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Exelixis, Inc. (EXEL)

Q1 2012 Earnings Call· Thu, May 3, 2012

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Transcript

Operator

Operator

Good day, Ladies and Gentlemen, and welcome to the First Quarter 2012 Exelixis’ Financial Results Conference Call. My name is Keisha and I'll be your operator for today. At this time, all participants are in listen-only mode. Later, we will conduct the question-and-answer session. (Operator instructions). As a reminder, this conference is being recorded for replay purposes. I would now like to hand the conference over to Mr. Charles Butler, Vice President of Investor Relations. Please proceed.

Charles Butler

President

Thank you for joining us the Exelixis’ first 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 March 31, 2012. They also will discuss upcoming objectives 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 the future performance of the company. 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 May 3, 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.

Michael Morrissey

Management

Okay. Thank you, Charles and thanks to everyone joining us on the call today. We continue to make strong progress, advancing cabozantinib or cabo for short in the first quarter of 2012, and we are well positioned as we move forward towards the ASCO annual meeting in early June. Before I pass the call over to Frank for the finance update and to Gisela for our R&D update, I want to provide a few key points about how we are thinking about our Q1 performance, and what our work to date in 2012 says about our plans for the rest of the year. First and most importantly, we continued to advance our highest priority in terms of development programs in MTC and CRPC over the last quarter. Our progress on the MTC filing continues as planned and we expect to complete the NDA submission in the second quarter of 2012. COMET-2 is up and accruing subjects and we expect to initiate COMET-1 in the second quarter. The first quarter was an important one in terms of cabozantinib’s clinical progress. As we’ve said previously, cabo is more than just a bone drug and it’s more than just a Prostate Cancer drug. Our data presentation since the end of 2011 continued to support this perspective. We have presented encouraging interim data from both the metastatic liver and breast cancer cohorts of our phase 2 randomized discontinuation trial, as well as new interim data from both the renal cell carcinoma and differentiated thyroid cancer cohorts of our phase 1B drug/drug interaction study to support the MTC filing. In each study, we saw a dramatic tumor regression in the majority of patients, encouraging rates of durable resis responses, high rates of disease control and prolonged progression free survival. It’s important to know that these…

Frank Karbe

CFO

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 first quarter financial results reflected dynamics that forecast towards the end of last year. Namely, compared to Q1 last year, our revenues are lower as a result of having realized the majority of our deferred revenue in prior periods, and our operating expenses are down mainly as a result of lower R&D expenses as well as having essentially completed our restructuring activities resulting in slightly lower net loss year-over-year. We ended the quarter with over $330 million in cash, up from last quarter predominantly as a result of our equity offering in February of this year which brought in approximately $65 million in net proceeds. Revenue decreased $17.4 million or 48% to $18.5 million year-over-year, mainly due 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. This reduction was partially offset by the remaining and final revenue recognition of $10.7million in connection with the upfront payment from the out-licensing of our PI3k delta program to Merck which we announced in December of last year. R&D expenses decreased by $12.6 million or 28% to $33.1 million compared to the first quarter last year mainly due to lower clinical trial expenses, lower allocation of general corporate costs and lower headcount expenses. The decrease in clinical trial expenses was predominantly due to the transitioning of our PI3K assets and costs to Sanofi mentioned a moment ago, as well as the gradual winding…

Gisela Schwab

CMO

Thank you, Frank. As Mike described, the first quarter was a productive one for the Exelixis’ development team. The cabozantinib development program is driven by three distinct areas of effort. First as you know, our internal efforts are highly focused on the NDA filing and Medullary Thyroid Cancer, the randomized discontinuation in trial, and on the execution of our Prostate Cancer phase 3 program. Second, our Investigative Sponsored Trial program or IST program that is executed by numerous investigators. These trials are exploring potential new indications and combinations for cabozantinib. And third, we have just announced the approval of the initial program of 13 clinical trials under our CRADA with CTEP. As you recall, we entered into a CRADA with CTEP late last year that covers a broad program including up to 20 active trials per year. These studies will be executed under the R&D helped by CTEP and are supported by NCI funds. Through both the IST and CTEP programs, we believe that we will be able to greatly expand the development efforts and to support cabozantinib’s development in a cost efficient manner. The result is a broad global development program for cabozantinib that builds on all of the activity they’ve seen to date, including activity in 12 of 13 tumor types tested. It gives us the ability to generate the clinical data that will be integral to maximize the clinical and commercial value of the compound. Now let me update you on the status of each of these work streams. Starting with our Medullary Thyroid Cancer program. We are preparing to present results from EXAM, the Phase 3 trial in Medullary Thyroid Cancer at ASCO. Meanwhile the work on the NDA filing is proceeding as a high priority. We are on track to complete the submission for the…

