Earnings Labs

AstraZeneca PLC (AZN)

Q2 2013 Earnings Call· Thu, Aug 1, 2013

$189.31

+2.14%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+1.57%

1 Week

+0.14%

1 Month

-1.79%

vs S&P

+1.89%

Transcript

Pascal Soriot

Management

Hello everybody. It’s Pascal Soriot here from AstraZeneca. It’s really a pleasure to welcome you to Q2 and Half Year Conference. It is my pleasure to introduce some of our team members here. Simon Lowth, of course our CFO; but also Briggs Morrison, our EDP for Global Medical Development; and Marc Dunoyer, who is our EDP for Product Strategy, M&A and Business Development and we also here in the room together with some of our Finance and Investor Relations team members. So I’d like to start by first giving you a high-level summary of the highlights for the quarter as I see them. Second quarter revenue was down by 4% on a CER basis, $500 million decline coming from loss of exclusivity, which is very much inline with our expectations. Despite this we saw a good double-digit increase from our four key growth platforms – five growth platform, sorry, which provided in aggregate more than $400 million of incremental revenue in CER terms. I would also highlight our growing late-stage pipeline with two NDA submissions, 1 Phase III start and more to come later this year and importantly three late-stage projects that have been added to our pipeline via business development. The headline from a sales and profit view point, as you can see here our revenue was down for the quarter by 4% in constant currency terms of $6.2 billion. Our core operating profit was down 10% as we continue to invest behind our growth platforms in our pipeline. Our core EPS was down 21% at CER with the main driver beyond the operating profit line, a higher tax rate in the quarter compared to last year, where we had a $0.19 per share benefit from tax settlements. And after the usual core adjusting items, reported EPS was $0.66…

Simon Lowth

Management

Well thank you Pascal and good afternoon or good morning to everyone on the call. So I’m going to cover the second quarter P&L, I’ll briefly touch on our restructuring program. I’ll then cover the cash performance and the first interim dividend and then finally I’m going to close with our thoughts on guidance for the full-year. So let me now turn to the second quarter P&L. Am going to focus here on core margins and profit. The press release does of course contain all the strategy numbers and a detailed reconciliation to our core measures and then as with sales, when I refer to growth rates they will all be on a constant currency basis. Now Pascal has already covered the revenue performance which as you saw was down 4% to $6.2 billion. Core gross margin in the quarter was 82.3% of sales, now that’s up a 110 basis points compared to the second quarter last year. Core gross margin benefited from lower core Merck expense related to the second-option amendments that we implemented in the middle of last year, but the full-year results I mentioned that we would expect core gross margin this year to be below the level achieved in 2012, the math as you recall was 82.4% and that remains our view going forward. Core SG&A expense was up 6% in the quarter, it was down 2% in the first quarter which I flagged then was largely due to phasing. Core SG&A expense for the first half is up 2%.Now investments, in support of our growth platforms particularly in emerging markets, Brilinta and the diabetes franchise were only partially offset by benefits from restructuring and tight spending discipline in support of material brands and in developed markets. Core other income of $218 was 19% higher than…

Operator

Operator

Pascal Soriot

Management

Thank you very much, Simon. So now I'll invite you to ask your questions and maybe I could ask Tim Anderson from Sanford Bernstein to ask his question. Tim, over to you.

Tim Anderson - Sanford Bernstein

Management

Thank you very much. I have a few questions, modeling questions to start with. In our forecast at least of, as your company moves into 2014, we have SG&A and R&D declining year-on-year but your new guidance for 2013 raises the possibility that operational spending could actually increase in 2014, and I know you probably won't want to comment on 2014, but directionally maybe you can say whether this line of thinking is correct? Second question was on M&A. I know you kind of talked about this subject back in March, but can you refresh us on the upper limit of deal sizes you're considering? I've been under the impression that they're mostly bolt-on types of arrangements, is that still the plan going forward? And then last question is I'm wondering if you would be willing to say what the trough year for earnings for AstraZeneca is likely to be? Some analysts models show it happening in 2017, show it happening in 2019. I'm wondering if it could really be that far away.

Pascal Soriot

Management

Okay, Tim, thank you for those three questions. I'd ask Simon to address the first one and maybe you could also address the trough year question, Simon, if you don't mind.

