Earnings Labs

Sanofi (SNY)

Q3 2011 Earnings Call· Sat, Nov 5, 2011

$46.04

+0.18%

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Transcript

Operator

Operator

Welcome to the 2011 Q3 Results Conference Call. Today, I am pleased to present Mr. Sébastien Martel. Sir, please go ahead. Sébastien Martel – Investor Relations: Thank you. Hello, everyone, and welcome to Sanofi’s conference call on our Q3 2011 results. Before we start, I must advise you that our presentation today contains forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different. These factors are detailed on our annual report on Form 20-F and in the Document of Reference. I would also like to remind you that our slides can be downloaded from our website. So our presentation today will be divided in three parts. First, Chris Viehbacher, our CEO, will share with you the key highlights for the quarter. Then Hanspeter Spek, President, Global Operations, will provide some color on the Q3 2011 business performance. And then Jerome Contamine, our CFO, will conclude with the Q3 2011 financial performance. After the presentation, we will as always host a Q&A session. Without any further ado, I will now hand the call over to Chris. Chris Viehbacher – Chief Executive Officer: Thanks, Sébastien. Good afternoon. Good morning, everybody. Good quarter here, pretty much in line with expectation. A little ahead of consensus, but certainly very consistent with the medium term guidance that we gave on the 6 of September, when we had an opportunity to go and do a deeper dive in to the medium-term outlook of the business. I think I said at that point that really the focus of the company now shifted to really execution on that, and I think we see that in this quarter. If we go the first slide on five, we talk an awful lot about the patent cliff, but…

Operator

Operator

(Operator Instructions) Our first question is from Mr. Tim Anderson from Sanford Bernstein. Please go ahead. Tim Anderson – Sanford Bernstein: Thank you. A couple of questions. Can you remind us what the potential benefits of your new insulin glargine formulation might be? And then second question is on emerging markets. It’s increasingly clear that not all products are insulated in emerging markets from loss of exclusivity. As you’ve shown in your Q3 sales by region by product, there’s sales declines in a handful of products, like Taxotere, Tritace, Xatral and Actonel. It seems to me what’s happened in the western world – I know you’ve mentioned Brazil in the past as a market where meaningful generic erosion happens. What are the other more important emerging market countries where you see generic erosion? And do you think this will increasingly spread to other countries?

Chris Viehbacher

Analyst · Morgan Stanley

All right, thanks, Tim. Just we’re not going to say at this point an awful lot on the new glargine formulation. It will offer different and unique PKPD profile. Once we’ve got the Phase III protocols, we’ll disclose those, once we’ve got the studies that begin to recruit. And we are going to show the Phase I results at one of the future diabetes congresses. So I think you can look towards first half of next year for more information on it. But this has become a pretty competitive space, so we prefer not to say an awful lot. Hanspeter, do you want to take on the emerging markets question?

Hanspeter Spek

Analyst · Morgan Stanley

No, what can be said evidently is that we have such effects from generification, especially now in Turkey, where a law was put in place that those products having launched since a certain number of years the patent protection had to undergo a kind of haircut price reduction of approximately 20% to 25%. Today, I see no other market. So the question is little bit speculative. Where could it happen? Where will it happen? I would say that as closer you get to Europe, as high as the risk may be. I don’t see any of those tendencies, let’s say, today in Far East or also in South America, for different reasons. I believe that there may be some indications in Eastern European markets like Poland, eventually also over time, like Russia. Tim Anderson – Sanford Bernstein: Okay, thank you.

Operator

Operator

Thank you. The next question is from Peter Verdult from Morgan Stanley. Please go ahead. Peter Verdult – Morgan Stanley: Hi, good afternoon. Pete Verdult, Morgan Stanley. Two questions. Just Chris, if I could follow up on the previous question on Lantus. I mean, just playing devil’s advocate, if you are going – if you are bypassing Phase II, would it be right to assume this is more a sort of an ultra-long-acting, once daily formulation that you’ve got it mind, rather than something that’s more longer acting for Lantus. And if you could give us any sense as to why you are confident that you can buy pass Phase II studies? Perhaps you’ve realized there’s a strong incentive to get this project in the market sooner rather than later. And then just again on emerging markets, just on Turkey, it seems to be continually surprising on the downside, not just for Sanofi but for the industry over the last few years. Is there any signs of stabilization there? And then just could you remind us as it relates to Africa, and the growth rate there. What is the size of your MENA business for Sanofi? And could you quantify some of the impact maybe from the Arab Spring? Thanks.

