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Exelixis, Inc. (NASDAQ:EXEL)

Q1 2011 Earnings Call

May 3, 2011 5:00 PM ET

Executives

Charles Butler – VP, IR

Mike Morrissey – President and CEO

Frank Karbe – EVP and CFO

Analysts

Joel Sendek – Lazard Capital

Eric Schmidt – Cowen and Company

David Miller – Biotech Stock Research

John Sonnier – William Blair & Company

Cory Kasimov – JP Morgan

Operator

Good day, ladies and gentlemen, and welcome to the First Quarter 2011 Exelixis Incorporated earnings conference call. My name is Shanelle, and I will be your operator for today. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session. (Operator Instructions) As a reminder, this conference 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 proceed.

Charles Butler

Thank you for joining us for the Exelixis first quarter 2011 financial results call. Joining me on the call today as usual are Mike Morrissey, our President and CEO; and Frank Karbe, our CFO, who will review our first quarter financial results. They also discuss our 2011 financial guidance, corporate strategy and provide a general business an update.

As a reminder, we report our financial results on a GAAP basis and as usual the complete press release with our results can be accessed through our website at exelixis.com. During this call we may discuss a non-GAAP financial measure related to our 2011 financial guidance. For a reconciliation of the differences between this non-GAAP financial measures and the most directly comparable financial measures calculated and presented in accordance with GAAP. Please see the non-GAAP financial measures link on the investors and media section of our website at elexilis.com. During the call, we will be making certain statements that are forward-looking, including without limitation, statements related to the key cabozantinib related events during 2011, the continued development plan and regulatory strategy for cabozantinib, the clinical, therapeutic and commercial potential of cabozantinib, the future presentations and releases of data and our 2011 financial outlook.

These statements are only predictions and are based upon our current assumptions and expectations. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of risks and uncertainties discussed in the materials accompanying this call, the comments made during this call, and the Risk Factors section of our 10-Q for the quarter ended April 1, 2011, and our reports filed with the Securities and Exchange Commission. We expressly disclaim any duty to make any updates or revisions to any forward-looking statements.

And with that, I will turn the call over to Mike to begin his remarks.

Mike Morrissey

Okay, thank you Charles, and thanks to everybody for joining us on the call today. The first quarter was very productive for Exelixis as we were able to continue the momentum from the end of 2010, with the presentation that new CRPC data for cabozantinib or cabo at the ASCO GU Meeting in February and then successfully fund raising approximately $180 million in net proceeds from a public offering in March. There are several significant cabo related events throughout the remainder of 2011 that we expect to serve as potential catalysts for further value creation.

Three key areas of near-term interest include, first, our participation at the Annual ASCO Meeting in June; second, the planned initiation of our first pivotal trail for cabo and CRPC; and third, top line data and planned NDA fillings from our phase 3 pivotal trial of cabo in MTC. Let’s first turn to ASCO. As many of you may have seen on the ASCO program website, all three of our accepted abstracts will be featured in oral presentations at the 2011 Annual ASCO Meeting in Chicago. And Saturday at June 4 at 4:30 P.M., Dr. Ronald Buckanovich [ph] of the University of Michigan will present data from the ovarian cohort of the RDT as part of the oral abstract session in the gynecology cancer track. On Sunday, June 5th at 12:00 noon, Dr. Michael Gordon of Premiere Oncology will present data from the comprehensive cabo RDT in the oral abstract session and the development of therapy abstract. And finally on Monday, June 6th at 1:15 P.M. Dr. Maha Hussain from the University of Michigan will present data from the prostate cancer cohort of the cabo RDT as part of the oral abstract session in the GU cancer prostate cancer track.

For obvious reasons, we won’t be able to say a lot about the ASCO abstracts and data today. The three oral presentations include substantial updates for the overall RDT which covers online tumor types as well as the latest results on the individual prostate and ovarian cancer cohorts from the RDT. The prostate cancer presentation will include more mature data from the update given at ASCO GU including patients and including additional patients and longer time to follow-up. In addition, cabozantinib will also be featured in the ASCO sponsored press briefing on May 18th in conjunction with the publication of the ASCO abstracts.

