Earnings Labs

GSK plc (GSK)

Q3 2012 Earnings Call· Wed, Oct 31, 2012

$54.66

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Transcript

Andrew Philip Witty

Management

Thank you very much. Good afternoon, and welcome to today's call. I'd like to particularly welcome people joining us from the East Coast after what's been a very rough few days. And we hope very much that things settle back down and the disruption is resolved quickly. I'm actually speaking to you from our headquarters in Singapore. Simon Dingemans is joining us on the call from London. I'm in Singapore. I spend a lot of time in the emerging markets. It's one of our key areas in which we've chosen to invest aggressively over the last 4 years to help rebalance the group sales profile. And that's evident in this quarter with a very -- with a further strong performance in the region, helping offset some of the very obvious pressures we're facing in Western markets, particularly in Europe. Emerging market/Asia Pac sales grew 11% in Q3, which I think puts it very much at the top of the industry growth rate for emerging markets, and it's a clear acceleration compared with the early part of the year. Particularly strong performances in India, up 9%, China up 15%. And within the Chinese business, our Seretide business was up 46% for the quarter. I'm also encouraged by the continued strengthening of our business in the United States, while our reported sales were down in what is a noisy quarter with several discontinued or disposed products and some generics really hiding the underlying sales growth of 2%. Respiratory in particular performed well. Business up 7%. Advair was up 5% during the quarter. And that represents the fifth consecutive quarter where we've seen an improvement in the underlying performance of Advair, both as our shares hold well and the overall market starts to improve. Newer products in our specialty franchise has also continued…

Simon Dingemans

Management

Thanks, Andrew. On our half-year results, I highlighted that we expected the third quarter to be negative in terms of sales growth, particularly given the tough comparison with Q3 last year when we reported very strong sales of Cervarix in Japan and flu vaccines in the U.S. And together, these comparators, as Andrew highlighted, contributed around 3% to our overall decline of 5%. Much of the remainder of the decline reported this quarter was also expected, being down due to the continuing impact of disposals such as the consumer OTC products and the Vesicare unwind that we completed earlier in the year. And together, these accounted for the remaining 2 percentage points of our decline. They will largely annualize during the first half of next year. What was more unexpected was the extent of the pressure in Europe, where not only have further austerity measures been implemented in the quarter, but we've also seen a further expansion of parallel trade and generic substitution measures. This has impacted European volumes as well as price in the quarter, but importantly, also leaves the outlook more uncertain than before. Recognizing that the risk from Europe remains real, we still expect we can deliver a positive quarter for growth in Q4, helped in part by the absence of the specific challenging comparisons seen in Q3, but also the momentum in our growth businesses, particularly the strength of our consumer delivery and a strong backlog of EMAP vaccine tenders in Q4, which could add up to GBP 50 million of sales to the quarter. We also expect to deliver sales for the full year on a constant currency basis broadly in line with 2011, although Europe clearly remains a challenge. Turning to the quarter in detail, as usual, the focus of the commentary will be…

Andrew Philip Witty

Management

Thanks very much, Simon. And let's open up the call to questions. So first question, please?

Operator

Operator

[Operator Instructions] You have our first question, and it's from the line of Andrew Baum of Citi.

Andrew S. Baum - Citigroup Inc, Research Division

Analyst

Two questions please. Firstly, to Andrew. You have previously spoken about the benefits of incremental cost savings. Obviously, reading the press release, it sounds like the pressures in Europe kind of precipitate the material cost reduction program. Could you identify the potential magnitude and timing of that program? Second, the restructuring of ViiV, as well as having operation efficiencies, to what extent does it facilitate the separation or potential separation from the company in the form of a spin-off at some point in the future? Then finally, my -- would be a question on tax. You've obviously reached your target 2 years ahead of schedule. Perhaps Simon would like to comment on where he thinks is a realistic goal for GSK's tax rate given the [indiscernible] and some of the other ongoing factors further out?

