Clovis Oncology, Inc.
Q4 2014 Earnings Call Transcript

Published: 26 Feb 2015

[Operator:]

Good day, ladies and gentlemen, and welcome to the Q4 Year-end 2014 Clovis Oncology Inc. Earnings Conference Call. My name is Steve and I will be your operator for today. At this time, all participants are in a listen-only mode. We will conduct the question-and-answer session towards the end of the conference. [Operator Instructions] Now I’d like to turn the call over to Breanna Burkart, Senior Director of Investor Relations. Please proceed.

[Breanna Burkart:]

Good afternoon and welcome to the Clovis Oncology fourth quarter and year-end 2014 conference call. You should have received the news release announcing our fourth quarter and year-end financial results. If not, it is available on our Web site at www.clovisoncology.com. As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our Web site during the call and will be available in our archive for the next several weeks. The agenda for today’s call is as follows; Patrick Mahaffy, Clovis’s President and CEO will discuss the highlights of the quarter and provide an update on our clinical development program. Then Erle Mast, Clovis’s Chief Financial Officer will cover the financial results for the quarter and year in more detail. Patrick will then make a few closing remarks, and then we will open the call for Q&A, field instructor Andrew Allen, our CMO, will also be available. Before we begin, please note that during today’s conference call, we may make forward-looking statements within the meaning of the Federal Securities Laws, including statements concerning our financial outlook and expected business plans. All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made and Clovis undertakes no obligation to update or revise any forward-looking statements. Now, I’d like to turn the call over to Patrick Mahaffy.

[Patrick Mahaffy:]

All right. Thanks, Breanna. Welcome, everybody. Thanks for joining us this afternoon. I hope and expect that 2015 will be a transformative year for us. We advance and expand our clinical development programs and importantly lay the foundation for the potential launch of our first commercial product. I’ll begin with rociletinib, starting with the recap of the data we presented in late 2014. Then we will turn to our plans for 2015, most importantly our planned NDA and MAA submissions to take place mid year. In November 2014, at the ENA Meeting in Barcelona, data from our TIGER-X and TIGER-2 studies demonstrated an objective response rate of 67% in 27 evaluable T790M-positive patients receiving either 625mg or 500mg BID in what we refer to as the clinical dose group. The disease control rate for this group was 89%. The immature median PFS was 10.4 months, with follow-up for some patients exceeding one-year. These data derived for most of the patients who are typically heavily pretreated and typically progressed from an immediate prior EGFR TKI. As a result, we believe these data demonstrate the safety and effectiveness of rociletinib in a real world patient population seen from the U.S market point of view. Data presented to date demonstrate that rociletinib is well tolerated, with no evidence of systemic wild-type EGFR inhibition. The only common grade 3/4 toxicity reported was hyperglycemia, which occurred in 14% of patients and was readily managed with an oral hypoglycemic agent. We believe that rociletinib has a unique profile compared with other EGFR inhibitors on the market or in clinical development, in that we do not see the cutaneous toxicity, which was the hallmark of wild-type EGFR inhibition, such as acneiform rash, stomatitis and paronychia. All of these can significantly impact patients’ quality of life, result in treatment discontinuation and cost patients stress, and we just don’t see it. Furthermore, having treating over 400 patients, we can see that IOD is rare and even when it does occur; it does not always necessitate rociletinib discontinuation. In January, we also provided an update on activity in T790M-negative patients. Interestingly, we continue to see activity in this patient population as well. In 19 patients in the T790M-negative clinical dose group, we reported a 42% overall response rate. 16 of the 19 patients were treated with rociletinib immediately following TKI therapy, eliminating a TKI re-treatment effect as an explanation for this activity. The median PFS for the T790M-negative population was 7.5 months. In contrast, when these advanced patients were treated with chemotherapy, the response rate shown had been around 10% to 15% with the PFS of under three months. Clearly there is a need for new therapies for this patient population. Based on the activity we’ve seen, we're now actively exploring rociletinib as a treatment for T790M-negative patients. In particular, we have amended the TIGER-2 and the TIGER-3 studies to include T790M-negative cohorts to further investigate this activity. TIGER-3 of course is a comparative registration study. Let's move now to our ongoing development strategy for rociletinib. We continue to enroll patients in the two Phase 2 expansion cohorts of TIGER-X, the original Phase 1/2 study. In addition to TIGER-X, there are three additional global studies in the TIGER program, an EGFR-mutant non-small cell lung cancer patients, a program spanning four continents now with over a 150 sites. TIGER-1, a randomized Phase 2/3 global registration study versus erlotinib in newly diagnosed patients, which is actively enrolling. TIGER-2, a single-arm study in second-line patients directly after progression on their first and only TKI therapy. Importantly, as I noted, TIGER-2 includes both T790M-positive and T790M-negative cohorts and includes sites in the U.S., Europe, and importantly Asia. As a reminder, data from the TIGER-2 study T790M-positive cohort combined with data from the TIGER-X study are expected to service the basis of the first regulatory submissions for rociletinib. After the TIGER program, we also have TIGER-3, a randomized comparative study versus chemotherapy in both T790M-positive and T790M-negative patients with acquired TKI resistance. We are running as well a Phase 1 study of rociletinib in Japan which will soon transition into Phase 2 and further more later this year Japanese patients will be enrolled in the TIGER-1 and the TIGER-3 studies. Given that rociletinib has been demonstrated to be highly active and well-tolerated as monotherapy, during 2015 we intend to initiate a number of combination studies. The initial combinations include rociletinib planned or initiating the PDL1, PD1, MEK and Aurora kinase inhibitors. We also anticipate announcing additional combination studies over the course of the year. We remain on track to submit both our NDA and MAA submissions in mid 2015 and as a reminder, rociletinib was granted break through therapy designation in May of last year. We do have meetings planned with the PMDA in Japan regarding the registration path and we will be in a position to update that plan later this year. Finally, we intend to be prepared for potential U.S launch during the fourth quarter. Our marketing, market access and sales leadership is in place and the US MSL team is being fielded this quarter. One last item, we expect our next updated clinical data for rociletinib to be at ASCO 2015 at the end of May or early June. Turning now to our PARP inhibitor rucaparib. It's been an exciting time for rucaparib. We have shown very consistent and very compelling response rates in a substantial number of ovarian cancer patients. In fact, these recent data are so encouraging that we have been able to accelerate the development of rucaparib. In January, we showed combined data from 54 ovarian cancer patients with germline or somatic BRCA mutations. In these patients, who have received the median of two prior chemotherapy regimens and overall response rate of 70% and a disease control rate of 80% was observed. This is clearly the highest response rate seen in a meaningfully sized ovarian cancer patient population for any PARP inhibitor. As an important reminder, the ARIEL2 study prospectively assesses and correlates rucaparib activity with the molecular characteristics of each patient’s tumor, resulting in three pre-specified subgroups of ovarian cancer patients