Chris Viehbacher

Analyst · Morgan Stanley

I mean again, I don’t really want to say an awful lot. But I think just on the part, why can we skip Phase II? Since we talked last on September 6, we’ve had regulatory interaction which gives us the confidence that we can go straight through to Phase III. I’ll just say a word about Turkey. In my personal view, Turkey is and is not an emerging market. Really what characterizes emerging markets is really low spends on healthcare, coupled with extremely high economic growth. And you know, Turkey is kind of between Middle East and Europe. In the 10 to 15 years I’ve seen Turkey, you have a couple of good years, and they come along and cut you back. There is enough growth to continue to be optimistic about the market, but I would agree with Hanspeter, that I kind of look at Turkey a little differently than I do other emerging markets. Hanspeter, do you want to just make a comment about the Middle East, North Africa business? How big is it? And what about the Arab Spring?

Hanspeter Spek

Analyst · Morgan Stanley

Our African business, including Egypt because it’s in our definition of Africa, is this year very close to €1 billion of sales. About €975 million is what we expect….

Chris Viehbacher

Analyst · Morgan Stanley

That’s all of Africa.

Hanspeter Spek

Analyst · Morgan Stanley

That’s all of Africa. Out of this, you would say that potentially half of it may have an impact on what is being called the Arab Spring. Now there, you get in a debate, was there an Arab Spring in Algeria, which is for us a very, very important market. We are by far market-leading company there. My personal opinion on Algeria is, no, there was not such a movement like let’s say in Egypt or in the neighboring countries. So in rough terms, half of our billion has a certain impact from what is called the Arab Spring. The other half is totally neutral, because it’s really the heart of Africa and especially within South Africa. Now in the Arab Spring markets, we have very controversial developments. We can say that we didn’t see any shortfall, for example, in Egypt, during the whole period, despite the fact that we are producing locally. Of course, we saw some shortfall in other markets, like for example Tunisia. Peter Verdult – Morgan Stanley: Thank you.

Operator

Operator

Thank you. The next question is from Mr. Michael Leuchten from Barclays. Please go ahead. Michael Leuchten – Barclays: Thanks. It’s Michael Leuchten from Barclays. Thanks for taking my question. Two quick ones. Just yet another one on glargine please, it looks like Lilly is now is now in Phase III with a biosimilar Lantus, so your thoughts on the timing maybe on your program? How that’s going to stack up in relative terms. And then on Jevtana, it looks like the momentum is kind of gone from the launch. Can you maybe comment on why that maybe and what you are doing there?

Chris Viehbacher

Analyst · Morgan Stanley

So, I don’t know what time line Lilly is on. It would be too early to start commenting on our own timeline. I think one thing we have said is Lilly has obviously been doing full clinical. So we don’t really see Lilly coming up with a fully substitutable biosimilar at this stage. Lilly comes into a market that’s got Lantus as market leader. There is Levemir. Degludec will get there. It’s going to be a fourth entry into the market, and we’ll see what happens. Thus far, Lantus has maintained roughly around 75% market share in the United States despite Levemir. I don’t really see anything really putting Lantus off its perch any time soon. We have got – between a new formulation, between a combination with our GLP1 and a different device – given just the sheer volumes of this market. Remember that it’s only a small portion of the market is treated with modern insulins, with – certainly with long-acting basal insulins. So I think the market is certainly big enough. I would actually suspect that you’re going to see some market expansion. I mean really because Levemir hasn’t been a phenomenal success for Novo, they haven’t really been putting all that much commercial effort behind it. You got Degludec and a few others, you’re going to have an awful lot of commercial effort going to really converting towards basals. And we’ve certainly seen this in plenty of other categories. When you actually have new entrants coming in, it helps it to accelerate the convergence process. So I wouldn’t see this is a zero-sum game in the marketplace. I think you’re going to see market growth, you’re going to see everybody get a little bit of share. But first of all, nobody has got the emerging markets presence that Sanofi does. Certainly Lilly doesn’t. And Novo is clearly strong in a few key BRIC markets, but for the most part, doesn’t have our presence either. So I think this is one of the biggest and most important markets out there. We’ve got a few number of players in it. And so I’m not too worried about it. And we’ve got plenty of innovation coming along to keep our franchise going. Do you want to just comment on Jevtana?

