GlaxoSmithKline's (GSK) CEO Andrew Wittyon Q2 2014 Results - Earnings Call Transcript

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GlaxoSmithKline (NYSE:GSK)

Q2 2014 Earnings Conference Call

July 23, 2014 09:00 AM ET


Andrew Witty - CEO

Simon Dingemans - CFO


Graham Parry - Bank of America Merrill Lynch

Tim Anderson - Sanford Bernstein

Alexandra Hauber - UBS

Andrew Baum - Citigroup

Mark Clark - Deutsche Bank

James Gordon - JPMorgan

Steve Scala - Cowen

Nicolas Guyon - Morgan Stanley

Seamus Fernandez - Leerink Swann LLC

Andrew Witty

Good afternoon, welcome to today's call to everybody. GSK's performance in the second quarter provides evidence of the very significant changes are taking place in the Group's portfolio. As you know our strategy over the last six years has been to fundamentally reshape the Group and our R&D operations in particular, so that we can replace the significant sales we lost to generics and ensure that the Company can succeed in an environment where our biggest product Advair faces increasing competition.

It's clear we are now in that period of transition and this is a critical moment to ensure we made the right strategic choices particularly around investment for the long-term health of GSK in the new products and this is reflected in some of the decisions we have taken during the quarter.

Group sales for the quarter declined 4% to £5.6 billion, largely driven by lower sales in the U.S. where we are seeing earlier and more significant generic competition to Lovaza than expected and continued pricing and contracting pressure in the respiratory market including for Advair. However, while Advair sales are now likely to continue to decline, we expect new respiratory products Breo, Anoro and Incruse to generate new sales growth. Already we are seeing some recovery in our overall respiratory volume share as new launches progress albeit at lower price points. These assets together with the six other respiratory products in development will diversify and strengthen our respiratory portfolio and we remain confident we can maintain our leadership position in this therapy area well into the next decade.

Outside the U.S. performance is more positive with emerging market sales up 11%, driven by a very strong vaccine performance in the quarter, up 26%. Europe with flat sales also performed strongly in a tough trading environment with continued negative price pressure. Japan was down 7% in the quarter, reflecting destocking following a consumption tax increase and sales for the year-to-date are up 5%.

I was particularly pleased by the performance of our HIV business, the healthcare where sales grew 13%. This has been driven by the extremely strong launch of Tivicay, our new integrase inhibitor which is on course to be one of our best launches so far.

As flagged in the last quarter, our consumer healthcare business has been affected by some supply interruptions to several brands particularly in the U.S. and Europe. This led to sales decline of 4% in the quarter. The supply situation is beginning to improve and for the year we expect total consumer sales to be broadly flat. Strategically we have decided to maintain support foreign investment in our substantial portfolio of new product launches as this is essential for the future health of the company. Ongoing investment behind these launches combined with lower sales led to earnings per share down 12% in CER terms. Taking all factors into account, it is unlikely we will now deliver sales growth for the year and we now expect full year core EPS on a constant exchange rate basis to be broadly similar to last year. The dividend is up 6% this quarter to £0.19. So we are clearly in the part of our long-term investment cycle where we are seeing the delivery of significant new product flow from R&D. What's critical is for us to continue to stay focused on ensuring the launches of the first six products are successful.

Looking ahead I believe this existing strength will be supplemented both by further delivery from the pharmaceutical pipeline and the anticipated completion in the first half of 2015 of the three part transaction with Novartis that we announced in April.

Opportunities in the pipeline for our core therapy areas remain extensive. In respiratory, we filed Breo for asthma this quarter and expect to file our first respiratory biologic the anti-IL-5 monoclonal mepolizumab in the second half of the year. We expect to be first in class in that particular case. We also began phase III studies for the first triple combination product for COPD in the quarter. In HIV, we received a positive CHMP opinion for our combination HIV product Triumeq and we expect an FDA decision on this asset in the second half of the year. Overall, we have over 40 new molecular entities in late stage development and across the R&D pipeline we believe there are total of 30 drugs with the potential to be first in class in areas such as immuno-inflammation, epigenetics and cardiovascular disease.

This should lead to a regular flow of new product introduction over the next few years. The three part transaction with Novartis provides the opportunity to reshape the group and strengthen our positions in the long-term growth businesses of vaccine and consumer healthcare. Post completion these businesses will represent around half of group revenues over the coming years and should be capable of generating mid-single-digit sales growth on a consistent basis.

To give you more details on the quarter, now I would now like to handover to Simon Dingemans, the CFO.

Simon Dingemans

Thanks, Andrew. This has clearly been a challenging quarter, one that has made us even more convinced that our strategy to build a more balanced set of growth drivers across the group is both the right one but also one that is showing visible progress despite the significant headwinds we are currently facing. Clearly the most significant step forward in the quarter was the agreement with Novartis of a major three part transaction which we believe accelerates our strategy significantly and strengthens the long-term durability of our key franchises. We continue to expect the transaction to complete in the first half of 2015 subject to regulatory and shareholder approval.

More immediately, our core results in the second quarter are particularly impacted by the shift in U.S. pricing and contracting that we have been discussing with you for some time. This is a specially effected Advair which has now seen a step change in its outlook exacerbated net out of the transition to our new respiratory portfolio is underway.

Reported sales for the quarter were also impacted by a number of other factors included supply interruptions impacting several parts of our consumer business which we now believe will take somewhat longer to fully resolve than we originally anticipated and earlier and sharper generic competition to Lovaza. The impact of these issues on the quarter (most) [ph] important momentum in other parts of the business. We continued to deliver strong growth in several strategic areas where we'd be investing in emerging markets the vaccines especially in the emerging markets. And our oncology portfolio also delivered further progress.

