Susan Hubbard - Investor Relations Mike Morrissey - President and CEO Chris Senner - CFO Gisela Schwab - CMO P.J. Haley - Vice President, Commercial.

Eric Schmidt - Cowen & Company Stephen Willey - Stifel Financial Varun Kumar - Leerink Partners Stefan Quenneville - Morningstar.

Good day ladies and gentlemen, and welcome to the Exelixis' Third Quarter 2015 Financial Results Conference Call. My name is Eric, 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, Eric, and thank you all for joining us for the Exelixis' third quarter 2015 financial results conference call.

Join 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 will together review our corporate, financial, and development progress for the quarter ended September 30th, 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 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'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 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 Exelixis' capital and other resources to fund its operations over time; and the risk of product commercial success and market competition.

Now with that, I will turn the call over to Mike.

All right. Thank you, Susan, and thanks to everyone for joining us on the call today.

Exelixis has had a very busy and impactful third quarter marked by the achievement of several significant milestones including first the topline release and subsequent data presentation from METEOR, our Phase 3 pivotal trial for cabozantinib and second line RCC at the Presidential Symposium of the European Cancer Congress in Vienna on September 26th.

Second, the concurrent publication of the METEOR data in The New England Journal of Medicine. Third, the granting of break through therapy designation by the FDA for cabozantinib and for advanced RCC which expedites our NDA filing timelines to 2015.

And, fourth, the completion of a financing where we raised approximately $146 million net which helps us implement our plans to commercialize cabozantinib for advanced RCC in the U.S. pending approval.

Since the end of the third quarter, we have continued to make an important clinical and regulatory progress for both cabozantinib and cobimetinib including first the initiation of our rolling NDA filing with the FDA for cabozantinib and advanced RCC; second, CHMP's recent decision to grant accelerated assessment status to our future MAA for cabozantinib and advanced RCC in the EU.

We expect to complete that filing in early 2016. Third, announcements from Exelixis and Roche-Genentech, coBRIM, met its second end points demonstrating a statistically significant and clinically meaningful increase in overall survival for patients receiving the combination of cobimetinib and vemurafenib as compared to vemurafenib alone.

These data will be presented at the Society of Melanoma Research Meeting next week. And finally we announced today with our partner Roche-Genentech that the FDA approved cobimetinib in combination with vemurafenib for the treatment of patients with BRAF mutant positive melanoma.

cobimetinib will be sold as Cotellic and is the second drug discovered at Exelixis to be approved in the U.S. This achievement represents an important milestone for our company and is a significant advance for patients with melanoma. I'd like to take a few moments now to discuss cabozantinib for advanced RCC and the rapidly evolving RCC landscape.

We're excited about the METEOR data which has been well received by the medical community. Our highest priority is to expedite the regulatory applications for cabozantinib in advanced RCC with both the FDA and EU regulatory authorities.

Gisela will review that progress momentarily, but the bottom-line is that we anticipate completing our NDA filings in the U.S. later this year and are EU filing in early 2016, thus creating the potential for both approvals next year. 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 2014. Our early market research suggests that this market opportunity could grow significantly over time as more patients access new and potentially improved agents with longer duration of therapy.

We believe this market is currently underserved and that it will be able to support multiple new and potentially improved therapies.

The cabozantinib second line monotherapy and advanced RCC, we're also pursuing additional opportunities in this indication and are working to build on METEOR's success by cabozantinib alone in the first line setting and by evaluating rational combination approaches including the cabozantinib, immunotherapy combinations under investigation at the NCI.

Following the announcement of positive topline results for METEOR, we executed financing that raised approximately $146 million net of expenses. The initial funds are being deployed to help expedited our regulatory submissions and to expand our commercialization capabilities necessary to support a full scale U.S.

launch of cabozantinib for advanced RCC pending approval. To this end, we made several key hires including new heads of sales, marketing and medical affairs in the third quarter. We're delighted with the caliber of these individuals and with the depth of experience that they bring to the organization.

Our commercialization infrastructure and potential marketing plans continue to expand at a rapid pace. While we keep the details confidential for the immediate future, for competitive reasons, we plan to be launch-ready as early as April 2016.

