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Exelixis, Inc. (NASDAQ:EXEL)

Q1 2014 Earnings Conference Call

May 1, 2014 5:00 PM ET

Executives

Susan Hubbard – IR

Michael Morrissey – President and CEO

Frank Karbe – EVP and CFO

Gisela Schwab – EVP and Chief Medical Officer

Peter Lamb – EVP, Discovery Research and Chief Scientific Officer

Scott Garland – EVP and Chief Commercial Officer

Analysts

Ted Tenthoff – Piper Jaffray

Eric Schmitt – Cowen and Co.

Joel Sendek – Stifel Nicolaus & Co.

Whitney Ijem – JPMorgan

Biren Amin – Jefferies & Company

Richard Resnick – William Blair & Company

Michael Schmidt – Leerink Partners

Operator

Good day ladies and gentlemen and welcome to the Exelixis’ First Quarter 2014 Financial Results Conference Call. My name is Britney and I’ll be your operator for today. As a reminder this call is being recorded for replay purposes.

I would now like to turn the conference to your host for today Ms. Susan Hubbard, Investor Relations. Please proceed.

Susan Hubbard

Thank you, Britney and thank you all for joining us for the Exelixis first quarter 2014 financial results conference call. Joining me today are Mike Morrissey, our President and CEO; Frank Karbe, our CFO; Gisela Schwab, our Chief Medical Officer; Peter Lamb, our Chief Scientific Officer; and Scott Garland, our Chief Commercial Officer who will together our corporate financial development and commercial progress for the quarter-ended March 31, 2014 as well as providing specifics around the priority activities for the year.

As a reminder we are reporting our financial results on a GAAP basis only and as usual the complete press release with our results can be accessed through our website at exelixis.com.

During the course of this presentation we will be making forward-looking statements regarding future events or future performance of the company, including statements about possible future developments regarding clinical, regulatory commercial financial and strategic matters. Actual events or results of course can differ materially. We refer you to the documents on file with the Securities and Exchange Commission and in particularly the company’s quarterly report on Form 10-Q filed today.

These documents contain and identify under the heading Risk Factors important factors that could cause actual results to differ materially from those contained in any forward-looking statements including the availability of data at reference times, risk and uncertainties related to the initiation, conduct and results of clinical trials, the risk that unanticipated developments could adversely impact the launch, commercialization, distribution and availability of COMETRIQ, the degree of market acceptance of and reimbursement for COMETRIQ, risk and uncertainties related to compliance with applicable regulatory requirements and market competition.

With that I’ll turn the call over to Mike.

Michael Morrissey

All right, thank you, Susan and thanks to everyone for joining us on the call today. The first quarter of 2014 was a busy and productive one for Exelixis. I’ll take a few minutes to review several key milestones and then turn the call over to Frank, Gisela, Peter and Scott for a review of our financial, cabozantinib, cobimetinib and commercial highlights.

First, we achieved a key regulatory milestone during the quarter. At the end of March the European Commission approved COMETRIQ for the treatment of adult patients with progressive unresectable locally advanced or metastatic medullary thyroid carcinoma or MTC. Although this is a small commercial indication, this achievement is still notable for European patients with metastatic MTC. We are one step closer to gaining access to an important and novel treatment option. This is a constant driving force behind everything we do at Exelixis to advance the care of patients living with cancer on a global basis.

This also marks the first European approval of an Exelixis’ compound demonstrating our growing in-house capabilities to navigate regulatory pathways effectively on a global scale. This critical scale will serve us well as we advance the cabozantinib clinical development program in other tumor types and potentially it’s commercialization in other indications. And as previously discussed EU marketing for COMETRIQ in metastatic MTC will be coordinated by Sobi. Scott will speak to the details of that collaboration and our near term plans shortly.

The COMET 1 study also reached an important clinical milestone. The interim analysis was completed in March and the Independent Data Monitoring Committee or IDMC recommended that the study continue to the final analysis. Advancing COMET-1 to the final analysis doesn’t change our confidence or plans for cabozantinib in metastatic CRPC. Exelixis as a whole and specifically our COMET development team continues to do their work with great urgency and focus. Anticipate achieving events required to conduct the final analysis in 2014. We will be prepared to move quickly and decisively once we have that final data in hand.