We've continued to see greater stability from the business in Europe and our portfolio of new products is starting to make a material contribution with Tivicay, Mekinist and Tafinlar are doing particularly well and Breo and Anora are beginning to build. While the respiratory launches are clearly developing more slowly, we've always expected that it would take time and investment to build them to their full potential compared to the relatively rapid uptake of a more special allergy launches.

In the mean time looking at the second half of 2014 and as always there are a number of variables that increase the degree of uncertainty caused during the quarter including stocking patents and securing and delivering on large tenders and at the same time we expect Advair in the U.S. the consumer supply issues in Lovaza to continue to impact our reported growth. As a result and given where we are year-to-date we no longer expect to grow sales this year.

We continue to manage our cost base tightly and still expect to deliver at least £400 million of incremental restructuring savings during 2014, including the benefit of the structural savings of £200 million I have previously highlighted. And it looks likely that these will now fall into Q3.

As we've discussed in the past our plan has always been for most of these savings and other cost control measures to be reinvested behind our new launches and other growth opportunities as well as in new capacity and technology for our manufacturing operations.

Continuing with these investments is key to delivering the full potential of our pipeline and securing the future growth drivers for our key pharma vaccines in consumers businesses. As a result given our revised sales expectations we now expect full year core EPS to be broadly similar to 2013 on a constant currency basis and ex-divestments.

Before commenting on the detail of the Q2 core performance, I should point out that the sustained strength of sterling against most currencies is negatively impacting our reported top line growth and given the large proportion of our manufacturing and R&D cost base is located in the UK, the negative impacted currency is even more pronounced on our earnings, it's also up impacting our sterling cash flows.

We currently estimate the full year adverse impact of currency if rates remain at their current levels to be around 7% on the top line and around 12% core at EPS level. This is a bit lower than the first half negative currency impact in part because in the second half of last year we had exchange losses of around £63 million.

Turning to the quarter, group sales down 4% reflecting the challenges we've already discussed. And in particular in the U.S., US pharma and vaccine sales are down 10% in the quarter and this primarily reflects a 21% reduction in the underlying performance of Advair.

Price pressure remains significant with price impacting Advair sales in the quarter by 7%. Volume reductions of 14% reflected the contracting changes we discussed at Q1, but also the early impact of our new launches which together have adjusted Advair on to a new trend line that would likely see it continue to decline in sales over the next two to three years while we transition to our new respiratory portfolio.

Oncology sales in the U.S. continues to do very well growing 42% in the quarter. In Europe pharma and vaccine and sales were flatter than last year despite increasing competition in the respiratory market particularly. Growth from oncology products Avodart and [indiscernible] all help to offset lower Seretide sales which were down 4% mainly due to price reductions. Vaccines down 5% due in part to a number of shipments to several products that are now expected in the second half.

In emerging markets total sales of our pharma and vaccines business grew 11% or 15% excluding the China effect. Sales in China were down 25% including the established products, showing further stability in the quarter-on-quarter trend that we've reported on over the last several quarters. Growth in the region was led by 26% growth in vaccines with significant tender wins for Synflorix and pediatric vaccines.

In Japan sales were down 7% as a result of wholesalers destocking following their Q1 stock build ahead of a tax increase and year-to-date Japan is up 5% despite a weaker allergy season.

Turning to ViiV, ViiV Healthcare sales grew 13% in Q2 in large part due to the very successful launch of Tivicay in the U.S. The launch of Tivicay is now just getting started in Europe and Japan, and the business is also waiting regulatory decisions in the U.S. and Europe for its new three-in-one [indiscernible]. If all goes well these could be launched in some markets during the second half of the year.

For consumer the business was down 4% in Q2 and reported terms of sales in all three of its regions were impacted by supply disruptions particularly for smoking cessation products. We now have in place remediation plans for these issues and the supply position is beginning to improve. Overall we expect the consumer business to be broadly flat at the top line for the year.

Look at our operating costs. The operating margin excluding currency effects was down 3.2 percentage points. The margin decline partly reflects the impact on cost of goods and an adverse shift in mix particularly given the U.S. decline in respiratory sales. But the primary driver was the increase in the quarter in SG&A as we reinvest cost savings to support our new launches particularly in the U.S., Japan and Europe. We delivered further financial efficiencies in the bottom half of the P&L with interest down from 183 million in Q2 last year to £156 million this quarter, reflecting the improved funding profile of the group. And our effective tax rate was also down 2 percentage points from Q2 last year to 22% for the quarter in line with our expectations for the full year.

Turning to cash flow. Fundamentally, our business remains strongly cash generative and we continue to focus on improving the conversion of earnings into cash. Cash flow in the first half howsoever been impacted significantly by currency with the strength of sterling cost against around £500 million of £1 billion decline in cash flow relative to the first half of 2013. The remainder reflects the disposals we made last year and the decline in operating profit reflecting the impact of trading particularly in the U.S.

First half cash flow is generally a bit lower than the second half looking at historic patterns, with working capital a negative factor given seasonal and other requirements particularly in vaccines. New launches are added to the pressure this year and inventory is the main driver of the increase in approximately 14 days in working capital compared to Q2 last year.

Inventory days, in particularly, are likely to remain higher over the balance of the year, leave working capital at the end of 2014 slightly high overall than last year in days terms, as we ensure supply behind the rollout of new products and launches. Our focus on longer term improvements in inventory and other working capital efficiencies is unchanged.

Net debt at the end of the quarter was 14.4 billion, 1.3 billion lower than a year ago but 1.8 billion higher than the year end number. This increases the year end is due to the 0.7 billion spent on increasing our shareholding in our Indian pharmaceutical company and cash returns to shareholders mainly dividends. We continue to prioritize the dividend and our returns to our shareholders on the 6% increase in the dividend to £0.19 for the quarter reflects our confidence in the momentum across the business despite the near term challenges we are addressing.

