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Exelixis, Inc. (EXEL)

Q4 2011 Earnings Call· Wed, Feb 8, 2012

$44.85

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Q4 Exelixis Conference Call. My name is (Kim) and I'll be your coordinator for today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's conference. (Operator Instructions) I would now like to turn the presentation over to your host for today's conference, Mr. Charles Butler. Please proceed, sir. Charles Butler – Investor Relations: Thank you for joining us this afternoon for our fourth quarter and full year 2011 financial results conference call. Joining me on today's call is Mike Morrissey, our President and CEO; Frank Karbe, our Executive Vice President and CFO; and Gisela Schwab, our Executive Vice President and Chief Medical Officer. As usual, Mike will start off with a brief overview and then turn the call over to Frank who will review our performance over the financial reporting period, then Gisela will provide a research and development update before the team takes questions. As a reminder, 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 documents that Exelixis files from time-to-time with the Securities and Exchange Commission, specifically, the company's most recent Form 10-Q filed on October 27, 2011. These documents contain and identify under the heading Risk Factors, important factor that could cause actual results to differ materially from those contained in any forward-looking statements, including risk related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing, Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the sufficiency of Exelixis' capital and other resources, and the uncertainty of the…

Operator

Operator

(Operator Instructions) Our first question comes from the line of Mr. Eric Schmidt from Cowen and Company. Please proceed sir. Eric Schmidt – Cowen and Company: Thanks for taking the questions. First on the medullary thyroid cancer filing, Gisela, do you have an end of Phase III meeting with the FDA and what is anything would be re-limiting on finishing the role in BLA there, sorry, rolling NDA?

Gisela Schwab

Analyst · Karen Jay from JPMorgan

To your first question, yes we had an pre-NDA meeting late last year, during which we obtained agreement from the FDA to initiate a rolling NDA. And regarding the completion of the filing we are on track to complete that in the first half of 2012 with the subsequent section toward the (CM&C) part and the clinical part. Eric Schmidt – Cowen and Company: Okay. And then on the COMET-1 trial, did I hear you correctly that you are looking not just at Taxotere failures, but 3100 – MDV-3100 failures and Zytiga failures or which patients exactly would be eligible for enrollment?

Gisela Schwab

Analyst · Karen Jay from JPMorgan

So, the eligibility is defined as patients who have received and failed prior docetaxel and abiraterone or MDV-3100. And we are not limiting the numbers of prior therapies including also the docetaxel or other agents, but these are the ones that are required. So, it's Zytiga or MDV-3100. Eric Schmidt – Cowen and Company: You have to say at least one of those you could have failed both and others?

Gisela Schwab

Analyst · Karen Jay from JPMorgan

That is correct, yes. Eric Schmidt – Cowen and Company: Okay. And what it sounds like the protocol with the FDA is coming along well there. What is actually rate limiting to enrolling the first patient that you had many IRBs or approvals yet?

Gisela Schwab

Analyst · Karen Jay from JPMorgan

For the COMET-1 study? Eric Schmidt – Cowen and Company: Yes.

Gisela Schwab

Analyst · Karen Jay from JPMorgan

We are identifying sites are now moving through the selection of sites we are anticipating that this study will begin enrolling patients in the first half of 2012. Eric Schmidt – Cowen and Company: So, is the protocol finished?

Gisela Schwab

Analyst · Karen Jay from JPMorgan

The protocol is complete yet. Eric Schmidt – Cowen and Company: Thanks a lot. Congrats on the progress.

Gisela Schwab

Analyst · Karen Jay from JPMorgan

Thank you.

Operator

Operator

The next question comes from the line of Karen Jay from JPMorgan. Please proceed. Karen Jay – JPMorgan: Hi, this is Karen Jay in for (Craig Heatter), thanks for taking my questions. I just have a few. First on the XGEVA panel, could you give me a comment on what you thought of the discussions or whether or not there are any takeaways or lessons learned for cabo?

Mike Morrissey

Analyst · Karen Jay from JPMorgan

XGEVA panel.

