AstraZeneca, Plc (NYSE:AZN)
Q1 2014 Earnings Conference Call
April 24, 2014 07:00 ET
Pascal Soriot – CEO
Briggs Morrison – EVP, Global Medicines Development & Chief Medical Officer
Marc Dunoyer – CFO
Ruud Dobber – EVP, Commercial Operations, Europe
James Gordon – JPMorgan
Alexandra Hauber – UBS
Andrew Baum – Citi
Tim Anderson – Sanford
Sachin Jain – Bank of America Merrill Lynch
Keyur Parekh – Goldman Sachs
Jo Walton – Credit Suisse
Seamus Fernandez – Leerink
I'm Pascal Soriot and I'm joined here today by Briggs Morrison, our EVP of Clinical Development and our Chief Medical Officer, as well as Marc Dunoyer, our Chief Financial Officer. And we will share the presentation.
I've also got here with me in the room, Ruud Dobber, who is our EVP for Europe and our temporary head of Global Product Strategy. And I'm also joined by some of my colleagues from the finance and the investor relations teams here in the room. We have posted a set of slides on the investor page of our website that we'll follow along with to this presentation. And we'll try to cue the slide numbers as we go though.
I will provide a brief overview of our financial performance to date and, as I promised when we last spoke at the full-year results, I'll provide an update on our strategic priorities. I will then hand over to Briggs for an update on the progress we are making on our R&D pipeline and finally to Marc to run through the financial performance in more detail before I give my closing remarks and open up for questions.
So, as you can see from the title slide, this has been a quarter of continued momentum across the business. You've heard me say a few times before that I believe that AstraZeneca is on a journey, and while we are only reporting the first quarter, I'm pleased to say we've made great progress on the journey so far this year. I'm especially pleased with the significant progress made towards achieving scientific leadership in the development of our pipeline.
Looking at some of the highlights of this quarter on slide 5, which we will run through in more detail shortly, we can see that revenues have increased by 3% on a constant currency basis. Our five growth platforms have performed, strongly by about 15% together over the period. We actually successfully launched Forxiga in the U.S. market following FDA approval for the treatment of adults with type 2 diabetes in early January. And it has been performing strongly so far. We've also had Forxiga approved in March in Japan. And we've had continued success in Germany and in Europe.
This has also been a significant quarter for scientific leadership with great progress of our late-stage pipeline. Olaparib, which targets ovarian cancer, had a priority review accepted by the FDA, while AZD9291, our small molecule EGFR inhibitor, has actually been granted breakthrough therapy designation by the FDA. We've also made four phase III investment decisions. And Briggs will come back to this in a moment.
Moving to slide 6, we can see that we now post the first growth in revenue after 14 consecutive quarters without growth. Global revenues were up 3% on a constant currency basis to $6.4b. And our core EPS was down 11% to $1.17, as we increased our investments in our growth platforms and to support our rapidly- progressing pipeline. Marc will discuss these numbers in more detail shortly.
There's further good news from the emerging markets, which delivered double-digit growth at 11% CER, driven essentially by another successful quarter in China, up 22% at constant exchange rate, where AstraZeneca is outpacing the market. Japan also posted a very strong quarter for us.
If we now turn to slide 7, considering our strategic priorities I've already touched briefly on the developments made in achieving scientific leadership, and Briggs will give you a further update on this. I will now review the performance of our key growth -- five key growth platforms.
So if we start with the slide 8, each of our five growth drivers has contributed to the strong overall progress in the quarter. We added $3.3b of revenue from these growth platforms. And I will now look at each of those in turn.
Brilinta has improved in the quarter, with revenues up 94% to $99m, as you can see on slide 9. We see strong performance, especially in Europe, as well as good growth in the emerging market and the established rest of the world; Canada, Australia doing very well. And we have leadership positions now in several markets in Europe and elsewhere.
In Europe in particular, on slide 10 you can see the good market share performance of Brilinta in a number of countries. We continue to believe in the potential of this product and we invest to support it.
And the drug has now demonstrated that it has really provided strong benefits to patients and can be successful. A few markets have really shown that. Over the next few years there is reason to believe that we can keep building Brilinta to the leadership status we believe it deserves.
If we turn to the U.S. performance on slide 11, 2014 will be an important year for Brilinta around the world, and in particular in the U.S., where we will certainly continue sharpening our commercial focus.
The Department of Justice investigation remains ongoing and there's no doubt that this has set back the overall performance of the drug. Once this has been resolved we'll be able to give you a better update.
It is actually reassuring to see, though, that in the last few weeks we've seen an uptick in the market share trend for Brilinta in the United States. And we see a growing momentum. And that's quite encouraging to see this progress.
Turning to diabetes on slide 12, the acquisition of the remaining half of the alliance with BMS has clearly enhanced our revenues and has improved our offering and our performance. We've seen a rise in market share of Bydureon. The share of Onglyza in the U.S. market has remained stable.
The franchise is in the very strong position to growth, with revenues in the quarter for -- of $347m, and the integration of the alliance is on track. Really notable to say that we were able to integrate this alliance, this business, in about two months, so very rapid integration.
If you look at slide 13, the launch in the U.S. of Farxiga in February this year has been very successful. And while it's only early days the program -- the product has progressed strongly. Farxiga is adding to the growth of SGL-2 class and, importantly, two out of five of the Farxiga trialists are new to the SGL-2 class.
And if you look at slide 14, the launch uptake so far has shown that the absolute new-to-brand prescription number is exceeding all recent non-insulin anti-diabetic drug launches since the launch of sitagliptin back in 2006.
