Good day ladies and gentlemen and welcome to the Exelixis’ First Quarter 2014 Financial Results Conference Call. My name is Britney and I’ll be your operator for today. As a reminder this call is being recorded for replay purposes. I would now like to turn the conference to your host for today Ms. Susan Hubbard, Investor Relations. Please proceed.

Thank you, Britney and thank you all for joining us for the Exelixis first quarter 2014 financial results conference call. Joining me today are Mike Morrissey, our President and CEO; Frank Karbe, our CFO; Gisela Schwab, our Chief Medical Officer; Peter Lamb, our Chief Scientific Officer; and Scott Garland, our Chief Commercial Officer who will together our corporate financial development and commercial progress for the quarter-ended March 31, 2014 as well as providing specifics around the priority activities for the year. As a reminder we are 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 will be making forward-looking statements regarding future events or 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 can differ materially. We refer you to the documents on file with the Securities and Exchange Commission and in particularly the company’s quarterly report on Form 10-Q filed today. 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 the availability of data at reference times, risk and uncertainties related to the initiation, conduct and results of clinical trials, 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, risk and uncertainties related to compliance with applicable regulatory requirements and market competition. With that I’ll turn the call over to Mike.

All right, thank you, Susan and thanks to everyone for joining us on the call today. The first quarter of 2014 was a busy and productive one for Exelixis. I’ll take a few minutes to review several key milestones and then turn the call over to Frank, Gisela, Peter and Scott for a review of our financial, cabozantinib, cobimetinib and commercial highlights. First, we achieved a key regulatory milestone during the quarter. At the end of March the European Commission approved COMETRIQ for the treatment of adult patients with progressive unresectable locally advanced or metastatic medullary thyroid carcinoma or MTC. Although this is a small commercial indication, this achievement is still notable for European patients with metastatic MTC. We are one step closer to gaining access to an important and novel treatment option. This is a constant driving force behind everything we do at Exelixis to advance the care of patients living with cancer on a global basis. This also marks the first European approval of an Exelixis’ compound demonstrating our growing in-house capabilities to navigate regulatory pathways effectively on a global scale. This critical scale will serve us well as we advance the cabozantinib clinical development program in other tumor types and potentially it’s commercialization in other indications. And as previously discussed EU marketing for COMETRIQ in metastatic MTC will be coordinated by Sobi. Scott will speak to the details of that collaboration and our near term plans shortly. The COMET 1 study also reached an important clinical milestone. The interim analysis was completed in March and the Independent Data Monitoring Committee or IDMC recommended that the study continue to the final analysis. Advancing COMET-1 to the final analysis doesn’t change our confidence or plans for cabozantinib in metastatic CRPC. Exelixis as a whole and specifically our COMET development…

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 filing for additional details. Net revenue for the quarter was $4.9 million, which was entirely related to the sale of COMETRIQ. The decrease of $4.8 million as compared to Q1, 2013 is due to contract and license revenue of $7.8 million in Q1 of last year. Net revenue from the sale of COMETRIQ year-over-year in fact increased by $3 million reflecting that COMETRIQ had only been launched at the end of January last year. R&D expenses for the quarter were $54.8 million. The increase of $22.1 million as compared to Q1 last year is predominantly attributable to increases in clinical trial related expenses by approximately $18 million. About 70% of this increase relates to METEOR, our Phase III study in RCC. These increases are driven predominantly by two factors; one a significant increase in activity for the study. Remember that we only began enrolling patients in Q3 of 2013, and two the inclusion of approximately $7.5 million in expenses for the purchase of comparative drug. The remaining increase in clinical trial expenses relates mainly to the progress of our other Phase III studies, namely the two COMETs and CELESTIAL as well as increases in CMC related expenses. The remainder of the increase in R&D expenses to the most part reflects higher personnel expenses which were also associated with supporting our various Phase III studies. SG&A expenses were $14.7 million for the quarter. The increase of 4.1 million as compared to Q1 last year was mainly driven by higher personnel expenses primarily due to our expansion of our sales force, higher stock-based compensation expense as well as an increase in expenses for…

