Good day, ladies and gentlemen and welcome to the Exelixis Second Quarter 2015 Financial Results Conference Call. My name is Tyrone and I will be your operator today. As a reminder, this conference 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, Tyrone and thank you all for joining us for the Exelixis second quarter 2015 financial results conference call. Joining me on today’s call are Mike Morrissey, our President and CEO; Chris Senner, our newly appointed Chief Financial Officer; and Gisela Schwab, our Chief Medical Officer, who will together review our corporate, financial and development progress for the quarter ended June 30, 2015 as well as recent key development and corporate events. 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 the 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 website at exelixis.com. During the course of this presentation, we will 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 identifies important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation, risks and uncertainties related to the timing of data presentations and the regulatory approval pathways for cobimetinib and cabozantinib. Clinical trial risks, risks connected with compliance with applicable regulatory requirements; the uncertainty of Exelixis’ ability to maintain its rights under existing collaborations and enter into new collaborations; risks regarding Exelixis’ financial outlook and the sufficiency of the company’s capital and other resources over time; and the risk of product commercial success and market competition. With that, I will turn the call over to Mike.

Alright, thank you, Susan and thanks to everyone for joining us on the call today. Exelixis had a productive second quarter and significantly expanded our momentum in July in several fronts, including by first, with the release of positive top line results for METEOR, our Phase 3 pivotal trial for cabozantinib and second line RCC and second, by a successful financing where we raised approximately $146 million net to help us implement our plans to commercialize cabozantinib for RCC in the U.S. pending approval. With positive top line results for METEOR in hand, the top priority now for Exelixis is to expedite the submission of regulatory applications for cabozantinib in advanced RCC in both the U.S. and EU, which we expect to file in early 2016. We are very excited about the METEOR top line results, which Gisela will review momentarily and look forward to being able to provide this new treatment option to RCC patients if approval is granted. Over the last several years, the RCC indication has been impacted by the entry of a number of new therapies that offer only modest benefits. The evolving treatment landscape continues to be very dynamic. In fact in the last month, we saw both our positive top line results for METEOR and the announcement from BMS for nivolumab in second line RCC patients. Assuming that these therapies succeed in securing regulatory approval, we believe that the future RCC opportunity is large enough to support multiple new potentially improved therapies, which could each play a meaningful role in providing greater benefit to RCC patients. As a reminder, the current market for second and later line RCC includes about 17,000 patients in the U.S. and approximately 37,000 patients worldwide with global revenues for current second line RCC agents of approximately $1 billion in…

Thank you, Mike. I would first like to say that I am thrilled to have joined Exelixis at this exciting time in the company’s history. I am eager to work with Mike and the team to build an organization that can maximize the opportunities that are before us. I will begin with a review of our second quarter 2015 financial results and then provide an update on our 2015 financial outlook. My comments will be focused on the highlights of our financial performance and I refer you to our press release and Form 10-Q filed earlier today for additional details. Net revenue for the quarter ended June 30, 2015 were $8 million compared to $6.6 million for the comparable period in 2014. Net revenues consisted entirely of product revenues related to the sales of COMETRIQ. As a reminder, first quarter 2015 net revenues of $9.4 million were positively impacted by one-time adjustment of $2.6 million due to the conversion from the sell-through to the sell-in method of revenue recognition for our domestic revenue. Research and development expenses for the quarter ended June 30, 2015 were $24.5 million compared to $51 million for the comparable period in 2014. The decrease was primarily related to net decrease in clinical trial costs predominantly due to the continued wind down in costs related to common studies in metastatic castration-resistant prostate cancer and decreases in personnel-related expenses resulting from an overall reduction in headcount. Selling, general and administrative expenses for the quarter ended June 30, 2015 were $12.8 million compared to $16.5 million for the comparable period in 2014. The decrease was primarily related to a decrease in personnel and stock-based compensation expenses resulting from an overall reduction in headcount, consulting and outside services and legal and patent costs. Those decreases were partially offset by…

