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Bristol-Myers Squibb Company (BMY)

Q1 2016 Earnings Call· Thu, Apr 28, 2016

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Transcript

Operator

Operator

Good morning. My name is Tiffany and I will be your conference operator today. At this time I would like to welcome everyone to the Bristol-Myers Squibb 2016 First Quarter Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question-and-answer session. Thank you. John Elicker, you may begin your conference. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thank you, Tiffany, and good morning, everybody, and thanks for joining the call on what I know is a very busy day for all of you. Before we get to the call, let me take care of the Safe Harbor language. During the call we will make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any subsequent date. We specifically disclaim any obligation to update forward-looking statements, even if our estimates change. We will also discuss certain non-GAAP financial measures adjusted to exclude certain specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available at our website. Joining me this morning are Giovanni Caforio, our Chief Executive Officer and Charlie Bancroft, our Chief Financial Officer, who will both have prepared remarks. And then joining for Q&A is Francis Cuss, the head of R&D, and Murdo Gordon, our Head of Worldwide Markets. Giovanni? Giovanni Caforio - Chief Executive Officer & Director: Thank you, John, and good morning, everyone. We just finished a very good quarter. Performance across…

Charles A. Bancroft - Executive Vice President and Chief Financial Officer

Management

Thank you, Giovanni. Good morning, everyone. As Giovanni mentioned, we had a very good quarter, driven by strong performance across our key products. Overall, FX had a negative 2% impact on sales and about $0.03 on EPS. Giovanni covered the sales performance highlights from some of our key growth drivers. I will just add some additional color. Eliquis continues to do very well. Sales in the U.S. were $468 million, which includes a one-time positive adjustment related to the Medicare coverage gap of $25 million. We continue to see strong performance for Opdivo across the three tumors. Opdivo continues to be the most prescribed drug for new patients in lung cancer. Renal has also seen strong early adoption. And in melanoma the strong performance of the Opdivo/Yervoy regimen is contributing to the growth for both Opdivo and Yervoy. Opdivo has now been approved in 50 countries. International sales in Q1 were $110 million. Until recently the EU approval was in squamous lung cancer and melanoma only. Pricing and reimbursement for melanoma and squamous lung cancer has been secured in most of the major markets and uptake remains strong, notably in Germany and France, where we are operating through an early access program. Additional indications for renal and non-squamous lung cancer have now been approved in the EU. The CHMP has also granted a positive opinion for the Opdivo/Yervoy regimen in melanoma. Yervoy sales in the U.S. grew 10% over last year, based on the strength of the regimen, which as Giovanni mentioned has seen strong adoption in first-line melanoma. Internationally, sales were down over 50% as Yervoy monotherapy remains under pressure from Opdivo and Keytruda. We expect that to continue until the launch of the regimen, which should take place over the next year or so. Our hep C business…

Operator

Operator

Your first question comes from the line of Chris Schott with JPMorgan. Your line is open.

Christopher Schott - JPMorgan Securities LLC

Analyst

...much. And then congrats on the strong results here. First question is can you talk about the commercial ramp of Opdivo in Europe in lung cancer now that you have the broader label? Are you expecting similar dynamics for the U.S. in terms of rapid uptake? Or do you see any hurdles being put in place that could limit use in for example PD-L1 positive patients? The second question was just on the timelines for Opdivo in first-line monotherapy in lung. And you've been talking about a readout late this year, I think it's about 18 months from the time your study completed enrollment. I'm just trying to get a little color as to what's taking so long in terms of getting the data here? In that it seemed like much of your control arm would have progressed well ahead of that target? Thanks so much. Giovanni Caforio - Chief Executive Officer & Director: Chris, thanks. This is Giovanni. Murdo will address your question on international Opdivo sales. Let me say that we are very pleased with how reimbursement negotiations and activities are going internationally. That really reflects the value of Opdivo and the data. And then Francis will cover your question regarding timing for first line. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Yeah, thanks, Chris. Overall we're feeling very good about what's happening in Europe. Our performance in Germany and France has been very good. France is hard to see, because we're currently not recognizing those sales until future price negotiations. But we are doing very well across the indications that we have. If you will recall we have our indication in metastatic melanoma, squamous lung at the beginning of our uptake curve, and then recently additional approvals coming in that are yet really showing in…

Operator

Operator

Your next question comes from the line of Seamus Fernandez with Leerink. Your line is open.

