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Incyte Corporation (INCY)

Q4 2015 Earnings Call· Thu, Feb 11, 2016

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Transcript

Executives

Management

Michael Charles A. Booth - Vice President-Investor Relations Hervé Hoppenot - Chairman, President & Chief Executive Officer Barry P. Flannelly - Executive Vice President & General Manager Richard S. Levy - Chief Drug Development Officer & Executive VP David W. Gryska - Chief Financial Officer & Executive Vice President Reid M. Huber - Chief Scientific Officer & Executive VP Steven H. Stein - Chief Medical Officer & Senior Vice President

Analysts

Management

Matt M. Roden - UBS Securities LLC Salveen Richter - Goldman Sachs & Co. Carter Gould - Barclays Capital, Inc. Brian Abrahams - Jefferies LLC Cory W. Kasimov - JPMorgan Securities LLC Eric Schmidt - Cowen & Co. LLC Ying Huang - Bank of America Merrill Lynch Charles Butler - Guggenheim Securities LLC Christopher Marai - Oppenheimer & Co., Inc. (Broker) Joseph R. Klein - Gauss Capital Advisors LLC Liisa A. Bayko - JMP Securities LLC Reni Benjamin - Raymond James & Associates, Inc. Alethia Young - Credit Suisse Securities (USA) LLC (Broker)

Operator

Operator

Greetings, and welcome to the Incyte Corporation Fourth Quarter and Year-End Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. It is now my pleasure to introduce your speaker, Mr. Michael Booth. Thank you, you may begin.

Michael Charles A. Booth - Vice President-Investor Relations

Management

Thank you, Danielle. Good morning, and welcome to Incyte's fourth quarter and full-year 2015 earnings conference call and webcast. The slides used today will be made available for download on the Investor section of incyte.com following the call. Speaking on today's call will be Hervé Hoppenot, our CEO, who will begin with a strategic review and highlight our progress during the last 12 months; and then Barry Flannelly, who leads our U.S. organization, will provide a commercial update on Jakafi. Rich Levy, who is in charge of Incyte's drug development activities, will give a brief update on our clinical progress, and Dave Gryska, our CFO, will summarize our fourth quarter and full-year 2015 financial results. Dave will also outline our financial guidance for 2016. We'll then open up the call for Q&A, for which we'll be joined by Reid Huber, our Chief Scientific Officer, and by Steven Stein, Chief Medical 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, 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-Q for the quarter ended September 30, 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? Hervé Hoppenot - Chairman, President & Chief Executive Officer: Thank you, Mike. Good morning, everyone. Thank you for taking the time to participate in our call today. First, let me briefly cover the disappointing news we announced this morning that we are discontinuing our ongoing studies of ruxolitinib in solid tumors.…

Operator

Operator

Thank you. We will now be conducting a question-and-answer session. Our first question comes from Matt Roden with UBS. Please proceed.

Matt M. Roden - UBS Securities LLC

Analyst

Great. Hi, guys. Good morning and thanks for taking the question. First on the guidance, I might have thought that shutting down the JAK and solid tumors program might have given you a little bit of a break on the growth of R&D but we recognize you have several other programs ongoing, including epacadostat. Just trying to get a sense for whether or not or to what extent there's any of the existing JAK1 and JAK2 trials still in that R&D guidance and whether or not that would be – your R&D guidance is aggressive or conservative. And then if I'm allowed I have a pipeline follow-up. Thanks. David W. Gryska - Chief Financial Officer & Executive Vice President: Hi, Matt. That's a great question. This is Dave. Our guidance includes the results from today's press releases. When you look at our guidance in terms of R&D expense, there's a lot things going on in our pipeline, a lot of value to be built for shareholders, and we believe that the guidance is appropriate and the investments we're making in the pipeline that Rich talked about today are right in line to where we have to go for our long-term plans. So there is no, I would say, conservatism in that number. It's a number that we looked at and we thought is about appropriate for where the year is going to be.