We've repurchased £238 million of our own shares during the first half. We will keep our share repurchase program in place but given the net impact of currency on our cash flows share repurchases over the balance of the year are likely to be immaterial. Any proceeds from disposals including any from our established products portfolio will be retained in the short term to ensure our flexibility to invest behind the new launches. Our manufacturing enhancements as well as the continued restructuring of our cost base but longer term we will continue to consider share buybacks alongside the dividend whether those repurchases offer an attractive return.

And with that I'll turn it back to Andrew for questions.

Andrew Witty

Thanks Simon. And if I could ask the operator to start the Q&A session please.

Question-And-Answer Session


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

Graham Parry - Bank of America Merrill Lynch

Thanks for taking my questions. So firstly kicking off with questions on the Breo and Anoro, can you just give us an update there on what percentage of product is not being picked up in the Rx data so how much sampling is still there and what are the pharmacy rejection rates for each product?

And secondly on Advair the negative price of $0.07 year-on-year in the U.S. is being fairly consistent across first and second quarter. So is this just a one-off step down and your release today seems to indicate that you expect further pricing pressure. So should we read that to be the second half pricing impact would be greater than 7%? And to what extent do you think we can expect this granulized event of 2015?

And then thirdly on the shape of margins in 2015 this year it's clear there is no margin recovery but next year how do we think about margin dilution from the asset swaps along with cost savings and margin leverage from the new portfolio playing into how your margins might progressed into 2015? Thank you.

Andrew Witty

Thanks very much Graham. So, if you just on the first question the initial launches what we're seeing is less rejection of Anoro than we saw with Breo. So in the first month and this is I am talking really about Medicare Part D which is really the key part of the COPD market. So if you look at the initial months of launch of Breo, we were seeing about between 55 and 60% of scripts being rejected and then another 20% being reversed, so that's the patient who could have had the opportunity but at a very high co-pay chose not to go forward.

We're seeing the rejection rate for Anoro more like the 40%-45%, but again we're only in the first four to six weeks, so very-very early data. But looks significantly better. We also have substantially more coverage on Anoro at this point of the launch. So in the case of Breo at this point we have basically 3% I think of Medicare Part D as of today we've got about 27% coverage of Medicare Part D for Anoro that kicked in July the 1st. So we've seen a much more rapid pick up on Anoro in terms of access.

In terms of sampling both continue to be very heavily sampled so, a substantially more samples being put into the marketplace than are being prescribed and we also as you know have various vaccines which are also offering patients the opportunity to stop medicine, so quite a bit of product still not within the audits.

Having said all of that if you look at Breo in particular for the US we're seeing some very encouraging trends over this quarter actually, so one of the leading indicators that we use is NBRx that's new to brand prescription so this is not NRx, TRx data that you're used to but more NBRx. So this looks at the really dynamic part of the marketplace and in COPD about 12% of the market is dynamic where you've got people really changing drugs. That's a relatively small proportion compared to some other categories particularly in specialty but that's what it is for COPD.

We already have a 12% market share of pulmonologists in that NBRx section so if you look at this behavior of specialists in the dynamic section we've seen very-very good uptake in fact one in two pulmonologists in the US have now prescribed the drug. About 14,000 people altogether or 14,000 physicians all together have prescribed the drug. So we're seeing quite good movement there first of all.

Secondly we're seeing continued upward trajectory of the NBRx performance. That's important because typically when you look at primary care launches, after the first 10-15 weeks you tend to see the performance on that leading indicator beginning to plateau. We have not seen that with Breo, we continue to see an upward trajectory, that's a very-very encouraging sign and if you look all products launched during 2013 Breo now is looking like maybe the fifth or sixth best performance so far and continuing to improve whereas the vast majority of launches have either not performed as well as Breo or are flattened out and that may surprise all of you. But I think it's very reflective of the change in the marketplace in US primary care launches, big difference between specialty and primary care.

But the signals for Breo look encouraging, we're now up to, I think when we last spoke we had something like a 1,000 prescriptions a week, we're now well over 5,000 prescriptions a week in terms of NRx, looking encouraging. And we're seeing similar encouraging signs on Anoro, but as I said it's extremely early days. But if you are going to characterize it you'd say that Anoro was tracking at a better trajectory than Breo was and we feel okay about Breo.

In terms of the price effect, what you're seeing essentially on price is the effects of increasing discount rates playing through and obviously neutralized in any list price increases and you're quite right, the effect is broadly similar across the two quarters.

My expectation is that you probably see a broadly similar trend going forward. Whether or not there are further steps down in that really depends on the various contracting cycles. But clearly what you would want to see is as you start to step down if you indeed you start to step down that should reacquire volume market share so you should be seeing some offset in the volumes whereas this phase we've just been through has been a little bit more of an adjustment to competitive dynamics.

As you look forward I think you should start to expect us to see more puts and takes around price and volume swinging back and forth, and we've certainly been winning a number of contracts over the last few weeks which give us quite good confidence overall for our respiratory volume position going forward.

And I made the final point, if you look at volume market shares Advair plus Breo what you see is over the last three months, actually we stabilized and been growing the total GSK volume market share, everybody else is essentially under pressure for share. And while that's very-very early days that's exactly what we want to see, because what we want to see is that our volume level that we can build of the existing Advair volumes and that's where obviously the sustainable business sits. Clearly that is a different price point to the prices we were achieving two-three-four years ago, but that's the adjustment we're going through over this period and what's encouraging is that although there is a price adjustment we are seeing the acquisition of incremental volume into the market place and actually that there are I think very encouraging signs but as you think about Anoro and then Incruse and then the rest of the products being loaded into that portfolio, the opportunity for us to grow share back is very substantial that's where our confidence sits for long term leadership in the respiratory marketplace. Next question?


