Earnings Labs

Merck & Co., Inc. (MRK)

Q1 2016 Earnings Call· Thu, May 5, 2016

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Transcript

Executives

Management

Teri Loxam - Vice President, Investor Relations Kenneth C. Frazier - Chairman, President & Chief Executive Officer Robert M. Davis - Chief Financial Officer & Executive Vice President Adam H. Schechter - Executive Vice President & President-Global Human Health Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories

Analysts

Management

Geoffrey Meacham - Barclays Capital, Inc. Steve Scala - Cowen & Co. LLC Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC Colin N. Bristow - Bank of America Merrill Lynch Alex Arfaei - BMO Capital Markets (United States) Jami Rubin - Goldman Sachs & Co. Amalan R. Selvarajah - Citigroup Global Markets Ltd. Charles Anthony Butler - Guggenheim Securities LLC Christopher Schott - JPMorgan Securities LLC Seamus Fernandez - Leerink Partners LLC Jeffrey Holford - Jefferies LLC David R. Risinger - Morgan Stanley & Co. LLC Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker) Marc Goodman - UBS Securities LLC

Operator

Operator

Good morning. My name is Darla, and I will be your conference operator today. At this time, I would like to welcome everyone to Merck's Q1 2016 sales and earnings 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. I would now like to turn the call over to Teri Loxam. Please go ahead.

Teri Loxam - Vice President, Investor Relations

Management

Thank you, Darla, and good morning, everyone. Welcome to Merck's first quarter 2016 conference call. Today I'm joined by: Ken Frazier, our Chairman and Chief Executive Officer; Rob Davis, our Chief Financial Officer; Adam Schechter, President of Global Human Health and Dr. Roger Perlmutter, President of Merck Research Labs. Before I turn the call over to Ken, I want to point out a couple of items. First, you will see that we have items in our GAAP results such as acquisition-related charges, restructuring costs, and certain other items. You should note that we've excluded these from our non-GAAP results and provided a reconciliation of these items in Table 2 of our press release. We've also provided a table to help you understand the sales results in the quarter for the business units and products, which can be found on Table 3 of our press release. Second, I would like to remind you that some of the statements we make during today's call may be considered forward-looking statements within the meaning of the Safe Harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Such statements are made based on the current belief of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A in the 2015 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck undertakes no obligation to publicly update any forward-looking statements, and you can see our SEC filings as well as today's earnings release on Merck.com. With that, I'd like to turn the call over…

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Roger. Darla, I think we're ready to go to Q&A.

Operator

Operator

Your first question comes from Geoff Meacham with Barclays.

Geoffrey Meacham - Barclays Capital, Inc.

Analyst · Barclays

Good morning, guys. Thanks for the question. Just on ZEPATIER, I wonder if you can go into a little bit more detail about where you are with commercial formularies and what opportunities you have to expand that prior to the cycle next year. And then also on Hep C on next-gen regimens, how much value do you guys place on a shorter four-week regimen in terms of differentiation in the market? Thank you. Adam H. Schechter - Executive Vice President & President-Global Human Health: Hi, Geoff. This is Adam. And I'll start off with the update on ZEPATIER regarding how we're doing in the marketplace. I'll start by saying we really are pleased with the progress that we're making since the launch. We're still early in the launch, but we have been working really hard to secure access. And we have conversations ongoing across all segments, many different customers. Many of them are for access in 2017, but some of those such as the VA we're hoping to have access sometime in 2016. So it's still a little bit too early to give you exact accounts and names of accounts, but I can tell you that we feel good about potential access for 2017, and then we'll see where we end up for 2016, but I do think that there is opportunity there. And then if you look at how we're approaching the marketplace, we really are focusing on having access, and it's important that we have parity with the competitors. So we're spending a lot of time trying to get access at parity across the different segments in the United States so that there's physician and patient choice.

