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GlaxoSmithKline plc (NYSE:GSK)

Q1 2011 Earnings Call

April 27, 2011 9:00 am ET

Executives

Andrew Witty - Chief Executive Officer, Executive Director, Member of Corporate Administration & Transactions Committee and Member of Finance Committee

Simon Dingemans - Chief Financial Officer, Executive Director, Member of Corporate Administration & Transactions Committee and Member of Finance Committee

Analysts

Brian Bourdot - Barclays Capital

Andrew Baum - Morgan Stanley

Tim Anderson - Sanford C. Bernstein & Co., Inc.

Alexandra Hauber - JP Morgan Chase & Co

Kerry Holford - Crédit Suisse AG

Michael Parekh

Seamus Fernandez - Leerink Swann LLC

Gbola Amusa - UBS Investment Bank

Emmanuel Papadakis - Collins Stewart plc

Unknown Analyst -

Michael Leacock - RBS Research

Naresh Chouhan - Liberum Capital Limited

Operator

My name is Simon, I'm the operator today. The format of the call will be some opening remarks from Andrew and Simon, and

[Audio Gap]

Andrew Witty

Thank you very much. As I laid out in February, we see the performance and the shape of GSK business developing over the next 2 years. The Q1 that we've just reported really displays I think very clearly that the trajectory we expected is playing out and that GSK is making good progress against our strategic priorities. We're seeing continued good underlying sales growth momentum, up 4% in the quarter. And this is being driven by growth from a broad range of the businesses that we've been investing in over the last 3 years. In particular, the Emerging Markets, Japan, our Vaccine business, Consumer Healthcare, all of which are offsetting the declines we've seen in the U.S., which of course were augmented during this quarter by the various price cuts which are going on.

Just to look in a little bit more detail at 1 or 2 of those areas of growth, the Emerging Markets in particular. If we look at our Emerging Market, Asia Pac business, which is the business that Abbas Hussain runs, was up 21% in the quarter. Within that, just to pull out 1 or 2 examples: Rotarix, up 71%; Augmentin, up 25%; Ventolin, up 26% and the Derm range, obviously largely made up of the Stiefel portfolio, up 25%. Very strong performance across innovative classic and our branded generic business within the Emerging Market business area.

The Consumer business continued to perform extremely well, up 7%. Within that business, Sensodyne, up 16%; Lucozade, up 5%; Panadol; up mid-teens and the Emerging Market Consumer business, up a full 15%. So across our businesses, we're continuing to see great responsiveness as we've moved investment resources behind different areas of opportunity.

Group level, reported sales were down 10%, reflecting the £1 billion reduction in sales of Pandemic products, Valtrex and Avandia versus a year ago. As expected, as we progressed during the rest of this year, we expect the impact to decline pretty rapidly as this headwind starts to diminish versus last year's performance. And we expect our underlying sales growth to translate into sustainable reported growth toward the end of this year and certainly into 2012. We're also focused on driving operational leverage throughout the business.

The cost of our restructuring program are diminishing, while the majority of the benefits are now embedded and flowing through the P&L. At the same time, during the quarter, effective disposal of non-core assets, for example, our Quest shareholding in Zovirax, has enabled us to release value for the business. Altogether, this is reflected in the improved EPS numbers we report today, both at pre- and post-restructuring levels, up 9% before restructuring and up a full 18% after restructuring charges. That last number obviously reflecting the deceleration of restructuring charges being taken and the continued delivery of the benefit.

I'm also delighted with R&D delivery in output this quarter. We received 3 approvals for new molecular entities, Benlysta for Lupus and Horizant for Restless Legs Syndrome in the U.S. and Trobalt for the adjunctive treatment of epilepsy in Europe. We are also in discussions with regulators on 2 new vaccines for meningitis, Nimenrix in Europe and Menhibrix in the U.S. Visibility on our late stage pipeline also continues to grow.

As I set out in February, we're expecting data on 15 Phase III assets by the end of 2012. Remember, that's about 1/2 of the total Phase III portfolio of 30 assets. And we've received in the first quarter read outs on 3 of these programs. In one, otelixizumab for Type 1 diabetes, the first trial unfortunately failed to show efficacy. We continue to wait further data coming in and continue to assess this molecule over the next few months. Two of our other trials also reported this time with positive results, both in important treatment areas with current limited options. One in Parkinson's disease and the other in Sarcoma. The data for Votrient that we announced today to treat Sarcoma is obviously new news today, and we hope to present it fully at ASCO later in the year.

GSK is delivering good progress on a broad set of fronts and our strategy is clearly working. We've moved investment resources around the group to drive better, more sustainable growth and we continue to be able to demonstrate that we're able to do that with a very effective management of our costs. If you look at the way in which SG&A in particular has been managed during the first quarter, you see continued reductions in SG&A cost in America and Europe and continued investments behind consumer and emerging markets, exactly the kind of disciplined allocation of resources you would expect.

R&D continues to perform extraordinarily well in terms of output and approval rates, continuing to lead the industry in terms of FDA approvals while continuing also to demonstrate that we can achieve this with a very tight grip on R&D costs. This improving operating performance, together with good cash generation is allowing us to increase returns to shareholders. We now expect to repurchase shares toward the upper end of the £1 billion to £2 billion range that we set out in February, and we have increased the dividend for this quarter by 7% to 16p.

With that, I'd like to hand over to Simon. Welcome him once again as the new CFO at GSK, but now to ask Simon to take you through a little bit more detail on the numbers for the quarter before we open up to questions. So over to you, Simon.

Simon Dingemans

Thanks, Andrew. As we've said before, our strategy aims to increase growth, reduce risk and improve our overall long-term financial performance. And we believe our first quarter results showed good progress and delivery of those objectives. However, there's clearly still more we can do and I'm certainly very focused on making sure that our financial strategy is tightly aligned with our overall objectives.

Although it's still early days for me, I have a number of areas under review, which I'll update you on in due course. But I believe there are still considerable opportunities to strengthen our focus on costs, returns and cash generation. And doing all of this should also allow us greater flexibility to optimize total shareholder returns, while being able to continue to invest in our well-established growth strategy where we see attractive opportunities. Central to that strategy is driving the top line for each of our Pharmaceuticals, Vaccines and Consumer businesses.

