Good day, ladies and gentlemen, and welcome to the Quarter One 2013 Exelixis, Inc. Earnings Conference Call. My name is Carolyn and I am your conference operator for today. At this time, all participants are in a listen-only mode. We will be conducting a question-and-answer session towards the end of the conference. (Operator Instructions) As a reminder, today’s event is being recorded for replay purposes. I would now like to turn the call over to Charles Butler, Vice President of Investor Relations. Please go ahead, Sir.

Thank you for joining us for the Exelixis’ first quarter 2013 financial results call. Joining me on today’s call are Mike Morrissey, our President and CEO; Frank Karbe, our CFO; Scott Garland, our Chief Commercial Officer; and Gisela Schwab, our Chief Medical Officer, who will together review our corporate, financial and development progress for the quarter ended March 29, 2013. They also will discuss priority activities for the remainder of the year and provide an update on the COMETRIQ launch and ongoing clinical development activities for cabozantinib. As a reminder, we’re reporting our financial results on a GAAP basis only. And, as usual, the complete press release with our results can be accessed through our website, at exelixis.com. During the course of this presentation, we’ll be making forward-looking statements regarding future events or the future performance of the company, including statements about possible future developments regarding clinical, regulatory, commercial, financial and strategic matters. 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, and in particular the company’s annual report on Form 10-Q filed today, May 7, 2013. These documents contain and identify, under heading Risk Factors, important factors that could cause actual results to differ materially from those contained in any forward-looking statements, including the risk that unanticipated developments could adversely impact the launch, commercialization, distribution, and availability of COMETRIQ, the degree of market acceptance of and reimbursement for COMETRIQ, risks and uncertainties related to compliant with applicable regulatory requirements, market competition, the availability of data at the reference times, and risks and uncertainties related to the initiation, conduct, and results of clinical trials. With that, I’ll turn the call over to Mike.

All right, thank you, Charles, and thanks everyone for joining us on the call today. We had a productive first quarter. and I’ll take a few minutes to introduce today’s call before Frank, Gisela and Scott dive into the details of our progress from a financial, clinical and commercial perspective. I’ll start off by saying that the primary vision for the company remains the same that is to build cabozantinib into a significant oncology franchise by advancing it in multiple high value indications. Three keys topics from the first quarter will continue to be our top priorities as we move into the second quarter and beyond. First, the approval and a recent launch of COMETRIQ for progressive metastatic MTC. It's an important milestone for the company. We launched COMETRIQ for Metastatic MTC in late January. It’s important to acknowledge that any new drug launch, whether large or small, involves a substantial and concerted effort across the entire organization. And we believe that this is reflected in the results we’ll present today. Before I move into the top line COMETRIQ revenue number for the quarter, please remember that our Q1 results are based on a little more than two months of scripts. I’ll risk stating the obvious here, but additional data from future quarters are needed to better understand the evolving sales trends for COMETRIQ. I’ll also say now that we will not be speaking to any metrics beyond MTC, our labelled indication. With that said, the net COMETRIQ revenue, for nine weeks for the first quarter was $1.9 million. This is the only product revenue related number that we will provide today. Frank will discuss the COMETRIQ revenue in the context of the full first quarter financials. And Scott will review the MTC market dynamics in more detail in the…

Thanks Mike. As usual I will focus my comments on the highlights of our financial performance in the quarter and refer you to our press release and today’s 10-Q filings for additional details. Net revenue for the quarter was $9.7 million, of which $1.9 million related to the sale of COMETRIQ and $7.8 million to contract and license revenue. As is typical for first-time drug launches, we are for the initial period of our launch, recognizing revenue based on the sell through method, which means we are recognizing revenue when the specialty pharmacy ships products to patients. Our gross to net discount in this initial quarter, was less than 5%. It is too early in a launch to determine whether this will level out in the long run. But we do expect this percentage to increase, as sales through program subject to government mandated discounts increase. During the first quarter we entered in to the customary agreements to ensure access and reimbursement for Medicaid, as well as Medicare patients. We're in the process of finalizing our federal supply schedule with the VA. We expect these agreements will broaden patient access to COMETRIQ but a government mandated discount and additional expenses to Exelixis to reduce out of pocket costs for certain patients. Cost of goods sold amounted to $280,000 in Q1. These costs include manufacturing and distribution costs as well as the 3% royalty on net sales to GSK. Please note, that for the time being, our cost of goods sold are not a good representation of our true manufacturing costs since the majority of the costs associated with our current inventory on hand have been expensed in prior periods. R&D expenses for the quarter were 32.7 million which is roughly in line with expense in the same quarter last year.…

