Earnings Labs

GSK plc (GSK)

Q1 2013 Earnings Call· Wed, Apr 24, 2013

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Transcript

Sir Andrew Witty

Operator

Thank you very much and welcome to First Quarter Conference Call for GSK. I’m with here with Simon Dingemans as normal. I’m going to make a few comments followed by Simon and then we’ll open up the call to Q&A. The first quarter was very much in line with our expectations with sales down just 2% and up 2% for ongoing operations, i.e. excluding divestment such as the consumer product sale in Vesicare from last year. My commentary from now on is going to focus on just the ongoing business. I was very pleased to see once again broadly based growth coming from U.S., EMAP, and Consumer Health. With Japan held back only by the Cervarix year-on-year comparison without which it would have been up 11%, and even Europe showing some signs of improvement, although I continue to think that Europe will remain very challenging for the rest of the year. There was good delivery in respiratory, especially from Seretide/Advair, Flovent, and Ventolin in the U.S., oncology especially Votrient in the U.S., a robust vaccine delivery, particularly Synflorix in the emerging market. Our European restructuring is progressing well and we’re around a half way through that particular program of change. Our Consumer Healthcare business delivered excellent growth in all four categories. Wellness was up 8%, oral care up 5%, nutrition up 6%, and skin health up 6%, and in all regions especially international and the U.S. both up 7%. For our largest consumer healthcare product Sensodyne, we saw growth of 19% in markets outside of Europe and the U.S. and I think that just signals once again the very significant opportunity that exists for consumer health in emerging markets and also underpins a lot of the opportunity we see for Rx/Cx synergy in that particular high growth part of the…

Simon Dingemans

Analyst

Thank you, Andrew. While it’s still early days, I’m pleased with the start to the year and after the challenges of last year, I’m particularly pleased that we have been able to deliver another quarter in line with our expectations with continued momentum across all of our key growth markets. This may be less visible in the reported numbers, given the already flat comparators. But it gives us confidence as Andrew has highlighted that we remain on track to deliver against our guidance for the year of EPS growth in constant currency terms of 3% to 4% on sales growth of around 1% again in constant currency. Our financial architecture is allowing us to prioritize better the investments we need to make to drive those growth objectives as well as identify more clearly where we can release costs and resources and improve our efficiency. As we flagged before the main contributions to the leverage this year will come from financial efficiencies and I’m pleased to be able to report good progress this quarter with both financing costs and tax charges in line with where they need to be to deliver our full-year objectives. We’re also using our financial architecture more rigorously to drive earnings ahead of sales over time and convert more of those earnings to cash that we can either reinvest in the business or return to shareholders, and the 6% dividend increase this quarter is clear evidence of the progress we’re making on this front. Now, let me comment on the quarterly turnover and regional highlights in a little bit more detail. As usual, the focus will be on CER growth rates and core results. Group sales were down 2% but excluding the divestments made in 2012, sales grew 2%. This 2% is after absorbing the headwind of…

Sir Andrew Witty

Operator

Thank you very much Simon and I’m delighted to be able to open up the call for Q&A. So perhaps the chair of the call could once again describe what the protocol is.

Operator

Operator

So, ladies and gentleman, your question-and-answer session will now begin. (Operator Instructions) Thank you. And we have a question for you straightaway. It’s from the line of Andrew Baum with Citi. Please go ahead Andrew. Andrew Baum – Citigroup: Good afternoon. I have three questions, if I could. First, both with your global health business now and previously with ViiV – you have two assets which could be monetized outside GSK as well as within. Perhaps you could talk through the operational issues and potential triggers which will determine both the decision and timing for any move to externalize the assets and monetizing them. Second, I know that you’re reluctant to give any long term guidance on tax, but perhaps you could give some kind of sense of the increase in economic profit that’s going to be booked in the UK over the next five years as a function of the investment you’ve announced last quarter in terms of restructuring some of your operations and bringing them back to the UK. And then thirdly, regarding emerging markets, your first quarter growth in EMAP in 2012 was 2%, which make the 8% you post here look somewhat less than you might have imagined. Is vaccine the only reason for that or are there additional factors to explain why there wasn’t a stronger earnings growth given the pretty low comp first quarter 2012?

