Earnings Labs

Sanofi (SNY)

Q4 2011 Earnings Call· Wed, Feb 8, 2012

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Transcript

Chris Viehbacher

Management

All right. Well, good afternoon everybody. Let me add my words of welcome. Now it was three years ago almost to the day when I had the first opportunity to present results of Sanofi. It were the 2008 results to which I had contributed all of one month but it was an opportunity really to layout our strategy. In 2008, we pointed out and I think this has been kind of the hallmark of what we've been doing, we did point that while results were great in 2008 we could already envisage a time three years, four years hence, when things would not be so great, and that we, as management, have decided to be (a) both transparent but (b) also to layout a strategy that would prepare us for the patent cliff and would actually build a strong and growing company coming out of the patent cliff. We'll go through some of that in a minute but I would say, three years later I think we've struck to the strategy. I think if you look at 2011 results this should be really unremarkable to you even though they are remarkable to us because they should really just be inline with what we intended to do and where we intended to go. Now, it was a busy year for us. Clearly, 2011 was particularly marked by the Genzyme acquisition. That was a big move for us in a lot of different ways. Anytime you spend $20 billion is a big deal, but doing a hostile acquisition of a biotech company especially one that had manufacturing difficulties was clearly an element of risk. But equally it gave us an opportunity to create significant value, and I think as we look at 2011 we can already see that we have down the…

Jerome Contamine

Management

Well, thank you, Chris. Good afternoon everybody. As Chris had already commented the dividend I’m just wondering what I should say now, but however I will go to the P&L for 2011, give some details on the financial performance also for this year. Well, you are used to the graph, which will present quarter after quarter and I still feel that it is quite impressive. So just of the year of 2011, we have lost €2.2 billion of sales from the key products which are being genericized year-on-year, and that we all know I mean these products are not only safe, but also high profit. On top of that, we are still booked €450 million of sale of H1N1 vaccines in 2010. So we started the year with a sort of handicap as compared to where we expected to be 2011. I mean, as impressive is the contribution of the growth platform, I mean Hanspeter will go through that later on. €1.9 billion of new sale created organically from the growth platform 10.8% growth I think that’s really signaling that these are really the drivers of the Sanofi for tomorrow, today and for tomorrow. On a couple of that of course we booked Genzyme. Genzyme I suppose exceed the frequent sales on which we have booked the sales 7.6% increase of sales including double digit of growth we know in this as well as the Myozyme. The FX impact, there's always a lot of volatility as we know in the exchange rate. Actually the FX impact negative as mainly driven by the US dollar. We tend to look at the US dollar being a strong currency against the euro today, just six months ago, which was exactly the reverse. So in fact, out of the 700, 600 is coming or…

Hanspeter Spek

Management

Good morning, good afternoon. I would like to lead you through the performance in essence of our growth platforms in 2007, and I start this with the total picture. As you see here we have achieved €33.4 billion, sales growing by 5.3%. On the left, the positives in essence the growth platforms achieving an additional growth of approximately $2 billion sales compensating there nearly the total losses on the right of the picture caused by newly generalized product, most of them being Taxotere, Lovenox, (inaudible) smaller products mainly in the United States. For the third time coming incremental sales for Genzyme €2.5 billion to nearly €2.6 billion, giving a total of €4.7 billion new sales size against €2.2 billion sales coming from gentrification. Now to focus on the growth platform achieving €19 billion spending such for approximately 60% of our total sales over the total year of 2011 growth platforms has been growing by 10.8%, and you’ll see then the rise of remarkable growth for each of them, and most importantly as mentioned by Chris earlier of course Consumer Healthcare with nearly 23%, Animal Health is a relatively modest growth 4.3%. You will see later that we have a nice acceleration of growth for Animal Health in the fourth quarter getting around 7% of growth. Important to see the way we really get through the cliffs, the patent cliffs, you see here for the last five quarters the impact of generification, which has been in the fourth quarter 2010, nearly €1.1 billion for the third quarter alone and you see that this is coming down, has been coming down to less than €700 million in the fourth quarter. Actually we are losing 14% of sales by the end of 2010 either went down shows remarkable 8% but nevertheless just a…

