AstraZeneca Group plc (NYSE:AZN)
Q3 2013 Results Earnings Call
October 31, 2013, 08:00 PM ET
Pascal Soriot - Chief Executive Officer
Simon Lowth - Chief Financial Officer
Briggs Morrison - Chief Medical Officer, Executive Vice President, Global Medical Development
Marc Dunoyer - Executive Vice President, Product Strategy, M&A and Business Development and New Chief Financial Officer
James Gordon - JPMorgan
Tim Anderson - Sanford C. Bernstein & Company, Inc
Amy Walker - Morgan Stanley
Andrew Baum - Citigroup
Kerry Holford - Credit Suisse
Lars Hevreng - SEB
Seamus Fernandez - Leerink Swann & Company
Mark Clark - Deutsche Bank
Damien Conover - Morningstar
Naresh Chouhan - Liberum Capital Limited
Hello everybody. It's Pascal Soriot here from AstraZeneca. It's really a pleasure to welcome you to our Q3 and Nine Months Conference. It's my pleasure to introduce some of our team members here present with me in the room. We have Simon Lowth, of course, our CFO. We also have Briggs Morrison, our CMO and our EVP for Global Medical Development and, finally, Mark Dunoyer, who has been our EVP for Product Strategy, M&A and Business Development, and is our newly appointed CFO. We also are here in the room together with some of our finance and investor relations team members.
All right. So let me just move on to the first slide. Our plan today is to provide a business performance update focused on the third-quarter financial results, while also providing a progress report on the strategic priorities that we are working towards.
On business performance, third-quarter revenue was down 4% and again, as in previous quarters, largely due to the loss of exclusivity on some of our products. We estimate around $350 million in impact this quarter. Our five growth platforms grew productivity by about 8%. And as you can see here the emerging markets grow by 5% and so did Japan. We experienced growth in all five of these growth platform.
We made a lot of good progress this year with our pipeline. Sorry about this, we started Phase III development on three NMEs. We filed three regulatory applications in the quarter and we also announced four business development transactions, so to support our ever-deepening oncology portfolio.
I will now turn to the headline financial results for the quarter. And for the most part I will be focusing on performance on a constant currency basis. Simon will of course make more detailed remarks on the P&L in his presentation. I'd also like to attract your attention that we are reconciling our financial guidance for the full year.
So results in the third quarter was down -- revenue in the third quarter was down 4% in constant currency terms to $6.25 billion. That is an improvement from the 7% decline from the year to date, reflecting the moderating trend on the revenue impact from losses of exclusivity.
We said at the half year that we expected to see an uptick in core operating costs in the quarter as we continue to invest behind our growth platforms and our pipeline. Core operating costs that is, R&D and SG&A combined, were up 9%. That is higher than the nine-month figure. And as Simon will show later, some of that is phasing of last year's spend. As a result, core operating profit and core EPS declined more than revenue. Core EPS was $1.21, which is down 26%.
Of course you will remember that the third quarter last year we had the proceeds from the sale of Nexium OTC rights, which flattened results by $0.16 per share. This accounted for nine percentage points of the declining core EPS for the quarter. After the usual core adjusting items reported EPS was $0.99, a 16% decrease. That is better than the core EPS performance due to the intangible asset impairment related to olaparib, which was reversed following the resumption of Phase III development earlier in the quarter.
I will now look at revenue on original basis. Moving to the next slide, as I said earlier, we tend to focus our business performance discussions on a constant currency basis so as to have a true picture of underlying performance. However, it is important not to lose sight of the impact that currency movements also have in our business. But clearly, when they are concentrated in one market, Japan, where we have lost $150 million to the yen's weakness in Q3 alone and more than $360 million year to date.
Looking at revenue on a constant currency basis, the U.S. was down 8%. Loss of exclusivity accounted for around half of the decline. Nexium were also -- Nexium and Crestor were also down in the quarter. Also, both products were somewhat affected by destocking in the quarter. The declines were partially offset by growth for Symbicort, the diabetes franchise, FluMist and Brilinta. Revenue in Europe was down 4% on exclusivity losses, partially offset by revenue increases from Brilique and diabetes products.
In the established rest of the world, revenue was down 8%, largely due to generic competition for Nexium in Canada and for Crestor in Canada and Australia where generics entered the market and media. In Japan, revenue increased by 5%. There's always a bit of knowledge in the reported numbers as several of our key products have partners where the timing of our shipments to them can markedly influence the quality trend. But in terms of in-market demand, as you can see on this slide, we continue to drive strong volume market share in Japan with increases for Nexium, Crestor and Symbicort, irrespective of the shipping pattern.
Revenue in the emerging markets was up 5% in the third quarter including a 13% increase in China, which was impacted by some inventory destocking in the quarter. As far as China, we have the second largest international pharmaceutical market in that country -- firm in that country. And our year-to-date growth was 18.5% which ranks as fourth. Most of the data is pretty volatile. And as you can see here the August data shows a slowdown in the market, but we still outperformed most of our peers and September looks to be back on track.
Another factor to keep in mind when looking at our emerging markets business is that the quality sales evolution in 2012 was impacted by the supply chain issues we encountered last year, with sales depressed in the first half and with recovery in the second half. For the full year, we expect a high single-digit growth rate in the emerging markets.
I will now turn to the three product franchises amongst our five growth platforms. And let me start first with Brilinta. Brilinta revenue in the quarter was $75 million, up from $24 million last year. In the U.S., we're driving the execution of our performance acceleration plan, while we make steady progress in our rest of the world markets, in particular in Europe.
In the U.S., the performance plan includes new promotional campaigns with sharper differentiation and a strong competitive focus. The addition of the primary care sales support to [implement the in-hospital] selling activities so that we manage the continuity of care from patient initiation in the cath lab through to discharge in the full cost of chronic outpatient treatment. We also have the transition of care specialists, the 200 person force of former cardiac nurses that are now fully deployed since the beginning of the third quarter. We finished this in July.
We've improved our [formider] access in managed care, and we are also launching retail stocking programs to make sure that there is Brilinta on the pharmacy shelf when the patients get their first prescription filled. As I said when we launched these programs, we expect them to drive performance throughout the back end of this year. At the full-year results in the early part of next year we will make an assessment of the Q4 performance and make any adjustments to our plan in the light of that review.