The cabo RDT is one of only seven noteworthy studies to be discussed with the press at this embargoed briefing at noon Eastern daylight time on May 18th, ahead of the full abstract release at 6:00 P.M. Eastern daylight time at that same day. The full details can be found at the press center on the ASCO website. The inclusion of cabo in the press program recognizes the efforts of our investigators, and reflect the high degree of interest in both cabo and the emerging data from the ongoing RDT.

Our ASCO Investor briefing will be held on the evening of Monday, June 6. So before turning the call over to Frank, let me give you a brief update on our cabo related activities. The key cabo highlights of the quarter was the presentation of the updated interim data from the prostate cancer cohort at ASCO GU in February. The data supports the earlier findings that cabo reduces or stabilizes metastatic bone lesions in nearly all patients evaluable by bone scan, reduces bone pain and narcotic analgesic medication as reported by investigators, results in shrinkage of soft tissue and visceral lesions in the majority of patients, it leads to an increase in hemoglobin and patients with anemia.

In the early analysis of PFS, we observed similar PFS time in both docetaxel naïve and pre-treated patients. The early data from the randomized portion of the study showed a shorter PFS meeting at 40 days for the patients randomized to placebo than for those randomized to cabo. The data from the cabo arm were not mature enough at the time of ASCO GU to providing meaningful and median value. We continued to advance our comprehensive development plan and regulatory strategy for cabo and CRPC. As discussed previously, our plan to initiate our first potential phase 3 pivotal trial in the syndication is focused on resolution of bone pain and metastatic bone lesions by bone scan in CRPC patients post texture.

The trail which we referred to as the 306 study is designed to compare cabo to Mitoxantrone plus prednisone as the control. We expect to initiate the 306 study by the end of the year and our goal is to have agreement with the FDA on the 306 protocol and to execute it under an SPA. We recently held an initial meeting with the local regulatory authority in Europe to discuss our plans for the study including the proposed endpoints. Overall the feedback we received during the meeting was positive and we’re encouraged that we will have additional productive interactions with European regulators going forward.

Our end of phase 2 meeting with the FDA to discuss the CRPC data from the RDT and the NRE and a proposed 306 study is scheduled for later this month. We intent to work closely with regulatory agencies with both the U.S. and Europe to ensure that we design our first pivotal trial to leverage the unique clinical profile with cabo that will support our initial registration strategy in prostate cancer.

And in addition to these near-term activities, focus on the design and implementation of the 306 study, we’re also planning two additional phase 3 trial for cabo and prostate cancer, that we hope to initiate in 2012. First, we are investigating a pivotal trial that will assess the impact of cabo on extending overall survival in CRPC patients. The specific line of therapy and compared with drug will be chosen once we have further information from our ongoing RDT and NRE cohorts.

In addition, we are also planning to explore the potential of cabo to prevent the formation of bone metastases in prostate cancer patients who are castration resistant but have not yet advanced to metastatic disease. We will provide additional details as we refine our planning to these trials which will continue to be informed about our ongoing trials in CRPC.

We also continue to investigate the mechanism of action for cabo’s effects on metastatic bone lesions as visualized by bone scan. Today this unprecedented observation can be documented in five different tumor types where bone disease is common including prostate cancer, breast cancer, melanoma, renal cell carcinoma and thyroid cancer. Technetium-99 bone scan technology was the functional imaging assessment where regions of uptake or hotspots reflected area of new bone formation resulting from high osteoblast activity. CRPC and other tumor types to a lesser degree through a pattern of predominantly osteoblastic disease in the bone.

MRI technologies can more directly assess the effect of cabo on the actual tumor located in the bone. We have seen several recent examples of bone tumor regression by MRI from ongoing trials with renal cell and thyroid cancers. One striking example is shown here for our patient with papillary thyroid cancer who presented with an outwardly protruding focal skull metastases as base line. A dramatic regression of this tumor was observed by MRI after eight weeks of cabo dosing. We are planning to systematically investigate MRI technologies and several new investigator sponsored trials or ISTs where sophisticated MRI techniques will be employed to characterize the extent of tumor shrinkage in bone metastases and patients with CRPC.

