Earnings Labs

Bristol-Myers Squibb Company (BMY)

Q3 2015 Earnings Call· Tue, Oct 27, 2015

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Transcript

Operator

Operator

Good morning, my name is Jonathan, and I will be your conference operator today. At this time I would like to welcome everyone to the Bristol-Myers 2015 third 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. Mr. John Elicker, Vice President of Investor Relations and Public Affairs, you may begin your conference. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Jonathan, and good morning, everybody. I know it's been a busy day, so we do appreciate you joining us for today's call to review our third quarter results. With me this morning is Giovanni Caforio, our CEO; Charlie Bancroft, our CFO. They will both have prepared remarks. And then joining for Q&A as well will be Francis Cuss, our Chief Scientific Officer, and Murdo Gordon, our Head of Worldwide Markets. Before I turn it over to Giovanni, 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. During the call we'll also discuss 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 on our website. Giovanni? Giovanni Caforio - Chief Executive Officer & Director: Thank you, John.…

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

Management

Thank you, Giovanni, and good morning, everyone. As Giovanni just mentioned, we had a very good quarter, driven by strong sales growth of 4% or 11% excluding the impact of foreign exchange. Overall, FX had a negative impact on EPS of approximately $0.05. Let me provide a few highlights. Opdivo sales were $305 million for the quarter. In second-line lung cancer, Opdivo has quickly become the standard of care. Roughly 75% of new squamous patients are being treated with Opdivo, and physicians are also prescribing Opdivo in the non-squamous setting, given the updated NCCN guidelines in June. With the recent FDA approval in non-squamous and no biomarker testing requirement, we believe Opdivo is in a very strong competitive position in all second-line lung patients. In melanoma, we are beginning to see usage in combination and expect our competitive position to be strengthened with the expected upcoming approvals for studies 066 and 067. Importantly, access continues to be very strong, as we have nearly 100% coverage for Opdivo in the U.S. Internationally, Opdivo has now been approved in over 38 countries. In Europe, we have approval for both first- and second-line melanoma and squamous lung cancer. Our trends in Germany are strong, and we are working through the reimbursement process for most other EU countries. Yervoy sales were $240 million in the third quarter. As we've discussed, we continue to see an impact of the PD-1 in melanoma in both the U.S. and EU. We do believe Yervoy will play an important role in combination with Opdivo going forward, not only in melanoma but potentially in many tumors, including lung and renal. Over time we expect the regimen, once launched around the world, will allow the Yervoy business to stabilize. Eliquis sales were $466 million, up 7% sequentially from the second…

Operator

Operator

And your first question comes from Mark Schoenebaum with Evercore ISI. Please go ahead.

Mark Schoenebaum - Evercore

Analyst

Guys, thanks a lot for taking the question, and congrats on nice Opdivo sales. Yervoy's obviously declining. I was just wondering if you could, at least qualitatively, describe just kind of where you think that will bottom. Obviously, it should begin to pick up once the combination – if and when the combination of Yervoy and NIVO become standard of care in melanoma. Maybe you could help us understand how long you think that will take to happen. Is that going to require a lot of physician education, or is that adoption going to be quite rapid, and thus stabilize or grow Yervoy from here? And then, on hep C – maybe you said this on the call, but I'm sorry, John, if I missed this – but did you guys actually break out specifically, sales in the EU and Japan? Japan I'm the most – I'm interested in, if possible. And then, when will you have the next data update on the Yervoy plus NIVO combo in lung? Thank you. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Yes, hi, Mark. It's Murdo here. Thanks for the question. Yeah, you're right in your observation. Yervoy is obviously seeing some pressure from the rapid uptake of the PD-1 entrants into the melanoma marketplace. And Yervoy monotherapy in front line has decreased. We're obviously very happy about the recent approval of the regimen by the FDA, and we are fully promoting that regimen now. So in the U.S., I think we'll see some stabilization of Yervoy between now and the end of the year. It's obviously a very early launch, so we don't have historical trends. We have seen some early uptake of the regimen already in the market, and in fact, about 10% to 15% of new patients are actually receiving the regimen. So that's a good signal that there's already good demand in the market. And we're hearing positive things from community oncologists about their interest in using the regimen as well. I think, when we go outside of the U.S., it's going to obviously take a little longer, because it'll take time to secure reimbursement. So I would expect Yervoy to continue to be under some pressure ex-U.S. On hepatitis C, the Japan sales, I'll turn it over to Charlie. He can break that out for you.