[Erle Mast:]

Thanks, Pat, good afternoon, everyone. Our fourth quarter and full 2014 financial results are included in this afternoon’s press release, so I’ll direct my comments to some financial highlights and additional commentary. We reported a net loss of $54.9 million or $1.62 per share for the fourth quarter of 2014 and $160 million or $4.72 per share for the full-year. Our operating cash burn for the fourth quarter of 2014 was $34.2 million and it was $120 million for the full-year. As expected and in line with our previous guidance, we ended 2014 with $482.7 million in cash. Research and development expenses totaled $50.1 million for the fourth quarter and $137.7 million for the full-year of 2014, and both of these amounts increased significantly over comparable amounts from 2013 and that’s primarily due to the significantly expanded clinical development activities for rociletinib and for rucaparib, increased manufacturing and clinical drug supply for both of those programs and higher personnel expenses to support the expanded development activities for the Company. Fourth quarter research and development expenses also increased by $50 million over the third quarter of 2014, and this increase is primarily due to increased activities in the TIGER clinical study program, the manufacturer of clinical supply for rociletinib, and increased investment in disease education and other pre-launch activities for rociletinib. As a reminder, the development expenses for lucitanib are continued to be fully funded by Servier, so its addition to our development activities for 2014 did not impact our R&D expenses. Total operating expenses were $49.8 million for the fourth quarter of the year and $146.5 million for the full 2014 after excluding non-cash charges, which relate primarily to share-based compensation expense. Now as we look toward or into 2015, there are multiple variables that will affect our operating expenses and our cash flows for the year, most notably the timing of a potential approval and launch of rociletinib including a payment, the regulatory milestones pursuant to our license agreement. So accordingly this time we are not providing cash guidance for 2015. And one observation I’d make as you look at our 2014 operating trends for purposes of looking into 2015 and making financial estimates. Our fourth-quarter results highlight that our cash burn for the quarter were not keep pace with our expense growth, as is often the case for our clinical trial and manufacturing related expenses. Now we certainly expect that gap to disappear as we move into 2015. So accordingly our operating expense totaled is a more accurate indicator of our current cash burn trends than actually looking at the actual cash burn for the fourth quarter. And with that, I’ll turn the call back to Pat, for some closing remarks, and then we will open-up for Q&A.