Elias Zerhouni

Management

What we wanted to do in this presentation is focus a little bit more on R&D. And the reason we wanted to is because 2011 has been an extraordinary transition year for the R&D organization. But first, I’d like to show with you some of the principles, the underpinning of the strategy that we followed. First and foremost, our global R&D goals are really based on the fact that we for the first time created a global R&D organization. And the fundamental reason we did this because, one, there is an enormous convergence in science in terms of vaccines and understanding immunology or in terms of multiple sclerosis, animal health. The convergence of biology gives us some ideas about how to synergize between the different components of what has become today one of the largest biopharma companies in the world because we can produce insulin, biologics, we can do vaccines, monoclonal antibodies and now with Genzyme, one of the best biotechs in the US, we have a spectrum of capabilities that where we think we can get synergies that would not have been available to any other organization. It allows us to exploit the economies of scale. And more importantly, as I will describe to you, we've had a deep exercise in terms of restructuring our R and our D and improving our cost structure, which was inherited from the integration of multiple processing entities. The second strategy has been to focus on high value projects and what does that mean? Incrementally that there are only three things that will make the R&D organization successful. One, create products with high added medical value. And that is a very profound statement because we don’t know at this point what the market is going to look like in five to ten years,…

Chris Viehbacher

Management

All right. Thank you, Elias. So let’s have a look at now where we’re going in 2012. So, as we thought about guidance, we said all right, what do we want to signal that’s new? Why do you we want to tell you in the guidance that the change from what we’ve already told you? The answer is nothing. 6th of September a lot of us were up here. We gave you a vision of where we saw the company going into 2015. What’s going to happen in the mean time? We had a very solid first quarter. All of growth platforms performing exactly in line. In fact, for any doubting Thomases on emerging markets, I think we put those to rest. And anything if there is any new news is the fact that we have derisked the Genzyme recovery through the approval of the Framingham facility. So let’s have a look specifically at 2012. This is just the things that are going to happen. Again, I wouldn’t expect for anybody who has been following us to have any surprises in any of this. Clearly what are the headwinds? Well, March Aprovel is going to go, May Plavix is going to go, August Eloxatin is going to go, on the full year effective Taxotere. We’ve seen that the Momenta has lost the injunction on a second generic and we would expect that in the market. We’ve already put our own generic out there. The Copaxone agreement terminates in Q1 of 2012. On the other side, we clearly got very strongly performing in our growth platforms. They’ve been performing for three years, and I think they’re going to continue to perform. We will get an additional quarter of Genzyme. So we will consolidate four quarters instead three quarters in 2011. And…

Luisa Hector - Credit Suisse

Management

Thank you. It’s Luisa Hector at Credit Suisse. I have got three questions for you. Firstly, on the guidance, Chris, you showed the slide with the tailwinds and headwinds, you got the guidance range. Is there anything specific driving that range, Lovenox and Genzyme are probably the two bigger benefactors?

Chris Viehbacher

Management

Well, I mean, you got obviously the €1.4 billion that’s Plavix and Aprovel. We only had Taxotere for three quarters last year, you're going to have a fourth in this year. And we have got Eloxatin, we are very thrilled to get Eloxatin back last year, but Eloxatin will go again in August. We don't expect anything new on European pricing. Last year, European pricing cost is about €300 million. I don’t see things getting better in the Europe, we have no particular evidence, and it isn’t getting worse either so we would kind of expect difficult times in Europe to continue. I think we will make an extremely strong progress with Genzyme and more confident ever than in the recovery of Genzyme. And I think the ability for us to really work with Genzyme is not just a recovery, I think it is excitement in Genzyme when you look at the new products coming on. And we are clearly seeing the ability, we can’t speed this organization of what we can do behind biosurgery and behind the renal and oncology business. So there's in particular just -- this is 2012, we've always known this is the cliff year. And so, that’s where we are. And as I said, I think our view of the world is pretty much in sync with where our investors are.