Let me move to the next slide and show you that our MBX, as far as new to brand prescription share, we continue to see steady growth with Brilinta in the United States. We've been adding somewhere between 70 and 100 basis points in share each quarter, which is now up to 6.3%. And that is our share of the total new starts for all indications, not just the ACS indication that is our label, and which we are currently limited to.
Total prescriptions, of course, lagged the new brand to share but are also steadily growing. And it's important to see the lag between the 6.3% you see here on the 1.6% total script. It takes some time for total scripts to catch up with new scripts, of course.
In Europe, as you see here, the market share trends in the larger markets are also continuing in the right direction. We're now among the three global oral anti-platelet agents. And we are number two in Germany, in Italy and in the U.K. and we continue to gain ground in France. And it's not only in Europe. We are also number two in Canada and in Australia behind [copidadrel]. So, as you can see, good progress in a variety of markets around the world, in particular in Europe.
If I move now to the diabetes franchise, revenue from our share of the Alliance reached $206 million in the quarter. Of course, some of the growth is compared to only a partial quarter of revenue in 2012 for Byetta and Bydureon in the U.S. And we only started reporting revenue in the rest of the world in April when we took over from Lilly.
If I look at the Onglyza performance, you can see the yellow line on the chart is a new-to-brand share for the franchise. You can clearly see the decline in new-to-brand prescription share in the fourth quarter of last year and the first quarter of this year. An important driver of this was the changes in our formulary status in some managed care plans as well as the increased competitive intensity for the DPV4 class. We've maintained a relatively stable new-to-brand prescription share, hovering around 16% despite the launch of new entrants. So you can see here we have stability over the last few months in our prescription share for Onglyza.
So I now move to the Exenetide family share, you can see that after many weeks of declining new-to-brand share in the U.S., we started to see some improvements in the quarter based on growth for Bydureon and some stabilization of the Byetta declines, as we fully integrated our combined salesforce and sharpened our brand positioning. So, some good news for this Exenetide family.
Let me now move to Forxiga. For Forxiga, it's very early days. Of course we're seeing good physician acceptance in Europe, but it is also a very challenging reimbursement environment, especially in Germany. In the U.S., we're looking forward to an advisory committee in December ahead of the January 11 PDUFA date for review of the NDA.
There's no doubt that with growing prevalence of Type II Diabetes across the globe, it will continue to be a long-term driver of growth. Because it does consume an increasing share of available healthcare resources, governments and payers are ratcheting up the price per share in the industry. Combined with increasing competitive intensity, this is affecting performance in the short term. But we are in diabetes for the long haul and we are determined to be a competitor in that market.
Let me move to Symbicort. And Symbicort continues its strong performance across the globe, with sales up 7% to nearly $840 million. If we look at the U.S. share trend, it is still very strong. Share of new starts for combination CRP are up almost 3.5 points this year. Total prescriptions are up 18% compared with just 2% for the market. Very good results in the U.S. for Symbicort.
Let me now move to our scientific leadership agenda. We've made a lot of progress since our last pipeline update at the half year. We had three regulatory filings accepted for review. The U.S. NDA for Epanova for the treatment of patients with severe hypertriglyceridemia was accepted for review by the FDA. The European MAA for naloxegol for the treatment of opioid-induced constipation was filed, and we are waiting acceptance by the FDA. The European MAA for olaparib was accepted for review. Here we filed based upon the results of Phase II studies in BRCA mutated platinum insensitive relapses serous ovarian cancer.
We've also had three new Phase III starts for NMEs. We started the SOLO 1 and the SOLO 2 Phase III pivotal trials for olaparib and we started a Phase III program in gastric cancer in Asian patients, called the GOLD study. We initiated a Phase III program for selumetinib in second-line [CRNP] patients with advanced or metastatic non-small cell lung cancer. Those tumors are KRAS mutation positive.
And just this week, we began a Phase III program for benralizumab, a [potent] inhibitor of IL-5. The first study in the program is designed to determine whether benralizumab reduces the number of exacerbations in patients with severe asthma that remains uncontrolled, despite receiving high doses of inhaled corticosteroids in combination with a second controller such as long-acting beta agonist.
We started the year with six new molecule entities in our late-stage pipeline. Since then, unfortunately, we lost Fostamatinib. But we added two more through business development. And we progressed four more NMEs into Phase III clinical trials. So that our late-stage pipeline has grown to NMEs and is in Phase III or in registration.
We remain active on the business development front and we've recently entered into four transactions that will significantly complement our in-house efforts in oncology. The acquisition of ImpliMed adds another immunotherapy mechanism of PD1 monoclonal antibody to our increasingly comprehensive [anti-c] portfolio. We entered into a world-wide licensing agreement with Merck to develop and market MK1775, a small molecule inhibitor of WEE1 kinase, which is currently in Phase IIa clinical studies in combination with standard of care for the treatment of patients with certain types of ovarian cancer.
Our acquisition of Spirogen will depend our own in-house technology platform in the area of antibody drug conjugates. In [parlaid] we are collaborating with an affiliate of Spirogen, ADC Therapeutics, where we can select two preclinical ADC programs for development and commercialization. And, finally, our oncology portfolio in Japan will be strengthened by a collaboration with Janssen to co-promote Abiraterone acetate, their innovative treatment for prostate cancer. This is a close-to-market opportunity as the regulatory application for Abiraterone acetate was submitted in July of this year.
All-in all, it has been a very productive quarter as we strive to achieve scientific leadership and advance our pipeline. I'm actually going to stop here and turn it over to Simon who will take you through the third-quarter financial performance, after which we will hold a Q&A session.
Simon, over to you.
Well, thank you, Pascal. And good morning and good afternoon to everyone on the call. So I'm going to cover the third quarter P&L, I'll briefly touch on restructuring and on our cash performance. And then finally, I will close with our thoughts on guidance for the full year. Turning first to the third quarter P&L and I'm going to focus here on the core margins and profit. Of course the press release does contain the statutory numbers and indeed a detailed reconciliation of those to the core measures. And when I refer to growth rates they are all going to be on a constant currency basis.
