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Exelixis, Inc. (EXEL)

Q2 2017 Earnings Call· Wed, Aug 2, 2017

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Second Quarter 2017 Financial Results Conference Call. My name is Takia and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Susan Hubbard - Exelixis, Inc.

Management

Thank you, Takia, and thank you all for joining us for the Exelixis Second Quarter 2017 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO; Chris Senner, our Chief Financial Officer; P.J. Haley, our Senior Vice President of Commercial; Gisela Schwab, our Chief Medical Officer; and Peter Lamb, our Chief Scientific Officer, who will together review our corporate, financial, commercial and development progress for the quarter ended June 30, 2017 as well as recent key development and corporate events. As a reminder, we are supporting 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. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding clinical, regulatory, commercial, financial and strategic matters. Actual events or results could of course differ materially. We refer you to the documents we file from time to time with the SEC which under the heading Risk Factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing. Today, including, without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, the availability of data at reference times are dependent on collaboration partners and the level of costs associated with commercialization, research and development as well as other activities. With that, I'll turn the call over to Mike.

Michael M. Morrissey - Exelixis, Inc.

Management

Thank you, Susan, and thanks to everyone for joining us on the call today. We had a very busy and productive Q2 of 2017 with strong operational performance across all components of our business, which included achieving several important strategic and tactical milestones. I'll begin today by providing a brief summary of the key events for Q2 and then turn the call over to Chris, P.J., Gisela and Peter for updates on our Q2 financials, the ongoing CABOMETYX RCC launch and development activities for cabozantinib, cobimetinib CS-3150. Key highlights for Q2 2017 include first, our continued financial performance with $99 million of total revenue, including net product revenue of $88 million for the cabozantinib franchise based on the strong continued uptake of CABOMETYX in the advanced RCC. market. Second, the use of our improved cash position to further optimize our balance sheet by paying off the remaining Deerfield debt of $124 million, which leaves us debt-free. Third, we favorably settled our arbitration with Genentech and entered into an amendment to the collaboration agreement for the development and commercialization of COTELLIC. The amendment provides for a revised revenue and cost sharing arrangement effective as of July 1, 2017, that is applicable to current and potential future commercial uses of COTELLIC. Fourth, we continue to make meaningful progress in R&D by advancing developments and regulatory activities for both cabozantinib and cobimetinib. We're initiating our internal drug discovery efforts and exploring potential business development opportunities. Importantly, an analysis of CABOSUN based on the blinded IRC review confirmed that cabozantinib demonstrated a clinically meaningful and statistically significant improvement in PFS compared to sunitinib in previously untreated RCC patients. In addition, we initiated the first cabo-I/O combination trials in our clinical collaborations with BMX and Genentech. Fifth and finally, we entered into a lease agreement for office and research facilities in Alameda, California, which will become our corporate headquarters in 2018. We are pleased to have achieved these important corporate milestones in Q2 and continue to build momentum in our business with strong financial, commercial and development performance. We've posted another profitable quarter on an operating basis with diluted earnings of $0.06 per share, while at the same time continuing to manage our expenses carefully and becoming debt-free by repaying the Deerfield loan. We remain focused on running the business to generate positive cash flow through expanding product revenues with the goals of reinvesting the resulting free cash into advancing additional late-stage trials for cabozantinib and rebuilding our product pipeline. With that, I'll turn the call over to Chris, who will provide more details on our Q2 2017 financials.

Christopher J. Senner - Exelixis, Inc.

Management

Thanks Mike. Total revenue for the quarter ended June 30, 2017, was $99 million compared to $36.3 million for the comparable period in 2016. Total revenue includes $88 million and $11 million of net product revenue and collaboration revenue respectively, compared to $31.6 million and $4.6 million for the comparable period in 2016. The increase in net product revenue primarily reflects the impact of the U.S. commercial launch of CABOMETYX in late April of 2016. Net product revenue increased approximately 28% when compared to the first quarter of 2017. This increase was primarily driven by the continued growth in CABOMETYX prescriptions. Collaboration revenue for the quarter ended June 30, 2017 includes $5.5 million, $4.1 million and $1.4 million earned under our collaboration agreements with Ipsen, Takeda and Genentech respectively. In comparison, during the quarter ended June 30, 2016, collaboration revenue includes $3.6 million and $1 million earned under collaboration agreements with Ipsen and Genentech, respectively. Research and development expenses for the quarter ended June 30, 2017 were $28.2 million compared to $23 million for the comparable period in 2016. The increase in research and development expenses was primarily a result of increases in clinical trial costs and personnel expenses. The clinical trial cost increase was predominantly due to increases in costs related to CABOSUN and startup costs associated with the previously announced cabozantinib and immuno-oncology trials. This increase in clinical trial expense was partially offset by a decrease in costs related to the wind-down of METEOR. Selling, general and administrative expenses for the quarter ended June 30, 2017 were $40.7 million compared to $35.8 million for the comparable period in 2016. The increase in selling, general and administrative expenses were primarily a result of increases in personnel expenses resulting primarily from an increase in head count connected with the build-out…