So I think it's fair to say, as a summary of this diabetes franchise, that Farxiga so far is doing very well in the U.S., Bydureon's market share is improving and Onglyza is rather stable, and essentially because we are focusing our efforts behind Farxiga and Bydureon. If I now move to respiratory, Symbicort is up 13%. And in the U.S. our sales were $344m in the first quarter, up 20% over last year. Global sales are up 13% to $928m. It's also worth noting that Pulmicort recorded over $250m in the first quarter, growing at 13% CER.
On slide 16 you can see the continued strong Symbicort U.S. market share performance. Symbicort new-to-combination therapy market share grew by 4 percentage points in the first quarter and the total prescription share was up by 3.5 points, as you can see on the right-hand side of this slide. We also have good news on the emerging markets on slide 17. You see that we had a strong quarter, with 11% growth at CER, and we've seen particular strong growth in China, up 22% in the quarter. This is the highest growth rate of all large multinational companies in China.
China is now our second-biggest market in quarterly sales. As you can see from the chart, we continue to outpace the Chinese market by nearly 10% in growth rate and we've further strengthened our number-two position amongst multinational companies in the country.
Also good news from Japan, turning to the next slide, slide 18. Sales were up 13% on a CER basis, driven primarily by the outstanding performance of Nexium, which has consistently grown market share and has been one of the best brand launches in the pharma market since -- in the last 10 years.
Nexium is now the number-one potent proton pump inhibitor in Japan in value. Symbicort and Crestor are also performing strongly in Japan. And Forxiga was approved in the country in late March. That concludes my initial remarks. So I will now hand over to Briggs for a pipeline update.
Thank you very much, Pascal. At the full-year results we announced our intent to update the pipeline table quarterly instead of biannually, as our pipeline continues to progress quite rapidly. And so therefore it gives me really great pleasure to present our first update of the quarterly pipeline update.
Our goal, of course, in spending our R&D dollars is to make very thoughtful decisions about how we invest those R&D dollars and then to make sure that we deliver on the things that we decide to invest in. And what I'll try to do in this presentation is give you a little more insight into some of the decisions that we've been making in addition to the deliverables that we've achieved. If we can go on to slide 20, you will remember this slide from the year-end results, where we talked about 19 candidates that could potentially enter registration trial starts. And I want to be very clear about this slide.
When I show the cohort for 2014 these are molecules that we believe the phase III programs will start in 2014. The molecules on the right-hand side are molecules that could potentially start phase III. I'm going to also talk to you now about investment decisions that we've made to progress molecules into phase III. We may make an investment decision this year, but the molecule may not start phase III until next year. So this slide is really about phase III starts.
If we go onto slide 21, what I'm going to talk you through here are three categories of things we wanted to share with you. On the far left are phase III starts. In the middle are phase III investment decisions, which -- again, this is our commitment to progress the program, but it doesn't mean that the program has actually started. And finally phase III investment decisions that we still have left to make. What I'm showing you here above the line are the phase III starts, phase III investment decisions and pending decisions for our new molecular entities. On the previous slide, again, we were highlighting new molecular entities and we'll talk about lifecycle management in a minute.
So, as Pascal noted, we have made three additional phase III investment decisions for new molecular entities this year; tralokinumab in severe asthma; AZD9291, our molecule that inhibits the EGFR receptor and second-line non-small cell lung cancer; and MEDI4736, the PD-L1 antibody for non-small cell lunch cancer as well, as was highlighted in our press release.
We still have a number of phase III investment decisions pending as the year progresses. These are a number of molecules that we will -- we'll have to look at the data as the data comes out, look at our portfolio and decide whether we want to -- if the data supports it, do we want to invest in these additional molecules and move these into phase III as well.
On slide 22 you'll see below the line lifecycle management, important lifecycle management programs. So phase III starts; we've started phase III for brodalumab in psoriatic arthritis, for selumetinib in metastatic uveal melanoma and for Olaparib in metastatic breast cancer.
We've also made a phase III investment decision to invest to progress our anti-IL-5 receptor antibody, benralizumab, into phase III for COPD. And we have again some additional phase III investment decisions pending as the year progresses, including additional tumor types for PD-L1 antibody and potentially first-line lung cancer for 9291.
If we move on to slide 23, this is a slide just to remind me to highlight to all of you that we did get breakthrough designation from the FDA for 9291 for the treatment of non-small cell lung cancer that is EGFR mutant. And that has progressed after an FDA approved TKI.
The breakthrough designation we believe signals to us that the FDA is seeing the same potential in this molecule that we're seeing. This is a slide that was shown at the Lung Cancer Conference in Sydney, Australia last year, in October, just highlighting the very good response rate that we've been seeing.
Of course, we will present additional information on 9291 at ASCO. And I just use this slide to remind you all that we did get the breakthrough designation.
Slide 24 is the delivery. So, as I said, we want to make good decisions about what we spend our R&D dollars on and then we hope to be successful in delivering the things that we said that we would do. So these are regulatory milestones that we have achieved in the first quarter. Pascal talked about the U.S. approval of Farxiga. Forxiga was also approved in Japan.
The Bydureon Dual Chamber Pen was approved in the U.S. Xigduo, which is the combination of Forxiga plus metformin, was approved in Europe. Metreleptin, or Myalept, was approved for generalized lipodystrophy here in the U.S.
As Pascal noted, we have got -- the FDA has accepted our filing for Olaparib, has granted priority review. We have an advisory committee in June and we have a PDUFA date in October. And, as I just mentioned, 9291 in second-line mutant lung cancer containing the T790m mutation achieved breakthrough designation. As the year progresses on slide 25 we have some additional key data readouts that I'm sure you will all be interested in tracking.