Total reported turnover in the quarter was down 10%. But this reflects the expected decline in Pandemic, Avandia and Valtrex sales, which were just £140 million this year versus £1.1 billion in the first quarter last year. We continue to expect that the distorting effect of the decline of these products will diminish rapidly during 2011, such that by 2012, reported sales and underlying performance will be much better aligned.

Excluding these items, underlying sales grew around 4% to £6.4 billion, with pharma up 3% and consumer up 7%. Overall Pharma sales reflected declines in the U.S. and European businesses, offset by continued strong growth in the Emerging Markets and particularly strong results in the quarter from Japan. U.S. and European results were both impacted by the effects of healthcare reform and government austerity measures, which totaled approximately £85 million in the quarter. And we continue to expect the full year impact will be approximately £325 million plus the U.S. industry levy, which will add approximately £80 million to SG&A in the year.

Adjusting for the impact of healthcare reform and the sale of Zovirax, the U.S. business overall was down approximately 1.5%, reflecting primarily the impact of a 5% decline in Advair, which was largely due to wholesale and retail destocking. Excluding this effect, we estimate Advair was down approximately 1% in the U.S. versus last year's first quarter and this reflects really the net of volumes decline of around 4% and a net positive benefit from mix and pricing of around 3%. Seretide in Europe and emerging markets also reported declines, again, primarily due to price cuts from government measures and also a comparison to a relatively strong performance in the first quarter last year.

Elsewhere across the business, Advair delivered good performances, particularly in Japan, where Advair grew around 30% in the quarter. Beyond Advair, the overall underlying Pharma results of plus 3% reflected contributions from the broader respiratory franchise, vaccines, derms and new products, which grew over 40% in the quarter and now contribute over 11% of total Pharma sales.

Our Consumer business also made a significant contribution to growth, delivering 7% in the quarter, outpacing its markets with particularly strong growth across all categories in the emerging market region. We're continuing to implement measures to leverage our cost base and our restructuring program is well on track to deliver the program's annual savings target of £2.2 billion with the annualized run rate now up to £1.9 billion. Overall, we're very much where we thought we would be on cost at this stage of the year and we're making no changes to the expectations we laid out in February. Specifically, cost of sales increased to 27% versus 26% last year. This is primarily reflecting the lower sales of high-margin Pandemic products and Avandia and Valtrex, but also some mix effects, particularly in emerging markets that we expect will reverse later on in the year.

SG&A costs were 31%, which excluding legal charges, were approximately 3 points higher than last year. This change is driven primarily by the reduction in Pandemic, Avandia and Valtrex sales. More importantly, in absolute terms, SG&A levels also reflected the continued progress in our cost reduction programs, which in the quarter delivered a reduction in SG&A of around 10%, mainly from our more mature businesses, allowing us to continue to invest behind our target growth markets, absorb the U.S. healthcare reform levy while still reducing overall cost by net 6%.

As we said in February, we expect the first portion of the year to be more difficult on cost margin comparisons with last year. But this should improve over the course of the year as our underlying performance becomes clearer and our restructuring programs continue to deliver. Given the reduction in sales from the Avandia, Pandemic and Valtrex businesses, we still expect a 1% decline in overall operating margin for the year before legal and other operating income. But as Andrew has highlighted, as our cost-reduction programs continue to deliver during the year, they're bringing real leverage into the P&L as shown by the earnings performance in the quarter, with EPS up 9% before restructuring charges and 18% after as these cost programs come to their end.

Turning to our cash performance, net debt was down £440 million to £8.4 billion to the end of the quarter. The ongoing operations continue to generate significant cash and net cash for operations was £1.4 billion for the quarter. As expected, this was down from the roughly £2 billion reported last year, again, primarily reflecting the lower sales in Pandemic, Avandia and Valtrex products. We continue to focus on business efficiency, improving our working capital performance and driving cash conversion over the balance of the year. We also realized proceeds on asset sales of approximately £1.3 billion, giving us total cash inflows of £2.7 billion, covering legal payments of £450 million, dividends of just over £800 million and share repurchases during the quarter of £320 million.

We've also continued to invest in the quarter, with over £500 million spent in capital expenditure and acquisitions for Consumer Healthcare and expanding our presence in China. The cash generation and business performance during the quarter supported our decision to increase the Q1 dividend by 7% to 16p for the quarter. We are also now expecting to repurchase shares during the course of the year, at the top end of the £1 billion to £2 billion range we gave you in February.

So in summary, we're very much on track to deliver on the expectations we set out for the year to continue to drive costs out of the business, improve our operating leverage and convert more of our earnings to cash in order to optimize returns across the company. With that, I'll hand back to Andrew.

Andrew Witty

Great. Thanks very much, Simon, and I'm very happy to open up the call to questions.

Question-and-Answer Session

Operator

[Operator Instructions] And our first question comes from the line of Andrew Daum (sic) [Andrew Baum] of Morgan Stanley.

Andrew Baum - Morgan Stanley

It's Andrew Baum. Three questions, please. Firstly, in relation to the subpoena on Lovaza. If you have further details from the OIG, can you share whether it relates to off-label marketing? Is it mispricing kickbacks? Second question is from your comment, Simon, should I assume that your previous guidance of further reductions in working capital for full year '11 is still intact despite the first quarter? And then finally, third question. There are some brave vocal investors in GSK who argue that the business, your Consumer business, benchmarks fully versus standalone competitors. When you benchmark your business, where do you think it rates versus its peers and how much further improvement is there possible to do?

Andrew Witty

Andrew, thanks for your questions. We haven't got more to say on the Lovaza subpoena than you've seen in the release. As we've said in the release, they're asking us for documents related to the marketing promotion of the product. So that's basically as much as we've got that we can share with you today. I think it would be inappropriate to go into too much more detail just speculatively. We've only just received it ourselves. Once we get a clear understanding of what it is that they're interested in, obviously as appropriate, we'll release that. But clearly, the focus looks to be on marketing and promotion. So we'll see going forward on that. Let me hand it over to Simon to comment on working capital, then I'll comment on Consumer.

