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GlaxoSmithKline plc (ADR) (NYSE:GSK)

Q2 2013 Earnings Conference Call

July 24, 2013 9:00 am ET

Executives

Sir Andrew Witty – Chief Executive Officer

Simon Dingemans – Chief Financial Officer

Analysts

Graham G. Parry – Bank of America Merrill Lynch

James D. Gordon – JPMorgan Securities Plc

Andrew S. Baum – Citigroup Global Markets Ltd.

Ira Das –- Sanford C. Bernstein & Co. LLC

Keyur Parekh – Goldman Sachs International

Seamus Fernandez – Leerink Swann LLC

Peter Verdult – Morgan Stanley

Jeffrey Holford – Jefferies LLC

Florent Cespedes – Exane BNP Paribas

Vicki Bakhshi – F&C Asset Management

Fabian Wenner – Kepler Cheuvreux SA

Sir Andrew Witty

Thank you very much and good afternoon, everybody. Welcome to this Q2 Conference Call. I’m going to also in addition to talking about the quarter just make a few comments on the current situation in China, although these will be limited given the status of the investigation.

Let me first of all start by just summarizing where we are for Q2, and I'm pleased to say that our business is performing well. We’re delivering on our strategy to improve financial performance for the group and during the quarter, EPS grew 4% to 26.3p in commission exchange rates and we’ve increased our dividend by 6% to 18p a share.

Importantly, we continue to deliver very encouraging progress on our pipeline, this quarter alone we saw three major new products approvals in the U.S. Breo a new treatment for COPD and Tafinlar and Mekinist for the treatment of metastatic melanoma. These new medicines are clear evidence of the innovation GSK is producing in areas of higher medical need. And these approvals also speak to GSK’s rate of R&D productivity with further readouts expected on 13 more assets over the next 18 months.

I can also let you know that the first two of those 13 have already readout positively in the last few months. We’re very optimistic that we can deliver valuable new product flow. And in terms of current products, Group sales grew 2% this quarter in commission exchange rate with strong performance across the Group. We’re very pleased with the performance of our U.S. Pharmaceutical and Vaccine business, which was up 5%, the best performance for long time held by strong growth in Respiratory, Oncology and Vaccines.

In emerging markets in Asia-Pacific, pharmaceuticals were up 7% while vaccine sales were down 13, reflecting the timing of vaccine tender shipments, which we previously signaled. In Europe, sales were flat and in Japan sales were down 5%. This was largely due to the continued generic erosion of Paxil sales, which is masking the good contributions we're seeing from new products.

Japan remains a very positive environment for GSK with around 13 new products to launch there in the next three years. We’re continuing to implement measures to increase the focus of the Group by targeted divestments. We expect to reach agreement to sell Lucozade and Ribena by the end of the year. And this quarter, we also received an offer of around £700 million for two anticoagulant products Fraxiparine and Arixtra and the related manufacturing side. In terms of our outlook, we continue to expect core EPS growth of around 3% to 4%, and turnover growth of around 1% on a constant exchange rate basis during 2013.

Before, I pass to Simon, let me just make a few comments on the situation in China. By the way unfortunately, there is a limit in terms of what I can’t say to you now and during questions given the investigation is ongoing under an early stage. As we saw 10 days ago, our China pharmaceutical operations are the subjects and investigation by the Chinese authorities into allegations of fraudulent behavior.

From what we understand from the authorities, it appears that certain senior managers in the Chinese business have acted outside of our processes and our controls to both defraud the company and the Chinese healthcare system. To see these allegations made about people working for GSK is as we have said shameful and for me personally they are deeply disappointing. The alleged activities are not what we expect of our people and are totally contrary to our values.

Outside and inside the company, people rightly expect us to operate with integrity and to be crystal clear, we have zero tolerance with this kind of behavior. I can assure you, we are absolutely committed to rooting out corruption and we are absolutely committed to getting to the bottom of what has happened here. We are cooperating fully with the authorities and obviously, we are looking into what happened ourselves. We’ve already put in place new resources to deal with this and we will continue to do so.

In addition, we are also going to commission an independent review to investigate what’s happening. As I have said, at this stage, there is still a lot we need to find out, but one thing I can guarantee you is that we will learn from this and we will make changes. In the meantime, let me say we are committed to China.

We support the efforts of the Chinese government to reform the medical sector and we are open to looking at all ideas to improve affordability and access to our medicines, including change in our own business model in China. We have a long history and a very large footprint in China, and we continue to see the country as a key environment for further investment.

We also continue to believe that in a country facing significant healthcare challenges and with critical needs in areas such as hepatitis B, respiratory disease and diabetes, GSK has many important medicines and vaccines that can potentially benefit the people of China.

With that, I’m going to hand over to Simon to give you a more detailed update on the quarter and then, of course, we’ll go to questions.

Simon Dingemans

Thank you, Andrew. Our performance for the second quarter highlights how our strategy to invest behind a range of growth drivers and build the linkages between our pharma, vaccines and consumer businesses, is delivering a more balanced and broadly based set of results. Stronger momentum is evident across the business even though we continue to deal with a drag from a number of generics and the contribution from new products is still relatively small.