Tim Anderson, Sanford Bernstein

Tim Anderson - Sanford Bernstein

Well, thank you, I have a few questions. On respiratory if we're seeing price competition with Advair why won't we end up seeing the same thing over time with newer products like Anoro where in that case the (Lava/Lamic) [ph] category will become more crowded.

Second question is on your GLP-1 Albiglutide at least on a list price basis you seem to have entered the US market at a very big price discount relative to the competition which is something that you really don't ever see drug companies do especially with new drug launches, so any comments behind your decision on that would be appreciated.

And then last question on the basket of products you're considering for sale, could that represent an opportunity for tax inversion for the acquirer and also why not sell of more than just the £1 billion that you referenced?

Andrew Witty

Yes, thanks, Tim. So, let me just nail the EPP thing first of all, a £1 billion it's mostly Europe, U.S. as I have described previously we separated into the separate reporting category, the EPP, give you clarity of what's going on in the business but also to give us focus in terms of how we can streamline that business, take complexity out and there is a huge program going on in GSK to strip out SKUs and brands, something like 200 brands being deleted, so the smallest products around the world, just to take out complexity as we bring-in the new products obviously we want to make space, if you will, within the organization for that. But as we have also said there are opportunities for disposal but those opportunities practically speaking really are resident in Europe and America.

This represents something between a third and half of the Europe and American tail business or EPP business, so it's a substantial part of that business. We are not close minded to doing more but the reality is finding those clusters of brands and businesses which are reasonably straight forward to disconnect from GSK, not everything is reasonably straight forward.

And therefore as I have guided repeatedly the idea of an on-block sale for the whole thing I think is not frankly practical. I do think though where you can get this sensible ring fence and it's relatively straight forward to disconnect then you can generate decent reward. I don't know whether or not somebody will look at this an inversion opportunity, certainly not our -- we are not particularly interested in that or have a priority on it but of course in this current environment, there are plenty of potential buyers for these source of blocks of business, some of whom might have that in their mind, others have very different agendas. And I am pleased with the level of interest we've got there and we'll pursue that.

I'll remind you also Tim we have, remember we've divested a number of tails over the last four years, so we divested our consumer tail, we divested our drinks business and we divested Fraxiparine and Arixtra, we divested Treximet. We exited Prolia in Europe. So, this is another on a long journey and if you look back at the amount of tail that we've taken out, it's very, very substantial but we have done I think in a practical. I know there's an awful lot of talk about divesting tail but it's quite illusive to create that magic bullet on block transaction. I think what we have done is actually execute, we delivered it. We continue to deliver it.

Anoro price competition, yes, there is going to be Anoro price competition. We priced Anoro at discount to the marketplace and there is going to be a significant negotiation I think in that space just like any other primary care space. And I think whether you look at the long acting the LABA-steroid combinations or you look at the LAMA marketplace, there are going to be degrees more competition than we've had historically and I would anticipate we may get some of that with Anoro.

And I think you will see across the board in primary care and you will certainly see in diabetes. You have seen a significant amount of price pressure build up in the diabetes marketplace in the last six or nine months and frankly the pricing strategy for Tanzeum, GLP-1 we think is exactly resident with what's going on in the U.S. marketplace and we've had a tremendous response and level of interest from payers not surprisingly when you're offering something so substantially more value based than perhaps they've seen. So, it will be very interesting to see how that shapes things up and I don't think it's particularly sensible of us to sit on calls and tell you if there is more price competition and then not think about using price as part of our own competitive set and that's exactly what we're doing and you will see more of that from GSK.


Thank you. Next question is from the line of Alexandra Hauber from UBS. Please go ahead.

Alexandra Hauber - UBS

Thank you for taking my questions. I have got three please. Firstly, if you are selling a £1 billion worth of products that will be about 4% to 5% of your gross profit, conceptually how should we think about your corporate cost and your R&D budget? Is this going to decline or will you compensate the impact from the lower gross profit through cash elsewhere?

Secondly, your increase in SG&A, can you give us a bit more color on exactly which franchises in the geographies are benefiting most from that and also in what form the increased SG&A is coming from, it's probably not sales force, so what is it?

And then finally just a follow-up on the Advair pricing question, the 7% decline in increasing discounts, is that the uniform 7% increase in the discount or is it more something like may be 14% decrease in discount on 50% of the contracts. So, is this going to be uniform or very discrete?

Andrew Witty

Okay, Alexandra, I'll deal with the last question and I will touch on the first but I am going to let Simon really cover the first and the second. So on the first, I think let's see whether we sell this business or not. We have made it very clear that we will only sell it if we achieve the value that's commensurate with the profitability of that business. So, first of all I just want to reinforce that caveat.

If we do, remember as well next year that if all goes well then the proposed transaction with Novartis will also take place next year. That will have a much more significant effect in terms of margin structure of the group. And therefore the right time to really describe to you all of the -- where the ongoing margin structure of the group will be after those events or when those events are real and we can give you that detail.

I would say -- I'd also remind you that obviously when you look at, for example, pharma R&D with the proposed transfer of the oncology business to Novartis is a significant proportion of GSK R&D cost embedded around oncology which of course goes with that business. So I just wanted to make the point that you're going to see a lot of puts and takes through the portfolio, not just the EPP. Actually much more so around the Novartis transaction and I will ask Simon to cover more of that when he gets on to those first two questions.

As far as the Advair pricing is concerned, it's not a uniform phenomenon, but there are different movements going on in the different classes of customers depending on the competitive situation. A lot of this is being driven by payer consolidation over the last 24 months. A lot of it around provider control levels, those sorts of things. And some of it driven by competitive dynamics.