Thank you, Chris. A couple of weeks ago, we announced positive results for METEOR, our Phase 3 trial comparing cabozantinib and Everolimus in advanced RCC patients who have experienced disease progression following treatment with at least 1 VEGFR TKI. We were very excited to see the trial succeed in meeting its primary endpoint of improving PFS for cabozantinib as compared to Everolimus and to also observe a strong trend in overall survival at the planned interim analysis. In addition, cabozantinib was generally well-tolerated with a low rate of discontinuations for adverse events not associated with disease progression. Just a reminder, I will quickly run through the top line data. The primary endpoint of the study was progression-free survival. The analysis of progression-free survival per the independent radiology committee showed a highly statistically significant benefit for cabozantinib with a hazard ratio of 0.58% and 95% confidence interval of 0.45 to 0.75 and a p-value of less than 0.0001. Cabozantinib treatment reduced the risk of disease progression or death by 42%. In METEOR, we have now seen a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival compared with Everolimus. Data pertaining to overall survival in the entire study population of 658 patients, a secondary endpoint of the trial were immature at the data cutoff as would be expected. But an interim analysis triggered to occur at the time of the primary analysis for PFS showed a strong trend favoring cabozantinib with a hazard ratio of 0.67, an unadjusted 95% confidence interval of 0.51 to 0.89 and a p-value of 0.005. At the time of the interim analysis, the pre-specified p-value of 0.0019 to achieve statistical significance was not reached. Needless to say, that we were very pleased to see the strong trend in overall survival at this…

Alright, Gisela thank you. I will add a couple of closing remarks before we can get to your questions. We are rapidly moving towards two key milestones for Exelixis in the months ahead. Our team is completely focused on the next significant drivers for the business, including first the U.S. and EU regulatory filings for cabozantinib in advanced RCC. And second the potential approval and launch of cobimetinib in combination with vemurafenib in patients with mutant BRAF positive melanoma. We are entering a new and very exciting phase in the company’s history with the near-term possibility of having two approved products that address commercially significant patient populations. We look forward to keeping you up-to-date on our continued progress. I will close now by thanking our entire team here at Exelixis for their unwavering dedication and great efforts over the last quarter on behalf of patients with cancer. Thank you, all for your time today and your interest in Exelixis and we are happy now to open the call for questions.

Thank you. [Operator Instructions] Our first question is from Eric Schmidt with Cowen & Company. Your line is open.

Good afternoon and thanks for taking my questions. Mike, do you now have a targeted medical meeting for a presentation of the METEOR results or is that still up in the air?

Yes. I will let Gisela answer that question, Gisela?

Sure. Yes, we have submitted at this point in an abstract for the ECC meeting that is taking place in Vienna at the end of September. Obviously, it’s not up to us to decide upon acceptance. So we will just have to stay put and weight for a response and we will be sure to update you when we have it.

Okay. And then maybe also for Gisela what’s rate limiting on your ability to file the sNDA in the U.S.?

So obviously, as the highest priority as I said a little earlier, working on the regulatory filings both for the United States and the European Union and we are mobilizing all resources to move things along as quickly as possible we have guided towards a submission timeline in early 2016, but are certainly working towards beating that submission timeline. And the usual things that need to occur to achieve that obviously, the generation of regulatory documents and finalization of the study reporting and so on. So, that takes a little bit of time.

So, not waiting for anymore cuts to the data or any manufacturing, I don’t know checks and balances or anything like that just processing the filing itself?

That is correct. And also just to clarify, it’s not an sNDA, it’s an NDA.

Oh, sorry, correct.

Yes, from the COMETRIQ capsule.

Thank you. Last question, in terms of the European MAA filing and your ex-U.S. partnership discussions, are those independently tracked or do you think a partner might want to have some say in the MMA and therefore might the timing of one be dependent on the other?

Yes, Eric, it’s Mike. We view those two work streams as being at this point in time, separate. Obviously, if we had a partner in place by the time we had the MAA ready to file that would make future discussions with agencies in the EU probably easier, but we are not going to wait for that. We can file sooner. We will do that. And again, the goal there is to find really the best partner from a broad perspective and our focus is to get the MAA and the NDA filed as quickly as possible.

Thank you.

Thanks, Eric.

Thanks, Eric.

Thank you. Our next question is from Stephen Willey of Stifel. Your line is open.

