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GSK plc (GSK)

Q1 2014 Earnings Call· Wed, Apr 30, 2014

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Transcript

Sir Andrew Witty

Management

Thank you very much and welcome to our Q1 call. I’m joined today with Simon Dingemans who I’ll hand over to in a couple of minutes to take you through some of the detail of the quarter. I thought before doing that though, it was worthwhile and actually I think the quarter is quite good exemplar to just remind you and review where the strategic shape of the group is particularly in the light of the three-way transaction that we announced last week with Novartis. Clearly we are focused on successfully launching and establishing further growth opportunity in our respiratory portfolio, secondly, development of our vaccine business in particular of course helped with the proposed transaction with Novartis and then of course developing that premiere Cx business, consumer business between ourselves and Novartis, all of that really built on the foundations of very strong industry-leading R&D capability and global footprint. I think the first quarter is a key quarter in terms of signaling the kind of transition that’s underway for the business. Of course there are as always other issues like price competition and the like in the environment. What’s really going on in this quarter is the beginnings of the full row relative [ph] on new product portfolio including of course in respiratory and also the transmission if you will of business from the older portfolio to the new. As we’ve said many times before, it’s very difficult to synchronize that transmission perfectly quarter-to-quarter, but our goal is to make sure that gets done over the next several years. So our strategy is very clear. I think the transaction last week really emphasizes where we’re focusing our attention for the future. Key to all of this is new products and actually I think we’re seeing good performance from new…

Simon Dingemans

Management

Thank you, Andrew. This quarter we’ve seen continued momentum across many of our key growth businesses included in emerging markets, Europe, Japan, ViiV and vaccines and this helped to partly mitigate the impact of increasing competition in the US particularly for Advair and supply disruptions to our consumer business in the US and Europe. The quarter was also impacted by a number of items we previously flagged including the phasing of vaccine tenders and stocking patterns by wholesalers and retailers, but despite these pressures, the benefits of the reshaping of the group over the last few years are clearly evident in the breathe of positive contributions to growth that we are now delivering across the business. New products are making an increasing contribution although it’s still relatively early days in the launch cycle for the eight key new products we’ve had approved since the beginning of 2013. The more specialists’ launches in HIV and oncology have made the most progress to date. With ViiV on the back of ongoing success of Tivicay in the US grew growing 4% and our MEK and BRAF oncology products are also continuing to gain share. The broader respiratory launches are now also underway although coverage for Breo has taken longer than originally anticipated to negotiate. Despite the assess of May 1, coverage levels for Breo will be over 70% of Medicare Part D lives and Anoro has started shipping during April which should contribute to improve momentum from the new respiratory products during the balance of the year. Although we continue to expect that it will take time to build this new portfolio to its full potential and the progress will be more visible in the top line in the second half of the year. The quarter also delivered further progress in our continuing…

Sir Andrew Witty

Management

Thanks very much, Simon and now I would like to open up the call. If the operator could perhaps read out the instructions, then we’ll start the Q&A session.

Operator

Operator

Thank you. Ladies and gentlemen, your question-and-answer session will now begin (Operator Instructions). Our first question is from the line of James Gordon from JP Morgan. Please go ahead. James Gordon – JP Morgan Securities Plc: Hello. Thanks for taking my questions. James Gordon from JP Morgan. One question I had was about darapladib. When I looked at the Press Release I can see that the primary endpoint for the SOLID study has changed, so it’s now just coronary events rather than overall MACE endpoint. On that, presumably, that has been discussion with the regulator? If you did have positive results on the amended study endpoint and they were in a similar level of efficacy as we saw in the STABILITY study, would that potentially be enough for approval do you think or do you think you’d still need another phase III study? Also one question on respiratory which was the Breo, the prescriptions you’ve seen so far, where are patients predominantly coming from. Are they coming from Advair or Symbicort, are they new LABA/ICS patients?