P.J. Haley - Exelixis, Inc.

Management

Thank you, Chris. We are pleased with the continued progress of CABOMETYX and the Q2 2017 cabozantinib franchise net product revenue of $88 million. Q2 CABOMETYX net revenue of $80.9 million compares favorably with the Q1 net revenue of $62.4 million, representing growth of 30% quarter-over-quarter. End customer demand increased by approximately 25% in Q2 relative to Q1. This encouraging trend was driven by increases in new patient starts, refills for patients already on therapy and continued expansion of the CABOMETYX prescriber base. The number of prescribers who have written CABOMETYX through the specialty pharmacy channel increased in Q2 by approximately 30% (11:08). We are also pleased with the growth we have seen in the specialty distributor channel of our business. In addition to strong volume growth in this segment, the number of outlets that have ordered CABOMETYX increased by 20% in Q2. This growth is coming from the dispensing community oncology practices, hospitals and academic institutions as well as government facilities. We're particularly pleased with the growth in the community oncology clinics as we have focused on these key practices. Taken together, these data depict solid fundamentals and momentum of the CABOMETYX business. We are gratified to see that our strategy and approach to the RCC marketplace is producing impactful results. RCC is a mature market with a relatively small number of high volume prescribers, and beyond that, there are a large number of low volume prescribers. Our data indicate that we have already been competing effectively in the high volume segment of the market. So we believe the continued growth we saw in Q2 adoption was driven primarily by community oncologists, suggesting that our promotional efforts are broadening the prescriber base, which continues to be a key strategic focus for the team. Approximately 60% of our growth in…

Gisela M. Schwab - Exelixis, Inc.

Management

Thank you, P.J. I will provide an overview of the development progress in the quarter and cover our activities in support of a regulatory filing for first-line RCC on the basis of CABOSUN, the status of CELESTIAL, our randomized Phase 3 study in second-line HCC and our progress on important new development plans for combining cabozantinib with immune checkpoint inhibitors. I will close with a brief preview of ESMO 2017 taking place in Madrid from September 8 through the trial. First, I'll start with CABOSUN. The randomized Phase 2 trial that compares cabozantinib and sunitinib in the first-line treatment of intermediate or poor-risk RCC patients. Results of this trial were presented at the ESMO Conference last September and published in the Journal of Clinical Oncology later in 2016. This study is being conducted by The Alliance for Clinical Trials in Oncology in collaboration with NCI-CTEP. The trial met its primary endpoint of significantly improving progression-free survival as assessed by investigator in the cabozantinib arm compared to sunitinib. The results showed a clinically meaningful and statistically significant improvement in progression-free survival for cabozantinib as compared to sunitinib. We have recently announced that the analysis based on the independent radiology committee review of the radiographic images from the trial has confirmed the significant improvement of progression-free survival with cabozantinib as compared to sunitinib. We are delighted with this outcome and are on track for an sNDA filing in the near future. We will provide additional updates on progress towards this important goal as appropriate. We also look forward to the presentation of the results at ESMO where it has been accepted as a poster discussion on Sunday, September 10. Second, I'll provide a brief update on CELESTIAL, our Phase 3 study in second line HCC. The randomized, placebo-controlled study is designed to…

Peter Lamb - Exelixis, Inc.

