Good day, everyone and welcome to Merck's Second Quarter 2015 Earnings Conference Call. Today's call is being recorded. At this time I would like to turn the call over to Joseph Romanelli, Vice President, Investor Relations. Please go ahead.

Thank you, Darla, and good morning, everyone. We'd also like to say good afternoon and good evening to everyone listening outside the United States. Welcome to Merck's second quarter 2015 conference call. Before I turn the call over to Ken, I just 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 have excluded those items from our non-GAAP results. There are reconciliation tables available in our press release so that you can get a better understanding of their underlying performance. We've also provided tables to help you understand the sales results in the quarter for the business units as well for products. This can be found in table three of our press release and the reconciliation table as I mentioned earlier are in table two of the release. During the call we will be referring to table two for the P&L and table three as it relates to revenue. Second, I would like to remind you that some of the statements we make during today's call might 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 2014 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. So with that, this morning I'm joined by Ken Frazier, our Chairman and Chief Executive Officer; Adam Schechter, President of Global Human Health; Rob Davis, our Chief Financial Officer; and Dr. Roger Perlmutter, President of Merck Research Labs. Now I'd like to turn the call over to Ken. Ken?

Thanks Joe. Good morning everyone. Thank you all for joining the call today. Before I discuss our quarterly performance, I want to take a moment to thank Joe Romanelli for ably leading our investor relations efforts for the past two years. Joe is moving on from explaining our numbers to a role in which he will be generating revenue as Managing Director for our business in Taiwan and Hong Kong. We have benefited from Joe's expertise and leadership and he has done an outstanding job. We wish him and his family all the best as they relocate to Asia. Thank you, Joe. I am also pleased that joining the call today is Joe's successor, Terry Locksome [ph]. Terry [ph] comes to Merck with a wealth of experience in financial investor relations and has worked in the pharmaceutical, entertainment and investment banking industries. Welcome to Merck Terry [ph]. We're pleased to have you on our team. This is an exciting time for Merck as we advance our promising pipeline and launched new products in the marketplace. It is also a propitious time for biomedical research generally as we are witnessing the introduction of breakthrough therapies and in some cases cures for some of the most difficult to treat diseases. Merck's late-stage pipeline and ongoing launches reflect scientific and therapeutic progress that will provide significant value to patients in society. Over the past few months I've seen and heard first hand some stakeholders across the healthcare ecosystem including patients, payers and government about the critical impact that our current and future medicines and vaccines can have on improving their health and productivity of both individuals and populations. These experiences continue to reinforce my conviction that in the evolving healthcare environment success will accrue to those who development products that not only enable…

Thank you, Ken and good morning everyone. This morning I'll discuss the second quarter results for Global Human Health and my comments will be on a constant currency basis. Our performance in the quarter reflects continued efforts to drive growth within our core business coupled with increasing contributions from new product launches. Sales increased 3% with growth in all of our core focus areas of diabetes, hospital acute care, vaccines and oncology. Collectively, these core focus areas grew 9% excluding the acquisition of Cubist. I'll start by reviewing the performance of several key products followed by brief update by region and then on several launch products. Starting with the JANUVIA franchise, we delivered our seventh straight quarter of growth. We have steadily increased resources for JANUVIA to drive growth and our results reflect the positive impact of our strategic resource allocation and the strength of the products. In the second quarter the JANUVIA franchise sales reached approximately $1.6 billion dollars and grew 9%. In the United States sales grew 14%. While we continue to drive underlying volume growth of about 4% we had some benefits this quarter from adjustments to rebate accruals. In the international markets sales grew 4%. Volume growth in Europe was a key contributor to performance and emerging markets delivered steady double-digit growth. Also we are pleased that the data presented in the TECOS study at the American Diabetes Association meeting last month, confirmed that JANUVIA did not increase the risk of major adverse cardiovascular events or hospitalization for heart failure. We're now educating customers on these important results. Sales of ZETIA/VYTORIN declined 8%. In the United States ZETIA was flat offset by declines in VYTORIN. Outside the U.S. sales fell as a result of ZETIA's loss of exclusivity in Canada and prescription has changed in restrictions…