Matt M. Roden - UBS Securities LLC

Analyst

Okay. Great. Thanks for that clarity. And then on the pipeline side, specifically on the IDO program, we understand that you guys want to present results when you have a certain critical mass of data. But we also know that these are open-label studies and you can probably have a sense of what you're seeing along the way. So can you just talk in very general terms about whether or not the emerging data up until today still support the initial conclusions you've drawn on IDO and checkpoint combos in terms of efficacy and safety? And then related, Rich, if you could just amplify your prepared comments on the triggers for starting additional Phase III studies. Just curious if there's competition between your collaborators about getting into lung cancer first, and at this point whether or not you would be able to rule in or rule out starting a Phase III in lung this year. Thanks. Richard S. Levy - Chief Drug Development Officer & Executive VP: Thanks, Matt. So in terms of the data, let's first deal with melanoma. So as I said in my prepared remarks, the emerging data in melanoma remains consistent with what we've presented before and continues to support our conclusions both in terms of efficacy and safety. And we remain fully confident in our decision to start the Phase III study in melanoma with Merck within the next few months. With respect to decisions on other programs, as you know we have very little data in any of the other tumor types, none of which was able to allow us to make a decision based on the dose escalations in the Merck study or, for that matter, in any of the other studies. We're going to be enrolling a total of about 900 patients. We expect to enroll about 600 of them this year in the 13 different tumor types. And it doesn't mean that we need to get to the end and have scans on 600 patients to 900 patients. What that trigger will be will depend upon the data in terms of relative response rates and other information that we have. So in no sense are we saying that there's no trigger for a Phase III this year, but we're also saying that there's not enough data to present or submit abstracts to scientific meetings that will occur within the first half of 2016. I can't really comment specifically on competition between the companies, but it is clear that it is not one or two companies that have interest in things like lung cancer and other tumor types.

Matt M. Roden - UBS Securities LLC

Analyst

Great. Thanks very much for the added color.

Operator

Operator

Our next question comes from Salveen Richter with Goldman Sachs. Salveen Richter - Goldman Sachs & Co.: Thanks for taking my question. Just wanted to get a sense of the Q4 organic growth. So if you exclude the price increase and just maybe give us a sense of inventory here. And then when you look out to 2016, what's the contribution from PV versus existing MF demand? And then I just have a follow-up on the JAK1 studies. Barry P. Flannelly - Executive Vice President & General Manager: Hi, Salveen. This is Barry. So getting to Q4 first, so we took a 4% price increase at the end of September, so that's built into it. But we really – our demand – our inventory remains constant at about three weeks. So there wasn't a big inventory build in the fourth quarter, so you can figure out what the rest of the demand is for Q4. And then for the rest of the year... Salveen Richter - Goldman Sachs & Co.: For 2016, just in terms of contribution from the PV ramp versus MF demand. Barry P. Flannelly - Executive Vice President & General Manager: Okay. So PV patients, as we know, continue to grow rapidly. At a certain point very soon, new PV patients will exceed myelofibrosis patients. But we have a very big base of myelofibrosis patients that continue to stay on therapy. So MF will continue to contribute to the top line, and PV patients will eventually – and PV sales – will eventually exceed the MF sales that we have now. Salveen Richter - Goldman Sachs & Co.: And then – sorry about that. But finally, just in solid tumors, we recognize that JAK1 studies are based on immune-modulating hypothesis, and that's different from the high-inflammation hypothesis…

Operator

Operator

Our next question comes from Geoff Meacham with Barclays.

Carter Gould - Barclays Capital, Inc.

Analyst · Barclays.