Teri Loxam - Vice President, Investor Relations

Management

Roger, do you want to answer the... Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories: I think with respect to shorter regimens, we'd love to be in a position to provide treatment that would massively shorten the regimen because adherence is a problem in this patient population, and many patients who are infected with hepatitis C lead somewhat chaotic lives. Unfortunately, I think there's really very little data to support the use of an oral direct-acting antiviral regimen at four weeks, and there are reasons to be concerned that that might not be possible. Over time, additional advances in other approaches, which could for example involve long-duration implantable therapies, that sort of thing, could improve that. And there are of course other kinds of intervention, for example, at the transcriptional level, that could help that. But right now, four weeks seems like a reach.

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Roger. Darla, can we go on to the next question, please?

Operator

Operator

It's from Steve Scala with Cowen. Steve Scala - Cowen & Co. LLC: Thank you so much, a question for Dr. Perlmutter. All companies are analyzing I-O data with the FDA-required Cox stratified proportional hazard statistical test. However, Bristol implies that it analyzes I-O data in a unique way, which emphasizes the non-proportional aspect of the I-O curve. And I guess in support of their view, they have stopped more studies early than any other company. And it's also true that Bristol's studies generally are longer than competitors' studies. Does Merck understand what Bristol is doing? Does Merck believe it is doing the same thing? And if not, how is what Merck is doing different? Thank you. Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories: Hey, Steve. There's no mystery here really. The mechanisms for statistical analysis of these kinds of studies have been refined over a period of many decades. And while the statistical literature continues to advance in ways that are quite intriguing, the reality is that we have a lot of data based on all of the prior studies that we've done with KEYTRUDA and with OPDIVO, the studies that have been done and published with OPDIVO as well that provide a substantial amount of positive predictive value. So in a Bayesian sense, one can predict outcomes fairly comfortably, and we know therefore we can put that information into our power calculations. We have pretty good understanding of where we're going and when we have to look. Of course, you can get surprises in different tumor types. But I guess one thing to stress is the general consistency of the responses that we've seen across a very large number of tumor types, both with respect to response rates and durability. So we don't find it mysterious. I think the explanation for the early stopping of the Bristol-Myers studies is largely related to the size of the studies more than anything else and there's nothing special about non-proportional analyses.

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Roger. Darla, next question, please.

Operator

Operator

It's from Tim Anderson with Bernstein. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC: Thank you. On KEYTRUDA, so obviously you and Bristol will both have first-line data this year in lung and that is in patients that need to be tested for the biomarker. Bristol of course points out that their testing encompasses a much greater proportion of patients than your testing. I'm wondering how you see that playing out commercially. Won't there be an advantage in their favor, the fact that it will be applicable to more patients? Do you think that's going to make a difference? And then what were sales of KEYTRUDA in the quarter in lung, so what proportion of sales were in lung? And then were there any wholesaler shifts or timing impact of purchasing that could have impacted what the results were? If I look at U.S. sales, they were flat versus Q4. Internationally, they continue to ramp. Is that reflective of demand in both geographies, or were there some timing issues? Adam H. Schechter - Executive Vice President & President-Global Human Health: Hi, Tim. This is Adam. So if you look at KEYTRUDA, as we said, we reported about $250 million of sales for the quarter, so we're now trending if you just look at about a $1 billion product just based on where we are today. About half the sales were outside the U.S., half the sales in the U.S. And we continue to see growth in the U.S. There are really not inventory issues to any large degree for this product, frankly. If you look at where sales are coming from, the vast majority of the sales are still coming from melanoma indications. And if you look at that, a lot of it is still coming in second-line,…

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Adam. Darla, next question, please.

Operator

Operator

It's from Colin Bristow with Bank of America.

Colin N. Bristow - Bank of America Merrill Lynch

Analyst · Bank of America

Good morning and thanks for taking the questions. So maybe just switching to anacetrapib, can you update us on your level of optimism for the CV outcomes study in light of the data we saw for Lilly's evacetrapib? And can you perhaps comment on the baseline HDLs in the involved population at least relative to Lilly's ACCELERATE study, since this is potentially an important consideration for the realization of a treatment effect? Thanks. Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories: Hi, Colin. It's Roger. So my feeling about the anacetrapib study really isn't much changed. We knew, of course, about Lilly's evacetrapib study. It's nice to have the data now in much more detail. The differences between the two studies have been discussed in terms of the patient populations that were enrolled and in terms of the duration of the studies, which the follow-up duration is important since you do expect that as you manipulate lipid profiles, the effects should accrue over time. So that's probably the biggest impact. I think that when we look at this, because of the dramatic lowering in LDL cholesterol, the dramatic increase in HDL cholesterol, the changes in Lp (a), the expectation is that patients who are receiving anacetrapib should do better in terms of major cardiovascular events. That's what we're testing. It's a 30,000-patient study. And we're going to have the data next year and we'll have a chance to look and see. We're approaching the end of the treatment period, and at some point the clouds will part and the sun will shine and we'll have a chance to see what the landscape looks like. At the moment, there's no point in speculating. This study is nearly complete.

