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Sanofi (SNY)

Q4 2012 Earnings Call· Thu, Feb 7, 2013

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Transcript

Christopher A. Viehbacher

Management

Good afternoon and good morning, everybody. Thank you for the savings, Sébastien. I could probably add that actually, as part of our overall cost reduction measures, reorganization of Paris-based office space will have eliminated 100,000 square meters of office space of an annual saving of EUR 50 million. So you can see that we continue to be cost conscious and focused on growing the business. As I present to you today, I'm thinking about the very first time that I did this in the name of Sanofi, which was in February of 2009. Back in 2009, we were looking forward to the patent cliff, and actually on that day, that was the very first time we, as a company, admitted there was a patent cliff and announced, really, a strategy about how we intended to deal with the patent cliff. This morning, I was on TV, and the journalist was very kind in saying, "You've never deviated a single line from that strategy." And I think that's true. It hasn't always been easy. Not everybody's believed it. But I would say today that we have successfully navigated through the patent cliff because if you look at all of the products that we lost, we have had certainly the most concentrated and deepest patent cliff of anybody in the industry, and I'll show you some numbers on that. The objective is, as we laid out 4 years ago, it wasn't just to replace the sales of those products we were going to lose. It was to put the company on a completely different path. It was meant to provide long-term sustainable growth of the business, and you can't do that if you're really only ever going to be focused on R&D and patents. So what we were looking to do were…

Jerome Contamine

Management

Well, thank you, Chris. Good afternoon or good morning, everybody. So we go quickly through a bit more detail on the financials. So I'll start with sales. I mean, you are used to this graph, and I would say that probably we'll continue to see this graph for another 2 quarters as long as we get out of the falling back to the patent cliff. So as we know, I mean Q1, Q2, we still saw a difference in 2013 as compared to 2012. So the lesson on the -- of this graph is pretty much always the same. Well, on one hand, we've lost, over the years, EUR 1.3 billion of sales from this definite list of key genericized products. On top of that, we terminated -- it was great that we had to terminate our agreement with Teva on Copaxone, and we sold out our Dermik business in the U.S. At the same time, the growth platform has contributed for EUR 1.6 billion of extra sales, on top of which we can consider that in 2012 another quarter of Genzyme, which we did not consolidate, obviously, in 2011, which leads us to basically a slightly increasing sales all in all on a consolidated sales basis. And clearly, in 2012, in comparison to 2011, but we know that they always fluctuating, we had a very positive tailwind impact of ForEx exchange rates, in particular, because the euro was pretty weak in 2012 versus most of the other currencies, leading to this overall increase of 4.7%. Well, maybe a few more words on the currency impact. I mean, this graph is particularly here to tell you -- to give you more detail. I think that we've presented this graph in the previous quarters. Also to show there is volatility in…

Hanspeter Spek

Management

Thank you, Jérôme. Good afternoon, good morning. I'm here to give you some more insight into the performance of 2012. As you have heard, 2012 has been mainly marked by the strong, by the good performance, by the performance that's expected of our growth platforms. This represents now more than 70% of our sales. You see that those growth platforms were standing in the first quarter of 2011 for EUR 4.6 billion and in the last quarter, for EUR 6 billion. They are composed of a still small but growing share of other innovative products, evidently New Genzyme, Animal Health, CHC, Vaccines, Diabetes and the Emerging Markets. What has changed also and what is a premier in our reporting for the first time, the Emerging Markets became the most important part or important piece of our business. As you see from the chart, we have achieved EUR 11.1 billion, which is a growth you have heard before already from Chris, 8.3%. And this represents 31.9% of our total business, which means the Emerging Markets have overtaken the United States and by far, also Western Europe. Remarkable also is that the share of Europe continues to decrease for reasons you understand. You see that we have a decrease of 9.3% in Western European sales, and the sales in the United States have been stable in 2012. And by the way, we expect to grow [ph] as of 2013 in the United States. How did this all happen in the Emerging Markets? You see that we always had a strong position. I have mentioned many times before, but to some extent, this is even a historical effect due to the early entry of companies like Hoechst and Roussel in those parts of the world. We had 2005, approximately EUR 5 billion sales.…

Olivier Charmeil

Management

Thank you, Hanspeter. Good afternoon, good morning. I'm afraid I have nothing in my pocket, but I'm happy to report that Sanofi Pasteur ended 2012 on a very high note. We had a very strong fourth quarter, with our sales up 20.5%, with a strong growth coming from the Emerging Markets, where we show a very strong performance, with sales up almost 24%. For the full year, for Sanofi Pasteur, our sales have reached EUR 3.9 billion, up 5.7%. We continue to drive our profitability up due to rigorous management of our OpEx and targeted investments. Beyond our growth drivers, our profitability has gained 1 point -- 1 percentage point from 20.4% to 29.5%, getting closer to the profitability of the rest of the business. After a couple of years of very sluggish sales in Europe with our joint venture with Merck, now we are happy report that we have regained some momentum. We had a very strong fourth quarter, with a growth of 9%. And for the full year, we show a growth of 6.8%. For 2013, we get prepared now for the launch of our hexavalent vaccine, which is expected in 2013, at the end of the first half. And it will be an important growth driver for 2013. Sanofi Pasteur had another very good flu campaign in 2012. The history of flu is very different each and every year. We are the undisputed leadership on the flu market both on the mature market but also in the emerging market. In the U.S., as you know, the disease activity has been a little bit late in a sense that it came at the end of Q4 and beginning of this year. And we have continued to ship, even although for small quantities, in January. Overall, in terms of…