In the second quarter we have the first phase III results from brodalumab. This is a placebo-controlled trial. The top-line result communication path will look a lot like what you've seen from Amgen.
This is an Amgen-run trial. We'll be working with them and the way we communicate will be consistent with the way that Amgen communicates their top-line results. Saxa/dapa phase III data will be presented at ADA. And we will have updates on both PD-L1 and 9291 at ASCO. In the third quarter we have the phase III top-line results from all -- the three remaining phase III studies for lesinurad in combination with febuxostat and the two trials in combination with allopurinol.
We'll have the top-line results for CAZ AVI in complicated intra-abdominal infections and some phase II data on our two different mechanisms of interfering with the interferon pathway in lupus. Again, at ESMO we will continue to update you on our oncology portfolio and there'll be some data on Alzheimer's disease coming up as well in the third quarter on our base inhibitor.
And finally, in the fourth quarter the brodalumab psoriasis trials, the fourth-quarter trials reading out, these are the two head-to-head trials against Stelera, as well as the 2B data on mavrilimumab. So some very important data readouts that will help us understand and help you understand the potential of our molecules. A number of regulatory milestones as the year progresses. We are tracking for the approval of Epanova. The PDUFA date is coming up soon. As well as filing the Bydureon Dual Chamber Pen in Japan.
We are on track to file Iressa in the U.S. -- refile Iressa, I should say. We have an naloxegol PDUFA date in September and have an advisory committee meeting on the whole class of molecules in June. And we're working with our Japanese regulatory colleagues to try to get Brilinta approved in Japan. In the fourth quarter I've noted the PDUFA date for Olaparib; potential approval for Xigduo XR in the U.S.; the filing of saxa/dapa fixed-dose combination at the end of the year; the CHMP opinion for the Bydureon Dual Chamber Pen; the filing of Myalept for lipodystrophy in Europe.
If the phase III trials readout favorably for lesinurad in the third quarter we'll be on track to file that in the fourth quarter, and the same with CAZ AVI. I've highlighted on slide 27 some of the data readouts that you'll see at upcoming congresses. We will be holding analyst meetings at both the ATS and at ASCO.
And finally, on slide 28, this is a slide that I showed you at the year-end results, which -- again, above the line I have potential new molecular entity submissions. And we've checked off that we filed Olaparib in the U.S. And then below the line are potential lifecycle management submissions in 2014 through 2016. And I will just highlight a couple of additions. The first is related to the Pearl [ph] program. We had told you that in 2015 we anticipated filing the LAMA/LABA combination for COPD. We have decided to also file the LAMA component alone, which is being studied as part of that overall program.
With the starting of the uveal melanoma program for selumetinib there is a potential for a submission in 2015 for that indication.
And then if we look at the lifecycle management submissions below the line, all of these we showed you at year-end results. The one new additional one is the potential for Olaparib to be filed for metastatic breast cancer, given that we've not started that phase III program.
So I will stop there in terms of the pipeline. Again, I think we're very pleased with the progress of our pipeline. As Marc I think will touch on in his comments, it is putting a little bit of pressure on our budget to accommodate all these wonderful molecules, but we're trying to be very disciplined in the molecules we invest in.
And with that I'll turn things over to Marc.
Thank you, Briggs, and good afternoon, good morning everyone.
Today I will provide a little more details on the drivers of the headline results for the first quarter and how we are redeploying our resources to invest in our growth platforms in a rapidly-progressing pipeline as we work towards returning AstraZeneca to growth.
I will also discuss the currency effects on our regional revenues, discuss the key drivers of operating profit and margin, as well as provide an overview of our cash generation, cash application in the quarter.
I'll turn to the next slide, which presents the headline results for the first quarter. We can see that the revenue for the first quarter grew by 3% to $6.4b at constant exchange rate. The currency impact on the first-quarter revenues was minus 2%, which I will explain on the next slide.
I note here that the first quarter includes two months of 100% of the revenue from the diabetes brand following our acquisition of the remaining stake in the alliance with BMS. Core EPS for the quarter was $1.17, declining at minus 11% at constant exchange rate. The impact of the foreign exchange lowered EPS by 6%.
Next slide; the slide shows the regional currency impact on our revenues in the first quarter. In Europe we had a small tailwind, but in the established rest of the world markets the currency headwind was almost 2% with Japan comprising about two-thirds of the negative effect due to the weakening yen. In emerging markets the headwind was a negative almost 1% effect of currency on revenue.
I will now turn to the P&L for the quarter and focus here on core margins and profit. The press release contains the statutory numbers and a detailed reconciliation to the core measures. As a reminder, when I refer to growth rate they will all be at constant exchange rates.
Core gross margin was 81.4% of revenue. There are a number of moving parts in the quarter; the benefit from lower Crestor royalties more than offset by the inclusion of diabetes-related cost. Core SG&A expense was up 14% compared with last year. The increase in SG&A was driven by the inclusion of all the cost associated with the diabetes portfolio as well as the investment behind the launch of Farxiga in the United States and continued investment in the emerging markets, and particularly in China.
The excise fee imposed by the enactment of the U.S. healthcare reform measures amounted to 2.4% of core SG&A expense for the quarter. Core R&D expenditures were up 13% to nearly $1.1b in the first quarter.
The doubling of the late-stage portfolio over the last 12 months, together with the support of Brilinta through the Parthenon program, are the key drivers of R&D cost growth. The strong progression across all stages of development of oncology portfolio does put pressure on our cost base, in particular, for the rapid advancement of immunotherapies.