As we had disclosed previously, we expect to file our MAA for advanced RCC in the EU in early 2016 and could have approval before the end of next year. Before capitalize on the broad global commercial opportunity, Exelixis is seeking an ex-U.S. partner for cabozantinib.

We believe that with the strength of the METEOR data and the additional cash from our July financing, puts us in a strong negotiating position as potential partnering discussions continue to advance. With respect to cobimetinib, Exelixis and our partner Genentech have made significant progress over the last few months.

In August, cobimetinib in combination with vemurafenib received its first regulatory approval in Switzerland. In addition, in September, CHMP adopted a positive opinion for the MAA for cobimetinib in combination with vemurafenib for advanced mutant BRAF positive melanoma. We look forward to our regulatory decision from the EMA by the end of this year.

And as mentioned earlier, Genentech received approval today from the FDA to market cobimetinib in combination with vemurafenib for patients with advanced mutant BRAF positive melanoma. This is an important milestone for the company as well as for patient with melanoma and their physicians.

The label contains updated progression-free survival and overall survival data which Gisela will discuss in detail later in the call. As a reminder, we will cope a multi-drug in the U.S. in the field one quarter of the sales force.

We are prepared to support the launch of Cotellic now that approval is in hands and it is our understanding that product will be ready to ship in the next couple of weeks. In conclusion, with the U.S. approval of Cotellic, Exelixis has two drugs discovered in our laboratories which are now approved for use in patients.

This significant achievement is rare for a company of our size, but we're not slowing down for a single moment. We continue to make rapid progress towards the filing, potential approval and launch of cabozantinib and RCC.

Ultimately, the key driver for all of us at Exelixis is to improve treatment options for patients with cancer and that goal keeps us focused as we navigate the exciting months ahead. So, with that, I'll turn the call over to Chris to review our financial performance for the third quarter of 2015..

Thank you, Mike. I'll begin with a review of our third quarter 2015 financial results and then provide an update on our 2015 financial outlook. Comments will be highlights of our financial performance and I refer you to our press release and Form 10-Q filed earlier today for additional details.

Net revenues for the quarter ended September 30th, 2015 were $9.9 million compared to $6.3 million for the comparable period in 2014.

Net revenues for the third quarter of 2015 consisted of $6.9 million of product revenue related to the sales of COMETRIQ and $3 million of contract revenues for milestone payment received from merge related today worldwide license of our PI3K delta program in December of 2011.

Research and development expense for the quarter ended September 30th, 2015 were $26.1 million compared to $43.6 million for the comparable period in 2014.

The decrease is primarily related to net decrease in clinical trial costs related to the comment media trial and to a decreases in personnel related expenses resulting from an overall reduction headcount.

Those decreases from partially offset by an increase in non-cash stock base compensation expense of $6.6 million due primarily to performance based stock options that vested as a result of the positive topline data received from METEOR.

Selling, general, and administrative for the quarter ended September 30th, 2015 were $17.8 million compared to $9.9 million for the comparable period in 2014.

The increase was primarily related to non-cash stock-based compensation expense of $4.7 million, due primarily to the vesting of performance based stock as a result of the positive topline data received from METEOR and higher marketing expenses including expenses for cobimetinib under the company's collaboration agreement with Genentech.

Those increases are partially offset by decrease in facilities cost and consulting and asset services. Other income and expense net for the quarter ended September 30th, 2015 was a net expense of $11.8 million compared to a net expense of $11 million for the comparable period in 2014.

The net expense is comprised primarily of interest expense which includes $6.9 million of non-cash expense related to the accretion of the discounts on both the 4.25% convertible senior subordinated notes to 2019 and the company's indebtedness under the Deerfield notes for the quarter ended September 30th, 2015 as compared today $7.5 million for the comparable period in 2014.

Net loss for the quarter ended September 30th, 2015 was $47.6 million or $0.22 per share compared to a net loss of $62.6 million or $0.32 per share for the comparable period in 2014.

The decrease net loss for the quarter was primarily research and development expenses and an increase in net revenues, partially offset by an increase in selling, general and administrative expenses.

Cash and cash equivalents, short and long-term investments and short and long-term restricted cash in investments totaled $282.1 million at September 30th, 2015 compared to $242.8 million at December 31, 2014. Turning to our financial guidance, for the second half of 2015, with the positive METEOR data and the U.S.

break through therapy designation in hands, we will continue to make the investments necessary to expedite our regulatory efforts to fully support our U.S. and EU filings as well as building the incremental infrastructure necessary to prepare for the potential U.S. launch of cabozantinib and advanced RCC.