Simon Lowth

Management

Certainly. Tim, thanks very much for the question. I mean I think certainly in terms of operating costs, as I mentioned, we have a significant restructuring program underway. I sort of mentioned that for you earlier. That program continues. It's very much on track and it's going to deliver reductions in our cost base and improvements in the flexibility of our cost base. In addition to that, we have a wide ranging series of productivity improvement programs underway across the business again, will improve our efficiency and give us the headroom to invest. We do see significant opportunities for continued growth behind our growth platforms and I indicated that we're going to sustain that investment where we can see that it drives long-term value and growth, so that's behind particularly sales and marketing costs but predominately, Tim, I mean there's some increase in sales and some selling resources, but there's also a significant investment in variable, promotional and (indiscernible) support, medical spend as well. So there's a high degree of flexibility behind that investment and we're putting in a targeted way during the course of this year. And then in addition to that, we've obviously brought in a number of late stage and later stage assets this year, which as I said, do bring some upward tension on our late stage development budget. And of course we've also, as Pascal described, had one or two progressions into late stage development and we hope to see that – some further late stage progressions during the course of this year. So we do see increased investment opportunity this year which is why we've moved our guidance in 2013. As we look into 2014, as you'd expect we'll update you with our full year results as we shaped up our plans for 2014.…

Briggs Morrison

Management

Thanks, Simon. That's very clear. And Tim just to repeat again what Simon said is that our guidance for 2014 we will precise it early next year, but what we said in March remains correct. We will keep targeting the pre R&D margin that Simon described for you and we will keep targeting a R&D budget that is moderately flat and so that's what we said in March and it remains valid. As far as M&A as we said before is also still valid and I think what we said was that we don't see the need for large acquisition for us to succeed. We believe we can actually succeed through acceleration of some of our pipelines, reshaping of our internal project of pipeline, accelerated business development which you called this bolt-on acquisitions or collaborations, some of those you've seen in the last few months and we keep doing this. So this is really our base plan is to get the best out of our own portfolio, complement this with business development activities and we believe we can actually succeed with that approach. Now that doesn't mean we'll not consider a larger acquisition if we – but we'll only consider this if we think we can add value. And if you look at all the business development initiatives we've launched in the last few months, those are projects where we think we can add value. We can add value because they are in our core therapy areas where we believe we know the market, we can add value in the way we develop those products, in the way we commercialize them and we will keep doing this. So if we find an acquisition of a larger size where we believe we can add value one way or another whether it's geographically driven or because of lack of abilities we'll do that. But it is not our best plan. The best plan is really our internal pipeline and business development activities.

Pascal Soriot

Management

Okay. So maybe I could ask (indiscernible) if you want to ask your question.

Unidentified Analyst

Management

Good morning. A couple of questions. First, you typically got a very large 60,000 patient child population ongoing for Brilinta. Could you remind us how many years of patent term extension you think Brilinta's eligible for? I’m just thinking about the period of economic for that drug given the investments taking place? Second on SAVOR, are there any circumstances that you feel the disclosure from that trial could be used to actually constrain (indiscernible) and Onglyza growth given the pressure particularly in Europe compares? Finally on tralokinumab could you comment whether you would consider licensing the compounds with another PD-1 aside from your own? And then finally just on the outlook for Symbicort in the U.S. and in Europe given the impending launch (indiscernible), to what extent can you anticipate the impact on volumes and pricing as GSK increased their assets and there's a new differentiated compound, how will that impact Symbicort over the near term? Thank you.

Pascal Soriot

Management

Thanks, (indiscernible). So maybe what I could do is ask Briggs, do you want to comment on (indiscernible) I mean the one thing I could do is tell you that we're (indiscernible) two collaborations with all the companies in term of combinations. We believe that (indiscernible) has potential for combinations with a variety of products in particular for sure PD-L1 or PD, but we certainly would not license this product out with combined effort. So, if you want to say a few words on same, Briggs and (indiscernible) as well.

