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Incyte Corporation (INCY)

Q1 2016 Earnings Call· Mon, May 9, 2016

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Transcript

Operator

Operator

Greetings, and welcome to Incyte Corporation First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Mike Booth, Vice President of Investor Relations. Thank you. You may begin.

Michael Charles A. Booth - Vice President-Investor Relations

Management

Thank you, Diego. Good morning, and welcome to Incyte's first quarter earnings conference call and webcast. The slides used today are available on the Investors section at incyte.com. Speaking on today's call will be Hervé Hoppenot, our CEO, who will begin with a strategic review and provide further detail on our acquisition of ARIAD European business announced this morning; Barry Flannelly, who leads our U.S. organization, will provide some detail on Jakafi sales during Q1; Steven Stein, Incyte's Chief Medical Officer, will give a brief update on our clinical portfolio; and Dave Gryska, our CFO, will summarize our first quarter financial results, the impact of the ARIAD transaction, as well as our upcoming news flow for 2016. We'll then open the call up for Q&A, for which we'll be joined by Reid Huber, our Chief Scientific Officer. We'd like to remind you that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for 2016 guidance, our expectations regarding the planned acquisition of ARIAD European operations, the commercialization of Jakafi, and our development plans for the compounds in our pipeline. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our 10-K for the quarter ended – for the year ended December 31, 2015, and from time to time in our other SEC documents. I'd now like to pass the call to Hervé for some introductory remarks. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Thank you, Mike, and good morning. So, moving to slide five, let me start with a reminder that Incyte has a very unique profile within the biopharmaceutical industry. As we have a fast-growing top line, we have been cash flow positive for…

Operator

Operator

At this time, we will be conducting the question-and-answer session. Our first question comes from Brian Abrahams with Jefferies. Please state your question.

Brian Abrahams - Jefferies LLC

Analyst

Hey guys. Thanks for taking my question and congrats on all the progress. I guess, my question would be, in terms of timing, what prompted you to seek to expand the European infrastructure at this time versus in a couple of years once some of the Phase 3s for epacadostat and the other programs are a little bit more advanced? And I'm curious if you have any other plans for Iclusig development other than the cost sharing that you suggested. And then, I guess lastly on that front, as we look towards sort of future investment, you mentioned the potential to expand out that infrastructure, what's the right way to be thinking about the potential SG&A impacts going forward? I know ARIAD has mentioned that they plan to save $65 million in expenses next year. Should we be thinking about an additional $65 million sort of an exact offset or other potential synergies or conversely additional investments that you might make that might increase the impact to SG&A beyond that? Thanks. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Okay. Thank you, Brian. Let me try to take it through your question. I think the timing is a very important question, and thank you for asking that. The way we look at our maturation of the portfolio is obviously the initiation of the Phase 3 study with epacadostat is an important milestone, but we're also looking at the advancement of many of our own projects including our JAK1 selective inhibitor 110 in multiple indication, as you know. We also – and you saw some of the data at ACR, moving our Phase 3 kinase delta and our EGFR inhibitor is also now reaching in the Phase 1 stage where we are looking at the next step. So, it's not…

Brian Abrahams - Jefferies LLC

Analyst

Thanks, Hervé. That's really helpful. I appreciate it.

Operator

Operator

Our next question comes from Salveen Richter with Goldman Sachs. Please state your question. Salveen Richter - Goldman Sachs & Co.: Thanks for taking my question. So, I just want to follow up on the earlier question regarding the ARIAD transaction. So, we should assume at this point you're comfortable in the size of investment in the European operations? And could you also give us some color on the $135 million in milestones and what the breakdown is and the threshold levels here? And I have a question on the pipeline to follow up with. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Yes, I'll take these two. Starting with the milestones, the way all the milestones that we have are attached to new indications, some of them are related to the second-line potential indication based on the study versus the nilotinib. And some of them are attached to potential indications that could be in oncology or outside of oncology. So, it's a very broad field, obviously we don't know yet if there is there is or will be any effort in any of these indications. So, that's where the – except for the second-line Tasigna that we discussed. I don't think we will be disclosing exactly the details by indication, so that gives you the perspective, which for us, is basically that we have a base case based on the current indication that works for us, and we see everything else coming in addition to that as a upside from that base case. In terms of the size of the infrastructure in Europe, which was your first question, we are very comfortable with where it is. It's well spread across a number of countries where we want to be able to actively develop our products, and that will…

Operator

Operator

Thank you. Our next question comes from Michael Schmidt with Leerink Partners. Please state your question.