Luisa Hector - Credit Suisse

Management

Okay. And then, Jérôme, just coming back to the cost savings. You've got about €1.7 billion left to deliver. And I think you were saying basically for 2012, it would really be the residual Genzyme cost savings coming through. So can you put any more color on the timing of the rest of the savings and why they are more delayed? Jérôme Contamine: Well, there is no delay. We have this €2 billion objective for 2015, so if you -- this is a for four years, it’s €500 million per year. The way you need to look at it is the following, I mean, (a) you have Genzyme, so, we have generated $330 million in 2011. We have $700 million full-year impact 2013. And clearly, the savings in 2012 will be somewhere in between because all this change in organization that we started implementing such as an example, I mean funding out a new ERP, you take country by country for the 80 countries where Genzyme is located, and then I mean get assessing of the time of those years. So, I can take examples like that. So clearly that is another contribution from Genzyme this year. I mean in industrial, I mean you saw the slide I presented. We have implemented all our industrial LEAN approach, having the total cost of ownership approach to see how we can generate maximum value of the production. I mean we’re also having the commercial people speaking more with the field people to use the number of SKUs to stabilize the weak sales, which you are producing (inaudible). But actually all this take a bit of time to be implemented, because on the other hand, we are going to benefit this year from the savings, which resulted from the decisions we took in 2009 and 2010, for instance, to restructure of our chemical network in France and Europe. So there is always a delay between the time you harvest the saving and the time start doing tightly implement them. Of course, if you decide to reduce fixed cost in the US it is probably much quicker. On the R, we still (inaudible) taking place. By midyear and even maybe before all people working in Bridgewater will have either move to Cambridge or left the company. That’s I mean, still you have to move all the infrastructure the IS, I mean the information system as well. So these are how things work. So at the end of the day, from what I tried to describe to you, out of the average five times we should see more of these taking place this year. In another term it will be some frontloading of the €2 billion, which will be already in 2012 onto ’13.

Chris Viehbacher

Management

So in other words, if you take €2 billion between now and 2015, you could say it’s €500 million a year, that ain't going to happen. I mean the only thing that takes longer is industrial spares. The rest of it, all is going to come much closer in the period. So most of the savings actually are upfront. And I think, if you look at our last €2 billion, originally in 2009, we said, we will take €2 billion out before 2013, and actual fact we took the €2 billion out in the 2011. So I think we got a pretty good track record of when we sit down to do it and taking cost out. We’re always cautious in how we express that because we got a big cost base in Europe and there are always negotiations and consultations that have to be done, and we never want to get out ahead of those. But I think if you look at what we’ve done on cost that’s what we’re going to do in the front. So most of those cost savings will come in in the next couple of years and not in 2012.

Luisa Hector - Credit Suisse

Management

Thank you. Could I also just ask on the Lantus new formulation? Does that -- the studies that you’ve started that’s with once daily dosing just sort of pitching as of it true, true once daily? And then, could you comment on the timing of the data and whether this would be filed as a novel drug or as a supplemental to Lantus please?

Elias Zerhouni

Management

Well on the current phase III trial, we’re really focusing on high (inaudible) the goal of glycemic control and hypoglycemia. So that’s exactly the point. And then can we do it in that mode, and reduce the number of injections that you have to do, and, but also more importantly is really understand whether we can get better glycemic control or well with less hypoglycemia. The formulation is really a patented formulation. So it has actually some specific component, I mean completion of matter issues to it in terms of the physics and the biophysics and so it is starting proceed. Jean Jacques Le Fur – Oddo Securities: Jean Jacques Le Fur, Oddo Securities. The first one is could we have a little bit more color on the impact of austerity measures/healthcare reform, which impacted through 2011, and what could it be for 2012? And my second question is about Iniparib. You found a new mechanism of action. So could we have a little bit more color on this new mechanism of action? And what could be now as new indications for this product and the timing for Phase III timing and launching? Thank you.