Briggs Morrison

Management

Yeah. So, Andrew let me just finish off with Pascal’s comments on Treme. We think Treme is a very important part of our portfolio and we were not interested in licensing it out. We were quite interested in licensing it in actually. And so in combination with other things in our portfolio we think it's quite important and as Pascal said we have entertained and we continue to entertain overtures from others who want to partner with us. In terms of SAVOR, as Pascal said the full results that we presented as ESC at the end of August beginning of September, you can imagine from a 16,000 patient trial we’ve generated, we think the largest data set now on foreign inhibitors and are able to answer many of the questions that have been raised around this class. So we think that the ESC presentation will provide quite a bit of information. I think that your question was do we believe there is anything in there that would in anyway dampen the enthusiasm for the class as a whole? Again until you see all of the data, I don’t know if it's fair to have that conversation. We can talk about that once we have all had a chance to review the totality of the information.

Pascal Soriot

Management

Thank you. Briggs, let me just cover up the other two questions, I think one was Brilinta, and the patents, the expiries they range from 2018 to 2019 in Europe and up to 2021 in the U.S. we have filed for extensions. We don’t have the time yet in terms of the (indiscernible) of those extensions, but the extensions would extend the patent protection to 2023 and beyond in the various geographies. So we still have quite a number of years in front of us for – to gain a return out of this product. As far as [Bydureon] we certainly expect some impact of this class on Symbicort, but we in the short-term we don’t expect that there would be a very substantial impact because Symbicort is used for different type of patients who have a more advanced say form of the disease. So our assumption at this point is that [Bydureon] and other similar products will – sorry actually, Andrew I thought you're talking about LABA/LAMA, you’re talking about [Bydureon] the newer combination products, and I’ve got to start again. And [Bydureon] and essentially the expectation is that we will have an impact there for that one. The pricing I would imagine will be in the same range as Brilinta would be – as Symbicort would be, but the – and it will be competing with Symbicort, but it will also be competing with (indiscernible) and we have to see what they actually, I were to do from (indiscernible) United States, the launch has been delayed as you know, and the excess we’ll have to see what kind of excess this product can achieve. There will be for pricing competition we don’t believe that it will impact Symbicort so much, but there will be of course war in…

Pascal Soriot

Management

Thanks Peter. As far as Brilinta, our investment isn’t that substantial, and we’ll basically repeat what we said earlier which is we are going to invest very substantially this year to drive the penetration of this product, and we will actually look at how we’re progressing early next year. So we always said we have to wait till the last quarter of this year and therefore we look at it at the end of the year early next year and we decide what we do. Now if we were not on track with our plan we certainly would revisit -- we’d have to revisit what we do. We can’t wait until 2015 to adjust our investment if sales don’t come through. But so far I have to say we are on a good track. I think the problem is that everybody has to realize that there’s a big pool of prescriptions of course for [IPs]. First of all the big pool covers variety of indications, we only have access to one indication to the ACS, that’s the first point. And the second point is that the big pool of total prescriptions is filled by new prescriptions, and the only access we have is to this new prescriptions, new patients. We gather those new patients and then of course there is -- we loose prescriptions when patients are discharged. So many of the things we do are targeted at of course increasing our share of new prescriptions more or so retaining patients when they leave the hospital which the last part of our plan as you know was to put in place 200 critical care nurses in the United States. But I think it's important to remember when you look at the progression of the product to remember that we only…

Pascal Soriot

Management

So let me now move to James (indiscernible) with JPMorgan.

Unidentified Analyst

Management

Hello. Thanks for taking my questions. I just had a question on the pipeline on the FibroGen deal. I wanted the FG-4592, there's been a previous clinical hold to hepatitis and I know (indiscernible) withdrawn from the market and in that case, it was due to a worst (indiscernible). But in the two different indications you're going for, the pre-dialysis to post-dialysis. How competitive does this look in terms of the pre-dialysis? Could safety be an issue and for patients who are on dialysis, what sort of advantage having an oral product that patients are already getting dialysis?

Pascal Soriot

Management

Thanks, Jim, great question. Can I ask Briggs if you want to address this?