Thanks Adam, good morning everyone. As Ken and Adam stated, our results this quarter and for the first half of the year showed that we're executing the focused strategy we first outlined nearly two years ago. We are driving top line growth in core therapeutic areas and delivering our leveraged P&L. This morning I'll provide some additional detail on the quarter and comment on our outlook for the second half of the year. My remarks will focus on our non-GAAP financials. Total company revenues were $9.8 billion for the quarter, a decrease of 11% year-over-year while the underlying base business great 3%. This excludes a negative 7 percentage point impact from foreign exchange and a net negative 7 percentage point impact from acquisitions, divestitures and the now ended AstraZeneca JV. I should note that the impact from foreign exchange includes the benefit of approximately $190 million of revenue from our hedging program. Growth overall was primarily driven by all core focus areas of diabetes, hospital acute care, oncology and vaccines in our pharmaceutical business and by the 10% growth in our animal health business. Moving now to expenses, gross margin was 75.4% in the quarter an increase of 280 basis points year-over-year. Lower inventory write-offs and foreign exchange provided the primary benefit in the quarter. Total operating expenses were $463 million lower this quarter, primarily driven by marketing and administrative expenses which declined 15% versus prior year due to the favorable impact to foreign exchange, net favorability from acquisitions and divestitures and lower direct selling costs. Research and development expenses declined 2% as increased spending in the quarter was more than offset by foreign exchange. With our ongoing cost reductions we are on track to meet or exceed the $2.5 billion in savings versus 2012 by the end of this…

Thanks Rob. I'll briefly review some of the accomplishments in research and development during the second quarter. First with respect to KEYTRUDA our PD-1 directed monoclonal antibody designed to promote activation of pre-existing tumor directed immune responses we announced that the European Commission granted marketing authorization for KEYTRUDA in the first and second line setting for patients with advance melanoma. This approval includes data from our Keynote 006 study which compared KEYTRUDA to ipilimumab in the first and second line treatment of patients with advanced melanoma. Details of this study including the favorable outcomes observed for response rates, progression free survival and overall survival were published in the New England Journal of Medicine. They were also incorporated into regulatory approval of KEYTRUDA in Australia. We have filed the Keynote 006 data as a supplemental BLA with the FDA and have also filed an SBLA for our Keynote 002 study where therapy with KEYTRUDA proved superior to traditional chemotherapy with respect to both response rate and progression free survival. During the quarter the FDA granted priority review to our supplemental license application for the use of KEYTRUDA in patients with advanced treatment refractory, non-small cell lung cancer where EGF receptor or ALK-directed therapy is not indicated. Data supporting this application also published in the New England Journal of Medicine demonstrated that expression of PD-L1 one or two ligands were PD-1 the target KEYTRUDA in greater than 50% of tumor cells was associated with substantially higher response rates than were seen in patients whose tumors did not express PD-L1. These responses occurred irrespective of the underlying histologic classification of the presenting non-small cell lung cancer. These data were included in our recent submission to the FDA which has an action date of October 2. We continue to see responses in patients suffering…

Thanks Roger and Darla we'll begin the Q&A segment of our call this morning and if you are a caller if you can limit yourself to one or two questions, that way we can get to as many people in the queue as possible. So Darla we'll take our first caller.

Great. [Operator Instructions] And our first question comes from the line of David Risinger with Morgan Stanley.

Thanks very much and I guess I should start by congratulating you Joe. It has been great to work with you and we will miss you and I wanted to offer my congrats to Terry as well, I look forward to working with you again.

Thanks Dave. With respect to my questions, I guess one question on Remicade biosimilar that I'm not clear on is our government is trying to leverage the Remicade biosimilar and push down pricing of other branded anti-TNFs and along those lines do you expect any implications from the NOR-SWITCH study when that report is out? So that's my first question. And then I guess my second question is, could you just walk through what we should focus on in the fall at upcoming cancer conferences on your IO franchise? Thank you.

Adam?

Yes, good morning Dave. We forget the biosimilars. Right now we're not seeing a major impact in products outside of Remicade. So for example if you look at Simponi we continue to see good growth for Simponi and we haven’t seen any significant impact to Simponi based upon Remicade being biosimilar. At this point in time we are not seeing a major impact from substitution. As you mentioned there is the study that's being done in Scandinavia. We'll see by the results of that study and over time I believe that there will be additional impact from studies as such but I think it will take time Dave.

Great, Roger?

Yes, the question was the fall conferences in the fall. Yes, I mean we're going to have a lot of data at AASO [ph] meeting and I expect that we'll have the opportunity to present some data with respect to our triplet therapy which will be quite interesting going forward. And in immuno-oncology there are a variety of oncology meetings at CPS [ph] more meetings are probably going to be the most interesting in Europe.

Okay, thanks Dave. And Darla the next caller?

Is from Marc Goodman with UBS.

Yes, just to continue on the Remicade just curious, can you help us with how pricing is being with the biosimilar? And can you talk about China a little bit? Obviously sales were pretty good there, but we're hearing a lot of slowdown in China, there's a lot of things going on there can you talk about your new product launches relative to what's happening in China and how we should expect your growth, can we grow double-digits for the next couple of years there? And then just lastly on the gross margin, can you just give us the impact that foreign exchange had on the gross margin? Thanks.

