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Exelixis (NASDAQ:EXEL)

Q3 2011 Results

October 27, 2011 5:00 p.m. 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

Ted Tenthoff - Piper Jaffray

Karen Jay - JP Morgan

George Farmer - Canaccord

David Miller - Biotech Stock Research

Ryan Martins - Lazard Capital Markets

Eric Schmidt – Cowan & Company

Maged Shenouda - Stifel Nicolaus

Operator

Good day ladies and gentlemen, and welcome to the third quarter 2011 Exelixis Incorporated earnings conference call. [Operator instructions.] I would now like to turn the presentation over to Mr. Charles Butler, vice president of investor relations. Please proceed.

Charles Butler

Thank you for joining us this afternoon for our third quarter 2011 financial results call. Joining me on today’s call is Mike Morrissey, our president and CEO; Frank Karbe, our executive vice president and CFO; and Gisela Schwab, our executive vice president and chief medical officer.

Mike will start off by making a very brief overview and then turn things over to Frank who will cover Q3 highlights and review several financial announcements we’re making in conjunction with today’s call. The remainder of the call will be devoted to the top line results of EXAM, our Phase III registration trial of Cabozantinib in medullary thyroid cancer that were released earlier this week, and then that will be followed by Q&A.

As a reminder, during this call we will making certain forward-looking statements that are forward-looking, including, without limitations, statements related to our updated 2011 financial guidance, our plans to build value for patients and shareholders; the continued development and clinical, therapeutic, and commercial potential of, and opportunities for, Cabozantinib; the expected timing of the initiation of the planned XL184306 pivotal trial of Cabozantinib in metastatic castration-resistant prostate cancer; additional planned Phase III pivotal trials in prostate cancer; our plans to file a new drug application for Cabozantinib in medullary thyroid cancer and the timing of the FDA’s response thereto; and upcoming data presentations for Cabozantinib as well as other statements identified as forward-looking in the slides accompanying this call.

These statements are only predictions and are based upon our current assumptions and expectations. Our actual result and the timing of events could differ materially from those anticipated in such forward-looking statements because of risk and uncertainty discussed in the slides accompanying this call, the comments made during this call, and the risk factor section of our 10-Q for the quarter ended September 30, 2011, and our other 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’ll turn the call over to Mike.

Mike Morrissey

Thank you Charles, and thanks to everyone joining us on the call today. We’ve had a very exciting week and are moving forward to build momentum from the outstanding results we have attained in the EXAM study.

Based on that data, it’s clear that Cabozantinib’s significant antitumor activity translates into a profound PFS benefit in patients with advanced MTC. We’re thrilled with the EXAM data and its implications and will continue to move thoughtfully and aggressively to build value for both patients and shareholders.

We have a number of important topics to discuss today including first, our Q3 financial results that Frank will discuss shortly; second, the top line EXAM results that we released on Monday; third, a brief update on the 306 SPA process; and finally a review of additional upcoming data presentations in Q4.

Now I know that everyone has a lot of questions on EXAM and the supporting data that led to the top line results we disclosed on Monday. As I’m sure you’ll appreciate, we’re not going to dive into the details on EXAM today as we’re continuing to review the broad EXAM data set and do not want to jeopardize a future presentation and publication at a top-tier medical meeting and journal by sharing data beyond the top line information we disclosed on Monday.

As you know, we submitted the 306 SPA documents to the FDA in June 2011. We expect to get feedback from the FDA shortly on the 306 protocol and its acceptability to support a regulatory filing in metastatic CRPC if the resulting data are positive. We will communicate this information publicly as soon as we have completed the SPA process. In the meantime, we are actively planning to initiate the 306 study this year and have selected clinical trial sites and vendors to enable an expeditious start before the end of 2011.

We remain confident that we will secure a SPA for 306 that will allow for a robust investigation of the potential clinical benefit of Cabozantinib in an indication with substantial commercial potential. As we outlined a few minutes ago for the EXAM trial, we’re not going to delve into the details of the 306 protocol or entertain detailed questions on the SPA process today as to not preempt agency feedback on this topic.

Finally, we also announced this week that Scott Garland joined our executive team as EVP and chief commercial officer. With 20 years of sales and marketing experience in both Big Pharma and biotech, Scott comes to Exelixis from Genentech, where, since 2009, he served as vice president of the Avastin franchise, the largest product at Genentech and one of the top five global oncology products. Scott provides the additional domain expertise, experience, and perspective that we need to advance Cabozantinib as a leading oncology franchise.