Hanspeter Spek

Analyst · Morgan Stanley

On Jevtana, yes, I agree that the third quarter could give the impression that the momentum is gone. I believe it’s a wrong impression nevertheless. We evidently suffer in terms of future growth in the U.S. You are of course aware that there’s a new competitor in the U.S. on the market, which is an oral agent, which is not easy for us to fight because it is being used by different physicians in different stages, in earlier stages. And also of course, the patients may prefer to get an oral agent before being treated with an intravenous agent. So we have a slowdown in the U.S., which we can only counteract in general terms through accelerated life cycle management. In countries in new approvals of Jevtana, in terms of sales in Europe and outside Europe, which we have obtained in the second quarter and in the third quarter, could not really kick into, in terms of sales. And so I’m very confident that in the fourth quarter, we will see once again growing Jevtana sales, as a effect coming out of the European launches which took place since the middle of this year.

Chris Viehbacher

Analyst · Morgan Stanley

I’ll just – to complement what Hanspeter said, I’ve just been reading some notes that clearly Jevtana is still going to get used. I mean it may get delayed a little bit because of earlier use of J&J’s product. But equally, there is still going to be people who relapse and need other therapy. So in some ways, there’s actually a movement out there in the oncology world to see how these products can be used in combination. So they are not necessarily in head-to-head competition. The marketplace is just at the moment trying to sort out exactly how these two products should be used, in what sequence, and whether simultaneously or the same – in sequence. And we treat later stage patients. I mean all of that is still being worked out by the oncologists. But I don’t think fundamentally there is anything to remark up on Jevtana’s potential. Michael Leuchten – Barclays: Thank you.

Operator

Operator

Thank you. The next question is from Mr. Graham Parry from Bank of America/Merrill Lynch. Please go ahead. Graham Parry – Bank of America/Merrill Lynch: Thanks for taking my questions, and firstly is on animal health, I was just wondering if you could clarify how long you expect the washout of generic Frontline happen? And then also what happens next in litigation, so when are you planning for potential generic launch that does hit the market? And secondly just could you give us something on pricing outlook for Europe for 2012? Having seen another quarter of changes in Europe, are you expecting anything different to what we were at the second quarter or at your business every day? And then similarly, for the emerging markets, any view on the pricing outlook for 2012? And then thirdly just on your enoxaparin generic, now that Watson’s off the market for the time being, can you actually take that authorized generic off the market, and would there be any merit in doing so?

Hanspeter Spek

Analyst · Morgan Stanley

Frankly, I didn’t understand you last question or the last part of your question.

Chris Viehbacher

Analyst · Morgan Stanley

The authorized generic of Lovenox. Could we actually – are we going to keep it on the market?

Hanspeter Spek

Analyst · Morgan Stanley

Yes. That’s an easy one. For the time being, at least, we have no intention to take it off the market. We believe it’s an interesting part of our overall strategy, that this is a market which de facto is split between, let’s make it simple, the retailer and the hospital market. And we believe it is good to have various options with different pricing. So we have not at all any intention today to discontinue the generic. On the pricing outlook in Europe and the emerging markets, I think bad news is that I don’t expect anything good in Europe. You know of course that the European situation in terms of loss-making healthcare systems is being maintained unfortunately, so we will see continued pressure on European prices. Now you may speculate, some major countries in Europe will see elections within the next 6 to 18 months. Is this a good time to make major changes? I would say probably not, but nevertheless, I believe in your models you should incorporate whatever you have in the past. I don’t see any upside. In the emerging markets, there are a number of discussions going on about an overall healthcare program. In China, I believe that this is in very, very early stages. I believe nevertheless that during 2012, we will see clearer how this may be set up, how it may be financed. I believe that there is today a serious will inside the Chinese government to make more access to overall healthcare. But for the time being, there is no clear picture how this is supposed to be financed. In all other markets, I’m not aware of any major changes, being it in Africa, being it in Middle East, or being it in South America.

