Good day ladies and gentlemen, and welcome to the Exelixis' Fourth Quarter and Full Year 2015 Financial Results Conference Call. My name is Sabrina, and I will be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today Ms. Susan Hubbard, Investor Relations. Please proceed.

Thank you, Sabrina, and thank you all for joining us for the Exelixis' fourth quarter 2015 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO; Chris Senner, our Chief Financial Officer; and Gisela Schwab, our Chief Medical Officer, who together will review our corporate, financial and development progress for the quarter ended December 31, 2015, as well as recent key development and corporate events including this afternoon's announcement of our collaboration with Ipsen. P.J. Haley, our VP of Commercial and Peter Lamb, our Chief Scientific Officer are also here with us and will participate in the question-and-answer session of this call. 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 Web site at exelixis.com. During the course of this presentation, we'll be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding clinical, regulatory, commercial, financial and strategic matters. Actual events or results could, of course, differ materially. We refer you to the documents Exelixis' files from time-to-time with the Securities and Exchange Commission, which under the heading Risk Factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation, uncertainties related to the availability of data at the reference time, risk and uncertainties related to the regulatory review and approval processes, risk associated with conducting clinical trials and compliance with applicable regulatory requirements, risk and uncertainties associated with the Exelixis dependent on its collaboration partner and ability to maintain its rights under existing collaborations and uncertainties related to Exelixis' ability to enter into new collaborations, risk regarding Exelixis' financial outlook and sufficiency of the Exelixis' capital and other resources over time. And the risk and uncertainties related to commercial planning, product commercialization success and market competition. With that, I will turn it over to Mike.

All right. Thank you, Susan and thanks everyone for joining us on the call today. The fourth quarter of 2015 and the first few months of 2016 have been marked by a continuing series of significant events for Exelixis from a clinical, regulatory and corporate point of view. We believe our recent progress puts us in a position for an exciting and potentially transformative year. At the end of Q4, we completed our NDA submission to the FDA for cabozantinib in advanced RCC and in February, the FDA accepted the NDA and granted a PDUFA date of June 22. In early January, we completed our MMA submission to the EMA who accepted the application on January 28. The EMA has previously granted accelerated assessment to the filing. Our preparations for a potential launch continued to advance as planned and we have now completed the staffing necessary to be launch ready in the U.S. pending approval. Of particular note, we also announced on February 1, that we have obtained positive overall survival results from METEOR, our Phase 3 pivotal trial of cabozantinib advanced in RCC. These data have been shared with both the FDA and the EMA for potential inclusion in the label, if approval is granted. Importantly, the achievement of a highly statistically significant and clinically meaningful improvement in overall survival makes cabozantinib, the first and only drug in this setting to deliver improvements in all three measures of clinical benefit, mainly, overall survival, progression free survival and objective response rate. We plan to present the OS data at a METEOR medical meeting later this year. We are excited about this traditional lead-off for METEOR, which we believe will be well received by the medical community and will put us in a strong position to compete in this rapidly evolving…

Thank you, Mike. I will begin with a review of our fourth quarter and full year 2015 financial results provide a detailed financial background on our collaboration with Ipsen, and then, provide our 2016 financial guidance. My comments will be focused on the highlights of our financial performance and I will refer you to our press release and Form 10-K filed earlier today for additional details. Net revenues for the quarter ended December 31, 2015 were $9.9 million and consisted almost entirely of net product revenue from the sale of COMETRIQ. This is compared to $7.4 million for the comparable period in 2014. Net revenue in the fourth quarter 2015 were impacted by an approximate 160 carton increase in U.S. wholesale inventory, when compared to the level of their inventories at the end of the third quarter 2015. For the year ended December 31, 2015, net revenues were $37.2 million compared to $25.1 million for the comparable period in 2014. Full year 2015, net revenues included $3 million of contract revenues for milestone payment received from Merck in the third quarter of 2015 related to their worldwide license of our PI3K-Delta program as well as net product revenue related to sale of COMETRIQ. Research and development expenses for the quarter ended December 31, 2015 were $23.5 million compared to $39.7 million for the comparable period in 2014. And for the year ended December 31, 2015 were $96.4 million compared to $189.1 million for the comparable period in 2014. The decreases for both the quarter and the year ended December 31, 2015 were primarily related to net decrease in clinical drug, cost related to COMET, the company's Phase 3 trial in metastatic castration resistant prostate cancer and METEOR, the company's phase 3 trial in advanced RCC and to a lesser degree…