The company is refining its guidance that operating expenses for the second six months of 2015 will be at the upper end of the $80 million to $930 million range.

This results in guidance towards the upper end of the $150 million to $160 million range for the full year 2015 and includes approximately $10 million of incremental non-cash stock-based compensation expense related to the diversifying of performance stock options tied to the positive topline METEOR trial results.

We ended quarter with $282.1 million of cash which includes approximately $146 million cash, we raised during the third quarter following the release of the topline METEOR results and as Mike highlighted we're in discussions with potential partners for ex-U.S.

territories which if successful, ultimately could bring additional financial resources to the company in the form of upfront and other near-term milestone payments. So, with that, I'll now turn the call over to Gisela. .

Thank you, Chris. The last few months have been very busy following the positive results from METEOR, our Phase 3 trial comparing cabozantinib an Everolimus in advanced RCC patients with experienced disease progression following treatment with at least one VEGFR TKI.

We were very excited to the see the trial succeed and 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. The METEOR results were presented in September at the ECC Conference in Vienna and concurrently published in The New England Journal of Medicine by the Principal Investigator for the trial, Dr.

Toni Choueiri. Both the presentation and publication of the METEOR results were back to back with the nivolumab study that also met its primary endpoint in the second or later line RCC setting. All studies achieving their primary endpoint is certainly good news for RCC patients. METEOR's primary endpoint was a progression-free survival.

The analysis of progression-free survival per the independent radiology showed a highly statistically significant benefit for cabozantinib with an HR of 0.58 and 95% confidence interval of 0.45 to 0.75 and a key value that was less than 0.0001. cabozantinib nearly doubled the median PFS with a 7.4 months as compared to 3.8 months with Everolimus.

cabozantinib treatment reduced the risk of disease progression or death by 42%. In METEOR, we have now seen a clinical meaningful and statistically significant improvement in the primary endpoint PFS compared with Everolimus.

The PFS results consistently favored cabozantinib across the subgroup analysis used for stratification including the number of prior VEGFR inhibitor therapies one versus two or more and the MSKCC risk categories.

Interestingly in the subgroup of patients who received the most commonly used drug in first line RCC therapy, sunitinib as the only prior TKI. The median PFS for the cabozantinib arm was 9.1 months and for Everolimus it was 3.7 month.

This is of interest as the PFS and other second or later line trials including RECORD-1 and access showed a median PFS for the that group of patients of 3.9 month and 4.8 months respectively. The treatment relation was consistent with the PFS duration.

Patients on the cabozantinib arm had a median treatment duration of 7.6 months compared to 4.4 months on Everolimus. When focusing on the first 375 patients involved who had a longer minimum follow-up of 11 months, the treatment duration on cabozantinib was 8.3 months as compared to 4.1 months on Everolimus.

Data pertaining to overall survival in the entire study population of 658 patients, a secondary endpoint in the trial were immature at the data cutoff with a minimum follow-up time of only six months.

An interim analysis triggered to occur at the time of the primary analysis for PFS showed a strong trend favoring cabozantinib with an HR of 0.67 on adjusted 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.

The trial will therefore continue to the final analysis of overall survival that we anticipate in 2016. The overall survival interim analysis provides a first early look at this data and we're encouraged by the observed strong trend favoring cabozantinib. This trend was observed despite a frequent use of subsequent systemic anticancer therapies.

On the cabozantinib arm, 38% of patients received subsequent systemic anticancer therapies whereas the rate was higher on our Everolimus with arm with 47% of patients receiving such treatments.

This is of interest as to-date for the majority of available agents Phase 3 studies in advanced RCC and in particular in the second line setting, the RECORD-1 study and the access study failed to show a survival benefit for the respective compounds and the evaluation, although they succeeded in improving PFS.

The rates series adverse events regardless of causality were similar between treatment arms and discontinuations for adverse events were low at around 10% in both arms and consistent with those previously reported for Everolimus. Further details analyses are ongoing and will be presented in the future.