Sir Andrew Witty

Management

Thanks. Thanks very much, James. On the second question, they’re coming from a variety of sources, but certainly a healthy mix coming from new starts to ICS/LABA. As far as darapladib’s concern, you’re quite right. We have a different endpoint, obviously that’s informed by what we saw in the first study. You have seen from the first study that if you – that the effect in stroke essentially was the outlying effect compared to the other elements of the MACE calculation. Of course we’ve informed the regulators on the issue. In the event that the second study were positive on the endpoint, it would clearly be a conversation to have with the regulator, but you would essentially then have two very large studies, one at least of which would be highly supportive to the second although recognizing that they originally pre-defined different endpoints. So I think it’s a scenario where you could see a way through, but it all depends on the results. And we have not too long to wait. Next question?

Operator

Operator

Thank you. The next question is from the line of Andrew Baum from Citi. Please go ahead. Andrew Baum – Citigroup: Hi. Few questions please, on darapladib, what is the statistical penalty that you’re going to have to pay from changing the endpoints given there’s already been, I think, a couple of interim analyses? Second, on Anoro, I think we’re just waiting for approval in Europe. I noticed Incruse has been approved. I just wondered if you’d give us an update on the approval for Anoro and what’s holding it up? And then finally on the consumer, firstly, is the smoking cessation product damaged by the e-cigarette? Is there anything to do with the weakness, the safe and stocking issue – or the supply issues rather? And then secondly, perhaps, you would like to give some sense the way you think you can take consumer margins over the long term given at least quarter around the 15% level?

Sir Andrew Witty

Management

Okay, so thanks very much, Andrew. Nothing more to add on darapladib. We’re not going to give any further details on that. Sorry to frustrate you. Anoro, we’ve got the positive opinion in Europe. We’re obviously just waiting for the time to go through and the process to happen, so again no drama there. Consumer, it’s basically a supply, temporary supply disruption, so again nothing particular to report. I mean there’s no doubt that the e-cigarettes have some effect in this marketplace, but I wouldn’t say that that has so far been dramatic. And in terms of margin, in the context of the conversations we’ve had last week following the announcement with Novartis, clearly as we – if everything is approved and we bring those two businesses together, we’ve historically trended up the sort of upper teams. They were very much at the upper teams before they had their Nebraska issue. They’re clearly planning to rebuild. So my expectation is that overtime we can build towards upper teams and that would be our initial goal and then we’ll see how we can go from there. And I think that’s entirely reasonable. And we’re obviously a little bit hurt in the first quarter because of the supply issues on the smoking products. Actually remember the first quarter consumer was grown an underlying rate of 5%, clearly by losing some of that supply, that’s affected the margin a little bit. So nothing super dramatic there and certainly we’ve got a goal to be in the upper teams pretty quickly once we combine the businesses. Next question?

Operator

Operator

Thank you. Our next question is from the line of Graham Parry from Bank of America Merrill Lynch. Please go ahead. Graham Parry – Bank of America Merrill Lynch: Thanks for taking my questions. Firstly on guidance, I think you said on the full-year call that you’d need Lovaza for a good part for it to reach to upper end of the guidance and clearly that hasn’t happened. Advair is looking a bit weaker, so what is the offset do you see to retain that upper end of the guidance and what is your level of confidence of being able to get towards the upper end of this as the lower end? Secondly the price swung very negatively on Advair in the quarter as historically been obviously a positive, can you just quantify whether we should be expecting a similar level of negative price impact on subsequent courses throughout the year and clarify comments on your portfolio approach in respiratory you say are you looking to offer bigger rebates on Advair per volume with a higher Breo price of vice versa? Thirdly R&D, very low quarter-on-quarter, you talked about some of the R&D trials falling off. You’ve also talked historically about upward pressure there as well, as new trials start. Could you just help us think about phasing on that line through the rest of the year? And finally on COPD and mepolizumab could you talk us through how you see the market opportunity there. We understand it’s about 30% of the COPD population who are hyper-eosinophilic. Is that the kind of proportion of the market that you’re thinking about potentially targeting here? Thank you.