Thank you, Frank. In the next few minutes I will provide an update on the progress of the development program for Cobimetinib. Our clinical and regulatory effort is intensely focused on expanding the Cobimetinib opportunity across multiple indications. As we’ve discussed previously we have a broad strategy in place of evaluating the compound in a variety of indications. We use internal resources to support Phase III trials and also work in partnership with a wide ray of individual physicians and cooperative groups through our collaboration with the National Cancer Institute’s cancer therapy evaluation program or CTEP and in investigative sponsored trial program. Our highest priority for 2014 is preparation for a data read out and potential filing for advanced metastatic castration-resistant prostate cancer. So I will start the update with our ongoing COMET trials which are our two Phase III pivotal trials in MCRPC. As you know COMET-1 a randomized study of Cobimetinib versus prednisone is focused on the assessment of overall survival as the primary end point and COMET-2 a randomized study of cabozantinib versus Mito/Prednisone is focused on pain response. COMET-1 reached its enrollment target of 960 patients in September of 2013 and COMET-2 continues to enroll patients in the United States, the UK, Ireland and Australia. Consider together the basic objective of the COMET studies is to evaluate whether cabozantinib demonstrates a survival benefit and improvement of pain associated with bone metastasis. If this objective is achieved we believe this would differentiate cabozantinib from other agents used in the treatment of MCRPC. As Mike mentioned earlier in March the independent monitoring committee or IDMC for COMET-1 has conducted the planed interim of our survival analysis for the study after 386 events have been reached. The IDMC had the following options at this interim analysis. They could have…

Thank you, Gisela. I’ll provide a brief update on the landscape for the combination of RAF and MEK inhibitors in metastatic melanoma, since there have been interesting new developments regarding the GSK program and our upcoming presentation schedule of data from the BRIM-7 trial of cobimetinib and vemurafenib. While note Novartis recently announced their intent to acquire the GSK BRAF and MEK inhibitors as part of larger deal involving GSK marketed and late stage oncology assets, I will have however still refer to them as GSK compounds in rest of my comments. First, with respect to the GSK program, In January of this year GSK received accelerated approval for the combination of the RAF inhibitor, Dabrafenib and the MEK inhibitor, trametinib for the treatment of patients with unresectable or metastatic melanoma with the BRAFV600E or K mutation. Both the BRAF inhibitor and Trametinib have previously been approved as single agents in the same patient population based on the results of randomized Phase III trials where they demonstrated superiority to chemotherapy. The accelerated approval for the combination was based on Phase I/II data that included a comparison of Dabrafenib, Trametinib with the Dabrafenib alone. I wouldn’t step through the data supporting the accelerating approval but it is provided on the accompanying slide for your reference. In March GSK released top line data from a confirmatory randomized double-blinded Phase III trial comparing the combination of Dabrafenib, Trametinibto the Dabrafenib alone in the same patient population. The independent review committee audited data showed a progression free survival for the combination of 10.1 month versus 9.5 months for the Dabrafenib alone and then overall response rate of 61% for the combination versus 47% for the Dabrafenib alone. The modest benefit for the combination seen in the study prompted the GSK to issue a deer…

Thanks Peter. It’s been over a year since COMET first launched commercial and we are pleased with the acceptance of the products in the U.S.. As we have said consistently in the past MTC is a small market opportunity and our commercial infrastructure is scaled appropriately with the size in the market. Small scale size was enabled to make meaning traction and driving the uptick of COMETRIQ in the approved indication and the launch has been extremely viable for – already in commercialization expertise in a relatively low cost, low risk environment. This expertise will be in valuable in terms of helping us ramp our commercial organization quickly and effectively should COMETRIQ be approved for additional larger indications. In addition to providing the usual revenue numbers today, I’ll be sharing some insides on treatment duration. Our treatment duration is still at the evolving metric given where we are in our launch we now have over years with the data on the market and we can analyze. I’ll share that with you in a moment but first let me cover the revenue numbers. As you heard from Frank, total net COMETRIQ revenues were $4.9 million for Q1 representing a 13% increase compared to Q4 of last year. Similar to last quarter essentially all of COMETRIQ sales came from the U.S., net COMETRIQ sales in the U.S. were $4.8 million representing an 11% increase compared to Q4, 2013. U.S. revenues were positively impacted by increases in treated patients and treatment duration. Let me spend a few minutes now focusing on treatment duration. What one typically sees in a new oncology drug launch and what was true for COMETRIQ is that a bolus of prevalent patients started COMETRIQ right after approval. These patients are typically sicker than average and do not stand drug…