Simon Dingemans

No change, Andrew, in terms of the prioritization of working capital. I think the comment I'll make on the quarter is that there are a number of moves, which really come down to investment behind some of the growth objectives we have for the year, very much as expected. And I think as they delivered during the course of the year, you'll see that unwind. So no change.

Andrew Witty

And as far as consumer benchmarking is concerned, we do benchmark very actively against not just other Consumer Healthcare companies but other more general consumer FMCG-type companies further out from the sector. Across the board, we benchmark very well in most areas. So if you look at our profitability, if you look at our sales growth, if you look at our growth versus market, if you look at our concentration of investment behind key brands, if you look at our exposure to global GDP, all of those things we compare extremely well. Obviously, the reshaping of the business we're making with the disposal of a tail simply serves to even further push that ahead. The areas where we benchmark

[Audio Gap]

less well, working capital, inventory management, obviously 2 aspects, which we'll focus on in across the board as part of our working capital agenda. Those are areas where we continue to look very aggressively. Now, if you ask what more, Andrew, could we do in the Consumer business? Actually, I think the answer to that lay in these results. You see, a 7% growth rate for the Consumer business as it stands today, if we'd only been talking today about the business, which will remain after we've disposed of the tail, then the business would've grown 11%. And of course, what you're talking about then is a business of essentially 15 strategic brands and a very heavy exposure to emerging markets and that we think that's a very exacting profile of the Consumer business. The change of the disposal gives us tremendous opportunity to further change the way in which we run our Consumer business. Remember, this is being synchronized with Emma Walmsley coming in from outside of the company with an FMCG background from L'Oreal. You're going to see a very significant change in the way Consumer operates. It will operate on, I think, an extremely competitive basis with any FMCG firm that you want to compare against, once we've gone through this change and we've built on the foundations which are already extremely strong.

Operator

The next question comes from the line of Alexandra Hauber of JPMorgan.

Alexandra Hauber - JP Morgan Chase & Co

Thank you. I'll start with a question on Advair in the U.S. I think Simon said that it was the underlying 1% decline was 4% volume plus 3% price and basically, that was for me the big unknown going into here. We've seen across the board companies taking the price increases yet again in the U.S. but we didn't know how much is going to stick this year. Is that 3% going to be just the sort of level we should model in for Advair for the rest of the year, or is really a substantial proportion of that mix? If so, is that just higher dose? And the other question I have on Advair is why do we see that destocking in the trade, especially given that we had this very early on to the allergy season reported by other companies. Moving on to consumer, the oral Healthcare business had 12% growth. Is that all organic or is there some initial trade stocking in the countries where you launched Sensodyne Repair, which was specifically mentioned in the press release? And also, I think we can probably work it out. Can you just roughly tell us what the growth rate is off the OTC portfolio that you're actually planning to dispose? And the final question is on cost of goods. You have alluded to mix effects that will result in lower cost of goods later in the quarter. Can you just give a bit more color on those factors that will result in cost of goods going down later?

Andrew Witty

Okay. I'll try and do my best to cover all of that. I'm going to let Simon come back to COGS at the end. Just very quickly, Sensodyne, not massive amount of impact from stocking. The product was launched in the quarter. An extraordinarily good start. The stuff is flying off the shelves and I have to say as a user, it's the best product we've ever launched in the Oral Care business.

Alexandra Hauber - JP Morgan Chase & Co

And with the new markets that's going in, is that a typical emerging market roll out or is there a place for something else?

Andrew Witty

No. But Sensodyne Repair, it's actually rolling out into all markets. So we're currently in the U.K. We just launched into some of the other European. It will be across about 50 markets in the next 12 months. So this is a major -- this is a new technology we've put into the Sensodyne product, Novamine technology. It's a very, very exciting innovation. Just started and, obviously, has also allowed us to premium price. So for those of you who shop in the U.K., you might know we retail this around £3.90 per pack. Obviously, very much a high-end product. As I've said already, the shelves are kind of emptying very quickly. So Sensodyne going very well. As I said earlier, the growth of Sensodyne around 15%, 16%. That's actually the eighth quarter in a row of double-digit growth for Sensodyne. And for those of you who are interested, this is a super justification for the value of the Consumer business when you get it absolutely right on a brand. 2011 is the 50th anniversary of Sensodyne's launch, which just gives you some sense of the cash flow generating capability of these brands if you can keep on investing behind them and really making sure you're innovating and getting the distribution. So here we are 50 years on, we're putting new technologies into Sensodyne. We're selling the pack at £3.90. We've just got into another 20 cities in China. Across the world, this is going to be a phenomenal product for the company going forward. So Sensodyne, very positive. As far as Advair is concerned, let me make a comment more generally on pricing. We've observed some really high price increases being taken by other companies in the U.S. I think I've even heard of some companies taking price increases up in the 30% range, which I just find absolutely incredible. We've been, I think, very much more measured on that front. We've taken much lower price increases. If you look at the positioning of GSK, we're very much at the low and middle end of the pack in terms of company's ambition. We think it's probably not the right moment for people to be taking crazy price increases. We think ultimately that's going to come back to bite. So we're not going to be up at that higher end. We will take price where we think we can justify it, but we're not going to go for it simply as a stop gap for performance gaps that maybe explains it elsewhere. In terms of Advair, specifically, there is a number of things going on within Advair in the U.S. Estimated volume as Simon has already said, we think was down about 4%. The mix of the highest strength drift, which has been going on for a long time, was about a positive 0.5%. The size of prescriptions has been growing as well and that's about a 1.2% positive and then the rest is price. So you end up with this negative minus 1 combination of volume offset by mix and strength and price. And that's basically what's going on with Advair in the U.S. And I'll hand over to Simon to talk about COGS.

Simon Dingemans

Was the question COGS or growth rate of the businesses that were being disposed of?