Beyond COMET-1, the COMET-2 study evaluating cabozantinib in pain [palpitation] is another important part of the story that will add significantly to our understanding of the drug’s potential utility for patients with metastatic CRPC.

Looking at COMET-1 and COMET-2 together, we expect if the results are positive that the data will clearly differentiate cabozantinib from other agents in prostate cancer. We expect top line results from both Phase 3 pivotal studies in 2014 and we are taking action now to be ready to advance our global regulatory filing plans expeditiously. Gisela will provide more color on the COMET program as part of her development update.

Before I close my – I would like to share a few thoughts about promising developments in the cobimetinib program. As you know cobimetinib is a selective MEK inhibitor discovered at Exelixis and being developed by our partner Roche Genentech. In the pivotal coBRIM clinical trial cobimetinib is being studied in combination with vemurafenib in first line BRAF mutant positive metastatic melanoma.

Based on information provided during their recent earnings call Roche continues to expect top line data in 2014. They also announced that data updates from the Phase 1b BRIM7 study will be presented at two oncology conferences over the next month. We’re pleased with the progress being made in the development of this promising new agent. Peter will provide more details about the cobimetinib program and the general competitive landscape in this area later in the call.

So with that I’ll turn the call over to the team for more detailed update on our progress over the quarter. I will return at the end of our prepared remarks to sum up and close the session by reviewing our top priorities for 2014. So Frank’s up first to review our financial results for the quarter.

Frank Karbe

Thanks Mike. As usual I will focus my comments on the highlights of our financial performance in the quarter and refer you to our press release and today’s 10-Q filing for additional details. Net revenue for the quarter was $4.9 million, which was entirely related to the sale of COMETRIQ. The decrease of $4.8 million as compared to Q1, 2013 is due to contract and license revenue of $7.8 million in Q1 of last year. Net revenue from the sale of COMETRIQ year-over-year in fact increased by $3 million reflecting that COMETRIQ had only been launched at the end of January last year.

R&D expenses for the quarter were $54.8 million. The increase of $22.1 million as compared to Q1 last year is predominantly attributable to increases in clinical trial related expenses by approximately $18 million. About 70% of this increase relates to METEOR, our Phase III study in RCC. These increases are driven predominantly by two factors; one a significant increase in activity for the study. Remember that we only began enrolling patients in Q3 of 2013, and two the inclusion of approximately $7.5 million in expenses for the purchase of comparative drug.

The remaining increase in clinical trial expenses relates mainly to the progress of our other Phase III studies, namely the two COMETs and CELESTIAL as well as increases in CMC related expenses. The remainder of the increase in R&D expenses to the most part reflects higher personnel expenses which were also associated with supporting our various Phase III studies. SG&A expenses were $14.7 million for the quarter. The increase of 4.1 million as compared to Q1 last year was mainly driven by higher personnel expenses primarily due to our expansion of our sales force, higher stock-based compensation expense as well as an increase in expenses for Cobimetinib under our collaboration agreement with Roche-Genentech.

Total constant expenses for the quarter were $69.9 million. The increase of $26.2 million as compared to the first quarter last year reflects the increased R&D SG&A expenses mentioned a moment ago.

For other income and expense, we incurred a net expense of $9.6 million for the quarter. The decrease of about $1.1 million as compared to Q1 2013 mainly reflects a gain associated with the mark-to-market valuation of the new Deerfield warrants issued in Q1 of this year. As in previous quarters I would like to note that $7 million of the interest expense incurred in the first quarter reflects non-cash charges.

Regarding our cash position we ended the quarter with approximately $408 million in cash. This cash balance includes net proceeds of approximately $76 million from our stock offer in Q1 of this year. It is also worth noting that in addition to funding our non-operating activities in Q1 we satisfied the second and final $10 million mandatory early debt repayment under our issued notes, and we purchased comparative drug for METEOR, our Phase III study in RCC of approximately $7.5 million.