But we believe that the low discontinuation rate may in part be due to the optimized dose of cabozantinib at 60-milligram per day and the high level of similarity of the RCC treatment community with the use of both Everolimus and VEGFR targeting TKI.

On the regulatory side, FDA has granted break through therapy designation for cabozantinib in the treatment of advanced RCC patient in August of this year. We have recently announced the initiation of the rolling NDA filing in the United States and the team here is highly focused on completing that filing by the end of this year.

In the EU, we have been granted accelerated assessment status which could shorten the review time by approximately two months compared to a regular review. We're planning to submit the Marketing Authorization Application filing in the European Union in early 2016.

Thus, if the filings are successful cabozantinib could achieve regulatory approval both in the U.S. and EU in 2016.

Beyond our focus and effort to complete our regulatory filings based on METEOR, additional clinical development in RCC continues in the form of trials sponsored by our collaborators at the National Cancer Institute Cancer Therapy Evaluation Program as well as through our investigative sponsor trial program.

Most notably, an important study in first line advanced RCC is currently ongoing in the cooperative group the alliance under the CTEP IND. The cabozan trial is a randomized Phase 2 comparing cabozantinib versus sunitinib in first line therapy of intermediate or poor risk patients per the standard risk classification.

The timely end point is progression-free survival and the study achieved its target enrollment of 150 patients in March of this year. Given the historical PFS duration in patients with intermediate or poor risk RCC and first line setting, we're expecting data in the first half of 2016. We look forward to providing you with the results when available.

In addition, our CTEP collaborators have initiated a Phase 1 study evaluating the combination of cabozantinib plus nivolumab with or without ipilimumab in patients with genitourinary cancers including RCC.

There is strong rationale of combining about with cabozantinib with these types of immune oncology agents including evidence of the compound's abilities to create a more immune-permissive environment as well as pre-clinical data suggesting that cabozantinib can increase T-cell infiltration into tumors.

This study was opened for enrollment in July 2015 and continues to actively accrue patients.

Data on the tolerability and anti-tumor activity of the combinations studied in this early phase trial could set this stage for later phase evaluation not only in the genitourinary section, but in other areas as well, like non-small cell lung cancer and histologies that appear sensitive to both agents.

Now, turning to other indications, with regard to our Phase 3 study in advanced hepatocellular cancer Celestial. The study continues to involve patients globally. In this study, patients with advanced HCC who have received prior treatment with sorafenib are randomized to receive either cabozantinib at 60-milligram per day or matching placebo.

The primary endpoint for this trial is overall survival, and we are expecting data in the 2017 timeframe. There is currently no standard of care available in the second or later line population who have received prior sorafenib, highlighting the unmet medical need in this indication.

And lastly based on results in non-small cell lung cancer presented at the ASCO Meeting a couple of months ago, I want to touch on potential next types for cabozantinib in this indication. All presentations showed positive results from two trials of cabozantinib and molecularly defined subtypes of non-small cell lung cancer.

An investigator sponsored Phase 2 trial of cabozantinib in RET rearranged non-small cell lung cancer met its primary endpoint exceeding the predefined number of objective responses.

And a second trial conducted by the ECOG-ACRIN Cancer Research Group under our cooperative research and development agreement with NCI-CTEP showed that cabozantinib extended both PFS and overall survival in a statistically significant fashion both as a single agent and in the combination with erlotinib as compared with erlotinib alone in EGFR wild type non-small cell lung cancer.

Exelixis is committed to working with its collaborators at the NCI and at ECOG-ACRIN to explore further development of cabozantinib in lung cancer, including the evaluation of combination of purchase within immune oncology compound.

Before turning the call back to Mike, I'd like to provide an update on cobimetinib, our MEK inhibitor that is being developed in partnership with Genentech-Roche. BRAF V600 mutations of about 50% of patients with malignant melanoma and BRAF V600 mutations lead to uncontrolled signaling and cell proliferation.

Targeting of mutated BRAF and MEK with the combination of vemurafenib and cobimetinib has been evaluated in patients with advanced BRAF mutant melanoma in Genentech's program Phase 3 study that formed the basis for regulatory filings in 2014.

Updated coBRIM results for the primary endpoint of PFS were presented earlier this year at the ASCO Conference and are now reflected in the U.S. label. These results showed that with additional follow-up, the median PFS on the cobimetinib plus vemurafenib was 12.3 months as compared to 7.2 months for vemurafenib alone.