We have been relatively quiet over the past several weeks as we’ve focused on executing the key components of our near-term plan for Cabozantinib. We believe our efforts are clearly paying off. With the success in the EXAM trial, we’re on a path to our first filing and potential approval for Cabozantinib based on strong antitumor activity in MTC. Building value in the Cabozantinib franchise will continue to be our exclusive focus.

So, with that intro, I’ll turn the call over to Frank to give you an overview of the Q3 financials and then Gisela will discuss the EXAM top line data and other Cabozantinib related activities. Frank?

Frank Karbe

Thanks Mike. I will limit my remarks to only the key elements of our Q3 financials, and refer you to our press release and quarterly 10-Q filing for additional details. Revenue for the quarter was $128 million, up substantially from previous quarters, mainly due to the acceleration of deferred revenue associated with the termination of the BMS collaboration for Cabozantinib and XL281, which we already highlighted on our last earnings call.

Operating expenses for the quarter were approximately $49 million, reflecting further reductions in our cost structure as a result of our restructuring activities. We were earnings positive for the quarter, with a net income of approximately $78 million and earnings per share of $0.60, again mainly as a result of the acceleration of deferred revenue I mentioned previously.

We ended the quarter with $313 million in cash, including a $2.5 million milestone under our ROR Gamma collaboration with BMS as well as cash inflows of approximately $4.3 million from the exercise of stock options.

Let me now turn to our financial guidance for full year 2011. Our previous guidance for revenue and operating expense remains unchanged, but we’re updating our cash guidance by reducing our expected year end cash from $380 million to approximately $300 million.

There are a lot of moving pieces contributing to this change, which can be summarized as three main factors. First, we are extending our timeline for the evaluation of a potential transaction for Asian rights to Cabozantinib. The strong top line EXAM data announced earlier this week, as well as anticipated milestones including the outcome of our discussions with the FDA on the 306 SPA, and the upcoming low-dose CRPC data from Matthew Smith’s investigator sponsored trial, that will be presented in November at EORTC, are important catalysts for potentially increasing the value of the broad Cabozantinib franchise.

With a projected cash balance of $300 million at the end of the year, Exelixis is in a solid financial position, and we believe we can best realize Cabozantinib’s commercial potential and create value for shareholders by leveraging the recent and upcoming Cabozantinib clinical and registry milestones.

Second, we expect lower net cash inflows as a result of a number of smaller factors. These include specifically a delay of a tax refund under our collaboration with Sanofi, a delay of proceeds from non-Cabozantinib-related BD activities, a shortfall in proceeds from the exercise of stock options as a result of our volatile stock price, as well as higher than originally forecasted expenses for various Cabozantinib trials, which is, however, to some degree driven by an acceleration of certain Cabozantinib-related activities into 2011.

Third, we decided to repay the final installment under our loan facility with GSK in stock. The payment was due and paid today, October 27, and amounted to $36.9 million. The shares were priced at $6.66, based on a 20-day average shortly after the filing of our second quarter 10-Q, and consequently we issued approximately 5.5 million shares to GSK.

Under the terms of our agreement with GSK, we were required to elect to repay the loan with cash, or with stock, by the end of September, at which point our stock was trading at approximately $5.50 in a volatile and deteriorating capital markets environment. Moreover, the outcome of the EXAM trial was unknown at that time and in an effort to manage our financial risk, we deemed repayment in stock to be the prudent choice.

We remain confident that our cash resources will allow us to execute our near- and medium-term clinical, regulatory, and commercial plans for Cabozantinib, including submitting a new drug application, or NDA, for the treatment of MTC, initiating the 306 trial in CRPC, and advancing the planning of additional Phase III pivotal trials in other prostate cancer indications.

With that, I’ll turn the call over Gisela to discuss the top line EXAM results.

Gisela Schwab

Thank you Frank. I’ll cover the two key topics for Cabozantinib development efforts as we move forward. I’ll first speak to the positive top line data from the EXAM study, and second highlight upcoming Cabozantinib presentations at EORTC and HEA.

As you know by now, we announced the top line results for the EXAM trial on Monday morning. This was a very significant achievement for us. The top line results showed a 2.8-fold increase in progression-free survival for Cabozantinib over placebo. Cabozantinib substantially improved median progression-free survival by 7.2 months compared with placebo. The median progression-free survival under Cabozantinib arm was 11.2 months versus 4.0 months on the placebo arm with a hazard ratio of 0.28. And the P value for that was less than 0.0001.