Briggs Morrison

Management

Yeah, let me talk specifically about the molecule that we're partnering with FibroGen on there. It was an earlier molecule they had that had an LFT issue but this molecule, in our review of the safety data and the trials they've done today, it actually looks quite clean to us so far. Just going into Phase III, some more data will come out. But from what we've seen so far, we think the molecule is clean. The question about the use in both dialysis and pre-dialysis clearly in the chronic kidney disease patients having something that's not parentally administered, we think provides an important advantage to physicians and the dialysis segment I think the safety questions around (indiscernible) opens up an issue for – an opportunity for new mechanisms. Again, this mechanism keeps your [EPO] levels almost at physiologic ranges which we think potentially could provide a safety advantage. So it is – all that tests was coming on the market. But from a medical and scientific point of view, I think there are theoretic advantages to this mechanism over parental administered uses.

Pascal Soriot

Management

Marc, do you want to add a few comments on this and the market (indiscernible) as well?

Marc Dunoyer

Management

Yes. Basically the pre-dialysis market will – if we succeed in all development programs it'd be about two-thirds and the dialysis market will be about one-third. So this is basically a different territory from the [operating].

Pascal Soriot

Management

We have a large number of patients in pre-dialysis who have an (indiscernible) should be treated, there are not treated because EPO is not necessarily the best response for this, and has a substantial opportunity there. In dialysis, of course it'd be different and EPO will still play a big role in the future even though you could also make an argument that if the patient is started on an oral agent when they get to dialysis, they might stay on it. But really the core of this program will be pre-dialysis. Should I now move to (indiscernible) at Goldman Sachs, (indiscernible), do you want to ask your question.

Unidentified Analyst

Management

I have three if I may. One, just a quick R&D question. I believe my understanding is when you bought (indiscernible) from Pfizer, they did retain the rights to combination therapies. I was just wondering if you would be able to confirm that. And if that is indeed the case, then did they retain rights to all combination therapies or only combination therapies that are included to other Pfizer compounds? Second, again on the immunotherapy side, recent updates on clinical trials seem to suggest that all of your trials for the (indiscernible) are either suspended or on hold. I was wondering if you might be able to confirm that and confirm that you haven't seen any new safety signals there. Third question on the SG&A level, I realized that you're guiding to a 48% to 52% pre-R&D margin for next year. But if you were to think about it in absolute dollar senses, can you help us think about costs that you are incurring this year that you may be able to roll off next year. But if I'm hearing you correctly, Pascal, you're kind of investing more behind Brilinta, you're investing more behind that but you said in July, should absolute levels of cost be same or higher than this year? Thank you.

Pascal Soriot

Management

Thank you. Can I start maybe with the general level questions, I mean do you want to address that one.

Simon Lowth

Management

Yes, certainly. I mean (indiscernible) as I mentioned for a combination of restructuring productivity improvements, efficiently care we are continuing to reduce the fixed cost space, so growing numbers, physical infrastructure, the fixed cost base, across SG&A particularly in the established markets and also in R&D and that's a trend that will continue on beyond '13 and into '14 and '15 as our productivity and restructuring programs progress. And therefore an increasing proportion of our cost base is pretty variable. What do I mean by that? I mean promotional spend, I mean external clinical project spends and also in fact we can move up and down sales resource in a pretty flexible variable way. So the increase this year relative to our expectations at the beginning of the year is coming as I said – selling activity, promotional spend and external clinical project spend. As we roll into 2014 in the same way that we have the flexibility to lift up our investment where we see good opportunity in that same way, we've got the ability to dial it down where we see opportunity diminished or indeed in saying if we see the opportunity there. It's a very flexible cost space. I'm not going to on this call look into 2014 and tell you exactly what the run rates are going to be. We'll be doing that at the full year results in January. But I think what I can leave you with is that the cost base is flexible and variable and we can dial it down or dial it up depending upon the opportunity within that overall frame of goals for our pre R&D margin. Pascal, back to you.

Pascal Soriot

Management

Thanks, Simon. In terms of your other two questions of the combination CRP rights we have to our service basically. This was a full acquisition. Having said that, indeed if Pfizer or any other company had a good combination proposal for us to propose and we've been in discussion with other companies, we would certainly consider it but it's a full acquisition rights for (indiscernible). And the other one is I hope I understood your question but if I understood it correctly it relates to moxetumomab and it's actually not on hold, it's in Phase III unless your question was about the OX40…

Unidentified Analyst

Management

It was about the OX40.