Andrew Philip Witty

Management

Thanks, Andrew. So let me take the first 2. As far as Europe is concerned, we -- as you know, we changed the management of our European business a couple of months ago and I've asked Abbas and the new team in Europe to take a couple of months basically to comprehensively review what capabilities we think we need and what deployment we think we need in Europe to compete in what we perceive to be a shifted environment. So while I think everybody in the industry hopes that this kind of level of price pressure isn't going to be sustained, it clearly isn't obvious when it's going to retreat from the current levels, and we need to make sure that we've got a capability which is built in that context and also in the context of very challenging access to market hurdles, which have been thrown up in a variety of different European countries. So the question is very simple. Nothing is ruled in or out, and I'm not in a position and I wouldn't want to give you any guidance specifically as to what the conclusion of that recommendation will be. I think the best I will say to you is that you should anticipate an update on this at Q4, and we'll be taking the time between now and then to ensure that we've configured our European capabilities in a way that we think makes the most sense for what we think is the environment we're likely to be dealing with. As far as ViiV is concerned, obviously the deal really simplifies things. As you know, there was previously a joint venture structure in place and this really takes that off the table, creates a very straightforward mechanism for ViiV to now commercialize dolutegravir and hopefully other elements of the integrase program as we go forward. Our focus right now, Andrew, is on the successful filing and approval and launch of dolutegravir. As far as the future status of ViiV, nothing ruled in, nothing ruled out. And this simply makes it operationally more straightforward to work, and most importantly, from our perspective, gives GSK a greater share of the economics than we would have had under the previous structure. So in the short run, good news for GSK shareholders. In the longer run, nothing ruled in, nothing ruled out. And Simon, maybe you could address the tax question?

Simon Dingemans

Management

Okay, Andrew, I'll give you my traditional quarterly answer as well, which is that at this point, I'm not ready to give you a specific target. I think we are working on a number of measures which could take the tax rate down again. And I think we've always been clear that the trend is to consolidate the 25% and then move on from there. So I think the objective is clear. When I've got a bit more visibility, which again, hopefully, will be in the next quarter or 2, I can give you some more specificity, hopefully. But I think it's a bit early to call that yet.

Operator

Operator

Your next question comes from the line of Tim Anderson from Sanford. Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division: I have a few questions. On operating margins, you of course, lowered your prior guidance for 2012, but you're saying that they will expand over the next few years. And I'm hoping you can give us a little more precise direction on 2013. In particular, do you expect margins will likely again be same year-on-year? Do we expect to see some expansion as we head into 2013? And then on Advair or Seretide in Europe, can you update us when you expect generic versions or branded generic versions, to show up in Europe? I'm just wondering what you have in your planning assumptions for the next few years. And then on the MAGE-A3 pipeline timing guidance, is Phase III results in 2013 for both melanoma and lung and then darapladib, what's the updated timing on seeing Phase III?

Andrew Philip Witty

Management

Okay, Tim, thanks for those 3 questions. In terms of operating margin, we're just well through coming toward the end of our planning finalization for 2013. So obviously, a little bit premature to give you very specific guidance on operating margin. I think what I'd probably do is simply reiterate what I said at the midyear, which is that essentially, we've seen that European pricing pressure this year essentially shift our view of the company 1 year backwards, if you will. So we expected to break the surface this year in terms of sales growth, and that would allow us to deliver some margin expansion. We haven't been able to get that minimal sales growth that we hoped for this year. As we look forward, we're optimistic that we will be able to achieve that, not least because of the strength, the underlying strength of all the various businesses with the exception of Europe. And therefore, I would simply, at this point, leave you with that sense, that we've kind of moved things a year from where we were at the beginning of 2012. Obviously, as we finalize the plan, we'll then be in a position to give you a better view when we get to Q4. But that's probably as far as I'll go today. As far as Advair, Seretide generics in Europe are concerned, we have a generic product which was originally registered in Greece. It's now been approved in 1 or 2 other countries. It's on the market in 1 or 2 others. Extremely low level of sales, extremely low level of activity. Very different kind of product, not at all like Seretide in terms of what it is, in terms of the way it feels and looks to the patient. And I think what we'll see…

Operator

Operator

Your next question comes from the line of Graham Parry from Merrill Lynch.