Chris Viehbacher

Management

(inaudible) I'll take the austerity measure?

Hanspeter Spek

Management

If I take the austerities, I think it was mentioned before we estimated at approximately €300 million in Europe and I think we have said another $100 million in the United States coming out of previous measures in 2010 possibly even in 2009 out of this so called Obama plan. So round about €400 million. And in anticipation we anticipate nothing more dramatic which has to be handled with care as the overall macro economic situation became a little bit unpredictable and a small pressure is on the macro system as modeled beyond the micro system of healthcare, but in our estimates we have anticipated approximately the same impact 2012 as in 2011.

Elias Zerhouni

Management

As far as Iniparib is concerned as you can see from the day -- I mean the information that you have would definitely considering the trials that were ongoing. So, we are going to have a redial on that. In the meantime though we did elucidate the mode of action and Iniparib is acting in a way that we understand better which will lead us to redesign some of our approaches to it. Fundamentally it is acting like a prodrug and really is metabolized within cancer cells which really has unique advantages in our view and explains also some of the results that we have had. And so, we are trying to, to really exploit this knowledge right now. So two phases, one, we continue what we had in the trials because we now we have some confidence that we understand what’s happening; second, redesigning some of the or designing de novo a new approach to it dose wise as well as delivery wise.

Chris Viehbacher

Management

We are not saying much because we have actually new intellectual property pending on this drug.

Vincent Meunier - Exane BNP Paribas

Management

Okay, Vincent Meunier from Exane BNP Paribas. A few questions if I may. The first one is web question on the new Glargine formulation is it required to perform cardiovascular studies with that new compound? And will you test the usual Glargine molecule as the comparator? Also, what’s your commercial strategy against Novo Nordisk Degludec which is potentially launched or at least approved by the end of July this year? And last question on Lemtrada, what could be the pricing for this drug assuming its early infusion.

Elias Zerhouni

Management

I think we are going to have to take one question at a time. I don’t have that you know so go back to the first one on the Glargine if you don’t mind? And I will take that.

Vincent Meunier - Exane BNP Paribas

Management

Yes, sir.

Elias Zerhouni

Management

You mean 300? Yeah.

Vincent Meunier - Exane BNP Paribas

Management

For the Glargine the question is do you have to perform cardiovascular studies and will you compare it to the usual Glargine molecule?

Elias Zerhouni

Management

Well we don’t expect to do that I mean it’s an interest in its own as a molecular matter, its different in its PK/PD so we have to document that we have to find out what happens in terms of the typical endpoint glycemic control and hyperglycemic event. Second question was?

Vincent Meunier - Exane BNP Paribas

Management

Was on Degludec?

Elias Zerhouni

Management

That you see, first, we will not define our commercial strategy before they are through Phase III and have a labeling and even if we would, we would not communicate today about it. Overall, we are not too excited about compounded (inaudible) I think I have said before the events where similar phase with [Tetamer] near you will know as Tetamer has not been such successful. We have seen of course the recent clinical data where we see according to what Novo Nordisk said no difference at all between Lantus and this product in the mainly loss of (inaudible) group of diabetes run patients what we see in diabetes 2 population is very marginal. Already from a clinical point of view I think they have 0.05 (inaudible) per patient here so whatever you show statistically maybe interesting but it has not a lot of clinical relevance. But as I also said earlier we have to see how this product comes to the market at which price and so on and so forth. And then we have a number of options to react or just to let it go by as we did with (inaudible). The last one was on the potential pricing of Lemtrada.

Chris Viehbacher

Management

So did maybe I will add I mean the only thing I would say on Degludec from what we are hearing is that basically if Tetamer was too short you know, Degludec is too long. So, we can deal with that commercially. Let me start at pricing I think we are not going to comment on it at this stage but given the results we would certainly just not going to comment actually. Sébastien Martel: Chris, I will jump in with couple of questions from webcast. We have got one (inaudible) from (inaudible) at BNP Paribas. He is asking what are the expectations in terms of payout increase for the dividend in 2012 already. And he wonders whether we’ll naturally increase the dividend 2012 despite an EPS decline this year. And we’ve got another one maybe I guess for our Head of Vaccines here, Olivier Charmeil. There is a question on whether the strong Q4 performance of vaccine in the emerging market is related to any specific tender process or other growth drivers?

