Exelixis Inc (EXEL) 2014 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to Exelixis third-quarter 2014 financial results conference call. My name is Chris and I will be your conference moderator for today.

(Operator Instructions)

As a reminder, this conference is being recorded for replay purposes. And now I would like to turn the call over to your host for today, Ms. Susan Hubbard, Investor Relations. Ma'am, you may proceed.

Think you, Chris, and thank you all for joining us for the Exelixis third-quarter 2014 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO; Debbie Burke, our Chief Financial Officer; and Gisela Schwab, Our Chief Medical Officer, who will together review our corporate, commercial, financial, and development progress for the quarter ended September 30, 2014.

Peter Lamb, our Chief Scientific Officer, is 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 will be making forward-looking statements regarding future events or the future performance of the Company including statements about possible future developments regarding clinical, regulatory, commercial, financial, and strategic matters. Actual events or results, of course, could differ materially. We refer you to documents Exelixis files from time to time with the Securities and Exchange Commission and in particular, the Company's quarterly report on Form 10-Q filed today.

The 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 statement, including without limitation, the availability of data at the referenced times, risks and uncertainties related to the initiation conduct and results of clinical trials, risks and uncertainties related to the regulatory approval processes and compliance with applicable regulatory requirements, Exelixis' ability to maintain its rights under collaboration, the sufficiency of Exelixis capital and other resources, and market competition. With that, I will now turn the call over to Mike.

Thank you, Susan, and thanks to everyone for joining us on the call today. We had a busy third quarter and I'll take a few minutes to review the three key drivers of our business before turning the call over to Debbie and Gisela for a detailed review of our financial and development highlights.

First, the enrollment in METEOR, our phase 3 pivotal trial in metastatic second line RCC, is nearly complete. We are now confident that we'll meet our enrollment goal of 650 patients in the coming days, which allows us to be more specific about our timelines for when we expect the study to read out. We now expect top-line results for the trial's primary endpoint, progression-free survival, in the second quarter of 2015. Gisela will provide more details in the development update section of today's call.

Second, we continue to be pleased with the development and regulatory progress made with cobimetinib and our partners Roche and Genentech. The positive phase 3 results from the coBRIM pivotal trial evaluating cobimetinib in combination with vemurafenib in first line BRAF mutant positive metastatic melanoma were recently presented at ESMO. Based on these data, Roche has completed the MAA filing for the combination of cobimetinib and vemurafenib in the EU.

In the US, cobimetinib has received Fast Track Designation from the FDA, and Genentech expects to complete its NDA filing for the combination before the end of this year. We and our colleagues at Genentech continue to make progress in our US commercialization planning, including our involvement in the promotion of cobimetinib if and when approved. As a reminder, we are entitled to receive revenue from the profit share agreement in place for the US market and double-digit royalties on product sales outside of the US.

Third, in regard to the Company's financial guidance and cash position, we continue to expect to end the year with better than $200 million in cash and cash equivalents. Given our recent rapid actions to reduce operating expenses, we now expect that this cash position will be sufficient to support the business beyond the METEOR readout in Q2 of next year and through the end of 2015. This guidance assumes no receipt of additional funds from either business development or financing activities.

We also expect to exercise our option to extend the maturity date of the Deerfield notes from July 1, 2015, to July 1, 2018, as provided for by the January 2014 amendments to the note purchase agreement with Deerfield. We have until March 31, 2015, to exercise this option.

So with that, I'll close by thanking all of our fantastic employees, including those that have recently departed as part of a restructuring, for their steadfast efforts and support on behalf of patients with cancer everywhere. There's no doubt that we've had a challenging couple of months but our focus and urgency are unwavering as we move forward towards key milestones in the remainder of this year and throughout 2015. So with that, I'll turn the call over to Debbie.

