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Exelixis, Inc. (NASDAQ:EXEL)

Q1 2012 Earnings Conference Call

May 03, 2012 5:00 PM ET

Executives

Michael Morrissey – President and Chief Executive Officer

Frank Karbe – Executive Vice President and Chief Financial Officer

Gisela Schwab – Executive Vice President and Chief Medical Officer

Peter Lamb – Executive Vice President, Discovery Research and Chief Scientific Officer

Charles Butler – Vice President of Investor Relations

Analysts

Eric Schmidt – Cowen and Company

Joel Sendek – Stifel Nicolaus

Matthew Lowe – J.P. Morgan Chase & Co.

David Miller – Biotech Stock Research, L.L.C.

Ryan Martins – Lazard Capital Markets

Biren Amin – Jefferies

Echo He – Maxim Group

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

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

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 patient populations were heavily pre-treated, which potential provides another important aspect of cabozantinib’s differentiated product profile.

The depth and breadth of our clinical activity and tumor indications outside of MTC and Prostate Cancer was a critical component of our decision to establish our CRADA with the MCI’s Cancer Therapy Evaluation Program or CTEP, and also expand our own Investigator Sponsored Trial or IST program. These two initiatives will be critical in our efforts to maximize cabo’s potential beyond MTC and CRPC, and we have made significant progress in both the initiatives in the first quarter.

From a high level perspective, we have initiated five ISTs to date and recently approved 12 new trials for CTEP. In addition, we were notified today that a 13th new trial was approved for a Phase 2 trial in second line differentiated thyroid cancer. Together we believe the ISTs and CTEP for us will help us better document cabo’s unique activity profile and harness that knowledge as we prioritize additional late stage clinical development programs beyond MTC and CRPC.

We continue to execute from a financial perspective in Q1 as well. We demonstrated our fiscal discipline as we maintained our tight focus on cabo, and we continued to apply our resources in an efficient and effective manner. Frank will review the specifics in a few minutes, but as Q1 results largely reflect our successful transition to a company focused on the cabozantinib’s development program and the dynamics that we forecasted at the end of last year.

We finished the quarter with a cash balance of over $330 million including the net proceeds of our public offering of common stock.

Our progress in the first quarter provides us with a good foundation as we approach ASCO, where cabo will be the subject of nine separate data presentations. We expect that cabo will have good visibility at the meeting and we’re looking at it as an important opportunity to further document cabo’s broad clinical and commercial potential in MTC, in Prostate Cancer and in a variety of other tumor indications where cabo has shown activity.

I’ll share some more thoughts about our cabo in line of ASCO towards the end of the call. We obviously can’t say much at this stage. Our hope is that ASCO attendees will walk away from the meeting with an up to date picture of how cabo’s differentiated clinical profile, driven by dual inhibition of MET and VEG-F can translate into meaningful clinical activity in a variety of tumor indications that potentially improve the treatment experience for patients.

So with that, I’ll turn the call over to Frank who will provide an overview of our first quarter financials. Frank?

Frank Karbe

Thanks Mike. As usual I will focus my comments on the highlights of our financial performance and refer you to our press release and today’s 10-Q filing for additional details. In summary, our 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 down of our EXAM pivotal study for cabozantinib in MTC. The remainder of the decrease and expenses primarily reflects the completion of restructuring activities.

G&A expenses decreased by $1.3 million or 14% to $7.9 million despite low allocation of general corporate costs to R&D. Expenses have decreased across most cost categories, but the biggest contributor are lower rent expenses as a result of having successfully subleased significant portions of our campus.

Operating expense overall decreased by $18.8 million or 32% to $40.8 million compared to first quarter last year, which in addition to the aforementioned reductions in costs, also incorporates the reduction restructuring charges year-over-year by approximately $5 million.

I would like to point out that the Q1 operating expense levels are not necessarily representative for the remaining quarters of this year. In addition to COMET-2, we expect to soon also be actively involving COMET-1, and as these two pivotal studies ramp up, we expect our quarterly operating expenses to increase. However, for the full year we expect operating expenses in line with our previously issued guidance of $190 million to $220 million which is in line with our 2011 expenses.

Net loss has decreased slightly by $1.3 million or 5% to $26.2 million or $0.18 per share.

And finally, we ended the quarter with approximately $332 million in cash, which includes cash inflows of $95.7 million during the first quarter of 2012 of which $65.4 million related to the net proceeds from our equity phone offering in February, and $27.3 million related to BD payments from Merck and Sanofi.

With that, I will turn the call back to Gisela, who will review the cabozantinib development program in more detail.

Gisela Schwab

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 end of the second quarter, and plan to request priority review for the filing. If the FDA accepts the filing for priority review, we would expect an FDA decision on our application for cabozantinib in MTC before the end of the year. We are also preparing a manuscript on EXAM for submission to a key medical journal.

