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Sanofi (SNY)

Q3 2014 Earnings Call· Tue, Oct 28, 2014

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Transcript

Operator

Operator

Ladies and gentlemen, welcome to the Sanofi Third Quarter Results Conference Call. I will now hand over to Mr. Sébastien Martel, Vice President, Head of Investor Relations at Sanofi. Sir, please go ahead. Sébastien Martel: Thank you and hello everyone and welcome to our Q3 conference call. As always, the slides to this call are available on the Investors page of our website. Maybe before we begin, as you can see on Slide 2, I'd like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. I refer you to our Form 20-F documents on file with the SEC and also our document reference for a description of these risk factors. As you can see on Slide 3, for today's call we have with us Chris Viehbacher, our Chief Executive Officer; Jérôme Contamine, our Executive VP and Chief Financial Officer. First, Chris will discuss key highlights of the third quarter and first nine months, and then Jérôme will review our financial performance during the period. After that Chris will return and make concluding comments and then we will take your questions. Peter Guenter, Executive VP, Global Commercial Operations is also with us and he will join us for the Q&A session. I will now turn the call over to Chris.

Christopher A. Viehbacher

Analyst

Thank you Sébastien. So, good set of results here. Net sales up 5.1% at constant exchange rate which has led to earnings per share -- business earnings per share up 10.3% at CER. And as you have seen earlier this year we have put an awful lot of emphasis on cash management and so we actually see free cash flow up 15.8% in the nine months. The growth platforms which when we started were about 38% of our sales has now grown to 78% of our sales. And those were all up at double-digit collectively at 10%. And obviously we will say more about the diabetes market later. Importantly vaccines are back to growth and animal health doing well. And we have got some very good progress and I will come back on that on what we are seeing in R&D. So if I go to slide, the next slide you can see that one of the benefits of the quarter has been that the foreign exchange impact has got less. Obviously there has been a strengthening of the dollar versus the euro. And since 25% of our sales are done in the euro, 75% obviously foreign exchange matters a lot to us but we are not seeing the same erosion as we have seen in the past. But you can see again very good growth on top and bottom line and that has really been driven if you look at Slide 7 by the growth platforms. And when we set these growth platforms up, the reason we did that was normal years in the industry you will always find that there is something will happen somewhere in the business and the more international businesses become, the more research and development progresses. You are not always going to be able…

Christopher A. Viehbacher

Analyst

Thanks Jérôme. So now again good results. We continue to grow the sales at mid single digits where they leverage P&L. Growth platforms up at 10%, earnings per share guidance is reconfirmed and I think as I said before, I think what's really driving a lot of us internally is the opportunity to launch a number of new medicines, not only next year but in pretty much pretty regularly in the years to come. So with that we will Sébastien open up for questions. Sébastien Martel: Thanks Chris. Operator we are now ready to open the call to questions. I would like to ask participants as always to only ask one or two questions at a time. Anybody can always come back into the queue to ask further questions if need be. Operator we are ready.

Operator

Operator

Thank you. (Operator Instructions). We have a question from Peter Verdult from Citi. Please go ahead.

Unidentified Analyst

Analyst

Gil for Peter from Citi. Two questions one for Peter, one for Chris. Peter can we just talk about diabetes, I mean just want to get a better sense in terms of the significant change in the outlook for the diabetes market, how much of that is Novo specific versus just the general deterioration of the U.S. reimbursement outlook from a payer pressure perspective and what you expect from channel mix changes? That's question number 1. And one for you Chris, I mean you laid out a clear strategy when you arrived as CEO and it clearly showed that you created value with Genzyme. Is the company now in a good position in your view to execute another major transaction to diversify away from diabetes, thank you?