Hi, guys. This is Carter on for Geoff. Thanks for taking our questions. First on epacadostat, I appreciate the earlier color on your plans to report out data in 2016. Just wanted to clarify, should investors expect clinical data from each of the remaining PD-1/PD-L1 combination studies in 2016? And then real quickly for Dave and Barry on the SG&A guide, obviously we saw SG&A reset higher following the PV approval but we're still looking for 2016 at a pretty good growth clip, 30% plus, when I think both (27:24 – 27:29). Can you maybe talk about the projected drivers for that spend in 2016? Thank you. Barry P. Flannelly - Executive Vice President & General Manager: Hi. So it was a little bit hard to hear. There was a lot of static on the line. But with respect to the data from the epacadostat trials in 2016, I don't specifically know yet whether every one of the four collaboration trials will have data in the second half of 2016. We used the word that we would be starting to present data in the second half of 2016. But until we see how those studies enroll and whether the data gives a clear picture, we don't know that all of them will come out in the second half of 2016. David W. Gryska - Chief Financial Officer & Executive Vice President: Hi. It's Dave. On the question on the SG&A guidance, it's a mix of many different things for this year. There is a slight element in there for our work that we're doing in Europe in building that out as well as what we're doing here in the U.S. to build out further Barry's team and some more marketing expenses, plus some G&A expenses. So we're getting ready for our growth in the future years, we're making some investments this year. And I think right now, as we look at it, it's right in line with our expectations for the year.

Carter Gould - Barclays Capital, Inc.

Analyst · Barclays.

Thank you.

Operator

Operator

Our next question comes from Brian Abrahams with Jefferies.

Brian Abrahams - Jefferies LLC

Analyst · Jefferies.

Hi. Thanks very much for taking my question. A couple of questions on epacadostat. You discussed the melanoma Phase III trial design in your slide deck. Wonder if you could expand on that a little bit more in terms of potential size, timing, costs there, whether this is – one single Phase III would be sufficient, and clarify that that will not have a CTLA-4, PD-1 control arm. And then separately, I know we're expecting to see data from several other companies, combination studies with multiple checkpoints this year. I'm curious if there's any preclinical data or clinical plans to test epacadostat on top of multiple checkpoints. Thanks. Richard S. Levy - Chief Drug Development Officer & Executive VP: Thanks, Ryan. So with respect to the Phase III melanoma design, we're not going to get very specific about this until we post the results on clinicaltrials.gov a little bit later in the year. I will say, however, that what we have guided to is that the study will be epacadostat plus pembrolizumab versus a control of pembrolizumab alone. The study will be typical for Phase III studies, but I can't – in terms of size and cost. Of course, that cost will be shared 50/50 with Merck. And in terms of combinations of a number of our drugs in our portfolio which have immunologic approaches, which is by no means limited to epacadostat, at this point we are interested and we have plans to start to study not only epacadostat with other drugs in our own portfolio as well as drugs in our own portfolio with PD-1s. And as our own portfolio matures, we do plan to look at combinations. But we don't have anything to announce at this point in time with respect to anything beyond what we've specifically guided to in the past. I don't know if Reid wants to add anything. Apparently not.

Brian Abrahams - Jefferies LLC

Analyst · Jefferies.

Thanks.

Operator

Operator

Our next question comes from Cory Kasimov with JPMorgan.

Cory W. Kasimov - JPMorgan Securities LLC

Analyst · JPMorgan.

Hey. Good morning, guys. Thank you for taking my questions. I'll stick with the two-question theme here. So I guess first probably for Reid, in addition to your R&D event what can we be expecting at AACR in terms of potentially new data? And then I have a follow-up. Reid M. Huber - Chief Scientific Officer & Executive VP: Yeah. Thanks, Cory. So we'll have more to say about the presentations at AACR once titles and abstracts publish, which is a little bit later, in a few weeks. I think the theme will very much be similar to last year in the sense that we want to certainly ground people in the scientific rationale for the newest entrants into the portfolio. As Rich also mentioned, we're looking forward to being able to potentially share some 50465 data with you and provide a little bit more color on that program. I think it also gives us a time to just sort of step back, look at the portfolio and strategy as a whole and talk about what might be some of the emerging drivers within the development portfolio that are important for us and important for you to pay attention to. So a little bit early, but we'll have more to say over the next few weeks and as we get through the end of February.

Cory W. Kasimov - JPMorgan Securities LLC

Analyst · JPMorgan.