Thanks, Mike. I am pleased to provide you with the highlights of our financial performance in the third quarter of 2014. I refer you to our press release and today's 10-Q filing for additional details. Net revenue for the quarter was $6.3 million consisting entirely of product revenue from the sale of COMETRIQ. Product revenue for the third quarter is net of a $1.8 billion project management fee due to our European distribution partner, Sobi, with an additional $600,000 expected to be recorded in the fourth quarter of this year.

These fees are tied to our expectation that they will have purchased a targeted amount of COMETRIQ by the end of 2014, and beyond that, there are no further fees of this nature expected in the future. Despite the unusually large offset for Q3 2013, COMETRIQ net sales increased 32% over the same period last year. Sales growth in the US was driven by increases in treated patients as well as extended treatment duration per patient.

R&D expenses for the quarter were $43.6 million versus $47.4 million for the same period last year. The decrease of $3.7 million in R&D expenses in primarily due to cost saving initiatives we launched following the negative COMET-1 results that we reported in September. The savings are primarily due to personnel related expenses, in particular, the reversal of the Company's bonus accrual for 2014 and a reversal of stock-based compensation expense previously recognized in connection with the performance options issued in anticipation of positive COMET-1 data.

SG&A expenses were $9.9 million for the quarter versus $13.6 million for the same period last year. The decrease of $3.7 million as compared to Q3 last year was primarily due to lower professional fees including lower patent costs, lower personnel related savings similar to the R&D personnel expenses I spoke about, and lower consulting costs. These cost savings were offset in part by precommercial preparation expenses due to Roche/Genentech in connection with our share of the cobimetinib co-promote expenses.

Restructuring charges were $3.8 million for the quarter, versus $100,000 for the same period last year. The restructuring charge for Q3 2014 was particularly related to employee termination benefits and asset impairment charges resulting from the restructuring plan initiated in the September 2014. Total operating expenses for the quarter were $57.9 million. The decrease of $3.5 million as compared to Q3 of last year reflects the changes in R&D and SG&A I spoke about, offset by the increases to the restructuring expenses.

Further income and expense, we incurred a net expense of $11 million compared to $11.2 million in Q3 last year. Included in the 2014 amount is $7.5 million of non-cash interest expense related to the accretion of discounts on both our convertible senior subordinated notes and financing arrangements with Deerfield. We ended the quarter with $293.5 million in cash.

I will provide you with an update of our financial outlook for the remainder of 2014. As Mike stated, with regard to our cash guidance, we are maintaining our guidance to end 2014 with greater than $200 million in cash, and further expect that will provide sufficient financial resources to support our business through the full year of 2015.

With regard to operating expenses, we are tightening our previously provided guidance of $250 million to $280 million and now anticipate the full year 2014 operating expense will be in the range of $250 million to $260 million. This range includes the employee termination benefits and asset impairments related to our restructuring activities but does not include any restructuring costs associated with potential building exits.

With that, I'll pass the call to Gisela.

Thank you, Debbie. I will my focus my cabozantinib development update on our phase 3 trials on renal cell cancer, prostate cancer, medullary thyroid cancer, and hepatocellular cancer. And per the press release we issued along with our earnings release today, I'll also provide an update on progress in our CTEP program evaluating cabozantinib in non-small cell lung cancer.

At the end of my remarks, I will provide a brief update on XL888, our wholly-owned HSP90 inhibitor, and it's being evaluated in BRAF mutated malignant melanoma in combination with vemurafenib. As you know, we are intensely focused on exploring and ultimately expanding the cabozantinib opportunity across multiple cancer indications.

They have a broad strategy in place for evaluating the compound in a variety of indications. Using internal resources to support phase 3 trials, and working in partnership with a wide array of individual physicians and cooperative groups through our collaboration with the National Cancer Institute's Cancer Therapy Evaluation Program, or CTEP, and an investigator sponsored trial program to enable evaluation of cabozantinib in earlier stage exploratory trials.

So starting with renal cell cancer, or RCC , the completion of enrollment in our phase 3 trial METEOR is the company's highest priority in 2014. Top-line data for the primary endpoint of PFS are expected in 2015. I am pleased that involvement in the study has proceeded very well. The trial was initiated about 15 months ago and is now nearing completion of enrollment.