Without question, this is a highly statistically significant and clinically meaningful result. The top line safely analysis is consistent with other Cabozantinib trials to date. We are now looking forward to presenting the EXAM data at a major medical meeting in 2012.

Let me remind you of the trial design for Cabozantinib in medullary thyroid cancer. EXAM is an international randomized placebo-controlled double-blind study of Cabozantinib in patients with progressive, unresectable, locally advanced or metastatic MTC. Patients were randomized in a 2:1 ratio to receive Cabozantinib administered as a daily dose of 175 mg or placebo. The study did not allow for crossover from placebo to Cabozantinib.

With an enrollment target of 315 patients and a planned event-driven analysis, the trial provided 90% power to detect a 75% increase in progression-free survival, the primary end point of this study. This target was clearly exceeded, as demonstrated by the top line results released earlier this week. Also, the study is designed to assess overall survival at a later time point once those events have been achieved.

In terms of timelines, we initiated EXAM, a large, global Phase III study, in the second half of 2008, and completed enrollment in the first quarter of 2011. We’re very proud of achieving the striking top line results now in a relatively short timeframe from study initiation. This took an enormous effort by our global investigators and our incredibly dedicated and knowledgeable internal staff as well as the highly competent team at the contract research organization we used for the study. We want to particularly thank the patients and their families for participating in this clinical trial.

This study employed rigorous patient selection, ensuring that all patients had progressive disease at study entry, per RESIST. We deliberately chose to enroll patients with progressive disease, a population with a very high unmet medical need. This eligibility criterion of documented progressive disease sets the trial apart from the only other Phase III study ever conducted in MTC, the vandetanib versus placebo evaluation that was recently published by Dr. Wells and colleagues in the Journal of Clinical Oncology.

The patient population enrolled in the vandetanib study was not required to have PD at study entry, resulting in a rather indolent population that had a median PFS on the placebo arm of 19+ months. The EXAM placebo population, on the other hand, has a 4-month median PFS per IRF, or independent radiology facility, indicating the severity and advanced nature of the disease in the patients enrolled in EXAM and again highlighting the unmet medical need of this patient population.

EXAM is being conducted under an SPA which provides for potential full approval based upon progression-free survival. We will continue follow up to assess an overall survival benefit. Based on the striking results on PFS in the Cabozantinib arm, we are initiating discussions with the FDA on the most appropriate manner to complete the trial going forward.

The trial remains blinded to investigators and patients at this time, and we want to discuss whether it should remain blinded or whether patients and investigators should be made aware of the treatment assignment and placebo patients given the choice of receiving alternative anti-cancer therapy. We do not anticipate introducing a crossover at this time.

Regarding next steps for bringing Cabozantinib to patients with advanced medullary thyroid cancer, we are scheduled to meet with the FDA in late December for our pre-NDA meeting, after which we plan to initiate our rolling NDA submission and we expect to complete the submission in the first half of 2012.

As Mike has indicated, we are awaiting the FDA’s feedback on the 306 SPA for our planned pivotal trial in metastatic prostate cancer. This study is designed on the basis of the data from our randomized discontinuation trial that has shown substantial activity of Cabozantinib in metastatic CRPC. We have seen dual effects on both soft tissue tumor and bone lesions in the majority of patients.

These findings were accompanied by striking resolution of pain and the ability to reduce use of narcotic medication per investigative report. In our ongoing nonrandomized extension cohort of the RDT, we are now collecting patient reported outcomes using the brief pain inventory, or BPI, the same tool that we are planning to use in the pivotal 306 study.

We are also using the same computer-aided lesion detection technology, or CAD, to evaluate bone scans centrally by independent radiology facility as intended in the 306 study. Data from the NRE will be presented at the EORTC, AACR, NCR conference in November, which I will speak about in a few minutes.

We are expecting the SPA response from the FDA shortly and will update you regarding the status of the SPA as soon as we receive feedback from the FDA.

Now to conclude my remarks, I’d now like to highlight upcoming important data presentations on Cabozantinib at key medical meetings this fall. At the American Thyroid Association’s annual meeting this weekend, Dr. Maria Cabanillas, from MD Anderson Cancer Center, will present data from the Phase I trial of Cabozantinib in differentiated thyroid cancer.