Teri Loxam - Vice President, Investor Relations

Management

Next question, please, Darla?

Operator

Operator

It's from Alex Arfaei with BMO Capital.

Alex Arfaei - BMO Capital Markets

Analyst · BMO Capital

Good morning, folks. Thanks for taking the questions. Apologies if I missed this, but did the extra calendar days in 1Q benefit the quarter in any way? And, Adam, do you think that PD-L1 testing will be restricted to a specific test by treatment, or do you anticipate that it will basically be at the discretion of the labs and that we will eventually see that the labs basically concentrate towards one that's the preferred one, arguably the more sensitive test? Thank you. Robert M. Davis - Chief Financial Officer & Executive Vice President: Good morning, Alex. This is Rob. To your question on the impact of the days of sales, we did see some benefit from that impact in the U.S., but it was largely offset by channel, so it did not materially change our results. Adam H. Schechter - Executive Vice President & President-Global Human Health: And with respect to PD-L1 testing, first of all, what we're saying is that PD-L1 testing is not specified in the label of the products for any certain test, so it just says if you have a PD-L1 positive patient in the label. So therefore, it doesn't matter what test the lab uses in order to designate whether the test is PD-L1 positive or not. I don't think that is going to change. I think it will be up to the labs to decide which testing that they use and then how they determine it to be positive or not. I think that there are two other points that are important. First of all, we're already seeing about 30% of patients with lung being tested, and about 70% of those are in first-line. The other thing that's important is that when patients are being tested, if it's positive right now, the vast majority of those patients are going to KEYTRUDA. So therefore, I do think that the testing irrespective of what test they use is occurring more often and actually over time could be helpful.

Teri Loxam - Vice President, Investor Relations

Management

Next question, please, Darla.

Operator

Operator

It comes from Jami Rubin with Goldman Sachs. Jami Rubin - Goldman Sachs & Co.: Thank you, a few questions. Ken, first to you, I was intrigued that in your press release you highlighted business development as a high priority. If you'll recall, at our CEO conference back in January, you highlighted your high priority to complete deals, being more aggressive this year, moving up the risk curve. Can you provide a little bit more granularity as to specifically what you're looking for? Clearly, we've seen a major derating of valuations of biotech stocks, yet we haven't really seen any motion or rumors or anything out of Merck. What are you looking for specifically? Are they late-stage assets? Are they early-stage assets? What compelled you to highlight that early on in your press release? That's my first question. And second questions are for you, Roger and Adam, if you want to comment. There's been a lot of focus on this call today on monotherapy. Obviously, we have first-line lung monotherapy. But our expectation is that monotherapy is rapidly going to move to combination therapy. And as you know, oncologists believe that the best way to treat cancer is with cocktail or combination therapy. And clearly, your competitors have all pursued combinations either with I-O or chemo combo. So just you have pursued a monotherapy strategy and are behind the curve on combination. What is your strategy to catch up? And then just as a corollary to that question, the market wisdom is that you have to own a combination to speed them to market. What is your strategy to do that? Thanks very much. Kenneth C. Frazier - Chairman, President & Chief Executive Officer: Jami, thanks for the question. Let me start by saying what I was trying to say…

Teri Loxam - Vice President, Investor Relations

Management

Thanks. Darla, next question, please.

Operator

Operator

It's from Andrew Baum with Citi.

Amalan R. Selvarajah - Citigroup Global Markets Ltd.