The HR was 0.56 and the results were highly statistically significant. Objective response rates were also significantly improved under combination arm as compared to the single agent vemurafenib arm. The objective response rate for cobimetinib plus vemurafenib was 70% compared to 50% on the vemurafenib alone arm.

We're very pleased that these results are included in the U.S. label as well as the [Indiscernible] graph of the analysis of overall survival showing a median 17 months overall survival for the vemurafenib arm and a median that has not been reached as yet for the combination arm.

The hazard ratio was 0.63 in the p value 0.0019 showing statistical significance compared to the allocated alpha of 0.019 for this interim analysis.

We also recently announced that our partner Genentech has informed us that a subsequent and final analysis of overall survival, a secondary endpoint of the pivotal coBRIM study showed that the combination of cobimetinib and vemurafenib helped patients with advanced BRAF mutant melanoma live significantly longer as compared to vemurafenib alone.

Details on these results will be presented melanoma research taking place in San Francisco next week.

Additionally, a broad development plan is in place to further advance the development of cobimetinib spanning multiple trials evaluating cobimetinib in various different indications and in combination with a number of other targeted agents including [Indiscernible] Genentech's PD-L1 targeting antibody.

We look forward to data from pricing trials when available. And with that I will hand the call back to Mike..

All right. Thank you, Gisela. The third quarter of 2015 marked one of the most eventful in Exelixis' history, as evidenced by multiple clinical and regulatory achievements. With these significant milestones in place, we have now turned our complete focus to executing on the next drivers of our business.

First, the completion of filings for cabozantinib and advanced RCC in both the U.S. and EU. Second, the continued preparation for commercial readiness in support of the potential U.S. launch of cabozantinib and RCC next year, and third supporting our partner Genentech with the U.S.

launch of our second commercial product Cotellic in combination with cabozantinib in patients with mutant BRAF positive melanoma. I'll now take a moment to commends and offer my sincere gratitude to those whose contributions have led us to this point.

Our current and past employees, our clinical investigators and their stuff and the patients with cancer we individually and collectively aim to serve. So thank you all for your time and interest today in Exelixis and we're now happy to open the call for questions..

Thank you. [Operator Instructions] And your first question comes from the like of Eric Schmidt from Cowen & Company. Your line is now open..

Thanks for the update and for taking my question -- or questions. Mike, you mentioned that you hope to be launch ready by April 2016 for cabo and RCC.

What's special about that date?.

It's April Fool's Day. Look, I think it's an important milestone for us from the standpoint of making sure that we have all the infrastructure and certainly all the capabilities in place to launch a full scale launch.

So, I think from the standpoint of how we view progress in terms of the trial, in terms of our filing it's the point in time when we want to be launch ready. So, and we're making good progress in that regard. .

Okay. And then it's been a couple months now since you received the break through designation from the FDA in that indication.

How have things changed or how do you perceive the FDA's urgency to move forward over the last few months?.

Yeah, maybe Gisela can take that question..

Yes.

We're making very good progress regarding advancing our efforts towards this filing and we have initiated as I mentioned earlier on the rolling NDA submission which is part obviously of the break think therapy designation that enables that and we are working hard to complete the filing before the end of the year and we are on track with that so things are going pretty well there..

Okay.

Maybe a better question for Roche, but perhaps the answer do you guys know when we might get pricing information on Cotellic?.

So, Eric, its Mike. Let me take that question.

That information has been -- has been shared and let me start by saying first and foremost that we are very pleased with today's announcement not just because it's our second approved drug from Exelixis, but because it's really an important new treatment options for patient with cancer and that's why we come to work every day, that's why we work as hard as we do as to really help patients with cancer.

So, we're very excited about that and very proud of that, first and foremost. Secondly, as Gisela mentioned in some detail we're very pleased with the label and the opportunity to have the updated both progression fee survival and overall data survival in the label.

We think it's very competitive and provides a very good foundation to launch the drug and market the drug in I space that has seen certainly a lot of progress and a lot of competition over the last few years. So, in terms of pricing, let me get to the facts first.

So, again, per our contract with Genentech, they have the sole authority to set the price for Cotellic and any combination product that contains cobimetinib and another drug which in this cases is the situation in terms of the BRAF positive melanoma indication.