Christopher A. Viehbacher

Management

All right. A number of these points I have mentioned earlier, so I'll go quickly. But as you can see, a very strong performance of all of the products within the rare disease portfolio. Clearly, the United States, with no competitor for Fabrazyme, was a significant opportunity for the company, taking advantage of now the increased competition. I think it's very good, though, to see a strong performance of Cerezyme where the competitive situation is different. And this is where I think you start to see the importance of the Genzyme business model, the real proximity to the patient. Now we've had good news on both Phase III studies on eliglustat, and then, I think eliglustat becomes another element to add to really allow Genzyme to regain leadership in the Gaucher market. And then of course, Myozyme, growing also at double digits. So I think, in addition to the financial success, what I can tell you is that within the -- around the corridors of Genzyme, being able to fully supply the market has had a huge morale boost. And I think has been a factor that has allowed us to really successfully have Genzyme come into the Sanofi family. Now the other was a trickier proposition. We put multiple sclerosis into Genzyme, no real experience in multiple sclerosis. We actually had to build a team from scratch, which we have done. That was actually a very significant investment. And it's fair to say that Aubagio did not have a significant awareness level coming into this. However, I think when -- and when we started seeing the first data, we were encouraged by the launch. Personally, I'd like to see a little bit more than a couple of weeks of data to get excited. But here, we have 4 months of data and what you can see is, clearly, that the Aubagio launch is tracking at least as well, if not slightly better, than the Gilenya launch. 80% of MS specialists have now -- have prescribed Aubagio. 1 in 5 patients were treatment-naïve and then, obviously, the rest were switches, mostly from Copaxone and Avonex. In doing some of the initial market research, one of the key reasons is actually tolerability of treatment. So I think it augurs well because this also says that we have a team, that should be in good position to launch Lemtrada. It is obviously a huge opportunity that we have to be able to put 2 significant new medicines into an important area like MS. This is a market of some $14 billion worldwide. So with that, now to talk about the future in Research and Development, Dr. Elias Zerhouni.

Elias Adam Zerhouni

Management

Well, thank you, Chris. I think as you've heard through the presentation, 2012 has been an extraordinarily busy year for R&D. It's probably one of the busiest years the company has known. I think it's the result of a very driven strategy, starting in 2009 when we focused on: first, reinforcing the late stage portfolio; second, transforming R&D; and third, reinventing the model for R&D over time. I think what you've seen in the past year is 9 approvals, 6 registrations. And what I would like to talk to you about is what is it that we are currently executing on and what is it that we intend to do over time. First and foremost, we thought it was very important to have a focused portfolio. And therefore, we pruned the portfolio. Currently, we have about 64 New Molecular Entities in development. But the key to the progress was to focus on areas where -- in areas where we knew we had already great investments in platforms that were destined to grow, like Vaccines, like Diabetes. In addition, we thought it was very important to build out new therapeutic areas in areas of strength that we have. For example, immunology and inflammation, with multiple sclerosis, with anti IL-6, IL-4, monoclonal antibodies. We knew, clearly, that we had to maintain our competitive position in oncology. So what you will see today is a portfolio that essentially aligns to the 7 strategy areas -- strategic areas that we decided to focus on over the period of 2012-2015 and trying to execute along those specific lines. So in multiple sclerosis, you heard about Aubagio, I'm going to tell you about Lemtrada. In diabetes, you heard about Lyxumia, I'm going to tell you about the new glargine. In oncology, we have a JAK2 inhibitor.…

Christopher A. Viehbacher

Operator

All right, we'll close here. I think you've seen this -- the strategy. Essentially, an integrated health care leader, we are increasing, we've got a pipeline and we're bringing those products to market. We will continue to have an acquisition strategy, but I can tell you that it's getting tougher and tougher to find good value items out there, and of course, we need to continue to adapt to our future. So let's talk to guidance. What's in the background of the guidance? Well, you already know that we have EUR 800 million of over hang from Plavix coming into this year. But essentially, when I look at the businesses, it is going to continue to perform as it has been. I mean, our growth platforms will continue to be strong and I don't see any change, any disruption in the business. We have an awful lot of launches this year. We're suddenly seeing things like the IL-6, the IL-4, or the C. difficile vaccine coming into our program, that's all very exciting for the future and we clearly want to support that, so we are going to reinvest EUR 500 million of our savings this year into the future of the company. We don't want to get into underlying growth rates. But essentially, if you look at this guidance and said, all right, let's take out Plavix of EUR 800 million, the underlying business is growing at 5% to 10% on the bottom line, and I think that just demonstrates the confidence we have in the underlying business that's going on. So taking all that into account, our 2013 business EPS is expected to be flat to 5% lower at constant exchange rates, always barring major unforeseen adverse events. So the longer term guidance, everything we still see is completely aligned with that. We do increase our operating margin in our plans. We've got EPS, therefore, growing on a leveraged basis. And we still intend to, obviously, have our dividend payout ratio, achieve the target of 50% in 2013. With that, I'd like to invite my colleagues up onto the stage here, and we'll be happy to take any questions, obviously, through webcast or here in the live audience. So come on up, folks. Sébastien Martel: We'll probably start taking questions from the room, and at some point then we'll turn over to questions we have received through webcast. Shall we go? Philippe Lanone [Operator Instructions]