I will comment briefly on our financial outlook by saying that our financial guidance for full year 2014 remains unchanged. We continue to expect total cost and expenses and their rent of $250 million to $280 million and we anticipate to end the year with greater than $200 million in cash. Our outlook for the length of our financial run way also has not change and we continue to be confident that our run way extends speed out of the trial in RCC.

Finally Mike touched upon the promising development in the Cobimetinib program. And we thought it would be helpful to explain our deal with Roche-Genentech on this compound. In the U.S. we have a profit share arrangement that has multiple tiers. We are entitled to 50% of profits from the first $200 million of U.S. actual sales decreasing to 30% of profits from U.S. actual sales in excess of 400 million. For ex-US net sales we are entitled to low double digit royalties. Let me also remind you that as part of this world wide collaboration agreement Exelixis exercised its option to co-promote Cobimetinib with Genentech in December of 2013 entitling us to field up to 25% of the U.S. sales force. Finally Exelixis does not pay any expenses associated with the ongoing or future development of this compound.

With that I’ll pass the call on to Gisela for development update.

Gisela Schwab

Thank you, Frank. In the next few minutes I will provide an update on the progress of the development program for Cobimetinib. Our clinical and regulatory effort is intensely focused on expanding the Cobimetinib opportunity across multiple indications. As we’ve discussed previously we have a broad strategy in place of evaluating the compound in a variety of indications. We use internal resources to support Phase III trials and also work in partnership with a wide ray of individual physicians and cooperative groups through our collaboration with the National Cancer Institute’s cancer therapy evaluation program or CTEP and in investigative sponsored trial program.

Our highest priority for 2014 is preparation for a data read out and potential filing for advanced metastatic castration-resistant prostate cancer. So I will start the update with our ongoing COMET trials which are our two Phase III pivotal trials in MCRPC. As you know COMET-1 a randomized study of Cobimetinib versus prednisone is focused on the assessment of overall survival as the primary end point and COMET-2 a randomized study of cabozantinib versus Mito/Prednisone is focused on pain response.

COMET-1 reached its enrollment target of 960 patients in September of 2013 and COMET-2 continues to enroll patients in the United States, the UK, Ireland and Australia. Consider together the basic objective of the COMET studies is to evaluate whether cabozantinib demonstrates a survival benefit and improvement of pain associated with bone metastasis. If this objective is achieved we believe this would differentiate cabozantinib from other agents used in the treatment of MCRPC.

As Mike mentioned earlier in March the independent monitoring committee or IDMC for COMET-1 has conducted the planed interim of our survival analysis for the study after 386 events have been reached. The IDMC had the following options at this interim analysis. They could have stopped the study for efficacy if pre-specified parameters had been met. They could have stopped the steady or recommended modifications if there had been safety concern. Or they could recommend that they stay continue unchanged.

As if the case with most interim analysis the COMET-1 IDMC recommended that the study continue to the final analysis without modifications. And as discuss summary the IDMC did not share any data with us and the study remains. The final analysis requires 578 events. Together with our CRO partner our internal team continues to be highly focused on data retrieval and we are fully prepared for a data read out in 2014.

In the meantime we are making all preparations for potential regulatory filings provided we obtain suitable results from the final analysis. We are looking forward to the final analysis given the previously presented extensive Phase II experience with cabozantinib and CRPC that had shown activity in this disease.

Let me touch on slightly briefly of the Phase II experience for cabozantinib in CRPC. The non-randomized expansion cohort had evaluated 144 patients who have all previously received and progressed on docetaxel and the majority of whom had also received additional prior systemic therapy. Therefore this was the patient population similar to the one involved in COMET-1. In this advanced patient population we observed a median overall survival of 10.8 months. Additionally clinically meaningful pain relief was reported by 57% of evaluable patients. Reductions or discontinuation of narcotic analgesics in 55%, Bone skin response in 63% and a reduction in measurable disease in 80% of evaluable patients.

The most common grade 3 or 4 adverse events were fatigue or/and hypertension. So in summary there was evidence of clinically meaningful activity that provided support for further evaluation of cabozantinib in the ongoing Phase III program including COMET-1 and COMET-2. Also it is important to remember that there are important examples of large randomized pivotal Phase III studies in CRPC where a statistically significant and clinically meaningful improvement in overall survival was observed at the final analysis although the trial did not meet the primary end point at the interim analysis.