Yes so, Marc, this is Adam. Let me just start with the biosimilars. I'll give you some additional context, then I'll briefly talk about China. If you look at what's occurring in the marketplace, we've definitely seen an increased impact in our first full quarters since loss of exclusivity in the second wave in the core European markets. We've seeing mandatory price reductions based upon reference pricing impacts. And as we reported last quarter biosimilar discounts we've seen as high as 45%. However we still maintain about a 95% market share and we are facing mostly the reference pricing is the key issue as we speak right now. Over time we believe that as more new patients come into the market we will lose market share because we've been able to hold on to the vast majority. We've won most tenders for existing patients. So it really is the new patients coming in that over time will begin to lose. So taking all that together we expect that the impacts on loss of exclusivity on the Remicade business for this year will exceed the growth that we're seeing for Simponi. But I will mention as I said before we expect Simponi will continue to grow despite the increased utilization of Remicade biosimilars. If you look at China, we had 8% growth and we saw growth across our hospital acute care business and diversified brands. There is no doubt that we are seeing some macro trends of a slowdown, but I still believe there is significant opportunity there. We have good traction with multiple key products that we have, the products that you would think of, but we're also pursuing innovation and we are looking forward to having NRDL [ph] pricing approval for products like Januvia and Zetia in the future which I think could be growth drivers for us in that market. So despite the macro trends I do believe over time that China can remain an important market for us.

Good morning Marc, this is Rob. With regards to your question on the impact of foreign currency and gross margin it accounted for about half of the increase your saw 2013 second quarter versus second quarter 2014.

Great, thank you Marc and Darla, next caller please?

It's from Tim Anderson with Bernstein.

Thank you. A couple of questions, obviously one of the important controversies with investors is how KEYTRUDA's label will read in the second line lung, I am wondering if you can give us your latest thinking, will it likely be broad meeting and all comers or will it likely be narrow meaning only in PD-L1 positive patients? I know in the past you've said you think the label would probably want to reflect the data in both patient populations, but I don’t really know what that means in terms of the indication per se? And on the same line of questioning, what's the most updated data you have on KEYNOTE-001 in PD-L1 negative patients in terms of the number of patients you have? I think originally that data set was around 40 patients. I think at ASCO I saw that it had grown to about 70 patients that were PD-L1 negative. What's going to be the final number that FDA has in the KEYTRUDA application?

Tim, first of all with respect to the explicit language of the label, you know, I can't comment on what FDA ultimately will decide to do. Obviously the major claims in the study as I indicated relate to response rates in PD-L1 positive patients and that you know, fundamentally is what we'll be focused on, but at the same time as I've said before I don't think that the data that exists in the PD-L1 negative population can be ignored. The exact number of PD-L1 negative patients in the file, I think we'll have to get back to you on that, but you're right it's going to be somewhere close to 100 patients. So as I say it's a considerable number there and there are meaningful responses in that patient population which one would guess that will be reflected in one way or another.

Great, thanks Tim, and Darla, next caller please?

It's from Jami Rubin with Goldman Sachs.

Thank you. A couple questions, Ken first for you. Just I am wondering if you guys are giving any second thoughts to how you might consider unlocking the value of the diversified brands business? I know last year there were rumors in the press that you were considering bundling that business and selling it and I think you decided not to because of the substantial tax leakage that as you know we're seeing companies come up with all sorts of creative ways to either spin out certain assets, sell assets et cetera, et cetera. So, I am just wondering maybe if you or Rob can comment on what you might be thinking in terms of options for that business because obviously it is having a significant drag on your top line? And then my second question for you Roger is on anacetrapib. If you could comment on the drugs lung, half-life, how much of a disadvantage do you see this, obviously I think the street is basically written your CETP off because of this issue, if you could put that into context for us? Thanks very much.

Ken?

Okay, thanks Jami, for the questions. First of all, as we've said before we are really focused on prioritization and as we look across our entire business we continue to challenge ourselves to determine whether specific assets including diversified brands would have more value outside Merck or as part of our business. You've seen us take action and divest certain assets I would say ophthalmology, MCC when we felt that we can do that in a way that is advantageous to the company long-term. So while we are cognizant of the issue that you just raised relative to top line growth we have to look at the difficulty associated with it and what are the vehicles that we could use to do that. So, I can just summarize it by saying that we will look at these mature assets and will focus on the impacts that they have on the cash flow as well as the impact they have growth and we'll try to make the right decision relative to the specific opportunities that we have. Thanks.