Sir Andrew Witty

Management

Okay. Thanks very much, Graham. I’m going to try and cover up as much of that as we can. So I’m going to let Simon talk to guidance in a second. As far as US is concerned – what’s happening I think with Advair pricing is there’s clearly more price competition in the marketplace. We’ve historically been among, I would say, the most disciplined around discounts. So we’ve had a pretty low level of rebate running on Advair. As we’ve moved to increase that, to respond some of the competitive pressures, that has an initial impact in the way in which the broader discount rate is calculated. That is an initial cost of the new phase, I would say. You will see a pressure on price continuing during the year, obviously: the price came down at the beginning of 2014 and it is down for the whole of the year, most likely. You will see that flow through, at least partly, through the rest of the year. As far as the contracting strategy for Anoro, Advair and Breo is concerned, we are obviously not getting into the detail of that. However, what is very encouraging is that, while we have had to absorb some price pressure on Advair, simultaneously we have gone from being very uncovered on Breo to really exceptionally covered. There is 70% coverage in the Part B book, after seven or eight months on the market, which is an extraordinary achievement when even the most established products don’t get much beyond 90%. That has worked very well and, as I have said, the Anoro coverage has already started to happen very quickly and effectively. I am feeling pretty good about that and it is a shame that we obviously have to go through the trade, if I…

Simon Dingemans

Management

Thanks, Graham. As you pointed out, when we talked about guidance originally there were a number of moving parts at the top line. I think you will see from the statement today that that remains the case. Where we end up, particularly in relation to the existing US respiratory portfolio versus the new portfolio, and the pace of launches, will be a driver. The ultimate top line performance will be a significant factor in where we end up in the bottom line range. You also can see in the quarter how much more flexibility we are building into the company’s cost base, which showed through in the leverage in the first quarter. That will become an increasingly larger part of the drive and delivery against the range at the end of the year. Whether that is a little more operating leverage versus financial efficiency, we will have to see how that plays out during the course of the year and what the right investment decisions are – recognising the number of launches we have ongoing through the business. That is really how the mix will deliver ultimately, between four and eight.

Sir Andrew Witty

Management

Thanks, Simon. Next question.

Operator

Operator

It’s from the line of Tim Anderson, Sanford Bernstein, please go ahead. Tim Anderson – Sanford Bernstein: Thank you, I have two questions. In your view, what has been the catalyst for this suddenly intensified price competition in the US in Respiratory? There has been more than one competitor for a while and, historically, you have not really seen much price competition in the US. What has suddenly seemed to change here and how can this not be a harbinger of pressures to come in the US in other therapeutic areas? The second question is: I think investors would love to get your view of big pharma merger, especially because, theoretically at least, GSK could represent yet another tax inversion play if a US company wanted to do what Pfizer is trying to do with Astra. What does the future hold for GSK on this front? On established products, is any sort of disposal more likely to be a block trade or smaller, one-off disposals?

Sir Andrew Witty

Management

Thanks very much, Tim. On the price dynamic, there are two. I do not believe that these things will restrain themselves to the Respiratory market, and some of the elements I shall touch on now – at least one of them – we are already seeing play out in the diabetes market and other segments. Partly you have the phenomenon of the consolidation of the payors, and some of the competition, if I can put it that way, between various classes of payors, which are leading payors to think about how they can structure different propositions: whether it is high choice/higher price, or whether it is low choice/lower price, to put very simplistically the two ends of the continuum. With products like Advair as market leader but not alone and, if we look at other categories, you can see other market leaders being tackled in that way, some of that will go on. There are a relatively limited number of examples where you might anticipate that happening in the future but it is a phenomenon of the new marketplace. That is what has driven that step-down in market share which we saw from 1 January this year, and I am pleased to see that things have stabilised substantially since then. The second part of the price dynamic is much more of a GSK stimulated issue and I shall tell you what it is. It is because we have shown up with a bunch of new products and there are companies that are very keen to see us not succeed with those new products. Of course, they look for ways in which they can legitimately compete with us. The good news is that we are breaking through that. As I have just proven to you with Breo, and I believe you…

Operator

Operator

Next question is from the line of Dani Suarymper from Barclays. Dani Suarymper – Barclays: Yes, good afternoon. I want to clarify a little further on the Advair price mix situation. This is the first time, at least for the last 12 quarters, that we have seen negative price mix and I wonder whether there is any nuance between price and mix as you describe it: is it more mix, is it less price? Can you give us a little flavour around that? Also in relation to Anoro and your expectations for coverage levels, you said 70% Part D coverage for Breo after seven or eight months from launch. Where would you expect Anoro to be in that timeframe? Lastly, on Tanzeum, with the launch of that product in Europe and the US in the second half of the year, can you perhaps talk through your pricing strategy and your general thoughts around positioning as you launch into that marketplace?