The recent historical data in MCRPC is clear in this regard and provides some context for COMET-1. After six pivotal trials that generated positive and statistically significant overall survival data in MCRPC that ultimately resulted in regulatory approval only three of them met the primary endpoint at the interim analysis, including [COU-AA 301] for Abiraterone affirmed for enzalutamide and [inaudible] with radium-223.

The others including the TAX-327 study with Dr. Jacksaw, the impact study with [inaudible] and TOPIC with [Carbozitaxel] were shown to have significant and clinical meaning overall survival benefit at the final analysis and each represented an important clinical advance that led to regulatory approval in MCRPC.

Now turning to other important ongoing trials for cabozantinib. In addition, to the COMET study we are also actively working to evaluate the suitability of cabozantinib for use in the earlier line of treatment of CRPC patients prior to chemotherapy. And on our Phase III study in advance hepatocellular cancer and metastatic renal cell cancer. All of these studies are making good progress

The randomized Phase II study evaluating different doses of cabozantinib in combination with full dose abiraterone in CRPC patients prior to chemotherapy commenced in the fourth quarter of 2013 and is well underway. The Phase III study in hepatocellular cancer called CELESTIAL, this is 760 patient study in patients who have received prior sorafenib. CELESTIAL will compare the overall survival between patients treated with cabozantinib and those receiving placebo.

This study is actively enrolling patients in multiple continents. And our Phase III study in renal cell cancer which we call METEOR is a 650 patient randomized open-label study that is comparing cabozantinib with everolimus in patients who have received and progressed on or following at least one prior VEGFR tyrosine kinase inhibitor, i.e., second or later line therapy.

The primary endpoint is progression free survival and the secondary end point overall survival. This global study with balance accrual weighted towards Western Europe, North America and Australia is making very good progress. We now have nearly 90% of the sites activated and we are in the steep part of the curve for enrolment as a critical mass of sites are contributing to enrollment. The encouraging early phase data with cabozantinib in RCC, the design of the Phase III comparing cabozantinib with an active comparator, everolimus and the limited number of active competitive studies in the second or later line space in RCC have resulted in a high level of interest in this study.

We are encouraged by the enthusiasm for these trials in the medical community and the progress made to-date. Both Phase IIII studies are off to a good start and we hope to see top line data in RCC in 2015 and HCC in the 2016 or 2017 timeframe, following the COMET 1 and COMET 2 top line data that are expected in 2014.

Now to finish it is a great pleasure to share that on March 21, 2014 the European Commission has granted conditional marketing approval of COMETRIQ for the treatment of adult patients with progressive, unresectable locally advanced or metastatic, MTC. This follows the CHMP’s recommendation for approval. Additionally, the European Commission also followed the Orphan Drugs Commission’s recommendations to maintain Orphan Drug status for COMETRIQ in MTC in Europe. We are very pleased with achieving this important milestone and the news that COMETRIQ will now become available in the EU for patient with this devastating disease.

And lastly, a quick update on planned presentation of this year ASCO Meeting. For ASCO 2014 investigators have received notifications of acceptance for a total of nine presentations that span trial in progress presentations for our ongoing RCC and HCC Phase III studies and data presentations for studies from our very active ISP and CTEP and programs.

With this I will turn the call over to Peter, to discuss the progress made by cobimetinib.

Peter Lamb

Thank you, Gisela. I’ll provide a brief update on the landscape for the combination of RAF and MEK inhibitors in metastatic melanoma, since there have been interesting new developments regarding the GSK program and our upcoming presentation schedule of data from the BRIM-7 trial of cobimetinib and vemurafenib.

While note Novartis recently announced their intent to acquire the GSK BRAF and MEK inhibitors as part of larger deal involving GSK marketed and late stage oncology assets, I will have however still refer to them as GSK compounds in rest of my comments.

First, with respect to the GSK program, In January of this year GSK received accelerated approval for the combination of the RAF inhibitor, Dabrafenib and the MEK inhibitor, trametinib for the treatment of patients with unresectable or metastatic melanoma with the BRAFV600E or K mutation. Both the BRAF inhibitor and Trametinib have previously been approved as single agents in the same patient population based on the results of randomized Phase III trials where they demonstrated superiority to chemotherapy.