Core gross margin in the quarter was 82.4% of sales. That is down 120 basis points compared with the third quarter last year with an unfavorable product mix contributing to the decline. Over the last several quarters, core gross margin has benefited from lower core Merck expense that's related to the second option amendments implemented in the middle of last year. But that affect has now annualized.
The expenditures on core SG&A were $2.2 billion, in line with the stepped up levels of investment behind Brilinta, behind the diabetes franchise in emerging markets that commenced in the second quarter this year. If we look at the quarterly SG&A expenditures for the last seven quarters, you can see that spend in absolute terms is pretty level in both Q2 and Q3 this year. Part of the explanation for the pop-up to a double-digit increase lies in the quarterly patterns in 2012. You can see that Q3 last year was the lowest quarter of SG&A spend last year. So that provides you with some context for the 11% growth rate in this quarter.
You will also note that the fourth quarter in 2012 shows the customary seasonal move up in spend, which is a fairly well-established pattern for us. So I'd also expect to see this pattern repeat itself in the fourth quarter this year. Core other income of $176 million was 60% lower than last year. And as Pascal already noted in his review of the headline results, that's due to the $250 million proceeds from the sale of Nexium OTC rights in the third quarter last year. I'll come back to core other income when I review our guidance for the full year.
Moving on down the P&L that leads to a core pre-R&D operating margin of 49.4% of revenue. That's 960 basis points lower than last year's level. But the decline was largely driven by the higher core SG&A expense, and of course the significantly lower core other income, with lower core gross margins also a contributing factor.
Our core R&D investment was up 7% in the quarter, as increased spending on in-licensed, acquired or partnered projects was partially offset by productivity savings from our ongoing restructuring programs. In fact, productivity and restructuring programs are providing some of the headroom to invest not just in the pipeline, but also in the sales and marketing support behind our growth platforms.
However, given the opportunities that we see to drive growth and value, we have guided to an increase in core operating costs. That's the combination of core SG&A and core R&D expenses. And we expect that the increase in core operating costs for the full year on a constant currency basis will be towards the upper end of our low to mid single-digit guidance range.
Core operating profit was slightly more than $2 billion in the quarter, 29% lower than last year. But as I've already mentioned around nine percentage points of this was related to the Nexium OTC proceeds in the prior year. Core operating margin was 32.4% of revenue, 11.4 percentage points lower than last year, the results of the decline in core pre-R&D operating margin combined with the higher core R&D expense as a percent of revenue.
Now just a brief word on restructuring. Here, we've simply refreshed this slide from the last time to include the charges for the Phase 4 restructuring program that we took in the third quarter. You'll see that the year-to-date total is just over $1 billion of the $1.3 billion that we expect to charge this year. The program remains on track to deliver the $800 million per annum in benefits by the end of 2016.
Now turning to cash. Cash generated from operating activities was $4.9 billion for the nine months compared with $4.1 billion in the prior period last year. Lower tax and interest payments and improvements in timing benefits in working capital partially offset the lower operating profit in the nine months of 2013, which included some higher non-cash costs, while the lump sum pension contributions drove higher outflows in the prior year.
Our cash generation supports our commitment to our progressive dividend policy, whilst also providing the resources to invest in the business. Cash outlays on acquisitions were $825 million and net intangible investments of $913 million includes the various up fronts for licensing, investments in IT, as well as for the Merck arrangements.
So, let me conclude my remarks with our thoughts for guidance for the full year. As expected, the revenue impact from the loss of exclusivity has continued to moderate sequentially through the first three quarters of the year, with revenue for the nine months down 7% in constant currency terms. Based on the performance to date and the outlook for the remainder of the year, we continue to anticipate a mid to high single-digit decline in revenue on a constant currency basis for the full year. On core operating costs, the slide here simply reiterates what I said earlier, an increase for the full year towards the upper end of our low to mid single-digit guidance range.
Core other income is a change. We had previously guided for something under $600 million. Based on performance to date and the outlook for the remainder of the year, core other income is now expected to be around $700 million providing some mitigation to the core operating costs.
With a revenue and a cost profile in line with guidance, the Company continues to expect core earnings per share to decline at a rate that is significantly higher than the decline in revenue in 2013. Financial guidance for 2013 is being based on January 2013 average exchange rates for our principal currencies movements, versus guidance rates have lowered revenue by around 2% and core earnings per share by around 3% for the nine months.
I'll now hand it back to Pascal, who will chair the Q&A session.
Thank you, Simon, for this very comprehensive review of our third-quarter performance, which was very much in line with what we expected given the impact of loss of exclusivity on the top line. Before we open to your questions, I would like to say a few words of thanks to Simon, for his last day is with AstraZeneca today. Simon has made a very significant and lasting contribution to AZ, helping put the Company on a stronger footing for the future.
I know that I speak on behalf of everyone at AstraZeneca in wishing him well in the next chapter of his career. And I can say that on a personal level, I will miss him very much. I'm also, of course, delighted to welcome Marc Dunoyer into his new role of CFO starting tomorrow. Marc brings a rare blend of financial business and science experience that will be critical in his role as we focus on delivering against our strategy.
So now let me take your questions, if I may call for the first question, please?
Question-and Answer Session
So the first question is from James Gordon at JPMorgan. James, do you want to go ahead?
James Gordon - JPMorgan
Hello. Thanks for taking my questions. I had two legal questions and one pipeline question. One legal question was about Pulmicort Respules. So I saw you announced last night that you'd won your appeal. But the release refers to the case being remanded for further proceedings. So the question is, what's next in this case, or what could happen next. And how confident are you now that we won't see the other operating income line disappear, that that actually could continue out to mid 2018?
And the other legal question was on Brilinta. In the release you mentioned the investigation from the DOJ into the PLATO study. Is that the investigation to do with events in Eastern Europe and Poland and Hungary? Is that -- what exactly are the DOJ investigating?