Core other operating income for the quarter increased by 29%. It is worth noting, however, that this quarter was flattered by a one-off milestone payment, which accounted for about 70% of the growth.
Core operating profit was $1.95b, 11% lower than last year. Core operating margin was 30.4% of revenues. Looking at the first-quarter cost trends for the last three years it can be noted that the increase in first-quarter 2014 is enhanced by the relatively lower cost in first-quarter 2013 both on the SG&A and the R&D lines. Within SG&A particularly all growth comes from increased sales and marketing cost, whereas, G&A was flat.
The quarter-on-quarter growth rate has stayed constant within SG&A, as we have continued to support our growth products. On the other hand, there has been an acceleration of the growth of R&D cost as a result of a rapidly-progressing pipeline.
Moving to the next slide, we see that the net cash generated from operating activities was $1.2b for the quarter. The lower EBITDA was chiefly a result of the loss on disposal of our R&D site at Alderley Park and some negative ForEx. We had a favorable working capital movement in the quarter despite the sales growth, but it was lower than that of 2013.
On the next slide, the payment of the second interim dividend in the quarter, along with the cash associated with the acquisition of the diabetes alliance asset, results in a significant cash outflow in the quarter. Net cash distribution to shareholders were $2.2b.
As you have seen this morning, we are affirming our full-year guidance. We continue to anticipate a low to mid single-digit decline in revenue on a constant currency basis. We want to note that this guidance assumes the entry of a Nexium generic in the United States towards the end of May 2014. With continued investment in the pipeline and growth platform we still anticipate core EPS to decline in the teens at constant exchange rate.
We again reconfirm our commitment to our progressive dividend policy. AstraZeneca has made significant progress this quarter and we are confident we will see continuing momentum over the course of the year.
With that I will now hand back to Pascal.
Thank you, Marc. In closing, I would like to say it's been a busy period for AstraZeneca and we're very pleased with the progress we've made so far.
So in a nutshell this first-quarter revenue growth was driven by all five growth platforms. We've had strong continued momentum with our pipeline. We can expect, as you saw from Briggs' presentation, a very rich news flow in the quarters to come. And, finally, we've maintained our financial guidance for 2014.
So with that I would now like to open for questions, so over to you, operator.
And please remember that for those participating via telephone please press star one on your telephone keypad to alert us if you wish to ask a question. So the first question is from James Gordon at JPMorgan. James, do you want to go ahead?
James Gordon – JPMorgan
I had a couple of questions about the Pacific study, so the MEDI4736 study. One of my questions was will you be looking at PD-L1 expression and segmenting patients by their expression level as part of the study? And do you have a diagnostic for this?
Also can you talk at all about whether you'll be treating to progress or beyond and what sort of comparator background you'll be using? And also what you'll be expecting or what you'll be powering for in terms of the magnitude of overall survival? And then I also had a question which as on alliances. I've seen some comments on the media call this morning that you'd be interested in doing alliances and that there could be some announcements quite soon on that. Within the realm of alliances would you consider swapping or divesting rather than actually just forming alliances? Is it possible you would divest anything?
And would you be prepared to give away any economics on immuno-oncology in exchange for anything else? Or is that something off the table?
So, Briggs, maybe you could cover the questions -- the series of questions on the 4736 and the study. Let me just maybe quickly address the second question, the alliances. What we said this morning is not very different from what we've said in the past, i.e., we will look for alternative options to develop products that are not in our core therapy areas. We focus on those three cores, as you know.
And so we're looking for a variety of partnering options for products that come out of the other TAs. I can't be more specific than this. And I apologize for this, but you'll have to bear with us a little bit, because certainly we're looking at a variety of options that we hope to conclude very quickly on. As to the specific question about IMTs, we certainly would not at this stage plan to -- I don't know, how would you call it? We will not plan to let part of the value coming from our IMT portfolio go away.
Certainly, what we will and are considering is a series of partnerships with other companies that are willing and interested in developing their own products in combination with our IMTs. But we will not at this stage consider a partner in the IMT portfolio.
We believe it's a very important portfolio. We have a variety of products and we can combine them, as we've said before, and it's very much at the heart of our oncology TA. And certainly in that area we want to do it ourselves, but certainly again partner for combination purposes with other companies.
Maybe, Briggs, do you want to cover the PD-L1 question?
So the Pacific study, the details should be appearing on clinicaltrials.gov fairly soon and we'll be talking more about it at the investors' call -- at the investors' meeting at ASCO. What I would say just to clarify, it is -- as we said in the press release, it's sequential therapy, so patients with locally-advanced stage III disease will commonly get a combination of chemo-radiation therapy as definitive therapy. The intent is after that therapy to then follow on with PD-L1 antibody.
There is data to suggest that radiation induces PD-L1 expression and may account for some of the resistance and so the idea is to be able to convert those patients into higher response rates and improvements and overall -- progression free and overall survival.
When the data comes out and the trial design is better on clincicaltrails.gov and we have a chance to talk with you more we can say more about the design.
And we certainly look at PD-L1 expression as part of the range of studies that we are considering for sure.
So should we move to Alexandra Hauber at UBS? Alexandra, do you want to ask your question?
Alexandra Hauber – UBS
I've actually got three. Firstly, Symbicort in the U.S. seemed -- was very strong, which -- and it appears that you didn't buy your improved formula position by pricing concessions. Is that -- because you commented that in the press release pricing was stable. Is that just now this quarter, or can we expect this to stay like that in this year? And in this context can you also comment on any net price effects you've seen on Bydureon in the U.S.?