With three important approvals in place during the quarter, we’re now gearing up the launches of these new products and while it is still early days, we expect them to become a meaningful additional source of growth overtime, even if they may ramp up at different rates. Our financial architecture is allowing us to leverage the whole P&L to reallocate our resources more effectively and drive efficiencies from our cost structure. This is giving us the flexibility we need to invest behind our pipeline while also driving earnings per share ahead of sales growth.

This quarter, EPS growth on a constant currency basis was 4% on sales growth of 2%. This is after absorbing the impact of an exchange loss on intercompany transactions of £46 million and a £100 million one-off benefit to Q2 operating profit last year from changes to our pension plans. The financial architecture is also maintaining the organization’s focus on improving our cash flow and allocating our capital to the best returning opportunities.

Cash conversion remains strong and we generated approximately £3 billion in net cash inflows from operations for the first half. This is after investment behind the late stage pipeline and the costs of our ongoing restructuring programs. we also returned £2.3 billion of cash to shareholders over the same period via further dividend increases and continued share repurchases.

Overall, we’re pleased with the progress the business has made in the first half of the year. we are where we thought we would be at this point and we are on track to deliver the guidance for the full year that we set out in February.

Turning to the results for the quarter, as usual, the focus of comments will be on constant currency growth rates and core results. group sales in the quarter were up 2% after absorbing the impact of the £50 million headwind from divestments I highlighted for you previously, and this is primarily related to the OTC consumer products that we sold last year.

For the half, reported sales were flat, but excluding divestments, the ongoing business grew 2%. the divestments I highlighted in February will only have a very minor effect on the second half of the year. Details of the impact of the disposals and the discussion with Aspen, and the sale of our Lucozade and Ribena drinks businesses will be confirmed at the time final transactions are agreed. where we can see attractive values are available, we will continue to seek opportunities to improve the Group’s focus and release resources we could either reinvest or return to shareholders.

In the quarter, our U.S. pharma and vaccine sales was a key driver of growth overall with sales up 5%. the best reported quarterly growth for this business in over four years. This reflects getting past by the significant losses to generics as the business has experienced in recent years, as well as the loss of Avandia, but it also reflects the refocusing of the U.S. commercial organization and its growing capabilities in our core therapy areas.

Key drivers for the U.S. in Q2 where the respiratory portfolio up 8%, oncology up 10%, and our Vaccines business up 14%. In Europe, our Pharma and Vaccines Q2 sales were flat. Volume across the business was up 2% benefiting from the restructuring of our European business and in particular our efforts to redirect our sources behind a more focused range of growth opportunities. Seretide volumes benefited up 1%, as did vaccines up 5% with a number of key tender wins including Rotarix shipments into the UK Health in Q2 performance.

As expected pricing overall continues to be negative, but the pressure in Q2 was less than prior quarters due to the annualization of severe austerity measures. Nonetheless, we continue to have a cautious outlook for Europe. EMAP reported Q2 sales grew 2%. This particularly reflects the effective phasing of vaccine tenders and a tough compared to last year resulting in a 13% decline in vaccine sales in the quarter.

We're expecting a better vaccines performance overall in the second half, but as with last year, tenders will likely be waited to Q4 relative to Q3, and remember both quarters offer tough comparisons as well. EMAP Pharma continues to deliver well and consistently with growth in the quarter of 7% up to 8% in Q1, and we saw particularly good contributions from respiratory up 9% and especially Seretide up 14%.

We expect continued broadly-based growth from our emerging market business in the second half. The contribution from China is likely to be impacted by the currency inquiries, but it's too early to quantify this. In Japan, turnover fell 5% primarily due to the ongoing generic erosion to Paxil, which began in Q3 last year, a new competition Cervarix and Rotarix. Also, our respiratory portfolio was down 7%, as good growth from Advair, which was up 8% was offset by weaker sales in other products, reflecting an early allergy season and remembering Q1 respiratory products in Japan were up over 20%.

On consumer, the ongoing business grew 5% despite some challenges, which reflects its resilience. As we highlighted in Q1, our rest of world performance was impacted particularly by new regulations and price reductions in China. Wellness in the region was also impacted by some Panadol supply interruptions, but other categories especially Oral care and nutrition performed very strongly, helping to more than offset these issues.

Turning to the cost lines, at the operating level, the core operating margin was 29.4% in Q2, including the impact of a £46 million, net exchange loss on the settlement of intercompany transactions. You remember, we had an £82 million gain from the same source in Q1 this year and these gains and losses only arise on this scale when there are significant short-term movements in exchange rates.

Excluding currency, the overall margin declined 0.3 percentage points, and you will recall from last year that we noted operating profit had benefited by about a £100 million from changes to the cost of future pension obligations. Excluding this benefit, the margin improved 1.3 percentage points versus last year, reflecting an improved mix in Q2 this year, helped by growth in the U.S. pharma business, but also the better performance in Europe, as well as the benefit of ongoing cost savings in our restructuring programs after we funded investment in growth business and behind the pipeline.