Thank you, Chris. The last several months have been very busy and productive following the positive results from METEOR of Phase 3 trial comparing cabozantinib and everolimus in advanced RCC patients who have experienced disease progression following treatment with at least one prior VEGF TKI. We are very excited to have seen in early February 2016 that the trial also succeeded in meeting its secondary endpoint of improving overall survival [Technical Difficulty] as compared to everolimus update had met the primary PFF endpoint last July. With this important result in hand cabozantinib now has demonstrated significant improvement over an active standard of care treatment everolimus in all three key end points; overall, survival, progression free survival and objective response rate. We conducted the second overall survival interim analysis following consultation with FDA and EMA. Both agencies indicated that they would like to see the results while reviewing our filings. We submitted the results to both agencies in early February. I will now provide a summary of the presentation of the PFS subgroup results at the ASCO conference for genitary urinary cancers or ASCO GU in early January. I will then discuss our recent progress on the regulatory side. And I will close with a brief update on other ongoing trials for cabozantinib in HCC, RCC and other indication and an update on cobimetinib. METEOR's primary endpoint was progression free survival, the results represented at ECC in September 2015 by Dr. Toni Choueiri from the Dana Farber Cancer Institute and concurrently published in the New England Journal of Medicine. The analysis of progression free survival among the first 375 enrolled patients per the independent radiology committee showed a highly statistically significant benefit for cabozantinib with an HR of 0.5h and a P value of less than 0.0001. Cabozantinib nearly doubled. The…

All right. Thanks Gisela. The fourth quarter of 2015 and the first two months of this year had been extremely productive and have provided us with the event and considerable momentum that will dramatically shape our future. With these significant milestones in place, we will keep our focus on executing on the next key drivers of our business including first potential regulatory approval and launch of cabozantinib in advanced RCC in the U.S. Second the seamless transition of the MMA to our new partner Ipsen. And finally our continued support of our partner Genentech with the U.S. launch of our second commercial product COTELLIC in combination with vemurafenib and patients with mutant BRAF positive melanoma. Before I close, I want to take a moment to thank the entire team here who work so hard and tirelessly over the last few months to secure the right partner in Ipsen for cabozantinib. I also wanted to take a moment to welcome all of the new employees in commercial and medical affairs and thank them for bringing their energy, expertise and experience to our rapidly evolving organization and culture. We are excited to have them on board and look forward to them helping us take Exelixis to the next level as a commercial organization. We are making very significant strides in our efforts to bring new therapies to people with cancer; we individually and collectively aim to serve. And I'm personally very excited about what this shirt can look like going forward from today. So thank you all for your time this afternoon and your interest in Exelixis. And we are now happy to open the call for questions.

Thank you. [Operator Instructions] And our first question comes from the line of Michael Schmidt of Leerink. Your line is now open.

Hey, Michael. Are you there?

Mr. Schmidt, please check your mute button.

Sabrina, let's take the next question. See, if he is back up.

Sounds good. Our next question comes from the line of Cristina Ghenoiu of Cowen. Your line is now open.

Hi, congratulations on the deal. And thank your taking my question. The first one is on the European opportunity. And I was wondering you said that in the U.S. about 85% to 90% of RCC subscribers are the community oncologists and they're not particularly married to the IO treatment. I was wondering if in Europe -- do you expect the same kind of dynamic to play out with nivo? Thank you.

Yes. Hi. This is PJ. Thanks for the question. We've been obviously very focused on the U.S. market where we think we have an exciting opportunity for Cabo and RCC and European market depending on the country and who is treating the dynamics can vary. But, I would think of them is roughly similar to those in the United States.

Thank you. If I can ask one on, it's kind of a housekeeping question, do you happen to know how the OPEC for 2016 is divided between R&D and SG&A, and also you mentioned something about Ipsen supporting 35% of clinical cost can you clarify that a bit more? Thank you. Is this ongoing clinical trials or future once?