Gisela Schwab

Analyst · Karen Jay from JPMorgan

The XGEVA panel I think clearly this is very fresh from this morning, I think clearly the takeaway that we heard was that end point is such in the trial design is seemed agreeable, however, the magnitude of effect on the primary endpoint for denosumab was not sufficient, and it was not reported by evidence of other clinical benefit such as progression-free survival or overall survival. And so forth or symptom alleviation and if for that reason and in view of the safety profile in the panel voted 12-1 to essentially not approve the indication. Now with respect obviously to cabozantinib, we are looking at a very different profile from that denosumab, cabozantinib has a much broader activity profile. It affects tumor cells as well as bone component such as osteoblast and osteoclast. We've seen in our extensive program clear signs of anti-tumor activity with very marked effects on progression-free survival, now in two separate indications in MTC and in prostate cancer. We're seeing tumor regression as I described earlier. And we're certainly also seeing in very rigorously assessed studies the alleviation of bone pain and that concurrently with narcotic discontinuation or reduction. So, a very different picture from what was described this morning, and so I think with that in mind certainly our clinical trial program as it is planned now is not affected at all by this order panel's position. We are focused on COMET-1 and COMET-2 as the highest priority as we those along, at a lower priority we have in the plans also an earlier line of therapy study, but that is not imminent. Karen Jay – JPMorgan: Okay, thanks. And my second question is for Frank, the following timeline for MTC it’s possible that you could have approval this year, later this year. Is there any commercial factored into your operation expense guidance or MTC?

Frank Karbe

Analyst · Karen Jay from JPMorgan

Yes, there are some commercial cost factored into our expense, but I would characterize it as minimum and yeah, it’s very, very little. Karen Jay – JPMorgan: Okay, thank you.

Operator

Operator

Your next question comes from the line of Joel Sendek of Stifel. Please proceed. Joel Sendek – Stifel: Hi, thanks. I had a follow-up for both of those. So, with regard to the panel today, does it change at all your expected endpoints on the 306 study because it's really -- they've spent a long time talking about clinical benefit and survival. So, can you comment a little bit about that and then I have a question for Frank after that.

Mike Morrissey

Analyst · Joel Sendek of Stifel

Yeah, Joel, it’s Mike. Let me just be clear here. So, the 306 study that’s you mentioned has been on the back burner and a low priority for us for some time now and that will be the case as we continue to move forward. Again our main focus is going to be on the COMET trials to be able to show clinical benefit, in terms of both potentially survival as well as pain relief, narcotic reduction etcetera in the COMET-1 and COMET-2 trials. So, 308 its been backbone for a while and that it will say there. Joel Sendek – Stifel: Okay. It’s actually for Frank, I guess I know that came out from the meeting today anyway, the focus on safety I mean they spent the majority of the time talking about O&J. In that regard, since you have its very compelling studies going on of 40 milligrams, you know, how you potentially use that data within the current phase 3 program? Can you do that at all on or are you convinced that 60 milligrams is the right dose?

Gisela Schwab

Analyst · Joel Sendek of Stifel

Yeah. We feel quite good about the 60 milligram dose and that it's certainly based upon the fact that we have quite substantial information from our OTD study and the NRE study were patients reduced to 60 milligram and above 50% of patients reduced from 100 milligram to 60 milligram and they were able to maintain pain response and activity. And subsequent dose reductions were much less frequent. Now I think its very encourage that at 40 milligram we see such nice effects on bone scans as Matthew Smith and others have described and presented at OTD from the dose ranging study. So, should a patient on 60 milligram have to dose reduce they will be able to be expose to a still active dose and I think with that we are in a ideal spot for the dose going forward. Joel Sendek – Stifel: Okay. Thank you. And then just finally, financially, real quickly, I’m wondering like if the guidance on operating expense, you should consider that to be conservative, look at the 4Q run rate, if you back out the restructuring charge, it's only $38 million. Obviously there you're going to be depending on these additional clinical trials. It would seem to me that associated at the high end of 220, it seems kind of high to me. Can you comment on that?

Frank Karbe

Analyst · Joel Sendek of Stifel

I’d say that the guidance is a guidance that’s a range that we feel comfortable with. We feel comfortable that we can meet. And there is a lot of moving pieces here of course. Keep in mind that the 301 study and the 203 study as of winding down in 2012. That COMET-1 and COMET-2 will start up. On top of the remaining expenses of the ongoing studies we already have. The bottom line is, we feel comfortable with the guidance and that’s where we expect to come out. Joel Sendek – Stifel: Fair enough. Thank you.