Seamus Fernandez - Leerink Partners LLC

Analyst · Leerink. Your line is open.

Hello. Thanks for the question. So just a couple of quick questions on the increase in R&D spending. Can you just help us understand the quality of the increase? And what drove the increased guidance for R&D spending? Just it's noteworthy that you recently started the phase 2 FRACTION lung study, which includes your LAG-3 antibody, as well as Sprycel. So just interested to better understand the R&D spend increase. And if that's driven by the promise of I-O combinations? And then the separate question on FRACTION lung specifically. Is it possible that this study – given the fact that it incorporates and includes immunotherapy refractory patients, is it possible that it could be utilized as an – for an accelerated path to approval, should it show impressive results? Thanks. Giovanni Caforio - Chief Executive Officer & Director: Seamus, thank you. Francis will address your questions on R&D broadly. Francis M. Cuss - Chief Scientific Officer & Executive VP: Right. So let me just say, Seamus, that – let me give you a little bit of background on FRACTION. This is an innovative Phase I/Phase II design for early combination trials. And as you appreciate we have a number of potential combinations at the moment. And this allows us to look at promising signals of activity, to actually also test hypotheses about the underlying biology of combinations, and you know we're – as well as checkpoints, we have a number of non-affecter (22:01) mechanisms as well. And of course to generate data to inform future combinations. So therefore, the FRACTION trial should allow us to efficiently identify the activity of promising novel combinations and quickly move them into potentially registrational trials. Now as we've said, data from our early assets have started to come into house this year. And we're moving forward with the anti-LAG-3 antibody refraction study, as we think there is an opportunity to improve upon Opdivo monotherapy or the combination of Opdivo and Yervoy, particularly as you say in those patients who don't respond initially or who relapse. I think the important thing to say and to put this in the context, the broader context, is that we are very confident in our broad strategy in first-line lung. And we want it to address a very broad population. Now we clearly have emphasis on first line. We already have second line. But we do believe that the Opdivo/Yervoy regimens could further improve overall survival. And I want to note that we're really looking forward to presenting additional data from [CheckMate] -012 at ASCO. So overall, we want to ensure that as many lung cancer patients as possible can benefit. And whether that's with monotherapy, combination Opdivo/Yervoy, exploring other combinations, which FRACTION will allow us to do more quickly and efficiently, and whether that's targeted therapies or indeed chemotherapy. So very broad program. Thank you.

Charles A. Bancroft - Executive Vice President and Chief Financial Officer

Management

Yeah. And let me just – Seamus, just a couple of points on the R&D line. So in the quarter we were up 17%. But there are timing issues that relate to any quarter year to year. For the full year, as I mentioned in my comments, we are raising guidance slightly. We were at high single digits for R&D, and now we're in low double digit. Part of it's some of the things that Francis had mentioned and what I mentioned in my comments regarding clinical study supplies, some of the new BD things that happened since year end, and additional biomarker diagnostic work in oncology. They're the main elements. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Seamus. Tiffany, can we go to the next question, please?