Christopher A. Viehbacher

Analyst

Just on diabetes, you know we can't comment on any competitor. What I will say though is there is not really a -- deteriorating payer environment only works if you have actually people who are going to actually offer something in return. So in other words if someone wants price protection or someone wants a higher rebate it only works if there is a competitive offer on the table. I mean payers play one person off against the other, that's the way it works. So, there really is only one dynamic and that is competitive pressure out there. So, I think obviously what we do is we look at what has happened with previous accounts dialogue with payers. This I think is the important is that we believe we have secured extremely strong coverage and still at a very good price point. There is an adjustment in a one year time frame but I think it actually positions the company well. And we have Toujeo and Afrezza to launch, so we continue to believe that diabetes will contribute to the growth of the company over the medium term. Concerning diversification away from it, it is less than 20% of our sales today are in U.S. and Europe on diabetes and I think when you look at it, the company still grew its bottom line here at 10% even though clearly the diabetes growth is significantly less than what you saw in the first two quarters of the year. That is the advantage of the diversified model. The most accretive way that we can continue that diversifications through the launch of new products. Doing an acquisition doesn’t change anything on diabetes. So, we are going to continue to grow and develop our diabetes franchise, whether or not you want to add something in terms of an acquisition, is something you can do it anytime. You don’t have to wait until you are concerned about diabetes or not. The reality is that, you have to do a transaction though that makes financial sense for our shareholders. Today the cost of capital, of debt capital is virtually zero and that's often reflected in a lot of asset prices. We continue to look at everything but we have continued to look at everything no matter what the diabetes business is. We are still very big company and I think the growth prospects when you add a new product is good. So I don’t particularly see a need that we have to go do a deal. But I think the company is actually pretty well diversified today.

Unidentified Analyst

Analyst

Thank you.

Christopher A. Viehbacher

Analyst

Next question please.

Operator

Operator

The next question is from Tim Anderson from Sanford Bernstein. Please go ahead.

Timothy Anderson - Sanford Bernstein

Analyst

Hi, okay so obviously on Lantus, to me it is really strange to see this action you guys have taken and there is only two possibilities, one is that Toujeo was going to get fully blocked and so you are buying access for Toujeo. But I don’t see how that is hardly the case, because Toujeo is not approved. So, it narrows down to only one other possibility which was Novo competing on price with Levemir. So, I know you don’t want to comment on a given competitor but are there other competitors besides that I am missing, that's the only possibility I can think of and if you could comment on your ability to secure access for Toujeo at this point and whether I am mistaken by thinking that you probably can't wrap the part of the deal? And then last question on this whole topic, is this multiyear contracting we are talking about normally it appears that you only want to do this sort of thing one year at a time as we know that the market is changing?

Christopher A. Viehbacher

Analyst

No, all I can say is that we are talking about competitive pricing there.

Timothy Anderson - Sanford Bernstein

Analyst

That's it.

Christopher A. Viehbacher

Analyst

Yeah.

Timothy Anderson - Sanford Bernstein

Analyst

Okay and then Toujeo long-term access, you know, market access for Toujeo in 2015?

Christopher A. Viehbacher

Analyst

You know I think Toujeo is going to stand on its own two feet. It is a product that’s got a benefit on hypoglycemia. We have clearly been talking to payers and key opinion leaders. But the market access will occur when the product is launched as is normal. And we believe that actually Toujeo has a very strong market positioning. I think over time we're going to see this basal insulin market being a competition again between two players. It will be Toujeo against Tresiba and the benefit is to Toujeo; A) gets to market first and B) now we have a bigger base of prescriptions to build Toujeo off of. And three we actually believe we got a better profile in terms of the PK PD profile which leads a different titration schedule and actually better 24 hour coverage. So, that’s an independent thing. So that's why we are confident about launching Toujeo but that’s not on today's agenda.

Timothy Anderson - Sanford Bernstein

Analyst

And is it only one year contracting cycle most likely for Lantus and Toujeo?

Christopher A. Viehbacher

Analyst

It's kind of a mix, so we can't really say Tim.

Timothy Anderson - Sanford Bernstein

Analyst

Okay, thank you.

Operator

Operator

Thank you. We have a next question from Mark Clark, Deutsche Bank. Please go ahead.

Mark Clark - Deutsche Bank

Analyst

Jérôme Contamin: Mark on the rebate question I mean, basically you mean I tweak, so you start with the rough price which makes you work your rough phase. It is blocked in the 20-F and in one of the appendixes and then I mean you come for the rebates. And of course the rebates here will be a combination of milky factors. I mean, on one hand you have the rebates of the commercial channels, you have the rebates on the public channels, you have the impact of the coverage gap, so all that will be booked into the same line. So I think that we have given already the guidance for next year which will be more flat but I don’t think we are going to give more guidance, a more detailed guidance but the way it works is that you will see an increase in rebates clearly time passing. At the same time you should look at 2014 to start with, I mean clearly we have seen that everything being equal, an increase of the rough price, I mean transform into a net inflationary I mean a net positive in fact even after rebates and this will whatever is the rebate this will be made in two if we take any other price increase next year on the price point.