Alexandra Hauber - JP Morgan Chase & Co

There were 2 questions: one is the growth rate of the OTC that's being disposed and COGS. What mix effects will help your COGS ratio later in the year?

Simon Dingemans

Okay. Well on the first, in terms of overall growth, as you would have seen from the list of products that we published a week or so ago, most of those fall into the OTC category. And in line with the sort of breakdown in the release, I think sort of the overall growth rate of that piece being disposed of is probably around 3% to 4%. There's a bit of a boost in the quarter from some seasonal effects given the mix of products. But the overall market is growing at similar rates. So that's probably what you should guide on. And in terms of the COGS position, I think we're still trying to work through exactly the details of the package that we're going to dispose of. So I think it's a bit premature to call that, but we would certainly hope that the whole process of separation will allow us to identify a number of opportunities to improve and optimize the margin. And I think we'll have to report back to you on that in terms of the detail.

Alexandra Hauber - JP Morgan Chase & Co

Okay.

Andrew Witty

Thanks, Alexandra.

Operator

Our next question comes from the line of Gbola Amusa from UBS.

Gbola Amusa - UBS Investment Bank

It's Gbola Amusa at UBS. Could you comment on a couple of things? First of all, your underlying growth quarter-over-quarter, there was a bit of deceleration from the third quarter. This was mostly just a bit of noise or is this an impact of reforms of austerity and how do you think that growth impact will go from here? Secondly, where is Glaxo in terms of its China rollout in the Consumer business overall? How many cities were you in, in 2009, for example, and how many cities are you in now? And what are the costs associated with that rollout overall? Thanks.

Andrew Witty

Okay, good question. So your first question is exactly why we shouldn't get too obsessed about quarters because there is inevitably a lot of noise between quarters. If we look at Q3 last year, underlying was plus 6%, Q4 was plus 2% and Q1 is plus 4%. So we're clearly bouncing around that kind of mid-single digit type of level that we talked about last year. What we're not going to guarantee to you is every quarter's going to look the same. I'm not going to guarantee it to you on the top line. I'm not guarantee it to you on the margins because depending on whether or not tenders come in, depending on whether or not particular bits of the business are moving in a certain direction in a certain quarter, you're bound to get volatility. I think that underlying kind of mid-single digit plus or minus feels like where the pace of the business is. Now Q1 of this year, of course, we're absorbing a pretty decent chunk of price over last year. So if you look at 2011 versus 2010, we've got something like an extra £300 million of price coming into the business year-on-year, of which about 2/3 is in Europe and the rest is the tail, if you will, of healthcare reform. The bulk of healthcare reform pain obviously got into the business last year and the tail of it's coming through this year. But it's been augmented by very substantial quantum this year. I think actually the underlying performance in Q1, stripping out only the Avandia, Valtrex and Pandemic product headwinds is pretty creditable given the prices taken, given also, of course, is absorb in the disposal of the Zovirax brand and also any other generic intrusions that we've incurred, which include Hycamtin and Rythmol in the U.S. So I actually feel like that's pretty reasonable. Pricing going forward, I do think we're kind of through a big balls [ph] of U.S. government-driven healthcare -- government-driven price pressure. That is clearly moving more into the tail as you run through this year. Europe, at the moment, you would expect to have a lower incremental year-on-year price impact in '12 versus '11. But obviously, that forecast is only as good as the next European country's macroeconomic crisis. And there is clearly a very strong linkage between price pressure and what's going on inside these countries. Now, in terms of rollout of consumer products, just to give you an idea. We launched Sensodyne in China, I'm going to say 18 months ago. We're now in 120 cities in China. We've now also rolled out across all regions in India. We're in 170,000 retail outlets in India and we're supporting the brand rollout as we've done across all of the Sensodyne history through dental detail in which in India alone, we'll call in on 12,000 dentists. So it gives you a sense that just in that snapshot that, A, the roll out is there first of all. But just the scale of the presence of the company and its consumer strength, particularly in India, is just phenomenal. And our ability to build on the bedrock of the Horlicks business which, by the way, again, grew 40% in India this quarter. Our ability to build on that bedrock of consumer distribution presence with a product like Sensodyne is clearly in play as we speak. Thanks for the questions, Gbola.

Gbola Amusa - UBS Investment Bank

Just really quickly, is it therefore more a function of India, the growth acceleration in your Consumer business or is it more China coming online?

Simon Dingemans

Actually, I think it's really interesting but it's across the board. All businesses doing fine, but everything outside of Europe and America doing fantastic. So Middle East was terrific. The Middle East business was terrific. The Chinese business was strong, the Indian business was strong. The Japanese business was strong. It's a very, very strong performance. So if I give you just a couple of numbers, Latina -- I'll make sure to give you exactly the right numbers. Latina grew 18%, mostly driven by Panadol and the rollout of Sensodyne Rapid Relief. Middle East grew 26%. A lot of that was Sensodyne. Japan was up 12%, Africa was up 17%, driven by Lucozade. China and India both delivered double-digit growth, with their priority brands up over 20%. Overall, the x Europe, x America business grew 15%. Now, that's exactly the business we're trying to shape, is a strong brand business in America and Europe where we can deliver really good growth rates augmented by phenomenal exposure to the fast-growing markets across the world emerging markets and the very fact that I can talk to you about Africa, Latina, Middle East, China, India and Japan, and there are not many other CEOs who can talk to you about healthcare, consumer healthcare products in that way. People can talk to you about Europe or International or America. We've got great platform in all of these places and that's what we're really trying to shape and focus through the disposal of the tail and in the process, release some very good value we think for shareholders.

Gbola Amusa - UBS Investment Bank

Thanks for the detail.

Andrew Witty

Thanks.

Operator

And our next question comes from the line of Tim Anderson of Sanford Bernstein.

Tim Anderson - Sanford C. Bernstein & Co., Inc.