Michael Schmidt - Leerink Partners LLC

Analyst · Leerink Partners. Please state your question.

Hey, good morning. Thanks for taking my questions. Hervé, I had a follow-up on the ARIAD transaction. Given that there is still some time, as you mentioned, until your in-house sort of products could come online in Europe, how do you think about adding additional commercial or new commercial products to that existing infrastructure via business development? Hervé Hoppenot - Chairman, President & Chief Executive Officer: Yeah. Thanks, Michael. You're right. I mean it's something we don't sort of predict because, as you know, every BD&L is always an adventure on the anniversary of the result, but it has been the case that when we were looking at opportunities in the past, just having a footprint in the U.S. only was in fact a problem for the partners who were looking for somebody to commercialize their product on a broader basis. So, it was a little bit of a catch-22 where you don't have the team, you don't get the product. And if you don't have the product, you don't have the team. So, what we have now is a very efficient way to have a high-quality group of people, an interesting product that is growing and obviously, it will open new opportunities. And as we have always said, I mean we look at different options and if something seems to make sense from the strategic and financial standpoint, we will do it. But we don't need to do it, I mean, the way we are now deployed in Europe and the U.S., we have teams that obviously in the U.S. generating a lot of income from Jakafi. And in Europe, we'll have a team with a growing top line and interesting product and covering most of the cost from that Iclusig business. If we can have something else, it would be in addition to some upside on that scenario. But the best scenario now is very good and I think will help us maximize our launches when they come.

Michael Schmidt - Leerink Partners LLC

Analyst · Leerink Partners. Please state your question.

Okay. Thanks. And then, a question on the GVHD opportunity. You had some information there on an incident prevalence, I mean just – could you share some more information on the size of that opportunity, and especially is that a chronic type of therapy paradigm? Or is it a sort of a one-time treatment? And also what duration of Phase 3 development do you foresee for that product? Barry P. Flannelly - Executive Vice President & General Manager: Well, this is Barry. And maybe I'll hand it over to Steven for more information. But in terms of the opportunity, there's 21,000 stem cell transplants in the United States alone, about half of those are autologous, another half are allogeneic. If the allogeneic patients that end up having the GVHD, fewer patients have acute GVHD, and then more patients have chronic GVHD. And the way it generally breaks down is that then those patients who have acute GVHD might have a shorter duration of therapy and chronic GVHD might have a longer duration of therapy. We think it's an exciting opportunity, and we hope to help a lot more patients with GVHD as we hopefully successfully develop this drug. And I'll hand it over to Steven to answer the question about Phase 3 development. Steven H. Stein - Chief Medical Officer & Senior Vice President: Yeah. Thanks, Barry. And then, just in terms of the question, one of our slides in the presentation alluded to incidents in the U.S. of new patients of 7,000, about half acute, half chronic. And then in terms of prevalence, about 10,000 patients with chronic GVHD. In terms of development plans, obviously as Hervé said, we have an ongoing study with our JAK1 inhibitor 39110 which is in Phase 1 safety tolerability at the moment in GVHD. And now with the acquisition of the ruxolitinib rights and already having achieved, if you will, a proof-of-concept with the external data, we're developing registration plans. The ruxolitinib proof-of-concept data is in steroid refractory, acute on chronic graft versus host disease. So, that's the likely area of development there. And then, we will discuss our own 39110 development plans because there are other entities to consider. There is still first-line acute GVHD, and there's still potential for prophylaxis in this setting. So, those are the areas we're considering at the moment.

Michael Schmidt - Leerink Partners LLC

Analyst · Leerink Partners. Please state your question.

Okay. Great. Thanks very much.

Operator

Operator

Thank you. Our next question comes from Cory Kasimov with JPMorgan. Please state your question.