And then just one pipeline question, which was benralizumab, so your IR5 has gone to Phase III. You're about two years behind GSK and Teva's IR5s. I think your product target is the cytokine rather than the receptor. But are there reasons to think this would be a differentiated product versus those other two products? Are you going for a different population or anything like that?
Okay, thank you, James. Simon, do you want to take the first question, the Pulmicort question? And maybe, Briggs, you could take the pipeline question and the Brilinta study question?
Yes certainly, well thanks, James for the question. So, on Pulmicort, you'll have seen from our release that the Court of Appeals reversed and, as you said, remanded for further proceedings a trial court decision that the generics didn't infringe the 834 patent. But the Court of Appeals upheld, as you saw, the 603.
In terms of next steps, in the legal matter, we're obviously reviewing the decision. And we will be working through exactly what the next steps in the litigation process are in addition and not therefore able to give further information on that at this point.
The other aspect is that, as you'll recall, the Court of Appeals enjoined the generics from entering the market during the pendency of appeal. And a mandate hasn't yet been issued from that court. Upon remand, we'll just seek to extend the injunction during the pendency of further proceedings before any trial court. So that's an update on Pulmicort. Briggs, over to you.
Sure. James, thanks for your questions. Let me first take the benralizumab question. I think, if I heard the way you phrased it, I think you had it backwards. Our antibody targets the receptor and through ADCC enables depletion of peripheral eosinophils and the other molecules target the ligand.
What the differentiation will be, the clinical program will define. Obviously we're hopeful that because of the more profound depletion pharmaco-dynamically that we will see improvements in exacerbations and potentially also in FEV1 asthma symptoms, nighttime awakenings, things like that. So the program is set up in a way that hopefully, if that differentiation is there, it will be revealed through careful experimentation.
The question about Brilinta, I think all we can really say is that on October 21, we did get a civil investigative demand from the US Department of Justice. It is regarding PLATO, the clinical pivotal trial for the approval of Brilinta. We'll of course cooperate with the inquiry. And we really can't give any details on that ongoing investigation.
I think it's important that we re-emphasize that we have full confidence in the PLATO trial. It was, we believe, well conducted in collaboration with a number of strong academic groups. We had an independent data safety monitoring board. The FDA obviously rigorously reviewed that before they approved the product. And that's about all I can say about the DOJ request.
Thanks, Briggs. The next question is from Tim Anderson at Sanford Bernstein. Tim, do you want to ask your question?
Tim Anderson - Sanford C. Bernstein
Yes, thank you very much. It's a pipeline question, the first one is. Can you map out important news flow from here with your immuno-oncology assets, specifically your PDL1 and tremelimumab. And, importantly, on those two products can you talk about potential filing time lines in their first indications? So, when would that possibly occur, roughly?
And second question is, when you give earnings guidance for 2014, presumably in January, is that likely going to be qualitative like it was this year where all you'll talk about is earnings growth relative to revenue growth? And are you yet willing to identify for investors what you think will be the trough year in terms of revenues or earnings?
Okay, thanks, Tim. Great questions. The second one seems to be a question we've had a few times before. So Briggs, could you address the first one, the immunotherapy question?
Sure. Tim, thanks very much for the question. It's exciting to have someone ask us a question about the filing dates for PDL1 when we've reported at this point a small number of patients in Phase I. So obviously, you see the same potential that we do. But I would just comment that we are in the early stages of our PDL1 program and I don't think at this point we can forecast when we might be able to file. That program is still evolving.
As you know from I'm sure your search of clinicaltrials.gov, tremelimumab is in a Phase II trial, for mesothelioma. There was a recent publication showing some interesting early signs for treme in mesothelioma. But, again, I think it's a little early for us to tell you what the filing dates might be for that. And, of course, we're also just starting up combination programs with those two molecules. So I think it's a little early to tell you what the filing dates. In terms of news flow, obviously we would hope that there would be some additional information at ASCO in 2014 at the end of June as usual.
Thanks, Briggs. We shared some additional clinical data at the ASCO. The only thing I would add as far as our filing strategy is we're looking at all of the options that, of course, as you can imagine, would help us bring this product to patients as quickly as possible. But as Briggs said, it's a bit early and essentially our clinical data will guide our strategy. Simon, do you want to take the other question?
Yes, certainly, Tim. These questions obviously that you and I have debated and others over the last year or so. And indeed, I think we address these questions at our Investor Day. And certainly I think our thinking hasn't really changed since that time.
And the answer to your two questions, the one about annual earnings guidance and secondly about trough year, to some extent they are closely linked in the same core thinking. The success of our Company is going to be driven by our ability to grow and drive the growth in our growth platforms, the five key growth platforms and to accelerate the development of our pipeline. And you've seen, I think, good progress on that. That would drive the revenue growth.
We will invest hard behind securing that growth. And that will get led on top of the remainder of the portfolio which comprises a pretty well-established stable revenue of mature products. And then obviously the key expiring brands of Nexium, Crestor and Seroquel XR.
Exactly where that growth overtakes the decline on expiration is going to be a function of our success in driving the top line. And we don't measure the success of the Company by a particular 12-month window in which a trough might occur and we'll grow from. So we're not going to declare a specific particular date in time. We're building a Company for success for the long term.
And really the same thinking, then, flows back to our annual earnings guidance. The earnings in a particular year are going to be driven by our success in growing the revenue line, protecting the mature portfolio. The costs -- we're driving efficiencies in every area of our business. We've demonstrated we can do that. We've sustained high margins through a challenging period. But we're also committed to invest. And we want to ensure that we invest behind the opportunities as we see them.
And that applies within the year so the earnings in the year are going to be a function of the performance in driving the top line, and the investment decisions that confront us as we go through the year. And the resulting EPS, therefore, is going to be a function of revenue and the investment. And that's why we guided this year on our revenue, and why we guided to movement in cost independently. And I imagine that the same thinking will continue and be shared with the market at the beginning of January. But obviously Pasca and, indeed, Marc will have a chance to show you updated thinking at that time.
Thanks, Simon. As you can see Simon is as passionate about AZ as he was several months ago. It's really good to see. The next question is from Amy Walker at Morgan Stanley. Go ahead, please.