As expected, the cost of goods margin increased in the quarter even excluding the elements of the pension credit attributable to manufacturing as the continued unwind of under-recoveries from 2012 more than offset the restructuring and improved mix benefits, despite encouraging progress in the manufacturing restructuring programs in recent months.

Cost of goods remains an area of pressure as we initiate commercial volumes and new products. Restructuring benefits had more of an impact on our SG&A expenses, which remained broadly flat excluding the one-off benefit of last year and our restructuring programs are particularly helping us to be significantly more flexible in how we allocate our resources and how we can reallocate them behind the pipeline in particular.

I should remind you also that during the second half of last year we had a number of similar one-off benefits that reduced our operating costs including the £290 million favorable pension adjustment recorded in Q4. I expect the combination of ongoing cost management benefits including savings from existing programs plus other one-off value opportunities, to largely offset the comparative drag during the second half of 2013.

R&D expense was down 6% in the quarter, primarily reflecting restructuring savings coming through productivity improvements, but also the phasing of trial and study costs particularly as a number of late stage projects moved to filing and complete their development phases. However, I am currently expecting R&D expense to pick up again in the second half and to be high relative to first half.

On the bottom half of the P&L, we continue to leverage financial efficiencies to help drive EPS growth. We significantly lowered our net funding rate this quarter over the last year and it’s keeping our net financing cost broadly in line with last year, even though we stepped up our net debt materially.

Our core income tax rate of 24% is 1.5 points better than Q2 last year and keeps us on track to deliver an overall rate for the year of 24%. On cash flow, we continue to be strongly cash generative. Net cash inflows from operations after tax were £3 billion, up 8%, and cash conversion remained strong.

We made further gains in our working capital program and reduced cash conversion days a further day this quarter. This makes 10 days since this time last year excluding the benefit of assets being held for sale, which now drop out of the calculation. This is helping to minimize the additional cash requirements of working capital necessary to support the group’s growth and reduces the impact on free cash flow.

Cash returns to shareholders for the first half were £2.3 billion, including £1.9 billion in dividends and nearly £400 million of share repurchases. We are now up to nearly £500 million including purchases since the end of the quarter and we continue to target £1 billion to £2 billion for the full year. I should remind you that that we’ve been out of the market for extended periods and will continue to be out at times because of the status of our regulatory files.

So in conclusion, these results are very much inline with our expectations for this stage of the year and leave us on track to deliver our financial guidance for the year of 3% to 4% EPS growth on turn of the growth of around 1% both on the constant currency basis.

And with that, I’ll turn it back to Andrew.

Sir Andrew Witty

Thanks, Simon, very much and I’d like to now just open the call for questions. Operator, perhaps you could just remind people of the protocol.

Question-and-Answer Session

Operator

Thank you. Ladies and gentlemen, your question-and-answer session will now begin. (Operator Instructions) Our first question is from the line of Graham Parry from Bank of America. Please go ahead, Graham.

Graham G. Parry – Bank of America Merrill Lynch

Thanks very much and just starting off with the situation in China. I wonder if you can expand whether the Chinese investigation is part of the parallel investigation by the U.S. authorities prompted by or prompted by an FCPA investigation in anyway to a certain blog websites might have suggested.

And then a few product questions just on the FLAMINGO dolutegravir, why should we fix that that to presented and when? On Breo, it looks like, it’s a little bit of slippage in terms of the launch timeline to the third quarter, straight fourth quarter rather than just third quarter. Is that just reimbursement or is there anything else going on there?

And then finally on Drisapersen on Duchenne Muscular Dystrophy, I know that Sarepta has now announced that it intends to file its similar product on the back of Phase III data in 2014, is there any reason why GSK wasn’t able to file in Phase II or following this news, can you accelerate or augment your file? Thanks.

Sir Andrew Witty

Thanks, Graham. As far as we are aware that China situation is a China situation period and the investigation is a domestic investigation. Secondly, as far as the dolutegravir FLAMINGO data, we haven’t announced yet, where that will be probably, so obviously we’ll do that through the organization good time.

Breo timelines, everything is progressing on Breo. We are putting in place all the various steps we wanted to. We were tracking maybe couple of weeks behind where we initially saw, I’m pretty comfortable about that, because it’s absolutely critical we get this right, and we’re going to just take the time to make sure we get everything absolutely nailed, which is why we simply signaled it may slip out of Q3 into the beginning of Q4, no big deal or drama. Quite a lot has been done in terms of getting ready for this in terms of reshaping our U.S. sales force with extra focus on respiratory as an example. And obviously, we’re now in the process of making sure that we’ve got everything ready to go. As far as the Duchenne Muscular Dystrophy is concerned, the big difference is, we’re focused, we believe we’ll have a package, which is focused on clinical endpoints rather than Sarepta markets different strategy and we like that strategy. Next question please?

Operator

It’s from the line of James Gordon, JPMorgan. Please go ahead, James.