Michael Morrissey

Management

Okay. Thank you, Gisela. I’ll close today with a few final words about ASCO. Obviously with nine cabo presentations on tap for this year’s meeting, ASCO will both important and busy time for us at Exelixis. Cabo will be featured in four oral presentations for data from first, the MTC EXAM trial. In addition, the prostate cancer non-randomized expansion cohorts, the liver cancer cohorts and the RCC cohort. We’ll also have four posted discussion for breast cancer below those prostate cancer IST that Gisela just mentioned, melanoma and non-small cell lung cancer, and then finally a poster presentation for differentiated thyroid cancer. These presentations should provide additional support for cabo’s unique activity profile across a wide variety of tumor indications, and we believe that they will help to drive further interest in cabo as an important new cancer therapy. As we have in past years, we’ll also host an investor briefing at ASCO. This briefing will be an opportunity for some of our clinical investigators and members of the Exelixis clinical team to provide context on the data presented at the conference and discuss our plans for cabo going forward. Speakers will includes Doctors Jose Baselga, from Massachusetts General, Phil Kantoff from Dana-Farbaer, Matthew Smith from Massachusetts General, Karim Fizazi from IGR in Paris, Patrick Schoffski from University of Leuven, Steve Sherman from MD Anderson and Dan George from Duke. The briefing is scheduled from Monday evening, June 4 at 6.30PM and will be available via webcast at exelixis.com. So I’d like to end today by thanking all of our employees for another very productive quarter. The progress that we’ve made to date in 2012 is a direct reflection of your individual and collective talents, efforts and commitment to advancing cabo for the potential benefit of patients and to help build value for shareholders. So with that, we’ll stop here and be happy to take questions now. Operator?

Operator

Operator

(Operator instructions). Your first question will come from the line of Eric Schmidt with Cowen and Company. Please proceed. Eric Schmidt – Cowen and Company: Good afternoon. Thanks for taking my questions. First just on COMET-1, assuming, Gisela, that you’re able to kick off the enrolment this quarter, what’s your best guess on timelines for completing the enrolment?

Gisela Schwab

CMO

So we’re hoping to complete the enrolment in about one year and that is a timeframe that has previously been achieved for other phase three studies in the setting of CRPC. We are intending to go out to a large number of sites, up to 250 sites in various different parts of the world including Europe, the US and Asia Pacific. Eric Schmidt – Cowen and Company: Okay. And then a question on the NCI CTEP. It sounds like putting a lot of resources behind these now approved 13 or so trials. You didn’t provide the number of patients that might be included in those trials. I’d be curious if you could. And maybe financially a question for Frank if he’s got an estimate for what kind of spending they’re committing to this program.

Michael Morrissey

Management

Hi Eric, it’s Mike. Let me take a crack at that first. So the trials that we discuss today will cover a potential range of approximately 500 and 900 patients. I will look at this as a high level early estimate in that the protocols have to get written and finalized. So those numbers could change over time as those protocols get locked down. But you can do the math yourself to a certain degree. But even using – take a very conservative dollar per subject metric, I think this tactic is extremely cost efficient for us to expand the scope of the cabo development plan and really move forward outside of NTC and CRPC.

Frank Karbe

CFO

And I would add maybe – Eric, it’s Frank, that our financial obligation in connection with these trials is limited to $20,000 per trial per year, plus we’re providing the drug substance. Eric Schmidt – Cowen and Company: Okay. So, certainly very conservative estimates for the expense to you guys?

Frank Karbe

CFO

Absolutely. I think it’s a highly advantageous arrangement for us. Eric Schmidt – Cowen and Company: Okay. Thanks a lot. Good luck.