[Patrick Mahaffy:]

All right, thanks, Erle. Let me review our anticipated near-term key activities before opening the call-up for Q&A. Rociletinib, we intend to finish enrollment of TIGER-X and TIGER-2. We will also present interim clinical results at ASCO 2015. We will initiate TIGER-3 very shortly and we will commence the Phase 2 portion of our Japanese study as well as a combination studies discussed. Most importantly, we are actively preparing our first NDA and MAA submission for the mid year and continue to build out of our commercial and medical affairs teams to prepare for potential U.S product launch for rociletinib at the end of 2015. Rucaparib, we will continue to enroll ARIEL2 and ARIEL3. We expect that an update of clinical results from ARIEL2 will be presented at SGO in late March and at ASCO 2015. And one of the milestone for 2015, but very importantly we continue to plan for 2016 NDA submission to the FDA for rucaparib treatment in ovarian cancer patients who have failed three prior therapies. And of course, we will continue to enroll in the ongoing lucitanib studies. With that, we’d like to thank you for joining us today. Look forward to an exciting year. And we will now open-up the call for Q&A.

[Operator:]

Thank you. [Operator Instructions] Please stand by for your first question, which comes from the line of Terence Flynn from Goldman Sachs. Please go ahead.

[Irene Lau:]

Hi. This is Irene in for Terence. Thanks for taking the question. Should we still expect to see data in a fall from your TIGER-1 study, the head-to-head [indiscernible]? Will there be response rate in PFS data available at that time or only response rate data? Thanks.

[Patrick Mahaffy:]

We are hoping to present data from TIGER-1 in one of the four meetings. I think it's likely that in the event we do, it will be almost solely response rate data. It's going to be really unlikely that we would have anything meaningful to show in PFS at that time.

[Irene Lau:]

Thank you.

[Operator:]

And your next question comes from the line of Charles Duncan from Piper Jaffray. Please go ahead.

[Charles Duncan:]

Hi, guys. Thanks for taking the question and thanks for the thorough update. First question is with regard to the NDA, can you ballpark the number of patients that you might include in that or have data on at that time?

[Erle Mast:]

We’ve never exposed that number. It is agreed to with FDA and so I will tell you it is a sufficient number to meet FDA requirements.

[Charles Duncan:]

Okay. That's helpful. So you have discussed that and that's the basis of your plan?

[Erle Mast:]

It is.

[Charles Duncan:]

And then, Pat, with regard to that you mentioned a real population versus and maybe alluded to a clinical trial population at the beginning of your preferred remarks for OC. I am wondering as you think about the potential compounding variables, what is the one or two that you can point to that would, you feel that your trial is best emulating, what the real world is versus say a clinical trial population?

[Patrick Mahaffy:]

Yes. I don’t want to make comparative analysis or comparative claims. I think that would be inappropriate for me to do. So let me make clear what I think is appropriate and good in our trial. The difficulty of doing a Phase 1/2 study in academic centers in the United States is that it is the hardest test possible for a drug in a very advanced patient population. The majority of our patients have been on various therapies for several years. The majority have had two prior -- at the median have had two prior TKIs. Depending on the time we present the data, they’ve had a median of either two or three prior therapies. And they’re really advanced, often motivated patients who start out clinical studies in academic centers. But their disease has taken its toll; the performance status unfortunately can begin to diminish over the course of the disease progression and over the course of their therapies. I'll give an example. Approximately -- and again depending on the time you look at the data, but in general around 50% of our patients by the time they get rociletinib and these are the data they’ve been presented already have brain mets. So all we’re trying to point out is this the real world, real difficult, real important patient population that really needs new therapies and as we come into a commercial environment, this drug has been really been tested in the toughest patients of all for a drug of this nature.

[Charles Duncan:]

That's helpful. And then last question, go to market strategy, can you ballpark the number of sales folks that you think you will need to effectively address the market?