Morgan T. Haller - JPMorgan Securities LLC

Analyst · JPMorgan. Please state your question.

Hey. Good morning, guys. This is Morgan on for Cory. Actually, a quick question on the further development of Iclusig. How does that kind of fit into what the rest of everything you have going on with the pipeline, just with the bandwidth you have? And then, I've a follow-up. Steven H. Stein - Chief Medical Officer & Senior Vice President: Yeah. It's Steven answering you, Morgan. In terms of Iclusig, as Hervé said, there is ongoing work to do in the actual indication within chronic myeloid leukemia. There is a reasonable amount of safety evidence that dose ranging work may alleviate some of the toxicity as regards arterial occlusive disease. So, executing that study will be very important across three dose ranges. And then, there is ongoing effort, as Hervé always said as well, in second-line chronic myeloid leukemia head-to-head against nilotinib. In terms of further development, it's a relatively promiscuous agent in terms of different kinases that it does hit, and what's now the setup of a joint development committee with areas, we'll have to discuss those opportunities going forward, whether they're areas of interest to explore or not. But it's really too early to say more about that at the moment.

Morgan T. Haller - JPMorgan Securities LLC

Analyst · JPMorgan. Please state your question.

(37:05). Hervé Hoppenot - Chairman, President & Chief Executive Officer: And maybe just to complement that in terms of how does it fit with the rest of the portfolio, we don't see – there is no overlap. I mean, these two studies are already ongoing, and it's not going to compete with the rest of the portfolio. It's a project that would be managed in a totally separate manner than the rest.

Morgan T. Haller - JPMorgan Securities LLC

Analyst · JPMorgan. Please state your question.

Okay. Great. And then, I just want to confirm that the guidance of $25 million to $30 million is for post close, is that correct? Hervé Hoppenot - Chairman, President & Chief Executive Officer: Yes.

Morgan T. Haller - JPMorgan Securities LLC

Analyst · JPMorgan. Please state your question.

Okay. Great. Thanks a lot. I appreciate it.

Operator

Operator

Our next question comes from Geoff Meacham with Barclays. Please state your question.

Unknown Speaker

Analyst · Barclays. Please state your question.

Hey, good morning, guys. This is Carter on for Geoff. Thanks for taking our questions. I've got one on strategy. I appreciate the cost efficiency on today's deal and sort of the optionality it gives you in terms of involving EU sites and maximizing the launches. Was there any sense given to how this maybe changes prioritization of certain indications and thinking specifically on IDO? And then, on the GVHD opportunity, could you speak about the strategy of moving forward to both the 110 and ruxolitinib, given your motivations and – on the economics and the partnership with Novartis? Thank you. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Maybe on the first one, no, it has absolutely no impact. I'm sorry, I was – it has absolutely no impact on rethinking the IDO indication between hematology and oncology. I mean these are completely separate. I think there is – obviously, a lot of our pipeline that is in hematology, there are a number of solid tumor indication where we are looking at it. And Iclusig is not changing any of the balance between oncology and hematology in our pipeline. And maybe, yeah, if you can speak about the GVHD development. Steven H. Stein - Chief Medical Officer & Senior Vice President: Sure. It's Steven again. Thanks, Hervé. So, just to reiterate and maybe go a bit slower, in terms of graft versus host disease, there are at least four entities. There is steroid refractories. Steroids, particularly prednisone, is first-line treatment. But if you get steroid-refractory acute graft versus host disease and after about 100 days of this devastating medical condition, you can get what's called chronic graft versus host disease which is also steroid refractory. So, those are two separate entities. And then, there is also first-line acute graft versus host disease when patients are treated for the first time before they become refractory to steroids. And then, there is a fourth potential entity where you can actually think about prophylaxing for the condition in people post allogeneic bone marrow transplant who had high risk to develop graft versus host disease. So, all four of those are being considered. What I said in my earlier comments with ruxolitinib that the data published last year in Leukemia and presented at ASH, they have presented, if you will, proof-of-concept data for ruxolitinib in both of the first two entities, steroid-refractory acute and steroid-refractory chronic graft versus host disease. So, those are the likely areas of the development for ruxolitinib. And then for 39110, we would be considering the other entities. And that's where we are at the moment. And I hope that answers your question.