Operator

Operator

Your next question comes from the line of Jami Rubin with Goldman Sachs. Your line is open. Jami Rubin - Goldman Sachs & Co.: Thank you. Just a couple questions for you, Francis. The first one is more related to the near term. Obviously investors are very focused on the upcoming front-line lung studies from both Merck and you guys. Can you compare and contrast the two first-line monotherapy trials of Opdivo versus Keytruda? Since that's obviously what we're focused on? And I think that investors seem to have more confidence in the Merck trial, because they are looking at the highest expressors of PD-L1 expression compared to your trial. So I think there's more confidence that they're going to hit on PFS versus Bristol-Myers. Plus, there's also worry out there about PFS being a challenging end point, just given that chemotherapy works pretty well in front line lung. So if you can address that first. And then secondly, a more, bigger picture strategy question for the long term. Obviously monotherapy Opdivo is doing extremely well. But as you know doctors prefer combination therapy in treating cancer patients. And they also want to move away from chemotherapy. So can you set the stage for Opdivo combination strategies? And the outlook over the next couple years? Given that a number of companies have chosen the different path, which is chemo combo. Thanks very much. Giovanni Caforio - Chief Executive Officer & Director: Jami, this is Giovanni. Let me just start with your second question and give you my perspective on strategy in first-line lung cancer. Francis will add to my comments and then answer specifically your questions about study design. I feel very strongly, and I am very optimistic about our strategy in first line. Because we obviously have a lot…

Operator

Operator

Your next question comes from the line of Colin Bristow with Bank of America. Your line is open.

Colin N. Bristow - Bank of America Merrill Lynch

Analyst · Bank of America. Your line is open.

Thanks for taking the questions and congrats on the quarter. So on the CheckMate -568 study, to what extent do you see this data set, along with what we'll have from CheckMate -012, facilitating addition to the treatment guidelines ahead of formal regulatory approval? And then in terms of CheckMate -012 and the data at ASCO, can you give us some sense of the incremental duration of data we'll see, versus what was presented at World Lung? And then just finally, Eliquis, clearly a great quarter. Where do you primarily see growth from going forward? And how do you see the approval of an antidote to impact the growth of this class, given there's one currently under review? Thanks. Giovanni Caforio - Chief Executive Officer & Director: Murdo, why don't you start with Eliquis? And Francis will cover - Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Sure. Thanks, Colin, for the question. Yeah. We're really pleased with the Eliquis performance across all of our worldwide markets, inclusive obviously of the U.S. More than doubling our volume from first quarter last year. So really, really strong. We're seeing this growth really across all markets, in cardiology, in hospitals, and in the community setting. So we have very strong new-to-brand prescription shares evolving. We're now the number one NOAC in the U.S. in atrial fibrillation and VTE treatment. So we're very, very pleased in new-to-brand Rx there. That's a 47% share. And we're now within 10 points of our closest competitor, Xarelto, in TRx share in the U.S. So we've got nice leading indicators. We think we will continue to evolve that market share in cardiology and in primary care across all of our major markets in VTE and in AF. So really that's going to be a continued trend…

Operator

Operator

Your next question comes from the line of Tim Anderson with Bernstein. Your line is open. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC: Thank you. A few questions. So just going – just sticking on CheckMate -568. You have [CheckMate] -227 running. That's an OS trial. It's a larger trial. Suddenly you start -568, which is a Phase II study, looking at the same doses in front-line lung. I still kind of am struggling to figure out why you started that trial. My guess was maybe it's a way to get early registration ahead of having -227 results, which may not come out until 2018. So really what's the purpose of -568? And then on [CheckMate] -026 can you confirm that you have really the same exact efficacy endpoints and statistical analysis plan for that trial as you did maybe six months ago? I know the timeline has moved around a little bit. And now you're saying in third quarter. And then last question on the fractional lung trial, 685 patients. Is that going to be amortized across the three current arms? Or does that anticipate other combo arms coming in? And some of that 685 patients going to arms that have yet to be revealed? Giovanni Caforio - Chief Executive Officer & Director: Tim, let me start by [CheckMate] -568. And as we've said before, we have a very broad strategy in first-line lung. And obviously because of the strength of the profile of Opdivo and the importance of first-line lung, every study gets, rightfully, a lot of visibility. There are registrational trials, practice informing trials. And -568 is really a practice informing trial as we've designed it. The Phase III study [CheckMate] -227 is really the critical registrational strategy there. That's really the way to…

Operator

Operator

Your next question is from the line of Mark Schoenebaum with Evercore ISI. Your line is open.