Amy Walker - Morgan Stanley
I have three questions, if I may, please. The first one is that I think you mentioned in the second quarter that diabetes is the lion's share of the incremental operating cost spend in your revised guidance. But diabetes sales in the third quarter still came in some way below consensus expectations. And I think one of your competitors in Europe seems to have had a surprisingly weak quarter, as well. Can you just talk about how your overall revenue share within the market is developing and what you expect to be able to achieve with the higher spend than you'd originally budgeted for. And do you see any risk that there could be even more investment in absolute terms on a quarter-by-quarter basis required in diabetes beyond the end of this year?
So, that's the first question. The second question, in view of the FDA's recent decision regarding the [stepper] from amarin and the need for CV outcome study, do you expect to have the outcomes trial data available ahead of your filing for the Crestor epanova combination? And also, do you see any risk to your recent epanova filing in the high triglycerides around the potential need for an outcomes study in that indication?
And the last question, I'm sorry to come back to the Department of Justice investigation. I wondered if you could tell us is it having any impact on your activities in Brilinta at all from a sales perspective in the near term? Are there any restrictions that have been enforced on you as a result of that investigation? Thanks very much.
Thanks, Amy. Actually, Briggs, maybe I'll ask you in a minute to address the amarin question. In fact, we had a similar question received by e-mail from Mattias Haggblom, so hopefully we can address both at the same time, if you don't mind. Amy, let me just quickly cover the DOJ question. We haven't got any restriction on sale or promotion of Brilinta as a result of this investigation. As you can imagine, we support the investigation and cooperate as much as necessary. There's no impact we can see on our sales and no restriction to our promotional activities.
As far as diabetes, we are in the launch phase with diabetes. We have several products that require promotion. There's a very competitive marketplace. And some of those products are in launch phase or relaunch phase. Forxiga in Europe, for instance, is being launched.
So that explains why the investment is very substantial, combination of this launching period and the competitive intensity. I would say, overall, as you saw a minute ago, our market share with Onglyza has stabilized in the United States. And we can see that the share of the [exanta] family is slowly picking up. It's stabilizing and picking up. Byetta has stabilized and Bydureon is growing. So, with that franchise, we've got some good news, encouraging news.
As you probably remember, we mentioned it in the second quarter call, we increased our share of voice very substantially in the second quarter. In fact, with a full impact in the third quarter. And we also are addressing our presence in the endocrinology market segment, the endocrinology stuff. And we're hoping that all these actions will have an impact over the next few months in the U.S. So, Briggs, maybe you want to cover the amarin question?
Amy and Mattias' email question. So, first, let me be clear that what we have filed for in the U.S. is for the high triglycerides patients with triglycerides in both 500. And we don't think that the amarin add combo in any way affects that particular indication. That application is in. Our PDUFA date is May of next year.
The second question is, is there a utility for physicians to have a fixed-dose combination of epanova with Crestor. We believe that there is and we're continuing to work on that from a technical and development point of view. And then the third part of that really is your question around the claim for the population who has triglycerides between 200 and 500. And there we're in discussions with the FDA to get better clarity on their view of that and what implications that would have.
We're, of course, in the planning phases of setting up our cardiovascular outcomes trial. And we think that what we heard at the advisory committee will help us further refine the design of that trial and be able to answer that question definitively.
Thanks Briggs. Let me just maybe quickly add that, as you can imagine when we licensed this product, and we looked at a variety of scenarios, and the scenario where we would not get approval based on the 50% recruitment was one of the scenario we considered. And we fully weighted all of the scenarios in the variation of this opportunity.
Now, whether we will still be able to launch based in the mix [displiimidia] based on the 50% recruitment we don't know. We still have to go through the discussions with the FDA. But at the end of the day, our belief, our fundamental assumption here is that reducing triglycerides will actually deliver a positive cardiovascular benefit, in particular in those patients with high triglycerides level of over 200 and low HDL. But even that population, which is very large actually, in that sub population we should be able to show a cardiovascular benefit and bring to the market the first product, having demonstrated the cardiovascular reduction in this population.
So I'll move to Andrew Baum at Citi. Andrew, do you want to ahead?
Andrew Baum - Citigroup
Thank you, good afternoon. Three questions. First, Marc's background, perhaps, does not make him the immediate obvious choice for CFO. The Company committed [from retaining] its dividends through a significant period of LOEs. How comfortable should investors feel about continued high level commitments about keeping that progressive dividend policy in place, especially over the next few years?
Second, how much additional productivity improvements remain, net productivity improvements, after the very significant headcount -- I think it's about 15,000 jobs net taken out of the organization over the last six years, particularly in relation to the Crestor LOEs, which Marc will be looking to handle? And then, thirdly, leading on from that, would you like to comment in how comfortable you are with consensus earnings forecasts over the next three years. Thank you.
Thank you, Andrew. Let me just quickly address the dividend question. And maybe Simon you want to chip in, in terms of productivity. Basically, we are still very committed to the dividend policy. There's no change. We are committed to what we said earlier this year. We will support the dividend policy we've got in place. I see no reason to change that.
As to Marc's appointment, the role of a CFO is changing in companies. And what I'm looking for is someone who really can play the role that Simon played, actually someone who is able to understand the business and be a strategic thinker, not only a financial expert. And I'm looking to the same strategic partnership with Marc that I've had with Simon over the last 12 months.
Marc brings this unique blend of financial experience but also business experience in a variety of markets around the world. So I look forward to working with him. But his appointment doesn't change anything to the dividend policy that we communicated earlier. As far as the additional productivity improvements, Simon do you want to cover this?
Yes, certainly. Andrew, thanks for the question. Dealing with the four key elements of cost we see in cost of goods, we see continued opportunity to drive productivity improvement, efficiency improvements. And, indeed, you can see our gross margin staying up in a very robust level, despite both pricing pressures in a number of markets and also a business mix that's shifting towards markets that have historically been rather lower priced.
So we continue to find opportunities to drive efficiencies in our supply chain and our factories through continuous improvement in individual facilities, through restructuring of our supply chain and moving more production to lower cost locations. And, for example, we are committed to a pretty significant investment program in our China facilities, which give us very low cost of production for that region.
