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Exelixis Inc. (NASDAQ:EXEL)

Q2 2012 Earnings Call

August 2, 2012 5:00 PM ET

Executives

Charles Butler – VP, IR

Mike Morrissey – President and CEO

Frank Karbe – EVP and CFO

Gisela Schwab – EVP and Chief Medical Officer

Scott Garland – EVP and Chief Commercial Officer

Analysts

Eric Schmidt – Cowen & Company

Joel Sendek – Stifel Nicolaus

Terence Flynn – Goldman Sachs

Matt Lowe – JP Morgan

David Miller – Biotech Stock Research

John Sonnier – William Blair

Lee Kalowski – Credit Suisse

Biren Amin – Jefferies

Operator

Good day, Ladies and gentlemen, and welcome to the Second Quarter 2012 Exelixis’ Financial Results Conference Call. My name is Regina, and I’ll be your conference operator for today. At this time, all participants are in a listen-only mode. Later, we will be conducting a question-and-answer session. (Operator instructions) Today’s event is being recorded for replay purposes.

I would now like to turn the conference over to your host for today Mr. Charles Butler, Vice President of Investor Relations. Please go ahead Mr. Butler.

Charles Butler

Thank you, thank you for joining us for the Exelixis’ second quarter 2012 earnings call. Joining me on today’s call as usual are Mike Morrissey, our President and CEO; Frank Karbe, our CFO; and Gisela Schwab, our CMO. Who will together review our corporate financial and development progress for the quarter ended June 30, 2012. They also will discuss priority activities for the remainder of the year and provide an update on cabozantinib, our lead clinical development program. 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.

As a reminder, 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 could differ materially.

We refer you to the documents that Exelixis files from time-to-time with the Securities and Exchange Commission. Specifically, the company’s most recent Form 10-Q filed today August 2, 2012. 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 risk related to the potential failure of cabozantinib that demonstrate safety and efficacy in clinical testing, Exelixis’ ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the sufficiency of Exelixis’ capital and other resources, and the uncertainty of the FDA review and approval process.

With that, I will turn the call over to Mike.

Mike Morrissey

Okay. Thank you, Charles, and thank you all for joining us on the call today. We had a very busy second quarter, and I’d like to briefly highlight our key achievements for Q2 and our goals for the second half of 2012. First, we reached the critical milestone of completing our first NDA submission for cabozantinib for the treatment of progressive Medullary Thyroid Cancer or MTC. This is an important achievement for our company and for the cabozantinib franchise, which we believe has substantial clinical and commercial potential, we also advanced other aspects of the cabozantinib development program including the presentation of nine abstracts at the 2012 ASCO Annual Meeting in June and the expansion of our CRADA with the MCI.

As you would expect, we won’t be able to say a lot today about the cabozantinib MTC NDA submission. We’re pleased to have received priority review for the application and we’re working diligently with the agency to facilitate the review process. We had a prominent role at ASCO this year, where we presented the latest data for cabo in eight different tumor indications.

We believe this year’s ASCO data helps to find the broad clinical potential with cabo as a differentiated oncology drug. The data presented for the MTC pivotal trial exam and the two prostate cancer aspects covering the non-randomized expansion cohorts and a low dose IST for Mass General were well received. We have talked previously about our view that cabo is more is just a prostate cancer drug and more just a bone targeting drug.

Key ASCO data for cabo including renal cancer, liver cancer, non-small cell lung cancer, melanoma and breast cancer help to reinforce this perspective, with encouraging progression-free survival data and in some cases overall survival data, and we’re viewed positively by key oncology investigators, as we potentially differentiated compared to other commonly used agents dose indications.

Collectively, these data showed robust signs of clinical activity that support the expansion of the cabo development program already underway with CTEP. With our singular focus on cabozantinib, we have a clear set of priorities that will support the continued progress of the cabo throughout the second half of 2012, including facilitating the cabo MTC, NDA review, expediting the COMET trials and advancing the cabozantinib IST and CTEP programs. We obviously have a lot on our plate right now and our focus remains solely on driving cabo forward as quickly and as broadly as possible.

Gisela will discuss some of these topics in further detail in a moment, but first, I’ll turn the call over to Frank, who will provide an overview for our second quarter financials. Frank.