Okay. And then secondly for Jakafi in PV, now that you guys are a little over a year in the market, have you noticed the discontinuation rates and compliance basically tracking in line with what was observed in Phase III and should we kind of continue to model it that way? Thanks. Barry P. Flannelly - Executive Vice President & General Manager: Thanks, Cory. It's Barry. So we've only really launched – we've only really had 12 months of data for Jakafi in polycythemia vera. I think we'll need at least 24 months, if not more, to really figure out what is the persistency-discontinuation rate. You know that patients stay on – you know from the RESPONSE study that at least 80% of patients stayed on for two years. Now we don't – we're not saying that that translates to what happens in every day treatment of these patients. But nevertheless it's certainly trending in the right direction, but we need more data in order to figure out what the median is for persistency.

Cory W. Kasimov - JPMorgan Securities LLC

Analyst · JPMorgan.

Okay. Thank you, guys.

Operator

Operator

Our next question comes from Eric Schmidt with Cowen & Company. Eric Schmidt - Cowen & Co. LLC: Thanks for taking the question. Just two as well from me. Maybe first for Rich, going back to epacadostat in melanoma. I guess one of the criticisms of the SITC dataset was it was only 19 patients. With your new emerging data in this space, can you give us a sense of whether you're up to 25 patients, 30 patients, 35 patients when you now look at the totality of the data? Richard S. Levy - Chief Drug Development Officer & Executive VP: So the emerging data from the Merck dose-ranging study remains essentially those same number of patients but with additional scans on those patients. And that's part of the reason – so first, while we're not talking about the results of additional scans here, the ongoing result and more data on each patient continues to reinforce our prior decision. We are enrolling more melanoma patients into the expansion cohort, and that will contribute to future presentations of Phase II data in melanoma. But we have very little data in terms of results of scans on those Phase II patients from the expansion. Eric Schmidt - Cowen & Co. LLC: Got it. And then maybe one for Hervé on baricitinib and the Lilly development program. It looks like they're going forward in atopic dermatitis. Are you going to be opting into that program? And maybe you can give us an update on any Eli Lilly plans to move forward in CKD? Hervé Hoppenot - Chairman, President & Chief Executive Officer: Yeah. I will let – Rich can give you details. But in general, we are at the stage where none of these decisions have yet been formalized. So, Rich, if you want to... Richard S. Levy - Chief Drug Development Officer & Executive VP: So the way that we officially make decisions on buying in is we get the data from Phase II and – or proof-of-concept data from clinical trials and a cost and development plan, and then we decide whether to buy in. So in the case of atopic dermatitis, we think it's a very interesting indication. There are data with other JAK inhibitors that have been presented suggesting that this can be quite effective. But we would not necessarily need to buy into that until we actually see data with baricitinib in that indication. But when we see good data, we would tend to buy in. And with respect to the planned studies in diabetic nephropathy, we've seen the data from the Phase II and we are awaiting receipt of the buy-in package, which would also include the cost and design of the future studies. And we'll make the decision based on all the information when we have it. Eric Schmidt - Cowen & Co. LLC: Thank you.

Operator

Operator

Our next question comes from Ying Huang with Bank of America Merrill Lynch.

Ying Huang - Bank of America Merrill Lynch

Analyst · Bank of America Merrill Lynch.

Hi. Thanks for taking my questions as well. First one I have on epacadostat development program. If you look across all the PD-1 or PD-L antibodies, there's some subtle difference in terms of their effect in the PD-L1 ligand expression, positive or negative. Have you gone back and conducted more analysis based on the collaboration data with Merck in melanoma? Do you see any difference in terms of, when you add IDO inhibitor into the PD-1, do you see any difference at all compared to monotherapy PD-1? And then the second question I have is you're getting up to speed in terms of developing GITR in clinics now. There are two or three other programs as well from Merck, from Bristol. Can you tell us if there's any difference at all between your program and the other programs based on the pre-clinical findings? Thanks. Reid M. Huber - Chief Scientific Officer & Executive VP: Thanks for the questions. I'll try to take them both. So the first one with respect to PD-L1 testing, as you alluded to there are some differences. I would actually call them fairly significant differences between how the various PD-1, PD-L1 players try to quantify PD-L1 in the tumor microenvironment, very differences in terms of sustaining performance and whether you are quantifying L1 in a tumor cell or an immune cell. And this really leads to some pretty disparate results, as you alluded to, in terms of how those drugs perform in the various subgroups of patients. They're basically selecting in some cases quite different patients and then you have the whole other issue around tumor heterogeneity and whether a single section really gives you a faithful representation of what's PD-L1 positive and negative. All that being said, the translational components of our portfolio, of our…