Philippe Lanone - Natixis Bleichroeder LLC, Research Division

Analyst

Philippe Lanone from Natixis. Three questions, if I may. First one, can you make a comment on Lovenox in Europe, which is quite a big drug still for you. And we have new proposed guidelines that while they, again, restate that there is a lot households who do not close anymore their doors to substitutable generic? Number two question for Jérôme, maybe, on the R&D. If we extrapolate the trends in Q4, you have a number of drugs in Phase III now, how confident are you that you can be within the EUR 5 billion threshold if we extrapolate that Q4 trend that needs a lot of restructuring? One question, maybe more -- during the... Sébastien Martel: Philippe, maybe that's the last one. [Operator Instructions]

Hanspeter Spek

Management

Yes, you're absolutely right. There is a guideline for biosimilars in Europe, Aldrich [ph] -- and you had touched on Lovenox, we have been consulted in this process. We are overall, I would not say satisfied, but nearly satisfied with the outcome. The outcome is rigid, it's stringent as far as the definition of those products is concerned, we believe that it will not be easy for everyone to overcome those hurdles. Clinical trials are needed, but they can be raced [ph] but it will not be easy to race [ph] them. So overall, we believe those guidelines are okay, and they are okay because they are safe for the patients. Independently, and I have said so over the years, I don't believe that the European market will be extremely sensitive to generics for Lovenox. The European market, for the last 20 years, has seen a multitude of low molecular weight heparins. The market situation is not at all comparable to the U.S. market. And let's not overlook that even in the U.S. market the penetration of generics has been relatively slow, very slow in special side of the hospital market where Lovenox even today controls about 50% in terms of volume.

Jerome Contamine

Management

Philippe, I will give you -- if I understood your issue [ph], if you look at the fourth quarter of 2011 where we had the ratio of 15.2% to sales in terms of R&D expense, you would have told me even, "How on earth can you get to 14%?" And we did. So in other terms, I mean, this will be a combination of further pulling back of the optimization which has been put in place in 2012, and of course, I mean, there are things which are increasing. Not only PCSK9, but also Fluzone [ph], if I look at the overall Phase III expenses for -- from many years compared to the previous year, some have been on the roll already, so the cost will be somewhat lower. So there are things that go up and down, and I mean, I can just confirm what I said that we will stay within the EUR 5 billion envelope.

Vincent Meunier - Exane BNP Paribas, Research Division

Analyst

Vincent Meunier from Exane BNP Paribas. I have 2 questions, please. The first one is on your guidance for the long-term and especially in Emerging Markets, in the current context of 8% growth at constant exchange rate in '12 and also, in the current context of, let's say, uncertainties in a lot of countries everywhere, is it fair to continue to assume a double-digit growth in that part of the world even if, as you say, this is the single largest opportunity for the pharma industry, but maybe, high single-digit is better than double-digit? The second question is on the biosimilars of insulins you are launching, so you are talking about 2 Phase I projects. Can we have more details on that? Are you talking about human or analog insulin, long-acting, short-acting, maybe your biosimilar of nouveau rated [ph]?

Christopher A. Viehbacher

Operator

Hanspeter can talk some more about the Emerging Markets. I think we are barely scratching the surface yet on really achieving penetration into these markets. People get a little concerned about seeing maybe the Chinese economy slowing down, but it actually doesn't have an impact on the creation of middle classes. We grew double-digit in our key areas last year, and so you can count Eastern Europe in or out. I actually think, over time, Eastern Europe will come back because it is clearly under-investing. These are much more -- there's 80 countries in the Emerging Markets, you've got multiple layers of wholesalers and it's never going to be as smooth as what you all have been used to seeing in Europe and in the U.S. But from a potential point of view, and given our product profile, I'm not prepared to cede on our target on that yet. In terms of the biosimilars, we don't really want to say an awful lot because of competitive reasons. They are not biosimilars of our own molecules, obviously, since we've had that question come up. So you can pretty much figure out what they might be. You want to add anything on the Emerging Markets? Jo Walton - Crédit Suisse AG, Research Division: Jo Walton from Credit Suisse. A couple of questions please. 18 months ago or so, when you were talking about your long-term guidance, there was a view that 2012 would be the trough year. It doesn't seem that that's the case now. Would it be fair to say that Genzyme has perhaps done better in 2012 than you had originally expected, so you haven't got the incremental benefit to come through in '13 to offset what was always, clearly, going to be the second half of Plavix and Avapro.…

Christopher A. Viehbacher

Operator

So 2012, trough year, 18 months ago. First, a guidance of flat-to-down minus 5 doesn't actually preclude 2012 from being a trough year. So let's have a look at the end of 2013 as to where we get to. The second is, in my experience, the worst thing you have is when you've got a flat anywhere in your guidance. Because it only requires a little bit of -- here and there of things like tax rates, of a slight shift in 2012 to 2013 of Plavix that starts to make some of those things that you said 18 months ago, a little less precise. If I look above the operating profit line, I don't see anything that's changed. And when you, so let's say, you take out that EUR 800 million if you want to get into the underlying growth story, I mean, you can see that, that business is growing to 5% to 10%. So we have continued confidence in the underlying fundamentals of the business. Now the tax rate was unexpectedly lower last year, and we did have a settlement with BMS on Plavix, and that shifted a little bit. But as I say, the guidance doesn't exclude 2012 from being a trough year. But fundamentally, as I look at the business and I'm not really looking at it any differently than I did 18 months ago, with the exception that, actually, we have a whole lot more in R&D, 18 months ago IL-4 was not on my radar screen. The C. difficile was not on our radar screen. The ability to actually move as quickly as we did on PCSK9 into Phase III, I mean -- remember, we only opted into this with Regeneron in March of 2009, and here we are 3 years later in…