Frank Karbe

Thanks, Mike. As usual I will focus my comments on the highlights of our financial performance, and refer you to our press release and today’s 10-Q filing for additional details. In summary our Q2 financial performance was pretty much in line with the financials from the first quarter of this year.

And as you heard from Mike, we’ve made significant progress in the second quarter by initiating COMET-1, expanding the cabo development program under the CRADA with the MCI, as well as through ISTs and of course with the filing of our first NDA.

We expect these accomplishments to impact our operating expense in the second half of the year. Consequently, expect our quarterly operating expense to increase as compared to Q1 and Q2 of this year. Our financial guidance however that we provided in February for 2012 full year revenue operating expense and projected yearend cash remains unchanged.

Let me turn to our second quarter financial results in a bit more detail. Revenue as expected and in line with the developments we saw in the first quarter of this year, decreased $24.3 million to approximately $7.8 million, mainly due to the transfer of the development activities pertaining to the PI3K assets, XL147 and XL765 to Sanofi in April 2011, The wind down of the Sanofi discovery collaboration in December 2011, as well as the termination of the Bristol-Myers Squibb 2008 cancer collaboration for XL281 in October 2011.

So in summary as these collaborations ended in the course of last year, the recognition of deferred revenue stopped as well. R&D expenses decreased by approximately $10.3 million or 24% to $32.6 million compared to the second quarter last year. Mainly due to lower clinical trial expenses, lower allocations of general corporate costs and lower head count expenses. The decrease in clinical trial expenses reflects the wind down of the EXAM trial, as well as our randomized discontinuation trial. This was partially offset by an increase in expenses associated with initiation of COMET-1 and the continued ramp up of COMET-2, two pivotal trials in metastatic castration-resistant prostate cancer.

We expect the expenses associated with the COMET trials to ramp up further in the second half of 2012, which we expect to be the main driver for our operating expense in the second half of the year to be higher than in the first half. G&A expenses decreased by approximately $2 million or 23% to $6.8 million despite lower allocations of general corporate costs to R&D. Expenses decreased across most cost categories, but the biggest contributor is lower rent expenses as a result of having successfully subleased significant portions of our campus.

Operating expense overall decreased by approximately $9.6 million or 19% to $40.5 million compared to the second quarter last year, which in addition to the aforementioned reductions in costs, also incorporates an increase in our restructuring charges year-over-year by approximately $2.7 million. And finally, we ended the quarter with approximately $295 million in cash.

With that, I will turn the call over to Gisela to give an update on the Cabozantinib development program.

Gisela Schwab

Thank you, Frank, as Mike has already described, we have achieved significant progress in our cabozantinib development program over the second quarter and are focused on activity as we’ll further advance cabozantinib development over the next several months and into the future.

The FDA formally accepted the NDA for cabozantinib in MTC that was submitted in May. The NDA was submitted under the FDA’s Fast Track designation, which is designed to potentially accelerate the review of investigational therapy for an unmet medical need. FDA has now granted a application priority review, which means we should have a decision by the FDA by the end of November 2012.

In addition to our focus on completing the NDA process with the FDA, we are also preparing to file a Marketing Authorization Application or MAA for cabozantinib in MTC in the European Union in quarter four 2012.

Let me now move from MTC to our development strategy for cabozantinib in metastatic CRPC. As Mike mentioned earlier, it was COMET-1 and 2 are opened for enrollment, while initiating each of these trials was an important achievement, we are focused now on opening sites for each trial and getting patients enrolled rapidly.

Our goal is to have about 280 sites for COMET-1 and about 50 sites for COMET-2. COMET-1 is designed to enroll 960 patients with CRPC, while COMET-2 is designed to enroll 246 patients. Both trials will enrollment, who have previously been treated with Docetaxel and Abiraterone and/or enzalutamide in any sequence. Expediting the initiation of clinical sites and enrollment of patients in the COMET study is a tough priority for Exelixis, in addition to completing the NDA process in MTC.

Now I would like to take a few moments to provide some additional detail on our CRADA with the National Cancer Institute and our IST program. The high level of excitement for cabozantinib in the investigated community continues to drive progress for both of these initiatives. I’ll discuss each in turn.