The accelerated approval for the combination was based on Phase I/II data that included a comparison of Dabrafenib, Trametinib with the Dabrafenib alone. I wouldn’t step through the data supporting the accelerating approval but it is provided on the accompanying slide for your reference.

In March GSK released top line data from a confirmatory randomized double-blinded Phase III trial comparing the combination of Dabrafenib, Trametinibto the Dabrafenib alone in the same patient population. The independent review committee audited data showed a progression free survival for the combination of 10.1 month versus 9.5 months for the Dabrafenib alone and then overall response rate of 61% for the combination versus 47% for the Dabrafenib alone.

The modest benefit for the combination seen in the study prompted the GSK to issue a deer healthcare professional letter allotting positions to these findings. We look forward to seeing more detailed data from this trial at ASCO which will enable us to mitigate the competitive situation in this rapidly area.

I’ll turn now to the cobimetinib development program and specifically to the BRIM-7 trial. As a reminder the BRIM-7 Phase Ib dose escalation study was designed to evaluate the safety and tolerability of cobimetinib in combination with vemurafenib in patients with advanced BRAF-mutated melanoma. Cohort for meta protocol specified critical for maximum tolerate dose or expanded included BRAF inhibitor – and BRAF progressing patients.

Our presentation at the European Society Medical Oncology Congress last full of an earlier covered data from Brim-7 demonstrated the – study was designed to measure efficacy the results showed an overall response rate of 5% in the BRAF inhibitor – patients with the medium progress free survival that not yet been reached with medium follow-up of ten months. Updated data will be published as part of an ASCO abstract but this drug metabolic tumor responses to cobimetinib vemurafenib are the first by FDD in the BRIM-7 trial. The abstract has been accepted for an oral presentation which is scheduled for June 2nd.

Note also that an update on the BRIM-7 trial is on the program of The European Association of Dermato-Oncology in Vilnius on May the 7th.

Moving on to the Phase III trial, just a quick reminder about the status of the coBRIM. coBRIM is the randomized double-blinded Phase III study of cobimetinib and vemurafenib versus vemurafenib alone in previously untreated BRAFV600 mutation positive patients with unresectable locally advanced metastatic melanoma. They have indicated that the trial has been fully enrolled on the top-line data are expected to be available this year.

Cobimetinib is subject of five additional combination studies driven in funded budget Genentech. We are pleased with the Roche-Genentech commitment to this program and look forward to sharing additional data with you as the compound continuous to progress.

I’ll now turn over the call to Scott who will wrap up with an update on commercial progress.

Scott Garland

Thanks Peter. It’s been over a year since COMET first launched commercial and we are pleased with the acceptance of the products in the U.S.. As we have said consistently in the past MTC is a small market opportunity and our commercial infrastructure is scaled appropriately with the size in the market.

Small scale size was enabled to make meaning traction and driving the uptick of COMETRIQ in the approved indication and the launch has been extremely viable for – already in commercialization expertise in a relatively low cost, low risk environment. This expertise will be in valuable in terms of helping us ramp our commercial organization quickly and effectively should COMETRIQ be approved for additional larger indications.

In addition to providing the usual revenue numbers today, I’ll be sharing some insides on treatment duration. Our treatment duration is still at the evolving metric given where we are in our launch we now have over years with the data on the market and we can analyze. I’ll share that with you in a moment but first let me cover the revenue numbers.

As you heard from Frank, total net COMETRIQ revenues were $4.9 million for Q1 representing a 13% increase compared to Q4 of last year. Similar to last quarter essentially all of COMETRIQ sales came from the U.S., net COMETRIQ sales in the U.S. were $4.8 million representing an 11% increase compared to Q4, 2013. U.S. revenues were positively impacted by increases in treated patients and treatment duration.

Let me spend a few minutes now focusing on treatment duration. What one typically sees in a new oncology drug launch and what was true for COMETRIQ is that a bolus of prevalent patients started COMETRIQ right after approval. These patients are typically sicker than average and do not stand drug for very long. Takes a few quarters for the patient kinetics to begin to normalize and what you start to see is average treatment duration ramp up. This happens for two reasons. One is that sicker bolus patients begin the drop of therapy and two is because the cohort of patients that will be on drug for a long time, a group I’ll call long duration patients begin to pull the average up.