[Patrick Mahaffy:]

Yes, we’ve never disclosed that, but there is a pretty modest range of sales force sizes for oncology launches, oncology promotion in the United States and we’re well within that range.

[Charles Duncan:]

Thanks for the added color.

[Patrick Mahaffy:]

Sure. Thank you.

[Operator:]

And your next question comes from the line of Yaron Werber from Citi. Please go ahead.

[Unidentified Analyst:]

Hi, guys. This is actually [indiscernible] on for Yaron. Thanks for taking our questions here. So I had a question about the T790M negative patients. I was wondering if you could talk a little bit about the test that you use to confirm that those patients were T790M negative, whether it’s sort of a blood or biopsy. And then, just a little bit about sort of how sure you are that these are actually T790M negative patients?

[Andrew Allen:]

So there are two -- this is Andrew here. There are two FDA approved tests for detecting EGFR mutations in formalin-fixed paraffin-embedded lung cancer tissue. One is the Roche test and one is the Qiagen Test. As you know we’re working with Qiagen. And the reason we chose to work with Qiagen is because their test is unique and that it is analytically validated and FDA approved so the detection of T790M in formalin-fixed paraffin-embedded tissues. So, it is the gold standard for detection of T790M. That’s the test that we use and so when we refer to a patient as being centrally negative. What we mean is that a tissue specimen from that patient obtained at the beginning of their participation in the clinical trial has been sent to a central laboratory tested with the approved FDA Qiagen test and is come back with a negative result. And those patients therefore represent a homogeneous centrally confirmed T790M negative population using the only FDA validated test. So that’s what we mean.

[Unidentified Analyst:]

Terrific. And at ASCO, well we see data from more than the 19 patients that I think you presented on that were T790M negative, and could you just give a little bit more color on potentially what we’ll see at ASCO?

[Andrew Allen:]

You will see it, and well we hope we’ve submitted the abstract. You’ll see an update on both the T790M positive and T790M negative. Our priority is has been to enroll the T790M positive, so that’s what the majority of the enrollment you all have seen between the time your last presentation and ASCO. There maybe some additional T790M negative patients as well. But I couldn’t give you guidance as to what that number would be.

[Unidentified Analyst:]

Sure. Any sense of sort of how long those T790M negative patients might have been on drug for by the ASCO?

[Patrick Mahaffy:]

No, that’s one of the difficulties for all of us in rapidly enrolling trials or in ongoing trial presenting interim data as you’re always piling on new patients. So I can't give you a number or a timeframe.

[Unidentified Analyst:]

Sure. No, I really appreciate the color. Thanks so much.

[Patrick Mahaffy:]

You bet. Thank you.

[Operator:]

And your next question comes from the line of Cory Kasimov from JP Morgan. Please go ahead.

[Whitney Ijem:]

Hi, guys. This is Whitney on for Cory. Just wanted to see if I can dig into the sales force a little bit. I think you said you’re recruiting now preparing for a 4Q launch. So will you be bringing sales reps on ahead of time so that you’ll be ready to launch immediately post approval or will it be kind of making offers contingent on approval or how are you thinking about that?

[Patrick Mahaffy:]

Well that’s the tale [ph] we are not actively recruiting right now. We intend to bring them onboard in a timeframe that we think will be consistent with our need to be launch ready by the end of the year and prepare to launch at the end of the year. The goal will be to have that sales force on and trained at the time of an anticipated approval so that we can launch immediately or as close to immediately as possible upon a potential approval.

[Whitney Ijem:]

Great, thanks. And then I may have missed it, but will we get an update on the pancreatic trial through a cap rate at ASCO?

[Patrick Mahaffy:]

Could do.

[Whitney Ijem:]

Got it. Thanks.

[Operator:]

And your next question comes from the line of Howard Liang from Leerink. Please go ahead.

[Howard Liang:]

Thanks very much. I have a couple of questions on the ARIEL2 study. How many patients would you move to include from the already enrolled ARIEL patients before the additional 300 patients. I think it looks like from the presentation that most of the earlier patients were in earlier lines of therapy that wanted to confirm that.

[Patrick Mahaffy:]

So the first part of ARIEL2 enrolled just over 200 patients. And now we are embarking upon an additional 300 patients. And the enrollment criteria for the first part whether you had to have platinum sensitive the current disease with no very tight criteria on numbers of prior therapies and as you know based upon the FDAs guidance the next phase of ARIEL2 will be in patients who progressed upon three prior such toxic chemotherapies, three or more.