If you move to G&A, we're on a journey to continue to improve the infrastructure cost in the business. The footprint changes that we announced earlier this year, we're in the processes of indeed accelerating the pace with which we are able to implement those changes, which will allow us to bring down the facilities and infrastructure cost in G&A by moving people to a smaller number of locations, designing those locations effectively. So we see opportunity to bring down the facilities infrastructure cost.
IT is another area that's been -- and, indeed, you and I have talked about this in the past, Andrew, a very substantial area of spend for the company. With the introduction of new technologies, particularly cloud-based technologies our new CIO is seeing very significant opportunity to help us deliver better IT, but actually at lower cost. So I think G&A, the scope for continued efficiency improvements to allow us to more than offset inflation in that area.
In sales and marketing, we've worked very hard to optimize above market structure in our commercial organization. That's pretty thin at this point in terms of the overall organization. And, as you know, we've also worked very hard on the targeting and the efficiency of our sales and promotional activities.
So I think what will drive the sales and marketing spend -- of course, there are continuing efficiency but this is going to be about where we choose to invest and the level of investment we choose to make. And we're going to invest where we can see an opportunity to get a return.
And going to your specific question around Crestor and other LOEs, I think we've shown that when products go off patent, we either remove the resource behind them or we redeploy it, whether a good value creating opportunity is to do so and we'll apply exactly the same principles with the forthcoming LOEs.
And then, finally, on the R&D cost you'll recall Briggs, at our Investor Day, talked about the growth in our late-stage pipeline, talked about, I think, Briggs, from memory 12 in late stage by 2016. We're considerably ahead of that schedule, which is clearly putting considerable pressure on our late-stage spend. But we're finding ways through addressing productivity and infrastructure costs in earlier stages of R&D to absorb that and live to our commitment of keeping our R&D costs broadly flat. So that's a bit of a cook's tour through the cost base, Andrew, but important question. Hope it gives you a sense of where we are.
Thanks, Simon. Let me just add, Andrew, that, as I said, for the dividend policy, we remain committed to it. And we also remain committed to all of the financial guidance we gave earlier this year. And I could quickly address another question that is related to yours from Christopher a little back, which we received by email regarding costs and how should we think about those in 2014.
It's a bit early for us, of course, to give any guidance as to next year. The one thing I can say is that we have lots of productivity improvement programs in place, as Simon was saying. And we will stay committed to what we said earlier.
We will keep our R&D budget stable with the moving parts that Simon was describing a minute ago. And our SG&A we'll adjust according to the development of our sales so that we can stay true to our commitments -- our margin commitments that we presented to you earlier this year. And certainly Marc is very committed to supporting this and driving cost efficiencies next year so we deliver on those goals. Let me move to Kerry Holford from Credit Suisse. Kerry, do you want to go ahead?
Kerry Holford - Credit Suisse
Thank you, yes. Three questions, please, if I can. Firstly on Crestor, can you just detail what proportion of the incremental decline we saw in the U.S.? So the difference between the decline in demand and sales was due to the lower price realization you talked about in the statement versus inventory destocking, and whether you expect either to ease into Q4 and beyond.
On Pulmicort we saw a weaker than anticipated ex-U.S. performance. And that was despite the strong grid in China. And to me that looks like it's an increasing decline happening in Europe. I'm wondering whether this is a Pulmicort specific issue or is this an example of a broader trend where continued price pressure in Europe is essentially wiping out any growth from emerging markets.
And then lastly on diabetes, you talked about promotional spend having increased already year to date. And this is now reflected in your new guidance for the full year. But today we also heard that Novo will add an additional 400 reps in the U.S. in the Fourth Quarter. I wonder if we should expect AstraZeneca to follow suit here. Thank you.
Okay. Thanks, Kerry. Quite a number of questions here. Let me start with Crestor. In Q3, with Crestor in the United States, we had a slight volume decline and a slight price increase. Essentially the movement you see is quite a stock movement. The important piece for you is to consider that -- to look at the market share, and the market share is stable month to month. We have a very stable market share with Crestor in the United States. So, if you think of Crestor over the next few months for the U.S., just keep this in mind. Our market share is stable.
As it relates to diabetes, I don't see any substantial increase in promotion over the next few quarters. The only driver of incremental promotion will be the launch of Forxiga in the United States if we get approval early next year.
I just would like to make a quick comment on your remark regarding guidance. You said our new guidance, we are not giving new guidance. It's the same guidance. We are reconfirming our guidance. We just, I think, precising, or giving additional precision that costs should be seen as closer to the top end of the range of increase we described in our guidance. But it's not a new guidance.
Finally, as far as Pulmicort, I don't see any specific change in trend here in the United States. We are still on the same track. And in China, Pulmicort continues to do well. We've had some inventory movements in China across a range of products, but I haven't got any new -- I don't know, Simon or Marc, if you want to add anything. Personally I haven't got any addition or additional comment to make. I don't see a massive change in trend here.
For China, there was a slight slowdown in the third quarter. But the later months, the last month seems to be bringing back to normal trend. There was a slow small reduction in the stock level in China for many brands, including ours. And I think it's not to be lasting very long. So there's nothing very unusual in the quarter-to-quarter pattern.
Good. Let me move to Lars Hevreng at SEB. Lars, want to ask your question?
Lars Hevreng - SEB
Yes, thank you for that. Symbicort, the U.S., could you say anything about the pricing environment? We saw similar comments from Glaxo and it seems to have some negative effects in the Q3 sales. The other question is about regarding your comment about Nexium and the revenue recognition in the quarters ahead in the U.S. How should we think about the current level of inventories that will not be filled in the coming quarters?
Thanks, Lars. Simon, do you want to cover the Nexium guidance question?
Yes, sure. In the press release, we simply set out as a reminder the accounting treatment for, as you go into a period of loss of exclusivity, and just calling your attention, really, to a number of factors. The first is, as the market anticipates an LOE, you can get a process of destocking as the pipeline still slowly lowers down.
We then, at the point at which we go LOE, we essentially reflect a provision against the pipeline inventory because obviously that inventory is not sold and can then be returned. And we also move to demand-based accounting so we then record the revenue as the underlying demand.