James D. Gordon – JPMorgan Securities Plc

Hello, thanks for taking my questions. And I had one question on emerging markets. I appreciate it’s too early to comment on China. but more generally, do you think the level of visibility you had on employees marketing practices in China was similar to that in other emerging markets and now these activities have come throughout in China. Are you investigating practices in other countries? and also just one question on Anoro in the U.S., does they upon my ASCO meeting scheduled for the September 10, do you know yet whether that will be an outcome for Anoro?

Sir Andrew Witty

James, thanks very much. No comment on Anoro, nothing I can tell you there. in terms of sales force practices, basically what we have been told, what we understand from the Chinese investigators is that, what happened here was a number of managers who seem to be operating outside of our processes and systems in controls to allegedly generate this fraud, obviously we’re working through all of that.

Clearly, one of the things that we want to do is to understand exactly what’s happened here, which is going to take sometime I suspect, but we need to understand exactly what has happened here. and clearly, once we understand that, we’re going to be making sure that we’ve got all, whatever is necessary to try and prevent it in other places where it could be potentially possible. I would say, there are a lot of unique characteristics to state the obvious about China and therefore, some of the circumstances that may exist in China just simply aren’t replicated elsewhere, but the general point is important, which is that once we understand what’s really going on, of course, we’re going to be looking to make sure that there isn’t a similar risk elsewhere.

I should make the point that all of our group companies are subject to extensive control, audit, check-in, and we have a very strong policy in the company of expecting individuals to live up to the values of the organization. If we find people who’ve broken those rules, which we do from time to time, they get dismissed or they get disciplined, and you can see in our Annual Report that we published those numbers. So we are very active on that front. If it turns out that there is some new information in this particular situation, which maybe pertinent elsewhere, we will clearly act on that. Next question.

Operator

It’s from the line of Andrew Baum from Citigroup. Please go ahead, Andrew.

Andrew S. Baum – Citigroup Global Markets Ltd.

Good afternoon. My understanding is, that message clear evidence of further fraudulent behavior in your U.S. operations did no impact on the Corporate Integrity Agreement you’ve got with the Department Of Justice, whatever happens in China. Could you confirm whether that’s a correct interpretation when I am thinking about the potential for risks in your Medicare programs? And then second question, you’ve highlighted the potential for developing new distribution models, particularly in Europe, to reflect the new economic outlook. You’ve obviously created the mature products or brought us the mature products together you’ve divested some products, could you outline some of the movements and finder programs you’ll be getting to run as you think about reframing your cost base for that part of your business?

Sir Andrew Witty

Thanks, Andrew. Nothing else I am going to add on the investigations, which have gone on or anything else I think not helpful to – nothing that I can really help you at. As far as Europe is concerned, we are obviously in quite a big period of restructuring, if you will, our European business. If you think about what we’ve done in the last 8, 9 months, we’ve reduced the size of the cost base substantially, so significant reduction in back office in particular, reduction in sales force size, less of a percentage reduction in sales forces, but a very big redeployment of the sales force. So although, we’ve reduced the sales force by around 15%, we’ve actually increased the amount of resource we have behind respiratory, oncology and vaccine. Those are three big growth franchises for us in Europe. That I think is why we’ve seen an improved stabilization, if you will, and an improved relative competitive performance on volume. Data I have seen indicates that we are now the third best volume producer in Europe of our peer group competitors. That’s encouraging. We’ve also, of course, seen a somewhat more benign pricing environment, as some of the annualization phenomenon rolled through the system, so big changes there.

Secondly, as we created the established products, we began to actively look at how we might best then manage those products, which are not going to be drivers of growth for us in the future and where those products makes sense to be exited from the group, obviously we are doing that and you can see that with Fraxiparine and Arixtra significantly The majority of those businesses are set in Europe, and of course, subject to the agreements, we are divesting both the products a substantial number of personnel. The cost of the personnel will go with those products as will the factory. So that’s quite a major piece of infrastructure, which is going to be exited from the organization alongside the brands and we will now continue to work through that portfolio of established products and basically ask the question what is the right solution for each of those blogs of business. Now, for some of them, they’re just going to stay in the Group and unchanged, for others it may be that we partner and maybe there will be [we] like relationships for certain elements, and for others it may be we just exit them from the organization the way that we are doing for Fraxi, Arixtra.

So very much underway, as I said to you last year, we were determined to take not just a short-term, but a much more strategic response to Europe. We are doing that, I think, we are seeing the benefits of that in the short run, but of course, it’s fundamentally giving us a more streamline business. And then as and when we get new products approved in Europe, even though we know that’s going to be a relatively more difficult space, we should have a leaner, more focused organization able to take advantage of whatever opportunity we can access despite the austere environment in which we operate. Next question.

Operator

Thank you. The next question is from the line of Ira Das from Bernstein. Please go ahead.

Ira Das –- Sanford C. Bernstein & Co. LLC

Hi, good morning. This is Ira Das for Tim Anderson. I have two questions please. First, we are under the impression that FDA maybe putting out a guidance document on generic inhaler sometime in the current year, which could simplifies the pathway for generic version of Advair to launch in the U.S. maybe sometime in 2016. What are your expectations on this guidance in terms of timing and content?