Sir Andrew Witty

Operator

Thanks Andrew for the questions. I’ll ask Simon to comment on the tax guidance point in a second. As far as the two sets of portfolio globally established products and ViiV, they are obviously very, very different types of profile businesses, albeit we’re developing somewhat similar approach to the way in which we crystallize them as more visible groups within the company for you to look at and understand better. ViiV of course is moving into potentially a very interesting growth phase with the potential approval of dolutegravir later in the year. And as a consequence, our view of that business will be very largely dictated by what we believe to be the medium term growth prospects not just from dolutegravir, but also from the follow-on programs and particularly the long acting programs, which are looking very, very exciting actually. So, I think the ViiV business are judgments we need to let some water flow under the bridge around what the real growth profile of that will be over the next few years. I have to say it has been extraordinarily successful in achieving its goals since we created it and I’m delighted that we did it. The global established products business is very different kind of proposition, so this is a very, very substantial fragmented portfolio across the group. So the first order of business is really to bring that business under a coordinated focus to make sure that we’re driving out manufacturing efficiencies, simplification efficiencies, winning every tender we can win on these older products simply by focusing on it. Secondly, what we’re also doing is we’re taking the opportunity inside the company to really guide all of our employees, so we essentially have three sets of products within the company going forward. We have the new products…

Simon Dingemans

Analyst

Yeah, Andrew thanks for the question. I think as we have discussed before on the tax side my objective is to deliver a structure into the company, which allows us steady downward progress in the rate and you are seeing that delivered over the course of this year and the Q1 rate was very much part of that plan. We expect to get the R&D credit in the quarter, but its part of the overall position for the year. I think beyond 2013 to your point, yes we do see very material value to us and our shareholders coming from the patent box and the benefits of being able to move quite a lot of our pipeline into the fence that surrounds that but it’s also not just at it or about the shape of the business, pulling some of the revenues away of higher tax jurisdictions like the U.S. and making sure that our central activities are really benefitting from where the best incentives lie. So that’s really what makes us a sustainable proposition. I am not sure I can quantify at this point, because it depends how the product themselves do, but I certainly think we see a lot more opportunity to go for.

Sir Andrew Witty

Operator

Thank you, Andrew. Next question.

Operator

Operator

Thank you. Our next question is from the line of Brian Bourdot of Barclays. Please go ahead, Brian. Brian Bourdot – Barclays Capital: Thanks very much, so good afternoon, Brian Bourdot from Barclays. Two questions please, one on cost of sales and second question on the development pipeline please. First on cost of sales, I think you’ve mentioned that there was some cost due to the unwinding of cost of manufacturing volume shortfalls. Could you please explain little bit detail and illustrate what that actually is and how important that is in the context of the 1.4 percentage point increase? The second question on the development pipeline, specifically with regard to your BRAF and MEK inhibitors, I see you’ve filed the combination in Europe. You announced this a little while ago. There is no news about a similar submission in the U.S., I am just wondering if you are still hopeful of being able to submit data for the combination in the U.S. prior to the readout of the Phase III study whether you can get something similar there or whether there is a definitive no thank you from the FDA. Thank you very much.

Sir Andrew Witty

Operator

Brian, thanks so much. Let me ask Simon to comment first on the COGS and then I’ll come back to on the MEK, BRAF.

Simon Dingemans

Analyst

Yes, Brian. This issue really stem down to the way that we account for the inventory, we have in the supply chain. So if you think about our vaccines and pharma providers, we talk before about how long some of that supply chain dollar costs go to the balance sheet and inventory as we manufacture the product and release as we sell, and some of the volumes we made in 2012 are only now being sold in Q1 2013. And if you also remember, the environment we were in last year, where clearly we were under pressure in a number of our businesses, that led to lower volumes than we had originally been planning and some under-recovery of costs which will pause therefore the overall mix, and that’s why I flag to the full year that we were likely to see some pressure from the cost of goods in the quarter and in fact during the balance of 2013. Now, this will probably be largely a first-half effect or not completely but that’s how it arises, and it’s about 0.7% of the 1.4% increase that we called out.

Sir Andrew Witty

Operator

Thanks, Simon. Brian, as far as the MEK/BRAF is concerned, obviously we are not going to predict a specific filing time, but we fully anticipate being able to file during this year and we have no particular concern around timing or all the potential opportunity for us to file. So I think everything is on track there and not much more to say really. Thanks very much. Next question.