Thanks Ken and Roger?

Yes, Jami, with respect to anacetrapib, I think the really important issue is the benefit risk ratio. We have a very large as you know, study 30,000 patient study which will go on for quite a long time and we're capturing all the adverse experience data within that patient population. The benefit of reducing major cardiovascular events is significant. It's very meaningful. It can in fact it's certainly a morbidity benefit. It could in fact be a mortality benefit. That has to be then juxtaposed with the adverse experience profile. Because we have so many patients who have been treated for such long time, I think we'll have a very good sense of that and depending upon the magnitude of the benefit that we see the consequence we believe of LDL-cholesterol lowering also HDL raising or could a little lowering, all of those things together will have to be juxtaposed with what the adverse experience profile looks like. Once we have the data I think we'll have a better sense of that.

And Jami, this is Adam, the only thing I would add is, I am sure you remember when we launched the SSSS trial also we launched the [indiscernible] trial in the cholesterol area, I wished we had an outcomes trial at the time of launch for either Zocor or Mevacor, I think would have made such a substantial difference. So I am very excited about the potential opportunity of launching a product with 30,000 patient outcomes trial into an area that we know extraordinarily well, which is the cholesterol lowering market.

Great, thank you Jami, and Darla, next called please?

It's from John Boris with SunTrust.

Thanks for taking the questions and congrats Joe. First question on the oncology franchise for Roger and Adam, can you maybe just articulate, especially in lung when you think you might have an OS benefit? And Adam, for you having or not having that in the label how does that position you relative to your competition most notably after you wove that hazard in the label? And then second question, it looks as though Ken, and this is also for Rob, repatriation seems to be a real possibility this year in order to pay for some highway trust fund funding, you have a significant amount of cash on the balance sheet we estimate at the end of 1Q at about close to $29 billion with 80% to 90% of that offshore. If you do have an opportunity to potentially repatriate that, how are you thinking about deploying that if you are able to bring it back? Thanks.

So John, with respect to the 010 study, which is a study that will provide a first look at an overall survival benefit for KEYTRUDA in the non-small cell lung cancer setting, this is a study that compares two doses of KEYTRUDA 2 mg, 10 mg versus conventional chemotherapy, it is a good-sized study and there is the opportunity for an interim analysis which of course is event driven. At the time when sufficient events are accrued then the data monitoring committee will look at that. In principle they could see a benefit that would result in recommendation to modify the study or they could continue the study which is designed to end sometime around the end-of-the-year. So that's those are the times when we potentially would see the overall survival benefit.

Yes, and John, let me provide some context and then I'll answer your question directly. You know, first of all I am sure you've seen the IMS data and the May IMS data just came out and KEYTRUDA has more than 80% anti-PD-1 share and in all melanoma patients. In addition to that KEYTRUDA is now the number one treatment in melanoma at a 35% overall patient share. So hopefully you've seen that we are able to do well in the marketplace. With regard to lung, we've built an oncology business unit to maximize KEYTRUDA over the long- term. Just as we were ready to launch melanoma we will be ready to launch in lung, we are ready for that. We think it's a very significant opportunity. Of course we prefer to have overall survival data to promote and as Roger said those data are we are maturing in a broad clinical program, but we have the capabilities now to be successful and I think physicians have seen the overall survival data in melanoma. They've begun to assume that you'll have overall survival data once you have the studies underway. So although we prefer to have it at the time of launch the good news is that as Roger said, we have the studies to show it overtime.

And may be the only other thing to emphasize is if you look at the PD-L1 positive population, so in those individuals the proportion score is about 50%, the response rates are really quite extraordinary. So in treatment naïve patients the response rates were 50%. Those are really quite unprecedented response rates in non-small cell lung cancer. One would expect those to translate into survival data. We'll have a chance to see.

Thank you, Adam, and Roger, and Rob.

John, with regard to your question about repatriation, firstly I would say obviously we are very supportive of comprehensive tax reform and I think listening to the dialogue as it's evolving in Wall Street or in Washington, clearly it is something that I think is a possibility. As we look at it, it is important that it is comprehensive, that it does look at a territorial system, that it does consider flat tax and that does look at ways to advantage companies that develop intellectual property in the United States. So all of that is being discussed and we're very supportive of that. As far as the cash, we have offshore and what we would do if we did have a major repatriation, right now I don't want to get into specifics about a strategy. I would just go back to say our overall capital allocation philosophy remains the same. First and foremost we're going to fund the business and then beyond that we'll look to deploy capital towards the developmental opportunities, primarily focused in areas that help to augment our pipeline. I think you've heard some examples of that even this morning on the call from Roger and then clearly we remain committed to our dividend and we'll consider share repurchase. If you look at what we've done over the past, we have deployed meaningful capital back to shareholders and all of that would remain the same. So as we would see that all of that will form a new strategy we think of in using the cash.