The long duration patients form an important stable patient base for us to continue to grow revenues. In fact a he key focus for us has and will continue to be identifying appropriate first line MTC patients because these patients typically say on drug for a longer period of time. Another point that’s worth – that these long duration patients show that through effective modifications and adequate AE management, some MTC can remain on COMETRIQ for a relative long periods of time. Today average treatment duration for MTC patients currently taking COMETRIQ is approximately 7.5 months and continuous decline month over month.

About a quarter of these patients have been on drug for a year or longer. This is generally consistent with what we saw in our clinical studies. In EXAM 37% of patients were on drug for over a year. In the original Phase I 22% were on drug for two years and 11% of MTC patients were treated for five years. Of the 11 patients in our Phase I that were progression free for at least two years, 45% remained on treatment for a median of 4.5 years. When comparing the clinical data to use in the real world it’s important to note that duration is often longer in clinical studies because patients are monitored more closely.

Moving to Europe, now that we have the EMEA approval we’re busy working with Sobi, our distribution partner to launch COMETRIQ in the EU. We are finalizing reimbursement policies and we’ll begin submitting to submitting them to country reimbursement authority shortly. To gain pricing and reimbursement in Europe can be a time consuming process and we therefore expect Sobi to purchase a small amount of commercial product in May. We look forward to updating you on Sobi’s progress in rolling out COMETRIQ in the EU and their purchasing activities over the course of the year.

Finally we began to meet with Genentech to discuss the potential co-promotion of cobimetinib, if approved. It’s still too early to comment on specifics. But I can say that the conversations have encouraging. The opportunity to have a second oncology product to promote is an exciting one and not common for a company of our size. Having worked at Genentech for close to 10 years I feel confident that our co-promote relationship will be positive one. As always we’ll provide more specifics on the commercialization of cobimetinib when appropriate.

Now let me turn the call over to Mike.

Michael Morrissey

Al right. Thanks Scott. I’ll keep my closing remarks brief so we can get to your questions. As you heard from the team today, progress continues on all fronts and we’re on the critical path towards the very important set of milestones in 2014. I’ll conclude by reiterating our top priorities for 2014. First top line data readouts for both the COMET-1 and COMET-2 studies. Second working towards submitting regulatory filings assuming positive COMET data. Third, expediting enrollment from mid-year in second line RCC as our highest enrollment priority.

And fourth planning our commercial build out supporting the prostate cancer indications in the US and Europe pending positive COMET data. In addition we look forward to the Roche-Genentech release of the updated cobimetinib Phase Ib data from patients with advanced BRAF mutated melanoma at the EAD and ASCO conferences this quarter. And to the Phase 3 readout later this year. Collectively and individually we remain committed to our overall goals to bring new therapies to patients with cancer and build value for our shareholders.

I’ll end here with a note of sincere thanks to all of our great employees for their superb talents efforts and commitment in helping us meet our key goals and priorities. So we’ll stop here and be happy to take your questions. Operator.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). And your first question comes from Ted Tenthoff with Piper Jeffery Please proceed.

Ted Tenthoff – Piper Jaffray

Great, thank you. Can you hear me okay.

Susan Hubbard

We sure can, Ted, thanks.

Ted Tenthoff – Piper Jaffray

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

Gisela Schwab

Sure the interim analysis as we finally announced is both even driven analyses and the interim analyses occurred at the time they were projected it would occur. And regarding the timing for the final analysis we continue to expect that to occur in 2014.

Ted Tenthoff – Piper Jaffray

Okay, and can you just speaks to the toxicity profile that’s been seen with the Genentech combo of MEK, BRAF, how has you guys combo looked so far?

Peter Lamb

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

Ted Tenthoff – Piper Jaffray

We’re looking for to the data at ASCO and then the readouts later this year.

Operator

And your next question comes from Eric Schmitt with Cowen and Company. Please proceed.

Eric Schmitt – Cowen and Co.

