Exelixis' CEO Presents At Morgan Stanley Healthcare Conference (Transcript)

Exelixis, Inc. (EXEL)

Morgan Stanley Healthcare Conference

September 11, 2012 8:35 am ET

Executives

Michael Morrissey - President, Chief Executive Officer

Analysts

Marshall Urist - Morgan Stanley

Presentation

Marshall Urist - Morgan Stanley

So, good morning, everyone. Thanks for joining us. I am Marshall Urist, one of the biotech analysts here at Morgan Stanley and just one piece of business before we get started. Any and all of our research disclosures can be found on any piece of our research or on our website and with that, why don’t we jump in.

We are very happy to be here this morning, with Mike Morrissey, CEO of Exelixis, who I am sure many of you know and before we jump in, this is actually supposed to be open Q&A. So if there any question, please raise your hands and there is microphone circulating.

So with that, Mike, thanks for being here this morning, and maybe to start off, I think it might be useful, you guys just obviously completed a successful and large fundraising. So maybe talk about, give a quick overview for people, where things stand and then we will kind of jump in.

Michael Morrissey

Sounds good. So, again, I will be making forward looking statements this morning. So, please see our SEC filings for a description of the risks that we face in our business. So that’s, right. So we have had a very busy summer and certainly going into a very busy fall.

I think the company is still focused exclusively around the development and potential commercialization of our lead compound called Cabozantinib or cabo for short. It’s a very interesting dual inhibitor of the MET and VEGF pathways. We have seen profound anti- tumor activity, pre-clinically and clinically. I think the activity of cabo represents somewhat of an old school compound in today being the age of single compounds targeting either single populations or sub-populations within a given tumor type.

Cabo has shown very broad anti-tumor activity across a variety of different tumor indications and also showing activity in the key compartments where primary tumors either start of metastases too. So, a very broadly active compound. One that we are very excited about.

Our first real active indication is now under review at the FDA regarding the MTC NDA filing. So that’s obviously moving forward and we have a broad program in prostrate cancer with two pivotal trials COMET-1 and COMET-2 ongoing and part of the fund raising in the summer about a month ago. We have talked about now expanding the pivotal trial program to include other indications as well based upon some of the data we had at ASCO in June.

Question-and-Answer Session

Marshall Urist - Morgan Stanley

Okay, perfect. So, maybe you can start off by talking about the fundraising. You guys took a little bit of a different strategy than doing things piecemeal. So can you talk about how you thought through that and how you think this sets up the company now around cabo?

Michael Morrissey

So we have raised $415 million in the August time frame. That, coupled with the $295 million that we ended Q2 with, we are in a very solid position right now. We have enough money in the bank to be able to complete the COMET trials comfortably as well as initiate additional pivotal trials. So, really, it’s the momentum that we had hoped to gain by having a broadly active compound across multiple indications.

Obviously the NDA filing is being reviewed right now. It is in a (inaudible) process but I think we have got a very strong position now to be able to expand and really elaborate the really interesting activity we have seen to-date with cabo across different tumor infections.

Marshall Urist - Morgan Stanley

Sure, so maybe let's touch on the COMET program to start off with and first of all, can you talk about enrollment? How you guys are approaching that for the pain study and how challenging and how restrictive are you being about enrollment and what kind of patients do you think ultimately you going to end up in this study?

Michael Morrissey

So in both, COMET-1, which is a survival trial and COMET-2 which is trial focused on pain palliation, the goal here is to provide very convincing data which would help us differentiate cabo in the dynamic prostate cancer marketplace.

Lots of activity there, lots of success there over the last few years. Obviously we are not hearing anybody from the standpoint of prostate cancer death rate overall having changed. I think the whole goal with cabo in prostate cancer is to really build upon the very unique activity we have seen in the bone in soft tissue and CTCs to be able to, by showing both an extension of survival with COMET-1 and a reduction in pain, reduction in narcotics in COMET-2, really provide a very differentiated label that would help us market the drug potentially in that space.

So we have both trials up. We are continuing to add sites, continuing to screen, continuing to enroll. We think, again, that population for both trials is post Taxotere and post either Abiraterone or Enzalutamide in either sequence.

So really, if you will look at how the market could be evolving over the next few years, really the second line population post Taxotere, is both Abi and Enzalutamide move up first line, it’s a very important population. One that we think is sizeable for the first commercial focus with cabo in CRPC and one that we think we can build upon by doing additional either single agent or combination for us with a variety of different compounds as we move cabo up in lines of therapy.

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