Graham Parry - BofA Merrill Lynch, Research Division

Analyst

Firstly, just could you fill us in on exactly what broadly does mean there? So are we talking about roughly plus/minus 1% on sales? Plus/minus 10 basis points on margins? Or on the last comment on margins is that flat, but then less than 30 basis points from Human Genome Sciences. Secondly, on COGS in fourth quarter versus third quarter, if you could just run us through perhaps what the key differentials are. So how much of the third quarter was product write-downs that you wouldn't expect to see in Q4? And how does mix effects change between the 2 different quarters? And then thirdly, if you had any communication with FDA around the Breo filing, particularly around the acceptability of the dosing and also the trial, that technically missed significance? Were there any discussions with FDA prior to or immediately after filing?

Andrew Philip Witty

Management

Okay, Graham, thanks for that. I'm going to let Simon deal with the first 2 questions. But in terms of the latter, as you know, we don't comment on live filings. It's a bad habit to get into, to start to talk about this. So you shouldn't take from that, that we've either had or not had any feedback. We're just not going to comment on it. And the same is going to be true for all of our filings as we go forward. So what we -- what's discussed with the regulators stay confidential until it's public and we're not going to get into a blow-by-blow dialogue. So sorry about that. And we're going to stick to it on all of the drugs. So probably save some questions in the next year or so. But with that, Simon, maybe you could dive into the detail of COGS and the other elements?

Simon Dingemans

Management

So I think you had a couple of questions there. I mean, firstly, on what broadly means. I think as I've highlighted in my comments, there is a degree of variability around the environment, particularly given what we've seen in Europe in the last quarter and what we're certainly still expecting to be a challenging environment in Q4 that led us to indicate -- there's a range around the potential outcomes. What does broadly mean? Well, I'll leave that to you. But clearly, there's some risk, that it's below 0, rather than above 0. I think, as I've also indicated, from a margin perspective, we are very determined, given the pipeline prospects that Andrew has just described, that we invest to make sure that we can commercialize those as quickly and as effectively as we can, if and when we get approvals in place. And so to that extent, we're holding quite a lot of cost ready for that event, as opposed to pulling it out and putting it all back in again. That, clearly, puts a lot of leverage on the upside and the downside in terms of how we then respond to performance at the sales line. So I think, as I indicated in my remarks, the margin for the year will really be most driven by a direct translation of where we come in at the growth line for sales for the year. So I think that's kind of probably the best way of thinking about the math on that. I think at the cost of goods level, remember most of the cost-saving initiatives that we're now working on are beyond and built on the original restructuring program. So there's not big blocks of savings that sort of drop in into a particular quarter. There are a…

Graham Parry - BofA Merrill Lynch, Research Division

Analyst

How much is write-downs and how much is mix is the -- and how would the mix change between Q4 and 3Q in the COGS line?

Simon Dingemans

Management

I don't know that the mix factor changes materially, although clearly what Europe does is a key part of the mix. The write-downs are really relative to Q3 last year, so the principal driver. But remember, the cost of goods shift is relatively small, so we're talking of kind of pretty tiny numbers here overall. I think the mix and the volume is much more relevant at the cost of goods line because if you see pressure on the sales as we've seen in Europe, you can't move the manufacturing businesses quickly enough. Some of the benefit we're expecting in Q4 is the response to what we've seen earlier on in the year. It just takes time to work it through.

Operator

Operator

Your next question comes from the line of Brian Bourdot from Barclays.

Brian Bourdot - Barclays Capital, Research Division

Analyst

Just a question on ViiV, please. Can you help clarify what rights you retain to dolutegravir, particularly royalty rights on the single-agent and combination-based drugs? And could you tell us above what sales level of dolutegravir-based products needs to be reached to make this deal financially beneficial for GSK all-up? And second question is just one on India, really. The Indian government proposes broader price controls on drugs. Just wondering how this will impact you and whether you still see India as an attractive market for investment for you.