Operator

Operator

Your next question will come from the line of Joel Sendek with Stifel Nicolaus. Please proceed. Joel Sendek – Stifel Nicolaus: Hi. Thanks a lot. A couple of questions here. First, Mike you mentioned all the orals ASCO really quickly. Was there one for CRPC or not?

Michael Morrissey

Management

Yes. The NRE Cohort will have an oral presentation as well. Joel Sendek – Stifel Nicolaus: Okay. I understand. All right. And then with regard to that or the randomized discontinuation trial or is there going – I know you said you can’t give us detail on what’s going to be presented, but will you have – can you tell whether you’ll have duration of response in CRPC, an update there?

Gisela Schwab

CMO

Well, it’s a little bit premature I think to speak about the detailed data points. I think fair to say that we’re planning a very well rounded presentation of the Non-Randomized Extension of data. And I think as you know the study is a setup on the basis on the background of the learnings from the RDT study. And the value I think of the Non-Randomized Extension Cohort is one that allows us to evaluate cabozantinib in a very homogenous patient population all of whom had received prior chemotherapy with just docetaxel. Some could have had Cabazitaxel in addition. Some have abiraterone as well. So a pre-treated patient population and really we are evaluating the end points of pain and bone scan response, prospectively having learned from the RDT study. We are evaluating them prospectively in the same way as we are evaluating them for the phase three studies and therefore I think it will be very informative in view of the phase three studies. Joel Sendek – Stifel Nicolaus: Okay. And in regards to those new studies that you’re doing under your CTEP collaboration, especially the signal search ones, is there any basis for expectation that they’ll work in those indications or is it clearly a search mission? And then maybe correlated to that is what dose you use in those things.

Michael Morrissey

Management

Yes, so that’s a good question Joel. So we spend a lot of time with the NCI and our team going through the biology there. Peter Lamb is here today. Maybe he could take a few moments and just opine upon some of those different trials and biology that’s associated with both the role that MET and VEGF play in those. Peter?

Peter Lamb

Analyst · Stifel Nicolaus

Sure. Thanks Mike. I’d be happy to tell. So just in terms of some of the – my goal of the signal search trials, the basic rationale behind the selection basically follows some similar themes. In all cases there is data from clinical biopsy samples that MET and in most cases also (inaudible) MET is up regulated in those tumors versus the corresponding normal tissue. So there’s a signal of MET activation in those tumor types. In some cases that’s also accompanied by up regulation of VEGF. So the VEGF power play is also up regulated. So the good indications essentially to test the impact of (inaudible) of MET and VEGF. And a good example there for example would be the bladder carcinoma of Phase 2 trial that’s part of the agreement. There is some really nice data showing up regulation of activated METs, the degree to which it correlates quite well with the invasiveness and aggressiveness of the cancer. It’s a negative prognostic factor for overall survival. VEGF is also highly up regulated in that particular setting. So although there’s no clinical signals right now it’s a written indication to take a look in. Some of the other trials that we’re contemplating as well really start to address the question of how MET activation mediates or might mediate resistance to various current approved therapies and I think a really exciting one right now is Zelboraf in melanoma. There was some very interesting data discussed at ACR this year basically showing that MET activation via HTF produced by tumor stromal tissue can mediate primary resistance to Zelboraf in BRAF-mutant melanoma. So as you’re aware not all BRAF-mutant melanomas completely respond to Zelboraf. There’s a range of responses and there were some patients whose tumors just grow right through it even though they have the mutation. So it’s something in that MET activation might play a role in that. So a combination trial with cabo and Zelboraf is aimed at addressing that.

Michael Morrissey

Management

Gisela, you want to comment on the dose?

Gisela Schwab

CMO

Yes. The dose, generally speaking unless it’s in a Phase 1 combination study in which case we would start even lower. But generally the Phase two dose is going forward with 60 milligram daily dosing. Just to add to the tumor charts and various tumor types that I mentioned including renal cell cancer, hepatocellular cancer, ovarian cancer, differentiated thyroid cancer. We have already seen very encouraging signals of activity. So these studies expand on that experience and the expectations are that we will see activity certainly with cabozantinib and the attraction is that we’re now going forward with randomized Phase 2 studies in various indications and some of them with active comparatives. Joel Sendek – Stifel Nicolaus: All right. Thanks a lot for all the detail.