Patient screening has stopped recently and the last patients are now entering the study. So we expect to complete enrollment of the required 650 patients within the next two days. I'd like to briefly review the trial design and assumptions for you. The study is evaluating cabozantinib versus everolimus in a randomized open label fashion. The patient population is second or later line metastatic clear cell renal cell cancer.

Patients must have received and failed at least one prior VEGFR tyrosine kinase inhibitor. And enrollment is stratified by the number of prior VEGFR inhibitors received, one prior therapy versus more than one prior therapy, and risk factors according to the MSKCC classification. The primary endpoint is progression free survival, or PFS, and secondary endpoints include response rate and overall survival. PFS is assessed by an independent radiology committee that is blinded to the treatment assignment of the patients.

650 patients will be involved in the study. The primary analysis is based on the PFS observed among the first 375 patients involved. This will ensure sufficient follow-up and a PFS profile that is not rated predominantly towards early PFS events, which could happen if the whole study population of 650 patients that is required for the assessment of overall survival served as the denominator for the PFS analysis.

The 375th patient was enrolled in June 2014 and the median patient and this group was enrolled in early Q2 2014. Under the assumptions of the trial, with an assumed five month median PFS on everolimus, and an assumed 7.5 months median PFS for the cabozantinib arm, we now anticipate that top-line data for PFS will be available in the second quarter 2015. Given the rapid progress in the trial, the team is highly focused on collecting the data and preparing for an analysis of the primary endpoint in this time frame.

Now moving on to CRPC, we are working on the full analysis of the COMET-1 study for which we have announced top-line results in September showing that the study had not met its primary endpoint of improving overall survival, but that progression free survival was improved for cabozantinib compared to prednisone. We anticipate presenting a complete analysis at an upcoming conference in 2015.

COMET-2, our second phase 3 study in CRPC, stopped patient enrollment in September, and we continue to expect top-line data for COMET-2 before the end of this year. This study is assessing pain response comparing cabozantinib versus mitoxantrone/prednisone in metastatic CRPC patients who have previously received docetaxel and abiraterone and/or enzalutamide and then suffering from moderate to severe pain due to metastatic bone lesions despite narcotic medication.

Once all data from COMET-1 and COMET-2 are available, we will formulate our regulatory strategy CRPC, if any. Now moving on to MTC. EXAM is our phase 3 study in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer that compared cabozantinib versus placebo. EXAM results led to the full regulatory approval of COMETRIQ for patients with progressive metastatic MTC in the United States in late 2012, and to conditional approval in the EU in early 2014.

The approvals were based on the results of the primary endpoint of progression free survival showing a 2.8-fold longer median progression free survival for the cabozantinib arm compared to placebo. At the time of the PFS analysis in October 2011, the study was unblinded and placebo patients were allowed to receive other available therapies. Overall survival is a secondary endpoint that was to be analyzed once a total of 217 death events 217 had been reached.

With an additional three years of follow-up, the 217 death events required for the analysis have recently been reached and top-line final results for OS are now available. These data are in line with what has been previously seen in an interim analysis for overall survival in 2012. The estimated median overall survival for the cabozantinib arm was 26.6 months and 21.1 months for the placebo arm for an HR of 0.85 and a p-value of 0.2409, which is not statistically significant.

It is important to remember that given the rare patient population, the study overall was relatively small for the assessment of overall survival. The study had 80% power to detect a 50% improvement in overall survival with statistical significance. Additionally, more placebo patients than cabozantinib patients received subsequent anticancer treatments including tyrosine kinase inhibitors and cabozantinib itself after unblinding of the study and as cabozantinib became commercially available.

Such subsequent treatments may have muted between arm differences in the setting where OS is relatively long despite the requirement for progressive disease at study entry. Pre-specified subset analyses included RET mutational status. RET is a tyrosine kinase that is frequently mutated in patients with medullary thyroid cancer. Of particular interest in MTC is the most frequent RET M918T mutation which is present in 40% to 50% of the population.