Jerome Contamine

Management

Dividend last year is the not a Global Director of the (inaudible) up a meeting to report the dividend. So it’s not time to ask any (inaudible) norms and facts on what's going to be dividend to be paid in 2013 onto 2012 the reason precisely. Now, if you look at the graph I mean we are big. But the fact that if there is an increase in dividend up to 65, we see a 6% increase when our profit is decreasing, the signal that we are aiming slowly to have a regular increase of our dividend over years in order to reach the 50% payout in 2013 paid on the result in 2013 clearing representing 2013 should be higher than the results in 2012. Now how are we exactly to run these two figures and it is what we have to be decided next year. The other thing that I can say is that we said already that by all means we are not considering or we will not consider reducing the dividend even if our profit will be decline in 2012. So this is also clearly excluded. So between flat to slight increase going through the 50% payout in 2014, I will see where will be next year. Sébastien Martel: Thanks Jerome. And then so, the question was from Michael (inaudible) at Barclays on vaccines, Olivier.

Olivier Charmeil

Management

So we had a strong quarter in the emerging market as it goes to 16% when compared to a full year growth of 10%. We are leveraging our presence in the emerging market. Our growth is very much driven by our Pantaxim sales, our pediatric combination with strong sales in Mexico and in other parts of Latin America. We have also got the IPV on in sales. Brazil had made the decision to put on its immunization schedule IPV and this is a major achievement and we had first shipment at the end of December but it is of course sustainable sales. And the last element is the OPV sales to UNICEF that it could play from one quarter to the other is nothing -- very significant in here. We continue to see a strong momentum of OPV and since the beginning of the year 2012, we see in the level of requirements coming from UNICEF that the OPV sales continue to show us some fundamental.

Chris Viehbacher

Management

I think it’s also equally valid to say that India is now going two years without any polio outbreak. And, there is certainly a movement now I think that we will see acceleration from OPV to IPV and Sanofi Pasteur is exceptionally well-positioned to take advantage of that opportunity. Sébastien Martel: So we will take some more questions from the room. Yeah, go ahead.

Philippe Lanone - Natixis

Management

Hello, Philippe Lanone from Natixis, just one quick question on Lyxumia because you know slide you only presented and as on top of Lantus basically. Well, there has been a lot of change in the GLP1 environment but the negative results of the once at least. And, so what you see as a future for a monotherapy Lyxumia apart from the fixed combination?

Elias Zerhouni

Management

Oh, I hope I didn’t convey that, there is defiantly because of the postprandial effect and the ease of use it has a single free standing use per se, and I hope I didn’t misconvey the fact that it can only be used on top of Lantus. But because of that it has a unique profile to be in fact combined with basal insulin, not just Lantus, because of this postprandial control profile which is quite unique across GLP-1, and the fact that you can titrate it in one step you don’t have to wait for six weeks to get there. I hope I am answering it has both uses, GLP-1 alone and GLP-1 on top of insulin. And remember all GLP-1 have the advantage of weight loss versus weight gain so that you stabilize the patient on the better rate. And you, through the studies we have done I mean you can see there is a better achievements of A1c levels with a combination, but it is not just a combo product as a free-standing merit. Sébastien Martel: Mark, go ahead.

Mark Beards - Goldman Sachs

Management

Thank you. I am Mark Beards from Goldman Sachs. A couple of questions on the pipeline, if I may. Firstly, we didn’t see PCSK-9 on your new launches 2015 slide is that because it’s a long-term opportunity and still (inaudible) as developments, or was a just missing from that? And secondly, Lantus lixisenatide and new Lantus, obviously you've got a combination in development from Lantus lixisenatide. You are also developing a new Lantus. How should we think about those two programs and will they converge at some point?