Olivier Charmeil

Management

So predicting the right trend is always a very difficult exercise, and it starts in February and we have seen years where, at the end of the season, the strain had circulated and had changed. So it's a little bit premature to say what ACIP recommendations are going to be. What we could say that, in the last couple of years, there has been some mismatch especially for strain A and B. So to have 2 strain Bs will offer a better protection. In terms of manufacturing, it's not going have a significant impact. The way we view the impact in terms of manufacturing is on the fact that, of course, it will be able to put pressure on capacity, which means that at the end of the day, to manufacture 4 strain, of course, you need to have an installed capacity that is a little bit larger than for 3 strains, which means that we are expecting less price pressure for the whole market, in the Quadrivalent market than a Trivalent market. Sébastien Martel: We'll move to second row, Michael, Richard, one after the other.

Michael Leuchten - Barclays Capital, Research Division

Analyst

It's Mike Leuchten from Barclays. If I can just go back to the Emerging Markets, the slowdown really seems to be in the run [ph] EM business, which is not your growth platforms. And if I look at it full-year, that business was broadly flat and then down 3% in Q4. Can you help me understand how much of that is structural as to temporary i.e. how much of that was just some sort of price pressure in 2012 that may annualize in 2013, and hence, you'll see a natural acceleration? Or how much of that is really structural?

Hanspeter Spek

Management

Well, overall, we have seen in the marketplace in the demand an acceleration. And in the fourth quarter, if I take as an example off China, IMF, which has to be handled with very much of care because it's only selective for the market, but nevertheless, has seen a strong rebound in the last 2 or 3 months of the year. So I'm talking about demand. What we have seen and what has weakened our performance in Emerging Markets in the last quarter from a structural point of view was OTC Consumer Health Care. We have faced difficulties in China and in Brazil. In Brazil for Medley, and in China, mainly for one of the brands which is a multivitamin brand. The reason for the slowdown in the first quarter were quite different from market-to-market. You could say in both markets we had both channel issues. But then intrinsically, of very different origin. We have a problem in Brazil which is specific for one chain of a pharmacy chain, which is accelerated by a local problem, this VAT. There was a significant change in VAT in the state of São Paulo which, unfortunately, is a major market for Medley so far. So we have to actuate in a structural way which means we have to dislocate our resources and to -- and get to markets. Versus VAT problem which is a problem for the consumer, for the customer, not for us, that does not exist. In China, we have a situation where second- and third-tier distributors have severe financial problems, as they have lost most of the margin and so the distribution system, to some extent, collapsed. Which we also have to address from a structural point of view, which means we are today, in a reselection of our customers. We work with different customers respectively we will drastically reduce the number of partners. All of this should lead to a reacceleration of our performance in CHC during the second half of 2013. Beyond that, I see no structural change. I fully underline what Chris said before in Emerging Markets, this trend will continue. Some of the markets where we place, as I see -- if I look to markets like Indonesia or Vietnam, as they are just at the beginning of the real growth period.

Christopher A. Viehbacher

Operator

I think your question was around the growth in the nongrowth platforms so just to complement what Hanspeter said, there was a withdrawal of a product in Mexico, for example, which is a one-off. And in these price reductions in China, the Oncology piece, which is not included in the growth markets, there was an impact on Taxotere and Eloxatin. So the Taxotere and Eloxatin clearly carries forward in China, but the withdrawal of the products is essentially a one-off. But I think, fundamentally, there is no real difference. Sébastien Martel: We'll go to Richard on the second row. Richard Vosser - JP Morgan Chase & Co, Research Division: Richard Vosser from JPMorgan. Two questions please. Just thinking about the cost savings that won't be realized in '13, through '14 and '15. Presumably, with the pipeline coming through and new launches, those will be reinvested as well. And then, just thinking about that underlying growth, the 5% to 10%, what do you need from sort of M&A to come through the pipelines, to come through, to maintain the growth at that sort of level, or even accelerate it from the bottom line? And then, just one question on diabetes. Just thinking about Lyxumia as it comes to the market, have you managed to gain any insight into the cardiovascular profile of Lyxumia from the data you've submitted from ELIXA to the FDA? Clearly, the confidence interval should be relatively below 1.8, how should we think about that maybe impacting the launch of Lyxumia and the sales of that?

Christopher A. Viehbacher

Operator

Jerome, maybe, you could take the cost saving question; and Elias, the Lyxumia question?