Management

Thanks Gisela. As Mike highlighted in his introduction, we're pleased to have reached the settlement with Genentech regarding the arbitration proceedings relating to the development and commercialization of COTELLIC. We believe that the settlement equitably addresses all concerns and provides a firm foundation for moving the collaboration forward. The new amendment to the collaboration agreement defines revised revenue and cost sharing arrangements that will apply as of July 1 to the currently approved indication for COTELLIC in combination with Zelboraf and will also apply to any future indications for COTELLIC, either as a single-agent or in combination with a Genentech-branded product. Exelixis continues to be entitled to an initial equal share of U.S. profits or losses, which will decrease as sales increase as specified in the original 2006 agreement. However, the revenue applied to the profit/loss statement of the collaboration will now be calculated using the average of the quarterly net selling prices of COTELLIC and any Genentech-branded product or products prescribed with COTELLIC. We will continue to share U.S. commercialization costs with Genentech's portion of the costs now being allocated to the collaboration profit and loss statement based on the number of products in the combination. We will also continue to co-promote COTELLIC in the U.S. and provide up to 25% of the sales force for current and future indications. Outside of the U.S., the terms of the original 2006 agreement remain in effect, with Exelixis being eligible for low double-digit royalties on COTELLIC sales. As a reminder, the cobimetinib development program includes two ongoing Phase 3 clinical trials, the IMblaze370 trial in combination with atezolizumab in third-line colorectal carcinoma, which is fully enrolled in the first quarter of this year and the IMspire150 or TRILOGY trial combining cobimetinib with vemurafenib and atezolizumab in previously untreated BRAF mutant-positive locally…

Michael M. Morrissey - Exelixis, Inc.

Management

All right. Thank you, Peter. I'll close by saying that we made significant progress across the organization in the second quarter and continue to see growth in all aspects of our business. We are pleased with the continued strength of the CABOMETYX launch in advanced RCC, the additional late-stage development activities for both cabozantinib and cobimetinib and are actively exploring numerous opportunities to rebuild our pipeline through internal R&D efforts as well as through in-licensing of external assets where appropriate. Our unwavering focus on disciplined expense management, where new R&D initiatives are aligned with robust growth and product revenues, will continue to be our guiding principle as we move the company forward. As I stated on our Q1 call, we are one team with one mission: to advance medicines to treat patients with cancer, giving them and their families hope for the future. I'm incredibly proud of our team at Exelixis as we continue to work tirelessly to deliver on this mission. Even with all of our recent progress, we are not satisfied knowing that we have much more work to do. I'm excited to reiterate that we have the team and all the elements in place to advance both our science and business with maximal focus and urgency as we tackle the challenges that we will face in the future. We look forward to updating you on our progress. Thank you for your continued support and interest in Exelixis. We're happy to now open the call for questions.

Operator

Operator

Thank you. [Operating Instructions] Your first question comes from the line of Jeff Chen of Cowen & Company. Please proceed. Jeff Chen - Cowen & Co. LLC: Hi. Thanks for taking my question and congrats on all the progress as well as another fine quarter for cabo. Maybe the first one for P.J., if we could. Could you, with cabo being on the market now for a little bit over a year, could you share if there is any kind of difference between the real-world experience versus the trial results from METEOR?

P.J. Haley - Exelixis, Inc.

Management

Sure. Thanks for the question, Jeff. What I would say is that we're, as you kind of mentioned, incredibly pleased with the progress in the quarter that we've had and the continued growth of CABOMETYX, 30% revenue quarter-over-quarter. And really with regards to the experience, I think it's gratifying that physicians and ultimately patients, I think, are experiencing results similar to what we've seen in the METEOR trial, which is really a differentiated profile in RCC with the trifecta of efficacy of overall survival, progression-free survival and objective response rate, and we're really gratified that physicians continue to adopt it. We continue to increase the prescriber base of CABOMETYX. We added another 25% prescribers in Q2 relative to Q1. So very, very pleased with the progress and the way sort of the commercial launch is unfolding as we anticipated relative to the trial results. Jeff Chen - Cowen & Co. LLC: Thanks, that's helpful. And maybe just another one for Mike or Gisela. Notice in your prepared remarks that you mentioned for CELESTIAL, if the second interim is positive, you plan to submit sNDA. But meanwhile you're saying that data cleaning and other preparatory work has been ongoing. Could you kind of provide a little bit of insight on what other preparatory work are you working on, and also why do this at risk basically as the trial is ongoing?

Gisela M. Schwab - Exelixis, Inc.

Management

Thank you for the question. This is Gisela. Well, it is a standard practice and industry run studies to clean data as the study is ongoing because it avoids a long lag between ultimate trial readout and filing potential regulatory filings. So it is much favored to clean early on. And obviously, once an event account is reached, then there is a certain amount of data that needs to be brought into the database and documented by the size, and that again will have to be cleaned. So that's really a standard practice and approach that we're pursuing. Jeff Chen - Cowen & Co. LLC: Got it. Thanks very much.