Mark J. Schoenebaum - Evercore ISI

Analyst

Hey, guys. Thanks a lot for taking the question. Francis, maybe for you, just you've touched on this, but just to hit it directly on the head. Would you mind comparing and contrasting your front-line lung cancer trial with the trial that Merck is running? And the reason I'm asking is, it's possible we may see the Merck data first. Don't know. But if Merck were to fail for some reason on the PFS endpoint, how should we think about that in terms of reassessing odds that your trial would hit on PFS or not? As I know there are some design differences that are important, I'd love to hear you articulate those for us. And then also I don't – only one other question. I know it may be too early. And I know companies don't often like to provide this data. But can you give us any sense of where you're seeing duration of therapy in second-line lung right now? Thank you very much. Giovanni Caforio - Chief Executive Officer & Director: Mark, let me just add a couple comments there. First of all, on Study -026 it's obviously not appropriate to speculate on other trials. Let me just reiterate. We are very comfortable about the design of our trial. We are very comfortable about the depth of understanding that went into the statistical plans. And we are increasingly comfortable about the choices we've made in terms of the dosing and schedule of Opdivo, as it relates to the efficacy we are seeing, both in the marketplace and in clinical trials. And I think it will be important to really look at the results of our study to understand the performance of Opdivo in the first-line setting in lung cancer. With respect to length of therapy in lung, as we have seen get post approval, Murdo will give you some perspective there. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Sure, Mark, as you hinted it is early days. And we would prefer to have a 2-year in-market experience, so that we can do a full 1-year look back and provide more quantitative estimates of the duration of therapy that we're seeing in the second-line lung market. I would say we're very encouraged by the long-term follow-up data that were presented at AACR. So we expect to see duration of therapy in line with clinical trials and hopefully even a bit longer. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Mark, for the questions. Tiffany, could we go to the next one, please?

Operator

Operator

Your next question comes from the line of Geoff Meacham from Barclays. Your line is open.

Geoffrey Meacham - Barclays Capital, Inc.

Analyst

Morning, guys, thanks for the question. So a lack of testing has been obviously a very differentiated factor for Opdivo thus far. Is there any updated thoughts on how that's going to evolve commercially, when you look to first-line lung? And the second part of it does this harmonization of any technologies for testing matter to you guys? Help, hurt, or sort of indifferent? Thanks. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Okay. So, Geoff, I'll start. It's Murdo here. We're seeing some evolution in testing. And it's primarily in the first-line setting, when tissue is available. So we're seeing 1% or 2% increases month over month. We're currently running at about 30% of patients being tested. And over 60% of that is in the front-line patient setting. So very few second-line patients continue to be tested. So clearly, we have decided to commercialize our companion – sorry – our complementary biomarker PD-L1 test. We have a full commercial effort behind that. And we are setting the stage for what could happen in the front-line setting, which would be a testing market, as that's how we've defined our clinical trials. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good morning, Geoff. So I think what you're referring to is the blueprint study at the AACR. And just to remind everyone, these were the Phase I result, so a two-phase effort to compare four of the PD-L1 diagnostic assays across 39 non-small cell lung cancer tumors. This was cross industry collaboration between four pharmaceutical companies, including us, and two diagnostic companies. And the idea was to provide greater clarity on the analytical performance of each assay. Now the results indicated that two of the assays appear to be highly correlated. And three of the four assays were analytically similar. And in this first phase of the study, while some differences were due to scoring approaches and selective cutoffs, the assays were deemed not identical and interchangeable at this point in time. And I think one would say these preliminary results are not intended to alter the current guidelines for each diagnostic. But also I want to say is, very importantly, these findings confirm the quality and the utility of our assay. So anyway we're moving forward into the second phase. We'll have to see how that goes. But obviously we're working hard with others to try and get to a point where there is some interchangeability. Thank you. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Geoff, for the questions. Tiffany, could we go to the next one, please?