Al right. Thanks Scott. I’ll keep my closing remarks brief so we can get to your questions. As you heard from the team today, progress continues on all fronts and we’re on the critical path towards the very important set of milestones in 2014. I’ll conclude by reiterating our top priorities for 2014. First top line data readouts for both the COMET-1 and COMET-2 studies. Second working towards submitting regulatory filings assuming positive COMET data. Third, expediting enrollment from mid-year in second line RCC as our highest enrollment priority. And fourth planning our commercial build out supporting the prostate cancer indications in the US and Europe pending positive COMET data. In addition we look forward to the Roche-Genentech release of the updated cobimetinib Phase Ib data from patients with advanced BRAF mutated melanoma at the EAD and ASCO conferences this quarter. And to the Phase 3 readout later this year. Collectively and individually we remain committed to our overall goals to bring new therapies to patients with cancer and build value for our shareholders. I’ll end here with a note of sincere thanks to all of our great employees for their superb talents efforts and commitment in helping us meet our key goals and priorities. So we’ll stop here and be happy to take your questions. Operator.

Thank you. (Operator Instructions). And your first question comes from Ted Tenthoff with Piper Jeffery Please proceed. Ted Tenthoff – Piper Jaffray: Great, thank you. Can you hear me okay.

We sure can, Ted, thanks. Ted Tenthoff – Piper Jaffray: Excellent thanks so much for the update and congrats for European approval. Can you give us a sense and just remind us with respect to update on timing of COMET. Did the interim will earlier than kind of internal projections or was that sort of on track with what you are thinking and what is your updated or continued guidance for COMET 1 overall survival timing? And then I have a quicker follow up question on cobimetinib if I may.

Sure the interim analysis as we finally announced is both even driven analyses and the interim analyses occurred at the time they were projected it would occur. And regarding the timing for the final analysis we continue to expect that to occur in 2014. Ted Tenthoff – Piper Jaffray: Okay, and can you just speaks to the toxicity profile that’s been seen with the Genentech combo of MEK, BRAF, how has you guys combo looked so far?

Yes. This is Peter, Ted. So yes there was some data presented on this at the ASMO meeting last fall when adverse events from the BRIM-7 trail first presented. I would say the overall toxicity profile was I would say as expected based both on the individual toxicity profiles of the compounds and what would be expected for the class in general. The major toxicity seen are the major and most prevalent adverse events were things like rash, diarrhea and nausea, photosensitivity for example. So that’s kind of in the outline toxicity profile that’s been seen today. Ted Tenthoff – Piper Jaffray: We’re looking for to the data at ASCO and then the readouts later this year.

And your next question comes from Eric Schmitt with Cowen and Company. Please proceed. Eric Schmitt – Cowen and Co.: Thanks for taking my questions. I’m sorry if I missed it. I didn’t hear any mention of the exam MTC overall survival update this year.

Yes, Eric we are expecting to occur in 2014. Again this is an event driven analysis and we’re tracking events and will communicate data as soon as we have the analysis. Eric Schmitt – Cowen and Co.: Okay thanks. And is there any way you would disclose the amount of outflow you spent on the – at the interim analysis just so we get a sense of how statistically significant the P value on COMET-1 needs to be at the final analysis.

Right, so we employed as many people do a very commonly used outward spending function in the trail that we keep spending very little amount of P or the overall P that’s available for the analysis was observing the vast majority of the P4, the offer for the final analysis. So the interim analysis there is not negatively affect or impair the final analysis. Eric Schmitt – Cowen and Co.: Can you quantify that Gisela?