Unknown Speaker

Analyst · Barclays. Please state your question.

Just a quick follow-up. Does the Novartis deal preclude from moving forward with 110 in those earlier settings? Thank you. Hervé Hoppenot - Chairman, President & Chief Executive Officer: No, it does not.

Unknown Speaker

Analyst · Barclays. Please state your question.

Thank you.

Operator

Operator

Our next question comes from Ying Huang with Bank of America Merrill Lynch. Please state your question. Ying Huang - Merrill Lynch, Pierce, Fenner & Smith, Inc.: Hey, good morning. Thanks for taking my questions. I have one for housekeeping question. Does your Jakafi revised guidance for 2016 include any pricing increase for the rest of the year? And then secondly, how important is the second-line CML indication for Iclusig in Europe for you in terms of decision making in license their rights? Thanks. Barry P. Flannelly - Executive Vice President & General Manager: So, it's Barry. Obviously, we took price increase on April 1, and we don't really discuss our pricing strategy going forward after that. Hervé Hoppenot - Chairman, President & Chief Executive Officer: So, let me take that one on the second-line indication. The way our deal is constructed in fact makes it such that it works with and without the second-line indication. It works differently with the current indications that we have. And Iclusig is growing relatively fast in Europe, it's still in the launch – prelaunch mode in many of the countries as it is being reimbursed. And assuming there is no second-line indication, it will give us enough resources to cover the costs of the infrastructure. If we get the second-line indication, it's going to trigger our milestone payments as we have discussed and it's going to obviously increase the potential top line and it would be an upside to the base case, but both base case and the upsize case reaching our strategic objective which is to get the team in Europe to be self-funded in some way. Ying Huang - Merrill Lynch, Pierce, Fenner & Smith, Inc.: Thanks, Hervé. And then, if I may just squeeze in one follow-up on the data release. So, it doesn't sound like you guys have any significant update at ASCO, should we assume the next meaningful update for epacadostat at ESMO? Steven H. Stein - Chief Medical Officer & Senior Vice President: Yeah, it's Steven. So, you're right in that we are leading to the second half and we can't comment on what will be at ESMO until the abstracts are released, but that is the second half of the year is where we're targeting presenting more data. Ying Huang - Merrill Lynch, Pierce, Fenner & Smith, Inc.: Thank you for the color.

Operator

Operator

Thank you. Your next question comes from Ian Somaiya with BMO Capital Markets. Please state your question.

Unknown Speaker

Analyst · BMO Capital Markets. Please state your question.

Hi, this is Nathan for Ian. Thanks for taking the question. So, starting off with the ARIAD deal, how should we think about the buyback contingency plan within the deal? And then, could you comment on any tax implications of the deal and whether you may be able to see any tax advantages from an EU operations perspective? And then, I have a question on the pipeline. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Okay. Thank you. I'll take the buyback. I mean obviously, you can – you'll realize, and I think it's very rational that it was very important to ARIAD because in their overall strategic approach to the company which is basically we group resources in the U.S. territory. It makes sense to have this transaction about the European business done because it will reduce their spending and it just happened and it's also a very good deal from our side for all the reasons that we have discussed. So, I think it's a case of complementarity. And then, came this issue of what if somebody is willing to acquire ARIAD, so it's based on the charge of control of ARIAD, and is interested in the European business. So, we came up with this buyback option that is part of our agreement and the buyback option is obviously responding to their needs and is built in such a way where there is timing, so it can happen basically between three year and six year of that (44:45) signature of the deal. So, it gives us a certain amount of time to get prepare for that in case it were to happen, and it's based on financial terms that have been discussed, where there would be all the milestones that have been paid plus additional milestone based on the past 12 months of sales plus forward royalties of 20% to 25%. So, in some way, it was sort of meeting everybody's needs where there is a delay of a number of years, it's still allowing a potential buyer of ARIAD to have access to Iclusig, and it's giving us financial condition that would be certainly somewhat favorable. So, that's how it was built, and I think it's meeting everybody's needs in this transaction. David W. Gryska - Chief Financial Officer & Executive Vice President: On your second question, it's Dave, on the tax, there will be some tax efficiency because ARIAD does have some net operating losses that we will carry forward to us on the acquisition of the entity. And to the extent that the profits that this enterprise creates in the future are enough to offset the NOLs, we do have some NOLs in our entity that we started in Switzerland, so there is some tax efficiency that will be – that will benefit from by this acquisition.