Elias Zerhouni

Management

So, PCSK-9 go to page 55 its right there, on the bottom of the 2015 column.

Mark Beards - Goldman Sachs

Management

Okay. Thank you.

Elias Zerhouni

Management

Okay. And on the Lantus U100, U300 and you said PCSK-9 I did not hear the question.

Mark Beards - Goldman Sachs

Management

Now the question was that you developed a new Lantus. You also developed Lantus lixisenatide combination, with those two programs converge? Do you have any updates place on them?

Elias Zerhouni

Management

At this point I can’t comment on the new Lantus converging with Lexi. What we’re doing right now is Lexi plus Lantus. Yes, we do define that as a special, kind of give patient the beginning development for U300, the patients were not a target especially the high insulin use patients. So at this point, I can’t comment on whether or not a development is going to go there. First Phase III is only 20% of the patients really are at high doses with any basal insulin by the way and are not our goal.

Mark Beards - Goldman Sachs

Management

Do you have an update on the combination development plan?

Elias Zerhouni

Management

So the combination as I said we are launching the Phase III, 2013, the device you know the FDA requires that you do your Phase IIIs with your final commercial device. So that’s what getting to start into the end of 2012 beginning 2013. Sébastien Martel: I’ll take a question from Eric Le Berrigaud

Eric Le Berrigaud - Bryan, Garnier

Management

Thank you. Eric Le Berrigaud, Bryan, Garnier, I got three questions. First would be on emerging markets, for the six products to be filed you’re still very much focused on U.S and Europe. How far behind the filings in territories like China or Japan for instance?

Elias Zerhouni

Management

So actually we look at global development now. So if you look at our PCSK-9 already in files in Japan, for example. Zaltrap same thing we’re trying to submit to other health authorities. But you’re right I think the key is in many countries, if you don’t have a EU or an FDA approval it’s hard to go to Phase II. Like China for example will not allow you to do a Phase II trial unless you have or else you have to do the Phase I with compound produced in China. So when you strategize all that you have to understand that it’s almost only the authority you start in US and EU no matter what. So Japan, on the other hand, in Japan we have Lexumia there. We have PCSK-9. I can’t remember the others but I know that we’re put in Japan much earlier in the process because if you recall Japan used to have the tradition of waiting for all approvals elsewhere before starting. That has changed. They do want to reduce the time of access to new molecules by their patients. So it's now (inaudible) I could convey that information to you, if you wish.

Chris Viehbacher

Management

In fact it’s quite a mix because there are some countries also in an emerging market that once you have approval either in the U.S or in Europe you will automatically get approval in those countries. So, there is actually quite a wide range of variability but at least as Elias for particularly China and Japan there is going to be some delay but probably less than it had in the past.

Elias Zerhouni

Management

This is a disease that is specific to the region. We are still going to global development with US and Europe being key to the approval process pathway.

Chris Viehbacher

Management

That will go with dengue for example. It's Latin America and Asia.

Elias Zerhouni

Management

Right, so dengue is different and is halfway of approval.

Eric Le Berrigaud - Bryan, Garnier

Management

So precisely the second question relates to PCSK-9. The target for sale looks very much interesting but what could you say about safety and in terms of injection site reaction, whether you see anything? And whether your own formulation is already in too early stage development?

Elias Zerhouni

Management

No, no, the overall formulation is pretty -- we clearly understand we will be going into Phase III in three months if we didn’t have it. The devise is something, the dosing we're pretty clear on what needs to done. In terms of safety I don’t know if you went through the 8-K but we did report at the AHA immunology and we don’t see that in the Phase II trials. We have one skin reaction unclear whether it's the product or something else. So, it looks extremely safe from the current data that we have. No increase in other parameters that would say oh, there is a counterbalancing effect or lowering for example in HDL or something like that typically you would worry about. So, right now, we are quite comfortable with the safety profile. We will find out in Phase III.

Eric Le Berrigaud - Bryan, Garnier

Management

Okay. last one in terms of dividend. Do you plan as last year to pay too for the possibility for the dividend to be paid in shares?