While we work to realize the broad potential of cabo and prostate cancer, we continue to advance cabo and MTC where we hope to gain our first regulatory approval in 2012. Assuming a positive outcome from EXAM, our randomized phase 3 pivotal trial in MTC patients, we expect to file our first NDA for cabo in MTC by the end of 2011. As discussed previously, the EXAM study was fully enrolled in the first quarter of 2011. The primary PFS analysis is triggered after a pre-specified number of professional events as determined by an independent radiology facility or IRF.

Assuming we meet the pre-specified number of events, we expect to report top line results from EXAM along the middle of this year. We are closely monitoring the events from an IRF revenue and hope to provide an updated estimate of the timing at our ASCO Investor Briefing on June 6. We were recently advised that cabozantinib has received fast track recognition for MTC.

The fast track process was designed to facilitate the developments and expedite the review of drugs that treat serious diseases and fill unmet medical needs. A drug that receives fast track recognition is eligible for enrolling review, in addition those drug that received fast track designation are likely to be considered appropriate to receive a priority review.

So I’ll close here and reiterate that we have a number of important potential catalysts to look forward to throughout 2011, specifically ASCO, initiation of the 306 trial and the submission of our first NDA for MTC by the end of the year.

Now I’ll turn the call over to Frank, who will next review our financial results for the first quarter of 2011. 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 quarterly SEC filings for additional details. Overall, the first quarter financials reflect our successful stock offering in March of this year and a significant impact of the restructuring undertaken last year. We ended the quarter with over $390 million in cash and the change in strategic direction and exclusive focus on cabozantinib continues to drive improvements throughout the P&L.

In addition to our 2010 restructurings, we further reduced headcount during the first quarter. It is however important to note that the full savings impact of our various restructuring activities is still not fully reflected in our Q1 expenses. Revenue was down about $6.3 million or 15% year-over-year mainly due to a $7 million markdown under our MEK collaboration with Genentech which was recognized in full as revenue in Q1, 2010.

Operating expense decreased by approximately $30 million or 33% compared to the first quarter last year, mainly due to lower restructuring expenses as well as significant reductions in wages and benefits, flat supplies, rent utilities and stock-based compensation expenses as a result of our 2010 restructurings. The reduction in our R&D expense also reflects lower clinical trial expenses as compared to Q1 2010, resulting mainly from the elimination of unfunded clinical programs as well as the decrease in the allocation of general corporate costs.

G&A expenses increased marginally, however this is primarily driven by the lower allocations of general corporate costs of R&D mentioned previously. Excluding the shift in allocations, G&A expenses have decreased mainly driven by lower FTE expenses and lower rent and utility costs. So the Q1 expense numbers clearly reflect the difficult steps we took to reduce expenses, but they are not necessarily representative for the remaining quarters in 2011, mainly for two reasons. Firstly, we expect R&D And G&A expense in the second half of the year to be lower than in the first half of the year because a meaningful number of people that have already been terminated are still providing services and are therefore still in our payroll.

Many of these employees support the transfer of our clinical PFPK [ph] assets XL147 and XL765 to Sanofi-Aventis for which we also carry the development expense in our books until the transfer is complete by the middle of the year. Note that these expenses are however cash neutral to us since they are fully reimbursed. Secondly, we expect to record additional restructuring charges in the range of $20 million to $25 million later this year mainly driven by the ongoing consolidation of our real estate footprint.

Other income and expense changed by approximately $8 million, mainly due to a one-time gain of $4.5 million in Q1 2010 in connection with a sale of our plant traits business and an increase in interest expense by about $3.3 million in Q1 2011 mainly driven by the Deerfield financing we entered into summer of last year. Net loss has decreased by approximately 36% from $43.2 million in Q1 2010 to $27.4 million in Q1 2011, resulting in a net loss of $0.24 per share.

Let me finally turn briefly to our financial guidance for full-year 2011. Our guidance for revenue and operating expense remains unchanged. Year-end cash however is now expected to be approximately $380 million taking into account the $180 million of net proceeds from our recent public offering.

With that I will turn the call back over to Mike for some closing remarks.