Operator

Operator

Your next question comes from the line of Cory Kasimov with J.P. Morgan. Please proceed. Matthew Lowe – J.P. Morgan Chase & Co.: Hi there. It’s actually Matt Lowe in for Cory today. Just a couple of quick questions. I was wondering if you could comment on the early accrual or enrolment of patients in the COMET-2 study. And then with all the presentations of the RDT study at ASCO, is there one or two in particular you would direct our attention to which you think will capture a lot of attention at the meeting? Thank you.

Gisela Schwab

CMO

Regarding the COMET-2 question, as we said we initiated this study late last year and we are in the process. As you know it takes a little while getting all the sites up very actively. The study is enrolling and that’s going per the plan I would say at this point. Regarding your question on ASCO, certainly there’s a broad array of presentations I would think. Certainly all the oral presentations are of high interest. But I think the data from all the RDT Cohorts is of interest. Matthew Lowe – J.P. Morgan Chase & Co.: Okay. Thank you.

Operator

Operator

Your next question comes from the line of David Miller with Biotech Stock Research. Please proceed. David Miller – Biotech Stock Research, L.L.C.: Great. I appreciate you taking my questions. Can you describe in more detail the pre-chemotherapy prostate cancer trial, including when we might see data from that?

Gisela Schwab

CMO

This is an investigative sponsor trial that David Smith of the University of Michigan is conducting and it is a study that evaluates patients who have not been pre-treated with chemotherapy. So chemotherapy naïve patients and the main objectives in this study are evaluations of bone scan response, but also other markers of activity including bio markers, the usual response assessments and certainly a prolonged follow up of the patient as well. Circulating tumor cells is a part of the evaluation as well and… David Miller – Biotech Stock Research, L.L.C.: Is this a randomized study or is it…?

Gisela Schwab

CMO

I’m sorry. This is a single arm study. It’s not a randomized study. David Miller – Biotech Stock Research, L.L.C.: When would you expect that we would start seeing the first data generated from your randomized Phase 2s off of the CRADA that you just announced?

Gisela Schwab

CMO

CTEP

Analyst · David Miller with Biotech Stock Research

David Miller – Biotech Stock Research, L.L.C.: Okay. And then finally you had mentioned a cabo and MDV3100 trial. Can you give us some details on that, particularly when it might start, patient size and what indication, what kind of patient.

Gisela Schwab

CMO

Well, that study is in the planning phase. So we’ll defer that probably better to another call. David Miller – Biotech Stock Research, L.L.C.: Okay. Thank you very much.

Operator

Operator

Your next question comes from the line of Ryan Martins with Lazard Capital Markets. Please proceed. Ryan Martins – Lazard Capital Markets: Hi. Thanks for taking the question. Just wanted to ask something around COMET-2. OncoGeneX recently stopped their trial or their version of the pain trial due to they said what was for them difficulty in recruiting patients through their requirement for stable baseline pain analgesic use. Just wanted to find out how your requirements may compare to what they were doing and if you’ve been seeing any kind of problems in terms of recruiting patients initially at least in COMET.

Gisela Schwab

CMO

Yes, thanks for the question. So our study is different obviously in design from the OncoGeneX study and I will try to describe the key features that are different. I think that the first key feature is the patient population. We are allowing patients into the study who have been pre-treated with prior docetaxel and abiraterone or MDV3100 and we’re not limiting other prior therapies. So that difference obviously from the setup of the OncoGeneX study where it was a combination with docetaxel, the treatment regimen and that was – the patient population was one that had been exposed to prior docetaxel and I think that presented some issues that possibly investigators didn’t want to re-treat patients with docetaxel necessarily. I think that it’s not an issue in our studies since we are using a single agent cabozantinib approach versus midostaurin and prednisone. And so that requirement is basically very different. I think another point of differentiation is that we are in the phase of screening of the patients, requiring for the patients to have a moderate to severe pain and BPI of greater than or equal to four, BPI being the Brief Pain Inventory. And that their narcotic medication is optimized and not stabilized as it was for the OncoGeneX trial and I’ll explain that in a second. Optimization basically means that the best dose regimen of narcotics is identified in this running phase and patients receive a one long acting and then as needed short acting narcotic medication that doesn’t have to be exactly the same day to day. It’s dosed as to the patient’s needs. Whereas in the stabilization requires as the word and indicate a complete stabilization of the narcotics, which is difficult because patients obviously have breakthrough pain and need on occasion additional short acting narcotics. So I think those are two really important key features between – that differentiate the two approaches. Ryan Martins – Lazard Capital Markets: I appreciate the color. And just on the ASCO presentation for DTC, is that going to be an update to what has been presented previously?