Chris Viehbacher

Management

No. Sébastien Martel: It was a quick one. Maybe we will take questions here from Alexandra Hauber, second row.

Alexandra Hauber - JP Morgan

Management

Several questions. Question on (inaudible) first. I think you said in the press release that you saw conversion up to 50% up from 40%. Is that going fairly smooth and are you confident you can sort of increase that penetration that we tended to present to once 2014, 2015 we should be at this sort of 80%, 90%? And what are you actually doing to make sure that that’s happening? And then second question is just around the topic of pens. Have you finally defined which device you're going to take into the Phase III for the lixisenatide combination? Are you still pursuing the version of those components can be tritrated?

Jerome Contamine

Management

I will take conversion. Yes, I think 40% is not better size, you will remember it was a matter totally dominated by [cartridge] so that’s already the answer to the second part of the question, what do we do? We favor everything commercially from a promotional point of view, which goes into conversion and we de-favor anything which would keep the matter on cartridges. Can we bring the market to 100%, I don’t think so, because I think as we grow we are right. Would you like to grow faster? Yes, perhaps on the other side, we have to see that there is still a market of non-pens where we also have to continue to make offers with client is in not in pens but I think 40% today -- 50% today where we have been I think in 2005 or 2006, 10% or 15%, it’s a good rate.

Chris Viehbacher

Management

I think it’s fair to say that we have really increased our efforts in the last two years and that includes pricing and other commercial terms in addition to promotion.

Elias Zerhouni

Management

Absolutely, we are continuing with the development of devices that could give you fixed flex so that you can titrate the insulin, or we think it’s important for patients. I don’t think you have the ability – I mean, the fixed dose for us works well, because lixisenatide has fixed dose at the side of 10 or 20, so there is not a lot of complexity to that, but we have -- this is what we pursue, I mean, we have the devices to back up and aiming for some increased fee with a commercial device in 2013.

Alexandra Hauber - JP Morgan

Management

But it is still not finalized since it’s only in the year or are you initiating or have you nailed it now?

Elias Zerhouni

Management

Pretty much. I mean, all you have to do all the PK/PD trials obviously for that before you start your Phase III, so we are ongoing through that and we have primary devices back like every development plan.

Chris Viehbacher

Management

So, in other words, to be clear, the device is fixed, there is backup device, so we are not tinkering with the device at this stage.

Elias Zerhouni

Management

Yeah, we are just making sure.

Chris Viehbacher

Management

We are going through the PK/PD studies in the device to make sure it is valid and we are able to get authorization to go into Phase III with.

Alexandra Hauber - JP Morgan

Management

And then, I just would like to ask you for a little bit more color on the Genzyme situation. You said that you are going to initiate to the dose the patients on the waiting list (inaudible) 8th of March or the second quarter. How long is that waiting list and how long is it going to get to everyone’s full dosing? And on Cerezyme, I know you it is going to take you some time to get as much out of outcome fund as you would like, but can you just update us on what Cerezymesituation is in terms of patient dosing and waitlist? And just in general, how long do you think since you have to balance the patient dosing and inventory, how long will it be until we have completely normal inventoried that will begin?

Elias Zerhouni

Management

So, if we start with inventory levels, one of the aspects of this type of production is it that yields can vary further significantly. Historically, Genzyme had five, six months of inventories, so if you had some of the fluctuations in batch-to-batch yields, you pick that up. We were running that less than one month of inventory. Now, we came out of 2011 with actually inventory levels than we expected. And so, I think it will be gradual build-in, but clearly, there is a constant patient demand and so, until we really get every patient on a full doze who needs the drug, we are not about to start pointing in product in the warehouse. So we will continue to operate at least through most of 2012 with minimum levels of inventory. Now, batch-to-batch variability is interesting. We are just coming through the first time that Allston facility has been shut down for maintenance in 10 years. And our belief is that potentially, this could have the beneficial impact on yields as well. We have no evidence of it yet, but those are the sorts of things that could have a result. We won't be able to immediately be able to use the Fabrazyme we operate, but after Fabrazyme is completed, we actually have to go through a validation process to be able to use the other reactors. The real benefit is expected to come from eliminating some of the other downstream bottlenecks because we have taken Fabrazyme out and really significantly, simplified the operations of the Allston facility. The Allston facility was built 20 years ago and it was built really for one product. And so when four came in, we’d almost overloaded that facility. So we are now getting that facility back to really what it was originally…

Chris Viehbacher

Management

Go ahead. Anyone take the Merial question.