Mike Morrissey

Okay, thanks Frank. I’d like to take a brief moment to thank all of our employees for their hard work and dedication and tirelessly advancing cabo to help patients and build value for shareholders. I’d say this both to the employees that are working at Exelixis today and to all of those who have departed as part of our recent restructuring. Your individual and collective contributions have been absolutely critical for the success we enjoy today and the vision we are working towards in the future.

We are looking forward to seeing inductors on the road over the next several weeks as various healthcare banking leadings namely Deutsche Bank and BOA before ASCO and then Jefferies and Goldman right after ASCO. And we’re certainly very excited to be heading to ASCO very soon to present the next set of data for cabo in Chicago. So with that I will stop and thank you all for joining us and would be happy to take questions.

Question-and-Answer Session

Operator

(Operator Instructions) Please standby for your first question. And your first question comes from the line Joel Sendek from Lazard Capital.

Joel Sendek – Lazard Capital

Hi thanks a lot. So as we look to ASCO, can you help us at all kind of bracket what the PFS, what its duration will likely be, I know you can’t help me too much with that but what will you consider to be a good number there and then with regard to the second and third phase 3 trials, when might they start, could they possibly start end of the year or that would be more of a mid-2012 event? Thanks.

Mike Morrissey

Okay, Joel. So let me start with ASCO, again I can’t say a whole lot around what’s either in the abstracts or what we expect to present. I think certainly the PFS data from ASCO GU was I think very important new data that came out in February. It’s a data that we are looking forward to updating in June at ASCO. The overall follow-up time if you will, you could do the math there between February and June in terms of what’s theoretically possible. And we’ll again be excited to be speaking to those kinds of durability issues in the context of ASCO.

So stay tuned, we’re almost there and really looking forward to have in that data out. In terms of the next two pivotal trials, again, the OS trail and the bone met prevention trial. It’s difficult to give guidance on when those would start. They certainly won’t start in 2011. Those are definitely 2012 events. We need more data from – first from cabo in both the RDT and the NRE to really understand best how to situate those from the context of actually piling the trial and those kinds of things. And we also want to understand I think in more detail the different compounds in those two different segments and how they might impact what we choose to be a competitor where we go with the detail.

So that’s all work that’s in progress with, I would say a second priority after we get 306 up and running, but certainly this comprehensive development plan and broad regulatory strategy is one that we believe in and one that we think we can really again build value with as we take cabo forward in prostate cancer.

Joel Sendek – Lazard Capital

Thanks, Mike.

Operator

Your next question comes from the line of Eric Schmidt of Cowen and Company.

Eric Schmidt – Cowen and Company

Good afternoon, thanks for taking my call. Mike, a question on the ASCO press release briefing on May 18th, I was just wondering if we’re going to see more data on cabozantinib beyond what was included in the abstracts at that point in time and I guess I asked the question because I think I am correct in recalling that the abstracts were submitted even before the ASCO GU meeting?

Mike Morrissey

Yes, so its again I think we need to defer that question relative to what would be presented at that embargoed meeting with the press. Its I think a bit of a challenge to project that right now relative to what we would or what the investigator would say to the press and then what they would then take forward with any articles they might write. So I don’t mean to be evasive here but in terms of how that actually plays out we have to wait and see how that goes.

Eric Schmidt – Cowen and Company

So you’re just not sure what part of the embargo will be kind of broken at that point in time?

Mike Morrissey

Well I think the embargo will be around the RDT trail itself. That is the study that is the focus of that segment of the briefings.

Eric Schmidt – Cowen and Company

Okay, and then on the EXAM study, could you just remind us what the powering is and what the assumption on the PFS duration and control arm the placebo might be?

Mike Morrissey

Yes, sure. So it’s a 90% power that show a 75% increase in PFS. Placebo was modeled to be approximately eight months. And then the drug was modeled to be 14 months in terms of median PFS.

Eric Schmidt – Cowen and Company

Okay, thanks a lot.

Mike Morrissey

Yes.

Operator

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

David Miller – Biotech Stock Research

Hi, very good afternoon, thanks for taking my questions. First question I have is whether you expect to have any data or meetings at the AUA Urology meeting this month?

Mike Morrissey

We are not planning to present any data at AUA this month.