Pascal Soriot

Management

So essentially what we're doing here with OX40 is we're bringing a humanized version of OX40…

Briggs Morrison

Management

The current OX40 is not on clinical to my knowledge, (indiscernible). We have some drug supply issues that are delaying the progression of the program but not the safety hold.

Pascal Soriot

Management

And because we're developing this humanized product, we had delays in supply and therefore the (indiscernible) trials are not started yet. But there's no clinical hold. We'll double check this – maybe we could double check this and get back to you if what we tell you is not correct. But to my understanding there's no clinical hold.

Unidentified Analyst

Management

Okay.

Pascal Soriot

Management

There is an email question from (indiscernible). The question is what is your target for Brilinta in the U.S. in terms of the total market share? I don't have to answer this one because as you know we don't give specific guidance. I can only tell you as high as possible, but I don't know that that would satisfy you. So we typically don't give targets. If we gave you a target for share and prescription, it would be giving you a target for Brilinta sales. So I'm really sorry, I can't really be specific for that one. The only thing I can remind you is that we only consider this part as you know in the ACS segment and the ACS segment represents 20% of the total volume. So we only have access to 20% of the total volume. But that's as much as I can tell you. Maybe I can move on to Kerry Holford at Credit Suisse. Kerry do you want to go ahead.

Kerry Holford - Credit Suisse

Management

Thank you guys, three questions please. Firstly just quickly going back to operating costs, you talked a lot about SG&A and clearly it was higher than we’re anticipated in Q2 and you talked about that being part of the reason for higher cost guidance for the full-year. But I guess I’m interested to understand which of your franchises now require more promotional effort than you thought they would do, say three to six months ago. So you touch briefly on Diabetes, but I wonder where does the price has come to you? Secondly on Symbicort in the U.S., the sales were up inline with subscription growth suggesting they benefit from price and mix and I know you’ve got a (indiscernible) benefit from a list price expected year-on-year. Does that reflect increased rebate pressure or other stocking issues that we should be aware of them? And finally on the Pearl acquisition, just interested in hearing your thoughts on the competitive positioning of the lead product there, the twice daily LABA/LAMA which looks at least currently before the market. And also whether you can confirm whether the LABA compound have started Phase II, with you yet and when we might expect to see that later? Thank you.

Pascal Soriot

Management

So quite a number of questions, Kerry. So, let me maybe start with couple of comments on operating costs and Simon will also add few comments in a minute and then we talk a little on Pearl operating costs. I would say, the only place where we really can say surprise may not be the right word, but let’s say the landscape has changed compared to what we had in mind later last year when we designed our plans is really Diabetes, I mean, Brilinta is on track with what we had in mind. But diabetes suddenly the promotional pressure has increased and the market was, is a little bit slower than most people, I guess our peers and as we expected and the promotional spend has increased. : Now we also accept the fact that this is going to be very competitive. And the reason we went forward with this product is to maintain our presence in the field. Symbicort is a critical franchise for us. We believe we needed to be present in that LABA/LAMA market segment and that’s why we acquired Pearl. But as I said, we realize it’s going to be very competitive. Briggs do you want to add anything on LABA/LAMA, but first maybe Simon on the increased cost.