Chris Viehbacher

Analyst · Morgan Stanley

Merial?

Hanspeter Spek

Analyst · Morgan Stanley

On Merial, difficult to say. We believe that we have been winning also the litigations in a very convincing way. Evidently, they have been convinced already before we litigated that we have a very strong and a very solid patent situation. So yes, of course, we will go also for damages. How long it will take to wash the market out is a little bit more difficult to say, because we are now off-season and I’m afraid we can only say precisely when the next season starts, which means as of January, February next year. And I believe that until, we will still have to face a presence of generic products in the market. Nevertheless, of course we do everything legally possible to get them off the shelf.

Chris Viehbacher

Analyst · Morgan Stanley

I mean I think if you look at what has been done on gaining damages from Apotex on Plavix, on the ability to defend eloxatin, I think we clearly are a company that clearly defends its own interest here and intellectual property rights. I think we’ll do that with Frontline. I think on the authorized generic for Lovenox, it would be fair to say, Hanspeter, really, that we can’t access the retail segment of the market. You correctly point out that this is two markets, but we really can’t access the retail market without an authorized generic. So in order to compete there, that will happen. So I’ll just add those two comments. Sébastien Martel: Next question, please.

Operator

Operator

Thank you. The next question is from Alexandra Hauber from JPMorgan. Please go ahead. Alexandra Hauber – JPMorgan: Thank you and good afternoon. I just have one – quick question on the logistics for Framingham coming on stream sometimes next year. Firstly, I just wanted to confirm that once the validation that is produced, the machine – sorry, the plant doesn’t send out but continues to produce inventory. And it would be correct to assume that you can sell all the inventories after approval. Or if that’s not right, can you let us know? And the second question on that topic I have is at which point will Allston then stop producing Fabrazyme, so that it can fully concentrate on producing Cerezyme?

Chris Viehbacher

Analyst · JPMorgan

So the actual – obviously this is all subject to regulatory decision-making. But at the current moment, the scenario is not a one-day approval of the site. You have to produce three validation lots, all of which have to be approved. And then your site is inspected. We’ve had some ongoing inspections of the site, as we’ve been producing validation lots. And those have gone very well. It could well be that as we complete a validation lot and the individual lot is approved by the agency, if the agency is comfortable with the overall progress of the site, the agency could actually – either the European or the FDA – could actually approve the sale of one of the validation lots before the approval is given for the overall site, given the shortage of product. So, I think we’ll be able to give you a very clear update on that with the fourth quarter results. But this is more likely to be a lot by lot. And then once you’ve done all the three lots, then the overall site is produced. Now, Allston won’t stop making Fabrazyme until, however, all three validation lots have been approved and the site has had formal approval. There are six bioreactors within Allston. In order to be able to use those bioreactors – four are being used for Cerezyme, two for Fabrazyme – in order to be able to use two of the other currently used bioreactors for Fabrazyme, in order to convert those to Cerezyme, there has to be some change in equipment, and there has to also be certain regulatory approval. So this would occur over a number of months. So, an actual increase in bioreactor capacity is unlikely to occur in 2012. However, that’s not actually where we think the…

Operator

Operator

Thank you. The next question is from Seamus Fernandez from Leerink Swann. Please go ahead. Seamus Fernandez – Leerink Swann: Thanks very much. Most of my questions have actually been asked. But as we think about the recovery in Genzyme and some of the competitive risks, Chris, can you just talk about what is baked into the assumptions? Competitively, we know that Shire has filed foreign approval of REPLAGAL in the United States. What are your assumptions around the prospects for competition in the U.S.? And how the sort of relative roll-out should – we should think about that in that regard? And then also we know that, I believe it’s the taliglucerase from Pfizer that we need to also pay attention to, to some degree. Again just wanted to get a sense of your thoughts around the competitive dynamics relative to the Genzyme program? Thanks.