Second question, can you provide some ideas about launch timelines for the Bydureon Dual Chamber Pen, or is that still something which we just have to wait for?
And the third question is, if I look at the phase III study that you're announcing on 9291, second-line patients with T79 mutations after first-line TKI progression, that seems to be the most narrow indication you can possibly go for and seems to contrast a bit to what Cloves [ph] is doing with their waterfront approach to do all sorts of things in their Tiger [ph] program.
Is there any reason for that that you're going forward so selectively? Are you waiting for any more data? And are you planning to expand that at some point?
Briggs, maybe you could cover the 9291 question and certainly talk about our plans to go into first line as well. Let me just quickly cover the Symbicort U.S. question. The improvement in market share you see is not entirely due to the ESI improvement in access. We estimate that about half of the progress we've made with Symbicort comes from access improvement. The other half is simply the hard work that -- and the good work that has been done by the team over the last few months.
We were already as you know, before this improvement in access we were already on the growth trajectory. So we certainly believe that it can continue, because we are very focused on this product in the U.S.
As far as pricing, the ESI win was certainly not linked to -- as I've said before, linked to a large discount we offered. We didn't actually and, in fact, the price effect so far this year is relatively small. We have a minus 1% price effect and we estimate the price will be more or less stable for the rest of the year.
So I would not see a price war there, if you will, in Symbicort. It's really very good blocking and tackling and good commercial work done by the team in the United States that's driving this improvement in market share.
As far as Bydureon Dual Chamber Pen, we -- our plan at this point is to launch it later this year. We haven't given any specific date, Alexandra. And as soon as we have clarity we will communicate this, but at this point unfortunately a bit too early to comment.
And maybe I'll hand over to Briggs for the question on 9291.
So first I'd say we have ongoing single-arm trial to look at patients with the T790m mutation as well as patients who do not have the mutation. The second-line indication we believe is the area of the greatest unmet medical need.
Obviously, the patients who are newly diagnosed with EGFR mutant lung cancer have available to them agents and once they fail this is their biggest unmet medical need and has the highest probability we think from a scientific point of view. So that's clearly where we would go first. As you saw on slide 22, we are considering investing an investment decision to also study in first-line non-small cell lung cancer. I don't think there is additional data that we need.
Our scientists are just trying to work through the study design and what one would anticipate in terms of benefit if you were to give this molecule versus, say, Iressa in first-line setting. So that's what we are working through in terms of making that investment decision.
There is a question from Andrew Baum at Citi. Andrew, over to you.
Andrew Baum – Citi
Three questions please. First, Pascal, in the context of maximizing shareholder value what is your commitment to remaining an independent pharmaceutical company?
Second, in reference to the scale of divestments mentioned in the FT article you talk about infectious diseases CNS [ph]. My impression is that most of the likely divestible assets are ex-U.S. and relatively small. And it's tough to get that $15b number which is quoted. I just wonder whether you'd like to comment on the scale.
And finally for Briggs, with regard to the PD-L1, could you just confirm firstly it will include both resectable and non-resectable stage III small-cell lung cancer patients?
And then, additionally, what extent do you expect the screening program in the U.S. to expand the eligible patient population going forward? And do you think you will be first to market within that indication? Many thanks.
So the first question on shareholder value, we are of course very committed on creating shareholder value. And we believe the best way for us to do this is to focus on science, come up with medicines that will be differentiated and help patients. And if we do that well then we'll be successful commercially and create value for shareholders.
And we believe we have a clear strategy. We believe we are making good progress from a pipeline viewpoint. We believe there is more progress to come and certainly we are very committed to creating this additional value on an independent basis.
But of course we are always considering options to accelerate shareholder value where it makes sense. But at this point in time we are very convinced that our strategy is working. We are creating value through progressing our pipeline and we'll continue doing this on an independent basis.
As far as ID and infectious disease and CNS maybe you make me say something I didn't say actually, Andrew. And I didn't talk about divestments. I talked about partnerships.
And essentially what we said, and I said again today, is that in -- as far as products that are outside our three core therapy areas we will look for partnership options, and I've said this before. And so that would apply to our ID assets. Some are -- for some we have the rights outside the U.S. For some newer products we have global rights, would also apply to our CNS assets.
And with those we'll find solutions that are optimizing those assets and optimizing our presence and optimizing our capabilities, our development capabilities, our commercial capabilities. And so the answer to how we go about partnering those products will vary from product to product.
Now it may sound a little bit lacking in specifics, and it is because the options are multiple, of course, so you'll just have to wait to see how this shapes up. But that's certainly something we are going to be working on over the next few weeks and months.
Then there is a question from Tim Anderson at Sanford Bernstein. Tim, do you want to go ahead? Tim, before you -- I'm sorry, I forgot to ask Briggs to address the PD-L1 question that Andrew raised. I'm so sorry.
Yes, thanks very much. So, Andrew, you'll see in the press release we did it is locally-advanced unresectable non-small cell lung cancer. So this is stage III unresectable where patients are commonly treated with a combination of chemo-radiotherapy and then following onto that we would add PD-L1 antibody.
Your question about the screening it's -- your question, it's hard to know exactly how much the screening is going to increase the detection of earlier stage lung cancers. But we do believe that that is a trend that will be progressing, particularly in the U.S., and I think we believe that will be increasing the number of people we pick up at some of these earlier stages.
We received an email question from Kristofer Liljeberg at Carnegie and I want to address it, because unfortunately we cannot answer that question relating to MEDI4736. And the question is what's the timing of our pivotal trial and how soon will the file go according to our plan.