[unintelligible] are potently inhibited by Cabozantinib, and these targets are strongly implicated in driving the growth and spread of this form of thyroid cancer, making an investigation of Cabozantinib in this indication a logical next step for the compound’s thyroid cancer development program.

In addition, earlier this fall we have submitted five abstracts to the AACR-NCR-EORTC meetings and all five have been accepted for poster presentation. The meeting takes place from November 12 to 16 in San Francisco and investigators will present a variety of new findings on Cabozantinib.

We know that some of these data are highly anticipated. In particular on Sunday, November 13, data from Dr. Matthew Smith’s investigator-sponsored trial will be presented examining Cabozantinib’s activity in castration-resistant prostate cancer when administered at doses lower than those used in the randomized discontinuation trials. Data on Cabozantinib’s activity at lower doses will be important as we plan for trials in earlier stages of prostate cancer, and this will be the first public presentation of both antitumor activity and safety at lower starting doses.

On Monday, November 14, Dr. Ethan Basch of Memorial Sloan-Kettering Cancer Center, will present pain data from the nonrandomized extension CRPC cohort of our Phase II randomized discontinuation trial. These data are particularly interesting because the NRE cohort utilizes the same brief pain inventory tool that we will also use for the 306 pivotal trial. So this will be the first time we’ll have an opportunity to publicly present BPI-derived findings on Cabozantinib’s ability to resolve bone pain in CRPC patients whose cancer has metastasized to the bone.

Cabozantinib will also be the subject of three additional posters at the AACR-NCR-EORTC meeting: An imaging study that uses the same [CAT] technology that will be employed in the 306 trial, a preclinical exploration of Cabozantinib’s activity against bone metastases, and an initial results from a dose-ranging study in Japanese patients with advanced solid tumors.

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

Mike Morrissey

Okay, thanks Gisela. We’ve covered a lot of ground on today’s call, and I’ll keep my conclusion short so we can move directly into Q&A. The developments of this week, and those outlined for the remainder of the fourth quarter, further enhanced our position as an organization exclusively focused on maximizing the clinical and commercial value of Cabozantinib.

For Exelixis, the importance of the top line EXAM data is clear. Cabozantinib is the first compound solely discovered and developed at Exelixis to progress through early development and show success in a randomized Phase III pivotal trial.

I want to again remind you of the transformation we’ve undertaken over the past 15 months. We have done the heavy lifting to focus the organization on building value with Cabozantinib, a compound well-suited to a large number of clinically and commercially meaningful indications, and taken significant steps to grow our commercial organization. We believe we are a company rich with possibilities and the right resources and personnel to pursue them.

Thanks again for joining us today, and we look forward to updating you on our progress again at our upcoming R&D day in December. So with that, we’ll stop here and be happy to take your questions. Operator?

Question-and-Answer Session

Operator

[Operator instructions.] And our first question comes from the line of Ted Tenthoff with Piper Jaffray. Please proceed.

Ted Tenthoff - Piper Jaffray

Congratulations on the very exciting NTC data. That was really very impressive efficacy results. My question has to do a little bit on the safety profile, and I apologize if you did mention some of this in the opening remarks. There wasn’t really very much safety data provided in the press release. Can you share any of that now, or when will we be seeing the safety side of those great results?

Gisela Schwab

As I mentioned a little bit earlier, the safety profile was consistent with previous trials with Cabozantinib. We are not in a position to share detailed data right now. Obviously we want to present the data at a major medical meeting and at that point in time we’ll go into all detail necessary.

Ted Tenthoff - Piper Jaffray

Was there any deaths in the trial, or any SAEs that I can ask about?

Gisela Schwab

We can’t really comment on any details at this point in time. Again, the experience is very similar to what we’ve seen before.

Operator

And our next question comes from the line of Karen Jay with JP Morgan. Please proceed.

Karen Jay - JP Morgan

I have two questions. They have to do with your preparation for the 306 study. I know you’re waiting on the FDA, but you haven’t changed your timeline and year-end’s getting close. So I’m wondering if you have done any work to identify potential patients already or if you’ve gotten a sense from doctors that are involved in the other trials as to whether or not they have patients in their practices that are very accessible and could be easily enrolled in the 306 trial.

Gisela Schwab

Yes, we have in parallel with preparing all the documents for the SPA and stepping through the regulatory process, also initiated all necessarily activities on the operations side. We have selected sites and vendors and basically ready to go the moment we can. And regarding the SPA feedback, we are expecting that shortly from the FDA.