Chris Viehbacher

Analyst · Leerink Swann

Well, I mean, if we take the Pfizer product, I mean we’ve seen that Pfizer product already in a couple of other countries, notably Brazil. And it didn’t actually do very well. The dynamics of this marketplace are two-fold. One is the product, and two is really the level of service provided by the company. If you go out there in the marketplace and do market research, clearly Genzyme’s image has been dented by the supply shortage. There’s no question about that. But equally, all the market research I have seen says that nobody thinks of Shire in the same way they think of Genzyme and Pfizer, even less. So, I think there is an element Genzyme’s concern and care for patients. And that includes the fact that it’s the only company that has the product donation program to make sure this product is available to anybody in the world. And even during the supply shortage, it has equally allocated product that is given away for free to those patients who need it, to make sure that every patient has an equal opportunity at dosing. These are things that are hugely appreciated in these very tightly knit patient communities. If you look at the actual product profile, as I just said – I mean whether Replagal gets approved or not, I have no worries about competing against Replagal. It’s got one-fifth the enzyme for the same price. And this is one where you want the full load of enzymes on board. So I think on Fabrazyme, I have no worries about Fabrazyme’s ability to compete. I sometimes wonder why Pfizer and others are coming into the Gauchers market. We are talking about a market of 7,000 patients. There is already two companies in it. And Genzyme has an oral therapy that is probably going to make all the other guys obsolete anyway. So to me, coming in with a bunch of me-too products in rare diseases doesn’t show the same commitment as a company like Genzyme, which continues to do research in things like Niemann-Pick – is looking at other rare diseases. I mean nobody’s got the commitment to rare diseases that Genzyme does. Others are looking for market share. Genzyme I think is really committed to finding solutions for patients. And this sounds just maybe like marketing talk, but I can tell you, if you actually go out there and you meet with patient associations, as I have done, this level of commitment is extremely important. If I can liken it to areas like oncology, like HIV, where I’ve worked in the past, I wouldn’t underestimate the commitment to actually helping find solutions for patients. This is not just who’s got the sexier marketing brochure here sales leaflet. This is really around commitment to patients. And I think Genzyme gets through its manufacturing problems, and it wins out there in the marketplace, in my view. Seamus Fernandez – Leerink Swann: Thank you.

Operator

Operator

Thank you. The next question is from Steve Scala from Cowen. Please go ahead. Steve Scala – Cowen: Oh, thank you. Apologies for yet another question about insulin glargine, but will the new insulin glargine be a full NDA or a 510(k)? And what is the patent protection? And secondly, I assume you do not have the Lemtrada, the Teriflunomide, or the Zaltrap data in-house. Can you just confirm that? And could you be more specific on when we might get it between now and the end of the year? Thank you so much.

Chris Viehbacher

Analyst · Cowen

No, we don’t have anything on Aubagio and Lemtrada. And they never tell me too early, anyway, in case I spill the beans. No, that data is not available. It will be some time between now and year end. I can’t give you an exact date. Probably – Sébastien, anything? Sébastien Martel: Lemtrada is mid November.

Chris Viehbacher

Analyst · Cowen

Lemtrada is mid November, so a couple of weeks from now. Sébastien Martel: And late this year for…

Chris Viehbacher

Analyst · Cowen

And probably towards the end of the year on Aubagio. On the insulin glargine, I can tell you that we have filed patents on that, but that’s all that I can really give you. And really what regulatory filing, I actually don’t know the answer to that, so we can follow up with you on that. Steve Scala – Cowen: Thank you.

Operator

Operator

Thank you. The next question is from Eric le Berrigaud from Bryan Garnier. Please go ahead. Eric le Berrigaud – Bryan Garnier: Yes. Good afternoon. Two questions. First, in the New England Journal of Medicine a couple of days ago, it was suggested that you would had offered the FDA to sell some generics in the U.S. probably to solve part of the shortage for some oncology drugs. Could you just say a word on that and what’s the strategy behind that, if there is any? And the second, perhaps for Hanspeter to get a bit more specific about what you said about Jevtana and life cycle management. Is there about first line? Is there about any other tumor type for the drug or any combination with new oral agents? As we have also today some good Phase III data for another competitor. Thank you.

