Exelixis' CEO Presents At 30th Annual JPMorgan Healthcare Conference - Conference Call Transcript

Exelixis, Inc. ( EXEL)

30th Annual JPMorgan Healthcare Conference Call

January 11, 2012 6:30 pm ET


Mike Morrissey - President and CEO

Charles Butler - VP, IR



Cory Kasimov

Good afternoon, everybody. I'm Cory Kasimov, the Senior Biotech Analyst at JPMorgan. And it's my pleasure to introduce our next company, which is Exelixis. Presenting for Exelixis will be the President and CEO, Mike Morrissey. And following Mike's presentation, there will be a breakout down the hall in the Olympic Room. So Mike?

Mike Morrissey

So before I start, Charles Butler, our VP of IR, will read a brief forward-looking statement.

Charles Butler

During the course of this presentation, we'll be making forward-looking statements regarding future events and future performance of the company. Actual events and 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 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, our ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion, the sufficiency of Exelixis' capital and other resources and any uncertainty of the FDA review and approval process.

Mike Morrissey

All right, Charles, thank you. Good afternoon, everybody. Thanks for sticking around late today to hear about Exelixis. I have about 15 or so slides that give you update on where we're going in 2012. I'd like to be able to start by framing where we're today with really we were about a year ago to give you a sense of where we've come and help put that in the context of where we're going in 2012 and beyond.

So about a year ago, we had just released our first update in the CRPC with our lead compound called cabozantinib, which I will call cabo for short throughout the day. That's a dual inhibitor of MET and VEGF. We had some very striking results in a small patient cohort of 20 patients in regard to a bone scan resolution which in prostate cancer patients is very predominant as part of their disease.

Since that time, we have now enrolled approximately 300 patients into the prostate cohort between our work and some work that's been done at Mass General with an IST by Matthew Smith and have really been able to understand to a great degree the scope and the magnitude in the clinical utility and differentiation of cabo in this space compared to other compounds, hormonal compounds, hormonal targeting therapies, chemo therapies, et cetera.

So we have a very, very unique clinical profile with cabo in terms of CRPC and other tumor indications. We'll talk about that today. But it certainly provides a pretty compelling and important overview for where we're trying to take cabo commercially. And then our goal here is really very simple. It's to convert an emerging differentiated clinical profile and build that into a differentiated commercial profile to be able to then be effective in patients with prostate cancer and other tumor types.

We have a very good activity over the last few months in terms of showing that cabo has anti-tumor activity. We had our first pivotal trial readout in Q4 of 2011 where we had positive data from the Exam trial. That's a randomized pivotal trial in medullary thyroid cancer, which showed a very nice hazard ratio in the late-stage population, really underscoring any tumor activity of the compound.

In addition, we've had a great deal of regulatory clarity around our pivotal trial plan, which I'll talk about in more detail in a few minutes. Those are in process to be able to get started now. And again, moving towards, again having the opportunity to provide a very clear differentiated commercial platform for cabo.

We have all the news flow coming up for the year. We've been very productive in terms of at least presenting clinical data on a regular basis in the past, and I will certainly continue in 2012 starting the with ASCO GI and ASCO GU meetings both in San Francisco over the next month or so, followed by what we hope to be a very productive ASCO meeting in Chicago in June.

Financially, we'll have our Q4 call in February. So I won't provide any details today. Again, we're on a good overall position financially. And importantly, we own the cabozantinib compound asset and have really significant optionality to partner and monetize this asset to be able to build value with cabo and other assets as well. So we'll talk about that as we go along, but just a brief introduction for where we're going in 2012.

In terms of clinical differentiation, I think this is an important slide, because it really helps set the foundation for what we've seen in these first 200 patients with cabo in CRPC. We have profiled cabo to date in approximately 1,500 patients overall over the last five or six years since we filed the IND. We have seen the very broad and deep activity with cabo across multiple tumor types. To date, we have seen RECIST objective responses in 12 of 13 tumor types to date, and we've seen that activity in a variety of compartments where tumor metastasis can travel to.

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