Andrew Philip Witty

Management

Yes. Thanks very much, Brian. So as far the dolutegravir and Shionogi confirmed [ph], basically, they get a teens royalty, the same for whether it's single or combination opportunity for them. And in terms of whether it benefits -- it essentially benefits GSK from dollar 1 [ph] in terms of our share of the economics. But you have to remember, obviously, our share of the economics for the first 12 months or so is that we're taking on a bigger share of the R&D costs than we were previously, which is why Simon mentioned there's a penny of dilution effect in 2013 and '14 because what we're doing is we're moving from that JV sharing of R&D costs to a situation where essentially GSK is taking about 75%, 76% of the costs. Remember at the beginning, of course, you've got more investment cost in the asset. But in return, we end up with 76% of the ViiV share of dolutegravir plus various other payout mechanisms for the life of the asset commercially. So in terms of its value to GSK, this a fundamental uplift in the percentage of the economics that we will hold, both in, obviously, the short-run investment phase, but also then in the medium long-run commercialization phase, a very significant uplift in share. And I think we've said previously it takes us into the mid-60s in terms of share of the economics, which is -- makes this a very important commercial asset for us, not just for the sales line, where we will book, we'll consolidate 100% of the sales number, but also the consequence at the earnings line as well because of that increased share of the economics, so that's the way ViiV works. As far as India is concerned, we're still waiting to see what…

Operator

Operator

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

Mark Clark - Deutsche Bank AG, Research Division

Analyst

Just a, firstly, a question for Simon. Just wanted to check if I understand correctly on ViiV. It appears in the press release that the royalties aren't going to go through the P&L that are payable to Shionogi. They're going to be put on the balance sheet and reduced annually. So I just want to check if that is the correct interpretation. The reason I asked, obviously, is that most analysts are really upbeat on this product so we could be talking a couple of hundred million of royalties shifted to the balance sheet from the P&L. And secondly, peering into 2013, if we think about the sort of factors that have kept the lid on growth this year and kept things sort of broadly in line, really not a whole lot changes next year in terms of the flow-through of Europe, et cetera. And the timing of new product launches are such that they're probably going to be back-end 2013 loaded. So can you give us any more optimism that we won't have another broadly in line year in 2013?

Andrew Philip Witty

Management

Thanks very much, Mark, and let me ask Simon to address maybe both of those and I'll chip in if necessary.

Simon Dingemans

Management

Okay. I mean I think on the ViiV royalties, it's important to understand that these are royalties that are deferred consideration, they're not royalties in the traditional sense. So part of the structure of the transaction that we agreed with Shionogi was effectively to pay them partly by their share of ViiV, but also to pay them partly as the product is delivered in terms of an earnout-type consideration. So we have valued that. It will be held on the balance sheet and we'll amortize it over the life of the asset. Clearly, we'll have to look at the valuation of that as we go forward, but we think we've based it on our current expectation for forecast. But so if you think about it as deferred consideration, then you can see why we're carrying that on the balance sheet. And I think in relation to next year, I mean, I think as Andrew said, we're still in the process of working through our planning cycle. I think it's a little early to give you specific color or guidance on next year, which we would normally do in February. So I think that's probably the point when we should have more of that conversation.

Operator

Operator

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

Florent Cespedes - Exane BNP Paribas, Research Division

Analyst

Three quick ones. First, on new products, when we look at the new products on pharma and vaccines, their contribution remains still below the 10% mark. Could you tell us which are the new products which are the most attractive or the ones which are underestimated? And do you have any internal targets to achieve in the coming years in terms of contribution to the total group sales? And second question, on the emerging markets, the emerging markets are regaining momentum. Could we have some details on that? Is it due to a base effect or is it also due to the impact of the reorganization that you implemented earlier this year? And can we have an update on the reorganization of the emerging market business? And last question, on M&A. Given the tough environment in Europe and the still soft top line growth, would you be more active in bolt-on acquisition in pharma and/or consumer?

Andrew Philip Witty

Management

Thanks, Florent. In terms of the new products, so what we've seen in the quarter is our new products, those launched since 2008, accounted for about 7% of turnover and was up 27%. Within that portfolio, you've obviously got very new products like Benlysta, up 100%, partly benefiting, obviously, from the consolidation with HGS; Arzerra, up 58%; Promacta, up 59%; Votrient, up 70%; Volibris, up 40%. So it's a very punchy growth rate on what actually is a portfolio of specialized products. But I think what's really important, I think, we've made no huge secret about this, the company has been highly prolific in the last 4, 5 years in producing assets. In fact, we've had more products -- more NMEs approved by the FDA than any other company through '08 to '11, through the last full year, but they've almost all been specialist products. And what we've seen is that gradually those products are beginning to turn into something pretty chunky, but they're always going to be limited by the fact that they are in specialist marketplaces. Now what's encouraging is we're seeing them one by one move into material individual scale and keep very punchy growth rates, represented both across, particularly America, emerging markets and Japan, but in some occasions, also Europe; and in that case, particularly Volibris. If we look forward, what's critically different about the group is that the vast majority of products coming in are now major opportunities. So we're still producing a regular flow of new products in the way that we've proven we can over the last 3 years, but they're moving from being specialist-type products into more mass market or larger scale opportunities. And clearly, that is going to be the thing that drives the company forward if we can successfully get…