Thanks for taking my questions. I’m sorry if I missed it. I didn’t hear any mention of the exam MTC overall survival update this year.

Gisela Schwab

Yes, Eric we are expecting to occur in 2014. Again this is an event driven analysis and we’re tracking events and will communicate data as soon as we have the analysis.

Eric Schmitt – Cowen and Co.

Okay thanks. And is there any way you would disclose the amount of outflow you spent on the – at the interim analysis just so we get a sense of how statistically significant the P value on COMET-1 needs to be at the final analysis.

Gisela Schwab

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

Eric Schmitt – Cowen and Co.

Can you quantify that Gisela?

Gisela Schwab

We haven’t done that, no.

Eric Schmitt – Cowen and Co.

Okay and Mike I guess I was intrigued by your statement that the fact that COMET-1 preceded the interim to the final analysis doesn’t change Exelixis’ confidence in the ultimate common study. Obviously the market feels differently, little bit disconnect here. Can you just give us your reasons why you think that nothing is changed?

Michael Morrissey

Just to be clear. I think you might have misheard me. What I said was confidence in the compound and our plans with the compound. We provided no, obviously no guidance on the outcome of the pivotal trail that is ongoing, right. So that being said our confidence in the compound is remains to be strong. I think we’ve got a very intriguing datasets in prostate cancer and renal cancer and liver cancer across a variety of other tumor type in Phase II. And obviously that needs to be confirmed in Phase 3. And that’s what the plan is with the broad program that is ongoing right now with the compound in five pivotal trails.

So we need data and we’ve been very clear about that. I think we’ve communicated in a very consistent and conservative fashion and that will continue going forward.

Eric Schmitt – Cowen and Co.

Sorry if I miss paraphrase. Let me probe on a maybe somewhat related topic. When you provided the interim analysis of these six successful pivotal studies in prostate cancer, those studies all have somewhat different designs for the interims then I can see when the three or four that hit the three to hit has different interim criteria. Can you talk about which of those other trials COMET-1 is may be most similar to, or which should be a most relevant comparison and why?

Gisela Schwab

I think it’s difficult to make inter trial comparisons because these studies enroll somewhat different patent populations and COMET-1 as you know is enrolling a patient population that has received and failed prior docetaxel and abiraterone and enzalutamide. So it’s a different populations from the other studies. And in terms of the design I think it is fair to say that the study is fully powered at 90% for the final analysis and for an HR and employees and the 578 events that is a completely powered analysis.

And as I said earlier on the interim analysis takes away very little of the alpha and for the final analysis. So I think we three of the studies appropriately designed and we look forward to the results in particular given the fits to results that refer to prior remarks.

Eric Schmitt – Cowen and Co.

Okay may be the last question on with switching topics to the METEOR trial and renal cell carcinoma, sounds like enrolments really moving ahead fairly rapidly there. What’s the next announceable event that you’ve just complete the enrolment?

Gisela Schwab

Yeah I think that would be the next announceable event correct.

Eric Schmitt – Cowen and Co.

And you are not going to speculate on when that might that happen yet?

Gisela Schwab

No, not at this time, no.

Eric Schmitt – Cowen and Co.

Okay. Thanks a lot.

Operator

And your next question comes from the line of Joel Sendek with Stifel. Please proceed.

Joel Sendek – Stifel Nicolaus & Co.

Thanks. On the COMET trials I am wondering what you guys might have done to guard against protocol violators in the control alarm. Obviously to avoid the possibility that they might have taken actions at some point to increase the survival and now. Can you give us any color that that didn’t happened or what you did to prevent that from happening?

Gisela Schwab

Yeah and I think number one, there is a number of mechanisms in place to ensure adherence to a trial protocol and obviously it’s agreed when the trial protocol and the investigators commit to executing the studies. In accordance with the trial protocol it’s monitoring ongoing on a very regular basis and we look at the information emerging from the study, so that would be pretty tough. And if new anticancer therapy started that would be a reason to discontinue people from this study, patients from the study so that’s not allowed. And may be most importantly the study is a blinded study right, so not patients and physicians cannot be sure of what drug they are on and they can be on cabozantinib or on Prednisone.