First the CRADA, as you know we agreed an initial slate of 13 trials with the National Cancer Institute. First trial to prioritize is future development such as our six planned randomized Phase 2 trials in the settings of first line renal cell cancer, second line hepatocellular cancer, platinum resistant/refractory ovarian cancer, ocular melanoma, and two trials in non-small cell lung cancer.

Second signal search trials to identify indications for further studies including single arm phase 2 trials in endometrial cancer, bladder cancer, sarcoma and differentiated thyroid cancer. And third other trials which include phase 1 combination trials, an additional tumor types including CRPC in combination with docetaxel, melanoma in combination with Vemurafenib as well as a trial to evaluate cabozantinib in pediatric malignity.

We continue to make progress on these trials. For many of the searching trials including the randomized phase 2 trials, detailed protocols has been developed by leading investigators and reviewed by CTEP and Exelixis.

We expect that many of these protocols will be completed soon and start the IRB approval process during the next several months. It is possible that some of these trials will start later this year. In fact, CTEP has recently submitted the IND for the first study.

Second our IST program continues to see progress as trials begin to read out and behind them new trials come online. For example at ASCO, the IST program was in the spot light, when investigated to our Mass General presented data from a trial of low dose cabozantinib for the treatment of men with CRPC and bone metastasis.

We now have 10 ungrowing ISTs including the more recently announced two additional ISTs in non-small cell lung cancer and multiple myeloma. The non-small cell lung cancer trial is a Phase 2 trial that will evaluate cabozantinib in patients who have a fusion of the KIF5B and RET gene resulting in activation of RET, one of the key targets of cabozantinib.

The Multiple Myeloma IST is a Phase 1 study of cabozantinib in patients with relapsed or refractory disease. Multiple Myeloma typically has a high level of bone involvement. This is the first study evaluating cabozantinib in a hematologic malignancies in which MET is start to be a high important and we are very much looking forward to the data generated in this study. The IST program allows us to evaluate cabozantinib in a variety of new indications quickly. This may open doors to new indications or combination regimens and we expect to initiate further Investigative Sponsored study in the second half of the year.

I would now like to briefly turn to the data presentations plan for the second half of 2012 at key international conference, these include the European Society of Medical Oncology Annual Meeting in late September as well as the European Thyroid Association Annual Conference and the American Thyroid Association meetings, which both takes place in September 2012. The plan presentations include further data from our ongoing Phase 2 trial in CRPC, as well as additional analysis from our pivotal study EXAM in MTC.

We believe that these presentations will be important opportunities to further demonstrate cabozantinib’s clinical potential and differentiated activity profile, and to drive additional interest in cabozantinib.

We have a great deals to do and we are highly motivated to get it done and to get it done right. And we are looking forward to sharing the results of our efforts with you in the months ahead.

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

Mike Morrissey

Okay. Thanks, Gisela. I’ll keep my closing comments brief. It continues to be an exciting and busy year for us with the successful ASCO meeting and our first ever NDA filing. Our priorities are clear and simple, to successfully navigate the NDA process with the FDA, to aggressively enroll the COMET trials and to advance the cabozantinib’s IST and CTEP programs. Collectively, we believe these efforts will serve our ultimate goal of helping patients and building shareholder value.

Let me end here today by taking a moment to thank all of our employees for their individual and collective talents, hard work and efforts across every component of our business.

So with that, we are happy to take your questions. Operator?

Question-and-Answer Session

Operator

(Operator Instructions) And your first question today is from the line of Eric Schmidt with Cowen & Company.

Eric Schmidt – Cowen & Company

Good afternoon, and thanks for taking my questions. If we just turn on MTC for a moment, because it’s too early to speculate on whether there may be an ODAC meeting here, and secondly, the update that Gisela mentioned from the EXAM study in September, would that include an overall survival update?

Gisela Schwab

Thanks, Eric, this is Gisela. Regarding your question on ODAC, we have not been notified at this time of an ODAC tenants and regarding our second question, the overall survival for this study was assist as you know at the time of primary analysis of progression-free survival and the overall survival analysis at that time was a plan to interim analysis. We call that progression-free survival is the primary endpoint and that this study is being conducted under a FDA that was agreed with the FDA. The final OS analysis is planned when 217 events have approved. And we anticipate that currently to be in the 2013 or 2014 timeframe.