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

Management

Yeah, so in Japan, the sales were $175 million. And that's down from about $235 million, if I recall, in the second quarter. For Europe, the sales were roughly $75 million. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good morning, Mark. So, let me say that the 227 study is recruiting. We've added now a chemotherapy arm to the nonexpressors, and there'll be different chemo combinations, depending on histology and the geography, either Opdivo plus pemetrexed in the platinum doublet, or Opdivo plus gemcitabine in the platinum doublet. And in the study, Opdivo and chemo will be dosed concurrently. You'll see this amendment posted to ClinTrials.gov shortly, but of course we'll be updating you next year on the progress of the 012 combination studies as they become available. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Okay, Jonathan, can we go to the next question, please?

Operator

Operator

Your next question comes from Seamus Fernandez with Leerink. Please go ahead.

Seamus Fernandez - Leerink Partners LLC

Analyst · Leerink. Please go ahead.

Oh, thanks for the question. So just a couple of quick things. Can you guys update us, maybe a little bit, when we might see, first off, the updates in terms of other combinations that you're developing in I-O? I think previously, you had said that you would have data in-house from some of these other – the early combinations, early next year. The second question is just on specifically, when might we see data coming from other parts of your pipeline and the non-I-O parts of your pipeline? Or when would you hope to reveal some of that? And then the final question:. Just in terms of the recent NCCN guideline update, can you just lay out for us the importance of the NCCN guideline updates relative to the label, as well as reimbursements, and maybe just give us – can you give us a sense of how that might improve reimbursement rejections, if there are any, or if you see upside from that update? Thanks. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good morning, Seamus. So let me confirm, we will be getting data from some of the exploratory programs in-house by the end of this year and early next year. And we'll be presenting that data, at least on some of those assets, in 2016. As far as the rest of the non-I-O portfolio, we are looking to see some preliminary data in the second half of next year potentially. Does depend a little bit on the different programs, but we're hopeful to see some there. (19:29) Giovanni Caforio - Chief Executive Officer & Director: And, Seamus, this is Giovanni. Just on the I-O portfolio and specifically with respect to the early portfolio, to add on what Francis was saying, it's clearly – it…

Operator

Operator

Your next question comes from Chris Schott with JPMorgan. Please go ahead.

Christopher T. Schott - JPMorgan Securities LLC

Analyst · JPMorgan. Please go ahead.

Thanks for the question. Just I guess building off the second-line lung dynamics (21:46) out here, your competitor has talked about an expanded use of diagnostics (21:55) over time. I guess what role do you see for diagnostics? My second was on (21:59). Where are we right now with share there, and do you believe you'll be able to get that type penetration (22:04) as quickly as you did in the squam market? And then a final quick one is on the expense (22:13) going forward. Should we think about significant further step up in expenses going forward, or do these 3Q levels reflect the incremental investment that you're putting behind your growth franchises? Thanks very much. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Okay, Chris, you were breaking up a little, so I apologize if I don't catch all of your questions, but I think you had three things in there. You were asking us about what do we think the diagnostic dynamic's is going to be in the market, what is happening with non-squamous uptake, and lastly what should we be thinking about expenses going forward, which I'll turn over to Charlie. I'll take a stab at the first two. You know, it's really interesting, in second-line lung, the good news is physicians can use Opdivo in an all-comer patient population, according to our label across non-squamous and squamous. So really the testing for Opdivo is to better inform a physician-patient dialogue on what expectations should be around response to Opdivo. But the good news is you don't have to wait for that test result before treating a patient, and you don't have to inform a patient that they might not be eligible for treatment. And, as I mentioned before to the previous question, the prescriber can feel confident that they'll be reimbursed for the product across a broad range of patients. So we think that in second line having a broad all-comer label is definitely an advantage. Now, I do think testing will evolve over time, but I think the ideal time to test for PD-L1 expression is going to be when tissue is taken at time of diagnosis when other things like EGFR and ALK are ascertained. So in second line oftentimes there's no tissue available, and it's very difficult to get test results. In front line, more likely, so I think that's where it'll evolve, and it'll take time to see how that changes in the market. With respect to our performance in non-squamous, obviously it's a very recent event, so we have been promoting for just a few days now. But previous to our approval, there was some uptake in non-squamous, and at this point in time, we're probably – and this is an estimate – we're probably in the range of about 30% to 35% of new patients receiving Opdivo in non-squamous second-line non-small cell lung cancer. I'll turn it over to Charlie.