So, as I just talked to Tim about what we're doing with the [indiscernible]. We'll notice some companies of being aggressive discounts into [indiscernible] market and these things come around. So that's really the dynamic world we're dealing with, but the good news is we've got a lot of new products coming into these markets and I think that's where you want. When you've got this kind of noise, having a new product where you are able to position your pricing where you want to be for the medium term, is a great place to be; but clearly the transition isn't painless. And I think that's obviously for everybody. I am going to ask Simon to cover the detail on the margin and maybe comment more on the ongoing structure.

Simon Dingemans

Yes. So thanks Alexander. On EPP, as we talked about before, I mean these are relatively high margin products. One of the reasons we separated them out was to really focus the business on running them for profit and cash. As I said, when we think about the disposal, we're really looking at the value we've released from those on the cash contributions that we might expect over the next several years from those products rather than necessarily the profitability or the P&L impacts. I think almost by definition, as you sell out these products, there are likely to be dilution in the short-term, but it does free out resources for us to be able to invest in the growth driver for the company going forward. And that's really what you are already seeing in some of the shift in SG&A that you touched on in your second question.

And where is that investment going? It's going, some in sales force, but it's also going in marketing support, in promotional spend, evidence generation, R&D support, and making sure we got all the tools at our disposal to be able to optimize those launches. So we have put a lot of flexibility into the system. So given the discussions we had before, we don't see a significant step up in SG&A, but we are going to see quarter-to-quarter, some pressure as we invest in the U.S., Japan and Europe in particular where the launches had first advanced. And but that's probably keeping SG&A at broadly similar levels to where we are today rather than a big move upward as you challenged us on in the past. And that's really the benefit of the flexibility we built into the cost space over the last several years.

So that's the overall profile. But I think, from a margin perspective, and I know Graham asked on this question earlier, I think at this point we need to get to the stage of closing the transaction. And at that point we can give you a much more comprehensive view of the significant shifts in the margin mix, trends that we're going to see in profitability as you bring in obviously a significantly larger consumer and back scenes businesses which tend to be lower margin relative to the tackle. We will be taking out EPP products which are higher margin relative to the tackle plus oncology which is obviously also a significant profit contributor reflected in the valuation that we achieved for that business when we agreed terms with Novartis. So we'll give you that when the transaction closes.

Andrew Witty

Thanks Simon. And just while Simon was talking, I was just reflecting a little bit on how things have changed in the group and if you think back to the creation of GSK in 2001. Over the last 13 or 14 years, in the pharma business you've really had three big brands which have been built during that period, obviously Advair; Avandia which had its own destiny, and Avodart or [indiscernible]. You have those three big brands. From the peak of the promotional capability of the company in terms of cost; so from the peak of our size of sales force in America and Europe we have about 50% less sales force than we had at that peak, when those three brands were the big story of the company.

Now as you know a lot of that SG&A costs was invested in building up the emerging market business which has become a very substantial business, grew 11% in this quarter, 15% excluding China. When I was at, in a very interesting situation where after over 13 years, we essentially had three big brands to build. In the last 12 months alone we have launched six brands which have very substantial potential. And looking forward, we can see, I don't know maybe three on an average a year, every year going forward. It won't be every year the same, but something like that.

And so the ability of the company to be able to support that, with that Simon says broadly-broadly similar SG&A kind of spend really reflects the structural changes of the company. Because when you look at what we're now doing, even in the launch of Brio, just a contrast for you, when Advair was launched at the end of the 90s, it took seven years to get from the first European launch to the Japanese launch. It's now taken seven months to get Europe, Japan and America launched and the same true with Anoro and the same true with all the other products more or less.

So what you're seeing is that a much more successful globalization. So you've got more countries coming on-stream simultaneously than we've ever had in the history of the group. You've got more products coming on stream simultaneously and we're more or less holding that with an SG&A base which is essentially the base after the significant downsizing following A, the genericization of the old portfolio and the loss of Avandia and B, the investment in the emerging markets.

But it's inevitable on a quarter-to-quarter basis it may occasionally be the need for us to invest a bit more here and there to make sure that we've got it absolutely right. And that's really the pattern you will see and I think actually when you contrast that to various alternative ways of dealing with the big cyclical moves of pharmaceutical pipelines, I think this approach is the right strategic approach we've stuck to for the last six or seven years. It was in a good shape for going forward with this pipeline.

Next question.


Andrew Baum, Citigroup.

Andrew Baum - Citigroup

Yes, three questions if I may. Firstly regarding China, given the pressures on your infrastructure in China. Is GSK the right company to directly distribute its products within that territory? Or it's some kind of licensing an alternative here that you would consider?

Second with regards to your last two trial with losmapimod. Could you talk us through it, because obviously you have just had two negative expenses sizable Phase 3 trials in cardiovascular, not necessarily core area for GSK in the past which read out negatively and if it's initiated another 25,000 patient trial here with a [indiscernible] mechanism. So perhaps you could talk us through the rationale, the confidence behind this significant commitment.

And then finally on the consumer business, you cited the manufacturing issues regarding the toothpaste as being partly responsible for the positive sales. Certainly it seems to me that your competitors within the toothpaste space seems to have set up their promotion of rival premium brands. So perhaps you could comment for us on the relative market shares within the toothpaste assessments to help us understand how much is manufacturing versus market share issues? Thank you.

Andrew Witty

Thank you very much. Listen on China, we remain committed to China as a business for us both in our consumer and pharma vaccine business. And as you've seen in the quarter you're seeing a continued stabilization of the business there, obviously we want to work with the authorities to resolve the issues that we've got there. Nothing more to say on that subject.