Yes. Cristina, this is Chris Senner. So the answer to that question is, we're not giving specific guidance. But generally, I would say our R&D expense staying flat year-over-year generally flat with clinical development going down and our build-out of our MSL organization taking up the difference. And then from a -- the rest of the growth in SG&A expense.

And for spend the 35%?

So, Cristina are you asking about the allocation of the spend of 65:35, what do you -- I'm sorry.

Yes. I was just trying to better understand what is that referring to. Is that referring to ongoing trials or future trials?

Sure. Yes. Chris will handle that. Thank you.

So, right now we're going to pay for the current ongoing trials, and then, when we agree on new trials that's when the 65:35 split will kick in.

Thank you.

Thank you. [Operator Instructions] Our next question comes from the line of Stephen Willey of Stifel. Your line is now open.

Hi. This is Prakhar Verma for Steve today. Thank you for taking my question. So, first question on the combination studies with Cabo, so would you intend to wait to see the data from the Cabo plus nivo study before you initiate other combination studies and other tumor types like lung or breast or what's the timeline on those studies?

This is Gisela. Thank you for the question. We are looking forward to seeing foremost safety in dosing data from the ongoing Phase 1b study combining cabocantinib and nivolumab. And this is a study being done in genitary urinary cancers a dose emerging from that Phase 1b study could be applicable to other tumor types as well. So we hope to see such data on dosing throughout the year of 2016. That could drop into other indications.

Okay. And just trying to get clarification on the future trials but for Cabo, I wasn't sure if there is -- who decides what indication [indiscernible] in the future, is that a joint committee or you guys take the lead or is that Ipsen as a territory specific, can you clarify on who decides what indications to pursue?

Sure. Yes. There will be a joint development committee that is governing the clinical development plan. We are at the current time obviously very focused on our existing studies and driving these forward. The joint committee that will determine which indications go forward and each partner has the ability to conduct study, services their respective territories in support of development. In regards to future global development Exelixis will take the lead in those global development studies.

Okay. Thank you for taking my questions.

You bet.

Thank you. And our next question comes from the line of Stefan Quenneville of Morningstar. Your line is now open.

Hi. Thanks for taking the question. Sorry, I just wanted to do a little housekeeping, could you repeat the tiers for the royalties in the Ipsen deal. You said them quickly and I miss them. And then, my second question is, because you sort of talk to us a bit about how the launch is going with Roche for COTELLIC and just sort of any directional information you want to give about how it's starting and how it's looking from your perspective after its approval?

Yes. This is Chris. I'll answer the first question. So the royalty tiers that I identified were 22% to 26% we also have them on the slides out on the web in my section. So you can look there we are not giving the actual dollar tiers where they kick in.

Okay. I thought you did mention and I missed them.

Yes. The other royalties are 2% on the first $50 million and then 12% on the next $100 million. And then, after that the royalties will kick in at 22% to 26%.

Great. I just want to make sure I had those right. Thanks.

Okay.

Hi. And this is Mike. In terms of the COTELLIC launch. Look, it's still early days right now. We're going to play that one and kind of follow Roche's guidance with what they say. So, we will wait until they provide more updates to give you more updates ourselves.

Okay. Thanks.

Thank you.

Thank you. And we do have a follow up question from the line of Cristina Ghenoiu of Cowen. Your line is now open.

Hi. Thank you for taking my follow-up. The first one is on the OS data, do you have any more clarity whether this OS data will make it into the initial label?

We have announced in early February that this study met is key secondary endpoint of overall's survival with high statistical significance. And was also provided the results to both of the FDA and the EMA. We had conducted the study following consultation with both agencies and they wanted to see the results while they are reviewing the filing. So ultimately we cannot speculate what will be in the label. That's up to the agency, but we certainly provided the data in time for them to see all the data in context.

That's very helpful. Thank you. And lastly, I wanted to ask about Cabo and HCC, the ongoing Phase 2 trial, are you able to comment on what kind of events will trigger the interim analysis for that study? Thank you.

Yes. The HCC study is designed as a Phase 3 placebo-controlled study to 760 patients. The final analysis will be conducted when 620 events have occurred with integrated interim analysis at 50% and 75% of events.

Thank you.

Thank you. And at this time, there are no further questions. So, I will turn the call over to today's host, Susan Hubbard. Ms. Hubbard?