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

Management

Yeah, thanks, Chris. Yeah, we've been talking about, given our growth potential, particularly in Opdivo and Eliquis, that we need to make strategic investments to really leverage our position of strength. And with that you started to see some of the increase in expenses in the third quarter. And you'll see additional increase in absolute terms as we get into the fourth quarter. There is some level of seasonality and timing of expenses, as we think about the fourth quarter, so I wouldn't view that as the run rate as we think about 2016. And, of course, we look across the entire business as we think about where can we up-invest, but also where can we reallocate expenses. And, as you can appreciate, it's too early to be thinking about giving some sort of guidance for 2016. Giovanni Caforio - Chief Executive Officer & Director: And, Chris, this is Giovanni. From my perspective, when you look at the results of Q3, there's really strong trends in terms of revenues and top line growth for the key growth drivers. I think that speaks to the strength of commercial execution. And it really validates the strategy to strategically invest in the business in order to accelerate the right trends going into 2016, as we start what we've called our new chapter of growth. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Thanks, Jonathan. Can we go to the next question, please?

Operator

Operator

Your next question comes from Tim Anderson with Bernstein. Please go ahead. Timothy M. Anderson - Sanford C. Bernstein & Co. LLC: Thank you. Just staying on the topic of I-O, can you talk about what your research shows in terms of physicians that today want to actually do PL-1 testing in the second-line setting? So I know that it's much easier to use your product, and I would imagine that's a major competitive advantage, but I know from talking to physicians in the past, there are some proportion that actually want to do PD-L1 testing, and they put some value on that. I'm wondering what your research shows is the proportion of physicians that feel that way today in second-line lung? Is it one in 10 or one in five, or what exactly? And then a second question: Can you give us your updated perspective on how PD-L1 testing will be employed in Europe right out of the gates here in second-line lung? Is that something that's going to be used as a access-limiting tool? And then last question: Just off-label use of Keytruda at the moment, not that you're promoting it that way, but we've seen data from one treatment center that said that almost 30% of use was actually in renal, which I'm sure can't be reflective of the national average. But what percent is currently being used outside of those two indications? John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: So we'll let Murdo comment on anything related to Opdivo. But we'll leave Keytruda to the other company, Tim. Murdo? Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Yeah, Tim, so I think it's hard to fix a number in terms of physicians who prefer testing over those who are agnostic…

Operator

Operator

Your next question is from the line of Jami Rubin from Goldman Sachs. Please go ahead. Jami Rubin - Goldman Sachs & Co.: Thank you. Question for you first, Charlie, on operating margin leverage. On the last earnings call, you obviously signaled increased levels of spending and sort of threw cold water on the operating margin leverage story. Now we're seeing those increased levels of spend, but also greater-than-expected revenues coming through. So can you give us a little bit more color on when we can expect to see a greater magnitude of operating margin leverage? Are we going to start to see that in 2016, say, second half? Or do we have to wait until 2017 and beyond? If you can just give a little bit more color around that. And, Francis, for you, what are the key pivotal trials that you expect to see next year in terms of either reaching information at your interim analysis or when the trials conclude? But what are the additional tumor types that you expect to see reading out next year? Thanks very much.

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

Management

Hi, Jami, this is Charlie. I'll answer your cold-water question first. Operating leverage for us as we think about 2016 and beyond will start happening in probably the 2017 period. We haven't finalized our budgets and our plans. But we expect – and we did say this on the last call – meaningful expansion as we get back towards the back half of this decade. So we'll continue to update you as we give guidance for 2016, and then we can think about it further. But we do expect significant expansion towards the latter part of this decade. Giovanni Caforio - Chief Executive Officer & Director: And I think what's important, as I said before, is that – and as you mentioned, Jami – is that revenue growth is very strong, which really speaks to the strategy to invest in the business. And it's an important priority for us. But I just want to reinforce what Charlie said: Coming out of 2016 and going into 2017, we do expect leverage to begin to appear and become very meaningful. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good afternoon, Jami. It's Francis. So, as you recall, we presented encouraging data in new tumors at ASCO, such as hepatocellular carcinoma, small-cell lung cancer, and glioblastoma, and all of these could be firsts for BMS going forward. So, in addition to the nine to 10 positive registration studies we've had in the last 12 months, as you know, we've got 25 ongoing planned registration trials. And before the end of 2016, we could potentially see registrational data for head and neck, for Hodgkin's lymphoma, for non-Hodgkin's lymphoma, or for bladder. Thank you. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Jonathan, can we go to the next question, please?