Operator

Operator

Thank you. Your next question is from the line of Tim Anderson with Sanford. Please go ahead, Tim. Tim Anderson – Sanford Bernstein: Thank you. A few questions, in the past, you’ve described Relvar and Breo not really as a replacement for Advair, but rather it’s something that rounds up your portfolio of products in respiratory. Is this still how you view the drug? It’s not clear to me how you are going to position one product versus the other. Can you give us any guidance on likely pricing in the U.S.? Second question is on respiratory as well and FDA earlier this year commenting that they wanted to get a guidance document out on combination respiratory generics. Just be curious to get your perspective on this and whether you think that some point we might actually get through generics in the U.S. as the FDA putting this guidance document out, raises that possibility. And then last question can you just give us specific timing on seeing the Darapladib and MAGE-A3 data in 2013, I know both I believe this is the first set, somehow, but can you narrow down the timing?

Sir Andrew Witty

Operator

Tim thanks very much for the question. So as far as the Relvar/Breo is concerned, I mean, why I said repeatedly is that we shouldn’t – the observers of the company sometimes have got themselves into position where you think the only product GSK had in respiratory and sometimes the only product GSK at all in full development was Relvar/Breo. And one of the things I’ve been trying very had over the last five years to do is to ensure people understood that there was a lot more to our respiratory portfolio than simply Relvar/Breo and also that there was more to our development portfolio; and as a consequence we shouldn’t get over fixated just on that single product. Now obviously it goes in for a very significant and important strategy for us, and as I have made clear at least two Investor Days, one of the things that we are very keen to do is, is to secure and protect if you will our market share of the categories that the respiratory business that we are already in and to grow market share in categories in which we are already in. So Relvar/Breo plays a very critical role for us in terms of securing the long-term share for the company on the Seretide/Advair business. Obviously, we have generics Seretide in parts of the world and if possible we’ll have them at some point in the future in the U.S. and I’ll come back to that more specifically in connection to your second question. We don’t anticipate that in the short run, but of course in the long, long run, it is possible. So, it is appropriate for us to look to Relvar/Breo to be a product, which can take up some of the strain if you will for us…

Sir Andrew Witty

Operator

Thank you. Next question.

Operator

Operator

Thank you. We have another question. This one is from Kerry Holford of Credit Suisse. Please go ahead Kerry. Kerry Holford – Credit Suisse: : And secondly, on the global established products portfolio, I wonder if you could give us a broad idea of the current geographic split, of that group. I believe it is quite heavily rated to Europe. And then thirdly, just to clarify on [Novartis], which will set it stronger in Q1, you mentioned a prior-year catch up adjustment there. Is it fair for us to assume that the royalty income returns to around ₤70 million to ₤80 million per quarter going forward anytime?

Sir Andrew Witty

Operator

Thanks, Kerry. Let me say the established product question and then Simon can pick up the FX and the royalty question. Simply put, roughly, roughly about 30% U.S., 30% Europe, 20% EM, 10% everywhere else. But importantly to recognize that the U.S. 30% is dominated by handful of brands, everywhere else is more like 50%. So, the complexity and the proliferation is massively skewed ex-U.S. with Europe and the emerging markets been a bit similar in terms of profile, if you will of complexity, but the actual revenue report, it is about 30:30:20:10. On the FX, I want Simon address this.

Simon Dingemans

Analyst

Yeah, I think on the FX, the gain we recorded in the first quarter will stay with us. This is as I explained in my comments really about crystallizing again on intercompany trading. So there is genuine contribution into the earnings of the company. If you roll forward the period and rates from the end of the first quarter through the balance of the year and assume that [EGAL] is in place versus the exchange gain, then we would expect probably about 1.5% currency gain at the top line and about 3% bottom line really reflecting the amortized benefits of that exchange gain over the period of the time. That’s the reason for the difference primarily. And then on royalties, I think we’re expecting that these probably go back to similar levels quarter-by-quarter to what you’ve seen as them as a bit of a catch up in the first quarter but that’s not going to repeat itself. So you will commensurate in the right direction.

Sir Andrew Witty

Operator

Thanks, Simon. Thanks, Kerry. Next question.