Eric Schmidt – Cowen & Company

So there are no additional interim OS looks?

Gisela Schwab

Correct

Eric Schmidt – Cowen & Company

Okay. And then I guess also on MTC just the second half expense ramp that Frank, guided up – guided to does that include any pre-commercial activity?

Frank Karbe

Eric, it’s Frank, it does but it’s very minor. The main driver for the ramp in the operating expense by far is the ramp up in COMET-1 and COMET-2.

Eric Schmidt – Cowen & Company

Okay. And then just I guess maybe the last question pertaining to the randomized studies that you hope to conduct in renal cell first line Renal Cell and second line HCC obviously there was quite bit of interest in those two trials and after are they going to be two of the earlier trials at CRADA prioritizes is there a possibility of those two starting specifically in late 2012?

Gisela Schwab

Yeah, all these studies are in active protocol development stage. And it’s difficult to predict when each one of them start because it depends for large degree on the IMD process and how the individual trials are being reviewed in the timing there. But there is certainly high interest in these two studies.

Eric Schmidt – Cowen & Company

Thank you.

Operator

And your next question is from the line of Joel Sendek with Stifel Nicolaus.

Joel Sendek – Stifel Nicolaus

Hi, thanks a lot. Couple of questions maybe kind of early but can you give us any idea of how many patients you’ve enrolled so far in the COMET trials and then I have a follow-up after that?

Gisela Schwab

So we have initiated enrollment in both COMET-1 and COMET-2, we won’t comment on specific enrollment numbers because they change all the time and so our near term focus is certainly to get trial sites open and involvement in these studies is highest priority for Exelixis.

Joel Sendek – Stifel Nicolaus

Okay, and is it going according to your plan, little bit faster or slower or can you give us any directional commentary?.

Gisela Schwab

I can’t really add much to when I did that.

Joel Sendek – Stifel Nicolaus

Okay then kind of the separate question, first the approval if you get it. How will patients and physicians tell about potentially using Cabo and on a compassionate used and/or off label is an off label waiver, you facilitate that will that be possible to do, maybe talk about it?

Scott Garland

Yeah this is the Scott Garland, Chief Commercial Officer obviously we can’t facilitate off label usage of cabozantinib, we can’t promote it anyway share perform, that’s pretty much all, I can say about it at this time.

Joel Sendek – Stifel Nicolaus

Okay, I guess going backwards then, is it available now for compassionate use or I guess you’re trying to channel everyone through to the various MTI studies that if you – someone with one and could they get it?

Gisela Schwab

We don’t have at this time an official compassionate-used program and with generally the focus is to get patients on clinical trials in order to accelerate the meaningful data.

Joel Sendek – Stifel Nicolaus

Okay. Thanks and just one final question, is it possible for CTEP or MTI to Phase 3 trials through them or do you have to pay this on your own?

Gisela Schwab

In general, it is possible to conduct Phase 3 trials through the CTEP mechanism, does that address the question?

Joel Sendek – Stifel Nicolaus

Yep that’s it. Thanks a lot.

Operator

Your next question is from the line of Terence Flynn with Goldman Sachs.

Terence Flynn – Goldman Sachs

Hi, thanks for taking the question. I was just wondering in terms of the prostate cancer data you mentioned, you’re going to be presenting later this year from one of the Phase 2 trials. Can you just give us anymore details there, what we might see incremental and above what we thought ASCO this year?

Gisela Schwab

So we’re anticipating for the data from the non-randomized extension study but I think further than that, I can’t really comment on details at this time.

Terence Flynn – Goldman Sachs

Okay and then can you give us any sense of its more patients or longer duration?

Gisela Schwab

I think we would have to wait until the conference, which is in September.

Terence Flynn – Goldman Sachs

Okay and then any new thoughts on that prevention trial, I know that something you guys have talked about before any way to start there?