Operator

Operator

Your next question comes from David Risinger with Morgan Stanley. Please go ahead. David R. Risinger - Morgan Stanley & Co. LLC: Yeah, thanks very much. I have two questions. First, with respect to renal cell carcinoma, obviously the data was very impressive and you've filed it for approval. But just wondering if you can provide a framework for NCCN guideline update potential and timing? And then, second, with respect to the EU, could you just walk us through key events to watch for Opdivo and lung cancer over the next year? What we should think about in terms of timing for an approval in non-squamous, non-small cell lung cancer, and the rollout in the EU of that indication? Giovanni Caforio - Chief Executive Officer & Director: David, this is Giovanni. Let me just take your first question on renal and just confirm, as we said in our remarks, we are working with regulators to complete those findings in Europe and the U.S. by the end of the year. We don't have an update on NCCN. And the only thing I can say is that, on both the regulatory front and NCCN guidelines, we've seen in the past that those updates are made rapidly when they're as compelling as you just mentioned. And I'll ask Francis to comment on lung in the European Union. Francis M. Cuss - Chief Scientific Officer & Executive VP: Yeah. Good afternoon, David. Just – I'm not going to go into detail about our regulatory interactions in Europe, but they have always been very good with the regulators there. And we would expect to see some action next year on non-small cell lung cancer approval. Thank you. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Jonathan, can we go to the next question, please?

Operator

Operator

Your next question comes from Andrew Baum with Citi. Please go ahead. Andrew Baum with Citi, your line is open. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Okay, Jonathan, maybe we can go to the next one.

Operator

Operator

Your next question comes from Gregg Gilbert with Deutsche Bank. Please go ahead.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Please go ahead.

Yes, hi, good morning. A couple. First on Eliquis, Charlie, any inventory changes or rebating changes that affected Eliquis sales in the quarter versus the second quarter level on net revenue? Secondly, on Opdivo, do you expect share to go up in monotherapy in melanoma, given that docs may want to add Yervoy later and want to start with the mono agent that has the combo data? And lastly, for Giovanni, you talked, when you took over the CEO seat, that you wanted to win in I-O, and certainly help diversify the company. You made some comments about diversification earlier via the pipeline. I was curious if you're focused at all, maybe for Charlie too, on any efforts to diversify with commercial stage assets, or is it really a pipeline-driven phenomenon? Thanks.

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

Management

Yeah, thanks, Gregg. This is Charlie. I'll handle your question on Eliquis. And I did mention this in my remarks, that in the U.S., TRx growth was up actually 18% sequentially versus Q2. What we saw, though, is relatively flat sales, and that's because of the impact of the Medicare coverage gap, or what's infamously known as the donut hole. So that suppressed overall sales, but still strong prescription growth, and strong sequential growth. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Yeah, we had a little bit of inventory workdown on Eliquis in the quarter. It's about two-thirds of the change is about what Charlie mentioned, the coverage gap effect, and then one-third would have been inventory workdown. When you think about Opdivo monotherapy, it's actually a really good question, Gregg, because what we are hearing from our customers is, the fact that we have two immune checkpoint inhibitors in our portfolio has obviously very real potential benefits for them, but even for patients, once a patient enrolls in our patient assistance program for either drug, they are no longer required to re-enroll for assistance with the mixed drug. So, as you highlighted, a physician may decide to use Opdivo versus other PD-1 options in front line, because they know if they do progress, they don't have to fill out any additional paperwork or reapply for patient assistance when they get a patient on Yervoy. And it's a real convenience factor for physicians and patients. And obviously, if they are going to use the two in combination, then they only need to familiarize themselves with one PD-1 inhibitor in that setting as well. So, thanks for that question. Giovanni Caforio - Chief Executive Officer & Director: And, Gregg, with respect to your question on the two imperatives, I'm optimistic, and I feel that we are continuing to make great progress on both fronts in terms of winning in immuno-oncology. Our leadership position in this field has strengthened coming out of the third quarter. And in terms of diversifying, that continues to be a priority for us. And in terms of diversification, it's both within immuno-oncology, and that's really the discussion we had earlier about investing in new mechanisms of action and advancing the early immuno-oncology pipeline, and then obviously, outside of immuno-oncology. You've heard about at least one of our business development deals in the quarter, and how the rest of the pipeline is moving forward. Our business development strategy is really agnostic with respect to pipeline versus marketed assets. Obviously, there are fewer late-stage or marketed assets available, particularly given our focus on truly differentiated medicines. But we are looking at both, and obviously it is likely that we will continue to do more pipeline deals, just because of the nature of our business. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Jonathan, can we go to the next question, please?