Ying Huang - Bank of America Merrill Lynch

Analyst · Bank of America Merrill Lynch.

Thanks.

Operator

Operator

Our next question comes from Tony Butler with Guggenheim Securities.

Charles Butler - Guggenheim Securities LLC

Analyst · Guggenheim Securities.

Yes. Thanks for taking the question. Back to the SITC data in melanoma, are the additional scans and perhaps a more robust net number of patients which are adding in the cohort setting, will that be the subject of data presented at AACR or is that a Merck decision? And second, if we actually think about your PD-1 inhibitor and the pathways in solid tumors obviously a very crowded market and a market where there is a considerable amount of dollars being spent, could you provide maybe some additional color around directionally where you want to take that? And I understand you could say, well, it's where the data are, except that you have a proxy or at least two proxies in the market of where that may be able to – for where you may be able to go. And I'm sorry, just finally on the duration, would you tell us the duration of Jakafi in both MF and PV today and whether that has changed? Thanks very much. Richard S. Levy - Chief Drug Development Officer & Executive VP: Hi. So this is Rich. I'll start. So with respect to the Merck melanoma data from the dose escalation cohort that was first presented at SITC, we have not submitted abstracts to any of the first half of 2015 meetings, but we do expect that we will most likely present updated data at one of the several options in the second half of the year. With respect to PD-1, I'll turn that over to Hervé. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Maybe as a way to think about the PD-1 is obviously that there are a number of PD-1s that are in development. I think there are 10 of them, two of them are already approved,…

Charles Butler - Guggenheim Securities LLC

Analyst · Guggenheim Securities.

Thank you, Hervé.

Operator

Operator

Our next question comes from Chris Marai with Oppenheimer. Christopher Marai - Oppenheimer & Co., Inc. (Broker): Hi. Good morning. Thank you for taking the questions. First, just a quick one, with respect to your 2016 breakeven guidance, does that include additional milestone payments beyond the $55 million or so expected to be recognized next quarter? And then, two, on your JAK PI3K programs, I was wondering how you're looking at potential registration paths forward there. Obviously PI3K inhibitors and JAK inhibitors, frankly, have been clinically validated. How do you look at really bringing this forward in the clinic? And in registrational trial would you look at perhaps indications where PI3K was disappointing and adding JAK1 would augment a response or offer synergistic response, or would you go after some greenfield opportunities? Thanks. David W. Gryska - Chief Financial Officer & Executive Vice President: Hi. It's Dave. On your first question in terms of milestones, our guidance of breakeven assumes the milestones that I mentioned to you earlier in my script that we've received from Lilly, and then also the amortization of that $13 million item. So that's in the breakeven guidance. Thank you. Steven H. Stein - Chief Medical Officer & Senior Vice President: Yeah. And then, Chris, it's Steven Stein answering your question related to JAK and PI3δ. In terms of JAK1s that are in development, we have obviously, as Rich presented, 39110 and then 52793. 39110 is about twentyfold more selective for JAK1 if you use rux as a reference. And as Rich presented, the areas we are interested in now are graft versus host disease. And then the combination study with the AstraZeneca third-generation osimertinib EGFR inhibitor, which is, as Reid presented, builds on a different hypothesis to the CRP one. So those are both areas…

Operator

Operator

Our next question comes from Skip Klein with Gauss Capital Advisors.

Joseph R. Klein - Gauss Capital Advisors LLC

Analyst · Gauss Capital Advisors.