Great. Thanks Rob, and thank you John. Darla, next caller please?

It's from Mark Schoenebaum with Evercore ISI.

Hey guys, I really appreciate you taking the question. I'll start with Adam if I may. Maybe it's early, early days you don’t have a label understood, but post ASCO Dr. Cindy [ph] on the NCCN roughly speaking how many second line patients have you guys treated with KEYTRUDA? And do you anticipate that once fully approved by FDA that second line patients that want to elect for KEYTRUDA will need a biopsy prior, so in other words at the time of initiation of second line therapy they'll need what presumably will be second biopsy. It appears not to be the case with nivolumab because obviously they are not commercial, but what will you get, what Merck gets PD-L1 positive and negative in the label. I am just curious to know whether or not you think physicians are going to want to get a biopsy? And then also Adam, or this is more for Ken and Rob, I suppose, but you've obviously, this is built on Jami's question, you've considered in the past very thoughtfully I think what do with animal health and you elected to keep it, but now the PE arbitrage is substantial again, Zovirax at 30 times, Merck at 17 times, which is just a pretty dramatic opportunity if you were to separate those businesses and liberate value. Is your choice to not do it now have to do with you think that the PE multiple in animal health is not unsustainable or is there some other reason why you wouldn't come back to this and study it hard again? And finally for Roger, I just want to ask is there some confusion around this question, so I apologize, I have asked you this before right, I just want to just to get the truth out there, but the CETP may now come to trial with ongoing, is that trial power to hit on the final analysis assuming only in LDL impact on outcomes or there also need to be some sort of contribution from the raising of the HDL on outcomes under base case assumptions, in order for that trial to hit the endpoint? And then how is enrollment going in the prodromal base trial, we've heard it's slow, just wondering if that's true? Thank you.

All right.

If you don't want to answer all those questions you can pick and choose, but I feel it's Joe's last call, so I can pick him up a little bit.

So Mark, let me give you some context on KEYTRUDA. So if you look at KEYTRUDA as you know we only promote the product on label. And if you look at the data we have about 85% of the use we believe is in melanoma. Of that 85% we believe about 70% of it is on label, which is with an improved indication. So that gives you a sense of where that is. With regard to the diagnostic testing, diagnostic testing is for two decisions, it's really become a standard and widespread in the treatment of cancer. So those are two ALK, EGFR. So we believe that physicians will do that as a standard practice and we expect that we'll have the availability of the test on the day that we launch lung. So we believe that it will be easy for them to do. They typically are doing it already and we'll make sure it is widely available.

You think the FDA is going to require that for getting second line KEYTRUDA in lung?

You know, I can't, I really can't speculate Mark, on what the FDA say. I'd just say…

Okay, I'll look at the top.

Irrespective of what the FDA says Mark, I think it is going to become standard practice that the doctors are going to want to know if they are expressive because it is going to have a very different discussion with the patient if they know that they are expressive or not. You can say your patient based upon your expression on the clinical trials you could have a greater than 50% response that's different than saying you'll have 10% response rate. So I think physicians are going to want that information data irrespective of what the FDA label or not and I also believe that payers are particularly outside the U S. are going to be very interested in having that work done.

And Adam, just to be clear, you believe the physicians will want to have this second biopsy done at the time of second line standard of care?

I think they will do it as a first biopsy. I think they are going to just want to know it is part of standard of care or beginning as they move forward.

Okay, thanks. CETP base?

Yes.

And also the animal health PE arbitrage question?

Yes, but I don’t want to answer that pretty much. Just to be clear, you have asked a question before, but the REVEAL study is powered to see the LDL cholesterol-lowering effect based on the nomogram that associates LDL cholesterol-lowering their productions in major cardiovascular events. So we would see that we believe. And with respect to the base studies prodromal enrolment is always challenging, there is no question and a part of the issue with respect to prodromal enrolment is that there are a lot of people out there who believe they have cognitive impairment, are concerned about their mental functioning. And when you actually image those people a small fraction of them have evidence of plaque and so the screened tell you rate is significant, nevertheless we're making good progress in that study.

Joe Romanelli should likely be screened for that trial just FYI.

We're not going to screen you though Mark.

Oh thank you. Congrats on a good quarter. Thank you for the nice discussion.

Mark, This is Ken Frazier, I am going to try to take a short on your arbitrage question.

Okay.