As far as the ACS program as mepolizumab, basically we're moving this forward into Phase 3 as you know. Clinical evidence shows that the drug reduced the systemic and vascular inflammation, improves vascular blood flow and has a potential to reduce major adverse cardiovascular events in patients who've suffered a heart attack. That's the basic belief, the drug's being designed as an acute short-term 90 day treatment. So we're looking at a very different kind of approach to this treatment area than we've seen in other approaches to ACS.

And as a result targeting the high rate of inflammation occurs followed an initial cardiovascular event which is the period we think where the patient is most at risk of a further event. And very differently to the darapladib studies, this is specifically focused on a short, we're looking to try and demonstrate the effect of it in a short-term period. Now obviously it has to have a high number of patients to get the power but it's a short-term treatment program.

So we feel good about it, we think the profile looks good. But again like all major R&D particularly when you're looking at first in class opportunities, there is obviously going to be risk.

As far as the consumer business is concerned, you're quite right we're seeing a good recovery from the various supply issues in a number of the areas where we've had some disruption particularly in the toothpaste business. We see that recovery continuing through the rest of this year when we see the overall consumer business being flat for the year.

In terms of the performance of our toothpaste business, continues to be very strong, but it needs to be divided into -- so you got to think about our consumer oral care business in two parts Andrew. The first is the premium business, so this is the Sensodyne, Parodontax, denture, dry mouth business. This is the higher margin business that represents 76% of our portfolio; the rest is, is more the Aquafresh business. It's more the business that we compete with the general toothpaste market. That has continuously shrunk as a fraction of our business. Our priority is that premium Sensodyne led business.

The CAGR for that business over the last four or five years has been 13% has outgrown basically all our competitors, is clear that we've created the category. And actually as we look at other entries, our market shares remain very, very robust continued to see good underlying growth occasionally disrupted by supply issues but actually Sensodyne not too bad.

And overall we feel very, very robust about that, but it's important over time that business will become really very much at premium Sensodyne led business. It started the other way around with Aquafresh being the bulk and Sensodyne the new idea. But now it's all about the Sensodyne, Parodontax, denture dry mouth business. And I am very proud of the performance of that business. We're seeing continued good consumption numbers in the U.S. over the last six to eight weeks. Looks fine.

Next question?


Your next question comes from the line of Mark Clark, Deutsche Bank.

Mark Clark - Deutsche Bank

Yes, good afternoon gentlemen. I just wanted to ask a little bit about the dividend. If we assume the second quarter growth rate of 6% is as good guess as any for the full year outlook and we take your guidance on earnings and currency then it does imply that payout ratio is pushing 90% in the high 80s at least. Can you talk to us about whether you have some kind of a sealing or is there a point at which you would seek to hold but even though I not suggesting you would ever cut it but certainly hold the dividend rather than continue growing in the sort of mid-single digit growth rate that we have seen, also mid upper single-digit growth rate rather than we have seen in recent years? Thank you.

Andrew Witty

Okay, thanks, Mark. I think as I have said in my comments, the dividend remains our priority in terms of shareholder distributions. There is no change to the policy. Over the last couple of years, we have been paying out relatively high amounts as we go through this transition period and clearly decisions for the future for the Board of the time. But I think we have laid out our store on that front and there is no change in the policy.


Your next question comes from the line of James Gordon, JPMorgan.

James Gordon - JPMorgan

Hello, thanks for taking my questions. Two questions left please. One was on R&D which was presumably R&D on respiratory is reducing, and R&D is falling every year for the last few years only down about 10% year-on-year today. Can we think that you are actually going to be able to get some leverage over R&D because you [indiscernible] cut that quite a bit further and if you are more focused on vaccines are continually start require as much R&D, is GSK just getting less focused on innovation now?

And the second question was just to clarify on consumer and the oral care issues and Aquafresh, so it's down quite a lot today but I think in Q1, it sounded like the manufacturing issues have been fixed for toothpaste. So, what was the actual issue and why does it seem to fixed and now isn't fixed?

Andrew Witty

So, on that, so the oral care manufacturing issues are essentially fixed and they were at the end of Q1. What you have seen is it takes time to refill the supply chains that's basically the difference, so as you progress further and further through the year then the kind of the ripples if you will from the disruption just diminish. Obviously it takes time to refill pipelines and the like. So, nothing dramatic there at all, James.

In terms of respiratory, actual I'll spend on respiratory will not go down I suspect in the next few years. Why? A, we've got a whole number of more products coming through the R&D pipeline, so I am talking about the pre-approval pipeline, so you got the triples, you have got some of the very earlier novel mechanisms coming through, some very, very cool stuff coming out of the DPUs which you will start to hear more about in the next two or three years I think.

So, we continue to be very, very active in the traditional R&D space if I can call it that, but then of course as we have taken 1, 2, 3 hopefully 4, 5, 6 into the market, you are now going to see more phase IIIb, phase IV work going on and there is quite a shift in terms of our R&D spend in that direction. So, I don't think you should look for respiratory to be a sort of reduced R&D cost.

Now, assuming the Novartis transaction goes through as I have said already on this call that the transition of oncology from GSK to Novartis will have a significant impact in terms of reducing R&D cost. And the secondary which we've been, I think really a leader on over the last six or seven years is as we have developed new technologies, as we developed new approaches, our utilization of a lot of the traditional costs of R&D have diminished.

So, if you look at for example our efficiency in preclinical use of animals, we're remarkably more efficient today than we were a four, five years ago, something like 30% more drugs in development all the way through the system using more or less the same resources we were using six years ago. And you're going to see more and more of that over the next two to three years, so I think you will see a continued harvest of efficiency from R&D. You will see some of the bigger landmarks that is obviously unfortunately [indiscernible] didn't make it, that's been a big piece of the cost base. You see that drop out. You will see oncology transfer our subject to the transaction. All of those net-net, I think give us a lot of confidence around how we can manage this R&D number going forward.