And I apologize in advance, but we will not answer that question for obvious confidentiality reasons. So we'll certainly become more specific as time goes by, but for today will not address that question if you allow me.
So Tim Anderson at Sanford, Tim, do you want to go and ask your questions?
Tim Anderson – Sanford
Okay, so a question on immune-oncology and then an unrelated question. But on immune-oncology at ASCO that's coming up I know we are going to see various data sets from you on different products. Can you just give us your general level of excitement for tremelimumab at this point? And is there any reason to think that this CTLA-4 inhibitor may act differently and look differently than ipilimumab?
And then on PD-L1, slide 20 shows product submissions through 2016. I don't see PD-L1 there. I guess that implies a filing maybe in 2017, but if you could just expand on that.
And then my high-level question is I think a majority of big pharma companies have talked in recent years about how big mergers between big pharma companies destroy more value than they create because of things like disruption to R&D.
And I guess you could look at one clear exception would be Roche with Genentech, but that was a very different set of circumstances. It certainly wasn't big pharma plus big pharma. My question here is would you generally agree with the majority of your peer companies that these sorts of big tie-ups are too messy to really create value?
I'll address that last question first actually, if I may, Tim, and then in the meantime Briggs can think about the level of -- onto the other more excitement he's got for treme.
As far as your last question it would actually be difficult for me to tell you that I do believe that large mergers do not create value, first of all, because I am a pragmatic person and I think this -- it's never really good to have a philosophy that applies to everything.
I think you've got to be practical and look at things case by case. And secondly because the Roche Genentech merger that you mention, I led that integration, and I actually believe that it actually worked and created value, so I really think it depends on the companies you merge. It depends on whether you can integrate them. It really is a question of are there really true synergies you can generate, complementarity from a geographic viewpoint from a collaborative viewpoint. Can you bring the two cultures together? Can you operationalize the integration? And so there is never really a simple answer to those questions. It's really case by case.
So, Briggs, I hope I gave you enough time to -- for you to figure out how excited you are about treme. Do you want to cover this?
I'd be delighted to. So I think that the simple answer to your question of do we believe there is a profound difference between treme and ipi, I'd say the answer is no. I think that if done -- if the exact same experiments are done with the same -- with the two molecules most of the data would suggest they would probably behave similarly.
We are excited about treme. We have an ongoing program in mesothelioma and have decided actually to increase the sample size there to improve our chances of having that phase III trial potentially to be a registration trial.
And of course we are quite excited about the combinations of treme with the other molecules in our portfolio, so with PDL-1 or with other molecules. So we have a strong belief in treme and think that with the right experiments and the right clinical data it could be an important medicine.
As far as the PD-L1 filing question, Tim, just as I said a minute ago, if you allow me I won't be more specific than what you have in the table. And things may change as we go forward, but at this stage what you've seen is what we actually can share.
So I'll move to Sachin Jain at Bank of America. Sachin, do you want to go ahead?
Sachin Jain – Bank of America Merrill Lynch
First question again on M&A. So irrespective of the recent bid specs, so I'm not asking for confirmation of rumors otherwise, just a high-level comment of your process processing the value of bid approaches in terms of what valuation you reject outright versus what you would be open to.
So, for example, as a focus on bid premium to unaffected share price, intrinsic value of the business as you see it today, or value of the business as you see in three to five years? The reason for the question is that on a comment to an earlier question you said you would be open to opportunities for accelerating shareholder value. I just wondered how you defined shareholder value. That's the first question.
The second question is a PD1 -- PD-L1 question. There is a phase II lung Atlantic study that's recently listed on clinical trials which looks quite similar to Pacific, so I could just -- wondered if you could give any color as to why you're running two similar studies in a similar setting.
And then the final question is for Marc on cost progression. Is it fair to expect SG&A and R&D to increase sequentially into second quarter? Given only two months of Bristol consolidation in the first quarter, are there any costs offsets?
And then, related, in your introductory comments you commented on R&D spend potentially going up given accelerated immune-therapy development. I wondered if you could give any color there. Thank you.
So maybe I could take the first one. Marc you could take the cost question and Briggs you could take the PD-L1 Atlantic question.
So in terms of the first question, Sachin, the way we look at shareholder value, the way we measure it is CSR [ph], and I guess I will stop at this and not be more specific as far as the rest of your questions. We have a relatively good idea of what the value of this Company is and the value we can create with the implementation of the strategy that we have communicated and that we are implementing now.
And so that's basically our base line and anything that could enable us to accelerate this or do better, certainly, we will of course consider. We are very aware of our responsibility to our shareholders. And that's basically as specific -- as much as I can say.
Marc, do you want to cover the costs?
Yes. I think we have signaled the cost progression from the diabetes, but also from the other investment in emerging markets for the SG&A. We have also signaled this morning the -- we have also signaled the increase of our R&D expenses in the first quarter. So I think the increases are going to continue.
Whether they are going to continue at the same rate still needs to be seen. But we have signaled several times that the -- one of our key challenges will be the redeployment of our resources to our priorities and to our core areas. So this will continue to be a challenge for us.
You have seen how fast our portfolio and pipeline is maturing, so we will continue to allocate the best resources to the best programs across the year and the following year also.
The only thing I would add on this is we've communicated a guidance and we are committed to delivering this. We are committed to our dividend. And as we move forward into next year and the year after I think certainly we will look for ways to improve our productivity, improve the productivity of our SG&A, as you can imagine, look for synergies across our commercial infrastructure and continue improving productivity in R&D, and look at various options, as we said a bit earlier, partnering options and others.