Unknown Speaker

Analyst · BMO Capital Markets. Please state your question.

Great. And then, on the pipeline, can you help us understand, how your early-stage oncology portfolio fits together and how you plan to develop these drugs, and what data you have generated so far that could help direct development of combinations within the pipeline? Thank you. Reid M. Huber - Chief Scientific Officer & Executive VP: Yeah. Hi. This is Reid. Thanks for the question. So, as we've brought forward discovery programs and now into early development programs over the last four years to five years, there has been a concerted effort by the team to build and nucleate around certain aspects of the portfolio. One of those is really around JAK inhibition where we've had, I think, a long-standing leadership position beginning with ruxolitinib and baricitinib in JAK1 and JAK2 inhibition, but now more recently into more evolved profiles like JAK1 selective inhibition. Those agents with, I think, clear opportunity in hematologic malignancies offer us the opportunity to build around them and bring forward other agents which are very interesting in their own right and have their own potential development programs, but also leverage the JAK inhibitor space. And one example of that is PI3Kδ, and we've presented over the years a lot of the pre-clinical data and even some clinical data last year at ASCO that helps to reinforce the interest in that particular doublet, and that will be one that we continue to explore in the clinical setting. Beyond just JAK1 and delta, it's also given us the opportunity to bring forward mechanisms like PIM inhibition which really works as it correlate to delta inhibition, they are active on the exact same pathway and are sort of reciprocally regulated. And so, a PIM inhibitor in our portfolio makes a lot of sense and would allow us to do interesting things in the combinations base, again much of which we've presented over the years publicly. And finally, LSD1 and BRD, two epigenetic mechanisms both with a potentially important role in leukemias and potentially also in lymphoma for BRD again just build around that portfolio philosophy quite well. And the exact same thing is happening on the immuno-oncology side. Again, they are nucleated around IDO inhibition where we now have brought forward our first GITR agonist, soon an OX40 agonist and also in licensed a PD-1 inhibitor, and from a small molecule side began to explore some very novel biology around JAK and PI3-kinase delta inhibition on modulating the local inflammatory environment to provoke immune cell function. So, I think that you can look at our portfolio and hopefully see that around targeted therapies and immunotherapies, there is actually a very strong effort to bring forward mechanisms, which not only have their own potential monotherapy approaches, but also very much leveraged the adjacent molecules in our portfolio. And the idea frankly is to create a portfolio where the value and the totality is much greater than the simple some of the parts.

Unknown Speaker

Analyst · BMO Capital Markets. Please state your question.

Great. Thanks for the color and congrats on the deal.

Operator

Operator

Thank you. Our next question comes from Eric Schmidt with Cowen & Company. Please state your question. Eric Schmidt - Cowen & Co. LLC: Thanks. Good morning. Just a quick clarification question for Barry on the volume growth of Jakafi in the quarter. I think the slide says 13% growth. You autobold in your scripts 7% quarter-on-quarter growth, was there also some inventory stocking going on? Barry P. Flannelly - Executive Vice President & General Manager: No, the slides are referring to millions of dollars, so it's $13 million one way, $12 million the other way. Eric Schmidt - Cowen & Co. LLC: (49:56) Thank you. And... Barry P. Flannelly - Executive Vice President & General Manager: So, a 7% demand growth, I should say, as I said in the script. Eric Schmidt - Cowen & Co. LLC: Got it. And then, maybe for Steven, as you think about making a go, no-go decision and something like lung cancer for epacadostat, I think you've committed doing that before year end. Do you need to see the data from the ongoing PD-1 studies and first-line lung cancer given maybe dynamic nature of that tumor type? Steven H. Stein - Chief Medical Officer & Senior Vice President: Eric, Yeah, it's Steven. Thanks for your questions. So, again, 600 patients, 13 histologies, we'll have data availability across the second half of this year, and lung is one of those histologies where we will be looking closely and making decisions based on data. I – in terms of your question where we need to see first-line data to make decisions, to be honest here, it would be helpful. But I don't think we have enough historical controls and enough date already across many, many agents that I think we have to be able to make rational comparisons using things like response rate, so it's not an absolute. Eric Schmidt - Cowen & Co. LLC: Thank you.