Operator

Operator

Thank you. Your next question comes from the line of Michael Schmidt of Leerink Partners. Please proceed.

Michael Schmidt - Leerink Partners LLC

Analyst

Hey, guys. Congrats on a good quarter from me as well. Are you seeing use of CABOMETYX outside the second-line RCC setting at this point, for example, in first-line or other indications?

P.J. Haley - Exelixis, Inc.

Management

Yes. Hi, Michael, this is P.J. Thank you for the question; it's certainly been appreciated. As you know, first of all, we only promote our products at Exelixis within the label indication for those products. And with one prior exception, we don't discuss off-label utilization of our products. What I can say, though, is that we continue to have strong performance with CABOMETYX in RCC given the 30% revenue growth and as I mentioned in my prepared remarks, we continue to see an increase in new patient market share in both the second and third line settings, and we see an expansion of the prescriber base. So we feel very good about the business, and we believe we still have opportunity going forward to continue to grow the business by differentiating the product in both the second and third line settings.

Michael Schmidt - Leerink Partners LLC

Analyst

Okay. Fair enough. And a question on the plans, some of the life cycle management activities in combination with Opdivo, specifically in liver cancer. Wondering if the planned, possible, Phase III trial – Phase III combination study in liver cancer. If the decision to run that trial, is that tied by any means to the outcome of the CELESTIAL study or is this an independent decision should you decide to move forward there with Bristol? Thanks.

Gisela M. Schwab - Exelixis, Inc.

Management

Sure. Thanks for the question. So the currently ongoing study that has been started a few weeks ago is really a Phase II trial, evaluating the safety of the combination of cabozantinib plus nivolumab or cabozantinib, nivolumab and ipilimumab. That study is based upon the earlier observations in Phase 2, both for cabozantinib and also for nivolumab, a single-agent with (35:37) activity in this setting. And so we are, obviously, wanting to evaluate the safety and preliminary activity in the Phase 2 trial to set the stage for the next stage development. And in terms of timing, that will likely occur or certainly occur after CELESTIAL will have read out.

Michael Schmidt - Leerink Partners LLC

Analyst

Understood. And one last question. Could you provide any color on timing potentially for data from the Roche trial of COTELLIC with TECENTRIQ in colorectal cancer?

Gisela M. Schwab - Exelixis, Inc.

Management

The COTEZO trial or IMblaze370 – get the number 370.

Susan Hubbard - Exelixis, Inc.

Management

370.

Michael Schmidt - Leerink Partners LLC

Analyst

Yes, IMblaze370...

Gisela M. Schwab - Exelixis, Inc.

Management

Yes, thank you. So Roche has communicated that results for this trial may be anticipated sometime next year with in the positive case, the filing in 2019 and just cannot comment beyond that. So that is for Roche Genentech (36:44).

Michael Schmidt - Leerink Partners LLC

Analyst

Great. Thank you, guys.

Gisela M. Schwab - Exelixis, Inc.

Management

You bet, Mike. Thanks.

Operator

Operator

Thank you. Your next question comes from the line of Andy Hsieh of William Blair. Please proceed. Andy Tsan-Yu Hsieh - William Blair & Co. LLC: Thanks for taking my question and congrats on another stellar quarter. I am curious to hear your thoughts about the increased interest in combination trials with MAC inhibitors. I believe in the past three or four months, there is three collaboration agreements, maybe highlight some differentiating factors. And if my math is right, I believe your program is about three years ahead of competitors.

Peter Lamb - Exelixis, Inc.

Management

Yes, this is Peter. Thanks for the question. So I'll speak a little bit to the interest in combination trials with MAC inhibitors and, of course, you're exactly correct, there has been a real uptick in interest in combining MAC inhibitors with various Immuno-Oncology agents. And this really goes back to some observations – some frequent (37:52) observations originally made by Genentech and I think were extremely compelling unleashed the initialization (37:57) of the trial of cobimetinib with atezolizumab. And what the Genentech scientists were able to show and ultimately publish is that MAC inhibitors obviously use cobimetinib and related molecules in their experiment, but some very interesting effects both on the tumor cells and on tumor-associated T-cells. Essentially they were able to show the inhibition of MAC in tumor cells, increases expression of class 1 MHC. This is, of course, the system that enables presentation of mutant antigens, for example, to the immune system. So it makes the tumor cells more visible to the immune system. That has an effect on tumor cells. And then they are also able to show an increase in tumor – the number of CD8-positive tumor infiltrating lymphocytes in preclinical tumor models following treatment with cobimetinib. And that effect, they tracked down to a natural inhibition of T-cell death. T-cells often die if they're faced with a kind of chronic stimulation situation. And MEC inhibitors include cobimetinib into inhibit that T-cell exhaustion-induced death, if you like. So there were two very favorable things going on and that led to a kind of interesting synergy between PDL-1 inhibitors and cobi in preclinical models. So that led to the sort of the Phase Ib trial with cobimetinib and atezolizumab, that included a variety of different tumor types, included patients with colorectal carcinoma, non-small cell lung cancer,…