Jerome Contamine

Management

You're right, Richard, that as we said, and we're going to invest a large part of our cash in 2013. Well, it doesn't mean that we will do exactly the same in the coming year, there is a sort of a bolus effect in 2013 if you think about all the launches which, I mean, we all know which are just starting, or being prepared for, like Lemtrada. And we have a sort of seasonal [ph] effect, and today, we are clearly investing more than we will generate and save in 2013. Which, by the way, one of the reasons why you need to keep this in a range in terms of guidance because you don't know exactly what's the exact timing and what will be the pick up of, let's say, Lyxumia in Germany or whatever. So there is a certain degree of uncertainty, but as long as you are going into the next year, I mean, hopefully, I mean, you will get more save while you have no reasons to build up another sales team points in the support for Aubagio. So leverage effect will also automatically come from these launches in 2014. So we don't really consider that, yes, we're going to continue to generate savings in the next year -- next years. This will be, firstly, on the industrial side because as we know, I mean, each measure you take on industrial takes a bit of time to be implemented and to be feasible into the P&L. Also because it goes firstly into the inventory before going into to the P&L. But second, there is a leverage effect which really comes all the time just as a reason of increasing phase on the new launches, which means that, I mean, the success of these new launches is, by far, the most important thing when it comes to the evolution of profitability of all, let's say, taking of attention when it comes to the evolution of our performance in the 2 years to come.

Christopher A. Viehbacher

Operator

Yes, and of course, sales of new products are notoriously difficult to forecast. I think it's fair to say, in 2013, launch costs exceed the sales of those same products by about a 2:1 ratio.

Elias Adam Zerhouni

Management

In terms of the cardiovascular risk for Lyxumia, as you know, in the E.U. we could file. In the West the FDA requested to have the ELIXA study recruited significantly to be able to file. So we filed in December. And they have to do an independent study which is blinded to us, of the risk ratio and then, determine acceptance of the filing, not what you were expecting in the first quarter, as Hanspeter described. And this is an independent study that has to be done on an interim basis by the third party.

Christopher A. Viehbacher

Operator

So part of your question was what do we need to do in M&A to make the 5%? And the answer is, I don't think we have to do anything. If you go back to 2012, we've got a EUR 23.5 billion business called the Growth Platforms that grew at 10%. I mean, if you got that sized business growing at double-digits, it's quite a momentum that you've got going. And it, really, when you look at our sales forecast, actually nothing really has to happen in terms of sales growth, the main reason that sales go up is not because the Growth Platforms are growing any faster, it's just that every year, we have less dilutive effect of the stuff that's come off patent. So in some ways, just waiting actually causes the sales to go up. We don't have to buy anything, we don't have to launch any new products to get there, it's just a mathematical effect of that. The only wobble factor in there is how much does the -- do austerity programs cost us. But we've already baked into our numbers an assumption that the austerity measures have an ongoing impact on our business. Sébastien Martel: We're going to take a question from Switzerland, on the third row, with Odile.

Odile Rundquist - Helvea SA, Research Division

Analyst

Just coming back to the flu vaccine. I mean, we know that since 2009, there has been a recommendation for universal coverage, but still your flu vaccine has been downsized to some -- in 2012, we know that there is maybe a delayed effect that, that could recover in the fourth quarter. But we have seen that with, also, a competitive company, with flu sales being definitely down. So you guys have deemed in 2011 for U.S. flu vaccine to grow by double-digit number going forward, is this guidance still relatable? Or maybe a bit too bullish? And then, on eliglustat, I mean, it has definitely the advantage of being an oral formulation to overcome the challenge of infusing patients and then, that is typically what also are rising in the childhood. So this year, actually enrolled patients, are children in this study, or do you plan to do so in your 2 -- to study with some children and family, I don't know if you can maybe talk about the differentiating factor of your JAK2 inhibitor versus in market check out [ph] before it comes out. Sébastien Martel: Olivier, do you want to speak to the vaccine first?

Olivier Charmeil

Management

Over 2 last years, we have seen very low disease activity on flu. You have seen that, especially in the U.S. but also in Europe in the last couple of months, the disease activity has increased significantly. So it's obvious that after 2 years, after the funding, with relatively low activity, we have not observed a significant increase of the vaccination rate. We have seen that since the beginning of December, and this is one of the reasons how we have been able to ship until the last couple of days. The significant increase in terms of vaccination. To get back to, more precisely, to your question, what we are anticipating and we continue, and there is no reason to change the guidelines, what we are anticipating is, as we move forward we will be able to do better than the market with our differentiated forms. And we are very happy with our performance with the Fluzone High-Dose for the elderly people, that is growing more than 65%. We have invested very significantly on our Flu ID, small needle device for -- that is more friendlier for the people that are reluctant to get their shot each and every year, and of course, we're anticipating to get a price premium when Quadrivalent form will be launched. In the long run, we are also anticipating, and this is an important part of our strategy, when we finally get the efficacy data for the Fluzone High-Dose, this is going to be an important boost to our flu franchise in the U.S. Sébastien Martel: Elias, do you want to cover eliglustat and JAK2?