Simon Lowth

Management

Yeah, no I think the Kerry that the question you raise on costs around where the difference is versus our expectations at the beginning of the year and it surprises. And I think Pascal mentioned probably the most individually significant, which is that we’ve seen increased promotional cost across that, it isn’t we’re intending to respond to that and match in order to realize the full potential of our brands. But I’d say that we have a continual process of looking at the momentum in our different markets, developments in the markets and making decisions about where we lift investments, where there is a good opportunity. So, we put more resources into some of our emerging markets. You saw China performing very strongly where – ensure that we adequately resource that market and one or two other emerging markets. We’re seeing some positive developments in Japan for example, strong price in Nexium, but also are the two primary care brands Symbicort and Crestor and at the same time an opportunity to launch Forxiga, if we are successful with our filing there, alongside the (indiscernible). So we’re wanting to put a bit more resource behind those opportunities in Japan. Symbicort is performing well and so we does up a bit of promotional effort in certain markets with Symbicort. So, I think those are all areas that we’ve shown – taken some increase. It’s fair to say, there are also – and there is where we’ve taken some cost away, because we’ve seen markets being less promotionally responsive. As I stress throughout these are investments we’re making that we will dial up or dial down as the opportunities move. The other area perhaps we’ve not focused on is not [SG&A], it’s R&D. We spend a bit of time (indiscernible) SG&A. Of course you’ve seen and this is another important factor behind me of use on cost we’ve taken on board the series of late-stage projects. Briggs is bringing those into his development programs in the team and we need to and as we look into ’14, we will see to really prioritize our portfolio and spend, but clearly in the six months timeframe, that’s going to give us some upward tension. Such on the costs, I’ll just – Pascal just do it very quickly there was a question on Symbicort, I think question around the underlying drivers of the Symbicort U.S. revenue, which was up 16% in the quarter, prescriptions overall were up 16%. There was a very small destocking effect that really not material for the quarter. In terms of pricing, we did have – it’s a benefit of some mix effect from some good volume growth in some non-retail channels, but essentially the story for Symbicort is strong underlying growth in market share in a market that continue to show little bit of growth as well.

Pascal Soriot

Management

Thanks, Simon. So again, we dial up and down the investment, we hand various products for the year, but China was a big one that – the biggest one really at the end of the day, nobody expected Brilique not to be approved and I’m sure Novo expected it to be approved and launch it and when it didn’t get approved and Victoza and that being promoted by the sales force that was already to launch (indiscernible), so substantial increase in promotion or its we ended up having too much and we’re now matching, but certainly that was not in the plan. Do you want to cover the LABA/LAMA question?

Briggs Morrison

Management

Yeah, LABA is in Phase II. You can take exactly when we will be presenting data at scientific meetings, I would anticipate it probably wouldn’t be – at least the beginning of next year.

Unidentified Analyst

Management

Thank you. Got it. Okay.

Pascal Soriot

Management

Should I ask Jayesh that – Jayesh do you want to ask your question? Jayesh (indiscernible). He comes out of his question, so we may have addressed it. Sachin Jain with Bank of America. Sachin, do you want to go ahead?

Sachin Jain - Bank of America Merrill Lynch

Management

Hi. Thanks very much. Three product questions if I could. Firstly on Brilinta, the New to Brand chart for the U.S. you have is now a shared chart, not absolute script. So, firstly could you comment on absolute trends recently, which I think had been flat? And then secondly with the New to Brand market in the U.S., I think the overall market has been declining, is there any particular reasons for that and would you expect that to continue? Secondly on Onglyza as you look to increase SG&A, (indiscernible) your focus is there and the reason to the question is I think Merck is flagging market growth and chasing (indiscernible). I think Lilly’s commentary was more focused on the share gains and that commercial access improves. So just where is your focus and then a final pipeline question, benralizumab, I think you had flagged (indiscernible) expedite potential for Phase IIb data in asthma in the first half just wondering whether that data was in-house and whether we could see that nearer? Thank you very much.

Pascal Soriot

Management

Thanks, Sachin. Briggs, do you want to take the – that question?

Briggs Morrison

Management

The Phase IIb there for benralizumab as I’m pretty sure that it will be presented that year, so I don’t know for certain, but I’m – I think no. But what I can say is I’ve seen it and we’re just as bullish on the molecule as we were talk to you guys in March.

Pascal Soriot

Management

We get back to you as to when it's going to be presented, if we – as soon as we know to be honest, but I cant remember. But we send the data and we as Brigg said, we’re very confident in the data we saw in asthma. Okay, so we have the answer. Next year, I think yes. The second question you ask essentially relates to Brilinta and the share is increasing. You're right to say that another few weeks, the volume has been flattish, the market is actually – impacted the market. The total market is down and of course the total market – I think you got to look at it on a long-term trend basis not week-to-week basis. We had a few weeks of flattish volume growth. I focus on the market share and influencing that because that's really where we have the biggest progression we can make. We have no – we have looked at it, we have no specific reason why the market would be flattish to down in the United States, but it is true that the total AP volume has been relatively flat but the market share again keeps – still is going up. As far as Onglyza, our focus is – the primary focus is really access, making sure that we restore good access for this product and we will regain some of the access that has been challenged. It has been difficult for us and of course growing our market share. Those are the two focus areas. And to grow our share, we have basically increased our (indiscernible) in particular our sales force deployment has gone to Onglyza on one hand and [Brilinta] on the other hand and we have new sales force deployment from late June, early July in place. We should see the impact of those changes in the next few months. In fact in July we already had a slight impact on the market share of Onglyza as we could see. It's not only stabilized but we saw a slight pickup and very early days to say but certainly sales force investment and (indiscernible) priorities.