Gisela M. Schwab - Exelixis, Inc.

Management

Yes, I think you have it right in that the eligibility criteria for the CELESTIAL trial required for patients have been previously treated with sorafenib, but they could have received other – one other systemic therapy in addition and that wasn't specified so that could have been one of these other agents. And so there will be, in all likelihood, some detail emerging from the trial as well. And I think – so there is no limitation, I would say, with respect to what has been developed around us. Andy Tsan-Yu Hsieh - William Blair & Co. LLC: Cool, thanks. And congrats again.

Operator

Operator

Our next question comes from the line of Edward Tenthoff of Piper Jaffray. Please proceed. Ted A. Tenthoff - Piper Jaffray & Co.: Great. Thank you very much for taking the question and congrats on another impressive quarter from cabo and just all the other accomplishments from the balance sheet and everything else on the clinical side. Most of my questions answered. Quick one on sort of what you're looking at from a strategic basis. Should we sort of let the clinical trials that you guys are currently enrolling and running in terms of combinations with cabo, kind of show us where your interest may be or what kind of assets would you be considering to sort of add to the product portfolio?

Michael M. Morrissey - Exelixis, Inc.

Management

Hey, Ted, it's Mike. Let me say a few words and then I'll, maybe, pass it over to Peter to opine further. As we talked about previously, our main focus right now is using free cash to be able to generate potentially more value with the compounds we have in hand, cabozantinib and potentially cobimetinib. Obviously, we pay for development with cabo. Roche handles that with cobi. Amongst our peers in this commercial oncology biotech base, we're, I think, the only company that actually has two approved oncology agents really on the market right now. So that separates us to a certain degree in terms of kind of what we have in terms of product based assets that we're investing for cabo a lot in right now. And if you look at milestones that are kind of – we'll turn that card over the next 6, 12, 18 months, we've got a lot of balls in the air, which we think, again, if the data is there, can generate a lot of value for patients and for the company and our shareholders. Beyond that, we really want to make sure that as we invest in discovery and internal discovery and then new assets that we can bring in either through partnering or through some kind of acquisition, that they fit a profile that makes sense for where we want to go with the business in terms of using free cash then to drive that value. So we're looking at relatively small opportunities, late preclinical, early clinical data. Once that are not in the kind of on the hot seat from the standpoint of the I-O space that are certainly very competitive from the standpoint of partnering and would bring in a lot of big pharma as well. We're looking to…

Michael M. Morrissey - Exelixis, Inc.

Management

No, that's a great segue and Peter is right here next to me, he can opine upon that easily. So...

Peter Lamb - Exelixis, Inc.

Management

Yes, thanks a lot for that question. That's definitely appreciated. And in addition to the in-licensing acquisition strategy that Mike discussed, we're very much looking to restart discovery. In fact, we are restarting discovery. So that processes has started. We kept a number of the kind of key assets and certainly some key expertise from our kind of decades-long experience of having had a very substantial and intensive internal discovery effort over the years. We still have 4.6 million compound library, which we intend to gain access to, again, going forward. And we have learned a lot from that initial experience. Our thinking going forward is that we're probably not going to rebuild exactly the same kind of discovery organization that we had in the past, things have moved on. Yeah, one of the leaner internal footprints will make more extensive use of a lot of the very excellent external services that are now available. We're going to have a pretty high bar on kind of what we see preclinically in order to move into the clinic. We'll be staying in oncology, obviously. And our thinking is that we're really focused on some targets that have higher levels of validation. I think our historic experience was in line with the rest of the industry. If you jump on targets that look interesting, but are not well validated, they really don't work out. So we use our – I think our speed and our nimbleness to remain competitive in terms of targets that are well validated and probably competitive, but nonetheless attractive. And that's what worked for us essentially historically. I mean, if you look at cabozantinib or cobimetinib, were both well validated (48:40). Ted A. Tenthoff - Piper Jaffray & Co.: Yeah absolutely, good, very cool to hear.