Thanks Frank. We made progress on the commercialization of COMETRIQ and MTC and are pleased with the execution thus far. With just 9 weeks of product availability in the first quarter, we are obviously still early in the launch process and we look forward to continuing to drive COMETRIQ MTC revenues in the months to come. Our assumptions regarding the size of the MTC market has not changed and we continue to believe that there are 500 to 700 drug eligible first and second line metastatic MTC patients diagnosed each year in the United States. In the first quarter, sales reps called on approximately 500 of the original 600 MTC targets, around 80% of our target base. Feedback from the field is that MDs are impressed with the overall efficacy of COMETRIQ and MTC. And the address of that profile is similar to other (TKIs) in the oncology space. We have also received positive feedback regarding the support services provided by our specialty pharmacy diplomat. These services include reimbursement support, nurse appearance call and patient assistance. At launch, we took a conservative approach when sizing our sales organization deploying just five reps across the entire country. Since then we have noted the MTC market appears to be less concentrated than we had originally anticipated. With fully 50% of the COMETRIQ MTC prescription coming from physicians that were not on our original target list. About half of our MTC scripts came from the community setting where the vast majority wrote for just one script. We believe this data indicates that with two approved drugs in the MTC space, community physicians are becoming more comfortable treating MTC patients. And treatment is moving away from being consolidated in large academic medical centers. Based on this new data, we have decided to increase the…

Thank you sir. In the next few minutes I will provide an update on the progress of the development program for (inaudible). Specifically I will cover the status of the COMET trial, we start-ups at the RTC and HTC phase 3 studies, and activities in non-small cell lung cancer, particularly and RET fusion gene positive non-small cell lung cancer. I will also cover at a high level, our planned presentations at this year’s ASCO meeting. But let me start with a brief update on our activities in MTC, both the clinical and regulatory activities and the medical affairs support for COMETRIQ. With the approval of COMETRIQ in the U.S. for progressive, metastatic MTC achieved and submission to the EMA in November 2012, we have made significant progress in bringing COMETRIQ to MTC patients. The FDA approval was based on the primary endpoints of progression free survival or PFS that showed a significant increase in median PFS from four months on placebo to 11.2 months on cabozantinib. We are projecting that mature data for the secondary end point of overall survival will be available in 2014 time frame. As you recall COMETRIQ has received a category 1 NCCN rating for MTC in January 2013. We have deployed a small six person medical science liaison team as part of our medical affair efforts. And the MSLs are supporting the product in the approved indication and they are also importantly supporting enrollment in ongoing studies for cabozantinib. The review process of our EU filing is proceeding. The filing was accepted for review in November 2012. We are addressing the EMAs questions as while we are awaiting the final opinion from CHMP, we have set up the infrastructure to make our metric available on the Named Patient Use or NPU program and countries of…

I will keep my closing remarks short so we can move on to your questions. I would like to thank all of our great employees for their hard work and dedication in having Exelixis attain its key goals including the commercialization of the first indication for COMETRIQ, the continued advancement of the COMET trials, the expansion of the broad development program for cabozantinib and the aggressive management cash and expenses. Our commitment to patients and investors is to stay focused on these goals to advanced cabozantinib and multiple indications and to continue to build company value. So we will stop here and thank you for your time and interest and we’d be happy to take the questions. Operator?