Joel Sendek – Stifel Nicolaus & Co.

Yeah okay. And let’s see and then on Sobi I am wondering what if you guys have any insight on the GSK compound and whether it’s your combination. You know what kind of penetrance the combination has relative to the single agent at all at this point.

Michael Morrissey

Joel, it’s Mike. We don’t right now have that level of visibility into the market dynamics. That may or may not change overtime but right now can’t really help you there.

Joel Sendek – Stifel Nicolaus & Co.

Okay and then last question now. Frank can you give us some sense of the amount of licensing revenue you have for the year?

Frank Karbe

You mean for 2014?

Joel Sendek – Stifel Nicolaus & Co.

Yes.

Frank Karbe

Zero. We’ve guided at the beginning of the year when we provided and at the end of last year we’ve said already that we’ve burnt through all of the deferred revenue from our past collaborations. And unless we hit some milestones or enter into new collaborations our revenue will be made up exclusively from the sale of products.

Joel Sendek – Stifel Nicolaus & Co.

Okay. Alright thank you.

Operator

And your next question comes from the line of Cory Kasimov with JPMorgan.

Whitney Ijem – JPMorgan

Hi, this is Whitney on for Cory today. Quick question on METEOR and CELESTIAL are there interim looks in those trials and if so is the timing you are giving for top line for the interim or the final?

Gisela Schwab

The general timing that I have mentioned is four to five analysis of the primary end point of the studies respectively. And remember for METEOR that’s PFS progression free survival and for CELESTIAL that’s overall survival. And whether or not there are to your fresh – not there interim analysis built in and celestial you had said interim analysis built in.

Whitney Ijem – JPMorgan

Got it. And then moving over to you and Sobi deal, in terms of how we should be modeling revenue from that or I guess the flow of revenues. Can you remind us of the structure of that deal?

Michael Morrissey

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

Frank Karbe

Another thing I would add is that for Europe we recognize revenue on a sell in basis while in the U.S. we recognized based on the sell through method.

Whitney Ijem – JPMorgan

Got it. Thanks for taking the questions.

Operator

And your next question comes from the line of Biren Amin with Jefferies & Company. Please proceed.

Biren Amin – Jefferies & Company

Yeah, thanks for taking my question. I was wondering if the company still plans on initiating a [Sandy Combo] trial later this year, and if so do you plan to wait for the COMET-1 read out before initiating the study? Thanks.

Gisela Schwab

Yeah we are working on the protocol and its funnel and or new funnel for that combination trial and we are planning on initiating start up activities later this year yes.

Biren Amin – Jefferies & Company

Would that occur before or after the COMET-1 read out?

Gisela Schwab

I didn’t – I can’t really comment on that right now we are anticipating for this activity to occur in the quarter three, quarter four timeframe.

Biren Amin – Jefferies & Company

Great, thank you.

Operator

And your next question comes from the line of Richard Resnick with William Blair. Please proceed.

Richard Resnick – William Blair & Company

Hi, guys, Rich Resnic for John. So a lot of questions that I had have been answered, but may be one for the potential for cabozantinib in liver cancer. There has obviously been a lot of new enthusiasm about the potential for new treatments in Hepatitis C which is a cause of cancer. I thought maybe you could share some thoughts on how you view this might impact the market opportunity for cabozantinib in liver cancer, thanks?

Gisela Schwab

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

Richard Resnick – William Blair & Company

Okay. Great thanks.

Operator

(Operator Instructions). And your next question comes from the line of Michael Schmidt with Leerink Partners. Please proceed.

Michael Schmidt – Leerink Partners

Hi good evening. Are you still planning to initiate the RAF positive non-small cell lung cancer studies here?

Gisela Schwab

Yes, this study is also fully developed and we are anticipating for these start-up activities to occur in the second half.

Michael Schmidt – Leerink Partners

Okay, and do you expect any meaningful news flow from any of the out-licensed products or programs?

Michael Morrissey

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

Michael Schmidt – Leerink Partners

Okay, great. Thank you.

Operator

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

Susan Hubbard

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

Operator

Ladies and gentlemen, that concludes the presentation for today’s conference. You may now all disconnect and have a wonderful day.

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