Karen Jay - JP Morgan

And just one follow up. Is there a significant amount of overlap in sites between the ones that you selected for 306 and the RDT and NRE studies?

Gisela Schwab

There may be some overlap, but at this current time I think it’s a little bit too early to speak about that.

Operator

And our next question comes from the line of George Farmer with Canaccord. Please proceed.

George Farmer - Canaccord

I was wondering if these results have any impact on the SPA process with FDA regarding the 306 study.

Gisela Schwab

No, I don’t think that has any impact on the SPA at all. These are two different workstreams. They’re even dealt with in two different divisions of the oncology unit at the FDA at this point.

George Farmer - Canaccord

Can you comment on the dose that’s now being explored in the NRE? Is that still 40 mg?

Gisela Schwab

That is correct. We are exploring a 40 mg dose level in the NRE cohort and as you’ll recall we’ve spoken about that previously and data will come out at the EORTC meeting. In Matthew Smith’s study, we’ve seen encouraging activity in terms of bone scan responses at the 40 mg level.

George Farmer - Canaccord

And a question for Frank, this transaction to sell to Taconic, do you get cash for that? And if so when will that be recorded?

Frank Karbe

Yes, we do expect to receive some cash in return for selling our remaining 19.9% stake. That is estimated to be about $3 million, and we expect to receive this before year end.

George Farmer - Canaccord

And then one more quick question, perhaps it’s premature, but in thinking about how to position Cabo both in the MTC and prostate cancer market, it seems to me that dosing duration will be very different. Doses will be very different. How do you think about pricing? Or maybe I’m just jumping the gun on this.

Mike Morrissey

It’s probably, as you said, a little bit early to be talking about that right now. We’re certainly thinking a lot about all those commercial issues and I think now with Scott joining in on the team. Maybe he could say a few words as well.

Scott Garland

Thanks Mike. I just wanted to say that I’m thrilled to be joining the Exelixis team at this important milestone in the company’s history. The opportunity to build a commercial organization from the ground up and rethink the commercial approach doesn’t come along often in one’s career. It is premature to be talking about price or pricing strategy at this point. I will say that I’ll be sharing some very high level and early thoughts on the commercial strategy at the R&D day in December and I look forward to meeting some of you then.

Operator

And our next question comes from the line of David Miller with Biotech Stock Research. Please proceed.

David Miller - Biotech Stock Research

The first question I have is can you talk about your run rate without any additional financing given the new projection of your $300 million in end of year cash? How many quarters do you expect that to last you?

Frank Karbe

I would point you to the disclosures in our 10-Q from which you can tell that it will last at least through the end of 2012. And we will update our guidance on the Q4 call when we’ll give more specific outlook on 2012.

David Miller - Biotech Stock Research

In the GSK stock sale, are there any terms, like for standstill agreements, or sales restrictions as to how much they can sell over time, or how long it takes them to sell it on those shares that were sold to GSK?

Frank Karbe

No, there are no restrictions and no lockout provisions, but we’re not overly concerned about it. In the overall scheme of things, the 5.5 million shares is a relatively small number compared to the shares outstanding. Also, we have some experience with GSK selling Exelixis stock. They’ve done so earlier in the year, and have done it in a fashion that really did not impact our share price in any negative way whatsoever. And I’m confident they will apply the same behavior going forward.

David Miller - Biotech Stock Research

And the last question I have is for Scott, since he’s on the call. I know you’re just here, but can you look forward and talk about the side effect profile that we’ve seen traditionally for Cabo versus the side effect profile you’ve seen that’s out there and established with vandetanib and what that means for marketing in the MTC market?

Scott Garland

Again, I’ve been on the job now for about a week, and probably more like five business days, and so it is honestly a bit premature for me to be commenting on that. I’d just refer back to what Gisela said about what was observed in the trial. And really, I’ll be digging into that and looking forward to making this a successful drug.

David Miller - Biotech Stock Research

Okay. Michael, do you want to take a shot at that question?

Mike Morrissey

I thought Scott handled it perfectly! [Laughter] Again, there’s a lot of work going on there right now. We’re thrilled with the top line data and I think we have some very exciting times ahead in terms of the filing and getting the SPA done. So we will be happy to address those issues once a little the data comes out.

Operator

And our next question comes from the line of Ryan Martins with Lazard Capital Markets. Please proceed.