(Operator Instructions). Please stand by for your first question which comes from the line of Lee Kalowski from Credit Suisse. Please go ahead.

Great, thank you. I appreciate the opportunity to ask a few questions. First one for you Frank, on guidance you had previously given us some OpEx guidance in cash year-end guidance. I didn’t see anything in the press release or in your commentary. Has anything changed on that front?

No. Nothing has changed; I’m happy to reiterate those numbers so that full year revenue guidance we provided on the last earnings call was 16.3 million, contract and license revenue, no, we did not provide and will not for the time being provide any revenue guidance related to the product sales of COMETRIQ. On operating expense, on total cost and expenses the guidance was 200 million to 230 million and on cash we expect to end the year at about 400 million and all of those numbers still hold.

And as far as gross margins I just wanted to better understand your commentary. So it looks like we are about 15% COGS or 85% gross margins. Were you saying that you expect margins to actually deteriorate from here?

No, we certainly don’t expect it to deteriorate. So the short answer to your question is that we expect gross margin to increase and that is mainly due to the fact that going forward not all components of our cost of goods sold will scale proportionately with product sales. And so gross margin I expect it to go up.

You have talked about in Europe a named patient program. And product is being shipped to Sobi. So should we expect international revenues to start flowing through next quarter or this current quarter?

Yes, we have in fact already made the first shipment to Sobi and so in Q2 you can expect to see some revenue coming from those sales.

Next question we have comes from the line of Ted Tenthoff from Piper Jaffray. Please go ahead, Ted.

Looking forward to an exciting ASCO, and a lot of clinical trials getting started and ongoing. I have two quick questions if I may. I guess the first one has to do with sort of the kidney cancer space and some recent competitive updates that may be changed the landscape or may be not so much changed the landscape with respect to how you guys have been looking at it. Does the panel outcomes for Tivozanib change sort of the way you guys are prioritizing the liver cancer and or kidney cancer studies that you have been considering for cabo and then have a quick follow-up on new NSCLC study.

So the plans for our renal cell cancer study have not changed in view of the outcome of the ODAC committee meeting. We have designed the study such that the primary endpoint is progression free survival which is an endpoint that has supported approval of multiple agents and kidney cancer before and in our regulatory interactions prior to the start up activities on the study has been positively received by regulatory authorities. We have sized the study such that we can assess overall survival as a key secondary endpoint. We are not planning any crossover and so in that regard the trial design has not changed at all. I think the issues at ODAC were really attributable to the fact that there is PFS benefit and there was obviously not an OS benefit but there seems to be a decrement. So no change really.

And then the question, Gisela for you as well on that NSCLC study. So you said that you are going to go specifically after RET mutations in lung cancer. Is that correct?

That is correct. That’s under discussion right now.

Now remind me because I recall that this is both a RET and VEGF inhibitor and I think if I recall correctly some of the phase 2 data that you did in thyroid cancer showed that it was less of the RET, the activity was less RET-driven than it was VEGF-driven. So just maybe you can expand on that a little bit more with respect to how you see cabo hitting RET and maybe a little bit more on that rationale with respect to what you’ve seen in terms of potency against RET and some of the prior human experience.

Just to speak for a minute about the MTC data the medullary thyroid cancer data, RET mutations are very frequent in this population. And we have seen as you know very good activity that ultimately got the product approved on the basis of large progression-free survival benefit. We have seen activity both in patients who had activating RET mutations and those who didn’t. And we're certainly evaluating other populations or continue to evaluate other populations and the data that is to be presented at ASCO we’ll drill a little bit deeper into the genetic make-up of the patients. But as you’ve said we've seen activity regardless of the genetic option. And I'll ask Peter Lamb to speak a little more about the RET population in lung cancer.