Operator

Operator

Okay. Thank you for your question. Next question is from Graham Parry of Bank of America Merrill Lynch. Please go ahead, Graham. Graham Parry – Bank of America Merrill Lynch: Thanks for taking the questions. Firstly, just a broader question on the established and products business and the potential ultimate divestment and Pfizer has gone down that path and hasn’t been able to willing to divest that yet. So just wonder what your initial focus, would there be a buyer in the market for those kinds of products? And secondly on Advair dynamics in the U.S., we have obviously seen a bit of shifting around of price and inventory. Can you just explain to us where inventory sits now, so we hire low? And then on pricing, we’ve seen two price increases in October. There was a double-digit price benefit year-on-year in the quarter, should we be thinking that as a trend for the foreseeable future. And then thirdly, if you could just give us the exact price impact for Europe and year-on-year during the quarter as you’ve done in prior quarters. Thanks.

Sir Andrew Witty

Operator

Yeah. On the Europe, it’s minus 3 on price. Volume rounds to zero, it’s about plus 0.4 or something like that. So the price was minus 3 for the quarter. In terms of the established products business, there are buyers out there. Whether there are buyers out there for a single block like this is a different question but there will be buyers and there are buyers out there for long. So one of the interesting questions for the people, who’re going to be focusing on this is, are there elements of this business which would be better on the outside of the company than the inside. If it may and I think I would encourage you to think not just this is now, because we called out as a block that all actions going forward will only apply to the block. It may very well be that the focus giving to the block reveal that there are sub-segments where we want to do something different from other sub-segments, and I would just encourage you to think that way. I think that notwithstanding that this type of business is extremely amenable to these type structures rather than next service straight disposal type structures. And you could imagine that different companies will have broadly similar goals of trying to drive efficiencies and synergies through these sorts of tail businesses. So it maybe that those sorts of options have more legs on them than again a huge big block sale, so if you ask me today, I would say more likely to be sub-segment solutions for sale that indeed is the path we want to go down or possibly these type solutions rather than big block sales would be my guess, but I’d reiterate what I said all along. We’ve got no…

Operator

Operator

(Operator Instructions) Next question is from the line of Kyle Rasbach with Cowen & Company. Please go ahead, Kyle. Kyle Rasbach – Cowen & Company: Thanks for taking the question. Earlier this week Novartis, as you may have seen reported some LABA/LAMA combination data for QVA149 and sure that it met its primary COPD exacerbation standpoint. Glaxo doesn’t appear to have a comparable study underway for an oral. There is some longer term safety and tolerability trials underway of exacerbations with a secondary end point that these trials here to be undersized to gartner any kind of exacerbations claim. Maybe if you could tell us about how you see the competitive landscape for the LABA/LAMA combination is developing and how important in exacerbations right maybe and then just a quick and easy question and that is, whether or not the factors that contributed to the GBP82 million SG&A benefit in Q1, will also continue in the second quarter, thank you.

Sir Andrew Witty

Operator

To start on, why do you hit the SG&A question, I will come back later on in the call.

Simon Dingemans

Analyst

The GBP82 million really results from the period when you saw the dollar strengthened very rapidly, so, it’s about the inter-company trading during periods like that, assuming that doesn’t repeat itself, no, there will be no further contribution during the balance of the year from those kind of factors. As far as the LABA/LAMA competitive landscape is concerned, I think particularly for the U.S., I’m pretty optimistic as we stand today, obviously we have a file under review as we sound for once a day treatment if not totally from the timing competitors are going to be in terms of being able to get on a similar basis and we continue to build up our clinical profile. Whether we have everything there on day one, we may not in terms of every single claim that we hope on they will be able to get for the product. But in terms of timing of arrival, I think we’re in very good shape compared to where we used to two or three years ago and I think again if we went back and read, while the commentary was that the marketplace was in terms of who was going to get that first and with what type of profile. I think things are pretty reversed, very significantly, but I think timing is very good for us. I think dosing frequency look very good for us with the competitive advantage and gradually I think we’ll be building up a very compelling data package and we’re very, very optimistic about this program. And coming halt on the yields of Breo and Relvar and in advance of a series of further respiratory products, if all goes well with FDA then I think it was in a very strong position since the portfolio, both of inhaled and other products particularly excited to see the belimumab for Phase III date coming in next year as well. So, for me, the portfolio does in timing and clinical package. I think we’re absolutely that big time on timing subject to FDA dosing and portfolio and we’re building up our clinical packages being lot more later on Zephyr at the ATA in May. And I think that will continue to reassure people that profile as a product. So, thanks very much for the question, Kyle. Kyle Rasbach – Cowen & Company: Thank you.