If you go back, and I think the best way of guiding you on this one is to go back and look at what happened with Seroquel back in the early 2012. And if you apply a similar thinking to the revenues that you saw and the movement when that went to LOE, that's probably the best way of thinking about the same impact for Nexium. I'm not going to give you a guide on the specific inventory because it will very much depend on how things pan out in the first quarter of next year. So my encouragement to you would be to look at the pattern on Seroquel, and use that to guide your thinking for Nexium.
On your question on Symbicort, in the quarter for this year in the US, we had a little bit of a net price move against us more around mix of business in the Symbicort business in the US. Indeed, you'll have seen we've had one or two quarters over the last year where we've had quite a favorable trend on pricing. But in this particular quarter, there was a small net down on price level. I wouldn't say there's a new trend that I would call out in that market.
Nothing very material really, no new trend there. So let me move to the next question. And the next question is from Seamus Fernandez at Leerink. Seamus, do you want to go ahead?
Seamus Fernandez - Leerink Swann & Company
Sure, thank you very much. Can you hear me?
Seamus Fernandez - Leerink Swann & Company
Okay. Great. So just a couple of quick questions. Can you just maybe give us a little bit more color on the SG&A spend? Should we be thinking about this as a surge again? Or should we be thinking about this as sustainably higher rate of primary care spending?
The second question, if I may, and respectfully, I really struggle to see the science around triglyceride lowering and outcomes, and any correlation there in the 200 to 500 range outside of subset analyses. And I think in the context of the really impressive scientific and science-driven improvements on the R&D side, I'd just love to know if you would consider actually not pursuing an outcome study for this, should there be challenges with the FDA with regard to the 200 to 500 range. And then just pursue the north of 500 indication. And then, lastly, can you just update us on your time frame for expectations for Symbicort generics risk? How many patents are covering it and when would you anticipate Symbicort generic entry? Thanks a lot.
Thank you so much. Great questions. And maybe, Simon, if you want to cover SG&A. Let me just quickly address the triglycerides question and then please, Briggs, jump in as you see fit. First of all, thank you so much for the great comment about the great science in our pipeline.
As it relates to epanova, I would argue that this is science. In fact, that science is about looking at data and, of course, different people have different opinions. And until you've proven something you don't know whether it's true or not. And that's why you do clinical trials in the first place.
Now, if you look at the report of the FDA, they certainly pointed at a potential benefit in the sub population. Of course it's a sub population, and of course nothing is proven. There is a meta analysis that was just published, I think yesterday, that looked at a great number of clinical trials. I must say, I've not even had time to look at it in details. But the top line of that meta analysis is that there is, from the conclusion of the authors, there is a potential benefit in that high TG, low HDL patient population.
And I can tell you that from personal discussions I've had myself with some of the topics in dislipidemia in the world, many of them will argue that there is a good chance to show a cardiovascular risk reduction in that population. Now, maybe it doesn't work, of course. We never know. That's why we run the clinical trial. But that's what I would say about epanova and lower TGs. Briggs, do you want to add anything to that question, and then we'll ask Simon to address the SG&A?
Seamus, I think it's a good question. And I would also echo Pascal's comments of thank you for the recognition of the great science we have throughout the portfolio. I think what is probably reasonably clear, I think people would agree, is that patients who have high triglycerides despite optimal current therapies still have residual cardiovascular risk. So I don't think there's a debate about there's a risk population here. The question is will lowering those triglycerides actually lead to cardiovascular benefit.
And again, I think as Pascal outlined, there are many physician, scientists, experts in this field who believe it will. And there are probably some who believe that it won't. So that's why we do the experiment. And, as you know, I think we're quite good at doing these -- I shouldn't use my British -- very good at doing these kinds of trials. So we're going to test it and we'll find out.
Thanks, Briggs. Simon, do you want to cover the SG&A question?
Sure. Thanks for the question. You'll recall in my presentation I gave you a bar chart which showed the movement in our SG&A spend over the last seven quarters and the movement up from Q1 this year, up to Q2. And then we've held that level in Q2 and Q3. That movement up is concentrated very firmly in three areas. It's behind Brilinta, and the acceleration initiatives that we've put behind Brilinta, particularly in the U.S. And you'll recall Pascal showed a slide outlining that array of initiatives.
The second area has been in diabetes around the world, again particularly in the U.S. And in a variety of different areas -- in marketing and medical, additional salesforce into the specialist channel. And then the third area has been investment in our emerging markets where you've seen we feel good about the continued strong growth during a reasonably challenging quarter, generally, for the sector. So those are the three main areas.
And when we look beyond -- I then also indicated we would expect to get the same seasonal bump up in the fourth quarter relative to the run rate in the prior three quarters. And that really reflects the fact that quite a lot of events, conferences do tend to take place during the fourth quarter of the year. So it's a completion of a series of marketing programs for the year.
As we look forward, I think I'll go back to a comment that been a pretty consistent theme on the call which is we're going to continue to invest where we see good opportunities to drive the growth of our growth platforms, and we'll continue to do that.
Of course, conversely, if we're not satisfied with the progress we're making in any particular brand or market, we will remove that investment if it's not providing a return. And because most of this investment is of a variable nature, we can do that really very swiftly. And I'm sure that Pascal and Marc will give further thoughts on what the profile for '14 will look like at the beginning of February in '14.
Thanks, Simon. Let me just say again, we are going through a period of redeployment. We are redeploying ourselves to our future growth platform. We're committed to investing in our pipeline even though we also are committed to keeping our R&D budget stable and we are committed to investing in our growth platform.
Having said that, again we are also committed to the financial framework, we defined for you earlier this year. And we'll adjust our SG&A investment to whatever the sales look like so we can deliver on our financial commitments. Let me ask Marc, if you don't mind, if you want to cover the Symbicort patent question.
Okay. So the situation for Symbicort, we still have some valid patent on the combination itself as well as patents on the device. They are also, although the FDA has had some evolution on the hurdles for analogs or generics in the respiratory field, although this hurdle seems to have been lowered somewhat, they still remain pretty high for generic to overcome. So obviously, difficult to predict, but we don't see a clear and present danger with generics in the United States for Symbicort.