The RET fusion positive population in non-small cell lung cancer averages about 1% to 2% of all non-small cell. It looks like an interesting population to specifically target to us, we have pretty robust pre-clinical data that says that cabozantinib is a potent inhibitor of wild type RET both in-vitro and in-cells and in pre-clinical pharmacodynamic studies. In addition of course the data that was just published that Gisela referred to in Cancer Discovery from Rizvi group showed very early experience with two confirmed partial responses and a third patient with prolong stable disease. And then there is a fourth patient that was part of a Japanese phase 1 study, who also had a partial response on cabozantinib. So taken in combination that’s what’s really leading us towards a focused trial in the RET fusion positive population. That’s not to say as you alluded Ted that we won’t have benefit in other non-small cell lung cancer population that don’t have the RET fusion.

Or that you would not get the added benefit of the VEGF activity in those patients.

Yes, exactly.

The next question we have comes from the line of Imran Babar from Cowen. Imran Babar – Cowen and Company: Couple of questions. One if you could comment on, just COMET-1 and how compliance is looking, persistence for that trial, and also if you could comment on the percent of patients that are being dose reduced.

So COMET-1 is ongoing as you know and as I described actively accruing patient, as you would expect for a large global study there is a lot of activity ongoing and monitoring the study and making sure that physicians adhere to the protocol and the trial is conducted in a compliant fashion. So that’s all I can say at this point about the compliance aspect. And in terms of dose reductions that’s too early to say at this point.

Any comments on enrollment timelines any updates on that.

As I said earlier the trial is actively enrolling and our guidance towards data availability in 2014 has not changed. Imran Babar – Cowen and Company: Going back to the lung cancer, I was wondering if you can give some potentially any color you would have on just the trial I guess the clinical development that you would have going forward for that, if there is any more color you can give on that.

Yes I think it’s the encouraging early clinical data which you hold out and we have a high response rate in this population I think and at such circumstances single-arm study showing a higher rate of store responses can support regulatory approval in the United States. And so that is an avenue that we are actively exploring right now.

And do you have any thoughts in the number of patients that might be needed for that?

Sure other examples that is in the order of 100 or so patients.

The next question we have comes from the line of Joel Sendek from Stifel, please go ahead.

I have a follow-up to that question I guess regarding the lung study. When you go right for 90 patients or do you vary that I guess. Then I will follow up on the marketing energy statements.

That is a very interesting question and certainly one that we will be discussing in detail both with key opinion leaders and I have already discussed and then also with regulatory affiliates. I think it’s a very robust response rate that emerges and one can make the case that line of therapy really should not be of much relevance. So one could potentially make an argument to grow up front.

And firstly, as far as the marketing and the increase in the sales force. I'm trying to figure out how to interpret that because the on one hand you came in with decent numbers and things look good. I'm wondering if you need to increase that in order to get more coverage which would be maybe Barrish or it is that the market is even bigger than you thought and therefore you need more sales people to exploit it. I'm wondering if you can help me with that.

I think it's a really good question. The data is obviously very early. We have a single data point Joe. Arguably, two thirds of the data point from the stand points of the Q1 numbers. But I think it's really a mix of both from the standpoints of being able to reach out and you know cover a wider target area at the same time being able to really connect with all the MDs that are prescribing or could prescribe the drug or MTC relative to the label, the AE profile et cetera. So I think it's a very important component of what were are doing. We got data over the last quarter or so and I think, based upon that data we are moving forward in this direction. Scott do you want to?

Yeah you know they said on the call, we haven’t changed our assumptions around the size of the area the MTC market opportunity. We did go out of the gate at launch with what I would call a conservative number of sales reps. We did that just because this was, some uncertainty in the MTCs market opportunity and it was easy to go out small and expand if you have to. But this is really more about market concentration than anything else. We had made an assumption going into it that we would see these patients concentrated in large academic medical centers, and we are seeing more use in the community. That's not surprising. I had actually seen that a lot. I saw a lot of other companies. You see this with the real (inaudible) market where more drugs become available. Physicians in the community become more comfortable using them and they tend to refer at a later stage. To me this is more about market concentration than anything else.

We have no questions at this time. (Operator Instructions)