The second question is on your established part of division that you have now created and we are asking what we would like to know is, can you realistically see floating this division out into a separate publicly traded company, for example, and how should we think about it in 2014 and beyond for this division? Thank you.

Sir Andrew Witty

Thanks for the questions. I’ve got no comment or insight with regard to any potential guidance, and my overall position on the Advair marketplace in the U.S. really hasn’t changed. I remain of the view that a fully substitutable generic is extremely difficult, and I remain of the view that it’s unlikely that we’re going to see anything in the next several years. Obviously, the further we go in that projection, the less [certainly] anybody can have including me, but my view overall hasn’t materially changed. And as I say, we have no insight into any potential changes.

As far as established products are concerned, we have no intention at this point in time if floating is offered a separate business. I made it very clear that what we’ve aimed to do with the creation of the established products is essentially three things. The first is to make sure that inside the organization we have a mechanism to allow all particularly our support structures to allocate resources behind our new pipeline products, our existing promoted products, and then the established products. So that we create a structure in the business, which allows the appropriate dedicated resource to be attached to those different bids of business. They have different challenges, different needs, and as we now acquire new pipeline business through the R&D performance, we need to make sure that we are not in anyway can lose sights of what we have to do on some of the older products. So partly it’s an entirely internal management device.

Secondly, we believe that with a focus on the established products, which by the way our vast majority of which over the next couple of years will be outside of the U.S., I will explain why in a second. Those businesses are characterized by significant complexity lots of brands, lots of SKUs in lots of countries. There is a real opportunity for us to really have a simpler focused streamline that business take out costs, make our manufactured organizations like the easier, improve the margin and allow us to focus on new products, and we believe there are potentially selected tender opportunities, which by focusing in this space we can develop.

The reason why that business increasingly becomes a non-U.S. business, of course, is that the products, which are in the established portfolio in the U.S. are already genericizing. So as time goes by over the next couple of years, those products themselves will become less and less relevant in this context.

And then the third and final point really refers to the comment I made to Andrew a couple of minutes ago, which is that within that established portfolio, there are clearly blocks of business, which we could either sensibly sell from the company and create shareholder return quickly, and Fraxi and Arixtra are perfect example of that or where we may find alternative ways to develop those businesses perhaps through a ViiV like partnership in certain areas, which could again create and enhance value versus the way they are currently managed. So that’s really the story of the established products. No intention to flow this as a business at this point in time. Obviously, if somebody wants to come and make an offer I can’t refuse, different conversation, but in the absence of that, that’s where we stand on this portfolio. Next question.

Operator

Next question is from the line of Kerry Holford from Credit Suisse. Please go ahead, Kerry.

Kerry A. Holford – Credit Suisse Securities Ltd.

Kerry Holford from Credit Suisse, I have three questions please. Firstly on Breo, we saw that CVS Caremark announced its 2014 drug exclusion list for international formulary last week and Breo was on that list of drugs to be excluded from January next year. So I guess it’s notable that Caremark made this move even before you’ve launched the product in this market. It is the first time that managed care do not buy in to the benefits of a once daily dose product in COPD, whether in concern to this exclusion for Breo could extend more broadly across the U.S. market?

Secondly on Advair, we saw that the list price, year-on-year list price in the second quarter in U.S. is fully retained. I think that’s now contrast first and pervious quarters, and I wonder if that represents leaving you any reduced EBIT pressure around there or is that just really to be viewed as a one-off positive this quarter? And then lastly, quickly on albiglutide, any progress there on finding a partner to just put up to?

Sir Andrew Witty

So, on albiglutide, we continued to explore options there, but no definitive answer for you. On the Advair pricing piece, we have good news that we were able to retain that, but largely I think due to various year-on-year comparisons around ROA. So in terms of partly benefits this year, but partly also, less positive last year. So I think that’s as much an – there is no bad news in that, but it’s a little bit enhanced by the year-on-year comparator of ROA. And the Breo thing I think is not signaling. We are only just beginning to get into sensible contracting conversations with managed care companies. All of the signals we’ve seen from patients, physicians and payers, is actually there is quite a strong interest in the once a day COPD, but not least because of the sense of the cost of poor compliance with twice a day products and if there is anything that can be done to improve compliance there to reduce hospitalization, and of course, the managed care companies haven’t yet seen our pricing, net pricing proposition. I am well aware that the face prices in the marketplace, but nobody has seen the net price proposition. So I don’t think that should be read as in anyway signaling of what’s going on and over the next couple of months. We will start to see how the real conversations go. Next question?

Operator

It’s from the line of Keyur Parekh from Goldman Sachs. Please go ahead.

Keyur Parekh – Goldman Sachs International

Good afternoon, and thank you for taking my questions. Andrew I realize there is limited stuff, you can comment on what’s ongoing in China, but to the extent that you can’t, I would appreciate any color you might be able to share on if you believe this practices or this allegations are purely in the Glaxo or do you think this is an industrywide issue, that the rest of your peers will be facing as well? And what I’m just trying to understand is to the extent that you can, do you think Glaxo’s spectators are different to everybody else’s?