Gisela Schwab

The near term focus is definitely on the execution of those two COMET studies as I alluded to. And I think we are working obviously on various combination studies in CRPC and it includes a study as I mentioned in combination with docetaxel, but also one with abiraterone. And so these will pace away than forward into earlier settings in CRPC.

Terence Flynn – Goldman Sachs

Okay, thank you.

Operator

Your next question is from the line of Cory Kasimov with JP Morgan.

Matt Lowe – JP Morgan

Hi guys. It is actually Matt Lowe in for Cory today. Just wondering if you could share anymore details on your commercial strategy for MTC, perhaps how many reps you plan to hire and when they maybe hired? Thanks.

Mike Morrissey

Yeah, this is Mike. It’s little bit early for us right now to be commenting on the details of our commercial plans for cabo in MTC. We are in the process of finalizing both our plans and our specific tactics on the commercial side. As we’ve said in the past, we’re looking at this very pragmatically and I would think anticipate that our efforts will be commensurate with the size of the MTC opportunity. So as time goes on and we get make additional progress hopefully with the filing will certainly have more information to share.

Matt Lowe – JP Morgan

Okay, thank you.

Operator

Your next question is from the line of David Miller with Biotech Stock Research.

David Miller – Biotech Stock Research

Hi, thanks for taking my question. When would you, I understand you don’t know about (inaudible), when would you, when is the deadline, a lack of a better word for finding out about when you might have one?

Gisela Schwab

Today’s no official deadline to that and we will certainly let the FDA go to its normal processes and we will notify you when appropriate, when we have been notified.

David Miller – Biotech Stock Research

Okay, as your, and I understand you don’t have your sales strategy is finalized but can you talk about what you see is the competitively pertinent distinction and between Cabo and MTC?

Mike Morrissey

And you’re referring to the data, this is Mike, the competitive landscape within MTC itself or...

David Miller – Biotech Stock Research

Sure, sure I mean the competitive, I mean the pertinent distinctions between Cabo and...

Mike Morrissey

Yeah, it’s probably little bit early for that right now. It’s a fair question and it’s a question that I think we will be prepared to address at the appropriate time as again, we’ve made more progress either with the filing or we have a definitive answer.

I think that the EXAM Phase 3 data is out now and you can now look at the data that was generated with (inaudible) as well and come to your own conclusions there. But I think right now a solid – will be that one alone.

David Miller – Biotech Stock Research

Okay and have you provided a target data when you expect the COMET trials to be enrolled and could do if you’re having?

Mike Morrissey

I don’t believe, we’ve talked about a data, specific date when we would have enrollments completed, we have guided that we expect to have top line data in the first half of 2013 and that’s still to plan going forward.

David Miller – Biotech Stock Research

Okay and then just a quick question for Frank, can you, let me know what’s your cash use during the quarter was?

Frank Karbe

Well, I think you can do the math yourself, we ended the quarter with 295 and at the end of the last quarter, we were at 332.

David Miller – Biotech Stock Research

Okay, great. Thank you.

Operator

Your next question is from the line of John Sonnier with William Blair.

John Sonnier – William Blair

Hi, thanks for taking the question. I’ll ask Joel’s question just slightly differently. If you look across the broad development campaign, did you guys have ongoing with Cabo, is there a scenario under which data from some of the ongoing trials could be peer reviewed, published, content delisted prior to the COMET read out. And if so which trials would those be? Thanks.

Gisela Schwab

Well; as you know we have conducted very extensive Phase 2 work in the context of these randomized continuation study and we have certainly presented data on the various different cohorts we intend to publish of this dataset. And that has worked, that is in progress. So depending on the timelines to publication that is entirely possible that their publications quite robust publications available.

John Sonnier – William Blair

And I guess which specific areas do you have, you believe the data the most compelling? I think there is a lot of data?

Gisela Schwab

I think when you reflect back on the ASCO Meeting earlier this year, as shown data sets in CRPC in lung cancer, and breast cancer, in renal cell cancer, and hepatocellular cancer and also in differentiated thyroid cancers, it is a broad data set and melanoma as well. So these are certainly experiences that we intend to publish.

John Sonnier – William Blair

Thank you.

Operator

Your next question is from the line of Lee Kalowski with Credit Suisse.