Hanspeter Spek

Management

I am not sure if I had understood correctly I think the question goes with the joint venture this Merial also after having successfully integrated Merial and it should go through Béatrice Muzard - Natexis: How could you elaborate the joint venture the vaccine joint venture (inaudible) performance and (inaudible) asset valuation?

Unidentified Company Speaker

Management

It should be answered by Olivier Charmeil (inaudible).

Olivier Charmeil

Management

Well, we have clearly not happy with the performance of the joint venture. We have changed the management we have a new management on board since September. We are busy working in two directions the first one is identifying growth opportunities and we have clearly -- we are starting to identify growth opportunity I think just an example Glargine sales have been declining significantly since the end of the catch up period but we see now that the immunization rate when compared to the US are really on the low side. We have faced some issues in terms of supply in the last two or three and most by months and we get back on track and at some point would be in the position not to launch ZOSTVAX in UK. So the second dimension is really on making sure that we operate in a more efficient way in various countries and we are going to look to various opportunities to combine our force to make sure that we get really the full benefit of the Merck support and of the Sanofic support.

Elias Zerhouni

Management

On the JAK-2, I mean fundamentally you know it’s an equivalent pathway for JAK-2 inhibition, the Insight had and you targets on myelofibrosis, polycythemia, we are looking at other indications. But basically a JAK-2 inhibitor then the differentiation is going to be on relative efficacy and safety.

Chris Viehbacher

Management

So in other ways we’ll need to do the …

Elias Zerhouni

Management

I think the interesting thing for us is having an oncology portfolio that covers all the principle mechanisms of action and I think when you look at whether its MEK inhibiters or PICKs or JAK2s, Sanofi now has been able to build a portfolio and development of all those. I think also what is interesting is that we’re exploring ways of combing those which few companies will be able to do because we essentially have the full portfolio of those. Sébastien Martel: We had a number of questions from the web which were very similar of what we heard here in the room. Maybe I’ll just seek one last question from Mark Dainty. He basically says that marketing EPS estimate for 2013 seems to be a bit sadistic. So he wonders what are the main differences between how you view 2013 and what the market currently is?

Chris Viehbacher

Management

Right now we’re focused on delivering 2012. I mean in 2009 we gave guidance for 2013. Fundamentally I don’t see any major difference in what’s happening with the business in fact if anything, we’ve had to overcome somethings that weren’t anticipated. We probably lost since we gave 2013 guidance. We probably lost at least a €1 billion before tax because of European price reductions, healthcare reform in the U.S. and essentially we’ve been able to offset that largely because our €2 billion cost reduction program has come in to two years earlier than expected. So overall, I don’t see any difference in the kind of the business. I think we’ve been able to deliver over the three years since we gave the guidance in a manner that was really aligned with the expectations. Now the one thing that we’re going to be conscious about is, its one thing to give guidance in 2013 when you’re sitting there in 2009 because everybody looks out with error bars around it that are little different than when you're in 2012, I mean we're all pretty experienced in this. And so we don’t want to get into the game of already here in the beginning of 2012 giving pinpoint guidance for 2013. But fundamentally, I think compared to what we said out to do in 2009 we have been delivering on that. I think the growth platforms have come in, I have to say in particular I think the consumer health has done even better than I would have hoped for. Emerging markets, I think we have really been able to cease upon and we directly muffle out of our investment there and that’s quite a true competitive advantage. I think we have shown a lot of people wondered whether we can take cost…