[Andrew Allen:]

We do have some of those patients in that 200 patient population, but we haven’t disclosed the number.

[Howard Liang:]

Okay. And again on ARIEL2, what is the explanation that the proportion of germ-line BRCA mutated patients, I think it was 16% in the data present at the OTC [Ph], that seem to be somewhat lower than what other companies have said which during the sort of 35% to 40% range?

[Patrick Mahaffy:]

Yes, so we designed ARIEL2 to help us understand a definition of BRCAness. We didn’t need a lot of patients to tell us about what a germ-line BRCA mutation patient looks like and how they respond to drug. So we deliberately and actively kept the number of patients with previously known germ-line BRCA mutations in ARIEL2. So you should not look at ARIEL2 and the frequency of -- the fraction of patients with the germ-line BRCA mutation as being reflective of the population by design it was not. It was deliberately less.

[Howard Liang:]

Okay. And lastly, can you talk about the size of the T790M negative cohorts in TIGER-2 and TIGER-3?

[Patrick Mahaffy:]

Well, TIGER-2 we have opened it up to T790M negative patients and we’ve specified a number of patients, but I think is on the order of 40 or 50 T790M negative is that we look for. It’s an open-label single-arm study. In TIGER-3 as we have highlighted it’s a 600 patient comparative study. We suspect because we’re not prejudging whether you have to be positive or negative, but the characteristics of that patient group will reflect the general characteristics of the TKI failure population. So we’re guessing, predicting that it will be something like 60% T790M positive patients, and 40% T790M negative patients.

[Andrew Allen:]

Yes, just to add a bit of color. So these are all common trials, and so the fraction of positives versus negatives just reflects the population that comes in. And as Pat said, the current best guess is roughly a 6

[Howard Liang:]

Thank you very much.

[Patrick Mahaffy:]

Thank you.

[Operator:]

Your next question comes from the line of Peter Lawson from Mizuho Security. Please go ahead.

[Peter Lawson:]

Hi, Patrick just with the checkpoint inhibited combined studies. Could you give us any further details around that? Is that one or most of the partners, and when do you expect those trials to start?

[Andrew Allen:]

They will be starting -- this is Andrew, will be starting first half of this year. And we hadn’t given specifics yet as to who the sponsored study partner is obviously we’re contracting with another company on the PD-L1 combination. We have been public, but there is investigator sponsored trial being run out at MD Anderson in combination with Merck’s PD-1 Antibody, Pembrolizumab.

[Peter Lawson:]

Thank you. And then on the launch for rociletinib, could that be year end as well for Europe?

[Patrick Mahaffy:]

No, it could be year end in the United States given regulatory timelines, but the review process as you know is longer in the EU, and so we would not anticipate a launch in the EU, and it will be sort of country by country as you also know despite getting a central approval that would probably begin -- I would guess for the middle of next year.

[Peter Lawson:]

Thank you. And then just finally on the inclusion of the T790M negative patients, is that delayed the enrollment or could it potentially delay data releases on that?

[Patrick Mahaffy:]

No, the T790M negative population that has been added to each of TIGER-2 and TIGER-3 will not impact our NDA submission timelines at all. And I’m glad you asked that in a way. We are not -- in this first submission including T790M negative patients; the submission is limited to the T790M positive population. Our investigators to answer the other part of your question have been really excited to enroll patients who are T790M negative because in their minds the T790M positive population is now being reasonably well addressed through not just our but other drugs in clinical development. The T790M negative population really have nowhere to turn. And so their enthusiasm to enroll in this trial is very, very high -- in these trials is very, very high.

[Peter Lawson:]

Great. I’ve just got one follow-up just for Earl around R&D spend. How should we think about that? Does that increase from 4Q levels?

[Erle Mast:]

Yes, I think that as you look out into 2015, the studies we have ongoing will continue to enroll more patients. Currently all of our kind of pre-launch planning, spending goes into that R&D line. So yes, you will see that trend that will continue to go up as we get into 2015 and invest in all these activities, yes.

[Peter Lawson:]

Great. Thank you so much.

[Erle Mast:]

Yes.

[Operator:]

And your next question comes from the line of Bob Ai from Wallachbeth [ph] Capital. Please go ahead.