Thank you. I have one operational question and 2 R&D questions. You report underlying sales growth of 4% in Q1 when excluding certain products from the comparison, and I'm wondering what the underlying operating income growth or operating margins would be on the same basis, excluding those same products. And then on R&D, are your current returns on investment above your cost of capital? I know you've laid out aspirational targets for future returns on your late stage pipeline, but wondering what it looks like today at the present point in time across the entire R&D organization, not just that late stage pipeline. And last question on R&D. Andrew, back in late 2010, I asked you a question when you were out here in California about what 2 late stage pipeline compounds excited you the most. You cited the MAGE-A3 and darapladib. And if you had to pick 2 today that excited you the most out of the 12 that you talked about, would those still be the 2?

Andrew Witty

Okay. Thanks for the very big trap you just dug for me. So, in terms of the underlying numbers, let me ask Simon to quickly answer to that one and then I'll come back to you on the 2 R&D questions.

Simon Dingemans

Yes, I mean, I think the difficulty is in focusing on one quarter in particular, as I said in my remarks. We've seen considerable distortion in the overall margin because we're rolling off in this quarter alone £1 billion of Pandemic, Avandia and Valtrex sales. I think over the year, particularly kind of getting into the second half of the year, we will see those margins begin to true up to the guidance that we gave you at the beginning of the year and we feel very much on track with these cost reductions that go into that. So the underlying performance I think I'll kind of take the measures we've given you for the full year as the marker.

Andrew Witty

Okay. Thanks, Simon. As far as R&D is concerned, Tim, the last time we did a very full Internal Rate Of Return analysis for our overall R&D business was coming up for 18 months ago, I guess, maybe 2 years ago. We intend to update that formally for full year results next year, so February 2012. So first of all, you should put that date into your diary for a kind of proper full reanalysis. Having said that, when we looked at this data a couple of years ago, we think our overall rate of return on our R&D operations is around 10%, which is higher in vaccines than it is in Pharma but around 10% and that clearly exceeds our cost of capital. So at this point in time, and particularly recognizing that since that analysis was done, we've cut costs in R&D and we've increased output. My expectation is that, that statement is still true. We haven't done the analysis for a couple of years. We will do it toward the end of this year and publish it February. So February is going to be quite an interesting time from an R&D perspective because we'll have an update on the rate of return analysis, which obviously will have taken into account the various changes in the cost base. Remember last year, we took out all the neuroscience investment across the organization, about £250 million of cost coming out prior to the end of 2012. You've seen a good flow of progress. We continue to be the leader in the industry for FDA approvals over the last 3 or 4 years. So you'll see all of that. What we're also doing in the last quarter of this year is it's coming up to our 3-years review cycle for our discovery operations. So the Discovery Performance Units, the 36 or so discovery teams in the company are going through their review as well in the fourth quarter and that will be a very interesting period because we'll be able to share with you where in the early phase have we made great progress and we're carrying on, where are we refocusing and where are we stopping. At the same time, we will be able to talk to you about what's happening with the rate of return. So I think that will be a very interesting capsule of information for you to really get a clearer view of exactly what's going on in R&D, particularly in the discovery field and then in the background, you're going to have all of this news coming through on the Phase III development pipeline to give you a sense of what's happening on the late stage of the pipeline. So I think over the next 18 months, you're going to get a lot of light shone on the R&D operations, probably more than you've ever seen for many other company, about how we're making decisions, where we're investing, transparently showing you where we're pulling back, where we're advancing. I think it's going to be an interesting period from an R&D perspective. Now, in terms of your question that the CEO shouldn't answer about which they really are excited about in the pipeline, I continue to believe maze III is super exciting. And of course, it's very high risk. We're looking to do something very unusual. But we're far down the program. Yes, maze III remains one of the things I'm most excited about, Darapladib, yes. Absolutely. I've been so pleased at the speed with which trials enrolled and the efficiency in which that entire program has carried on. So yes, darapladib. If you'll indulge me for a couple of others, I would say that the BRAF and MEK programs look very exciting within the oncology area. And the one that we should all be excited about, although I know isn't necessarily going to make a lot of money for anybody is we may only be 6 or 9 months away from having the world's first vaccine for malaria and I think as a corporation which is trying to do more than just make money, that's one that we should all feel pretty excited about as well. So we have a lot going on in this pipeline. We've got some very big exciting ones. But you know, nothing's over until we finish across the finishing line. And we've to get all of these programs to the finish and see what happens. And as we saw in Q1, not everything goes perfectly and we saw with otelixizumab, another product which would've been fantastically exciting. First trial is a disappointment. We have to decide whether or not we go forward with the program. But it just is a solitary reminder that not all R&D news is going to be good.

Emmanuel Papadakis - Collins Stewart plc

Perfect, thank you.

Operator

And our next question comes from the line of Naresh Chouhan of Liberum Capital.

Naresh Chouhan - Liberum Capital Limited

It's Naresh Chouhan from Liberum Capital. A couple of questions for me, please. Firstly on R&D, would I be wrong to assume that if roughly 60% of your R&D spend is in Phase III, then once this current batch of 15 assets near completion of their Phase III programs then we should see a marked reduction in R&D spend? Or the kind of price market study that may happen once all these products hopefully come to market that we then may end up -- the R&D may not coming down as much as you may think. Secondly, on the OTC divestments, you told us excluding the products to the divested consumer segment grew 11%, which implies a 30% decline in the products to be divested. Could you just help me with this? Is this a clean number? Because this way, by the end of the year we'll just have just £350 million of sales around the £500 million we had last year, which we just put on model 3x rather than 4x? That leaves about £1 billion difference between what the market economy expects in terms of divestment proceeds than what you might actually get. So what I'm asking for is just some help in the trajectories of sales, so we can get kind of an idea as what the buyback potential might be?

Andrew Witty

Yes, I know. In terms of that second question, the year-on-year adverse comparison has all to do with alli because last year, we were at the peak of the European numbers. That's come down significantly in terms of where we are, in terms of run rate going forward, it looks like a very good solid stable portfolio of business. So I wouldn't have any anxiety. This is not going to suddenly become £300 million in 12 months and I wouldn't worry about that at all. It's simply an artifact of the prior-period comparator of alli and it's an alli-only issue rather than anything else. So I think work on the numbers that we published in terms of what the turnover of that business is, in terms of your models and then I guess the multiple would just be a function of how many people bid on it. And so far, we've had a lot of interest. So we'll see how this runs through the rest of the year.