So, we were informed this morning by Genentech that the monthly price for Cotellic would be $6,590 and that is I think put in the context relative to the price for zalberac [ph] which currently is $11,000 per month.

So, the price of the combination product therapy would be about $17,500 a month, which is priced at approximately about an 8% discount to what is currently available for the trametinib-dabrafenib combination which is being sold now by Novartis. So, again, it's a competitive label.

Certainly with the updated PFS and OS data in place it's competitively priced to be able to deal with that issue as well and, again, the broad development plan that is being instituted by Roche relative to the wide number of combination trials that are being examined right now as Gisela mentioned is certainly a good sign of the interest in the drug, the interest indifferent combinations and different tumor types and one that we think has the potential to potentially expand the size of the Cotellic franchise as alluded to in the Roche Investor Call last week..

Great. Thanks very much..

Thank you.

Thank you. And our next question comes from the line of Stephen Willey from Stifel Financial. Your line is now open..

Yeah hi. Thanks for taking the questions and congrats on the approval and all the progress. Mike, maybe just a question with respect to your thoughts with regard to how penetrated you believe the BRAF MEK market to already be.

I think if you look at trametinib and dabrafenib sales I think as reported by Novartis it looks to -- that combo looks to be run-rating I guess at something close to 550 million or 600 million a year and just kind of wondering based on the work that you've done with some of your co-promote activities to-date if -- if you think that there's considerable expansion opportunities kind of beyond where the market is already..

Yes, Steve. Thanks for the question. That's certainly our view as well based upon the initial look at the Novartis numbers from again the Q3 run-rate. If you look at the epi in terms of patient numbers, there's about 5,000 patients with the mutant BRAF positive can type in the U.S. similar number probably in Europe.

You can do the math there in terms of how much they cover versus what's left in terms of upside or potential places where this could grow in general terms. Certainly the PD-1 antibodies are used in this space and KOL community is certainly very bullish on those modalities for either the mutant BRAF wild-type or positive population.

So, again, we're excited with the label. Certainly, the -- having the PFS and OS in the label puts us in a -- I think a pretty strong position to be able to engage now and the -- our sales force is fully integrated with that from Genentech and Daiichi and we're ready to go.

So, we're excited about that and again, we've got a new Head of Sales and Infrastructure there that is going to help reinforce that and we're really, really excited about being able to engage now from a marketing and promotional point of view with the approval and think we've got a lot to talk about..

Okay. And with regard to the kind of the expansion of the franchise-based on some of these additional studies that Genentech is running with Cotellic, I know, obviously been implicated in NRAS melanoma which is a sizable chunk of melanoma itself and I think there has been some discussion regarding the traction of the immunotherapy as we gain there.

So, do you have any clarity from Genentech at this point as to whether or not they intend to initiate Cotellic study in NRAS and I guess specifically in the context of I think Roche talking about Cotellic as being one of the less immunosuppressive mix that are out there..

Yeah, Steve. Thanks for the question.

We're really not in a position to really comment on some of the thoughts and plans beyond what they have talked about publicly and they -- I was -- we were all pleased to see Cotellic play a prominent role in their Investor Day last week and I think the dialogue they presented in the slides I think really reinforced their interests and how they're a to a large agree pursuing that opportunity with different combination partners.

We just go I don't understand what they basically have said so far. So, I will refer you back to them if you want to pursue that question, but we've got to kind of stuck with the party line here..

Understood. Attend maybe just one quick cabo question.

With respect to the MCI C cup study, the Phase 1, I know that it's investigator initiated, but do you have any idea as to the number of RCC patients that may be included in that trial and if there's any kind of cap to make sure that there's an RCC representation amongst all of the GE malignancies that you are allowing to enroll? Thanks..

Yeah. Great question.

Gisela can you answer that?.

Sure. The initial part of the Phase 1 study is in dose rate and cohort study in which patients with any tumor can be include. There's no cap as to RCC.

And then in the second part of the study once the optimal doses have been identified, there are expansion cohorts and that include patients with different types of urothelial cancer and their plans to also add RCC..

Okay.

And do you know if the initiation of those expansion cohorts are based on some threshold response level that needs to be achieved in the dose-escalation or are those already pre planned?.