David Miller – Biotech Stock Research

Okay, I have a question about the 306 trial, I mean with cabozantinib maybe you got a very differentiated drug compared to the other three drugs that are in or about to be in the marketplace, but you chose to follow the same dev pathway as Abiraterone and 3100 instead of lead frogging them. Can you talk about why you are thinking that way?

Mike Morrissey

Well I think the overall development strategy is focused on first showing that, again as you said before that we do have a differentiated profile in the clinic, I think one of the stark differences is the apparent impact on not only bone scan resolution but also providing clinical benefit in terms of bone pain. So we think that 306 study is a very potentially efficient way to show clinical benefit with an accepted regulatory endpoint that would allow us to move relatively quickly in a relatively small trial in a population that has an unmet medical need is underserved in terms of the control of their pain.

So that’s I think one area that we’re actually different even though as you said we would be working again post taxotere in a space where other compounds are at. And then in terms of that then going forward, again in terms of this broad development strategy looking at survival we haven’t decided what line of therapy, what the comparator would be that would require more data and more I would say really clear crisp understanding of the durability of the response in this – in the broad RDT and NRE population to pick the detail, really to find the details of how we run that trial.

And then going forward then in terms of the bone met prevention, again that is a space that is I would say relatively underserved right now, certainly the 147 trial with Dmab [ph] which we’ll hear more about it at AUA, provides the first traction there. We certainly like to be in that space large, extremely large patient population, those patients could be on drug for a year. So again I would argue that the first pivotal trial looks at a different endpoint than is currently I would say encompassed by the labels for certainly Cabazitaxel, Abiraterone I don’t believe have pain label in their – in the label that just came out and the Medivation [ph] compound is still relatively early in that whole process.

So we are different and we are trying to capitalize on the different phenotype of our compound clinically and build value in that regard.

David Miller – Biotech Stock Research

Okay, can you talk about how the approval and especially the pricing of Abiraterone might have affected your positioning here and how you think about it going forward?

Mike Morrissey

Well I guess we weren’t surprised by the approval or the pricing from the standpoint of how that’s evolved. Again I think we are very different compound, different clinical profile in that space certainly from a standpoint how we’re operating mechanistically as well as the impact on the bone with cabo. So it’s certainly an important new player in this space. We’re actually very excited to and have planned ISTs to look at combinations of cabo with Abi in regard to some of the earlier lines of therapy to be able to really address what appears to be an important mechanism of resistance with hormonal therapies that actually up regulate met next drive to metastases (inaudible).

So again lots of opportunities there, we think cabo is a very different agent with the unique profile that we can again focus with our overall development plan and build value as we go forward.

David Miller – Biotech Stock Research

All right, thank you.

Operator

Your next question comes from the line of Karen Fling [ph] of Goldman Sachs.

Unidentified Analyst

Hi this is actually (inaudible) for Karen. So I was wondering, can you just give us an update on the enrolment in the prostate cohort of the NRE?

Mike Morrissey

That is moving ahead nicely, I am not prepared to give numbers today but we have the majority of sides up and that is advancing quite well as we go forward. So again we’re pleased to have that trial in place and I think it’s a very effective way to again further profile the compound in the post chemo population with a very rigorous data collection that would be useful to again help us plan additional trials going forward.

Unidentified Analyst

All right, great. And then what would be the earliest time point at which you guys think you’d be providing us with top line data for that?

Mike Morrissey

Yes, hard to estimate right now, if we’ll do that at one of the meetings in the fall or back at ASCO GU in the spring of ‘012. So that remains to be seen right now.

Unidentified Analyst

All right, thank you very much.

Mike Morrissey

You bet.

Operator

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

John Sonnier – William Blair & Company

Thanks for taking the question. Michael, it sounds like a lot of the CRPC planning is predicative on successful MTC registration. So I was trying to gain some additional insights as to how you guys risk assess EXAM trail, I know it went straight into phase 3 from phase 1. And I guess the broader question is how different would the cabo prostate program look if MTC fails, in other words the prostate is your indication versus the supplement does the registration program look a lot different?