Simon Dingemans

In terms of your R&D question, Naresh, about 60% of the R&D spend is on Phase IIb, Phase III and post-approval regulatory trials. As the pipeline progresses through, you would absolutely anticipate to spend less associated with individual product unless you pick up very, very substantial post-marketing approvals, of which there are more, let's be honest and there were. But, for example, if you look at the current pipeline, a very substantial amount of cost is absorbed by Tykerb in the various adjuvant and neo adjuvant trials and as they come to completion over the next couple or 3 years, that in itself is going to lead to potential freeing up of costs. Now, what then happens to the R&D budget is going to be very simple. It all depends on the success of R&D overall. So if we continue to deliver good high-quality output, then we're going to continue to invest in R&D. If we don't, then clearly we're going to ask ourselves some very fundamental questions about how much we want to spend on R&D. And the scale of spend will be a function of the opportunities that come through from the discovery organization and obviously, we've been through our Discovery Performance Units, through all of our external research partnerships, the 54 discovery engines outside of the company. We're building up what we hope is a very productive discovery flow to backfill what we're promoting from Phase III into the market. And as interesting last year, I think we had 6 products being promoted out of the Phase III pipeline into the market and we had 10 new entries. So, so far, our flow rate, if you will, of new opportunities is very, very good. So if that continues, you would expect R&D an absolute level to kind of carry on more or less like it is. Now if there were a situation where our flow rate of discovery opportunities began to dry up, we're in a much better position today than we were 5 years ago to be able to flex the R&D budget downwards because we've moved much more of our research away, our research costs, away from the fixed infrastructure to flexible and we do much more externally versus internally. So by having more of the research done outside, all less of the cost associated with build-ins and more of the cost associated with late stage, that number is much more flexible and can be much more responsive to a drop-off in R&D throughput. So although that's not the primary objective, if it turned out that our throughput from discovery began to dry up, you would clearly see us be able to pull down our R&D spend. Now clearly, Plan A is to make sure that we keep this big pipeline of advanced products going forward. We get a substantial amount promoted into the marketplace. That drives forward the pharma aspect of the business, complementing vaccines and consumer and we replenish it. And that's really what we're trying to do. And we're going to see in the next 2 years whether we can pull this off because we've got 30 assets in there right now, 15 of which we're going to know the answer on or before the end of 2012. We're going to show you again what our rate of return looks like, which as I've alluded to, I suspect, should be encouraging. I think we're going to see just whether this whole model is working or not.

Naresh Chouhan - Liberum Capital Limited

Okay, thank you.

Operator

And our next question comes from the line of Seamus Fernandez of Leerink Swann.

Seamus Fernandez - Leerink Swann LLC

Thanks for the question. So Andrew, maybe you can just update us on your thoughts with regard to price pressures as we think about Japan heading into 2012 and if there's been any indications from the government that austerity measures may be coming into play next year? And then, also maybe you did mention potential countries that we could see incremental austerity measures in Europe. Which countries are you focused on most right now in terms of just being prepared for potential changes? And then lastly, in terms of pricing freedom in the U.S., obviously

[Audio Gap]

Andrew Witty

Japan's nothing so far but I think we'd all be naïve to believe there is a possibility that something may come up as the Japanese government come to wrestle with the various macroeconomic issues that they now have to deal with. As you know, the new pricing regime, which was implemented last year, is a very positive one for innovation and encouragement of innovation and GSK does particularly well within that. I think we have twice as many products in the preferred pricing status as the next biggest company. Something like 68 different products were in that box, and that left us with the lowest exposed price reductions in Japan and the best prospects for the future in terms of pricing. Now, let's see what happens. I think it's just a bit early to call. Nothing so far. In terms of Europe, places to watch, you might be surprised to hear this. We should keep an eye on the U.K. because the PPRS is clearly coming to an end. The PPRS has been the price system for over 50 years. There's clearly a commitment from the government and a commitment from the industry to negotiate a new system. Not likely to become implemented until '13 or '14 but nonetheless, that's a very major European market with a new pricing system coming into discussion. And so, I'd be remiss not to at least highlight the U.K. as one that we're focused on. Of course, to be honest, I guess we follow the same markets that you follow in terms of those which have the biggest risk of debt default. And that's where our attention often lay. One of the things we've also been very focused on is recovery of debt and one of the reasons why you've seen our working capital perform well particularly during the end of last year and partly in the first quarter of this year is we've done very well at recovering sovereign debt from a number of European nations for exactly relate to maybe more vulnerable going forward than it has been in the past. So we're focused on that. I'd say actually, practically we can do more about debt recovery than we can around avoiding those Sunday 11:00 p.m. phone calls when you get summons in to see the Health Minister and told you're to take a price cut on Monday morning. Those are not the easiest things to avoid and they do happen. As far as the U.S. is concerned, I don't like IPAP. I don't think I've met anybody who does like IPAP, mostly because it's essentially a nonaccountable organization to the political system. And also, it appears to me to have a too narrow or brief, so it's given the job of reducing costs but it only focuses on 1 or 2 aspects of the cost chain including drugs. And I think that's really totally the wrong way to approach cost management. You need to look at full value chain and recognize that by simply saving cost in the pharmacy budget, if at all that leads to is more beds being filled up with chronically ill people, nothing much has been achieved. So, I think that frankly needs to be rethought. I think the scope of it at the very least needs to be rethought and I know there is a lot of cross political divide concern around that. I do however think that companies taking overly aggressive price increases just seems to be completely at odds with the reality of the world we're operating in, whether you're in the U.S. or you're outside of the U.S. And I think that ultimately, that's not a sustainable position and does potentially create tenable arguments for critics of the industry to try and push policies which will be more detrimental to the industry. That's why I think at GSK, we're trying to follow a very much more restrained approach where we think we deliver value. Of course, we want to price fully for it to reward our shareholders. But we're not going to simply go after substantial price increases to fill shortfalls in performance. And I think that's the right approach and that's the approach that we're deploying.