It's not dependent upon a threshold of response. It's dependent upon the choice of dose having been made and soon as its safe and optimal dose has been identified then the expansion cohorts can go ahead..

Okay. Thanks for taking the questions..

And the next question comes from the line of Michael Schmidt from Leerink Partners. Your line is now open..

Hi. This is Varun Kumar and on behalf of Michael Schmidt.

My first question is on Kobe what is expected timeline for the launch? And can you guide us what is the current at-home status on Kobe?.

Yeah. P.J.

is here from Commercial, you want our comment on the Kobe launch time?.

Yes. Absolutely. So, thanks for the question. So, the sales force is in place so our team is very excited to begin promoting Cotellic immediately now that we have the label in hand.

We've been working closely with Genentech now for some time preparing for the launch and as you know Genentech very seasoned in bio oncology in these launches, so we feel very good about partaking in this opportunity with Genentech.

So, our teams are ready to go to start promoting tomorrow and drug is going to be available within the next couple weeks. So, really all things are starting off tomorrow and we're really excited to have this opportunity. .

Okay, clear.

And the patent status do you have any idea about when it is set to expire?.

Yeah. My recollection and somebody can correct me if I'm wrong here is that it is -- the loss of exclusivity is 20, 30 for the composition of matter pattern..

Okay, great. And the second question would be on the cabo. So, you have S2 study going on in wet positive lung cancer.

Do you plan to continue the single therapy beyond Phase 2 or is the priority going to be combining with immunotherapy going forward in lung cancer?.

Yes. Thanks for the taking question. For the cabo -- cabozantinib single agent study that positive small cell lung cancer that is an investigator sponsored study that is conducted out of MSKCC, Alex Drilon is the lead investigator here and he also presented the data at the recent ASCO meeting showing very nice and encouraging response rates of 38%.

That study is continuing to accrue patients as it has expanded into its second phase or stage.

And regards to further development in lung cancer, there are various possibilities that are under discussion and we certainly are interested in continuing work in lung cancer and are particularly interested given the potential for cooperative activity that I spoke about earlier on in combining cabozantinib and immunooncology agent and that is in discussion that is also ongoing with the [Indiscernible] cooperative group as well..

Okay. Thank you. And congrats on will be approval. Thank you. .

Thank you..

[Operator Instructions] And the next question comes from the line of Stefan Quenneville from Morningstar. Your line is now open..

Hi. Thanks for taking the question and congrats on the approval today. I'm sorry if this has been asked already. I just -- I was jumping on and off.

How comfortable are you with Roche's guidance on the market opportunity for the Cotellic BRAF combo of I think they categorize at R&D day as small with sales up to 500 million for the combo and I guess with the pricing you gave, where you're getting about a third of the combined economics is that consist with what you're thinking or do you have a -- a differing view there in.

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Yeah. I wouldn’t -- this is Mike, I wouldn’t want to speculate further on kind of their take on this whole thing from their Investor Day last week. I remember the graph or the slide you're talking about and it was kind of segmented across compounds and indications and those kinds of things. So, you know, again that was their view, that was their data.

They're really the senior partner here driving the Cotellic marketing launch and they're certainly able to put that together so..

Okay. Fair enough.

That's a very good political answer given they're the managing I guess leading the launch of the how would you find other opportunities for it outside this combo, given its been tested a number of different indications? How do you feel that would be even qualitatively relative to the opportunity of melanoma?.

Yeah. I think there's a lot of very exciting work going on right now across again different combination partners, a wide variety of tumor types.

We're certainly very excited about the opportunity that is presenting therein terms of what those combinations could do to help patients and certainly expand again using the Roche terminology the Cotellic franchise.

But that's all data-dependent and we will take certainly some more time to work through the Phase 1b/2 data and then move whatever looks good into pivotal trials an we're very fortunate and happy to have a partner like Genentech and Roche with certainly a lot of experience there from both an obviously development and regular perspective.

So, again, we're focused primarily on developing an moving cabozantinib forward with our internal development capabilities and regulatory capabilities and we're very pleased to have a partner like Roche-Genentech that can again do the heavy lifting with cobimetinib and Cotellic to again bring value to patients and to our different stakeholders..

Great. Thanks..

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..

Thank you, Eric, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were able to address on today's call..