I am pleased that you characterized this as an arbitrage question. The fact of the matter is our animal health business grew very strongly this quarter. It continues to grow well. It continues to have a very good pipeline. And so we think about the issue that you put on the table as we did think about ways in which we can create value, but we also look at the business from a long-term perspective. And I would say that while we don’t take anything off the table we always consider changes in the marketplace. I want to come back to what I have always said. We plan to augment our animal health business with addition of BD. We continue to see this business as a key growth driver with healthy margins and a strong market outlook over the long-term. And actually the difference between potential PEs for the animal health business versus the human health business we want to continue to focus on running our business. We're going to continue to focus on what's in our control, which is running the business, getting our products approved, augmenting the pipeline, launching new drugs.

Great, thank you Mark and Darla, next caller please?

It's from Seamus Fernandez from Leerink.

Thanks a lot. I just more down with Mark's questions and congrats Joe. Just quickly, this is more for Roger than anything. Just in terms of the follow up on Tim's questions prospects for a broad level you know versus the filed patient group can you just give us a sense of the importance of KEYNOTE-010 to the initial filing? And then can you may be give us a little bit color on when you expect the KEYNOTE-010 study to read out? I know the primary analysis is in the patient group that's over 50% PD-1 expression which I think many of us would have thought could have stopped in the interim, but it would seem that that the overall patient group would also be very important to fully understand. So is that part of the reason why we continue to wait for KEYNOTE-010? And then lastly on REVEAL with anacetrapib Roger, can you just update us on when we might expect the paper on baseline characteristics? I think it would be interesting to know the baseline LDL in REVEAL particularly in the context of a similar design to [indiscernible] and just additionally on anacetrapib could you comment on some recent genetic findings correlating the risk of developing macular degeneration? I am interested just more if the FDA has requested any sub studies evaluating this risk? Thanks a lot.

Okay, lot of questions Seamus. First of all with respect to the KEYNOTE-010 study as you've said I mean there will be the final reasons which we expect some time towards the end of the year, but as I mentioned earlier we have a potential for an interim analysis which is event-driven. So I can't tell you when that interim analysis will take place, but that internal analysis could in principle result in a recommendation through the data, safety mild report that the study be changed or potentially even stopped I suppose depending on the strength of the data. So it could happen sooner than that. The information from that study could in principle then contribute to the initial finding based on the 001 after in particular cohort, but it depends again on at those analyses. With respect to REVEAL the baseline characteristics of patients we have - we will present those baseline characteristics. I don’t have the date exactly of when that would happen. And of course the study is being run by the Oxford Group. So they are the ones who are making decisions about publication of the REVEAL data, so we can get back to you on that. And of course we are well aware of potential association between CETP mutations and macular degeneration, one of the things that we've done is looked very carefully in our patient populations because we are aware of this, we did additional eye exams in our patient populations the data safety moderate report has been looking at that and thus fare we're not aware of any adverse effects, nothing has been called to our attention. Of course irrespective of the strength of the Genetic Association we have to keep in mind that what we are doing is interdicting CETP function quite late in life, individuals who have inherited generic can normally of course have it from the time of conception. So that could have a different impact, but thus far we're not aware of and we're looking at it closely and we're not aware of any impact.

Very helpful, thank you.

Thanks Seamus. And now Darla, next caller please?

It's from Tony Butler with Guggenheim Partners.

Yes, thanks very much. Adam I've asked this quarter of you in the past, but just want to get an update as the SG&A year-over-year declines Rob made some references to that, but yet at least you are launching ZERBAXA and KEYTRUDA in melanoma, and it would strike me that the need for additional capital given you are not in oncology in Europe would require a substantial expense, I'd love for you to touch on that? And then Roger lastly just some update if you could on your compound with Plexxikon and its role with PD-1and/or get it would appreciate that? And then finally Joe, all the best on your second tour and welcome back Terry.

So Tony, so we are very much focused on maximizing each and every launch opportunity that we have and when you look at the first hour we spent it is with the launch opportunities in Januvia frankly. And what we've been able to do is make sure that when we see growth we're able to put the money to exact growth. So even though you see SG&A declining overall, if you were to look at oncology or Januvia, you'd see SG&A increasing over the past several years. And if you look at oncology we're already there in Europe with demand and we have the sales force. We've increased that sales force and we're continuing to grow. So I just want to assure you that any time there is a growth opportunity we're making sure that we have the right resources to maximize those opportunities for patients, but also obviously to grow those products.

