of activity in resolving a well established bone metastases. 20 we have some activity, but it’s not as great as a 40 and that certainly is a well-tolerated dose based upon all the data we have so far and we’ve amended the non-randomized second cohorts to add another 50 patients at the 40 mg footing dose. Those patients have been enrolled, but they were still very immature, so we hope to update people on that later in the year, early in 2013.

But I think the Gestalt as it’s evolving now is such that we’ve been able to bracket the high dose of 100 where we see good activity with challenges from a tolerability point of view, long term prior to tolerability issues with a 40 mg dose with factoring in good activity and good tolerability and then 60 is kind of in the middle.

So we look at 60 certainly for doses in Phase 2 and the COMET as a very good starting dose. Most men who’ve been dose reduced from 100 to 60, stay on 60 for a long time. We see good durability of response, good responses overall across some parameters and then we’ve set it for prostrate cancer.

So it’s a good place to start knowing that then we can dose reduce for the small percent of patients that actually need a dose reduction to 40, which evolved from the active dose. So we are confident in that approach and looking forward to getting the comments evolved and going.

Terence Flynn - Goldman Sachs

Okay great. And in terms of the NRE study, maybe just help us think about the – I think the question of that trial was designed to address and I know you have some new slightly different patient population versus the Phase 2 trial and maybe walk us through some of the key findings on that front and how you think about those findings and thinking about probability and expense of the COMET trials and what you learned from the NRE trial.

Mike Morrissey

Yes, yes, that’s it, yes. So again, the NRE protocol was designed to be able to prospectively look at the key parameters and the key components of the activity profile with combo that’s in the RDT in a prospective fashion. Bone scan response looking with a CAD based system, we will quantify that in terms of not just resolution, but actually a response criteria.

Pain reduction was in the BPI prospectively looking at CTCs, certainly in tumor cells which have been I think a very biomarker for survival, so those other compounds looking at the bone biomarkers, looking at tumor shrinkage, PFF, etcetera. So it was done in a way that was I think done in a prospective fashion that would give us more confidence. We kind of were able to ask a better question because of the RDT and we designed the experiment in the NRE to address that, very, very I think thoroughly and exhaustively.

From a standpoint of the dose, I talked about that, I think the overall dataset I think is pretty compelling. All the patients in the NRE were taxotere pre treated, so that was 100% of patient population. 73% of those patients had a second therapy as well, about half or so had abiraterone or MDV3100. We had a lot of patients with taxotere as well. So it was a heavily pre treated population I think.

In Matthews presentation yesterday, he was on his way to talk about this being probably the most heavily pre-treated population that’s been studied in a prospective randomized basic trial. So it’s a tough population to work with, but I think it’s one that we needed to test upfront, because (a) it was a population we were going to study and the Phase 3’s for both COMET-1 and COMET-2, but (b) it’s an area that we think will be a good place to start commercialing.

We’ve always I think had the view that the new hormone therapies have a right around (ph) and MDV-3100 would move up in terms of pre chemo study and I think that pivotal came out from the Cougar 302 study that further reinforces that. So it really opens up the second line I think for us to be able to compete very effectively and most patients again usually have a lot of bone disease, a lot of pain, short overall time for survival, so it’s a very good place to start with a relatively low risk and a high PTS.

So what we learn from the NRE data, if you look at the totality of data is that the cabo appears to maintain its activity and look later on population. We saw about a 70% rate of bone scan response, all our pain response appears to be very good and I think in this standpoint about 50% of patients had a reduction of 30% or more in their pain score, in their BPI score.

We saw a very dramatic reduction in CTCs. More than 90% of patients had a reduction of 30%. Our CTC conversion rate of more than five to less than five is about 40%, so in line or superior to what we’re seeing of the compounds. Again, ALP goes down, CTX and other bone biomarkers go down as well.

So all the different parameters that are associated with shorter survival in terms of bone biomarkers, in terms of hemoglobin, in terms of pain, in terms of soft tissue tumor aggression, all those different parameters appear to be moving in the right direction in this population with cabo.

So I think it really reinforces the idea that we’ve got a good chance for success in both COMET-1 and COMET-2. Certainly the pain, probably which is exactly now and that’s what we are doing in COMET-2, that methodology I think correlates really well. So I think we are excited because the COMETs enrolled and so that might keep it out in the near future.

Terence Flynn - Goldman Sachs

Great. And just remind us, what you saw in durability of response, it was like the average follow-up on these patients in the NRE study and just kind of help us think about that and I guess case three expectations for the cabo arm and placebo arm and any read throughs there in terms of assumptions you guys made on power in and impact from the jury.