Yeah. Thanks. I've broken I can't tell you the number of pencils trying to value baricitinib and I was wondering if you could help me out a little bit. Given the strong clinical package, would you think I was crazy if I argued that bari could be bigger than Jakafi in terms of peak sales? And then given the very rich deal that you have with Eli Lilly, would you think I was crazy if I argued that the NPV of baricitinib is greater than the royalty stream from Novartis on in Jakavi? Hervé Hoppenot - Chairman, President & Chief Executive Officer: Hervé here. So it's difficult to judge about being crazy or not. I mean the entire guidance on what baricitinib could be is really in the hands of Lilly. Now the comparison you are doing, I can say, I mean the royalty rates that we have on baricitinib and we speak about 20% to 29% – it's a tiered rate based on the sales worldwide – is higher than the royalty rates that we have on ruxolitinib from Novartis. But the base is also completely different because the Novartis deal is a deal that is ex-U.S. where in fact the baricitinib partnership with Lilly is worldwide. And I would argue that it's relatively obvious to everybody that the potential of baricitinib in rheumatoid arthritis is larger than what we have with our ruxolitinib in PV and MF. So when you look at the geography, when you look at the indication, and when you look at the royalty rate I would say it's not crazy to think that way. The overall potential of baricitinib in RA, frankly, is interesting because when you look at the clinical profile and the result of the clinical studies, the Phase III studies, the superiority to Humira, it is a product that in my opinion could be very successful in a market that is relatively large. So there is a lot of upside there certainly.

Joseph R. Klein - Gauss Capital Advisors LLC

Analyst · Gauss Capital Advisors.

Thank you very much for that. It looks like the market, Mr. Market is saying that $3 billion was the NPV of solid tumors for Jakavi, in rough terms. And I could – busted a lot of pencils, but mostly could only get to maybe $1 billion. So what explains the $2 billion extra deterioration in value that we're seeing today? Hervé Hoppenot - Chairman, President & Chief Executive Officer: I cannot – it's difficult for me to explain everything. I think it is a program – frankly, it's a program that we were optimistic about. I mean we were confident that the scientific hypothesis we were pursuing was certainly worth doing the studies that we did. So we have obviously the proof-of-concept in pancreatic cancer with RECAP and the confirming Phase III studies that we have done and in parallel evaluating in Phase II some other studies if it was also applicable outside of pancreatic cancer and lung and breast and colorectal cancer. So I guess it depends how – what probability of success people are attaching to each of these programs. From my standpoint, when I – reacting to the news today, I mean obviously there is a certain level of saying, oops, that's not that we were expecting. But at the same time I must say that as we see the dynamic of the entire development portfolio, it is a company that has today more opportunities for value creation in the future than we had just maybe two years ago because of the quality of the molecules that we are bringing. So it is now for us to do the work to get these products further advanced in the clinical setting, and I think what we will see is a number of opportunities to contribute to the top line over the next few years coming from our current portfolio that we have.

Joseph R. Klein - Gauss Capital Advisors LLC

Analyst · Gauss Capital Advisors.

Great. Merci beaucoup, à tout à l'heure. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Merci.

Operator

Operator

Our next question comes from Liisa Bayko with JMP Securities.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities.

Hi there. Thanks for squeezing me in. A quick question. First just theoretically, as you think about what you've seen so far for rux in the solid tumor setting with respect to sort of the onco inflammation component, are you more pessimistic about your particular molecule, or do you think this whole concept perhaps is not what you thought it was? As we think about – there are some other people pursuing this approach as well. I was just curious about scientifically where you lie on that. Richard S. Levy - Chief Drug Development Officer & Executive VP: This is Rich. So all I would say is that the two negative studies with ruxolitinib in pancreatic and colon were enough for us to also stop with our own JAK1 inhibitor. But we really can't comment on whether anybody else's molecules may have a different profile or not and whether they will succeed or not.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities.