Operator

Operator

Your next question comes from the line of David Risinger with Morgan Stanley. Your line is open. David R. Risinger - Morgan Stanley & Co. LLC: Thanks very much. So I have a couple questions. First of all, with respect to ASCO I believe that you're going to be providing some updated data from CheckMate -012 that helped inform your dosing for the Opdivo plus Yervoy combo in [CheckMate] -227. Could you just provide some more color on that? Second, with respect to LAG-3 I noticed that you delayed and also downsized your key LAG-3 trial, so that was downsized from 540 to 360 patients and pushed out from September of 2016 to May of 2018. Could you discuss that? And then finally, is there any other commentary you can offer on your other novel I-O agents? Thank you. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good morning, David. So let me just talk about ASCO. And I just want to reiterate, we're really looking forward to ASCO. And there will be a number of areas of interest for us, as well as the updating longer term data on previous studies. But you did specifically ask about that. Obviously I'm under embargo, the ASCO embargo, so I can't really give you any more color. But what we have done in the past, and you should expect, is that in these studies, particularly ones that are particularly interesting, we are presenting updated data, where the patient follow-up is extended. And in the context of immuno-oncology, the durability responses is a particularly interesting aspect of this. So one would expect a complete update of the whole data set. As far as LAG-3 I think as I've already said, I was – and I appreciate how closely people look at…

Operator

Operator

Your next question comes from the line of Gregg Gilbert with Deutsche Bank. Your line is open.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Your line is open.

Thank you. First on Opdivo, I would like your view if PD-1s work well and move strongly into front-line lung, to what extent do you think the second-line lung opportunity moderates in size? And, Murdo, on Opdivo pricing in the U.S., are there any signs that payers are looking to negotiate price in any way? Or do you pretty much get a label, get added to the compendia, and your price is your price? And lastly, just a quick one for Charlie. On U.S. Eliquis in the quarter, was there any creep up in trade inventories or improvement in gross to net? I think revenues were up quite a bit more than the impressive Rx growth in Q1 versus Q1. Thanks. Giovanni Caforio - Chief Executive Officer & Director: So let me just start maybe, Gregg, with a perspective on second-line lung and what happens going forward, should there be a rapid penetration of Opdivo in first line. My perspective is that that really puts into context our strategy with novel agents, where we've consistently said that we're looking at really understanding the basis for patients that don't respond or progress following the response. I think FRACTION, as Francis mentioned, is a great trial for us to test hypothesis and advance our early pipeline very strategically. It also underlines the importance of the breadth of our early pipeline with up to eight agents in early clinical development this year. And obviously we're also investigating what happens in terms of retreatment potential and other evolution in how the sequence of care in lung cancer happens. That really positions us very strongly, because of the totality of what we have going. Murdo? Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Yeah, thanks, Gregg. Your question regarding pricing in the U.S. on Opdivo. So far we've actually seen very good access to Opdivo and a good appreciation of its value across all of its current indications. And are close to 100% reimbursement without restrictions to those indications. We're also seeing continued strong reimbursement of Yervoy and very good reimbursement of Yervoy plus Opdivo in regimen and in combination in metastatic melanoma.

Charles A. Bancroft - Executive Vice President and Chief Financial Officer

Management

Yeah. And, Gregg, on your question on the U.S. Eliquis, as I mentioned in my comments we did have a one-time positive adjustment due to the Medicare coverage gap. That was about $25 million. And there was a slight increase in (51:03) inventories, we think up to about $40 million. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Gregg, for the questions. Tiffany, go to the next one, please?