And Secondly, on the product side, I know that you all kind of Japan vaccine revenues were impacted this quarter by increased competition both on Cervarix and Rotarix, do you see this as kind of a quarterly phenomenal, is that kind of a new level of sale that we should be thinking of going forward? Thank you.

Sir Andrew Witty

Thanks very much for the question. As far as Japan is concerned, we’ve clearly seen a slowdown in the HPD marketplace. And over the last year, we’ve seen a significant share decline for Cervarix. I don’t think we are going to see anything both dramatically change in that scenario.

Rotarix is a – rotavirus is a much more positive situation where we continue to hold very substantial share despite new entrants. I think rotavirus is likely to develop into a continued positive story, so I think from HPD side less so. I think coming back to China, I mean, again, I just want to reiterate very early days, we haven’t been able yet to get into a full investigation mode ourselves. But working with the Chinese authorities, it appear that this is a consequence of the individuals working outside of the controls and processes of the company to defraud the company as well as, so then go on and do things which are potentially illegal.

I think that it’s important to recognize that it appear that we are also seeing an inflection point in the Chinese environment in terms of how the government wants to see their entire healthcare sector modernize. I don’t want to make comments about anybody else, but we’re all looking at the same Reuter screens, reporting what’s going on, and I’d leave it to you to draw your own conclusions. but it’s inappropriate to me to comment on anything beyond GSK. Next question?

Operator

It’s from the line of Seamus Fernandez from Leerink. Please go ahead, Seamus.

Seamus Fernandez – Leerink Swann LLC

(Inaudible)

Operator

Seamus, your line is open. Can you check if your phone is on mute?

Seamus Fernandez – Leerink Swann LLC

Yes. Can you hear me now?

Sir Andrew Witty

I can yeah, thank you.

Seamus Fernandez – Leerink Swann LLC

Okay, great. So just a couple of quick questions, more as it relates to first half kind of direction of gross margins, we see in the back portion, we report the growth in operating margin performance of ex R&D actually improving in most of the divisions. So can you talk a little about directionally where you see improvements kind of coming going forward?

There are questions for Simon. and then beyond that, as we kind of think about the key pipeline opportunities going forward, where are the areas that you’re particularly excited about, we’ve got alemtuzumab data coming up. We’re on the cost of the dolutegravir approval, but what are some of the key products that you focus on in the next call at 18 months we’re sort of through our first seven here and we have a number more to go, and I’d just love to know, which ones you’re most excited about? Thanks.

Sir Andrew Witty

Okay. Thanks for the question. On the operating margin going forward, I think as we highlighted in the quarterly commentary, we’re already seeing a number of benefits from our restructuring programs across all of the three major cost alliance, and we very much think about those together in terms of delivering operating performance. We highlighted back at the beginning of the year an additional restructuring program, which is designed to deliver about £1 billion of savings over the next three years, which will contribute to that. But alongside that, I think, as we’ve highlighted also, we are expecting to see some pressure particularly on the manufacturing side as we ramp up new products and that’s probably where the greatest strain is. But we will be working the whole of those mix factors to deliver against our medium-term objective to improve operating margin and it will come from a number of places to the overall total. I think that’s probably the best guidance I can give you at the moment.

Sir Andrew Witty

Thanks, Simon. As far as R&D is concerned, I mean, there is a tremendous amount going on in this company on R&D and I’ve worked in this company since 1985. I don’t think it‘s every been more exciting from an R&D perspective and that’s because we have significant products being approved, significant products are waiting approval, a whole lot more products and indication is coming through immediately behind and some very exciting stuff coming out of the early phase discovery organization. So almost at every level, we’re seeing some very, very cool stuff happening inside the R&D organization.

I mean, to focus on the short-term, the next couple of years what really stands out, obviously, the impending decisions over the next few months on dolutegravir, on Anoro, on albiglutide are important. The continued global process of seeking approval for the two melanoma drugs and Breo of course, that’s real, it’s right here. We’ve had a good year so far. Obviously, we’re working hard to ensure that we are able to continue to seek approvals around the world and also to convert those approvals into successful launches. That’s a very mobilizing phenomenon in the organization, and I can tell you, particularly in the U.S., it had an extraordinary impact in terms of the way in which the U.S. is thinking about the future, and at least partly, I suspect is one of the reasons why we’re seeing the U.S. perform so well even before those drugs are actually in the marketplace because I think it’s having a deep impact in terms of how they view their future.

I think if we then look into what else is coming up, I’m going to start in the places which you probably least expect me and it’s products like Votrient and it’s products like Arzerra, where we’ve got products in the marketplace, but we are gradually acquiring more data, gradually able to follow-up the new indications, gradually get those approved and gradually build a built-in momentum behind those products, and I think Votrient is a super example of our ability to do that. And actually, if we look at what’s happening in that marketplace, coming very quickly through the ranks into being a potential market leader, Arzerra, obviously, is a biologic with a very long period of potential exclusivity and we have great opportunity to continue to develop that ground as well.