Okay. Hervé Hoppenot - Chairman, President & Chief Executive Officer: And maybe a supportive comment on that, to put some perspective on that. We get the top-line results from these studies. At the interim level, it was a primary endpoint is what we look at. And it's really a question of is there a chance for these studies to be positive as planned, and the answer was no. And that's why we decided to change the program. Now we will have a lot of data that will be analyzed over the next few months. And so I think to better answer your question of saying where was the sort of the problem between the hypothesis and the Phase III studies, I think at the end of the process, when we are able to analyze the data including the data in blood cancer, on lung cancer for the few patients we have in that study, I mean that will give us a better picture of exactly what is the situation there. I think today it was more a decision that was based on the fact that the chance of having a positive study at the end was in fact very, very, very low. And it was the right thing to do for patients and for investigators and the company to discontinue the program at this stage. So...

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities.

Okay. Thanks. And then just a couple of commercial questions. Can you give us any more details on the breakdown of sort of where things are right now with respect to MF versus PV? And then any gross to net info you can provide would be helpful. Barry P. Flannelly - Executive Vice President & General Manager: Sure, Liisa. It's Barry. So in terms of – so MF, we still have a large number of patients and they continue on therapy for long periods of time. As I said before, we'll actually – PV sales will eventually outpace MF sales. In terms of gross to net, obviously we just – we have those discounts that everybody else has, and we're trying – we always try to maintain the value of the brand.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities.

Okay. Barry P. Flannelly - Executive Vice President & General Manager: So in Q1, though, the question is I suppose maybe you were getting at is that obviously we have a gross-to-net decline in Q1 just because 50% of our patients are Medicare patients and we have to close the donut hole. So we're picking up $1,800 or so of that cost for all patients in the donut hole. So that impacts our gross-to-net. And therefore, our growth from Q4 2015 to Q1 2016 could be impacted by a lower gross-to-net in the first quarter versus the rest of the year.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities.

Okay. And then just wanted to clarify, this is my last question, I think I heard Hervé say MPNs could be $1.5 billion in the U.S. Was there some timeframe around that? Or maybe you could clarify, I wasn't completely sure if I heard it correctly. Hervé Hoppenot - Chairman, President & Chief Executive Officer: No, you heard correctly. In the U.S., MPNs, like MF and PV, that's the guidance we – the guidance is our long-term potential number that we gave a few months ago, a year and a half ago – six months ago, sorry. Six months ago. And basically it's reflecting two things. It's reflecting the fact that we are in a market that has a lot of potential. So the number of patients that could potentially be treated with ruxolitinib and where we are today gives us a lot of room to grow. We have also 10-plus years before the first possible patent expirations. So that gives us a long runway. As you see, I mean we are speaking of a guidance for next year that is north of $800 million. So the $1.5 billion is really reflecting the fact that we see long-term growth for this franchise in the U.S. in the current indication that is very possible. It's also an indication where in MF we have a low competitive situation in the long term. There are other products trying to be developed in MF, but it's not the most crowded market. And in PV in fact there are very few products that are developed for PV. So if you look forward over 10 years, what we are saying is that we see this franchise as one of the growth engine for the top line of the company. And the $1.5 billion is a way to calibrate a little bit for everybody what we have in mind.

Liisa A. Bayko - JMP Securities LLC

Analyst · JMP Securities.

Okay. Thanks.

Operator

Operator

Our next question comes from Ren Benjamin with Raymond James. Reni Benjamin - Raymond James & Associates, Inc.: Hi, guys. Thanks for taking the question. Sorry about the rux results in solid tumors, but congrats on a steady growth in MPNs. Two questions, just one maybe for Barry. Can you talk – I think you mentioned that there are about 1,250 or maybe 1,500 docs prescribing for PV. Can you give us a sense as to what the target number of docs may be to reach your peak numbers given the current script rate? Barry P. Flannelly - Executive Vice President & General Manager: Sure. I'm not sure it's about the total number of docs. We're very happy that more and more docs are prescribing Jakafi for PV, but it's really more about the number of patients that will benefit. So eventually we'll have all of the docs who see PV patients and MF patients prescribe Jakafi at some point, but it's really making sure that in fact we help them identify patients that are truly going to benefit. Reni Benjamin - Raymond James & Associates, Inc.: How may docs is that? Barry P. Flannelly - Executive Vice President & General Manager: Well, it's really the total number of oncologists and hematologists in the United States, which is probably about 8,000. It could be as many as 11,000, but about 8,000 practice. So... Reni Benjamin - Raymond James & Associates, Inc.: Got it. I was just trying to get a sense is it following kind of like the 20/80 rule of 20% of the docs are giving out 80% of the scripts in an indication like PV. Barry P. Flannelly - Executive Vice President & General Manager: PV is a little bit different than lots of other tumors or lots…