Lee Kalowski – Credit Suisse

Great, thanks for taking my question. Actually a few if you don’t mind. I guess the first is, if you receive approval for the MTC indication in late November, do you expect to be ready to launch in Q4 or will that potentially be early 2013? And then, secondly Frank, it is centered like you are basically reaffirming guidance, revenues of $40 million to $60 million and OpEx of $190 million to $220 million as I recall, so with deferred revenue coming down basically and OpEx basically $80 million – $81 million for the first two quarters, can you say whether you think that both of those might be on the lower end of the range and then one last question I can follow-up though?

Frank Karbe

Well, I will just comment on the last question you had, and then on your first question, I will refer to Mike. But we did indeed reiterate the guidance in my prepared remarks today and the ranges you put out there were correct, the previously provided guidance was for revenue $40 million to $60 million, for operating expense $190 million to $220 million and for year-end cash approximately $200 million and we will not go beyond providing more guidance as to where we expect to come out in these ranges.

Lee Kalowski – Credit Suisse

Okay.

Mike Morrissey

Yeah Lee, it’s Mike. In terms of your first question I think it’s probably wise for us to defer answering that until we get more time to past, we get closer to the action date and that we can provide I think all the details around our commercial plan and activity. So third question, but I think it’s one that we should answer a little bit later.

Lee Kalowski – Credit Suisse

Okay, thank you and if you wouldn’t mind, one last follow-up question. In terms of the COMET-1 trial patients being able to take happier end, their ends in any order, I believe the Abi pre-chemo PDUFA is in December, so there may be an expectation to do in fact get it in different order, who get it that before tax year et cetera versus after. You expected that would have any impact on the response in the trial in any orders if they get it

Frank Karbe

We don’t really expect that, the criteria in the protocol require prior treatment with docetaxel, Abiraterone, and I think the order of the compounds is really not going to not – not expected to affect the outcome here.

Lee Kalowski – Credit Suisse

Okay, thanks.

Operator

(Operator Instructions) Your next question comes from the line of Biren Amin with Jefferies.

Biren Amin – Jefferies

Yeah, hi guys, thanks for taking my questions. How should we think about cabo pricing and MTC?

Mike Morrissey

Yeah, Biren, it’s Mike again. Very important question one that we will I think cover in the context of the broad commercial strategy rollup, that we’ll do later in the year. So again fair question but one that we’re not ready to answer today.

Biren Amin – Jefferies

Okay and then I guess on HCC given Cabos MET pathway, would you potentially see to develop in MET high patients in the second line setting?

Gisela Schwab

This is Gisela, so we are planning a study in the second line setting of that includes patients regardless of their MET expression status, it certainly have collected some information on MET expression and the existing data set and we do not see a difference in terms of too much shrinkage at one perimeter with respect to as it relates to function of MET expression.

And really you wouldn’t expect that necessarily either bit to see target profile of cabozantinib that includes VEGFR, MET and RET, so I think they are, are the mechanisms that contribute to the activity as well.

Biren Amin – Jefferies

Okay and then on the CRPC for COMET-1 and 2, can you may be discuss how many of the sites have started to enroll patients?

Gisela Schwab

Not really that is really a number also that changes day by day, so we’re not providing any guidance at this point regarding the types of patients in.

Biren Amin – Jefferies

And then I guess may be one last question on COMET-1, specifically with the PSS end point definition, is it consistent with definition that is used in the NRA trial?

Gisela Schwab

The PSS endpoint definition, I don’t think we’ve talked about the PSS end points definition in detail. Yeah, it uses the working group definition.

Biren Amin – Jefferies

Great, thank you.

Gisela Schwab

And also in the COMET-1, its overall survival that we are evaluating and also in COMET-2 overall survival in secondary endpoint.

Operator

Ladies and gentlemen this concludes the question-and-answer portion of our broadcast today. I would like to turn the call back over to Mike Morrissey for some closing remarks.

Mike Morrissey

Okay, I want to thank everybody for their time, attention and interest and we’ll look forward to seeing you in the near future. Thank you.

Operator

Ladies and gentlemen, thank you so much for your participation today. This does conclude our presentation and you may now disconnect. Have a great day.

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