Thank you, Marc. Let me ask Mark Clark from Deutsche Bank. Mark, do you want to ask your question?
Mark Clark - Deutsche Bank
Yes, good afternoon, gentlemen. I had a question on emerging markets. On the first quarter call, there was some commentary about the non-China business being a bit lackluster. And you suggested that there'd be a pick up outside of that. And we saw that in Q2. But by my rudimentary math it looks like growth outside of China dropped away to a little better than flat in the third quarter. I'm just wondering is this just the usual tender timing and phasing or is there any tougher trading conditions in some of the other key markets, like Mexico or whatever? I wondered if you could give some color there, please.
Thanks, Mark. Simon, do you want to cover this question? There's been some movements around the world in tenders and inventory. But, Simon, do you want to cover this?
Yes, certainly. So I think if we look at our quarterly rates through the year for emerging markets at 9 and 12 and then 5, I think we covered in our press release one of the drivers of the slower growth of 5% in Q3 was obviously the pattern of demand and, to some extent, inventory in China and that's addressed in the release.
The second driver of the slower growth rate in the third quarter relative particularly to the second quarter is we did have, really, I think, to some extent, Mark, you answered your own question. It was principally driven by a pattern of tender timing and tender business in our MEA region. And to some extent the wider social-political climate there is also impacting business a bit.
In addition to that, we did get some generic entry on Nexium in Turkey during this quarter. So that was the main pull-down. If you looked at the rest of our Asia business, I think performed quite strongly. Russia performed quite strongly in the third quarter. I'd also say that Lat Am was a bit slow also in the third quarter. I think there was generic entry in Brazil on a product and that was also on Nexium. So that probably gives it to you. Tenders in Middle East, Africa, Nexium in Turkey, Nexium in Brazil. And that probably gives you the seasonal pattern. We do get that volatility in these markets, Mark. Thanks.
Mark Clark - Deutsche Bank
That's great, thank you.
Thank you, Simon. Damien Conover at Morningstar is the next question. Damien, go ahead.
Damien Conover - Morningstar
Great. Thanks for taking the questions. Just a question on the challenges with reimbursement on Forxiga in Europe. Just wanted to see if you could characterize those a little bit and hear a little bit about your strategies to overcome those.
And then, second, just a question on R&D spending and the philosophy there as you go through some major patent losses over the next few years, whether or not you might employ a strategy like in Eli Lilly where you're comfortable moving into a R&D spend that kind of pushes into the low 20% of total sales or if you would want to cap that, obviously depending on the opportunities that come up through the pipeline. Thank you.
Thank you, Damien. The R&D spend question, we have said we will keep our R&D budget stable and as Simon was explaining a few minutes ago, we're essentially shifting our investment to late-stage pipeline to support our pipeline but also maintain our R&D spend over all stable.
Now, of course, if we demonstrate that the productivity of this investment is improving, and if we demonstrate this by progressing some of our projects and showing proof points of our ability to deliver there, we may have, at some point in the future, we may have to revisit our R&D spend. But for the time being I don't see any reason why we would do this. We can still manage the pipeline as it is with the budget as we've defined it.
The other question you had, Damien, related to Forxiga and our reimbursement. Essentially we are in discussion with all the payers in the various countries in Europe. And trying to establish with them the cost effectiveness of this agent, and highlighting the benefits that Forxiga brings to patients in particular weight loss. It has been difficult, I must say, in Germany. But we're now going back with our fixed combination product, metformin [dapa] and we have good hope that we will gain support for that fixed combination. So that's the other way for us to again access in the German marketplace.
Let me move now to Naresh Chouhan at Liberum. Naresh, do you want to go ahead?
Naresh Chouhan - Liberum Capital Limited
Thanks for taking my question. Just one question, please, on acquisitions and use of cash. So, this year, year-to-date there's been $1.7 billion of in-licensing and acquisitions. And the question, I suppose, is, are these just filling gaps in portfolio where as you've come in you've seen things that were technologies you need or opportunities you found? Or is this something that where we should expect ongoing levels of spend as and when the opportunities arise? Just gives us a sense of use of cash over the next few years. Thanks.
Yes, great question. Thank you for that question, Naresh. The first comment I would make is that if you look at our acquisitions, our business development activities, they've really been focused in three core TAs; oncology, [cat] metabolism, and respiratory, as we said we would do. And they span across early- to late-stage opportunities, but certainly focused in these three core TAs.
Essentially, we've really tried to rebuild our pipeline. But we've also found more opportunities than we thought. And certainly our teams have done a very good job identifying those opportunities and moving them forward. And I think we have built in particular in oncology a very strong platform with assets that are more advanced in development, and technologies that will support our oncology presence.
For instance, the ADCs that are only a little bit more long term, but they put us in a very strong position in that segment of the oncology market. We have been able to strengthen our INT platforms. So, clearly, I would say, a lot more progress than I would even have imagined at the beginning of the year.
Moving forward, we certainly will invest in opportunities if we find the right opportunities. It's just that this year, we've found a lot and we had to rebuild our portfolio. So we've taken advantage of the opportunities we identified. We will allocate funding as we go depending on what we find. But always focusing on our core strategic platforms.
I'm conscious that we have over run the timing so let me wrap up this session. I certainly appreciate all of your questions and your interest in our business. So, thank you for joining us and thank you for all of those questions.
In closing, our Q3 financial performance and, indeed, throughout 2013 has reflected the impact on revenue from the loss of exclusivity on several key products. However, as we said throughout this discussion, we continue to execute on our strategy, which means we are making the necessary investment in our growth platforms and our pipeline.
Our growth platforms are performing well, with growth in the quarter that was 8%. We're also making very significant progress on our pipeline. We have three regulatory filings that were accepted. We started three new Phase III programs since our last update, which brings our total late-stage pipeline to now 11 NMEs that are either in Phase III or in registration. We've also entered into four new business development transactions that have really strengthened our oncology portfolio in particular. And, finally, we reconfirm our financial guidance for the full year.
So with that, I would like to wish you all a good day. And again thank you for joining us today.
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