Gisela Schwab

CMO

On Differentiated Thyroid Cancer there will be more follow up, yes. There will be an update. Ryan Martins – Lazard Capital Markets: Okay. Thank you.

Operator

Operator

Your next question comes from the line of Amin Biren with Jefferies Biren Amin – Jefferies: Hi. This is Biren. Thanks for taking my questions. I wanted to ask when we should expect maybe the overall survival data from the RDP trial in CRPC patients.

Gisela Schwab

CMO

So the follow up is ongoing for the patients and we will – once the data a little bit more mature certainly share the data on overall survival. But right now there are a lot of patients still being followed up. Biren Amin – Jefferies: Great. Thanks.

Operator

Operator

Your next question comes from the line of Echo He with Maxim Group. Please proceed. Echo He – Maxim Group: Hi. Thanks for taking my questions. Just have a couple of questions on previous trial results. In the phase two trials and just cross comparisons those potential competitors of cabo, I collected this bone scan data was also reported abiraterone and also MDV3100 and I got impression that cabo in comparison to those two drugs, cabo probably have lower rate on stable disease but higher rate on part of response. Is that correct from what you concluded?

Gisela Schwab

CMO

Well, I think our results as they have been presented on various occasions now indicate that the majority of patients actually achieve what we determine as a bone scan response. So either complete resolution of the bone scan or marked improvement of the bone scan. And that in the view of many of our key opinion leaders as well as our own is a few unprecedented and that it hasn’t really been described with any other drug. And so maybe that addresses your question? Echo He – Maxim Group: Right. Okay so it’s significant better in the eyes of oncologists, right?

Gisela Schwab

CMO

That is what we are hearing, yes. Echo He – Maxim Group: Okay. And another one is on the pain palliation data. I think at least docetaxel and abiraterone also reported some pain palliation actually to a significant degree in their Phase 3 trials. What’s your comparison to cabo’s pain palliation effect?

Gisela Schwab

CMO

Yes, that is a very good question and I think the devil is in the detail, because and really depends on how the pain information is collected and we have a very rigorous – we are pursuing a very rigorous approach to that using a validated tool, the brief pain inventory that is utilized by the patient. And the patient basically provides the feedback every day, seven days in a row every three weeks and types it in basically into their cell phone. And so the patient reported outcome is directly collected and then we’re comparing really the assessments at week 6 and week 12 back to baseline. And patients who have a 30% decrease in the average of the pain score on these seven subsequent evaluations, who have an average decrease of 30% or greater are termed responders. And we require for a responder to be confirmed. So a responder has to have a response at week 6 and at week 12. So it is a pretty demanding threshold. And other trials that you mentioned, different instruments have been utilized and the pain assessment has occurred less frequent – other less frequently in some cases and also less rigorously if you will when you dig into the assessment reports of the approvals of these compounds and into the label of these compounds that you mentioned. Pain palliation is really not finding – has not found its way into the label, the regulatory label for abiraterone or other compounds that you mentioned. And that really is a function of largely of missing data oftentimes which is a really big issue for our patient reported outcomes. So our focus for COMET-2 is to have as complete as humanly possible data collection and a very rigorous assessment of the pain which differs from the other studies that were mentioned. Echo He – Maxim Group: Okay, I understand. So the stringent and also the high ratio of collection would differentiate your…

Gisela Schwab

CMO

Yes. Echo He – Maxim Group: Right, I understand. Okay, that’s it. Thank you so much.

Operator

Operator

There are no further questions in queue at this time. I would now like to hand the conference back over to Mr. Mike Morrissey for any closing remarks.

Michael Morrissey

Management

Okay. Thanks again for joining us today in the call. Appreciate your time and interest and we look forward to seeing you out on the road or during the next call in a quarter. Thanks again.

Operator

Operator

Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect your lines. Good day.