Elias Adam Zerhouni

Management

So for eliglustat, obviously, when you design a trial, the first trial is designed against placebo. And because of the ethical issues, do you opt for the treatment in children. With the established treatment versus a placebo, we obviously cannot. So you limit the exposure of children in the first trial. In the second trial, I don't have the exact numbers, and as I said, the ENCORE trial just came out, we've just had the top line efficacy endpoint. I don't the specifics within that trial, so I'll be happy to share them with you as I discover them, as they are analyzed as we speak. On the JAK2, the differentiation, it's a more selective JAK2 inhibitor. Our hope is that the very, the key factor of differentiation is whether or not you reduce fibrosis. Because myelofibrosis, basically, the outcome is driven by the growth of fibrosis over time. And if you can stop or reduce that, you will have a significant change in the outcome, we hope. Now in terms of the existing competitor, the target is about the same. The selectivity is the only difference at this point. But the question is fibrosis and we are looking at that in a different way. Sébastien Martel: Go ahead, Eric. Eric Le Berrigaud - Bryan Garnier & Co Ltd, Research Division: Two set of questions. First, to put 2013 in the context of your midterm guidance. First, in your revenue, last year revenue was flat and midterm guidance is above 5%, where do you see 2013 in this journey, as you try to achieve progressive trends somewhere in between? Or is it already achievable to think about 5%, and to see how much that is for '14 and '15. Second on core EPS, same kind of questions, midterm is above the 5%. This year it's between 0% and minus 5%, which suggests double digits for the next couple of years to reach at least 6%. Is it granted or under which conditions do you think double digit will be achievable in terms of extended growth, share buybacks or whatsoever. And the second question relates to GLP-1, should weekly GLP-1 become standard in monotherapy with semaglutide [ph] dulaglutide [ph] albiglutide [ph] on top of Bydureon. How do you plan to address this point with the existing agreement with Zealand [ph]?

Jerome Contamine

Management

Yes, on the midterm guidance, so I'm trying to do some math with you, Eric. So we start from 2012. In 2012, you're right, I mean, we've been basically flat on a constant cycle, slightly increasing on the cost of sales basis. Now if I look at 2013, we are still going to lose -- well, I mean, you can do the calculation by yourself. So EUR 1 billion, EUR 1.2 billion to EUR 1.3 billion of sales from these key products which have got to be precise [ph] 2012 obviously, mainly and firstly, Eloxatin. And of course, we have to beat that by Growth Platforms, and by how much, I mean, it's a bit early to say. The only thing I can say is that, I mean, that one reason to consider is the Growth Platform should grow at the same pace as last year plus the analysis [ph] we had before. We have basically no new launch contribution last year, we just had EUR 7 million of sales booked for Aubagio. So we think about that, and then you'll see there is some additions which could come from that. Now if I go into 2014 and 2015, obviously, the negative element coming from the loss of revenues, coming from the generic side of products will be much, much lower. So still, as Chris said earlier, I mean, the uncertainty remains around the impact of cost-containment measures, as an example. We know now for instance that in Europe year-over-year whatever happens, I mean, it's in the range of EUR 3 million so far for us. And then, I mean, of course it's a bit hard to predict more in detail, but it just gives you that -- I mean, still, in 2013, and this would be mainly in the…

Elias Adam Zerhouni

Management

Yes. I don't know if you're referring to the commercial agreement or the research agreement. I don't know what part of the agreement you're concerned about for GLP-1.

Unknown Analyst

Analyst

It looks like you don't have a weekly GLP-1. So how should you address the standard of care moving to weekly GLP-1 if all products in Phase III/regulatory phase succeed?

Elias Adam Zerhouni

Management

Right. So basically, I think that there is a panoply of needs that needs to be fulfilled. We do believe that when -- if you have -- as we've obtained with Lyxumia, [Audio Gap] indication Lantus, plus Lyxumia being approved, and you have to give the Lantus injection on a daily basis. There's no once-a-week insulin. So I think there should be -- there's still going to continue to be, because of the side effect potentials and so on, a significant demand for daily GLP-1, Lantus or -- in terms of the once-a-week, we're looking at several options there and not ready to comment.

Christopher A. Viehbacher

Operator

But I think it's also fair to say let's see if it becomes standard of care. We've seen 2 already fail. And my experience, when you got 2 failures in a class, I wouldn't bet on the third one. Sébastien Martel: So Chris, maybe a couple of questions from the U.S. There's one from Steve Scala at Cowen. Basically, he's asking what type of potential do we foresee for Aubagio, where is the business coming from, what are the main products from where we see it switches and, basically, what kind of percentage of the opportunity has already realized. Obviously, it's still very early days.

Christopher A. Viehbacher

Operator

When I look at this, what's interesting is I've spent a fair amount of time with neurologists just as a conservative prescribing audience. I mean, this is the -- these are the people that went to Fabry withdrawal and reintroduction. You're talking about patients who are diagnosed young in their life, often in their mid-30s, for example, many women, people who are going to be on medication for many decades. And, therefore, there's an awful lot of discussion with the patient that goes on. There are questions around safety, there's question about efficacy, there's a question about convenience. And so for me, the #1 factor is how quickly do physicians become comfortable with the tolerability profile of Aubagio. We know that Aubagio has at least the same efficacy as best-in-class interferon on Rebif. So there's no reason why anybody is going to go through injections if they can take an oral therapy once they become comfortable with the safety profile. What is interesting, I think, is the fact that, actually, this is a metabolite of leflunomide that actually helps us because the risk of suddenly a side effect coming out, as has been seen in others, is dramatically reduced because this is a molecule that has a known history. And I think the fact that one of the main reasons for switching is tolerability, is actually an extremely important sign. A lot of the products are coming from the #2 -- the 2 main products that we're drawing from are Copaxone and Avonex. I look at this tracking Gilenya that says that, actually, we're not really taking any product -- we're not taking any patients from Gilenya. So then the question in my mind is, what happens when BG-12 comes along? Well, we'll have to wait and see what the…