Operator

Operator

Your next question comes from Vamil Divan with Credit Suisse. Please go ahead. Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker): Great, thanks so much for taking my questions. So just two. First one around the topic of price, where obviously there's been a lot of discussion in the media, just – my question really is you guys, obviously, as you mentioned, had the first approved combination now, and we know how you priced that one. Just the feedback that you're receiving or of any pushback, just given how you've priced that relative to the monotherapies would be interesting to hear now that it's been a few weeks. And second one, one product that I think doesn't get discussed as much is elotuzumab, and you talked about the therapy (39:47) that's ongoing there. Can you maybe just sort of frame the market opportunity there? I think people realize it's a big market, but also pretty crowded, and it hasn't shown much impact in terms of – as a monotherapy agent. So how do you see the commercial potential for that product? Thanks. Giovanni Caforio - Chief Executive Officer & Director: Vamil, thanks for the question. Let me start on pricing, and then Murdo will comment on elotuzumab market opportunity. So first, clearly there is a lot of discussion about pricing and pricing of specialty medicines specifically. The way we think about it at BMS is that we are developing truly innovative medicines that offer significant value to patients. And we are also strengthening and continuing to strengthen globally the reach and the characteristics of our reimbursement support and access assistance programs. With respect to the combo, specifically, the value that the combination of Opdivo and Yervoy offers for patients with melanoma is very significant. And payers are responding…

Operator

Operator

Your next question comes from Alex Arfaei with BMO Capital Markets. Please go ahead.

Alex Arfaei - BMO Capital Markets

Analyst · BMO Capital Markets. Please go ahead.

Good morning, and thank you for taking the questions. Most of my questions have been answered. I have one on Sprycel, actually. It doesn't get as much attention. Obviously, a significant product for you. Our understanding is that it will face generic competition from Gleevec next year. So if you could comment on how we should think about the impact there. Thank you. Murdo Gordon - Senior Vice President & Head-Worldwide Markets: Yeah, thanks, Alex. Glad you mentioned Sprysel. We're having very good success Sprycel worldwide, growing rapidly in front-line share. We've done a really nice job, I think, in the U.S. and ex-U.S., in becoming a much more front-line, first-choice product. With the advent of generic Gleevec, we're definitely going to see some pressure in the U.S. and some markets ex-U.S. We're already seeing that in some locations like Canada, but I think given the strength of the share evolution in front line, we're going to be able to weather that quite well. Obviously, we're also focused on the ability for the oncologist or hematologist to test patients for depth of molecular response within the first three months, which should allow us to be able to use very rapid second line penetration in that market. And I think that will be important to continue to have good Sprycel growth long term. John E. Elicker - Senior Vice President, Public Affairs & Investor Relations: Jonathan, could we go to the next question, please?

Operator

Operator

Your next question comes from John Boris with SunTrust. Please go ahead.

John T. Boris - SunTrust Robinson Humphrey, Inc.

Analyst · SunTrust. Please go ahead.