Yes, and just with respect Tony to the combination studies, of course we have a very broad set underway. Nothing really to update you on there except to say that with respect to the Gitter studies the studies began, the Gitter agonist began to in June of last year, we have to progress very slowly because of the fact that is an agonist antibody and some immune stimulator as opposed to something that relieves inhibition or is a disinhibitor like KEYTRUDA. Nevertheless we have processed and moving forward now Phase 1 studies and we have just begun combination studies with our Gitter antibody and KEYTRUDA, so that's moving right along.

Great thanks.

Sure and Darla next caller please?

It's from Colin Bristow with Bank of America Merrill Lynch.

Good morning, thanks to take the questions and Joe congrats and now Terry looking forward to working with you. So, just as we think about the hep C opportunity recently one of your peers highlighted the U.S. hep volumes have been trading trending lower than anticipated. And the expectation was approximately 180,000 patients treated per year. Is it in line with your observations and expectations? And I was just curious see this evolving over time. And then secondly on the TECOS trial and Januvia trends just to what extent do you expect TECOS to have a positive impact on Januvia volumes in share. Thanks?

Hi Colin this is Adam. With regard to hepatitis C I still believe that that represents a very significant opportunity for Merck as well as the number of patients that will be treated. You've seen anywhere from 100,000 to 120,000 in patient's had maximum treated in the past. Now you're seeing even 170,000 to 200,000 which is still a significant increase from what was treated in the past even today. It is not uncommon to see warehousing before any drug comes to market. You saw that earlier move before compound came to marker and obviously as you have warehousing you get a big bolus of patients and then it slows down a little bit over time. But I don’t think there is fundamental issue in the overall hit the currency market. I still thinks it remains a very good attractive market and we are very excited about getting into that marketplace as soon as Roger and the team working with the rating agencies can get us in the market. With regard to TECOS obvious we were excited about the result. It is an important area for us diabetes with disproportionate investment area. I think that in general TECOS validated by physicians already were thinking in terms of the favorable tolerability profile of Januvia. With that said, in markets around the world we're able to promote it now. We've begun to promote it and I think that it has very good perception in the marketplace, in other markets like the United States, so we have to wait for it to be in the label before our representatives can actively promote the product. We're looking for it to start getting the data and a label so we can promote it in the future, but obviously are helpful.

Thanks and Darla next caller please?

Is from Gregg Gilbert with Deutsche Bank.

Thanks, a couple of quick ones first Adam on diabetes, what are the implications be in your view as we saw positive outcomes for Lily's SGLT2 inhibitor? Secondly given Merck's history and expertise, are you interested in the lipid disorder space either from a BD or R&D standpoint? And lastly perhaps for Ken and Rob, short of an overhaul of the U.S. tax system, which seems unlikely what is Merck doing to address the tax line longer term as well as maximize access to your ex-U.S. cash, obviously you have returned a lot of cash to shareholders, but you certainly could do more if you made certain corporation decisions? Thanks.

Yes so thanks Gregg. First with regard to SGLT2, in general if you look at the utilization of SGLT2, they are typically after the use of Januvia. So typically it is metformin first add on Januvia and then it is after the add on Januvia. So that's the way they are currently being used. I don’t see a significant change although obviously we are not going to speculate on what the trial results could be for the SGLT2 drugs. So I still remain optimistic about our diabetes franchise. With regard to lipids I'm very excited about the potential opportunity to launch the CETP inhibitor. Lipids is an area that Merck has been involved in for many, many years starting with Mevacor and Zocor and this is an area we know very well. We continue to be there for other reasons with cardiovascular medicines and we'll just see what the results of new REVEAL trial.

And Gregg with regards to your question about the tax rate, obviously and again the specific strategy has been safe to say that as we look forward we will continue to look for planning opportunities to bring the rate down and I do believe those opportunities continue to exist. So we are focused on understanding of what our tax rate can be and trying to optimize that position with or without repatriation.

Great, thanks Gregg and Darla next caller please?

Your next question comes from the line of Vamil Divan from Credit Suisse.

Great, thanks so much for taking the question, so just one more following up. You talked about TECOS and the impact on Januvia potentially, just on improvement with VYTORIN and ZETIA I would have thought it was not on the label yet that we may have seen some better fit there, but it didn’t seem to have much of an impact yet. So I'm just curious how you are thinking about the benefit from improving the maybe the project maybe for next year after presumably you will have the data and the label simply? And then second just separate topic on Pneumovax, if you can just kind of talk about the implications there with Prevnar having the adult indication have you seen any impact on Pneumovax from the added competition? Thank you.