Mark Clark - Deutsche Bank

Analyst

This is going to be probably pushing you too far but historically Chris you talked about growing the franchise in diabetes through to last of price increase, do you think we can look forward to a return to growth in 2016 or to the fact as we are talking about today flow through 2016 with further contracting pressure next year, etc?

Christopher A. Viehbacher

Analyst

I think it is difficult to speculate on what everybody else is going to do. I will tell you how I look at this. Generally what you see in these types of market is that you have some people, essentially in oligopoly situations here. So there is usually an attempt in that, we saw this in flu vaccine a number of years ago. Somebody comes in, tries to gain some market share with price, and everybody aligns their price. And so nobody really gains share. And so usually you don’t -- it is not really in anybody's interest but it could happen. But I think you are going to see people come in with branded products. I think you have to also remember that the basal insulin market is not an isolated market. There are other insulin markets and therefore pricing in one segment can have an effect on others. You may well see migration from premix for instance or even human insulin into the basal market. You have got players coming in, all three are proposing you know if I take Lilly as well branded products coming in, and none of us are going to make a return on the investment if everybody has a race to the bottom here. I think Toujeo will increasingly be the product that overtakes Lantus and you add in Afrezza, then you also add Lyxumia and then you add LixiLan. So I think we have a number of options to look for growth in this segment overtime.

Mark Clark - Deutsche Bank

Analyst

Okay, thank you.

Operator

Operator

Thank you. Our next question is from Alexandra Hauber from UBS. Please go ahead.

Alexandra Hauber - UBS

Analyst

Good afternoon, sorry just one more question from me again on the pricing in diabetes. Chris, I think you said the rebates that you are getting in from next year, so just wondering why were sales flat this quarter, why did all this positive pricing you had in the first half suddenly evaporate? And then secondly on the SG&A line, given that you are going to have about 4 to 5 or 6 new product launches next year, what does that mean for SG&A, it is already up significantly this year, are we going to see more demand for you to add probably in the various regions and in other costs?

Christopher A. Viehbacher

Analyst

Sorry, I was referring to some contracting that have been done towards the end of the year. There is an effect on price this year. There was an effect in the first half of the year and even some contracts are going to have an effect in this year. But the full year impact comes in 2015. But there is an impact in this year. Both probably on price but we actually lost some market share because we lost a couple of accounts at the beginning of the year. The SG&A, I mean I think we are not going to give guidance on the whole year. I would just say yes, we will be investing in new products in a particularly Praluent, Toujeo, and Afrezza next year. To a degree Toujeo and Afrezza can rely upon an existing promotional base from Lantus. But there will probably be an incremental investment beyond that. Praluent is a new product and there will be investment behind that. Again we're trying to leave the diabetes franchise and not because you are seeing an awful lot of co-morbidity in the patients at risk with high cholesterol and diabetes. And obviously we're not talking about especially at the launch period a primary care product. Cerdelga really can fit into the Cerezyme field for us. Dengue is a largely going to be a government contracting approach. So I think there will be some; we also believe we still have opportunities to reduce cost in the business. So we will be looking at cost mitigation on that. So -- but there is going to be some investment on these products next year absolutely.

Alexandra Hauber - UBS

Analyst

Thank you

Christopher A. Viehbacher

Analyst

But I would point out also Alexandra, I mean you know we launched things like -- we actually have put about €400 million into new promotional activity in 2012 and another €700 million in to commercial and R&D in 2013. We didn’t really see that because we were able to offset a number of those costs through cost savings. I'm not sure if we can do it a 100% but I wouldn’t also assume that a 100% of those costs are going to be translated to the bottom line.

Alexandra Hauber - UBS

Analyst

Okay. Thank you very clear.

Christopher A. Viehbacher

Analyst

Next question please.

Operator

Operator

Vincent Meunier from Morgan Stanley. Please go ahead.

Vincent Meunier - Morgan Stanley

Analyst

Good afternoon and thank you for taking on my question. The first one is a follow up again on the Lantus and diabetes. For 2015 assuming flat sales for the diabetes division globally, this suggests a U.S. sales decline for Lantus. Can you confirm that? And do you think that the pricing power can be regained in this market after that phase of higher rebates or not? And I have another question on the PCSK9 in the context of Amgen infringement against the patents of PCSK9. Can you confirm that there is no restrictions in terms of manufacturing of Alirocumab and also on your ability to file by year-end and more broadly what are the next steps and what kind of prediction can you put in place here? Thank you.