We haven’t done that, no. Eric Schmitt – Cowen and Co.: Okay and Mike I guess I was intrigued by your statement that the fact that COMET-1 preceded the interim to the final analysis doesn’t change Exelixis’ confidence in the ultimate common study. Obviously the market feels differently, little bit disconnect here. Can you just give us your reasons why you think that nothing is changed?

Just to be clear. I think you might have misheard me. What I said was confidence in the compound and our plans with the compound. We provided no, obviously no guidance on the outcome of the pivotal trail that is ongoing, right. So that being said our confidence in the compound is remains to be strong. I think we’ve got a very intriguing datasets in prostate cancer and renal cancer and liver cancer across a variety of other tumor type in Phase II. And obviously that needs to be confirmed in Phase 3. And that’s what the plan is with the broad program that is ongoing right now with the compound in five pivotal trails. So we need data and we’ve been very clear about that. I think we’ve communicated in a very consistent and conservative fashion and that will continue going forward. Eric Schmitt – Cowen and Co.: Sorry if I miss paraphrase. Let me probe on a maybe somewhat related topic. When you provided the interim analysis of these six successful pivotal studies in prostate cancer, those studies all have somewhat different designs for the interims then I can see when the three or four that hit the three to hit has different interim criteria. Can you talk about which of those other trials COMET-1 is may be most similar to, or which should be a most relevant comparison and why?

I think it’s difficult to make inter trial comparisons because these studies enroll somewhat different patent populations and COMET-1 as you know is enrolling a patient population that has received and failed prior docetaxel and abiraterone and enzalutamide. So it’s a different populations from the other studies. And in terms of the design I think it is fair to say that the study is fully powered at 90% for the final analysis and for an HR and employees and the 578 events that is a completely powered analysis. And as I said earlier on the interim analysis takes away very little of the alpha and for the final analysis. So I think we three of the studies appropriately designed and we look forward to the results in particular given the fits to results that refer to prior remarks. Eric Schmitt – Cowen and Co.: Okay may be the last question on with switching topics to the METEOR trial and renal cell carcinoma, sounds like enrolments really moving ahead fairly rapidly there. What’s the next announceable event that you’ve just complete the enrolment?

Yeah I think that would be the next announceable event correct. Eric Schmitt – Cowen and Co.: And you are not going to speculate on when that might that happen yet?

No, not at this time, no. Eric Schmitt – Cowen and Co.: Okay. Thanks a lot.

And your next question comes from the line of Joel Sendek with Stifel. Please proceed. Joel Sendek – Stifel Nicolaus & Co.: Thanks. On the COMET trials I am wondering what you guys might have done to guard against protocol violators in the control alarm. Obviously to avoid the possibility that they might have taken actions at some point to increase the survival and now. Can you give us any color that that didn’t happened or what you did to prevent that from happening?

Yeah and I think number one, there is a number of mechanisms in place to ensure adherence to a trial protocol and obviously it’s agreed when the trial protocol and the investigators commit to executing the studies. In accordance with the trial protocol it’s monitoring ongoing on a very regular basis and we look at the information emerging from the study, so that would be pretty tough. And if new anticancer therapy started that would be a reason to discontinue people from this study, patients from the study so that’s not allowed. And may be most importantly the study is a blinded study right, so not patients and physicians cannot be sure of what drug they are on and they can be on cabozantinib or on Prednisone. Joel Sendek – Stifel Nicolaus & Co.: Yeah okay. And let’s see and then on Sobi I am wondering what if you guys have any insight on the GSK compound and whether it’s your combination. You know what kind of penetrance the combination has relative to the single agent at all at this point.

Joel, it’s Mike. We don’t right now have that level of visibility into the market dynamics. That may or may not change overtime but right now can’t really help you there. Joel Sendek – Stifel Nicolaus & Co.: Okay and then last question now. Frank can you give us some sense of the amount of licensing revenue you have for the year?

You mean for 2014? Joel Sendek – Stifel Nicolaus & Co.: Yes.

Zero. We’ve guided at the beginning of the year when we provided and at the end of last year we’ve said already that we’ve burnt through all of the deferred revenue from our past collaborations. And unless we hit some milestones or enter into new collaborations our revenue will be made up exclusively from the sale of products. Joel Sendek – Stifel Nicolaus & Co.: Okay. Alright thank you.

