Exelixis' CEO Presents At Lazard Capital Market 8th Annual Healthcare Conference (Transcript)

Exelixis, Inc. ( EXEL)

Lazard Capital Market 8 th Annual Healthcare Conference

November 16, 2012 10:00 AM ET


Michael Morrissey – President and Chief Executive Officer

Charles Butler – Vice President, Investor Relations and Corporate Communications


Ryan Martins – Lazard Capital Markets


Ryan Martins

Hi, I’m Ryan Martins Biotech analyst here at Lazard Capital Markets. Our next presenting company is Exelixis and I’ll have Charles Butler come in and read a statement to us.

Charles Butler

Yeah, I’ll just quickly read the forward-looking statement. During the course of this presentation, we'll be making forward-looking statements regarding future events for the future performance of the company. Actual events and results of course could differ materially. I refer you to the documents that the Company files from time-to -time with the Securities and Exchange Commission, specifically our most recent 10-Q filed October 27, 2011. These documents contain and identify under the heading Risk Factors important 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 safety and efficacy in clinical testing, Exelixis’s ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion, the sufficiency of Exelixis’s capital and other resources and any uncertainty of the FDA review and approval process.

Michael Morrissey

Okay, thanks, Charles. I will go from there. So good morning everybody. I had a very, very busy year and we are looking forward to 2012 with I think clear signs of activity and the ability to move kind of go forward. Let me start today by putting cabozantinib our lead component in perspective relative to the prostate cancer in the CRPC space.

We’ve been working this in this area now for about 17 months. The index patients that we first described at ASCO in 2010 has really evolved I think fairly dramatically in the last 17 months we’ve been rolled now since that time over 270 patients into this cohort to-date with another 50 on the way as part of the non-randomized essential cohort.

I think what we’ve learned there, I think very important is that we have a clinically differentiated profile with cabo and we are seeing very different activity with cabo in terms of its ability as a tumor agent, it’s impact on reducing pain, reducing narcotics, certainly the bone scan resolution as well.

Very clear different clinical signal and our challenge going forward, is to convert that clinical differentiation into commercial differentiation and that’s our plan going forward in the CRPC space. First and foremost and then to be able to follow up on that broadly with other tumor types that are shown to be sensitive to cabo.

So we have, in that regard, announced that we had positive top line data from our randomized Phase 3 pivotal trial in medullary thyroid cancer MTC. Again very strong hazard ratio favoring cabo. We’ll talk more about that in a few minutes but again as a sign of I think very promising any tumor activity from that randomized Phase 3 trial in very advanced late-stage patients with MTC.

And then in prostate cancer, a pivotal trial plan has been strengthened and clarified over the last few weeks with regulatory feedback and discussions. I will talk more about that today and certainly really focused on that as part of our R&D Day on December 1. In terms of news flow, this year was a very productive year. We had major updates at both ASCO GU, ASCO and then this week at EORTC about cabo in prostate cancer across a variety of different tumor types.

We think that will continue moving into 2012 and beyond. Again, very large broad data set of patients who are on combo right now for prostate cancer other tumor types emerging trials, Phase 2 trials, ISTs coming up from a variety of different investigators and tumor types. So we expect that news flow about depth and breadth of activity with cabo to continue into 2012 and beyond.

We had our 3Q call recently. Again we are in a very good spot financially on top of which we have sole ownership of cabo and have all the optionality to partner that compound built into that sole ownership.

We also have five assets from previous collaborations that are in that sweet spot between late Phase 2 and moving eventually into Phase 3 with assets that we could monetize from milestones and royalty perspectives. So lots of optionality from a financing point of view. If you do our historic interest in developing compounds first-in-class, best-in-class compounds and certainly sole ownership in cabo.

But the main message today and the main message going forward is our desire, our focus on again taking the existing level of clinical differentiation and validation and converting that into commercial differentiation. We think it’s an important component to the overall cabo story and one certainly in prostate cancer that we think we can build value on as we go forward.

So again, in terms of its activity, we talk a lot about it, lots this year again, our activity profile in the overall oncology space is very, very attractive. We see a waterfall of very deep and broad activity with cabo across a variety of different tumor types. Certainly the most provocative is our activity in resolving existing metastatic bone lesions.

We’ve seen that in prostate cancer and for the tumor types to-date, it’s very, very important component to-date in terms of a major unmet medical many tumor types actually metastasized to bone are involved, that bone involvement that bone disease is involved in driving the morbidity, and the mortality in those patients very large underserved population that we think we have insight into.

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