Operator

Operator

Thank you. Your next question comes from the line of Andrew Peters of Deutsche Bank. Please proceed.

Andrew Peters - Deutsche Bank Securities, Inc.

Analyst

Hi, thanks for taking my questions and let me add my congrats on all the progress. So you mentioned a new series of studies as well as ISTs evaluating cabo in other indications. I just wanted to get a sense from a timing perspective, when you could expect to have a better idea on the success or on the outcomes of these studies? I think you specifically mentioned lung cancer as one of the areas of potential discussion. So just wanted to understand from a timing perspective, when we could hear a little bit more on those. And then a related question, do you think these data will inform the decision to start new studies from either Roche or Bristol, or would those studies in indications beyond either bladder, liver or renal? Are those plans ongoing regardless of the outcomes of the ISTs? Thanks.

Gisela M. Schwab - Exelixis, Inc.

Management

Sure, that's a great question. Thank you. So there are, as I mentioned earlier, a number of protocol proposals – actual protocols going through the review and initiation process through the IST and ticket program. This is, obviously, in the hands of the investigators in T Chip. So the timing is not dependent on our touring (50:14) so much as the investigators really coming through is quite a bit of interest, and we see these protocols marching forward. So over the next couple of years, I would think we see a data from these trials emerging. And to your second question, the plans with respect to other trials with immune checkpoint inhibitors that we will pursue internally over the clinical partners are not entirely dependent on the outcomes of these IST and T Chip trials, but maybe in the future, informed by those. But these are in large part parallel activity.

Andrew Peters - Deutsche Bank Securities, Inc.

Analyst

Great, thank you. And then just a quick follow-up. Do you have an update on the potential for getting CABOSUN added to treatment guidelines, if you could just remind us of kind of historically how the process has worked in terms of timelines and any sort of insight you have there. Thank you.

Gisela M. Schwab - Exelixis, Inc.

Management

Sure. This is, obviously, a process that is independent of us, and CCN is one of the key treatment guideline bodies, has their own process, and they're reviewing data as they're being publicly available. And so, the CABOSUN data has been available as you know in September or so of last year through the ESMO presentation and then subsequent through the (51:56) Committee, and CCN reviews these publicly available data and deliberates and makes their decisions entirely independently from us and when ready publishes the decisions and gradings and so on. So we look forward to their deliberations and updates.

Andrew Peters - Deutsche Bank Securities, Inc.

Analyst

Thank you and congrats again on the progress.

Gisela M. Schwab - Exelixis, Inc.

Management

Thank you.

Operator

Operator

Thank you. Your next question comes from the line of Peter Lawson of SunTrust. Please proceed.

Peter Lawson - SunTrust Robinson Humphrey, Inc.

Analyst

Mike, and, I guess, Pete, as you're kind of thinking about rebuilding, at what stage asset are you kind of looking at? Is it preclinical, Phase 1, or how does it fit in with liver and renal?

Michael M. Morrissey - Exelixis, Inc.

Management

Yes, it's Mike. Again, as I mentioned before, with Ted's question, we're really looking in that sweet spot of late preclinical, early clinical Phase 1, early Phase 2, depending upon the asset, the indication, potential combination with either cabo or I-O, et cetera. So we cast a pretty wide net, which I think we believe is appropriate, and we're going through a lot of different assets with fairly deep diligence and financial, commercial analysis as we feel we need to do to be able to prioritize and then execute based upon that priority. So – but again it's all around, as Peter mentioned before, having a pretty thick filter, wanting to maximize our chance of success, either as a single agent or in combination with different modalities, which we think are going to be important as time marches on in this area.

Peter Lawson - SunTrust Robinson Humphrey, Inc.

Analyst

Thank you. And then, P.J, just around, I guess, the off-label scripts, is there any way you can talk through any change you've seen in the percentage of off-label, say with CABOSUN or over time?

Michael M. Morrissey - Exelixis, Inc.