Operator

Operator

Your next question comes from the line of Steve Scala with Cowen. Your line is open. Steve Scala - Cowen & Co. LLC: Thank you. I believe it was stated on the Q4 call, which was three months ago today, that there are or were no interim looks at CheckMate -026. And that Bristol did not expect early stoppage relative to the November 1 completion. So a summer stoppage is a very positive development. Has anything changed but the event rate? It would seem to me that the company would be able to predict with great precision the standard of care event rate. So should we consider a scenario where the increased number of events are likely in the Opdivo arm? I know you don't know. But is that a reasonable conjecture? Or alternatively, what else could be driving this higher event rate? Thank you. Francis M. Cuss - Chief Scientific Officer & Executive VP: Steve, I think it's – I would be very careful about speculating at all. Let me just say – and I want to repeat what I've said already. We make a decision based on the event rate and the duration of therapy. And in this particular study, for all the reasons we've already discussed, it's really important to get that right. We believe based on our experience and our record of success, we have – or we will be getting it right. But I can't speculate about the result. I do think all I would say is, if this was – if I knew the results and I knew how to predict exactly the events, we wouldn't need to do the trials. So the thing is there is always a degree of uncertainty in this. But I don't think where we are towards the end of a trial, there is any uncertainty left in terms of months and months. So we are looking at the third quarter with a good deal of confidence. And I just want to repeat again, it's without any reduction in – oh, I should say no increase in the risk in terms of the study design. Giovanni Caforio - Chief Executive Officer & Director: And, Steve, this is Giovanni. Just to maybe address another of the elements you highlighted. So first of all, our timing in Q3 is not driven by an interim analysis. It's driven by our understanding of the completion of the study. And the time change is not driven by an increase in event threads. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Steve. Tiffany, could we go to the next questions, please?

Operator

Operator

Your next question comes from the line of Andrew Baum with Citi. Your line is open.

Andrew S. Baum - Citigroup Global Markets Ltd.

Analyst · Citi. Your line is open.

Thank you. Three questions, please. First, could I press Francis on how Bristol's thinking on the role of chemo to potentiate I-O agents, namely nivolumab, has evolved? There's been some recent publications on reduced clonality with chemo. Some publications on impact of chemo dependent on Immunoscore. Obviously you have your own clinical experience with the drug. But I just wondered whether you are more sympathetic or less sympathetic to advancing chemo in combination with PD-1 blockade? Second, one of your competitors, AbbVie, just made a material acquisition of a company with a DLL4 conjugated monoclonal for small-cell lung cancer. Obviously Opdivo is being developed in that setting. I'm interested in your views of that particular target versus a PD-L – PD-1 modality. And then finally, there are a proliferation of PD-1 monoclonals not yet approved but in development from a variety of biotech and pharma companies. Could you just remind us of Bristol's stance regarding prosecuting your intellectual property? And what you think the ultimate outcomes are going to be here for the late entrants? Thank you. Giovanni Caforio - Chief Executive Officer & Director: Andrew, let me just – this is Giovanni. Let me just start with a couple comments. And Francis will follow up on some of your questions as well. So first of all, with respect to intellectual property. Obviously as the leader and the innovator in this field, we have a broad estate of patents and intellectual property, which we are defending vigorously. There are a number of legal proceedings ongoing, some of them initiated by us, some of them initiated by Merck in the U.S. and Europe and Australia. I would say that in the cases in which we have received an opinion from courts, we are very pleased with the initial developments there. And…