Analyst · Citi

Hi, this is Amalan Selvarajah on behalf of Andrew. Thanks for taking the question. I have just one left. How does the pricing and rebate dynamic on your biosimilars work between you and your partners? And more specifically, does Merck have the ultimate decision, or can Samsung advise the list price? Thanks. Adam H. Schechter - Executive Vice President & President-Global Human Health: So this is Adam. And if you look at Europe for the pricing and rebates on biosimilars, it's determined by the Merck team and our European team. And what we've done is we've been very successful competing for patients that are on existing therapy, but we have lost many new patient starts. Hence, you see a decline year over year for REMICADE, and we expect that that decline will continue over time. But what we see right now is that existing patients are able to maintain on therapy in many of the European markets.

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Adam. Next question, please, Darla.

Operator

Operator

It's from Tony Butler with Guggenheim Securities.

Charles Anthony Butler - Guggenheim Securities LLC

Analyst · Guggenheim Securities

Yes, thanks very much. Roger, back to an earlier comment you made on IDO, I wanted to explore IOmet and the acquisition rationale for that relative to what you had with your partner and where you're going in melanoma. I assume only with IOmet you were thinking about a broader set of tumors. Was that the rationale? And second, Rob, to generic mometasone for NASONEX, how much pressure does that put on your gross margin? And more importantly, because that's a reasonably large product, would your tax rate not actually see a benefit because of the change earlier than you would have expected, or is it just marginal? Thank you. Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories: Tony, thanks for the question. On IOmet, we have data that we have presented for the IDO1 inhibitor from Incyte in combination with KEYTRUDA that is very suggestive with regard to a treatment effect in melanoma. And one of the good things about it is that the adverse experience profile for the combination of the IDO1 inhibitor along with KEYTRUDA really looks very favorable. With that in mind, we wanted to explore more fully the landscape of IDO1 and PD-L1 inhibitors. We have an opportunity with IOmet to gain access to actually quite a large set of starting materials and new chemistry, which enables us to think about how we would design an optimal molecule that could be used in a whole variety of different tumor types. We have a very good collaborative relationship with Incyte, and we're eager to see those programs advance just as quickly as possible for the benefit of patients. But we think there's some running room as well and an opportunity for us to use our chemical insights potentially to improve treatment regimens in that regard. And that was the driving force behind it. Robert M. Davis - Chief Financial Officer & Executive Vice President: And with regards to your question about generic NASONEX, if you look at NASONEX, it is a high gross margin product for us, but it does have a fair bit of discounting. So it will be a slight drag in the back part of the year to our gross margin, but it was fully reflected in the guidance we gave on gross margin. And as you look at the tax rate, this really has no meaningful impact to our tax rate to speak of.

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Rob. Next question, please, Darla?

Operator

Operator

It's from Chris Schott with JPMorgan.

Christopher Schott - JPMorgan Securities LLC

Analyst · JPMorgan

Great, thanks very much. I just had two quick ones here. One, just coming back to business development. I think you used the term bolt-on acquisitions in your release. Can you just help us understand a little bit how large a deal could be and still considered to be a bolt-on for Merck? I guess, for example, would Cubist or something a bit larger have been considered a bolt-on, or should we think about Merck targeting some smaller transactions here? My second question is on ZEPATIER and just the HCV marketplace in general. I think one of your competitors cited some pricing pressures in the space emerging again this year. I guess how do you see the pricing environment evolving over time with three main players in the space? And I guess specifically, should we think about price continuing to erode here over time, where you'll get more access, but we should think about a downward trend on price overall? Thanks very much. Kenneth C. Frazier - Chairman, President & Chief Executive Officer: So starting on the business development question, thanks, Chris. When I talk about bolt-on acquisitions, I think I'm not signaling anything specific with respect to the size of the deal any more than I was earlier with the stage of development. We want to find the best assets at the best valuation to help us grow our pipeline going forward. And so I guess what I'm signaling is I'm not focused on a large consolidation type merger such as we've seen in the industry in the past. But I also think that bolt-on acquisitions can be larger than, for example, a Cubist. It depends on what the company brings, what their pipeline brings, what level of scientific innovation they have internally, and how we believe it can complement our portfolio and pipeline going forward. Adam H. Schechter - Executive Vice President & President-Global Human Health: And, Chris, this is Adam. As we look at the hepatitis C market, we continue to be optimistic about our potential within the market. I think that price will continue to be under pressure over time in this market. But despite that, I think the lower prices have expanded access to some degree. And I think a good example of that is the VA and the removal of the fibrosis score restrictions. So there will continue to be price pressure in the marketplace. We will continue, as I said before, to try to get parity access. But we have to see where our competition and where the payers go. And the more they try to push for restricted access or exclusive formularies, we have to watch that closely.