But it is fair to say that on the R&D front there will be a little bit of pressure on the R&D budget, because suddenly the good news is the pipeline is progressing faster than we anticipated, but it on the other hand creates, of course, requirements for additional resources.
The next -- sorry, Briggs, do you want to jump in on the PD-L1 question?
Yes. So Atlantic is a phase II trial in patients with locally-advanced or metastatic 3B or 4 disease who have received at least two prior regimens, including one platinum-based. So it's a single-arm trial in patients with more advanced disease or have failed previous therapies.
Pacific is a trial in essentially newly-diagnosed patients who have stage III disease and as part of their definitive therapy are getting chemo-radiotheraphy for that disease. Today normally they would get chemotherapy as definitive therapy and then nothing additional. That's the setting where sequentially we would like to add PD-L1. So it's more of a -- Pacific is a newly-diagnosed, locally-advanced disease, whereas, Atlantic are patients who have failed at least two prior regimens.
Maybe we could take an email question. There is a question here on Pulmicort, the growth in China. And basically the question I guess is where does this growth come from. Sorry, I am trying to read. Yes, anyone else explaining the 50% growth for Pulmicort in the emerging markets in Q1. This is a question from Kristofer Liljeberg at Carnegie.
And the answer here is actually this growth is very much driven by China, quite a large number of markets, but very much China by a large amount. And that is not a one-off. This is very much the result of a lot of investment in building nebulizing centers in China. We have actually gone from a few hundred nebulizing centers about a year ago to more than 2,000 nebulizing centers.
And it's really pleasing to see, because this is, as you know, a very severe disease in children and the impact we are having on those patients is really tremendous. And it has, of course, driven a substantial growth of Pulmicort in China.
There is also another question about Crestor. Maybe, Marc, I don't know if you want to cover this one. Should we view the positive net price realization as a one-off? It is a one-off indeed for Q1. Do you want to cover this one?
So, to be clear, the question is whether we will see a more flattish price for the quarter 2. And the answer is the price for Crestor has not slipped much in the first quarter, so I think quarter 2 will probably a continuation of that.
Yes. For the one-off -- the first quarter is really a one-off. It's a true-up of managed care rebate, so a one-off for Q1 and then moving forward I think we'll be flat.
So I think we've covered the email questions. I'm just checking. Sorry about this. Yes, so maybe we could go back to Keyur Parekh, Keyur at Goldman Sachs. Do you want to go ahead, Keyur?
Keyur Parekh – Goldman Sachs
A couple of questions please. One, if I understood correctly you were attributing some changes in your focus from a diabetes portfolio perspective as it relates to the marketing efforts in the U.S. I just wanted to get your sense on moving resources from Onglyza to Farxiga as you're launching it.
And should we think of that as more long-term, or do we think of it as resources moving back to Onglyza and, therefore, the support to Onglyza? Or should we think of you needing more resources on the diabetes end? That's one. Secondly, and as you think about the quantum of products that the industry more broadly seems to be running on immune-therapy, especially smaller trial, single-arm studies, can you share with us your experiences of the dealing with the agency on their willingness to accept single-arm studies, 20, 30, 40 patient studies for these kind of projects? Thank you.
So the IMT and the attitude of the agency against smaller studies maybe, Briggs, you could cover in a second. Let me quickly cover the diabetes question in the U.S. It is clear that our focus is for Farxiga. Sorry, in the U.S. it's called Farxiga -- and Bydureon. And that has led to these -- the results you -- I've shown you with Farxiga. It's also fair to say that as a result you see a rather flattish picture with Onglyza and it is clear that our focus will remain Farxiga and Bydureon.
I would just simply here attract your attention to the data we will present at the ADA in June, combining Farxiga and Onglyza in a combination regimen on top of metformin and compared to a single agent on top of metformin. And I might also give you an idea of the potential that exists in combining those agents either as separate monotherapies or in a fixed combination regimen. This data will be presented at the ADA.
Briggs, do you want to jump in on the IMT question?
Yes. The question of how many patients do you have to treat before you can potentially get early approval in large part depends on the activity of the molecule. So it's the number -- essentially what the agency is looking for is a level of confidence around the activity and the safety of the molecule.
So with low response rates and a wide level of uncertainty around it you probably need to do more patients. With very high response rates where you can get some pretty small constant level around that response rate, as long as there doesn't appear to be significant safety issues I think the FDA has been willing to grant people accelerated approval with a commitment to follow on with additional studies.
Part of the breakthrough designation with 9291 is it enables us to have those conversations of exactly what do you need from a single-arm trial to reassure them of both efficacy and safety and a commitment to follow on with a larger randomized trial.
Keyur Parekh – Goldman Sachs
If I just follow up on just getting a sense for what do you mean by good or strong responses? Are we talking responses not of 40%, 50%, 60%, or do you think 20%, 30% response rates are good enough from a filing perspective? Thanks.
Yes, the signal that we've got from them as we had these exact conversations is response rates in the 30%, 40% range with a lower bound on counts interval clearly exceeding 20%, 25% I think is something that they would take notice of, of course, always balanced against the toxicity that your molecule brings as well. But I think that's the range of response rate where they've indicted they'd be willing to have a conversation.
So the next question is from Jo Walton at Credit Suisse. Jo, do you want to go ahead?
Jo Walton – Credit Suisse
Just a couple of questions. On the R&D front you filed Olaparib now a while ago in Europe. I wonder if you could give us an update on the timeline there and your negotiations. Looking at your upcoming events I can see that there is an oral argument surrounding Pulmicort early in May, but do you have a timeline when you think there could be some decision on the Pulmicort generics? And do you have any view as to whether there has been any wholesaler de-stocking yet for Nexium?