Chris Viehbacher

Analyst · Bryan Garnier

So the issue in the U.S. is that there is an extreme shortage of certain older generic injectible drugs, principally. This appears to be a result of the fact that, as the FDA is busy becoming more demanding on inspections throughout the industry, including the generic sector. We all know that you have to continuously invest in injectible manufacturing technology. This is some of the most sophisticated and demanding production in the biopharmaceutical space. And it appears that some companies are finding that the upgrades to manufacturing are not really justified, given the really low margins on some products. So a number of companies appear to have gone out of stock. I encountered this in meetings with the FDA in the U.S. I was actually surprised to learn that this isn’t really a short-term issue, this has been going on for a minimum of a year. So – and you’ve seen that the president has actually asked the FDA – it’s the first, I think, executive order that president of the United States has given the FDA in over 40 years – to actually look actively at how the FDA can facilitate others to come into the market and supply some of these products. Some of these are Sanofi products that we produce in Europe and around the world. And so we have made an offer that we could potentially – if there was a regulatory path, that we could potentially provide product. But at this stage, there’s nothing concrete to report and not clear whether the FDA will in fact provide that regulatory pathway. Eric le Berrigaud – Bryan Garnier: Not a change in terms of strategy versus generics into U.S. by any means?

Chris Viehbacher

Analyst · Bryan Garnier

No. Eric le Berrigaud – Bryan Garnier: Okay.

Chris Viehbacher

Analyst · Bryan Garnier

No, it’s really just – there are actually children who have apparently died because some of these generic drugs are not available. And so this is more of a question of how do we fulfill a public health need. Eric le Berrigaud – Bryan Garnier: Okay.

Hanspeter Spek

Analyst · Bryan Garnier

On Jevtana, in principle, we look in all three directions, but with priority of course to first line and second priority to other indications. No decision has been taken so far. Eric le Berrigaud – Bryan Garnier: Thank you.

Operator

Operator

Thank you. The next question is from Vincent Meunier from Exane BNP Paribas. Please go ahead. Vincent Meunier – Exane BNP Paribas: Good afternoon. Thank you for taking my questions. The first one is on pharma R&D. So three quarters below 15%. Is a level of 14% of sales sustainable? The question – the next one is on bolt-on acquisitions. Can you give us an update on your agenda? And also given the success of Allegra in the U.S., do you have any intention to further increase the size of your consumer healthcare division there? And the last one is with regards to healthcare reforms. You gave some comments regarding the situation in Europe, other countries. But can you be – can you give us your view regarding the supercommittee in the U.S., what do you expect from that, in terms of timing and potential impact? Thank you.

Chris Viehbacher

Analyst · Exane BNP Paribas

Right. So as R&D percentage of sales, yes, we can go lower than 14%. And yes, it’s sustainable. We are still spending €5 billion at the end of the day. I personally don’t think that R&D and sales have anything to do with one another. I think it’s a fundamental question of how much infrastructure in research you want to maintain, and then how much investment you want to put into individual projects. So your infrastructure piece is an element which is an ongoing expense. But the actual investment in projects, we tend to look at as a capital expenditure budget, an investment budget, rather than an ongoing revenue expense. There, I think our first objective is to say, well, how do we use the money that we’re spending now better? Because I can tell you that when you look out in the marketplace, how much you spend on R&D and how successful you are just simply don’t correlate. I think the last two years, we have spent significant time making sure we have a state-of-the-art development capability, and I think we’re there. The fact that we made a lot out of how many products we killed, out of the time when we did the stress test on our portfolio. But one of the most important aspects of that is what did we keep? Because in keeping a fewer number of projects, we’re able to focus on those and accelerate some of those. And that’s why I think we’re in the position of being able to launch as many products as we are in 2015. Of course, not all those came out of Sanofi’s development. But I think we’ve got a lot more focus around it. You take an Aubagio. I mean an Aubagio was lost in the shuffle within…

Hanspeter Spek

Analyst · Exane BNP Paribas

Well, on the question on CHC, and related to it, bolt-on acquisitions, we work on bolt-on acquisitions as we speak. We work on acquisitions from a geographical point of view, where we feel that we should become stronger, evidently South America, Africa and Far East. We work in our growth platforms evidently in CHC. And within, yes, of course, we would be eager to make another operation in the U.S. I’m a little bit less optimistic on the U.S. because the drugs have less opportunity for doing good sales figures in the U.S. than in other parts of the world. And yes, we have done really an outstandingly good deal with Chattem, and I’m afraid this will be not – first of all, it will be not considered probably as a bolt-on. And second, it’s not easy to be repeated. So far on this question – since we had a question on the super committee in the U.S., do you want to take it?