Teri Loxam - Vice President, Investor Relations

Management

Great, thanks. Darla, next question.

Operator

Operator

It's from Seamus Fernandez with Leerink.

Seamus Fernandez - Leerink Partners LLC

Analyst · Leerink

Thanks. Can you hear me?

Teri Loxam - Vice President, Investor Relations

Management

Yes, we can, Seamus.

Seamus Fernandez - Leerink Partners LLC

Analyst · Leerink

Okay, great, thanks for the questions, a couple of quick questions. Just, Roger, can you clarify the update on ZEPATIER in the EU with regard to the manufacturing issues that you mentioned? I think I missed a little bit of the facts there. The second question, again, Roger, you mentioned a number of internally developed assets and collaborations. Can you talk a little bit about GITR? We're hearing and seeing a lot of additional companies pursue this target. Enthusiasm amongst thought leaders is building. But there are questions about this target as to whether or not, A), it's an agonist at all, and also how efficiently one can actually develop antibodies to this target. And my last question is for the team overall. In terms of the areas of greatest interest for business development, should we anticipate that your focus is mostly on oncology specifically, or how broadly and what areas are of greatest interest to you on the BD side? Thanks.

Teri Loxam - Vice President, Investor Relations

Management

Why don't we start with Roger? Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories: So, Seamus, just to reiterate that in the course of our European review, the European Medicines Agency cited Merck's third-party manufacturer for issues that were largely related to inadequate record keeping and the need for improvement in their quality management systems. The problems do not affect, we do not believe, the safety, efficacy, or quality specifications of the product, and hence we don't believe the problems will affect the supply to the U.S. market. But we take these good manufacturing practice issues very seriously, and we're working with both regulatory agencies and the contract manufacturer to resolve the issues as expeditiously as possible. Secondly, with respect to GITR, as you know, our program has been in the clinic for quite some time, but we have been advancing it very slowly because of concerns on our part and on the part of regulators too. We share these concerns that an agonist antibody could stimulate a fairly profound immune activation response, and those responses can be difficult to manage. So we're just getting to the point in advancing that program where we believe we're in the therapeutic range. We certainly do have data that our anti-GITR antibody behaves as an agonist. I think one of the issues has to do with cross-linking and which Fc receptors are engaged by the therapy. As you know, we have two GITR antibodies that are in the clinic. There is a lot of enthusiasm in the community, but it will be some time I think before we understand whether to what extent GITR antibodies will be useful. Robert M. Davis - Chief Financial Officer & Executive Vice President: And, Seamus, maybe I can just add on the comments around ZEPATIER. I think it's important also to understand. That was fully reflected in our guidance. And in fact, just to give you a little bit more color, as you look at ZEPATIER in particular, thinking about roughly where consensus is now, which ranges bilitates (47:08) around $650 million, we're very comfortable with that and, as I said, was reflected in our guidance. I just want to make sure that we get that out there.

Teri Loxam - Vice President, Investor Relations

Management

Okay, and do you want to comment on BD, Ken? Kenneth C. Frazier - Chairman, President & Chief Executive Officer: Sure. Thanks, Seamus. I think as we look at BD, we look at it in two different ways. First of all, obviously we're very eager to build on areas of leadership like immuno-oncology. And you saw us do deals, for example, with cCAM Biotherapeutics. You saw us do the deal earlier with IOmet that we talked about. So we'd like to build on those areas where we already have leadership. But it's also important for us not to be too blinded to the fact that there's important science going on in other areas. And so what we want to look for are significant opportunities to have leading positions in growing areas of therapeutic significance going forward. Obviously, immuno-oncology would be one leading area, but we are also willing to do business development if we think we can get an asset that we can leverage inside our portfolio for leadership positions.