Mike Morrissey

Yes, so the assumptions on the COMETs were really pretty simple and lets focus on COMET-1 for the survival drug. We used the Cougar 301 study to really drive the assumptions around the placebo arm for COMET-1 and if you think about it, that population of Cougar 301 patients with taxotere were pre treated, who had progressive taxotere, it went on either abi or placebo. They progressed either PSA or (inaudible). They were treated to progression until they had some level of clinical deterioration, which then drove the physicians to then take them off the drug and then they survived and then they died.

So the key metrics for the drug arm of Cougar 301 is the median time for drug treatment, which was eight months and the median time for overall survival, which was 15 months. And the way to look at it and the impact and how it impacts cabos, the COMET trial is that the drug treated from Cougar 301 corresponds to the placebo arm for COMET-1. In that patients would come on post-tax, post-abi. So as they had progressed on abi, the clock starts in terms of the survival post abi in the placebo arm.

So it’s a conservative estimate of seven months. Obviously there will be time for COMET-1 to wash out onto site, go through screening and those kinds of things. So we think it’s a very conservative way to view the arm around the placebo group and have certainly gotten a lot of feedback from our key KOLs, Dr. Smith, Dr. de Bono, Kareem Fizazi and others to be able to kind of make sure that makes sense for us in terms of that.

On the cabo arm, we had from the NRE, we had several metrics of durability of response. The bone scan response had about a 5.5-month duration of response, which I think we are very pleased to see. Again, what would be the argument, it could be seen at the sub-optimal dose in terms of the 100 mg does. So we see that being longer with the lower more stable dose, number one.

The PFS for this late population, for both the overall group, as well as the abi preceded group was about 4.4, 4.5 months. So very good overall durability of progression free survival as measured by recess, which looks at all types of metastases, soft tissue restoral, as well as bone disease.

The one point I would make there is that we were enrolling patients with ligaments in the NRE and those patients will not be allowed to enroll in the COMET trail. So we will focus on patients with bone disease, predominate bone disease or bone disease and with no disease as well.

Terence Flynn - Goldman Sachs

Okay. So net-net comparing the I guess the 4.4 months from the NRE to the, I guess eight months treatment duration in your COMET study, you are saying essentially if we have a lower dose of cabo, your treatment duration might be longer to the target. Is there a patient been on drug longer...

Mike Morrissey

Yes exactly.

Terence Flynn - Goldman Sachs

And your treatment duration is likely to come close to the eight months versus…

Mike Morrissey

But we wouldn’t want particularly on what it would be I think the way to look at this is if you look at PFS as a predictive for OS, which I think is hard in prostate cancer. If you look at copits (ph) for example, the PFS in the input in the placebo arm was six weeks, seven weeks and that group lived probably 10 months. So the belt between the two is often very large.

Terence Flynn - Goldman Sachs

Okay great. And then in terms of I guess the responses, did you see any difference in cabos responses in the patients that you just received in the NRE, hence that you moved the (inaudible) versus the ones that had gotten three lines of therapy, so (inaudible) and was there any difference in bone scan response or other metrics across these patients.

Mike Morrissey

Yes. I think when you at the look at the fourth or so different component in terms of bone scan response, pain response, CTC response, soft tissue response, we saw roughly similar levels of activity in patients who are only treated with chemo or patients who are treated with chemo and abi and/or Cabozantinib and/or metavation, and that’s been a relatively consistent features of cabos clinical profile to-date across tumor types.

We saw that I think most stoutly in the RCC corporate, where we saw objective responses and durable responses in patients who had five, six different lines of therapy, including multiple different inhibitors, mTOR inhibitors, other biologics. So cabo seems to have and I think it gets back to the dual definition, a very profound impact on tumors, in either primary tumors on metastases and it really is -- the data would suggest empirically that that is consistent, whether its early or late lines of therapy.

Terence Flynn - Goldman Sachs

Okay, may be just last question on NRE. In terms of the, if you look at CT or MRI, I thought you guys are going to have included some of those stands in the trial design. Looks like we didn’t have any of that data at ASCO this year. Is that something we could get down the road or is that something that…

Mike Morrissey

Yes, we have a lot of work there right now, looking at different imaging technologies and techniques that either involve tracers or don’t, that I’m hopping will have information out later this year or early next year. It’s still relatively immature in the MGH, IST, but that’s an area of great interest for us and investigators and I think as that evolves over the next several months, we’ll be able to get information on that. But what I’ve seen so far and what we talked about, helping antidotal data, it’s very consistent that we have any tumor effect in the bone on top of resolution of the bone scan, so – and as that data becomes more mature we’ll discuss that.