Management

Yes, again, we – this is Mike. We've historically really avoided talking about any kind of off-label utilization or uptake with cabozantinib. We just really don't want to go there from the standpoint of having that dialogue, don't have much to gain by doing that, and certainly whether we're under review or about to be under review, certainly nothing to gain there with the regulator. So fair question, we just don't talk about it. So I think it's probably appropriate that we stay in that pretty narrow range there.

Peter Lawson - SunTrust Robinson Humphrey, Inc.

Analyst

Got you. Fully understand. And then COMETRIQ, kind of a nice bounce back, it seemed. Is that seasonality or I may have missed some comments around that, but it just kind of seemed interesting tick up?

P.J. Haley - Exelixis, Inc.

Management

Yeah. Hi, Peter, this is P.J. With regard to COMETRIQ, I think it was up slightly quarter-over-quarter. As we kind of talked about previously, there were historically RCC patients on COMETRIQ prior to the approval of CABOMETYX. And we knew they would kind of come off and it's kind of coming down to that range that we see as sort of the relative sort of stability in the sort of $6.5 million to $7 million range over the last few quarters. So don't think there is anything really specific with regard to seasonality. I think it's just kind of settled down in that kind of range with regards to that base.

Peter Lawson - SunTrust Robinson Humphrey, Inc.

Analyst

Got you. So we should think about that for the rest of the year, that $6.5 million to $7 million?

P.J. Haley - Exelixis, Inc.

Management

Yeah. I think that's very fair.

Peter Lawson - SunTrust Robinson Humphrey, Inc.

Analyst

Okay. Thanks for taking the questions.

Operator

Operator

Thank you. [Operating Instructions] Your next question comes from the line of Stephen Willey of Stifel. Please proceed. Stephen D. Willey - Stifel, Nicolaus & Co., Inc.: Yeah, thanks for taking the questions and congratulations on the execution. I guess, just a question on CELESTIAL first. I guess, that study is still recruiting. Just wondering if there is any kind of, I guess, maybe soft guidance you might be able to provide with respect to when you expect that study to wrap up from an enrollment perspective? And, I guess, along those same lines, have you seen any change, I guess, in the pace of enrollment, may be specifically through U.S. sites post the availability of regorafenib?

Gisela M. Schwab - Exelixis, Inc.

Management

Sure. This is Gisela. So, the study is still recruiting, but it is wrapping up, as I mentioned earlier on in the prepared remarks. So we're getting very close at this point. And certainly, we'll communicate when the recruitment is completely fulfilled. So again, stay tuned on that one. Stephen D. Willey - Stifel, Nicolaus & Co., Inc.: Okay. And then, I guess, a question on COTEZO. Roche has been speaking pretty enthusiastically about the CEA bispecific and the combination they have now with atezo and I think they were guiding to moving into a pivotal program on their most recent call. So just kind of curious as to whether or not there has been any discussion perhaps between yourself and Genentech maybe as part of this amended agreement with respect to how those two products, if at all, may coexist, how those two combinations?

Michael M. Morrissey - Exelixis, Inc.

Management

Yes, Steve, it's Mike. It's probably best that we don't really discuss publicly what we talk about privately. So we kind of play our COTELLIC communication efforts pretty close to what they say publicly. And we feel like we've got to do that. So it's really hard to answer that question relative to what they've – beyond what they've said about those two different assets separately. So can't help you there, sorry. Stephen D. Willey - Stifel, Nicolaus & Co., Inc.: Fair enough. And then maybe just lastly, I guess, on the frontline renal study that is now enrolling. I guess, it's CheckMate-90R. Just any color as to Takeda's decision not to participate in the funding on that study?

Gisela M. Schwab - Exelixis, Inc.

Management

Sure, Takeda is still reviewing this and obviously it's up to them ultimately to communicate whether they participate, but that is still an ongoing discussion. Stephen D. Willey - Stifel, Nicolaus & Co., Inc.: Okay. So that decision is not yet final there.

Gisela M. Schwab - Exelixis, Inc.

Management

Right, yes. Stephen D. Willey - Stifel, Nicolaus & Co., Inc.: Okay, thanks for taking my questions.

Gisela M. Schwab - Exelixis, Inc.

Management

Thanks Steve.

Operator

Operator

Thank you. At this time, there are no further questions and so I will turn the call over to today's host, Susan Hubbard. Ms. Hubbard.

Susan Hubbard - Exelixis, Inc.

Management

Great. Thank you, Takia, and thank you all for joining us today. We certainly welcome your follow-up calls with any additional questions that you may have, that we were unable to address in today's call.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone, have a great day.