Sachin Jain - Bank of America Merrill Lynch

Management

To take a quick follow-on, sorry just on Brilinta when you say your focus is share and we think about your reflection comments and accessing (indiscernible) end of this year into next year, it's fair that you'd be looking for inflection of volume not just share related to whatever the market's doing.

Pascal Soriot

Management

Actually both. The thing is that the market – the total market is really not something we can influence and that first of all we – just to repeat, we only access 20% of the total volume so there's not much we can do to influence the entire class (indiscernible) market. There are so many other indications that we don't have yet but we cannot say where we're about. So we can't influence the overall market. So our real focus is growing our share in ACS and certainly growing that ACS segment from a volume viewpoint, but the priority is the market share. Of course if we had good share progression at the end of the year and the market was completely declining and our sales as a result were flattish or not growing, we would have to revisit the level of investment. But I would not try to conclude anything out of three weeks of flattish volume in the market. I've been around long enough and walking the U.S. long enough to learn to not overreact to three weeks of data points. So as long as you're market share goes in the right direction, I think for a new product like this one you stick to what you're doing. Now of course we'll have to monitor this over the next few months. That's the best I can tell you at this point.

Sachin Jain - Bank of America Merrill Lynch

Management

Okay, thank you very much.

Pascal Soriot

Management

Let me just move on to Mattias Häggblom at Danske Bank. Mattias, do you want to ask a question? Mattias Häggblom - Danske Bank: Thanks so much. Given that there are a number of omega three assets out there in various stage of development, I'd be interested to hear why (indiscernible) some would argue that there are other competitions to this? And secondly, when could theoretically a once daily fixed dose combination of Crestor and Epanova be on this market? And lastly, you've done a number of deals in cardiovascular and respiratory but no late to mid stage for oncology, an area you've emphasized repeatedly that you want to rejuvenate. So is it fair to assume that upcoming business development deals should have a high proportion of oncology deals going forward or has something changed?

Pascal Soriot

Management

Thanks, Mattias. Your first question is sort of answered by your second question in fact is that the combination of Crestor with Epanova is a very attractive aspect of this acquisition and Epanova is a once daily omega three that is therefore easy to combine with a once daily Crestor. So clearly our focus is on developing a fixed combination of Epanova and Crestor. I don't think we have communicated a date or have we a date for fixed combination. I think at some point in time we'll communicate this, but I can tell you this was a critical part of this acquisition to have a fixed combo on the market as quick as possible. It's actually part of the deal construct and our goal as you can imagine is to get that fixed combo in the marketplace before the patent expiry of Crestor in the United States. So with that I guess you can get a sense for when we'd expect to introduce it. The second question as far as deal, I think just a couple of points here. One is we said we would focus on oncology, respiratory and cardiovascular/metabolism and that's what we're doing. Then having said that basically, you have to – we focus on acquisitions where we believe we can add value as I said before. So you have to find these opportunities and you have to convince yourself you can add value. So certainly we're looking at oncology but we only do acquisitions of business development if we can add value to those. The second comment I would like to make is that we don't – the way we would build our pipeline is not only through business development, it is also through our internal pipeline and we've moved or we are moving (indiscernible) Phase III, we have moved moxetumomab in Phase III and (indiscernible) smaller opportunity but (indiscernible) we believe is a large opportunity. We're moving selumetinib in Phase III. We have immunotherapies which we have presented to you in March which we believe have the potential to move into Phase III relatively, rapidly. So over the next, say, year or so you should see a very different late stage oncology pipeline on the (indiscernible) very much for the progression of our internal pipeline. But again we'll keep looking for acquisitions. We just have to find the acquisitions that make sense and we think we can add value. The internal pipeline is certainly in oncology stronger than it is in cardiovascular/metabolism and I think we will see a very strong pipeline just based on what we have in our hands. Mattias Häggblom - Danske Bank: Thanks so much.