Seamus Fernandez - Leerink Swann LLC

Thank you.

Operator

And our next question comes from the line of Kerry Holford of Crédit Suisse.

Kerry Holford - Crédit Suisse AG

I have some questions, please. First, on regional performance and then a question specific on Advair. So firstly on the regions, if we look at the EMs on the revenues, they look particularly weak in Q1, down 1% local currency, compare that to a run rate of around 20% during the course of last year. Margin was also down. The margin decrease, I'm sure, reflects this reinvestment in SG&A. But what's driving that top line weakness for the EM Pharma business?

Simon Dingemans

Yes, that's Pandemic vaccine and Relenza. So though if you look at EM alone, this is Abbas' region excluding Australasia, they were up 23% and if you look at Abbas' current region, which is EMAP, so emerging markets plus Asia Pac, Australasia, that was up 21%. The number you're looking at is the reported number, inclusive of Pandemic vaccine and Avandia, which obviously is not there. You're absolutely right. In terms of margin, that's just phase in of SG&A activity in the market.

Kerry Holford - Crédit Suisse AG

And then that phasing of SG&A, you spoke off in the context of the U.S. region, even if we adjust, if we look at the margin of the U.S. Pharma business, if we adjust the disposal gains in ROI. Still, the margin in that region was somewhat higher than it was through the course of last year. Is that sustainable going forward?

Andrew Witty

Simon, do you want to answer that?

Simon Dingemans

I mean, I think you've got a phasing issue with kind of the mix of products going forward in the year and I think we've been pretty clear on the underlying performance. So I think it's kind of above where you'd expect for this quarter and it will balance out during the balance of the year.

Andrew Witty

But my advice to you, Kerry, is I wouldn't get too bogged down in cherry picking a region or a business in a quarter. I think that it's better to be guided by the overall mix. So as we said, we're not changing any of our margin guidances for the company. For example, in the Emerging Markets, we made it very clear that we expect that to be around a 35% trade in margin business. We've seen that over the last year or so and nothing changes on any of that. And it is one of the slightly -- the oddities of the quarter reporting is we all get very fixated on one -- or just completely misleading factoids in the system that have no real bearing on the outcome of the year.

Kerry Holford - Crédit Suisse AG

Okay, lovely. And then a quick one on Advair, you touched on this earlier, but should we expect that destocking effect we've seen in Q1 to reverse fairly quickly through the course this year?

Andrew Witty

I would expect so. We've seen a bit of it through April. So we'll see when we get to the end of April just how much. But we have detected some of the reversal there. So let's see. But I would've thought it would come back. And I think our view is it was related to wholesaler expectations around price adjustments at the end of the year, which they do that from time to time. So my expectation is that will come back. Whether it'll all come back in Q2 or not, we'll see. But certainly we detect some of it already in April.

Kerry Holford - Crédit Suisse AG

Okay, lovely. Thank you.

Andrew Witty

Thanks, Kerry.

Operator

Our next question comes from the line of Michael Leacock of RBS.

Michael Leacock - RBS Research

Thank you very much for taking my question. I might just ask on Cervarix, which clearly was a stellar performance in Japan. How quickly can you capture those entire 5 cohorts that I think the Japanese government is willing to pay you for? And then could you make any comments about the pricing of Cervarix in Japan, at least relative to other countries if not on an absolute basis, please?

Andrew Witty

Yes, so it's gone very well in Japan so far this year. I think in the first quarter, we've shipped something like 900,000 syringes into Japan, a very, very strong performance. So we vaccinated so far this year, we think about 1 million people. They're talking about 5 cohorts of 600,000 people, all girls. So obviously, there's a lot still to go. Pricing is very similar to the European price or around EUR 70 a dose – sorry, £70 a dose.

Michael Leacock - RBS Research

Thank you very much.

Operator

Our next question comes from the line of Mark Benz [ph] of Goldman Sachs.

Unknown Analyst -

Thank you for taking my questions, 2 really. One on the Sarcoma, Votrient data, can you give any more detail on that? And secondly, you stated Andrew that you see Advair as a low-growth long-term opportunity. Given the lack of willingness to take larger price increase in the U.S., volume pressure and generics potentially entering Europe in the next 1 to 2 years, how should we see where the growth is going to come from?

Andrew Witty

So as far as Sarcoma's concern, I'm not going to give you any more details today. We've adopted an approach at GSK to govern our scientific engagement where unless we're obliged to, for example, because of contractual partnerships with other companies, it's going to be our intent to publish the detail of clinical trial results at Congresses or in journals. So I'm going to frustrate you a little bit on that. There's good reason why we do that and I think it's the appropriate way to communicate this information. But that's why we're not giving you any more detail on Votrient today. At if you will frustrate you in the future in other areas. So, for example on Relovair, highly likely that we won't publish date as soon as we get it to date for exactly the same reasons. In terms of -- sorry the second question was?

Michael Parekh

Where should we see the long-term growth coming from?

Andrew Witty

So Advair, what we would expect to see over the next few months, years is a stabilization in the trends in the U.S. Obviously, there's been a shift downwards in terms of asthma scripts. We've seen a relatively quiet COPD market for a year and a half, and whether you look at our business or the anticholinergic business, it's pretty much true across the board. So you'd expect to see some kind of stabilization and volume growth come back to the U.S. market at some stage. We clearly expect there to be some number of some modest price benefit in the U.S. going forward. We'd expect to see the European volume number, this is assuming there isn't more macroeconomic setback in major countries, we'd expect the European volume to come back to reflect on growth as growth whereas today it's all been absorbed by price reductions through austerity measures. And of course, we've got an ever accelerating and bigger base of business in Japan and elsewhere in the world. So those are going to be the mixes of growth. Now the question then is okay, are there going to be more out-of-the-box price reductions? I don't know but obviously if there were, that would change our expectation negatively. And is there going to be material genericization? We don't expect that at all in the U.S. and I think we've been through that many times. We don't know yet about Europe, although clearly, it's more possible in Europe than it is in America. But even if it's possible in Europe, it's not at all clear to us that is going to be substitutable at the pharmacy level. And so at this point in time, I think it's a reasonable plan and assumption for us to expect that we're going to hold on to substantial amount of the marketplace in Europe, that the generic pressure, if it does come, is likely to be more at the margin. We'll see. Maybe that's not right but that probably is a safe or kind of appropriate view for us to take at the moment. And we think the net of all that gives us something which is a low growth business going forward. And that's the base on which we're planning today. Now obviously, if one of those assumptions, if there was 3 years of sustained price-cutting going on or if there was a very different change or very different assumption on generics, then clearly, I would change that view. But as of what we see today, we kind of see it as that package of puts and takes and will give that something in the low growth area.