Christopher A. Viehbacher

Analyst

I think -- you know we try to be transparent here and trying to give you guys some outlook. We don’t really want to get into a 2015 guidance note on region-by-region conversation. I think you know the math is pretty obvious on this. I think also we're trying to be prudent at this point but I can’t really speculate on what assumptions are in market share. But I think the next question is important, there is and always has been more to Sanofi than diabetes. And that’s where we're going. And PCSK9 is one. You know the patent situation was something that was investigated by the company at the time we opted into the program with Regeneron. So obviously our own patent attorneys took a view of the strength of those patents that Amgen is trying to assert. And obviously, that analysis lead us to opt in and we're going to be vigorously defending our situation. And at this point we see no delay to the launch of PCSK9, to the filing of PCSK9.

Vincent Meunier - Morgan Stanley

Analyst

Okay, thank you very much.

Operator

Operator

Thank you. Our next question is from Graham Parry from Bank of America - Merrill Lynch. Please go ahead.

Graham Parry - Bank of America Merrill Lynch

Analyst

Thanks for taking my question. So again I am afraid on the like the diabetes share, I think everyone is surprised to see no growth –- there is no incremental competition from new entrants. So perhaps you could help us to understand the dynamics into 2016 little bit more. You made a few comments this morning talking about a sustainable path post this and still expecting diabetes to contribute to the growth over the medium term. Does that mean you've repriced the market now to a level that you are comfortable with and you expect less price competition in 2016 as you commence on sort of floor level? And could you comment on where you see your net pricing being versus 2011, do you think this brings you more into line? And then secondly a question for Chris. There's obviously a lot of stories surrounding the media about your relationship with the Board and your tenure. I'm just wondering if following yesterday's Board meeting you’ve received any reassurances from the Board that your position is secure and you have their backing to run the business and execute further deals?

Christopher A. Viehbacherer

Analyst

I think Peter I know you want to comment further but I mean I think at this stage we can't really start speculating on 2016. You know competitive pricing doesn’t really depend on us. But I would just say the pricing is far more complex obviously because you got a Medicaid segment, you have a Medicare segment, you have a commercial book of business segment. And as I said I think our view is that we've got a very, very solid competitive position now where we are. If you have got over 90% coverage, you got whole market to go after. You know I can't really say anything more than I've said this morning. I'm the CEO of the company, I'm focused on running the business. The Board put out a statement saying that the issue of succession was not on their agenda. And we are pushing ahead on all fronts. Jérôme Contamin: So Graham on your question on the cost margin, I mean A) I mean once again we're not going, we're not in the position to give you guidance for next year. So I mean how can you manage gross margin versus SG&A along with what Chris said earlier and even on the SG&A, I mean there are few ways to get cost on one hand when it is slow, keep projects on the other hand. What is important when you think about gross margin is the mix of the business. So it's clear that, I mean you're right, I mean if whatever happens of course when you increase the share price advantage -- it is looking favorable to the overall gross margin. So I mean this will not be exactly similar next year. Now I mean there are other trends. I mean we mentioned earlier today and…

Graham Parry - Bank of America Merrill Lynch

Analyst

Can you just come back on the Lantus and pricing, just in terms of where you said you are today relative to competitors. I mean historically there's been a much narrow rebate for Lantus than your main competitor, do you feel that you're more close to the pricing patchy level now or do you feel like there could still be pressure with that target for pressure in 2016? Thank you.

Peter Guenter

Analyst

So, Graham its Peter speaking. I mean, obviously we do not know the exact price point of the competition. And this is also a moving target. It varies, as Chris said account for account and channel by channel. And it is probably fair to assume that after the pricing actions that we have taken now, we are closer to where Levemir was or is. How this is going to unfold in the future is few speculations. I would not enter into that. Again the only thought I would give you however is that Lilly and Novo and ourselves are entering into the innovation phase in basal insulin. So I think it is not in the interest of the existing players to go for a race to the bottom.

Graham Parry - Bank of America Merrill Lynch

Analyst

Thank you.

Christopher A. Viehbacher

Analyst

Next question please.

Operator

Operator

Our next question is from Jeff Holford from Jefferies, please go ahead.