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Ken. Darla, let's move on to the next question.

Operator

Operator

It's from Jeff Holford with Jefferies.

Jeffrey Holford - Jefferies LLC

Analyst · Jefferies

Hi, thanks very much for taking my question. I wondered if you can just give us an update on your insulin glargine program. We were maybe expecting to see your pivotal data coming up with that program, perhaps a filing later this year. So an update there would be useful. And then we get a lot of commentary from your competitor on how entrenched the use of nivolumab is amongst particular lung cancer oncologists. That would seem to be the case from the commercial data you're giving us in Q1 versus their data. Can you just go through in a bit more detail why you think that isn't going to be a barrier for you in first-line lung cancer given the relatively close potential timing of the launches? And if it is more of a barrier than you think, what could you possibly do to change that? Thank you very much.

Teri Loxam - Vice President, Investor Relations

Management

Roger, do you want to start with... Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories: So with respect to glargine insulin, you'll be seeing data later in the year. We're filed in Europe and going through the process of gaining approval for that MK-1293 molecule. Probably not much more to add, I think, to that. Adam H. Schechter - Executive Vice President & President-Global Human Health: And if you look at KEYTRUDA, the first thing I'd say is right now, we're the ones that have to talk about PD-L1 testing for second-line therapy, and we're the ones that are training physicians and getting physicians to understand the utilization of PD-L1 testing. When you think about first-line lung, all competitors will be talking about PD-L1 testing. So I believe that barrier will go away because all of us together will be talking about it. And the other thing that I think is important is if the playing field is equal in lung and all else is close, every three-week dosing is an advantage versus competition. And therefore I think that the dosing for first-line lung patients could end up being an advantage for us if PD-L1 testing is communicated by all companies. But the other thing I want to emphasize, as I've said all along, this is a long-term view of this market. There will be multiple competitors that can do really well in this market. I don't think we should look at any one quarter or short period of time. This market over the next several years with the number of tumor types that we're studying, with the amount of – how well that we're continuing to develop combination products, we can continue to do really well. The last thing I'll say is that if you look at Europe, in countries in Europe, we actually came to market after competition. And in many markets, including big markets like Germany in melanoma, despite that, we now are the market leader. So I believe it shows our strength outside of the U.S., where I believe PD-L1 testing will be even more relevant and accepted by payers than potentially in the U.S. for second-line.

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Adam. Next question, please, Darla.

Operator

Operator

It's from David Risinger from Morgan Stanley. David R. Risinger - Morgan Stanley & Co. LLC: Thanks very much, so I have a couple questions. First, with respect to the timing of the upcoming first-line lung readout, Roger, I think you mentioned at the middle of the year. But could you just talk a little bit more about more specifically the timing that you expect and the factors that you are assessing to be able to convey that timing? And then with respect to ASCO, could you just talk a little bit about the chemo combo data that you'll be conveying? Obviously, it will be longer duration data that supports your move into Phase 3 for the chemo combo. If you could, shed some light on that. And then finally with respect to REMICADE biosimilar adoption, obviously REMICADE is an infused drug used by hospitals and clinics. Do you believe that that route of administration and those customers have been more inclined to adopt biosimilars than the marketplace would be for a self-injectable therapy? Thank you.