Terence Flynn - Goldman Sachs

Okay great. May be if you could just talk just in terms of kind of the competitive landscape and prostate cancer and walk us through any ongoing or planned trails of cabo with some of these other drugs. It may be on that either investigator sponsor side or anything you could do under your creator with MCI and how to think about the combination opportunity in may be trying to move cabo upstream. Obviously a big focus on the Phase 3 trials, but then if we’re thinking further ahead, yes.

Mike Morrissey

Yes. Well I think that argument strategically is that cabo has the ability to really be a foundation treatment in prostate cancer, based upon I would say the synergy and the overlap between the fundamental team in biology, in the endocistology (ph) and the pharmacology that we’ve seen with cabo to-date.

Basically you know I think the most profound component of cabos activity is this very rapid profound tumor shrinkage that we see with these existing regions. What’s also know about the whole med story is evolving those adaptation as they become refectory to entering the provision therapy and that’s from a wider ray or different compounds. These refractory resistant tumors that grow from that are often expressed in high levels of net.

So net, due to do its invasive metastatic kind of features drives the revamps of those different cells in those different tumors and this can hone in the under bone and you kind of get the whole cycle for yourself. We are getting excited and very aggressively perusing combination strategies to be able to really address that biology and with cabo as part of our overall approach.

So we’ve got several combinations already going. So we’ve got a cabo Taxotere combination and that’s about ready to start with the MCI. That was one of the first trials that was agreed to as part of C-Tech program and we have an IST currently enrolling at Dena Falbo, looking at combinations of abi with cabo to really address that very important feature around resistance with hormonal therapies as they move up in line.

So we were excited about going in that chemo space, either in combination with Taxotere or head to head against Taxotere, and then moving up pre chemo by combining with either and both abi as well as the MDB compound to be able to cover all those different cases relative to the biology of that system, right, so...

Terence Flynn - Goldman Sachs

Has the MET prevention study analysis, something that you guys would put on the back corner. But given the low dose data that you’ve seen, given now we are kind of – we have somewhat of an insight into how FDA is thinking about this indication following XGEVA, what’s the current thinking on that opportunity longer term.

Mike Morrissey

Yes, I think it’s an area that we are still interested in perusing in the mid term. Its certainly not a short term priority, not from a stand point of what we have to do to I think get over the goal line in the prostate cancer space, but it’s a large population, its an underserved population, the ODAC for the TN 147 study was I think very instructive and enlightening and I think continues to provide us with the level of insight into how we could live in that space at the right time.

And again, that was a, I think at least from a standpoint of a successful clinical trail, really highlight some of the assumptions that they used and the relative difference in terms of the activity you see with cabo around bone scan reduction, around pain resolution around, around – the clinical benefit that we can document in the COMET first I think would provide a very strong platform than to not only pre-chemo, but actually pre-metastatic as well, but those are studies for the future.

Terence Flynn - Goldman Sachs

Okay. May be we’ll turn now to thyroid cancer. So obviously this could be the first indication and cabo is in the market for it. Data at ASCO is very impressive. We all have positive feedback from the clinicians there. Help us think about how you guys are thinking about the commercial opportunity and the necessary spend there. I know prostate is obviously is big focus as well. But just help us, walk us through the kind of how you think about those two things as we near cabo commercialization.

Mike Morrissey

Yes, so our view on NTC is relatively simple. It’s a small micromesh population. There is approximately a 1000 or so patients in North America, about a 1000 or so patients in Europe, a fraction of those patients have, what’s arguably advancing metastatic, really aggressive disease.

Our clinical trail exam was designed to really ask the key question in that population. We had a IRF based inclusion criteria for active aggressive progressing disease. So we asked I think the right population – so we asked the right question in the right population to really focus on the sub-population with the most clinical need versus the others who have relative unknown disease for years or even a decade or more.

So how that plays out commercially, we are going through that right now. We don’t see this as one that we’ll invest heavily in and we certainly are interested in being able to use this to build up some level of infrastructure, get kind of our – all of our ducks lined up in terms of what we need to do to be able to commercialize the compound, but it will not be a large spend from the standpoint of building out for NTC, because that indication just doesn’t want that.

But that being said, we have the opportunity to get the compound potentially approved, which is no small pick for a company of our size and stature and to execute that across all the different components is what’s involved is a very important point and with prostate, not too far behind. So its one area that we are looking at very closely, but doing it in a very careful way and with an investment that matches the potential upside.

Terence Flynn - Goldman Sachs

And the filing will go in – the filling is already in and any sense of if it will be a priory or standard review.