Operator

Operator

The next question comes from the line of Terence Flynn of Goldman Sachs. Please proceed. Terence Flynn – Goldman Sachs: Hi, thanks for taking the question. Just one question on the COMET-1 study first, I was wondering if you can provide us what the design with respect to the powering assumption and then number two, just on your timing for data in the first half of 14. I mean looking back it looks like this Zytiga trial took I think like three to four years to complete. And so I know you guys are going slightly later have a patient population, but what gives you confidence I guess that the trial will indeed wrap-up in the first half of '14?

Gisela Schwab

Analyst · Terence Flynn of Goldman Sachs

Sure. Thanks for the question. So, regarding your first question around the statistics, the studies planned to enroll 960 patients its two-to-one randomization. We are applying in HR 0.75 for a 25% reduction in risk of death. And for that we need about 570 or so events. We are planning an interim analysis at two-thirds of the events. And with regard to the timing, obviously this is a sizable study and we are planning to got up to 200 sites and enroll of the study on a worldwide basis. Now the Cougar study actually involved rather quickly and so we hope to replicate that within about a year or so. And what is interesting is that in the space right now there is not much competition in terms of other studies ongoing and we can see that on the interest of investigators, who are taking great interest and participating in the COMET-1 study. Terence Flynn – Goldman Sachs: And so I mean what would you expect for the placebo arm survival then?

Gisela Schwab

Analyst · Terence Flynn of Goldman Sachs

We are assuming in the placebo arm disease almost survival time in the late patient population of seven months. That was derived from in part from the Cougar study also, where a patient was on treatment with abroad for about eight months and then at an overall survival of 15 months. Terence Flynn – Goldman Sachs: Okay, thanks. Can I ask you one question about the ASCO data, not sure how much you can share, but with respect to the NRE data that were going to see there. Can you give us any sense of additional data we’re going see beyond just bone scan response at ASCO this year?

Gisela Schwab

Analyst · Terence Flynn of Goldman Sachs

I guess it’s a little bit earlier. At this point we can’t really comment on that. Terence Flynn – Goldman Sachs: Okay. Thanks a lot.

Operator

Operator

Your next question comes from the line of David Miller of Biotech Stock Research. Please proceed. David Miller – Biotech Stock Research: Hi, thanks for taking my questions. In the assumptions you made for your cash guidance, can you does this specifically assume a partner for cabozantinib or is the partnering things are you talking about there for some of your drugs?

Frank Karbe

Analyst · David Miller of Biotech Stock Research

Let me clarify this, so our financial outlook is based on the number of assumptions, which some, but not necessarily all are expected to occur. And as you alluded in my prepared remarks there is a assumption include potential BDs activity, milestone some existing partnerships and potential financing activity, which include things such as monetizing our partner pipeline or accessing the capital market. So, subset of these, but not necessarily all of these we expect to occur. David Miller – Biotech Stock Research: Okay. And so when you're talking about BDs, you're talking about business development for cabozantinib. You're talking business development for some of other drugs?

Frank Karbe

Analyst · David Miller of Biotech Stock Research

That comment refers to both. But obviously the most valuable asset that we have is cabozantinib. David Miller – Biotech Stock Research: All right. I want to follow-up on Terence’s question about the placebo arm survival. Can you walk through again, how you got seven months for the post (Abi) or MDV population?

Gisela Schwab

Analyst · David Miller of Biotech Stock Research

So, let me just clarify the post Taxotere post (Abi) or MDV population with no restriction on other prior therapy. David Miller – Biotech Stock Research: Okay

Gisela Schwab

Analyst · David Miller of Biotech Stock Research

It’s a late line of therapy right. The way we arrived at seven months the survival, estimated survival time was just looking at the Cougar experience and when you look at the patient population on our abiraterone they were a treatment for about eight months. And then the overall, median overall survival was roughly 15 months so that give you a seven months data from end of treatment on the drug to death. David Miller – Biotech Stock Research: Okay. I get that. And then I was just want to make sure is that in your powering assumptions you said two-to-one randomization and HR or for COMET-1, 960 patients two-to-one randomization and HR of 0.75, 575 events and interim at two-thirds and what was the power percentage?

Gisela Schwab

Analyst · David Miller of Biotech Stock Research

The power is 90%. David Miller – Biotech Stock Research: Okay, great. Thank you very much. These are my questions.

Gisela Schwab

Analyst · David Miller of Biotech Stock Research

(You bet).