If I look then at the slightly newer stuff, so what would I call out probably three or four things in the next year and a half; one is Maze 3, the antigen-specific vaccine program, you know the first date when that’s coming; the second is (inaudible). Both I’m going to say what I’ve said in every comment for the last five years, high risk, but potentially high rewards. So I’m not naïve, I’m completely open to the possibility these programs failed, but we always believe there was a good reason to believe and a great price to go after in terms of the potential patient benefit and those two are going to come to fruition in this time period. Mepolizumab, I think, is an extraordinarily exciting program for severe asthma. We got tremendous amounts of data, particularly safety data and another indications, in which this drug was looked at before. It looks very, very exciting.

And the last one actually is the zoster vaccine, which overall it’s an event driven trial and it looks like that vaccine is probably going to report in 15 rather than 14. Actually, the opportunity for us to bring in a very competitive vaccine into those zoster space very important for us, we think the technology of that vaccine given that it’s not a live virus-based vaccine gives us much more flexibility, we think we has potential utility beyond where the current product is in the marketplace, that's another very exciting one.

So, I think there is a raft of products coming through. As I said, we’ve got 13 sets of data to readout, we’ve already had two. I haven’t even mentioned the multiple respiratory combinations in individual products, which are coming in the background.

So, I think that's where R&D sits today and it’s the product of an extraordinary amount of hard work over the last several years. And I’m extremely grateful and proud of our research and development organization at GSK. Next question?

Operator

It’s from the line of Peter Verdult from Morgan Stanley. Please go ahead.

Peter Verdult – Morgan Stanley

Good afternoon. I’m Peter Verdult from Morgan Stanley. Two questions Andrew; firstly on Relvar/Breo, just given the advantages you see versus Advair, can you just talk us through some of the pushes and pros in terms of deciding to price of parity in the U.S.? And the second part of the question on summit in Salford outcomes data, could you just remind us when we expect to see the top line data there comparing to Salford study is recruiting slow than expected?

And then secondly on China realizes those delicate and ongoing and I’m probably pushing my luck here, but in terms of how we should be thinking about a worst-case scenario could entail, those I include for price cuts, or may be in advance for certain reasons with therapeutic areas. So thanks very much.

Sir Andrew Witty

On China there is really nothing I can add to that detail, very early days we’re working very cooperatively with the authorities. But it’s way too early to take a view of – if any implications are all down the road. I remind you, we’re still – please our allegations, we need to get through the investigation figure out what really happened, what the consequences are, what the impact is on individuals and/or the company, plenty of time for that to come, we are very early in this situation.

As far as Breo/Relvar is concerned, I think what you’re seeing, I would refer you actually not just to Breo/Relvar, but also look at the pricing positioning of the two melanoma drugs, both of which we brought in at a discount to the current products in the marketplace. And I think this is all – we believe that over the next several years around the world and also in the U.S. pricing of new products is going to remain a focus. We’ve always made it very clear that our R&D strategy was to try and find the way to deliver multiple products.

We appear to be in a position where that maybe possible. That allow us I think to reduce the need for any individual product to on its own carry the entire future of the company, reduces the pressure on price, and allows us to be able to be more thoughtful, more creative, and I think price in very different ways for very different source of products. And our view on the Relvar/Breo positioning was that this gave an opportunity to deliver added value, different value in terms of the dosing frequency and the obvious consequences, new device, better device, device that now patients prefer. But actually for – actually build that proposition and add a value for money price and that’s what we’ve really aimed to do there.

In terms of summit in Salford, we’re looking at 2015, 2016 for those programs to conclude. Next question?

Operator

Next question is from the line of Jeff Holford from Jefferies. Please go ahead.

Jeffrey Holford – Jefferies LLC

Hi, everyone. Thanks for taking the questions. I’ve got three questions, none of which have the word China in them. So you would be glad to hear. But just first off on working capital, it looks like now you can give progress there, can you just remind us on how that has came versus the original plan you have there, and how much further you have that you think you can go on working capital in terms of days I am really thinking there?

Secondly, just on the respiratory market in general, you’ve got a number of new products coming to market. You got initial parity pricing announced, but can you just talk a bit more about is that a stable proposition going forward with the parity pricing, sometimes company will look to raise the price of the older products, ones that you went actually on the market to help folks switching over, can you just maybe talk about that a little bit and then just any further help you can possibly give just narrowing down timing a little bit on the Maze 3 and (inaudible) would be good if you can? Thank you.

Sir Andrew Witty

Simon, go ahead on the working capital.

Simon Dingemans

So on working capital, I think overall, we are probably a little bit ahead of where we originally expected to be, but with a very clear objective of trying to deliver steady and sustainable progress and so from a trend point of view, you’ve seen us do that over the last couple of years of making consistent reductions and that’s very much the objective of going forward. I think we probably made the largest progress on receivables, payables and the areas outside of the core inventory question and that is now where the focus is really sitting in terms of trying to restructure our supply chains to make sure that we can make sustainable reductions in the needs of inventory as we grow the company again in both the vaccines and the pharma business. So that’s where you should probably expect the greatest progress going forward.