So Vamil, with regard to improve it obviously we were very pleased with the result of the pivot trial. As you mentioned in the United States we cannot promote that trial until we have a label and we're looking for it to having a label as soon as possible. With regard to us having the marketplace, in the U.S. you've actually seen a flattening of ZETIA and since the announcement of improvement because I think a lot of physicians became aware of the trial through the New England Journal of medicine and reading about it very quickly. So what you haven’t seen is a stem in the decline of VYTORIN in the United States. Once it is in our label our representatives will actively be able to promote it. With that said, as you know in the U.S. the products will be going generic towards the end of next year. I think the greater impact from improvement is to try to help in the future when you start to think about a CETP inhibitor and the ability to get more patients to go and lower LDL cholesterol levels. Outside the U.S. in Europe we see where they are able to promote the product and it does have a positive impact, but at the same time we've lost the exclusivity of ZETIA in Canada which has had a significant impact and we've seen some changes in France in terms of the ability to have guidelines of when these products are utilized. Regarding Pneumovax we have seen increased competition from the ACIP recommendations that now include Prevnar and we've seen it in this quarter and we believe we'll see it in this year. However if you look at the ACIP Pneumovax is still recommended as a second dose after Prevnar. So we believe that over time we'll catch up again because the patients will get the second dose. So the question is how long will this short in term impact occur and when will patients come back to the second dose. And our teams have been working on how to find ways to tell the patients to come back for the second dose.

Great, thank you Adam and Darla I think we have time for one more call.

Your final question comes from the line of Chris Schott with JPMorgan.

Great, thanks very much Joe, the last question is here, a couple quick ones, maybe Roger can we get your updated view on the role you see for combination therapy as we think about the first line non-small cell lung cancer opportunity? And particularly just interested in your view of chemo, PD-1 combos versus IL-IL combinations and jus maybe also relative to the monotherapy as we think about this playing out next few years? Second question is on the base inhibitor and just updated thoughts on that opportunity in light of the Lily extension study and the updated Biogen data which is still at AIC and what is with that? Thanks so much.

Okay Chris, first of all with respect to combination therapy I believed absolutely that we will find over time that while KEYTRUDA is foundational for therapy for a wide set of malignant diseases that there will be ways to optimize that therapy still further. And I think it will be based on molecular characterization of tumors because we want to preserve the most favorable benefit risk profile. So that's one of the reasons why we have so many of these combination studies going on and we are exploring the full set of combinations. You know without going into detail the work which we've done and the work reported by colleagues at Johns Hopkins, really points to the importance of neo antigens in tumor recognition. So one expects the therapies that increase the representation of mutations within tumor that could be as simple as radiation therapy, it can be things that are chemotherapeutic agents that damage DNA. It can be ways of immunizing against tumor antigens. All of those things are things that we're pursuing. There are thousands of potential combinations one could pursue. We're trying to be smart about which one has the highest likelihood of success. So we're also looking at things that we've looked at tumor metabolism, all of those are quite interesting and data from those will become available in not too long a time. So I am expecting that we will move to that, but I again point out how remarkable it is when you look at the response rates to KEYTRUDA monotherapy particularly in selected patient populations they are very impressive. And second with regard to base the data that have been presented with respect to antibodies directed against a beta that's really quite a different mechanism from base inhibition and I go back to sort of bedrock data, there is very impressive genetic data that tells us that individuals who have relatively high activity of beta-secretase are at higher risk for developing dementia in their lives and they will develop it earlier as opposed to those who have lower levels of beta-secretase. And that strongly suggests the most powerful data that we have and it strongly suggests that we can phenocopy that low level of beta-secretase activity we should reduce the risk of dementia. Whether we can do that in an individual in their seventh decade is in fact exactly what we're testing using our base inhibitor in both mild-to-moderate and prodromal studies. I don't think that we can look at the data from an a beta sequestering an antibody directed against a beta and really interpret it in the same way because it's really unclear what those antibodies are doing. We know they cause an inflammatory response and are associated with an adverse effect exactly what they do in terms of delaying the progression if they do that all delaying the progress of either plaque or cognitive impairment. I think more time is needed.

Great, thank you Roger and Ken do you want to…

Thank you. Again thank you Joe for all you've done. This has been another solid quarter for us. Our four therapeutic areas grew 9%, animal health grew 10%, KEYTRUDA launch is progressing ahead of expectations. But the most important things is as we move into the future we're tremendously excited by the opportunities that we have in hep C with KEYTRUDA particularly with non-small cell lung cancer coming up and we'll continue to augment our pipeline as you saw this quarter we did BBDO, like cCAM, Ablynx, the chance to augment our pipeline is there. We are very excited about the transition to the future that's going on inside Merck. So thank you very much for your continuing interest.

This concludes Merck's second quarter 2015 earnings conference call. You may now disconnect.