Operator

Operator

Your next question comes from the line of Ryan Martins of Lazard Capital. Please proceed. Ryan Martins – Lazard Capital: Hi. I wanted to find out what are your thoughts on the updated Alpharadin data that we saw at the ASCO GU Meeting. And what do you think could be any kind of impact on enrollment globally and also potentially on overall survival for the 307 trial?

Gisela Schwab

Analyst · Ryan Martins of Lazard Capital

So, regarding the Alpharadin data, I can’t really comment any further. You seem the data at the conference and that is what the extent of knowledge we have in the data. And your second question again can you repeat that? Ryan Martins – Lazard Capital: Just what your thoughts on the Alpharadin being available and its impact on enrollment in the 307 trial and potentially the overall survival?

Gisela Schwab

Analyst · Ryan Martins of Lazard Capital

So, I think clearly the 307 study starting up imminently and Alpharadin is not even filed to my knowledge, so it will take a little while. We hope to involve the study quickly, and the study will be enrolled globally, so that the availability, I think, of Alpharadin will not be giving everywhere. And besides it's in the 307 study is set in the late line of therapy to patients could have received prior Alpharadin if that was the choice of the investigator. And subsequent therapy should not confound as much as when you conduct a study in the earlier line of therapy? Ryan Martins – Lazard Capital: Thanks. And are you planning on requesting or have you already requested a priority review for cabo and MTC?

Gisela Schwab

Analyst · Ryan Martins of Lazard Capital

That would be requested at the time of filing and then the FDA would come back after the review – the initial review within the first 25 days to indicate whether they consider this a priority review. Ryan Martins – Lazard Capital: Thanks. And Frank one last one for you, which is can you remind us what the debt is that is outstanding?

Frank Karbe

Analyst · Ryan Martins of Lazard Capital

Yeah, there is $80 million outstanding under the Silicon Valley bank term loan facility. And then there is about $91 million outstanding currently under the Deerfield note. Ryan Martins – Lazard Capital: Okay, thanks.

Operator

Operator

(Operator Instructions) Your next question comes from the line of Lee Kelowski of Credit Suisse. Please proceed. Lee Kelowski – Credit Suisse: Great, thanks for taking my question. So, just to be clear on the enrollment timeline for COMET-1, its sounds like it hasn’t changed very much. So, does that mean that the full dataset for MDV-3100, you don’t think that’s going to impact the enrollment timeline for COMET-1? And then on COMET-2 in terms of data reporting out in first half 2014, does that mean that any pain data will wait for the OS secondary endpoint?

Gisela Schwab

Analyst · Lee Kelowski of Credit Suisse

So, regarding, the question of an MDV-3100 impact on COMET-1, as I described the eligibility allowed for prior treatment with MDV-3100 and so shouldn’t really impact our enrollment in the study. And then the second question was sorry with respect to… Lee Kelowski – Credit Suisse: COMET-2 in terms of whether the pain endpoint would be – would put out first or whether that would come at the same time as the OS secondary endpoint?

Gisela Schwab

Analyst · Lee Kelowski of Credit Suisse

We are estimating right now that they good to report out about concurrently it might come a little bit earlier the pain readout, but in about that timeframe in early 2014. Lee Kelowski – Credit Suisse: Okay. And so, does that mean that enrollment for that trial is going to take longer than COMET-1, I am just trying to understand the timing on that seems like it could be quicker given the size?

Gisela Schwab

Analyst · Lee Kelowski of Credit Suisse

The size is smaller with 246 patients, but it is a different patient population. We are requiring obviously for patients to have moderate-to-severe pain, which is a proportion of the patients in that line of therapy. It’s not totality of the patient. And the study is also quite intention that it collects very stringently pain and narcotic use and so it puts some burden on the patient as well as sites to collect the data stringently, which is very important for pure outcome. And for that reason we are not going out to so many size, we are going to up to 40 size, not 200 size in order to enrollment study. Lee Kelowski – Credit Suisse: Okay, thank you.

Operator

Operator

At this time, there are no further questions in the queue. And I'd like to turn the call back over to Mr. Mike Morrissey. Mike Morrissey – President and Chief Executive Officer: Okay, thanks again for joining us today. I appreciate your time and your feedback and we’ll look forward to seeing you all on the road. Okay, bye now.

Operator

Operator

Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Have a great day.