This mutation is generally associated with a poor prognosis in MTC. The subset analysis among subjects positive for RET M918T mutation showed a large and statistically significant overall survival benefit of 25.4 months with median overall survival for the cabozantinib arm of 44.3 months and a median overall survival for the placebo arm of 18.9 months for an HR of 0.60 and p value of 0.026. Patients in the RET M918T negative for unknown subgroups showed no detriment in overall survival for cabozantinib.

Overall, the outcome of the survival analysis supports the previous data on progression free survival showing a benefit for cabozantinib. The 5.5 months improvement in overall survival in the total population is clinically relevant although it did not reach statistical significance. Overall survival benefits was most pronounced in the sub group of patients with a RET M918T mutation, which represents about 40% of the patients involved in the study.

We intend to submit these results to both the US FDA and EMA in the first half of 2015 as part of our post marketing commitments. This may potentially lead to labor updates in the future. And lastly regarding the phase 3 studies, an update on HCC. Our CELESTIAL trial in second line HCC patients who received prior sorafenib comparing cabozantinib versus placebo is also proceeding well.

It is actively enrolling globally and is designed to enroll 760 patients randomized in a 2 to 1 ratio to cabozantinib versus placebo and the primary endpoint is overall survival. So in summary, we are making progress towards our key goals for cabozantinib: OS results for EXAM in MTC are now available; results from COMET-2 are expected before year end; and enrollment for METEOR is coming to a close soon, positioning us for top line data in the second quarter of 2015.

The last point on the cabozantinib program is on the IST/CTEP program: . We are now beginning to see data from CTEP program and of particular interest are the randomized phase 2 studies CTEP has initiated in the cooperative groups in 2012.

The first study to report our data is the ECOG/ACRIN study E1512 which is a randomized phase 2 trial designed to enroll patients with second or third line EGFR wild-type non-small lung cancer who have failed at least one prior chemotherapy. Patients were randomized 1 to 1 to 1 to receive erlotinib, cabozantinib, or erlotinib plus cabozantinib.

The primary objective of the trial is to determine whether single agent cabozantinib or combination therapy including cabozantinib and erlotinib extends progression free survival when compared to single agent erlotinib for this patient population. Secondary objectives include estimation of overall survival, best objective response, and toxicity.

The total required sample size for randomization was 117 patients. Using an overall one-sided 0.10 level log rank test, the trial was powered at 90% to show a 100% improvement in the median PFS of 2.4 months on erlotinib alone to 4.8 months on cabozantinib alone or on erlotinib plus cabozantinib. The number of PFS events needed to achieve this power for each comparison is 58 events.

Earlier this year, 125 patients were randomized in E1512 to one of the three arms: erlotinib, cabozantinib, or the combination of erlotinib and cabozantinib. Very recently, we were informed that during a pre-planned interim ECOG-ACRIN Data Safety Monitoring Committee analysis for futility, it was found that the trial met its primary endpoint of improving progression free survival with cabozantinib alone, and also with the combination of cabozantinib plus erlotinib, as compared to erlotinib alone.

And the results were highly statistically significant. Safety data were consistent with those observed in other trials of cabozantinib. At the time analysis, the median follow-up was 5.9 months and overall survival data were immature. We cannot share the details of the data today in order to preserve the ability for presentation of this phase 2 study at an upcoming scientific conference.

We are excited about the outcome of this study and about working with the investigators on potential future studies. We look forward to updating you on the progress as well as more study details in different timelines.

Now before handing the call back to Mike, I'd like to briefly update you on XL888, another wholly-owned compound that was discovered by Exelixis. XL888 is a small molecule oral HSP90 inhibitor. Several years ago, we had conducted a single agent phase 1 study with XL888.

Given the subsequent prioritization of our cabozantinib program, the development of XL888 was paused until investigators from Moffitt Cancer Center requested access to the compound in order to initiate an investigator-sponsored phase 1 trial evaluating the combination of vemurafenib and XL888 in malignant melanoma.