Michael Parekh

Thank you.

Andrew Witty

Thanks.

Operator

Our next question comes from the line of Florent Cespedes of Exane.

Unknown Analyst -

Thank you for taking my questions. First of all, could you update us on the Benlysta launch in the U.S.? Second question would be a follow-up on research. Andrew, could you tell us what most meaningful that should be reported this year being it respiratory, being it oncology or other areas? And the last one on oncology, and we have an update on the discussions you have with the FDA about U.S. and notably the potential safety trial? Or are you confident enough that the program is sufficient to answer the potential FDA questions? Thank you.

Andrew Witty

Thanks, Ron. The very early days for Benlysta but so far, very encouraging. Very anecdotal but all the noise so far we're hearing is very good. We've got I think better-than-expected coverage so far in terms of reimbursement. We're worried that, that might be quite a major kind of delayer. So far, so good on that front and feedback from physicians encouraging. So very early days, encouraging. I would reiterate why I said many times before, I think the real potential of this struggle will only become clear 6 or 9 months from now when patients have had a chance to be exposed to the drug, have had a chance to feel what the drug can do and then have fed back to the physicians. And I think it's going to be that feedback cycle, which really makes -- will make or break the scale of what this product is going to be. But so far, so good. Very happy with the start, the collaboration with HGS in the field is working very well and we're obviously making good progress with our regulatory dossiers outside of the U.S. as well as obviously now launching in the U.S. As far as more specific timing on the assets which are coming through to results in the next year, we're not going to be more specific on that. We've told you we've got 15 assets between January the 1st of this year and the end of 2012. We're not going to get into precise forecasts. I don't want you all sitting by the phone, waiting for us to call you and then getting disappointed if we're a day late. So we're just going to avoid giving you that level of specificity. In terms of content though, obviously there's a lot of very important molecules in there so we've got the Relovair programs, we've got albiglutide, we've got the oncology programs, a variety of vaccines. So there's a nice variety, exactly a reflection of the breadth of the GSK pipeline coming through and as you've seen already, those programs are real. Three already started to report out, 2 of which are positive. So we're off to good start. In terms of Relovair, we have nothing new to say really on Relovair. We remain comfortable with the program we have. Obviously, we've been working with FDA on the safety studies for Advair. The FDA are well aware of the trials we are doing for Relovair. And we'll see as we go through the next year or so whether or not there's anything else required on that, either pre- or post-approval, but I've got absolutely no news to give you today. Clearly, we're very focused on listening to what FDA has to say and making sure that we're putting together a file, which we believe has a very strong probability of approval. And as of today, I feel very good about that. And I think when you look at the progress we're making on the Relovair program and also the full initiation of the dual combination program of the '444 and the LAMA, I think the GSK Respiratory advance pipeline looks very exciting and very comprehensive. I think we have time for one last question.

Operator

And that question comes from the line of Mark Purcell of Barclays Capital.

Brian Bourdot - Barclays Capital

It's actually Brian Bourdot, one of Mark's colleagues. Just a follow-up question on Respiratory please, and also one on perhaps gross margin ambitions. I was wondering if you could give us any insights into what is driving FDA seemingly very high degree of caution by imposing these new outcome studies requirements on Advair and possibly Relovair? And given that we've seen this new requirement recently and we've also seen an adverse label change for the class, over and above recommendations from the external advisory committee and how generalizable FDA's extremely volatile conservatism is to make it to non-LABA [ph] respiratory drugs in your view perhaps? And then secondly, just on the gross margin, I was wondering -- I know you've only given financial guidance for 2011 but you've talked about business prospects beyond that and I was wondering what your ambitions are for the gross margins, ex-royalties, would you hope to get that flat going forward beyond 2011 or whether it should decline as your business mix changes? Thanks very much.

Andrew Witty

I think on that one, I would simply reiterate what we've said at February which is as we come out of 2011, we'd expect to be able to deliver leverage on our operating margin going forward. Obviously, that's going to be a composite of gross margin and all the other cost lines, which happen inside the business. We're not going to get more specific than that today. In terms of your question on Advair and the safety studies, I think the suggestion to the safety studies was actually a recommendation of the advisory board. FDA had been for 15 years extremely focused on LABA safety. You'll remember that it had its origin in Fenoterol, a product which was around in the '80s. And that's really where this all began. It then moved on to the long acting beta agonists, Salmeterol and Formoterol. And essentially, I think what we've got here is the combination of those anxieties having gone through now several [indiscernible] all the data been analyzed and labels have been changed. Trials have been determined and we're obviously all going to go forward to deliver those trials for the FDA. I think the encouraging thing is we continue to develop next-generation, hopefully better products and we're working closely with FDA to make sure we do those in a way which meet their expectations. But clearly, this is an area where people do have anxieties and they do have a relatively high threshold for satisfaction and therefore, we need to be very focused in making sure we delivering programs to the high standard to meet those expectations and that's what we're obviously committed to do. With that, everybody, thank you very much indeed for your attention today. It's much appreciated. I hope very much you've got what you needed from GSK today and I just like to reiterate I think the progress the group's made over the last several years has been extremely robust and I think you're beginning now to see the pieces really start to fall into place in terms of the sales performance and what the shape of the group will be in the future. Thank you very much.

Operator

Thank you, Andrew and Simon. Thank you, ladies and gentlemen. That concludes your call for today. You may now disconnect. Thank you very much.

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