Sir Andrew Witty

Management

Sure, so thanks Dani. Basically, The Advair price mix is mostly price, there is some mix but it is mostly price. As far as Anoro coverage, we are off to a very good start and I shall not tempt fate by giving you precise predictions, but that looks very encouraging, not just the coverage we are achieving but also the positioning we are achieving in the formularies that we have already secured, so I am pleased with that. We are not going to get into describing our positioning and pricing strategy for Tanzeum. As I touched on in the answer to Tim – the US, Europe, different pricing environment. We have been market leaders and been on the receiving end of some competitive activity. It may be that with Tanzeum we have the chance for a bit of role reversal. Next question please.

Operator

Operator

Thank you, our next question is from the line of Alexandra Hauber from UBS. Alexandra Hauber – UBS: Thank you for taking my questions, three questions please. Firstly, on the Consumer supply issue at the full year results you commented that these were essentially resolved. Now they continue. Are these similar, the same issues or new issues and if it is the latter, are you reviewing generally what the quality standards are and how confident are you in the timelines that this is not turning into a bigger problem? A second question on the Breo coverage. If you have 70% coverage from 1 May, is there any lag until we actually see the impacts on that in the marketplace? I am asking that because at the full-year call you said as of the beginning of February that you had 50% coverage and in light of your comment at that time, until that point, 70% of all scripts are rejected, I expected some debottlenecking to happen at the script level which we haven’t seen. We have seen growth but it has been pretty no change in the trajectory, so can you just describe any additional potential things that have to work through for us to see the change in the script trend? And the third question is just on Tivicay. Do you have any intelligence on the source of patients here? Are the majority of patients using this actually already in combination with Epzicom or are there other combinations?

Sir Andrew Witty

Management

Just on the last point, Tivicay source of patients is very mixed between Epzicom and Gilead co-prescription so actually a very, very nice balance; not at all segmented to one or the other, so just on that one. On Breo unusually Alexandra, your recollection is wrong. What I said at the full year was that we had 25% coverage at February and we aspired to have 50% by the mid-year. We have actually achieved 70% by May 1. There is a bit of a lag because it takes a while sometimes for the systems to turn up and turn on. We have seen one or two of the plans who actually came on stream in February, it took a month or so before their systems actually all switched across so it doesn’t all happen instantaneously. That’s the first thing to say. The second thing to say of course, it is important that we go back to the physicians and now tell them that they are covered and there is a cycle of making sure that folks are aware because it may be they tried, they couldn’t get coverage and we need to remind them that it is now time to try again. The most recent data I saw said that we were about 45% of scripts were being rejected and that was as of two or three weeks ago, so there are still a very substantial amount of scripts being rejected but as I have said there is a big jump up in coverage starting from today and we hope that that will start to free up. Just in terms of you are right, the shape of the curve hasn’t changed much but that is positive because normally the shape of the curve starts to plateau out at this stage,…

Operator

Operator

It’s from the line of Kerry Holford from Crédit Suisse, please go ahead. Kerry Holford – Crédit Suisse: Thank you and I have three questions, please. Firstly on Advair in the US, just backing out from the growth figures, it looks like there was a 10% negative stocking impact which follows the positive stocking impact in Q4 last year. I wondered if you could just comment on whether the Advair stock levels are now considered normal or whether we should see any more impact on this item going forwards in the course of this year. Secondly, you talked at length about the coverage for Breo and Medicare Part D now being 70% but I wonder if you are able to discuss with us what proportion of that is at Tier 2 versus 3. Lastly could you just run through the reasoning behind the decision not to file fluticasone furoate in Europe and what is now giving you greater confidence to move ahead with the Breo asthma filing in the U.S.S? Thank you.