Operator

Operator

Thank you. We have another question please. This one is from Peter Verdult of Morgan Stanley. Please go head, Peter. Peter Verdult – Morgan Stanley: Peter Verdult from Morgan Stanley. Apologize as already these questions would have been asked, but I joined late on the call, but Andrew maybe on Ribena, Lucozade. Am I right in thinking annualized sales around the 0.5 billion mark at the moment, wondering if you could give us a sense to what growth rates were those brands in 2012 and in the first quarter this year and then may be support in terms of use of proceed if you do divest this year, should we think about as being used for general corporate use or is there any intention to fully redistribute those proceeds straight to shareholders. And then just again on the Global Established Products. Can you give me a sense as to what the geographic split is and again what sort of growth rates that business is posting any sort of detail there? Could you please share, thanks.

Sir Andrew Witty

Operator

Peter, thanks very much. So as far as the Ribena presently, yeah let’s wait and see when we started what we get and tell you what we’re going to do with the proceeds and we are too far ahead of myself. But you know I think as a general point going forward and we have a variety of different close on cash both in terms of shareholder and in terms of just managing the business. And I think it’s a general holding point, I would say, it’s going to go into that pool and support the various products which we make super clear in terms of what we want to with cash. So, we’ll be more specific about that when we get that. In terms of growth rates, was very, very strong growth particularly, so right Lucozade in particular has a footprint, which is dominated by basically Britain and Northern Ireland and that business in the quarter was basically down 2%, has a very significant business in Nigeria one or two other smaller emerging markets. That business is up 16%. So we got a bit of a mix going on and I think it’s not a surprise effect you can know that the UK was affected by a very long, very dull, very cold spring and when you’re selling a product like Lucozade having some sum makes it huge difference. So little bit down in the UK, Europe, down 7, up 16 in the emerging markets dominated by Nigeria giving an total quarter performance or down too. We got some very exciting new product launches coming up in the next few months and if I believe the BBC, I am looking at a hot long summer. I would expect that number to improve as we went through the rest of the year. Can you just repeat your second question for me? Peter Verdult – Morgan Stanley: It’s just on the Global Established Products, I’m sure this question has already been asked but can you remind me again what the geographic split is for that business…

Sir Andrew Witty

Operator

Yeah. Peter Verdult – Morgan Stanley: 3 billion, again what sort of growth you’re seeing from that business?

Sir Andrew Witty

Operator

Yeah. It’s more or less 30% America, 30% Europe, 20% and 10% everywhere else more or less. I made a comment earlier of the potential benefit, the complexity of the business i.e. the number of brands is not reflected that way. So there is a handful of brands in America there are then a lot of brands in Europe and EMAP and the rest of the world. So complexity isn’t reflected by revenue shares. In terms of growth rate, Q1 is down 7% and if you’d taken that business out of our numbers just for the sake of it, GSK would have grown 1% faster than we reported. So it’s dragging about 1% of the reported growth rate for the company and the business itself was down 7%. Peter Verdult – Morgan Stanley: Thanks very much.

Sir Andrew Witty

Operator

Thank you. Next question.

Operator

Operator

Thank you. Your next question is from the line of Florent Cespedes from Exane. Please go ahead, Florent. Florent Cespedes – Exane BNP Paribas: (inaudible). Thank you for taking my question. First one on cost, could you tell us how do you see the marketing and R&D cost in the next quarters knowing that you will launch a new product and you will hear us to invest in your portfolio? Second on research of more on the projects, we understand at May 3, you will be the next exciting products in the reports results. Can you share with us your force on this one and how are you – we should read the first data and when we should ask your idea of the potential of these projects? And last question on the European area, could you give us some color on the environment there and how would you see the trend going forward beginning for the deterioration or improvement or kind of statutory improvement? Thank you.