This study was based on preclinical evaluation of the activity of XL888 in vemurafenib-resistant malignant melanoma models conducted by researchers at Moffitt. While vemurafenib is clinically active in metastatic BRAF V600 mutant melanoma patients, resistance development is common. Multiple resistance mechanisms involve HSP90 clients such as BRAF and the preclinical data showed abrogation of resistance to the treatment with the HSP90 inhibitor to date.

We have recently been notified that the results of the phase 1 IST of XL888 and vemurafenib in patients with metastatic melanoma will be presented as a late-breaking oral presentation at the Society for Melanoma Research in mid-November in Zurich, Switzerland. Also, given the successful outcome of the phase 3 coBRIM study of vemurafenib and cobimetinib, the Exelixis discovered MEK inhibitor that was presented at ESMO in Madrid last month, a Moffitt team is now planning a phase 1 triple combination of vemurafenib, cobimetinib, and XL888 in patients with metastatic melanoma.

We look forward to keeping you up to date on the progress of this compound. And with that, I will hand the call back over to Mike.

All right. Thanks, Gisela. I'll keep my closing remarks brief so we can get your questions next. While the third quarter of this year was clearly a challenging time the Company, we moved decisively and rapidly to effect the change necessary to focus all of our resources on the next significant driver for the business, that is the readout of the METEOR study now expected in the second quarter of 2015.

We have other milestones on the horizon between now and then including potential regulatory progress with cobimetinib, and we look forward to updating you on this progress. So we'll stop here and I thank you again for your interest in Exelixis and we're happy to open the call for questions.

(Operator Instructions)

Edward Tenthoff.

Okay, great. Thanks for the update on all the programs, including cobi as well as our cabozantinib and the other programs. I guess my question has to do a little bit around the erlotinib data, and please take this in the right way because we've seen multiple phase 2 hits here, if you will, that then we see move into phase 3 studies where we don't see necessarily the study read out positive.

So what is it that we need to do or that we need to see to replicate some of these phase 2 findings to get some -- to get a win with cabo, for example, in lung cancer as we just saw the top-line data or some of the other indications that might crop up from the CTEP studies?

Yes, thank you. The study results were just very recently shared with us by ECOG-ACRIN so we can't really discuss the data in detail at this point in time, and it will take a little while to digest the data and discuss further plans, if any, as we go forward with and speak with the investigators about the data.

Hey, Ted. It's Mike. I think it's probably best if we delay answering that question, which is a good one, until we actually have a data available to be presented. I think in that context, once you see the data, it'll make that next discussion of what we do next, how we operate next trials, I think a much more relevant discussion

Fair enough. When should we should we expect that?

I think it's up to the investigators to figure that one out. Again, the data is relatively fresh so once we know and they make that public, we'll share that with you.

And then just this last question, if I may. On cobi, what are next steps and when should we anticipate that filing?

So next steps are, as I mentioned in the prepared remarks, is to have the filing completed with the FDA and Genentech and Roche continue to guide that will happen in 2014. So that's our expectations. We are having very good discussions with them around kind of precommercial launch type activities in discussions and as we know more and as we can say more based upon their public announcements, we'll share that with you as well.

Great. Great, I appreciate it, Mike. Thanks so much.

You bet. Thank you.

Eric Schmidt.

Thanks for taking my question, and thanks for all the updates. Maybe just on COMET-1, you've had the data now for a few months. Is there anything you've learned by going over the results that can help you understand, maybe the shortcomings of the trial design or the drug and make you think differently about it or might be applicable to how you conduct BDR going forward?

Yes, I think it's fair to say, we're still working through the data to launch trial basically and a lot of data coming in. I think but we've said in the past, it's holding true to the state and that is that the cabozantinib arm performed very much in line with what is expected from the prior experience in the non-randomized extension study.