Mike Morrissey

Okay, good afternoon John. So I think the best way to answer your first part of the question is to again refocus on the data we had at ASCO last year in 2010 in terms of the durable nature of the responses and the overall phase 1B if you will MTD cohort of 35 or so patients we had with MTC. So again very, I would say a very compelling evidence for tumor shrinkage in the vast majority of patients, nice response rates in the 30% or so range. And good levels of durable responses in patients. And we still have patients on from that trial that’s been going on now for many years.

So I think the overall preliminary dataset which then drove us into the EXAM trial including responses in patients that had previously progressed on Vandetanib really underscores the activity of the compound in that tumor type. I am not sure I would characterize the prostate cancer development plan or regulatory strategy as being highly dependent upon the MTC program, I mean we’re excited about the activity which we see with MTC and we’re pushing that forward very aggressively. I think the prostate cancer plan is designed to cover – in essence the major segments of that population that have the highest degree of unmet medical need early middle late if you will in terms of the bone met prevention looking at overall survival and we’re looking at pain as a again accepted regulatory endpoint, with a largest patient population.

So we have very carefully examined the prostate cancer space and to a large degree been very selective in how we’ve been gone forward in building this comprehensive regulatory strategy in development plans. So I think it’s the right way to go, we’ve got very strong advisors both from an academic point of view and a regulatory point of view, who are advising us in this process. And we’re excited with the data that we have to-date and looking forward to getting more data out of ASCO to really frame the opportunity across these different segments as we go forward.

John Sonnier – William Blair & Company

Great, that’s actually very helpful. And to be clear if MTC failed, I mean I understand why there is a reason to be optimistic, the program as you described in prostate would suffice as a standalone registration program?

Mike Morrissey

Well that again the prostate cancer program is designed to be a standalone registration program.

John Sonnier – William Blair & Company

That answers the question. I appreciate it, thanks Michael.

Mike Morrissey

You bet.

Operator

(Operator Instructions) Your next question comes from the line of Cory Kasimov of JP Morgan.

Cory Kasimov – JP Morgan

Good afternoon guys, thanks for taking the question. I did have some ASCO related questions for you but I’ll refrain from asking them and instead will ask something else that you probably will also probably be difficult for you to answer and that’s whether you can say anything about the recent Bloomberg reports that you hired a bank to field potential offers for the company?

Mike Morrissey

Well Cory, as you know we don’t, as a policy comment on market rumors, just not good policy to do so. We don’t do that, but let me reiterate kind of where we’re at, right. Our mission and our number one priority is to build value for patients and shareholders. That’s where we’re at, that’s what we focus on literally every hour of every day. We just raised additional money to aggressively develop cabo and CRPC and potentially other indications. And we really plan to do that in such a way to minimize risk along the way while maximizing the upside in our ability to build value and I think we discussion around some of the points that John just raised really speaks to that around prostate cancer.

Cory Kasimov – JP Morgan

Okay.

Mike Morrissey

So we’re focused right now on fine execution and on delivering on our key goals that will take cabo to the next level.

Cory Kasimov – JP Morgan

Okay. And then on cabo and its development, have you guys made any changes to the inclusion, exclusion criteria for patients in the NRE studies?

Mike Morrissey

There are certainly subtle modifications and differences between the RDT and the NRE. I would say the most important one is that the NRE is only for patients that are post taxotere. So it’s in the single post chemo study, number one. There is no requirement for measurable soft tissue or visceral disease as was in the RDT. So we expect in that post taxotere population to have a much more typical, much more normal distribution of patients with bone disease versus no bone disease, with soft tissue disease that’s measurable versus not measurable. It should be a very typical population for what most GU oncologist see in terms of their normal practice in terms of that population.

Cory Kasimov – JP Morgan

Okay, that’s helpful. Thanks and I’ll see you soon in Chicago.

Mike Morrissey

Yes, we look forward to it.

Operator

There are no further questions. I’ll now like to turn the call back over to the Vice President of Investor Relations, Mr. Charles Butler.

Mike Morrissey

Yes, I will take that and again thank you all for your time today. I appreciate the interest and the feedback and looking forward to seeing you all in Chicago very soon. So we’ll break here and thanks again.

Operator

Ladies and gentlemen, that concludes the presentation. Thank you for participating. You may now disconnect. Have a great day.

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