Jerome Contamine

Management

Okay. So first, I just gave the -- I mean, what we expect what was on '13, which is -- I can just repeat it between 26.5 and 27. Going forward, it's clear that we'll still see -- into the short term because, of course, in the long term, it may tend to gain. But we'll still see basically a disappearance of the royalties taxable at low tax income based on the French tax law. But on the other half, on the royalty evolution of -- I mean, of location of our phase and then our profit is moving towards regions which have an average tax rate which is lower than, I mean, both the normal French tax rate but also the U.S. tax rate. So if I go to that -- all that together, look at what we can do to manage that, I mean, we are still heading to an increase. But, I mean, I am, toward this increase, to be certainly below 30% and probably somewhere between 29% and 30%. Sébastien Martel: Are there any other questions in the room? Yes, we can go back to Philippe, and then I have a couple more also from the web.

Philippe Lanone - Natixis Bleichroeder LLC, Research Division

Analyst

One question on R&D again on Diabetes because some of your competition as Novo Nordisk is now developing new generation, at least in Phase I, there's the once-a-week injectable and oral insulin. When we look at your Phase I pipeline, this does seem to be any long term related to Lantus today. So do you have something looking for the long-term view on diabetes?

Elias Adam Zerhouni

Management

If I heard your question correctly, you're talking about what is our strategy beyond what we have today, right, and what's coming up. And so when you really look at our strategy for Diabetes, the 2 sections, one is obviously controlling hyperglycemia in a better way, in a greater percentage of patients. It's something that you have to do, and integrating care around that need is continuing to be our goal. With existing products or enhancement of existing products, like U300 basically for certain patients, we really cannot be at goal that easily. So we're going to continue that class of work. Second, if you talked about the GLP-1 or oral antidiabetics, we are definitely entering that. You may not see it in the published portfolio, but it's clearly something we need to be stronger at. And we are certainly starting that. As you know, we recruited some new heads of research, and we are definitely looking into that. In addition to that, I do believe that there will be a significant demand for peptides with -- CLIP peptides, with additional actions that will be of great benefit eventually. This is the direction that we are also taking internally. So I think that the expectations that you're pointing out to is that, pretty soon, you're going to see some of the emerging portfolio that currently is not published. But we are definitely working into that sort of multipronged approach to diabetes, that integrates vertically between all of the components we currently have and adds what I call the pre-hyperglycemia, the post-hyperglycemia issues that you deal with, including better cell preservation. Sébastien Martel: There's another question from Graham Parry at Bank of America Merrill Lynch. Jerome, about the cost-saving plans, you talked about 60% being achieved by the end of 2012. Also, about the fact that about 1/3 of that was reinvested in growth platforms, you announced an additional EUR 500 million for 2013. Graham is asking, by 2015, how much of the EUR 2 billion savings plan could fall to the bottom line, basically? Or what will be the...

Jerome Contamine

Management

I think we have 2 questions. And the question is, how much at the end of the day are we going to save by 2015? And if we just prolong the trend, you could say maybe we are going to save a bit more than the EUR 2 billion, a bit early to really be affirmative in that respect. The second question is how much we are going to reinvest. So, I mean, this is where we can be pretty clear when it comes to 2013. And, I mean, depending upon opportunities in terms of which new launches also, I mean, it's a bit more uncertain in the coming year. So it will be a net increase of the cost savings beyond 2013, in 2014, 2015. How much exactly? Well, it's a bit early to say. But I can say that, well, the EUR 2 billion is really something we will obviously achieve. And, well, I'm not really in the position to give a higher number today, but I think -- I mean, obviously, it will be on the high side. Sébastien Martel: Okay. Jo? Jo Walton - Crédit Suisse AG, Research Division: Jo Walton, Crédit Suisse. I've got 2 general and 1 specific question. The specific question first. Your attitude to getting involved with diabetes testing, you've talked about making as broad a possible offering in diabetes, and it was an area that you could go into. I wonder if you could update us on your thoughts there. And 2 general questions. You've talked about your R&D pipeline and how you've had more success than you might have expected, lower attrition. Do you think that we're going to see that generally across the industry? But the quality of knowledge when you put things into Phase III means that you have a better chance of success at the end or is that matched in an opposite direction by the increasing novelty of the pipeline so that investors probably won't see a marked difference? Sitting on this side of the fence, we're only seeing about a 60% success industry-wide in the Phase III, and that just still isn't good enough. So I'm interested in your thoughts there. And the other general question is about launch trajectories and particularly given the different way that you're promoting drugs now. So you point to having half as many sales reps in the U.S. now as you had a few years ago. Well, lots of the industry is like that, and lots of the industry is like that because they've had almost nothing to launch. So if we are moving back to a period with more launches, are we going to see you're going to need to put more sales reps in the U.S.? If you -- and just generally. And do you think we should be expecting generally slower ramp-ups because of all the extra problems that you have of getting access around the world?