Operator

Operator

Your next question come from the line of Vamil Divan with Credit Suisse. Your line is open. Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker): Great. Thanks so much for taking my question. So two more again on sort of the earlier stage I-O assets. One, if you could just comment on CD137. I don't think I've heard you guys mention much about that one recently, unless I missed it. And Pfizer does seem pretty optimistic with what they're seeing, that mechanism, so just curious on your thoughts. And then you did touch on the CD73 and said that's moving into the clinic this year. I think just there seems to be a lot of excitement around this adenosine pathway approach from a lot of companies. I'm curious if you can just kind of give your views on that approach as a monotherapy versus combination therapy? And then touch on sort of CD73 versus maybe directly going after the adenosine receptor with like the A2A receptor blockade sort of approach? And which one – what might be the advantage or disadvantage of the two? Thanks. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good morning. So let me first of all talk about 137. We will be – we've said for a while we will be presenting data later this year. And we will be doing that. And we have studies in monotherapy in a number of tumors and in combination with NIVO and actually other agents too. I think what's important to say here is that we believe the bar has been raised and will be continued to be raised quite high by the combination of Opdivo and Yervoy. So I think that's the benchmark to which we are looking to, as we look at the data and consider whether to bring further combinations forward. As far as CD73, I'd draw your attention to the fact we presented data on this at the AACR. It's one of a number of non-effector mechanisms we're looking at in combination. We believe we're certainly at the front of this. And we're certainly looking forward to bringing it in and moving it into our FRACTION approach to efficiently and quickly see if there's some activity there. Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker): Thanks. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Vamil. And, Tiffany, could we go to our last question, please?

Operator

Operator

Your last question comes from the line of John Boris with SunTrust. Your line is open.

John T. Boris - SunTrust Robinson Humphrey, Inc.

Analyst

Thanks for taking the questions. And congratulations on the results. First question for Murdo. In first-line lung cancer when you segment the market, and if you look at a label where you're restricted to just greater than or equal to 50% of PD-L1 patients, what percent of the market in first-line does that represent? Versus having a label that would have one, five, 10, or any positivity in PD-L1? Second question for Murdo and Francis on the regulatory timing around Hodgkin's lymphoma and head and neck cancer. Can you give some clarity on filing in U.S., Europe, Japan? And then on the commercial side what additional incremental investment do you have to make on those two indications? You obviously have the Sprycel salesforce in place, but don't actively sell in head and neck. Just a little bit of clarity on investment. And then lastly for Charlie on leverage with the revenue going higher, and potentially going higher in the out years, as you optimize all of these indications, how are you thinking 2017 and beyond about operating leverage? Thanks. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Okay, John, I'll try and handle the first and part of the second question. And then Francis and Charlie can jump in as required. So first-line lung segment. If you take a 50% cut off you're talking about 25% of the market, approximately. And if you take a greater than, let's say 1% cutoff, you're looking at about 70% of the market in terms of relative size. When it comes to second line – sorry – your second question. When you look at the other indications in the U.S. we believe we've invested appropriately for commercializing those indications. However, we've stated we want to be leaders in I-O. Right now we have dominate share of voice in all our core tumors. We think we can continue that with the hematological team that we have currently selling Empliciti and Sprycel. I think Hodgkin's lymphoma fits in really nice there, and there's a good customer overlap. And then other solid tumors, we think we're appropriately resourced as well for. Francis M. Cuss - Chief Scientific Officer & Executive VP: So let me very quickly say, the FDA has accepted our sBLA. We've got priority review. The EMA has validated our type 2 variation. The Japanese Ministry of Health has validated our application, and where we're presenting the data at ASCO in June. Thanks. Giovanni Caforio - Chief Executive Officer & Director: And obviously that's on Hodgkin lymphoma. Head and neck we are working on the dataset in anticipation of a submission.

Charles A. Bancroft - Executive Vice President and Chief Financial Officer

Management

Yeah, John, just on your question on leverage. Even our revised guidance in 2016 provides roughly (1:04:09). And as we stated many times (1:04:15) going forward throughout the decade, throughout the rest of this decade, but also beginning more acutely next year. Giovanni Caforio - Chief Executive Officer & Director: Thanks, everyone. So we are at the end of the call. I would just like to thank all of you again for your questions. I reiterate that we're off to a really strong start in 2016. We're beginning the chapter of growth I've discussed before. And we are successfully laying a strong foundation for our future. Thanks, everyone.

Operator

Operator

This concludes today's conference call. You may now disconnect.