Ryan Martins - Lazard Capital Markets

Just wanted to get your thoughts on the implications for overall survival on unblinding of the trial. I know you mentioned placebo patients maybe getting some of the alternative therapies in the setting. What are your thoughts around that?

Gisela Schwab

First of all, the primary end point of the study is progression-free survival and the study is being conducted under an SPA, so progression-free survival alone can support full approval in that context. And secondly, we’ve designed the study such that we did not allow a crossover in order to preserve the ability to show a survival benefit should there be one, and we’re still committed to that. Now obviously in light of the very striking data that were the top line results we talked about earlier this week, there are ethical considerations obviously to take into account, and we want to go forward and have a discussion with the FDA as to whether or not the protocols should be changed to allow patients to go on to other therapies, patients who have been randomized to placebo. And I think in terms of the impact on survival, subsequent therapies obviously are always impacting in some way overall survival analyses, but I think we have to weigh the ethical considerations versus the trial considerations.

Ryan Martins - Lazard Capital Markets

And then I know in terms of the SPA, you mentioned you should be hearing about that shortly. To me it sounds like it’s a final decision from the FDA. Is that a correct way to characterize it?

Mike Morrissey

I don’t think it’s appropriate right now to characterize it any further than we already have. We are waiting for their feedback. We expect that shortly, and when we have that in hand we will share that broadly.

Operator

And our next question comes from the line of Eric Schmidt. Please proceed.

Eric Schmidt – Cowan & Company

How quickly could you go from receipt of the SPA to kicking off the trial? How many days or weeks might that take?

Gisela Schwab

Well, I think we’re pretty confident at this point that provided we receive the feedback shortly, that we can initiate the study before the end of the year. Obviously there are lots of things that need to fall into place. IRB review is one of them. But we’ve made a lot of preparations to be ready to go the moment we know, and I’m confident that we can come through on that.

Eric Schmidt – Cowan & Company

And then Gisela, on the exam study, any sense of when we’ll see the overall survival result, or how long after a patient progresses he might live on average?

Gisela Schwab

I think clearly we need many more events for the overall survival analysis, and I would not expect any meaningful data for at least another year.

Eric Schmidt – Cowan & Company

And then what’s rate limiting on filing the NDA? You’ve given yourselves a good almost eight months if it goes all the way to mid-2012.

Gisela Schwab

Obviously we are very excited about the results and we’re working very hard on the NDA filing. We have a pre-NDA meeting with the FDA late in December. We hope to initiate a rolling NDA filing starting with preclinical and [CMNC] sections either very late in the year or early in the next year. And then follow through with the clinical modules and do so as expeditiously as we can. So I don’t anticipate that to go all the way to the middle of the year, but somewhere in the first half we will certainly hope to complete the filing.

Eric Schmidt – Cowan & Company

And then one financial question for Frank. I think you’d guided to restructuring charges for the year at one point as high as $25-30 million. We’re not tracking at anything near that rate. Is there going to be a big bolus in Q4?

Frank Karbe

That’s a good question Eric. We do expect to book an additional restructuring charge in the fourth quarter, but we do not anticipate at this point that we will actually have a full year restructuring charge in the order of $25-30 million. I would expect it to be more in the range of $12-15 million.

Operator

And our next question comes from Maged Shenouda with Stifel Nicolaus. Please proceed.

Maged Shenouda - Stifel Nicolaus

I hope you can provide an update on the dose findings study, specifically what’s the end point that they’re using in that trial?

Gisela Schwab

The dose findings study is Matthew Smith’s study, that he’s actively advancing, and the design is such that cohorts of prostate cancer patients with bone metastases that are visible on bone scan are involved and received a starting dose of 14 mg, and so in this cohort with 40 mg already completed and with Matthew seeing very encouraging results on bone scan with a good number of bone scan responses. Per the trial design he then steps down to the next lower dose level and that is now fully involved as well, a 20 mg, and so I think you’ll see a very nice update of that information at the upcoming AACR-NCR-EORTC meeting in a couple weeks’ time.

Maged Shenouda - Stifel Nicolaus

And just one followup. Is he using the BPI in that study?

Gisela Schwab

They are not required to have pain at baseline. Pain information will be collected should a patience have pain, but the key outcome measure here is bone scan response.

Operator

As there are no further questions, I’ll turn it back to Mr. Morrissey for closing remarks.

Mike Morrissey

Thanks again for your time, and interest today. We look forward to seeing you at EORTC for that data release, and then certainly in New York on December 1 for our R&D day. Thanks again.

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