Chris Viehbacher

Analyst · Exane BNP Paribas

So the super committee actually has to deliver its report – I believe its November 23. If the committee does not reach a decision, you may remember that part of the agreement that was reached at the end of July to increase the debt ceiling in the U.S. said that there had to be the creation of this super committee. If they didn’t reach at least €1.2 trillion of savings over 10 years, then there is a model where there are going to be some automatic decreases in budgets across the board. I think it depends on which one it is, but for instance, for Medicare, if I remember, it’s about 4%. So the question is going to be, first of all, do the members of this special committee on deficit reduction actually achieve an agreement or not, because if they don’t, you get the automatic cuts. If they do, then there’s a question of what’s in it. Obviously, there are two things which concern the pharmaceutical industry. One are dual eligible rebates for Part D patients. And the second is actually looking at the ASP for Part B medicines, where there has been some proposal to examine the 6% mark-up that gets charged on that. The Part B mark-up of 6% would really affect physicians, mostly, but – and would only indirectly affect pharmaceutical companies, in that this would likely have a significant impact on access to Part B medicines. Because at some point, physicians will say this is just not worth the cost of doing this. And so particularly in some rural areas, you might find that the patients are just not able to access those medicines. On Part D dual eligibles, I think at the moment, there is not the political support for imposing those rebates in…

Operator

Operator

Thank you. The next question is from Luisa Hector from Credit Suisse. Please go ahead. Luisa Hector – Credit Suisse: Thank you. Can I just check on Multaq? What has the physician reaction been after the label change in Europe? And when do you expect to hear back from the FDA?

Hanspeter Spek

Analyst · Credit Suisse

On the first part, in Europe, we clearly have seen a reduction in new patients. We have seen nearly nothing on existing patients. We see now in Europe a very, very careful comeback of new patients, but it is definitely too early to call this a trend. In the U.S., overall the reaction has been – to the ongoing label discussions has been more moderate than in Europe, which definitely has to do that we had a different – if you want to say a more restrictive label in the USA than in Europe. So let’s say the shock was therefore stronger in Europe than in the U.S. On the second part, it is very difficult to predict when we will have agreed with the FDA on a label, but I would say this should be a more a question of weeks than months, as there is a very constructive conversation going on. And I believe that from there, this should be settled within weeks.

Operator

Operator

Thank you. The next question is from Mark Beards from Goldman Sachs. Please go ahead. Mark Beards – Goldman Sachs: Hi. Thank you for taking my questions. Firstly on Fabrazyme, is there any update on the civil suit that’s occurring in the U.S.? And secondly the Genzyme-specific operating margins, how did they change in the quarter versus Q2? And then finally any update on the Lantus (indiscernible) pen device?

Chris Viehbacher

Analyst · Goldman Sachs

So on the civil suit, there is no new news. I mean the reality is that there is not really enough lot of objectives to doing this. It’s not like anybody can suddenly make a plant and produce Fabrazyme in any less than five years. So our objective is really to get back to full production of Fabrazyme as quickly as possible. And that’s really related to the Framingham facility, and there I think the company is making very good progress. Jerome, any comment on the margins?

Jerome Contamine

Analyst · Goldman Sachs

Stronger margin of Fabrazyme for Q3 was very similar to the one of Q2, whether you speak about the gross margin or of the net margin. Of course, the more you go, the more difficult it will be to follow the – let’s say the old Genzyme, as we call it internally, because part of the businesses will be transferred out – being transferred now to our pharma organization, when the remaining will be with the new Genzyme, which will cope with both the orphan disease, but also the MS business. So – but for the time being, if I take Genzyme as it was, I mean we stay in Q3 and Q2 exactly at the same level of margins. Clearly we see some cost associated to the consent decree, which we had planned from the beginning, in the gross margin for both Cerezyme and Fabrazyme. But we see as well that the leverage we could benefit of by the increase of sales will be quite significant, if you were just to compare the profitability, i.e. the net operating margin in 2010 versus what we have now in 2011.