Operator

Operator

Our next question comes from Liisa Bayko with JMP Securities. Please state your question.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities. Please state your question.

Hi there. Just strategically, I was wondering if you could kind of compare contrast the idea of acquiring ARIAD versus perhaps doing an acquisition like this, and might this be part of a longer-term strategy with respect to acquiring ARIAD? And any tax implications too would be helpful. Thank you. Hervé Hoppenot - Chairman, President & Chief Executive Officer: I think, I mean you have to do – to put it from our needs standpoint. I mean we have already a very large portfolio of projects in our pipeline. I think we have a strong discovery team for small molecule. It has been very productive over a number of years. So, our discussions were very much about what we need and we don't have, which is an organized European platform with infrastructure with medical team across the different countries, commercial team, and market access. I think it just happened that it was strategically something that ARIAD was interested in discussing for the reason I was explaining. And I think for the reason they have also communicated this morning that they are trying to concentrate their resources into U.S. to be ready to not only grow Iclusig, but also some of the pipeline products that may be coming soon. And that's where the discussion was centered, in fact. So, I see it as a deal that has a lot of win-win qualities for both organization and where we get really what we were looking for, which is related to our European infrastructure and being able to maximize our products there.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities. Please state your question.

Okay, thank you. That's helpful. And then, just a technical question, you mentioned amortizing the product rights for Iclusig, what period of time should we think about that over? David W. Gryska - Chief Financial Officer & Executive Vice President: That will be over – it's Dave speaking. Liisa, it will be over the life of the patent, and it will straight line.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities. Please state your question.

And when do the patents end, can you remind us your assumptions are there? David W. Gryska - Chief Financial Officer & Executive Vice President: The patents end in 2026.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities. Please state your question.

Okay. Thank you. And then, if you could just comment at all on – I know Concert put forward this oral JAK molecule that's (53:45) for alopecia, can you comment on any IP and kind of plus minus benefits on topical versus oral for that alopecia indication? And that's my final question. Thank you. Reid M. Huber - Chief Scientific Officer & Executive VP: Yeah. Sure, Liisa. This is Reid. Just – so on the IP side, so our patent applications for ruxolitinib do disclose an embodiment that includes all isotypes – isotopes of atoms occurring in the compounds for the invention, and that specifically includes isotypes (sic) (isotopes) (54:18) of hydrogen such as tritium and deuterium. So, we're very confident in the patent, at this state, we have around ruxolitinib. And we'll clearly look to protect that if it makes sense. In terms of the oral versus topical, we're doing a study right now with topical ruxolitinib, so we'll answer that question clinically in terms of how that formulation looks in that method of delivery relative to oral therapy. Obviously, on any oral therapy particularly in a condition like this one has to be particularly cautious around safety implications in this sort of a disease, and that's really what drove our interest in the topical formulation. And there's a considerable proportion of the patient population where a topical formulation could address the significant unmet need. Obviously, an oral therapy could be more appropriate for much more widespread disease and maybe effective there but it has to be balanced with the safety risk that come from oral JAK inhibition in those types of patients.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities. Please state your question.

Thank you.