Mike Morrissey

So we have the file. I completely announced that last week. So we need some time to go by to get feedback from the agency on kind of where that fits in their plan. So as we know that, we will update investors shortly.

Terence Flynn - Goldman Sachs

Great. May be now trying to the crater with MCIs. So it’s a really nice deal for you guys. It gives you the ability to kind of broaden development of cabo here significantly. May be just walk us through some of upcoming Phase 2 trials that you kind of laid out here for us and think about kind of data readouts from these and what that provides that company I guess here over the next…

Mike Morrissey

Yes, its really a wonderful vehicle for us to be able to, again, broaden the overall scope of the development plan for cabo, in a way that is financially enabled, since we spent so little money per trial with the MCI and they do all the heavy lifting in terms of actually running the trials, analyzing the data. So we see this certain level of operational control in that regards, but I think its certainly well worth the time and the investment that we make relative to being able to do a lot of other work outside of MTC and prostate cancer.

So we announced recently that we’ve agreed to the first wave of trails. That includes 13 trails overall to date and that we will certainly be more coming beyond that. Of those 13, there are now five discreet, randomized Phase 2’s that will run in – and we’ve agreed that to be done in renal cancer.

The first line in renal against sunitinib, the second line HCC against placebo. We will do a study in ocular melanoma in non-small cell lung cancer and one more that I’m blanking on. But there’s a pretty strong – ovarian cancer, excuse me. So there is a very, I think a very strong cushion out to be able to get those trials going.

CCAP has been moving very quickly for us in this, with us in this regard and we are able to – I think we they are very committed to making these things happen in real time and I think the whole goal is to get these trails up and running in a crude, very cooperative groups through key centers over the next couple of years.

So I think at a high level we are venturing towards kind of the vision where the COMET’s read out, enroll and read out over the next couple of years and at that same time frame, we are able to in parallel pursue those five, plus meeting more randomized Phase 2 trials.

So in the COMETs read outs, we have data on some of the other Phase 2 trials that will allow us and to prioritize the next wave of pivotal trails that go forward. So it’s a very nice way to be able to again fully capitalize of the overall profile of cabo and do it in a way that’s I think very fiscally efficient.

Terence Flynn - Goldman Sachs

Great. In terms of things about partnering the asset, when is the appropriate time. How do you think about that now? Where you are in this stage development of cabo?

Mike Morrissey

Yes, it’s a very important question and its one that we talked about in a fair amount over the last year or so. It’s a somewhat complex question from a standpoint of a opportunity with an asset that continues to I think gain momentum with the evolving clinical data at a time when – and really are only driving asset relative to how we kind of lifted the company around cabo.

So we have to be careful and diligent about how we are pursuing those options in such a way that we maximize the near term value or long term value and potentially increase the size of the opportunity in such a way and damage (ph) all those factors together.

I think cabo has a lot of visibility right now. Certainly there’s a lot of interest in the compound at the meeting in Chicago. Every poster was heavily attended. All the questions were I think were very well received by investigators and colleagues on the pharma and biotech side. So we are navigating those issues very carefully and as that evolves we’ll certain keep people informed.

Terence Flynn - Goldman Sachs

Great. And maybe the last question from me was just, plans about thinking longer term about building the pipeline beyond cabo. Is it too early to think about that, given the breath of the development you have with cabo or what is the company going to have to offer us.

Mike Morrissey

Well, we are always thinking about it and as with our former business model of doing a lot of early discovery and a lot of early clinical development, you certainly have the people and the expertise and the aspirations if you will to be able to add a pipeline of products in late state development as well.

Probably right now the kind of the, all cabo, all the time on results holds for us. It comes down to how we can invest our knowledge relative to a new compound in discovery or in say, early clinical development versus another Phase 1 or a Phase 2 IST C-TAP in our own funded program for cabo and that from my point of view, while there is a lots of emerging biology and interesting things out there that we can do, others are doing, the profile with cabo is still pretty compelling and I think when you come down to and screen the risk out with cabo across the consumer types, the opportunity to build the franchise around cabo as has been done with taxotere or with avastin is still a very interesting goal to pursue.

So right now we are solely focused on cabo if that makes sense. I think for the short term, may be the mid term, keeping our eyes opened and looking at opportunities whenever they come to us, either looking proactively or when they come to us kind of reactively. But the main focus for us and the main value for us is around cabo and pushing it forward as broadly and as quickly and as is also responsible.

Terence Flynn - Goldman Sachs

Great. Well, thank you very much Michael.

Mike Morrissey

Great to be here. Thanks again for the invite.

Terence Flynn - Goldman Sachs

Thank you. All right.

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