Thanks for taking the questions, and congratulations on the quarter. For Giovanni and Francis, you do mention that you want to dominate to a great degree through the new mechanisms of action in the I-O space. Can you maybe help us understand when we might begin to see some additional data on the anti-LAG-3, anti-KIR, anti-CD137? And I think there was also commentary out in Denver about other mechanisms potentially going into the clinics, so just some commentary on the strategy there. Secondly on Eliquis, new-to-brand share or percent of sales coming from cardiologists versus primary care? And then on ASH, anything you want to focus us on, relative to what we should be looking at, at ASH in your portfolio? Giovanni Caforio - Chief Executive Officer & Director: Yeah. John, let me just start on leadership in immuno-oncology and Francis will elaborate further; then Murdo will talk about Eliquis. So, from my perspective, we clearly are the leaders in this field. The field of immuno-oncology is moving probably faster than all of us had expected, in terms of the strength of the activity we are seeing in tumors and the number of tumors in which immuno-oncology is active. And we are working in order to maintain and strengthen our leadership position by growing and expanding our development programs into new tumors, but also continuing to lead in terms of understanding the potential role of combinations in increasing response rates and improving the impact on survival. And our goal, as we've stated before, has been to replace chemotherapy. We believe that combo I-O therapies are best positioned to do that. We have the most advanced data set with Yervoy/Opdivo combinations and, obviously, we are not sort of resting on our current position, but we are continuing to advance new mechanisms…

Operator

Operator

Your next question comes from Steve Scala with Cowen. Please go ahead. Steve M. Scala - Cowen & Co. LLC: Thank you, I have three questions. First, CheckMate 017 and 057 both stopped early, whereas KEYNOTE-010 went to its completion. Do you think this is likely attributed to a KEYNOTE-010 trial design that benefited from learnings from other studies? Or should we think more broadly than that? I'm sure you have thought about it, so I'd be interested in anything that crossed your mind on that topic. Secondly, Merck claims to have 70% share of melanoma with PD-1. To what do you attribute this dominant share? Is it the first-mover advantage, is it the Q3 week versus the Q2 week dosing, or is it something else? And then lastly, I could be wrong, but I think the last cut of CheckMate 012 data presented was from about a year ago. Maybe based on data that you have internally, I'd be curious if the NIVO-chemo combo arm continues to demonstrate an undifferentiated tail response? Thank you. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good afternoon, Steve. So, let me say, we obviously know very little about the overall survival data for Keytruda, and we'll obviously look forward to seeing the full results when they're published. But let me tell you what we do know. We do know that Opdivo has a clear overall survival benefit, and a benefit in a broad population. As a result, it's got the broadest label and, as you know, it's indicated for previously treated patients, both squamous and non-squamous, regardless of PD-L1 expression. And as Murdo said, there's no need therefore to test. Now, in both CheckMate 017 and CheckMate 057, Opdivo demonstrated PFS benefit versus docetaxel. And, in CheckMate 017, the benefit…

Operator

Operator

And your final question comes from the line of Colin Bristow with Bank of America Merrill Lynch. Please go ahead.

Colin N. Bristow - Bank of America Merrill Lynch

Analyst

Hey, guys, thanks for squeezing me in. So just a quick one to build on the business development comments. You've been doing a great job at continuing to build your I-O pipeline via BD. Could you comment on your level of interest in cellular therapeutics, given this is one area you're currently not in? And then, just on your initial comments on diversifying, should we expect a shift from I-O focused deals to other therapeutic areas? And, if so, what would those therapeutic areas be? And then, just lastly on your HIV pipeline, could you just provide some color on your attachment and your maturation inhibitors and the potential you see there, given this is a disease you clearly have great experience in? Thanks. Francis M. Cuss - Chief Scientific Officer & Executive VP: Good afternoon, Colin. So let me start with BD. Clearly, we've always seen BD as very important to complement our internally discovered efforts, and as you've seen in the last quarter, we've expanded our portfolio both in I-O and in – outside of I-O. And I would just comment, again, on the – I've talked about the CSF1R collaboration – sorry, the licensing – with Five Prime, but the fibrosis side is very important, too. And, just to give you a bit more color, we gained the worldwide rights to PRM-151, which is a recombinant form of a human pentraxin-2 protein. Now, this is in Phase 2 development, as you heard, for the treatments of IPF and myelofibrosis. Now, what particularly struck us about the early data, which is continuing to develop in myelofibrosis, that it suggests that pentraxin-2 may be able to reverse the fibrotic process and improve the downstream events, not just stop the progression. So pentraxin-2 clearly complements our growing early-stage fibrosis portfolio.…

Operator

Operator

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.