Sir Andrew Witty

Thanks, Simon. Respiratory market, I am sorry, Jeff, I am just going to be very irate, it’s obviously a very competitive space. It’s very important to us. We’re trying to take whatever competitive advantage we can, and I’m not going to go into a lot of detail on how we – what are our pricing strategy is going to be, I’m sorry about that. But clearly, it’s our goal to establish Breo, it’s our goal to continue to develop or absolutely strong position in the respiratory marketplace and with products like Breo and hopefully Anoro, we’ve got tremendous short-term opportunities to do that.

In terms of data production, we would expect the first study for both Dara and the first study from MAGE-A3 to report that before the end of this year with the second study for both reported on next year. Next question.

Operator

It’s from the line of Florent Cespedes from Exane BNP. Please go ahead.

Florent Cespedes – Exane BNP Paribas

Thank you, ladies and gentlemen, thank you for taking my questions. Two quick ones; first on the U.S. business, we have to breakdown of the U.S. performance then sort of volumes and prices, and is it good Q2 performance sustainable?

And the second question is more clarification, could you confirm that’s the realized trials on Breo without the results only 2015 and not 2014. And could you explain, was it possible to launch Breo without the results of this real life trial? Thank you.

Sir Andrew Witty

Thanks, Florent. As I said earlier, we are expecting those trials to report out 2015 onwards. We actually feel very – I think we feel increasingly good about launching Breo in advance of that. We always knew that was going to be the case and they totally clear that those trials would never be finished in time for the launch.

I think it was become clearer to us is the benefits of Breo in terms of not just the dosing frequency, but the device, the potential understanding and concern within the payor environment about compliance, costs and the like. And simply, the interest of patients if you will for a new option in COPD, we think is pretty real. and that gives us a degree of confidence. of course, I think it will be excellent to then come along a couple of years post-launch with further hopefully reinforcing data. So I think that for me, it makes perfect sense. In terms of the U.S. business composition, I think it might be worthwhile just reflecting on a couple of things. So yes to some price benefit, and yes, we’ve been able to, if you will capture more about price benefit for reasons I’ve touched on earlier. but I think it might be worthwhile, you understand in that. We promote in the U.S. 82% of our sales base. So, 82% of the revenue in the U.S. is promoted by the company. The residual 18% is not promoted by the company, and that’s made up either of products, which are going generic, so in the process of genericizing or simply a very small number of products, which are neither generic nor are they promoted.

Just to put that into context, 82% of the business is promoted, 8% of the business in Q2 was generic or genericizing, and about 10% of the business is simply not promoted or not genercizing. That 82% grew 11.5 percentage points. The generic 8% fell 31 percentage points and the non-promoted business was basically flat. So what you see in the U.S. is a lot of volume being destroyed as per usual in the generic side of the house, but a lot of growth and obviously some price benefit in the promoted side of the house. And I think when you see that 82% growing 11.5%, then you start to consider the introduction of the two melanoma drugs, Breo and then with the fair wind future new products. You can see our U.S. business is in a very robust shape to receive and start to move forward with the next-generation of the products. Next question?

Florent Cespedes – Exane BNP Paribas

Thank you.

Operator

Thank you. Next question is from the line of Vicki Bakhshi from F&C. Please go ahead, Vicki.

Vicki Bakhshi – F&C Asset Management

Thank you. I have two questions; it’s going back to China. The first question is, can you confirm that there is no connection between the previous difficulties you had around solidification of data and the exit of the Head of R&D and the current sets of allegations. And secondly, have you given any consideration to whether should these allegations be proven just they could be prosecuting under the UK Bribery Act.

Sir Andrew Witty

So, as far as we’re aware there is no connection between the individual behavior at the R&D side, which is being more reported. and I have no comment to make other than to say, as you would expect as it is appropriate we have open channels to various oversight regulatory agencies in different countries around the world and both sides of the Atlantic, and nothing further to say to that. Next question?

Operator

Next question is from the line of Fabian Wenner from Kepler Cheuvreux. Please go ahead, Fabian.

Fabian Wenner – Kepler Cheuvreux SA

Yeah, good afternoon. Just two quick questions, first one, what are the actual charges in China and are there any charges against you that involve economic damages in the sense of excessive drug prices or the likes? Thank you for any light you can shed on that. And then secondly, can you give us or remind us the milestones with Serevent with regards to potential approval of Anoro in the U.S.? Thank you.

Sir Andrew Witty

So, very little I can add on China, as I said, this investigation is at the early stage. You’ve probably seen reported from China the same commentary I’ve seen. We are going to continue to work with the authorities on this, our understanding at this point in time from the authorities is that this is around individuals, and the co-people and the senior management of the company in China, who are alleged to have worked around our systems and controls to both defraud us and then to potentially do things in appropriate in the marketplace. That obviously, is an early stage of investigation and we have to wait and see how that actually matures. And Simon, I think has the information you asked for on the milestones.

Simon Bicknell

Yeah, this £30 million due on launch and £30 million on approval for both Breo and Anoro is £30 million each. Twice, yeah, they get two payments of £30 million on each.

Sir Andrew Witty

Okay, thanks Simon. It’s time to bring the call to a close. Thank you very much for your attention. Obviously, the IR team of GSK are available to handle any detailed follow-up. Thank you very much.

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