Pascal Soriot

Management

Anything Briggs you would want to add…?

Briggs Morrison

Management

We did emphasize in March that when you looked at our pipeline what was missing was cardiovascular/metabolic and so we've put a lot of emphasis on trying to fill that hole. But the Phase I and Phase II with our own products and oncology is actually a much stronger part of our portfolio.

Pascal Soriot

Management

Okay. Let me move on to (indiscernible) you want to go ahead.

Unidentified Analyst

Management

Thanks. Can you say anything about the size of the Phase III programs that you're now targeting both for the (indiscernible), but maybe will support the Pearl develops and I guess (indiscernible) double acting product but also the triple actually and if you could shed some light there or the magnitude of trials that you will now undertake?

Pascal Soriot

Management

Very good question and Briggs do you want to take that? So on the [12 for 1], really the focus would have to be on the LAMA/LABA because the triple combination is a little bit away. And before it impacts us on the (indiscernible) front, it will be a little bit of time. But finally in the short term, it's the dual combination and the omega three programs.

Briggs Morrison

Management

Yeah, so the dual combination LAMA/LABA I would say is sort of ballpark comparable to what a Phase III program would be on the order of 2,000 or 3,000 patients. The triple therapy is a little further behind, so we don't really have the sizing of that yet. Then as you know they've already – they've done a fabulous job and they've already filed for their high triglyceride indication in the U.S., the big next piece of investment there is both the Crestor combination and of course the outcomes trial. So the outcomes trial for – given what they've told us and (indiscernible) most likely that will get underway this year. So over the next period that's another cardiovascular outcomes trial type expense that is similar to what we've seen in many of the other cardiovascular outcomes trial as we've done over the past couple of years and we have ongoing.

Pascal Soriot

Management

Thanks, Briggs. We have an email question from Christopher (indiscernible) from Carnegie. And the question is given the objection of a higher operating costs for this year, how should we think about costs going forward? Can you compensate an underlying expansion by the savings from restructuring? In the past year from restructuring in the past year, sorry, are you entering a bit of forced increase operating costs? Simon do you want to take this?

Simon Lowth

Management

Certainly. Christopher thanks for the question. It is we’ve responded to a number of questions along this theme on the call. But I think the – two, three points, I mean firstly we have a restructuring in productivity program underway and that will deliver significant benefits and we’re always looking to identify opportunities to find sort of underlying efficiencies in our business, that will continue and I think we drive that Christopher somewhat independent where we see short-term investment opportunities, that’s about creating a very efficient and flexible cost base to the long-term. Secondly, as we look at opportunities and imperatives to invest behind our growth platforms in late stage development, of course there is another side of that, which is we’re also looking at where can we deprioritize investment resource which is not delivered a sufficient return where – or where we can sustain the same level of sales activity with a low level of resource. And we will continue to seek out those opportunities and yes that provides an opportunity over a period to – if you like recycle over it reallocate resource from one area into another, we will actively – and always looking at those opportunities. And just the third thing as I’ve again stressed on the call, the investment we’re making step upping cost is predominantly of a variable nature. We will invest where we see the opportunity equally, we got the ability to dial it up or dial it down, I can say if that took a slight objection to toward a period of forced operating costs increase, these are investments in cost to drive future growth and value and what we’re absolutely doing is making that investment to drive long-term growth and value and in fact put some pressure on the operating costs base and margin in the short-term maritime window such as this year, that’s something we’re prepared to do because we believe its right for the long-term of the business. So Christopher hope that that helps you with your question. We got another question from Mark Clark from Deutsche Bank, on margins which I’m – we probably, I think Pascal need to make the last question. Should I do with this one and then…

Pascal Soriot

Management

Yes, (indiscernible) doing with this.

Simon Lowth

Operator

Okay. So Mark you’ve asked whether the core pre-R&D EBIT margin still be about 48% threshold, even with higher operating expense growth and as I’ve said, we provided that view back at our Investor Day between 48% and 52% and that remains our view as we look forward and so that is unchanged Mark and I think that probably brings up Q&A to a close. Pascal if you …?