Teri Loxam - Vice President, Investor Relations

Management

Roger, do you want to take the first one? Roger M. Perlmutter, M.D., Ph.D. - Executive Vice President & President-Merck Research Laboratories: Right, yes. So let me start with respect to the KEYNOTE-024 study, the first-line study in PD-L1 high patients in lung cancer. Again, it's important to recognize that this is an event-driven trial, and they have about 300 patients that are enrolled in the study. We've powered the study based on a certain number of progression events. Progression-free survival is the primary endpoint. So it's actually just a question of when we hit the event number. From the time we hit the event number to the time we get to database lock involves polling the sites, and there are a variety of questions that have to be answered. And then once the database is locked, the statistical analysis takes relatively little time. So there are no other factors that go into this. We're not in any way manipulating it. We're just waiting until we hit this pre-specified event trigger, which defines the power for the study. And once that's available, then we'll be able to do that. Just with respect to ASCO, since you mentioned it, I didn't have a chance to go into it, but there's going to be a lot of new material presented at ASCO. We have 84 currently abstracts, including 13 oral presentations that will be presented at ASCO. We're going to be discussing data from 20 different tumor types. We'll have additional data that we'll be presenting with respect to chemo combinations, and in particular, the data that comes from the KEYNOTE-021 study, which is combinations with traditional chemotherapy, carbo [carboplatin]/pemetrexed, where overall response rates are really very high, nearly 60%. So there's a lot of information that will be communicated at ASCO. Adam H. Schechter - Executive Vice President & President-Global Human Health: And, Dave, with regard to REMICADE biosimilar adoption, I think it has more to do with price differences for new patients and tenders than it does with the way in which the drugs are administered. So I wouldn't expect a very significant difference.

Teri Loxam - Vice President, Investor Relations

Management

Next question, please, Darla.

Operator

Operator

It's from Vamil Divan with Credit Suisse. Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker): Hi, good morning. Thanks so much for taking my questions. The one I just have one on the guidance, just to clarify, on the sales side, I believe you said you went from a 3% negative headwind on sales from FX to a 2% negative headwind. So I think there's about a $400 million benefit. But you only raised the guidance, the midpoint of your guidance by about $100 million. So I wondered if you could just confirm that I have the facts straight. And if so, what is it that's bringing down the sales guidance by about $300 million if you take out the impact of the currency moves? And then the second question I have is on Alzheimer's, and I would love to just get Merck's perspective on this. Obviously, there has been a lot of discussion around endpoints with the changes Lilly made recently to their solanezumab study. I know for yours, for your base inhibitor, in prodromal you have CDR [Clinical Dementia Rating] Sum of the Boxes as your primary, I believe, in the prodromal study. In the mild to moderate, you have ADAS-cog and ADCS/ADL as co-primary. So if you could just talk through those endpoints and how you think about the pros and cons of each in the different patient populations, I think that would be helpful just given all the investor interest in that area. Thanks. Robert M. Davis - Chief Financial Officer & Executive Vice President: Vamil, this is Rob. Good morning. So to your question, you are correct that, as we set original guidance at the beginning of the year, we expected three percentage points of negative impact from foreign currency. Using the mid-April…

Teri Loxam - Vice President, Investor Relations

Management

Thanks, Roger. Darla. I know we're hitting up against the top of the hour. We're going to try to squeeze in one more question.

Operator

Operator

And that's from Marc Goodman with UBS.

Marc Goodman - UBS Securities LLC

Analyst · UBS

Good morning. Emerging markets, we see the numbers in the press release. Can you give us a little more flavor on what's going on in the different areas, China, Latin America? How is it doing ex-Venezuela? Eastern Europe looked tough. How much of this is currency and how much of this is just underlying stuff? And then can you just comment on omarigliptin? I thought I had read that you're not going to be pursuing this in the U.S. and Europe. If you could, just comment on that. And on JANUVIA, were there any inventory changes? It wasn't clear from your comments. Thanks Adam H. Schechter - Executive Vice President & President-Global Human Health: So I'll get those quickly. If you exclude Venezuela, sales in emerging markets ex-foreign exchange were up about 5%. And we're seeing good growth in countries like China, where we had about 11% growth outside of foreign exchange. And we're seeing good success in the areas of vaccines, our diabetes franchise, and so forth. Where the pressure was primarily was Venezuela, but obviously there's some turmoil that's happening in some markets, particularly in the Middle East, that have some impact. If you look at emerging markets over time, there has been a slight decline in growth, but we still expect there to be growth as we move forward into the future. With regard to JANUVIA, I said in the U.S. we had 9% growth versus prior year. But the best way to understand that is to look at underlying volume growth, which was about 5% versus prior year. And therefore, we did see some inventory movement of JANUVIA. It's important to note that just like last year the quarters will fluctuate to some degree from one quarter to the next quarter. But overall, across the year,…

Operator

Operator

Ladies and gentlemen, this concludes Merck's Q1 2016 sales and earnings conference call. You may now disconnect your lines.