And my final question is just on -- to help us with our modeling. The net finance charge excluding the royalty stuff is very similar in the first quarter this year to the fourth quarter of last year, and yet you will have been paying for the Bristol Meyers deal for at least part of the quarter. Is there anything unrepresentative about that 1Q, or is it four times' the 1Q for the full year net finance charge?
So, Marc, maybe you could cover the finance charge in a few seconds and let me start with Pulmicort. There is nothing new to report here actually, Jo, on the Pulmicort front. And we typically do not comment, as you know, on our ongoing litigation, but -- so we don't have any more to report here.
Nexium de-stocking; there is no de-stocking we've noticed. The stock -- the inventory level in the U.S. at the end of March was very similar -- at the end of the quarter was very similar to what it was at the beginning of the quarter, at the beginning of January, so no inventory movements there. And maybe Olaparib, Briggs, do you want to say a word on that?
Yes. And thanks very much for the question. A little bit of an oversight on our part. Thank you very much. We should have had it on slide 26, because it is potentially -- potential to have the EUR approval in the fourth quarter of this year.
Since we are on Europe, and we need a little bit more time actually to address your finance question, Jo, let me just ask Ruud who is here with us today to tell us a -- tell you a little bit about Forxiga in Germany, because in the U.S. it's of course very important, but we are also doing very well in Germany, incredibly well, in fact, with Forxiga so far and also with the Xigduo, so do you want to say a few words about this one?
Of course, Pascal. And what I have mentioned also in the annual results in the first quarter we were in an arbitration process in Germany. I am happy to report that we came to a resolution and as a consequence of that we are in the phase of re-launching Forxiga in Germany. It goes extremely well. It's clearly tracking on a value basis the line of Genovia, so we are very pleased.
On top of that we are also very pleased to see the progress we are making with Xigduo, the fixed-dose combination of dapagliflozin and metformin, so both products are doing extremely well in the German market.
Thanks, Ruud. So, Marc, are you able to address the question? (multiple speakers). So Marc is going to address your question. So, Jo, did you have another question or comment?
Jo Walton – Credit Suisse
Sorry, the -- in Germany then does that mean that you have got a Genovia-type price?
Yes. So we had an active negotiation. As always, we are not disclosing exactly the price where we landed, but it's more or less in the ballmark of the Genovia price.
Do you want --?
Yes. Regarding the financial expenses which are treated in our core, I think the amount of 126 is in line with what we expect for the year, so there is nothing very extraordinary on the -- in these expenses. And we do have some expenses included for the acquisition of BMS on this.
Sorry, go ahead.
No, that's it.
Okay. So we'll -- I apologize for those of you who are still in line. We'll only be able to take one last question from Seamus Fernandez of Leerink. Seamus, do you want to go ahead?
Seamus Fernandez – Leerink
So I was encouraged to see you talk about the advancement of benralizumab into phase III for COPD. Can you talk a little bit more about where you see the overall respiratory pipeline, because I think there are also potential immunologic indications where we could see further advancements there?
So just maybe talk a little bit about the breadth of the opportunity that you see across the various mechanisms that can approach respiratory disease outside of just severe asthma. And then as a second question I was just hoping we could get a little bit of an update on the tax rate and where we see the sustainable tax rate. And then as we move forward what should we anticipate, or what are the possibilities for the patent box for all of the very rich pipeline that we see advancing forward from here?
Again, with so many products in the pipeline looking like they have a good start it would seem like the patent box could be something that could be quite beneficial to AstraZeneca moving forward in terms of the tax rate. Thanks so much.
So let me try to address the questions on the respiratory portfolio. Maybe, Marc, you could take the tax rate and the patent box questions. And also, Briggs, if you have anything to add on the respiratory portfolio, not the tax rate, but the respiratory portfolio, please jump in.
And I hope I actually -- Seamus, I hope I understand your question well enough. So the way we look at it is that in those respiratory diseases the treatment is likely to change and towards a more personal healthcare approach. So we see a sub-group of patients emerging and those -- some patients will respond to IL-5 that have eosinophilic disease. Others will respond more to IL-13 or some other mechanisms.
So what we are doing is building a portfolio of biologics. And we have benralizumab so far. We have also tralokinumab which we mentioned a bit earlier we are going to move into phase III. And essentially that's our approach to those respiratory diseases is to develop biologics that will be targeted at sub-populations of patients.
Over time we can also hope possibly that biologics might be useful in earlier stages of disease and influence the course of disease and it's certainly something we'll be exploring.
Briggs, is there anything you want to add to this?
No, I think that's a good initial summary. And again, Seamus, we'll probably have some discussions of this at the analyst presentation at ATS.
Yes, regarding the tax rate, so the rate for the quarter is 20 -- reported tax rate is 20.7%. It is not materially different from what we had in previous quarters or previous years. It is slightly better, but it is not materially different.
Regarding the patent box, progressively as our pipeline progresses we will make use of this possibility in a progressive manner. We will increase it over time. So I think the answer to the question is, yes, we are going to make use of the patent box as our portfolio progresses.
In that regard it's really good to notice that two of our products, Olaparib and 9291, originate out of our UK-based oncology team and certainly we'll take advantage of the patent box there too. So we'll stop here. And again I would like to thank you very much for joining us today and asking so many useful and insightful questions. And hopefully you'll agree with us that our pipeline is making good progress.
So we'll report back again at the end of quarter 2 with hopefully some further progress on those fronts. Thank you so much.
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