Operator

Operator

Our next question comes from Ren Benjamin with Raymond James. Please state your question. Reni Benjamin - Raymond James & Associates, Inc.: Hi. Good afternoon – good morning, guys. Thanks for taking the questions. I guess just one for me regarding the ECHO-301 study. Can you just talk a little bit about obviously the co-primary endpoints. Do both need to hit for an application or is there a potential strategy for – if you get the PFS first and application going in and waiting for the OS, or how are you thinking about it? Steven H. Stein - Chief Medical Officer & Senior Vice President: Hey, Ren, it's Steven. The ECHO-301, as you – the Phase 3 in first-line melanoma does have co-primary end points of progression-free survival and overall survival, and it doesn't have to be both. We could fall with a benefit in either. So, that's why we estimate data availability in 2018, and obviously that's based on the PFS endpoint. Reni Benjamin - Raymond James & Associates, Inc.: Got it. And then, maybe just going back to the ARIAD deal real quick, how many countries is Iclusig approved in, and as part of the strategy to either expand further in terms of building sales forces in individual countries? Hervé Hoppenot - Chairman, President & Chief Executive Officer: So, I can speak with the territories that we have organized this transaction around. So, it's approved at the European Union level, so that's where the technical approval is taking place. And then, there is a reimbursement that is done country by country. So, in term of the European Union, the reimbursement is obtained now in some of the large counties like Germany, but it still work – and Italy, which is obviously a very fast-growing country for Iclusig. But it's still not fully obtained, as you know, in France, there is a situation where you can have an ETU, you can basically sell the product before it is fully reimbursed but there is a clawback that is taking place at the time of reimbursement, and it's anticipating – anticipated to be happening relatively soon. And some of the other countries are still in the process of getting reimbursement, inside the EU. And then, in our agreement, there are countries outside of the European Union, like Russia is one of them, where we will have to find a partner which is probably what we will be doing to go through the entire process of approval and reimbursement. Reni Benjamin - Raymond James & Associates, Inc.: Great. Thank you, guys.

Operator

Operator

Thank you. Our next question comes from Andrew Berens with Morgan Stanley. Please state your question. Andrew Scott Berens - Morgan Stanley & Co. LLC: Hi. Thanks. Good morning, guys. Two questions, one on epacadostat and then one on Iclusig. As we prepare for the PFS data in melanoma later this year, I guess the first quarter of next year, how should we think about the benchmark commercially for the combination therapy, not just versus Keytruda but also maybe some of the other data that are out there for combination IO therapy? Steven H. Stein - Chief Medical Officer & Senior Vice President: Yeah. Hi, Andrew. It's Steven. So, just to be clear, so we – the ECHO-301 PFS data will be most likely 2018. Later this year, as I said earlier, we hope to be able to update our Phase 1 data that we presented at SITC and SMR last year. We'll have enough additional scan data to update that. In terms of the benchmarks, obviously, there is regulatory and then there is the clinical benchmark and you alluded to the latter. From a regulatory point of view, we will have to beat the labeled pembrolizumab monotherapy PFS of around six months, but the de novo of AP (59:23) clinical benchmark in the same setting is around 11.5 months, So, those are the sort of numbers we're thinking off. And then, there is a bunch of new answers around PD-L1 positivity, et cetera, which can come in. You just have to be really careful that you compare in an apple-to-apple in terms of the data sets and the staining that you're using. But we think about it mostly in terms of those two numbers I just alluded to. Andrew Scott Berens - Morgan Stanley & Co. LLC: Okay. And…

Operator

Operator

Ladies and gentlemen, we are out of time for questions. I will now turn the conference back over to Mr. Hoppenot for closing remarks. Thank you. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Okay, Yes, thank you. Thank you all for your time today and for your questions. I think it's a day today where we're sure that we have made three bigger steps for a while. I mean, one is obviously the growth of Jakafi in the U.S. because it's important to see that now we are a year after the launch in PV, and we are still growing very dynamically with both in PV and in MF. I mean, we spoke about second big step which is a progress of our pipeline, we are planning to initiate two pivotal study soon or over the next few months with epacadostat in first-line melanoma and with ruxolitinib in GVHD, and I think it's really important. And as you see, the third big step was now establishing Incyte firmly as a transaction-fee company with an organization in Europe. And as I said at the beginning, our goal with that organization is really to narrow the powerful and successful organization that we have in the U.S. with established now five years or six years ago, and be able to make sure that we maximize our launches when our products are maturing, and also grow Iclusig that has a lot of potential to grow as it's still in a phase of the launch that is relatively early. So, I think, it was a very exciting few weeks and months for us in the beginning of the year, and I'm looking forward to sharing our progress with you later this year or with Q2 call by midyear. Thank you.

Operator

Operator

Thank you. This concludes today's conference. All parties may disconnect. Have a good day.