Your next question is from the line of Steve Scala from Cowen.

Steve Scala - Cowen

Thank you, I have a few questions. What can you tell us about turnover in 2014 other than it won't grow, at constant exchanges they're more likely to be flat, down modestly, down significantly, I appreciate there are lots of moving parts but based on how those parts are lined up now, how would you answer the question?

Second on Advair, Simon you noted a decline over the next two to three years, why did you put a qualifier of two to three years on your insight, is that because of the 2016 patent or some other reason? And is Advair's decline seen recently kind of 12 to 14ish a good metric for extrapolation or would you expect an acceleration?

And then lastly you called out vaccines up 26% in the quarter in emerging markets, what tenders drove that and what is the outlook for the second half? Thank you.

Andrew Witty

Okay, I'll ask Simon obviously to answer the questions you directed to him, I mean I think what I would say about the sales outlook as we expect it to be broadly similar, which is the guidance that we've given. I mean obviously we're doing everything we can to deliver the best sales result we can. But given as Simon said on the call given where we are at this point of the year this feels like a sensible guidance to give you. As far as the other aspects, Simon.

Simon Dingemans

I think just on the turnover point, what we said in the comments quite specifically there is a lot of moving parts in the top line at the moment and that's why we always focused on guidance being around the bottom line. And I kind of remind you of that. But that's ultimately what we're aiming to deliver for the year. And on Advair also to repeat as I said in my remarks and I think a couple of quarters don't necessarily make a trend but I think that certainly our view is it's much clearer now what the likely rate of decline is over the next two or three years. I didn't really call that any further just from a visibility point of view rather than any particular hope related to patent expires or other factors. There is more just looking as far forward as we can to try and give you some sense of how Advair progresses. And it's mainly a U.S. comment as clearly the dynamics in Europe and EMA somewhat different, so hopefully that's helpful.


Your next question is from the line of Nicolas Guyon, Morgan Stanley.

Nicolas Guyon - Morgan Stanley

Actually I have two, the first one is on Anoro. I appreciate It's still early days but could you tell us where the prescription come from i.e. whether these are [indiscernible] or led by ACS combination?

And the second question is a follow up on OTC. Could you be a little bit more specific on what the supply issues are in smoking cessation and that why you are so confident that you will be fixing them by the end of the year, especially since your full year guidance of flat sales for consumer implies 2% growth in H2? Thank you.

Andrew Witty

Well I mean the confidence really is because in a number of areas as I have said already on the call really going back over the last couple of months, we've already seen recovery of supply. And we are making good progress on the smoking control arena and our current expectation is that we ought to be able to see further improvement there which is that combined with robust underlying demand.

So if you look at our underlying demand in the consumer business running at something like 5%. So we know that there is a really good position there and as we go through the next few months we anticipate being in a better position to supply those things.

I think the bottom line on Anoro as I said is very, very early days. It's essentially coming from a mix of sources which as you know what you'd exact way to expect is way too early to call a trend on I would say Nicolas. I think next quarter or maybe at the end of the year would be the right way to look at that. And I am sorry to sound a bit like a broken record but I really am in the place, it takes nine, 12, 15 months to really figure out where these primary care launches are going.

I think we're seeing that with Breo, I think the absolute fixation with the first few weeks is, I just don't think -- I think the world market has moved on a lot actually in terms of the way these products enter the marketplace.

Next question.


Your next question is from the line of (Vikee Parikh) [ph], Goldman Sachs.

Unidentified Analyst

I have three questions please. First on financial planning, the second on cash and the third on respiratory. Just on financial planning, is there something peculiar about the process that GSK uses kind of at the start of the year when you issue guidance? Is there more unpredictability about the GSK businesses that has led to operating profit guidances kind of being cut three years in a row?

Secondly as it relates to the cash, given statements today that you reaffirmed or reconfirmed that the cash from the Novartis transaction if it closes will be distributed at a special dividends or is that [indiscernible] given the effects might be and where business cash flows might be?

And thirdly on respiratory, your guidance for long-term leadership. How much of that is dependent on a positive outcome from the summit study so Breo actually showing the mortality benefit. If that does not work do you still expect to be in leadership position come 2017? Thank you.

Andrew Witty

So let me just see if I can knock those off. In terms of the guidance, I mean my recollection last year was we delivered our guidance. And there is -- I don't think there is any special phenomenon that goes on at GSK. Other than we have a lot of very big moving parts. So there are some very big drug companies who only have one or two products. There are a few drug companies like ours where you have a lot of big bits of the business.

Now you can look at that two ways. I look at it from the perspective that says you have lots of big bits of business and that gives you a stabilization or diversification benefit which gives you a broad confidence in delivering. If you look at this company's performance over the last seven or eight years where we've been able to absorb all the genericizations of the old portfolio, been able to absorb Avandia. And we've essentially been able to deliver sustained delivery of dividend of earnings for the company nothing exciting obviously but we delivered that versus lot of other companies where they have had one or two big issues and they've had to go through corporate level reductions of 10%, 20%, 30%, 40% in terms of business size. I cannot really reflect that benefit.

Now the downside is that if you have an issue in one of those big businesses it can just not vanish off at the top of the company. So if you think about what we're talking about here, we're talking about a year where we hoped we would grow somewhere in the 4 to 8 range. And we're now saying, we're going to be broadly flat and broadly similar year-on-year. So we're talking about a handful of percentage points on a company of £28 billion turnover. What that is driven by is you have a phenomena going on with our biggest product Advair. You have a phenomena going on with a big product going generic Lovaza, and then you have some friction if you will, in the consumer business.