Operator

Operator

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

Steve Scala - Cowen and Company, LLC, Research Division

Analyst

Two questions, first, regarding operating margin improvement. On the second quarter call, Andrew, I believe you said, or at least implied, 20 basis points improvement in 2013, which represents the 1-year shift. Is that correct or do I not remember that correctly? And then secondly, the headwinds that Glaxo has experienced in Europe appear a bit more severe than other companies. Beyond Advair, what products stand out as particularly problematic? And why will RELOVAIR fare better than Advair once it becomes available in Europe?

Andrew Philip Witty

Management

So in terms of the shift 1 year to the right, I think there's no question about it, it's exactly what I said at Q2, it's 2 different kind of elements of a conversation. I'm going to just reiterate the sentiment we want to signal to you is a shift to the right. The exact quantum, we didn't declare up front for 2012, we'll give you a view as we move into 2013, what the appropriate kind of measurement of quantum is, whichever level of guidance we ultimately decide to give. But the sentiment of a shift 1 year to the right is exactly right. So the notion that we feel we would -- if you remember, we had the long torturous discussion about slowly, gradually expanding our margin. That whole notion of the beginning of a slow and gradual expansion of margin, we believe, has shifted 1 year to the right. We will, as we give you guidance at Q4, we'll aim to try and give you some points to help you a little bit more. Whether we give you everything you want, we're very frustrating on that front, but -- and I apologize in advance of not giving you everything you want in Q4, which I'm sure we will fail to do. In terms of Europe, I don't really know whether we see massively different headwinds from other companies. I mean, I looked at a lot of the other companies who've reported sales down 20%, down 30%. Of course, they've got lots of genericizations going on. They're not really splitting out pricing from volume in all of those numbers. So I don't really know that it's massively different. If I look at our numbers, we think about 5 percentage points of the 7% are essentially straight price cuts,…

Operator

Operator

Your next question comes from the line of James Gordon from JPMorgan. James D. Gordon - JP Morgan Chase & Co, Research Division: Three questions, please. Firstly, on the EU and mandatory generic substitution, should we think that this going to persist at least for another 3 quarters? And can you give us any insights into what products you're now starting to see this mandatory generic substitution for? That's the first one. The second question was, in the release, you mentioned a proportion of the businesses is being tender-driven. Is that becoming more of an issue now for some reason? Does it now introduce more volatility? And if so, why is that increasing now? And then thirdly, you also mentioned in the release that there are some advanced assets with essentially a need for investment to drive returns were necessary. Are you able to tell us which assets you think they might be? And also, when do you think the increased investment might be required?

Andrew Philip Witty

Management

Yes, great. Thanks for the question. So there isn't a pan-European mandatory substitution regulation, James. There are various countries. So Denmark, for example, has long had a mandatory substitution. And if you look at the generic marketplace in Denmark, you see very rapid genericization. What we've seen in the last 3 or 4 months, in particular in France, increased pressure to get pharmacists to switch. So it's not correct to say that there is a single pan-European phenomena. What is happening is accelerated substitution is being used as one of the latest tools to drive -- try and drive down costs. And so hopefully, that may be just clear as that. As far tenders are concerned, I think that the only point we're trying to make, and I suppose in a way it wraps up in a general comment, that we think that the quarters are not all that -- because so many things go on quarter-to-quarter, we think it's quite difficult to track the performance of the company quarter-to-quarter, because you've got Q4 this year versus Q3 this year. You're going to have a huge burden of tenders in the fourth quarter. Why? Because a lot of governments have tried to push its phased purchases towards the end of the year, there's a tradition of shipments at the end of the year. Those are very simple reasons why you end up with these boluses of tenders at the end of the year. And I think we just want to signal that whether it's tenders, whether it's one-off events, that the quarters do tend to bounce around a little bit, and we feel much better looking at the kind of 6-month, 12-month trends rather than the noise quarter-to-quarter. Now I know for many of you, who are very focused on…