The placebo arm performed better than anticipated, and we're looking at all the aspects of subsequent anti-cancer therapy, et cetera, and that could have contributed to that. And we're anticipating that we will present full data at an upcoming meeting in 2015.

And then on EXAM, do you have the data broken out for these non-RET mutant subsets? Was there any trend in survival in that group and if not, should the drug only be reserved for RET mutant patients?

So, the group that did the best in the subset analysis is the RET 918T subset, and that is consistent with what has been observed in the interim analysis, be as well. And the survival difference between treatment arms was 25.4 months, quite considerable for this 40% of the patient population.

In the other subgroups, we did not see decrement in overall survival, and as you know, the drug was approved on the basis of progression free survival, received full approval in the United States and the progression free survival was quite pronounced at a 2.8 fold between treatment arms. So that holds true still.

So I think most striking to us is the market gain and overall survival in the RET 918T population. In terms of your question, should patients be tested prior to receiving the drug, that is currently not the standard and not in the United States and not in Europe. That is being done for research purposes mainly, but not for clinical trial decisions and that's an evolving field I would say.

And then as you look toward METEOR, again, I know the primary endpoint is PFS, but in your discussions with the FDA, is there do you think a need to show either a trend or statistical significance on the survival of secondary endpoint?

So progression free survival, as you know, has been the basis of approval for many drugs and several drugs in renal cell cancer, and we have certainly had discussions with FDA and other regulatory bodies and found that to be acceptable. We are following patients for overall survival and the expectation in the -- of the regulators and our hope is that there will be no decrement and that is the package that would go forward.

Thanks very much.

Brian Klein.

Hi, guys. Thank you for taking my questions. So first on the lung cancer trial, which you just reported some positive data on, just wondering how relevant is the usage of Tarceva in the wild-type second line in end plus population and how frequently is Tarceva being used in that setting?

So Tarceva is approved regardless of the status in terms of EGFR mutations and was in the basis of BR.21. I think it's fair to say in the second line and later line setting of EGFR wild-type non-small cell lung cancer patients, multiple agents are being utilized and those include the traditional agents such as docetaxel or Alimta or Tarceva, for that matter. And in terms of the frequency, I couldn't quote that off the top of my head.

Okay. I'm wondering how relevant is that comparator arm in the current treatment paradigm?

I think it's one of the main treatments utilizing the population. So it is a relevant comparison, and there are others such as docetaxel that perhaps resulted in similar progression free survival duration as has erlotinib.

Okay, and then just following up on Eric's question. Given prior experience with tivozanib, AVEO's compound, which showed a positive PFS benefit within an overall detriment in survival, has there been any specific communication with the FDA regarding survival data at the time of the submission? Would that be required for you to file your NDA in renal cell pending positive PFS data?

So the plan is the overall survival, much like for the EXAM study, the overall survival data would be mature much later than the PFS stage it would be. So the expectation and the discussed avenue forward is that this trial was (technical difficulty) interim analysis at that point in time for overall survival and that would be part of the package.

Also importantly, I think as you know, there is no crossover built into this study as patients progress. So there is no systematic crossover as was done in the TIVO trial.

Did that answer your question? Operator, can we go ahead and have the next question then please?

John Sonnier.

Thanks for taking the question and thanks for the update. It sounds like its early days with the lung data, so I will stick to what is more of a design question, Gisela. It's really around the use of the log rank test, and was the determination to use that methodology based on the small cohort sizes, A And B, do you know if they ran other statistical tests to confirm significance?

The log rank test is a commonly used statistical methodology, and the 0.1 cutoff is a commonly used cutoff in phase 2. Obviously, the hurdle in phase 2 is a little bit lower than in phase 3, so as to come to a conclusions with the smaller sample size.

Got it. Okay. That's kind of what I thought, and do you know whether or not they ran other tests? I mean it might have been interesting to look, for example, the two monotherapy arms on a t-test just to see if the p-values were close?

The details of the data aren't -- we are not privy to at this point in time, so these details would be revealed I think and discussed in future presentations.