[Unidentified Analyst:]

Hi. Thank you for taking my call, my question. And I also have a couple of question on this T790M negative patients. First, so there seems to be more higher activity for patients [indiscernible] of the prior TKI. Is there rational for that or just by chance? The other question is, given the medical need for these patients and you mentioned earlier the options are really -- it sounds terrible. I’m not sure that the requirement for another breakthrough designation application [ph]. Have you thought about you applying that for this T790M negative patients?

[Patrick Mahaffy:]

Well if you’re looking for the announcement for that today you’re not going to get one. I’m just teasing. Its really intriguing data for those of you who’re familiar with the general sort of whispered requirements for a breakthrough designation submission, mostly we need to have something like 50 patients or more with a compelling story to tell. As you have seen we have 19 or so, so there are few more there. So it hasn’t been on our mind. We also get great interaction a device from FDA and so we clearly could at the appropriate time interact with them about it, but it is not front in center for us as something we’re thinking much about now. I do think that in the event our data hold frankly even don’t hold but are still really good. There is a real possibility of getting the approval here and that’s why we’re pursuing it, because there’s a real unmet medical need and it clearly changes practice of a physician those that they could prescribe this drug and see activity independent of T790M standards. But we’re pursuing it but the breakthrough becomes a part of that pursuit is too early to tell. I think I can answer your second question, Andrew may add to it. It’s not so much that we don’t see activity in patients who had not immediately come up with TKI. It’s what surprising here and compelling here is there’s really good evidence that we’re not seeing a re-treatment effect. Because the vast majority, 16 of 19 I think is the patients in that trial had just come up off of TKI. And the vast majority of the patients who have responses had also just come off the TKI. So it clearly is not just EGFR mutants coming back into becoming sort of a driver mutation following around the chemotherapy.

[Unidentified Analyst:]

Okay. Thank you.

[Patrick Mahaffy:]

You bet.

[Operator:]

And your next question comes from the line of Brian Klein from Stifel. Please go ahead.

[Unidentified Analyst:]

Hi, this is Justin [indiscernible] for Brian. Thanks for taking my questions. I had just two. I was wondering, one was a PD-1 combination question. I believe both our EGFRs and PD-1 are the clinical profiles regards to safety are pretty well characterized at this point. I was wondering if you could share your thoughts about this potential synergy with toxicities of combining the two agents, like where are your concerns? Like where there might be and do you believe that your compound or Astrazeneca might have a better safety profile to combine with PD-1? And then my other question was in regards to the diagnostic. From a commercial standpoint would you ever consider giving away the diagnostic for free to minimize hurdles through your treatment, and do you think you would need to do that or do you think this is just like a non-issue payers will pay for? Thank you.

[Andrew Allen:]

This is Andrew; I’ll take the toxicity question. There are largely non-overlapping toxicities because of given mechanism are very, very distinct between small molecules, TKIs and anti-checkpoint -- inhibitory antibodies. So we don’t anticipate or fear combinatorial talks. I think if you look at the list maybe the one that you’d just be paying a little bit more attention to would be pneumonitis, which obviously has been described to TKIs and has also been described to its PD-1 antibodies. It doesn’t make you do anything differently. We always exclude patients with pre-existing [indiscernible] from clinical trials anyway. But you obviously just would keep a particularly vigilant eye for a new symptom of [indiscernible] obviously might be an early predictor of pneumonitis, but that’s about it. In terms of diagnostic, Pat.

[Patrick Mahaffy:]

Yes, so diagnostic -- now we do not anticipate giving it away in fact to the contrary, I think that payers see that relatively an expensive diagnostic is an important gatekeeper to ensure that this is only T790M positive patients in the current plan would gain access and be reimbursed for in our case rociletinib. So we have not heard of anybody doing this and we certainly aren’t planning to do it ourselves.

[Unidentified Analyst:]

Okay. Thanks for taking my questions.

[Patrick Mahaffy:]

You bet. Thank you. End of Q&A

[Operator:]

And now I would like to turn the call over to Breanna Burkart for closing remarks.

[Breanna Burkart:]

Thank you for your fair interest in Clovis Oncology today. If you have any follow-up questions, please call me at 303-625-5023 or Ana at 303-625-5022. This call can be accessed via replay over webcast beginning in about an hour and will be available for 30 days. Again we appreciate your interest and time. Thank you and have a good evening.

[Operator:]

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Thank you very much and have a very good day.