Sir Andrew Witty

Management

The Breo asthma filing is based on the data we saw from the study which reported out not too long ago. As far as stocking levels in the US, Kerry, we are seeing stock levels for the whole portfolio essentially at almost all-time lows. Certainly, going back to the beginning of 2011 we haven’t seen inventory levels as low as they are now. Our portfolio level, and Advair is particularly no exception to this, we are seeing about a week and a half, almost two weeks less inventory in the market place than we saw back at the beginning of ‘11. We have certainly seen that come down by three quarters of a week perhaps in the last 12-18 months. It is very hard to tell you whether it is at normal levels, because everything looks abnormally low, but it is certainly low. We would be a little bit surprised if it went a lot lower, but we have seen a sustained destock over the last three or four years. As far as the fluticasone point is concerned, this is to do with European requirements to do additional paediatric work which we think are practically impossible to do. It is not a strategic decision, it is more an inability to we just can’t see a way to do the kind of work that people are asking us for. Hopefully that might change, but we have to see. And next question, please.

Operator

Operator

Sorry – our next question is from the line of Florent Cespedes from Exane BNP. Florent Cespedes – Exane BNP Paribas: Good afternoon gentlemen, thank you very much for taking my questions. Three quick ones, respiratory related questions. First, on Breo asthma, could you give us some element on the timing for this new indication in terms of size of Phase III and duration? The second question on Advair in Europe – how do you see Europe environment and trend for Advair given the entry of new “me too” drugs on the ICS LABA space? The last question on Anoro. Have you learnt from the Breo launch to prepare the launch of Anoro? What are the leading indicators and could you give us more colour on what you call the extremely good feedback from the recent launch? Thank you.

Sir Andrew Witty

Management

Yes, so just On the Anoro launch it is very early days, Florent. We have been out there about 10 days so we have no hard data yet, but we can see – I am not going to share with you, but we can see the pick-up of things like free trial offers and that kind of thing which we get in real time; those are very encouraging signals, but until we start to see prescription data in the next three to four weeks, difficult to say. We have a very good position in the commercial book of business. We have already started to win Part D book, all of which is quite different to where we were when we started Breo, although we have fixed most of that. It is very different to where we were when we started. All of that very encouraging. As far as Seretide is concerned in Europe, we are seeing good performance; basically flat-ish, perhaps a notch down on 1% on volume and 1% on price type of thing, but nothing very dramatic. Very minimal impact from copies thus far, certainly no change in trend compared to what we saw through last year. Good quarter for Europe and good quarter for Europe Seretide. As far as timing on Breo asthma, obviously the file – my expectation is that the regulators are obviously going to take their time to think about this; this is obviously an area which has historically attracted quite a lot of regulatory review, so I have no really clear view to give you. I wouldn’t guide you to think this is going to be a very rapid review, because obviously it is an area of particular regulatory focus, but we feel like we have a good data package and that is why we are going forward. And last question please.

Operator

Operator

Thank you, last question is from the line of Damien Conover from Morningstar. Damien Conover – Morningstar: Thanks for taking the question. One follow-up on Advair. While I appreciate a lot of moving parts with the pricing environment and when we look at AstraZeneca talking about pricing being largely flat in the US for Symbicort and when you look at the pricing for Advair down close to 7%, but yet Advair gets excluded from the Express Scripts formulary, I was wondering how you might reconcile those different viewpoints? Thank you.

Sir Andrew Witty

Management

Thanks Damien. There are two completely different issues at play here. The ESI piece, which as you know well is not just about Advair, but it affects products in other categories like diabetes, there is a whole dynamic there, which you all have a view on I’m sure, about what works in that marketplace. The difference about what you are seeing in pricing is pretty simple to explain. As I said at the beginning of the call, we have had historically a pretty disciplined, relatively lower level of discount in the marketplace than we believe most of our competitors. We don’t know absolutely, but that is our belief. We tend to have relatively flat discounts across the markets; everything I’m saying here is relative, so that when we do move the discount level in the way that we have done and we have needed to do to respond to some of the pressures that we are seeing in the marketplace, what that can do for us is not only increase our discount rate for the customer who we are negotiating with, and it also changes our best price discount rate for the Medicaid book of business with the government. Therefore, in the period when you breach that best price level, you get an extra discount level. If – and let’s hypothesize – if my competitor has a very broad range of discount rate already in the market place, and therefore has already set a best price which is relatively low, then they have a great deal of room for maneuver in their discount rate without triggering that extra best price in the extra discount level. If you have a much more controlled discount environment, as we historically have, then you are more likely to trigger that kind of double effect…