And your next question comes from the line of Cory Kasimov with JPMorgan. Whitney Ijem – JPMorgan: Hi, this is Whitney on for Cory today. Quick question on METEOR and CELESTIAL are there interim looks in those trials and if so is the timing you are giving for top line for the interim or the final?

The general timing that I have mentioned is four to five analysis of the primary end point of the studies respectively. And remember for METEOR that’s PFS progression free survival and for CELESTIAL that’s overall survival. And whether or not there are to your fresh – not there interim analysis built in and celestial you had said interim analysis built in. Whitney Ijem – JPMorgan: Got it. And then moving over to you and Sobi deal, in terms of how we should be modeling revenue from that or I guess the flow of revenues. Can you remind us of the structure of that deal?

Yeah the deal itself is actually based on Exelixis paying Sobi certain fees for their commercialization activities. Ex-U.S. we actually book the revenues and we’ve said all along that MTC is small both in the U.S. and in Europe and I think the one caveat I would make to Europe which I’ve said on several calls this just takes longer to secure reimbursement. That can give you a general idea, sort of the revenue kinetics for the European market.

Another thing I would add is that for Europe we recognize revenue on a sell in basis while in the U.S. we recognized based on the sell through method. Whitney Ijem – JPMorgan: Got it. Thanks for taking the questions.

And your next question comes from the line of Biren Amin with Jefferies & Company. Please proceed. Biren Amin – Jefferies & Company: Yeah, thanks for taking my question. I was wondering if the company still plans on initiating a [Sandy Combo] trial later this year, and if so do you plan to wait for the COMET-1 read out before initiating the study? Thanks.

Yeah we are working on the protocol and its funnel and or new funnel for that combination trial and we are planning on initiating start up activities later this year yes. Biren Amin – Jefferies & Company: Would that occur before or after the COMET-1 read out?

I didn’t – I can’t really comment on that right now we are anticipating for this activity to occur in the quarter three, quarter four timeframe. Biren Amin – Jefferies & Company: Great, thank you.

And your next question comes from the line of Richard Resnick with William Blair. Please proceed. Richard Resnick – William Blair & Company: Hi, guys, Rich Resnic for John. So a lot of questions that I had have been answered, but may be one for the potential for cabozantinib in liver cancer. There has obviously been a lot of new enthusiasm about the potential for new treatments in Hepatitis C which is a cause of cancer. I thought maybe you could share some thoughts on how you view this might impact the market opportunity for cabozantinib in liver cancer, thanks?

Yeah sure. So Hepatitis C is one of the main reasons for patients to develop ultimately liver cancer besides Hepatitis B and there are some things like alcohol consumption. As you know the course of disease is very protracted one and the development of HCC out of HCV can extend over 20 years. So the impact of an improved therapy of Hepatitis C is going to affect that – the prevalence if you will liver cancer over time we hope but it will take quite a long time. Richard Resnick – William Blair & Company: Okay. Great thanks.

(Operator Instructions). And your next question comes from the line of Michael Schmidt with Leerink Partners. Please proceed. Michael Schmidt – Leerink Partners: Hi good evening. Are you still planning to initiate the RAF positive non-small cell lung cancer studies here?

Yes, this study is also fully developed and we are anticipating for these start-up activities to occur in the second half. Michael Schmidt – Leerink Partners: Okay, and do you expect any meaningful news flow from any of the out-licensed products or programs?

Yeah, Michael, it’s Mike. Yeah, I would stay focused in that regard on cobimetinib as the leading compound that we have out-licensed, the others in some [inaudible] reform are moving but I don’t think we are expecting a lot of news for any of those compounds in 2014. Michael Schmidt – Leerink Partners: Okay, great. Thank you.

At this time there are no further questions. I will turn the call over to today’s host, Susan Hubbard. Ms. Hubbard?

Thank you, Britney and thank you all for joining us today. This is all the time we have now for questions. We welcome all callers with any additional questions you may have that we weren’t able to address in today’s call.