Yes, thanks for taking the questions. Just with respect on the European partnership side, can you maybe just remind us what the flexibility is for the current arrangement with Sobi, I guess, with respect to maybe termination and is there any kind of breakup fee there associated with the ending of that agreement?

Yes, Steve, it’s Mike. Again, as we have talked about previously, we currently work with Sobi as our European distributor for COMETRIQ in the EU as well as supporting the named patient use program globally outside of the U.S. We have a great relationship with them. They are doing we think a great job in supporting again what is a very small, tiny orphan oncology indication and we enjoy that collaboration and we think it’s gotten off to a great start. That being said, we have the opportunity to move that compound to a future partner if we choose so as part of that ex-U.S. collaboration or potential collaboration that we are certainly talking about. Right now, there is a small fee that we would pay to Sobi, but it’s a rather small amount and is certainly not in the way of somebody who would like to be able to market COMETRIQ for MTC to move that forward with another partner. So, again, in fact, we are very happy with Sobi. We think it’s going really well and we will see where this goes relative to the broader RCC discussion term of the ex-U.S. deal.

Okay. And then with respect to again I guess on the partnership side, would you be looking for a partner that could concomitantly commercialize Japan or do you view that as being a separate deal in and of itself?

That’s a good question. We are looking at all those different scenarios very carefully. It’s only a math problem more than anything else in terms of the kind of the global economics in terms of both commercialization as well as future developments. So, if one partner can do that, that’s fine. If we need to go to two to cover Asia, Japan as well as rest of world, that’s okay too. So, we are flexible there. Again, we are looking to maximize our optionality and the economics that we receive as well as the really strong support from a development point of view to really build cabozantinib into the franchise that we think it could become.

Okay. And then maybe just a housekeeping question, I appreciate the second half OpEx guidance, but just want to make sure that, that doesn’t include any potential co-promotion costs under the cobi agreement?

Yes. So, yes, it does include the – this is Chris Senner, it does include the co-promotion costs for the second half, so both in the first and the second half include the co-promotion costs. So, they are both – they are in what you have seen in the run-rate, but also in the guidance.

Okay, I appreciate it. Thanks.

Thank you. [Operator Instructions] Next question is from Stefan Quenneville of Morningstar. Your line is open.

Hi, thanks for taking my question. I was curious about incremental sales force requirements given the RCC indications starting next year. How are you thinking about sort of adding people to what degree you think that’s going to be necessary?

Yes, thanks for your question. P.J. Haley is here. He leads our commercial group. It’s a great chance for him to say a few words about that. P.J.?

Yes, thanks for the question. I think it’s probably best to take a step back and think about our commercial capability that we have developed over the past few years leading up to our approval of COMETRIQ in medullary thyroid cancer. So, we have had a sales force on board promoting that for over two years now. So, we have developed that capability internally. We have expanded the team and expanded it again recently to be ready for the potential cobimetinib approval in partnership with Genentech, who are working very well and closely with as we continue to prepare for the pending cobi approval. With regards to that, we have 12 representatives, who will be going from promoting currently COMETRIQ to supporting cobi with that approval and we have 6 reps who will remain supporting COMETRIQ. With regards to COMETRIQ in MTC, it’s a very sort of niche and small population with a small amount of oncologists who are treating that niche indication. We know these physicians very well these customers and we believe we can continue to support patients over the time there. When we think about RCC going forward, it’s obviously an opportunity we are very excited about. It’s too early to comment on the details of that, but what I can say is that with the data, we have got a lot of unsolicited interest in folks reaching out with interest to join the commercial organization at Exelixis. We think that’s going to give us great momentum as we continue to move forward with our recruiting efforts. When I think about other capabilities to commercially that we have built, we have built in-house marketing capability. We have built in-house distribution capability. We have a third-party logistics provider onboard. We have a specialty pharmacy. We are currently distributing the drug through. So, at a high-level strategically what we will do is look to continue to leverage these capabilities as we prepare for potential launch in RCC.

Great, thanks.

Thank you. There are no further questions at this time. I would like to turn the call over to today’s host, Susan Hubbard. Ms. Hubbard?

Great. Thank you all for joining us today. We appreciate your attention and support and we look forward to answering any follow-up questions you might have following the call.