Christopher A. Viehbacher

Operator

All right. First, in terms of the diabetes testing -- and Hanspeter can talk maybe a little bit specifically about the business. But in general, the idea that we have behind that is not actually just to go and compete against J&J or Roche or whomever. But our view is that there is a growing tendency, not so much in Europe but elsewhere around integrated care, where people are actually starting to look at having those who supply care be reimbursed on the basis of outcomes and not simply on the basis of volume uptake. So increasingly, people just don't want to buy a pill or pay for a doctor visit or pay for a hospital visit. But there is increasingly some element of, well, what did you actually achieve in terms of outcomes. I mean, in diabetes, for example, how many people actually got to their A1c goal? Accountable care, organizations are driving down that path, but you're also seeing some of these being incorporated into some emerging markets. And the real -- if you're going to get into that, you have to actually understand what's happening to a patient between the touch point to the health care system. Because the way the health care system works today is you go in, you have a prescription, you walk out of that and then you don't see a physician for maybe 3 to 6 months. Well, we all know that outcomes are going to be based on a whole lot of other factors, including whether the prescription ever got filled, whether the person is paying attention to nutrition activity. And mobile phones are having a dramatic impact, and you're seeing a whole host of characters actually getting into this because this is something that we all have with us. I'm impressed that not too many people are actually looking at their BlackBerry even as we speak, but generally, most people's BlackBerrys or iPhone or whatever devices that you carry is not very far away. And suddenly, you have an opportunity to communicate with a patient that we've never had before. So for us, this diabetes testing was, in a sense, getting us prepared for some of this, and you're certainly seeing a lot of moves to marry digital technology with therapeutics. So we've dipped our toe in the water, we've certainly made mistakes in this area and learned what we don't know about software development. But equally, I think what we have learned has provided us with insights as to where this could go. How fast it goes, we'll have to wait and see. But everywhere I go, there are signs that this is actually accelerating. I used to think this was kind of a 2015 and beyond theme. I actually think this will come a lot faster than that. So if you like there's a strategic element to this and not just a business segment. But you might just want to add on the actual tactical piece.

Hanspeter Spek

Management

On the diabetes piece, I have really nothing to add. We have learned and we continue to learn. And I believe that, therefore, we are a little bit further advanced than others. But I have not the slightest doubt that this integrated model for diabetes, as for other chronic diseases, is absolutely to come. And the question is only time and who finds the fastest right doors to go into it, and learn the lessons that we had to learn. To give you a little anecdote, we have been totally hit by the fact that the latest iPhone, does no more fit into our IBGStar device, which is a way of marketing of the iPhone inventors. So we had to learn this the hard way, and the next time, we know it. I would like to say something on the field reps question. This is true that the number of field reps has diminished also because of lesser opportunity to launch, but I think the major reason was that the decision model on prescribing has dramatically changed in the traditional markets like United States and Europe. And coming from this, talking about our own headcount, I believe, yes, there may be little increases depending on will PCSK9 be a product for a GP or not. But overall, I'm convinced we will never go back to the 10,000 we had in the U.S. because the decision-making on prescription has totally changed. It moved upstairs, it went into treatment guidelines and lists coming from the health care providers. On the other end of the geographical scope, I never believe that we will have 10,000 reps in China either because of the said decision-making, and also the way information is being handled is not the same as it has been in the '80s and '90s in the United States. But the fact is, we have today more in Japan -- in China than in the U.S.

Christopher A. Viehbacher

Operator

Elias, do you want to talk about the attrition question? Does this get offset by novelty? How do you see that developing?

Elias Adam Zerhouni

Management

So as we mentioned, I think our portfolio is pretty amazing in the sense that attrition has not occurred to a significant degree. But I think if you look at general trends in the industry, I think, first of all, look at the FDA approvals last year, this year, they are up. So clearly, the base hasn't changed, and therefore, there is more approvals. So you can tell that there's something happening. The second, Biologics has an inherently higher rate of success, lower rate of attrition. And as you change your portfolio more towards Biologics, you have a lower attrition by nature because they have an intrinsically lower rate than small molecules. The reason being that with the biologics, you need to understand the biology, you need to understand the target. And typically, with an antibody or replacement enzyme, it's very specific, and therefore, you don't really have a lot of off-target effects. And, therefore, you have a lower attrition rate both on efficacy and success rates. I think the other point is I think that the selection process is changing and -- inside of R&D. In other words, in the past, there was many short-term goals. Any target that comes up from the literature is a good one to go after, you have the tools, you go after the target. Today, it's an inverted process. We are adopting the translational strategy, which I had been advocating for a long time, which is the goal not just from bench to bedside, not from bedside to bench, understand the disease biology in humans before you make a choice to go into a large expensive Phase III. So I think you're going to see a redistribution of the attrition rates. Hopefully, more attrition early, less attrition late. Sébastien Martel: Okay. So with that, I think, Chris, I will just ask you to just wrap up the call and conclude.

Christopher A. Viehbacher

Operator

Yes. Well, thanks, everybody, for being here. Thanks -- thank you, all, for your patience on the webcast. I could tell you personally, I am very happy to have 2012 behind us. This is the first time in 17 years that I can look forward, and I don't see a patent cliff anywhere. I think we've also been able to surprisingly build an R&D pipeline of a degree of robustness. So as we look out to the medium term of the business, we continue to have the confidence that Sanofi gets back to growth in the second half of the year and beyond. So thank you very much for your support over the years, particularly during the tricky patches in this business, and we look forward to your support going forward. Thanks very much. Sébastien Martel: So just for those of you who would like to have a trainer of the Auvi-Q device, we'll be distributing some just as you exit here. I know some of you have some already, so -- and we obviously invite you for a drink.