Operator

Operator

The next question comes from the line of Kerry Holford from Crédit Suisse. Kerry Holford - Crédit Suisse AG, Research Division: It's Kerry Holford, Credit Suisse. Three quick questions, please. Just to clarify, do you need the negative 7% price impact in Europe to ease as you move into Q4 in order to achieve your full year guidance or essentially not -- just not worsen? Secondly, could you tell us which vaccines have been pre-ordered in those EMAP tenders for which we should then see a bolus revenues to be booked in Q4? And then finally, at their Q4 results last week, Novartis highlighted that the IFRS pension change will increase the annual pension costs for next year. Do you have a feel for what this accounting change may mean for GSK pension costs next year and beyond?

Andrew Philip Witty

Management

Thanks very much, Kerry. I'll ask Simon to comment on the pension dimension. As far as the vaccines are concerned, it's a whole -- it's all of them, basically, so it's broad portfolios of vaccine business in a variety of geographies. So I don't think there's any particular thing to call out within that. If there was anything, I'd say that probably of the 30 or so tenders we expect in EMAP, maybe Simplirix will be the one that kind of tops within it. But even then, it's a bit to the bigger end of the scale, but it's pretty much covering the whole portfolio of business. Essentially, we're anticipating, at this point, that pricing in Europe doesn't get any better for the next 3 months. So we're not -- in our view for the year end, we're not anticipating that the 7% gets a lot better. We're not anticipating it gets a lot worse either, but we're certainly not anticipating that the 7% gets a lot better. And Simon, maybe you could comment on the pension point?

Simon Dingemans

Management

Yes. I think we're still working through the detail, but I think as a rough number, around GBP 100 million increase in terms of our pension expense next year will be the effect. There will clearly be some restatement to 2012 to make it comparable, but the additional cost will be around GBP 100 million.

Operator

Operator

Your next question comes from the line of Keyur Parekh from Goldman Sachs.

Keyur Parekh - Goldman Sachs Group Inc., Research Division

Analyst

I've got 2 questions please. First, Andrew, as you look at the shape of the business from kind of a 3- to 5-year perspective, it looks like a lot of the growth is going to come from the pipeline products delivering. And I think consensus and investors kind of seem to have a slightly less optimistic view of that than GSK. Can you point us to some markets along the way from a commercial perspective where your strategy might be prone to be the right one in that sense? And secondly, as you think about the growth rate for Advair, Seretide in China, up 46%, that's truly impressive, was there any onetime kind of stocking impact on that? Or should we assume that to be the running kind of growth rate over the next few quarters?

Andrew Philip Witty

Management

Okay, great. Listen, thanks very much for the question. In terms of -- ultimately, for investors in the market to come to their own conclusion about what our prospects are, our view is we're developing a battery of new assets, which really speak to major market opportunities, first of all. We think, in many cases, they are going to represent key points of differentiation, and we think they're going to give us -- and in many cases, we're going to be there potentially with best in class, potentially with first in class. We've seen, in a number of our competitive arenas, competitors run into quite a few problems with their own programs, particularly in the respiratory marketplace. So I think our sense is that we're in a good shape. I'd reiterate that although the products that we've introduced in the last 4 years have been, by definition, very small because they've been in specialist arenas, the individual performance and market share dynamics are looking more and more encouraging. And I think that reassures me that we have a capability to launch these products. And we're going to have, with a fair wind, multiple waves of opportunity. And I think if I've done a poll of everybody on this call in February of 2011 and said, "Okay, in October of 2012 you have to tell me how many of the 12 drugs that we report on are going to be positive," I don't think many people would have said 10. But 10 have come out positively. We still have 3 more to report before the end of the year. And as I said already on this call, we then have 2 very significant, albeit more wildcard-type opportunities, with MAGE-A3 and darapladib, next year. And then we're into the next wave of…