Our COMET program in Prostate Cancer continues to advance as well. As you know COMMET-2 was a focus on Pain Palliation came online in December. We expect to initiate COMMET-1, our Overall Survival Trial on CRPC in the second quarter of 2012. If these trials are successful, cabozantinib will demonstrate an ability to control pain in patients with CRPC and prolonged overall survival. This will potentially result in a differentiated profile that could well position cabozantinib in the oncology marketplace.

The Prostate Cancer program is also benefiting from our CRADA and IST program. First triggering our IST, even as we implement the COMMET trials, studies in other CRPC indications are underway. As we have previously reported, data from Dr. Matthew Smith’s IST evaluating cabozantinib at lower doses continue to demonstrate an activity profile that is consistent with that seen at higher doses, but with a clearly improved tolerability profile. We believe the profile of the loader’s regimen could support the use cabozantinib in earlier lines of therapy or in combination with other compounds in the treatment of CRPC. Updated data from this IST will be presented at ASCO later this year.

Recently, a new phase 2 IST has been initiated in Chemotherapy-naïve patients with CRPC and in addition, we look forward to the initiation of multiple combination studies with cabozantinib including the recently announced combination studies with docetaxel and with Abiraterone. We are also planning a phase 1 trial of cabozantinib in combination with MDV3100. Collectively, these studies could set the stage for further late stage evaluation of cabozantinib in the front line setting, which if successful would considerably increase the potential size of the cabozantinib market and prostate cancer.

Ongoing non-CRPC ISTs include a phase 2 trial in women with hormone receptive positive metastatic breast cancer and bone metastases, and a trial in patients with advanced Pancreatic Neuroendocrine and Carcinoid Tumors. Additional phase 1 ISPs in relapsed or refractory multiple myeloma, and a phase 2 trial in patients with solid tumors with bone metastases are also expected to initiated this year.

Now let me turn to the CRADA with CTEP. With regard to the program under the CRADA with CTEP itself we announced today, that we have reached agreement with CTEP on an initial list of 13 proposed trials, several randomized phase 2 trials with active comparative arms are part of these initial 13 approved trials. Indications for these randomized phase 2 trials are renal cell cancer, hepatocellular cancer, non-small cell lung cancer and ovarian cancer.

Briefly, the study designs are as follows. First, a randomized Phase 2 trial comparing cabozantinib versus sunitinib in patients with previously untreated Metastatic renal cell cancer. Second, a randomized Phase 2 trial comparing cabozantinib versus placebo in patients with hepatocellular cancer who have previously been treated with sorafenib. Third, a randomized phase 2 trial comparing cabozantinib versus erlotinib, and versus the combination of cabozantinib plus erlotinib in patients with EGFR wild-type non-small cell lung cancer. And fourth, a randomized phase 2 trial comparing cabozantinib versus weekly paclitaxel in women with platinum-resistant or refractory ovarian cancer.

Other phase 2 trials approved in the initial program under the CRADA will evaluate cabozantinib in the second line setting of differentiated thyroid cancer, in ocular melanoma and in EGFR-mutant non-small cell lung cancer patients progressing on erlotinib. These are indications in which we have previously seen activity with cabozantinib.

Further phase 2 trials for evaluate cabozantinib’s activity in additional tumor types, consisting of trials in advanced and endometrial cancer, bladder cancer and Sarcoma.

Phase 1 trials are also included in the program consisting of a trial evaluating cabozantinib in combination with docetaxel in CRPC patients. A trial exploring the utility of combining cabozantinib with vemurafenib, a BRAF inhibitor in patients with BRAF-mutated melanoma. And a trial to evaluate the safety and pharmakenetics of cabozantinib in pediatric malignancies.

With all of our ongoing clinical development activities, we expect to have multiple opportunities to present data over the rest of 2012. We will have a significant presence at the upcoming ASCO.

And I’ll now turn the call back to Mike for a discussion of planned ASCO event.

Michael Morrissey

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?

Question-and-Answer Session

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

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

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

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

Absolutely. I think it’s a highly advantageous arrangement for us.

Eric Schmidt – Cowen and Company

Okay. Thanks a lot. Good luck.

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

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

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

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

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

Gisela, you want to comment on the dose?

Gisela Schwab

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

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

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

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

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

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

Well, I think that it really depends on the time of initiation and then the speed of accrual. So it’s a little bit difficult to predict. Just to say in terms of the time to initiation from approval to first patient in. CTEP is certainly striving to shorten the timelines and expect a time frame in the order of six to 12 months time to initiation. And it depends on the individual trials, how large they are and how quickly they accrue.

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

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

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

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

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

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

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

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

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

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

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

Yes.

Echo He – Maxim Group

Right, I understand. Okay, that’s it. Thank you so much.

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

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

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

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