So three things together are add up to something which puts us in a position where we either decide to cut costs on our new product opportunity or we guide. The totally sensible thing to do is to re-guide. It makes absolutely no point for us to be making short-term investment decisions simply to hear a quarter or a guidance, when you got these three events which are, two of the three essentially to do with the older business. When you got those three events which just knock off your potential to get to where you originally thought you would get to and I think that's nobody likes to do those sorts of things, but I think it's the reality of the business line. But the plus side of this business is we haven't said to you in any time in the last seven years, by the way, product X is going generic, or product Y has disappeared and sales is going to be down 25%. And that's a fundamentally different proposition.

We have not seen that kind of volatility of the delivery now. You can argue that those companies, although stocks which go through very significant downturns, and have the benefit of very significant growth from the bottom, but the reality is the shareholders are in those stocks when they go down, are the ones who bear the cost of that. And we are avoiding that. We continue to believe that's the right approach even if it makes us somewhat less racy than some other companies might appear to be.

So that's the first thing I'd say. The second thing I would say, just for this whole point on Advair is that for as long as I've been Chief Executive, I've be having to answer the question about when would Advair go generic and what would we do after Advair? And when is that all going to happen? And that's a very big question everybody has had.

My views on genericizaton of Advair haven't changed. They are exactly as they were the last time we spoke, no change on that. But what we are seeing is a product which is now 14 or 15 years old, is a very substantial product, market leading product coming under inevitable price pressure, competitive pressure. You know, worldwide, the environment has changed fundamentally, where there are more products in the marketplace, not least from ourselves.

And so you are inevitably going to see the kind of pressure. Now that I think what that tells you finally is now is the moment to start thinking about what this group looks like post Advair. It's not about the generics, and about the patent expiration, it's about the transition that we're now engaged in where you're going to see a somewhat gentle, albeit probably continued downward pressure on Advair driven by this pricing competition offset by our ability to bring new products into the market.

Your question on Brio, again gives me the opportunity to restate something I said on every earnings call I think for seven years, which has never been unneeded as it remain our strategy to replace Advair with Brio. It's our strategy to build on Advair with the 5, 6, 7, new respiratory products we have coming and then to build drugs for the group with all the other products from our side of respiratory. That strategy is absolutely clearly active. The products are now there. The products have been rolled out. As a cumulative group of products, we are ahead of business plan in terms of the performance of the new products.

We are seeing a range of extraordinary performances in areas like HIV and cancer, obviously. And we're seeing the beginnings of good, relentless progress in the respiratory marketplace and that's exactly what we plan to do, and we will continue to prosecute that strategy. It's not about one product. And therefore it's not about one trial like SUMMIT. SUMMIT is an important study. If it's successful giving extremely important additive asset for Brio, but the whole strategy isn't about Brio. The strategy is about the portfolio of products which we brought through to market.

And then finally just to confirm absolutely if the Novartis transaction is blessed by the regulations as we fully expect in the first half of 2015, then the cash proceeds will be repatriated through a special dividend as we have previously announced.

And we have time just for one last question, which I'm sure will be in three parts. So go ahead.


Final question is from the line of Seamus Fernandez at Leerink

Seamus Fernandez - Leerink Swann LLC

Maybe I guess just as we're hearing -- and I will make it one question, but as we are hearing it from U.S.-based physicians, the promotional effort from GSK is simply fundamentally different from the competitors. So not only are the competitors taking advantage of a change in reimbursement strategy but they are also taking advantage of a difference in promotional effort from GSK, and the specific point being that even sampling programs are different and that actually is limiting the ability to prescribe Brio on some level and also to prescribe Anoro on some level. Or at least to get patients interested because the availability of competitors' products is that much higher and easier to distribute for an initial 30 days or 60 days.

So how are you going to respond to that? Are working through changes in your current promotional strategy to really step up your efforts in that regard as your reimbursement improves for Brio and for Anoro over the next six to 12 months, because it seems like that's going to be the key to re-establishing your -- and further growing those key franchises. Thanks.

Andrew Witty

So I agree with one aspect of what you said. I'm not sure I agree with the other. So, there is no doubt, that as we build access, so 60% of the COPD lives stick within the Medicare Part D marketplace; so as we build access into Medicare Part D, they're not crazy opportunity to pull through the product and to build that over time. Bearing in mind that the dynamic sector of this marketplace is not as big as you're seeing in some other categories, but there is no doubt that as the access opens up we have to really do everything we can to try and make sure that patients have the appropriate opportunity to try the medicines, and that's exactly what we're focused on.

Now all of the evidence we have around, share of voice, share of sampling, presence of sampling, having personally ridden with sales reps in the U.S. -- if there are particular physicians you want to send me the name or to make sure that for whatever reason we haven't got there and given them some samples I don't believe that is an issue. But there is no doubt that as we now move into the phase of greater access, as we saw with Brio where we've seen in the last quarter a 53% increase in prescriptions for Brio, as access began to come online. And remember, at Q1 everybody was saying, oh you haven't started to see the movement, kind of is it ever going to move? We said wait for the access to open. We'll then start to see movement. We saw access open. Scripts were up 53%.

As I explained in the beginning of the call, Brio is one of the very-very few products which is showing an upward trajectory at this stage of launch on the most dynamic sector, which is absolutely the lead indicator for long-term performance. We feel good about that. Now we are constantly looking at how we can do better in our execution of day-to-day promotion. Of course, we will look at those if there are particular customers who you think we need to spend more time with, I'd love to hear about, let me know after the call and we will make sure they get a visit from a highly trained professional GSK representative.

With that, I'd like to thank everybody for their attention on this call and the IR team are available at your disposal if you want have any follow-up conversations. Thank you very much.

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