Okay. And the only other observation, and it might be one you can comment on from a biological standpoint was, if I am reading this right, this exponential survival analysis, it looks like there was just a lack -- a complete lack of interaction when the two drugs were combined, at least on that outcome. And the question is whether or not that would have been expected.

So what you are referring to is depicted in both arms, the cabozantinib single agent arm and the combination showed a highly statistically significant benefit over the -- . (multiple speakers)

Well, 4.8 months, right, it looks like when you did the -- .

It was the assumption. Right. That was the assumption going in.

That's the assumption going in?

Yes, that was the design assumption going in. That's not the real data. That's the design assumption going in.

Got it. Okay. Thanks for the clarification.

Sure.

Biren Amin.

Thanks for taking my questions. I just wanted to ask some questions around COMET-2. How many patients were enrolled when the study was halted in September? And you make a statement saying that there may be path forward depending on totality of data, I guess. What type of a situation would that be? Thanks.

So in terms of the numbers of patients, we haven't communicated details in the study. We would anticipate doing so when we actually come to data before the end of the year when we have a top-line outcome of the study.

Regarding the package that might or might not support regulatory pause, I think it's a little bit premature to say, but just prefer to wait for the data and then assess the totality of the data and go forward and determine a regulatory path, if any really.

Okay. And then, Mike, maybe a question on XL888. How do you think about this compound strategically? Would you try to develop this on your own or would you look for a partnership?

Yes. So it's certainly a very interesting compound we've have had in our stable of compounds for a few years now. We are certainly excited about having the data come out in a few weeks in Zurich. I think it's probably best to answer that question once we have the data out, but certainly we are looking at all options and considering a number of different pads for that compound.

Great. Thanks.

Terence Flynn.

Hi. Thanks for taking the questions. Maybe one on cobi and one on cabo. So on cobi, just wondering in terms of the sales force sizing that you are thinking about as you head into next year and just wanted to be sure that was inclusive of your comments with respect to cash usage.

And then the question on cabo is with respect to the lung cancer trial, I know you can't give a lot of details here obviously, but can you tell us if the combo arm was better than cabo mono arm? Thanks.

Yes. Again, I will answer the second question first. We can't provide any additional details on the ECOG lung study until that data comes out. So appreciate the question, just bear with us. In terms of the cobi question, again the details of the plans around launching commercialization, we will get those out to you once again, following Roche's lead around communicating the plans for sales force sizing, those kinds of things.

That being said, we have taken into account in terms of the guidance we gave today for 2015, I think a pretty healthy basis for the cobi expenses as well. So we think we have that covered and we'll go from there.

Thank you.

(Operator Instructions)

Michael Schmidt.

Hi, it's actually Jonathan Chang stepping in for Michael Schmidt. Thanks for taking my questions. First for the E1512 trial, can you tell us about any biomarker analysis that was conducted in the trial, for example, was RET mutational status evaluated?

So there are a biomarker program associated with this study, in particular as it relates to MET and data with regard to that will be presented at a future date.

Great. And then lastly on cobimetinib. Are you considering or have you considered monetizing your stake in cobimetinib? Thanks.

Yes, it's Mike. Yes, our position right now is to move forward with a co-promote. We think it's a very valuable assets, not only in the context of the combination with vemurafenib in this first melanoma indication, but certainly looking at the broader program that Roche and Genentech are pursuing, including a combination with their PDL1 antibody.

So we are excited to have a second compound. In the mix here, we are looking forward to having the NDA filed by Genentech in the US in 2014 and then to push forward with hopefully commercializing the drug and being involved in that promotion in 2015.

Operator, do we have any more questions?

At this time, there are no further questions. Now I would like to turn the call back over to today's host, Ms. Susan Hubbard. Ma'am?

Okay. Thank you very much and thanks everybody for joining us today. We appreciate all of your calls and your attention and we are happy to take any follow-up questions that you may have after we conclude this call.

Ladies and gentlemen, that concludes today's conference. Thank you so much for your participation. You may now disconnect. Have a great day.