Operator

Operator

Our next question comes from Alethia Young with Credit Suisse. Alethia Young - Credit Suisse Securities (USA) LLC (Broker): Hey, guys. Thanks for taking my questions, squeezing me in. Just maybe two quick ones. Just one, I wonder if you could talk a little bit about maybe the potential for combinations with like the bromodomains or the FGFR program that we may get data on throughout the year. And then also on the IDO, some of the newer ones that are much, much earlier stage that popped up. Just maybe help us think about like how those assets compare. Do you think that there's reasonable similarity? Just kind of help us think about how like some of the newer assets may fit, since you guys are the leader there. Thanks. Reid M. Huber - Chief Scientific Officer & Executive VP: Yeah. Thanks, this is Reid. So on your first question in terms of combinations with the early pipeline, as we spoke about a little bit last year at AACR, and we'll revisit this a little bit coming up again in April this year at the meeting, we sort of tried to construct a portfolio that has a pretty high combination coefficient. And that doesn't mean that that's the only development path that a molecule like the bromodomain inhibitor, for instance, could take. But it's certainly one that we want to explore early on in the development program, both as a way to broaden the opportunity space where we could take a mechanism like that but also to potentially increase the depth or breadth or durability of response. So those are all the key tenets behind why we're interested in combinations and why molecules like the bromodomain inhibitor or the PIM inhibitor or, honestly, the LSD1 inhibitor are particularly attractive as they sort of coalesce in our portfolio. On the IDO inhibitor front, in terms of the competition, we're very pleased at the competitive environment we have right now, which is still relatively open. We have a molecule from NewLink Genetics that is partnered with Roche, and we've seen a little bit of data on that molecule. And I'm sure we'll see other IDO inhibitors in the future, but those are all going to be relatively early stage. And I think we have a pretty wide competitive gap that we can leverage, especially as we work towards enrolling upwards of 600 patients in more actionable Phase II program across 13 histologies. So hopefully that competitive gap only increases and it's of course very difficult for me to comment on any of the other IDO inhibitors, particularly those that have yet to be in a clinic or show any clinical data that I can speak to cogently. Alethia Young - Credit Suisse Securities (USA) LLC (Broker): Great. Thanks.

Operator

Operator

Our last question comes from Eric Schmidt with Cowen & Company. Eric Schmidt - Cowen & Co. LLC: Thanks for the quick follow-up. I guess this one is for Dave. I know you've been working for a while on trying to figure out ways to moderate Incyte's future tax rate. If there's any update on that or when we might get an update on that would be much appreciated. David W. Gryska - Chief Financial Officer & Executive Vice President: Hi, Eric. Thanks for the question. We'll give you an update towards the end of the year. I think there's another leg up that we're trying to work on with our infrastructure and our supply chain in Europe right now. And again we're working on that in terms of trying to manage that all through an international location. So by the end of the year we'll be able to give you more color on that. Eric Schmidt - Cowen & Co. LLC: Thank you.

Operator

Operator

This concludes our question-and-answer session. I would like to turn the floor back to management for closing comments. Hervé Hoppenot - Chairman, President & Chief Executive Officer: Okay, thank you, everyone. Thank you for your time today and for your questions obviously. After what has been a very, very robust 2015, obviously now we are looking forward for a very busy and productive 2016. So thank you and good bye.

Operator

Operator

Thank you. Ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you all for your participation.