Hanspeter Spek

Analyst · Goldman Sachs

On the combined device of (indiscernible) and Lantus, basically nothing new. I’ll remind you that these work and we have a combined device, which will contain both products, which means both products will be injected together. We believe that we have an interesting concept because it will allow countries to alter concepts to individualize the insulin dose, which we feel is an imperative, given the mode of action of insulin. We feel it would be not adequate to put it in a fixed dose and making then titration very complex. (indiscernible) with this device, given our large background in developing and producing devices in-house, we advance very well. And we are very optimistic that we will run to Phase III clinical trials with the combination as foreseen, starting very early in 2013 approximately in let’s say 15 months or latest 18 months from today.

Chris Viehbacher

Analyst · Goldman Sachs

Okay, maybe one last question, operator.

Operator

Operator

The last question is from Damien Conover from Morningstar. Please go ahead. Damien Conover – Morningstar: Great. Thanks for taking the question. I just want to follow-up on emerging markets margins. I think historically you’ve talked about margins being in the mid-40% range, excluding R&D and central administrative costs. Just with the current pricing cuts in certain markets, obviously offset by volume gains in most of the other markets, can you talk about the outlook there for margins going forward? And then secondly, just a question on Merial, just wanted to get your thoughts on when you think there would be a reentry of generics? And how the brand name of Frontline might be able to mitigate some of those generic launches, given it’s a little bit more of a brand-sensitive market? Thanks.

Jerome Contamine

Analyst · Morningstar

Jerome speaking. I can take the question on the margin in emerging markets. On the 6th of September seminar, we gave guidance for our overall emerging market business for pharma, with a 40% operating margin before R&D. As you mentioned yourself, I mean the fact that we are able to amortize our infrastructure and on growing volumes, I mean even in Turkey, I mean we see volumes continue to grow, helps very much – anyway to maintain at least the margin that we contemplate by now in emerging market. And if I look forward, I mean, I see the more we do, the more we should be able to somewhat leverage our P&L. Of course, we’re also investing into newer products and new era. I mean we are finding some to invest in CHC in China. So clearly I mean this will somewhat depress the margin, but on the other hand, we will continue to improve the margin on the rest of the Chinese business. So in short, we don’t really see – I don’t see any reason to consider that the margins should not at least stay at the level which we gave on September 6 seminar, and probably continue to improve slightly over time.

Hanspeter Spek

Analyst · Morningstar

Well, finally on Frontline, I think there are number of elements as an answer. First of all, we have proven that we have a very strong, very effective legal defense line. Second, I believe it’s important to remind that the penetration of generics in this field has nothing to do with the penetration in human pharmaceuticals because those products are much more dependent on a strong trademark. And since trademark is of course driven mainly by public advertising, which we do intensively with Frontline, behind we have a very, very complete program of life cycle management. The first step we have accomplished. We have launched (indiscernible) in the U.S., and we will be doing so at the beginning of 2012 in Europe. And then we work on new compounds, which will become available in 2013/2014 period in Europe and in the U.S. as true successors to Frontline. And those compounds will be not just old wine in new barrel, so to say. No, it will be a really new product with significant advantages over the market-leading product, which evidently by far is Frontline. And we progress with those products very well, and are very confident to make them available in about two years from today. Chris Viehbacher – Chief Executive Officer: All right. Well, I think that wraps it up. So again, just to summarize, I think we had a good quarter. Obviously again, even before we take into account Genzyme, I think the fact that the growth platforms could offset the significant erosion from generic competition is a positive sign in the progress of the company. 2011 was always going to be the bottom of the trough on sales, and obviously when we consolidate Genzyme, we’re actually growing back our sales line again. We’ve got costs under tight control. I think the research and development pipeline is looking good. We’ve got some new initiatives to really now expand upon our research model, in terms of open innovation and changing the configuration of our research network. And just given the strong underlying business performance, we feel totally confident in being able to maintain our guidance for the rest of the year. Business is in good shape, and I think we’re making excellent progress on integrating Genzyme. I was in Boston last week and was able to get the full update on the progress that’s being made on production. We appointed a new CEO of the new Genzyme with David Meeker, and I think David has been exercising strong leadership throughout an integration period. Huge passion for rare diseases, and I think is a demonstration of the continuity in the Genzyme approach that has made it successful in this area in the past. So, as I say, I think business is in good shape and progressing well. And look forward to talking to you all with the Q4 results early in 2012. Thanks very much, everybody.

Operator

Operator

This does conclude our conference call. Thank you all very much for attending.