Jeff Holford - Jefferies

Analyst

Hi, thanks for taking my questions. I'm still struggling a little bit on the Lantus and the pricing here because in what's still basically a co-preferred market and we've Novo planning the launch in new products here as well. Not too far it seems strange they might lead and you around this price competition here. Can you just maybe reassure us that this isn't push back from the payers on the Sanofi's own recent price action in 2013 Potentially the company had been too aggressive in the past on price increases? And then also as a follow up does this at all impact what your pricing strategy might be for Toujeo on launch? You had sort of referred to that as a premium priced product relative to Lantus in the past. I wonder if you're still thinking that might be the right strategy to go with? Thank you.

Christopher A. Viehbacher

Analyst

I'm not aware of ever having described Toujeo as a premium priced product. I think on the -- the payer dynamics you go in on a negotiating contracts and we obviously are in competitive situations on these contracts. The pricing on the VAC (ph) basis is not so relevant. And is largely followed with what Levemir has done. I think it’s a -- the competitive situation. I really don't know what to say more than that. Next question please.

Operator

Operator

We have the next question from Richard Vosser from JP Morgan. Please go ahead.

Richard Vosser - JP Morgan

Analyst

Thanks very much for taking my questions. Two please. Just on Lantus but in a different geography. If we could just talk about how you're seeing the growth in emerging markets at the moment. Whether you're seeing in certain markets increased competition from Tresiba and how you're seeing the Japanese market develop at the moment? And then away from diabetes just into animal health, obviously the NexGard launch has been pretty good, if you could give us an idea how the conversations are going with that into 2015 and also reassure us perhaps if frontline is now stable as well? Thanks very much.

Peter Guenter

Analyst

So I’ll take the question on Lantus ex-U.S. So emerging markets the product is growing extremely dynamically and we do foresee that this continues in the future. For example in China that we have well the effect accorded by a similar competition since -- well since a decade now. And I'm actually looking at the third quarter growth of Lantus in China, we had a very healthy 35% growth rate. So and that’s basically what you see in many emerging markets. And Japan we are in a specific situation to the extent that we Tresiba with a pretty liberal market access and what we see is that we hold on to two-thirds or let's say 65% new patient share with Lantus. So I think we’re doing a pretty good job in defending our share. In the overall share we still hold a 60% market share with Lantus whereas Tresiba must be somewhere a little bit above 20% in the last monthly data. So that’s basically what I can give you as an update on the ex-U.S. situation. Perhaps last point in Europe as Chris mentioned in the introduction is a very strong third quarter. We are close to 10% growth for Lantus, overall more than 10% growth on diabetes in Europe. And this is actually a with a very slight negative on prices even more than that in volume. So it’s a very healthy performance actually.

Christopher A. Viehbacher

Analyst

On animal health sorry, the question was?

Richard Vosser - JP Morgan

Analyst

It was just basically reassuring us on frontline being stable into going forward and into 2015 and how we should think about it element of the NexGard launch through the annualization of that launch next year?

Christopher A. Viehbacher

Analyst

So NexGard has not yet been launched in all markets so we would expect further launches particularly in Europe. And the only thing that will happen is we will have competitor activity as we know from very soon from Merck. So it is a competitive space. So I don’t think we're going to see as stronger growth in Merial next year. But we would expect to see the franchise continue to grow.

Richard Vosser - JP Morgan

Analyst

Thanks very much.

Operator

Operator

Thank you. Our next question is from Steve Scala from Cowen. Please go ahead. Steve Scala - Cowen & Co.: Thank you and apologies for a couple of more diabetes questions. First does your Lantus guidance assume Lilly launches the Biosimilar in the EU or does Sanofi have a legal strategy to block the launch, so no launch is assumed? Or maybe it's irrelevant whether or not Lilly launches as it relates to your guidance? So that’s the first question. Second question is Chris you’ve previously said that a good proxy for conversion of Lantus to Toujeo was compactone (ph) which I understand converted about 50% of prescriptions in about 6 months. Would you detail the strategy to deliver that degree of conversion beyond the superior hypoglycemia data? Thank you.

Christopher A. Viehbacher

Analyst

Will you do the Biosimilar here?

Peter Guenter

Analyst

Yeah, so and the assumptions for 2015 commercially we have embedded a Biosimilar launch in Europe by Lilly.

Christopher A. Viehbacher

Analyst

And in terms of the analogue, I mean what we're really trying to do this is obviously cannibalize Lantus. The -- you can look at either copaxone, you could look at a Tresiba. In Japan there is a number of other analogues out there. Obviously this will depend on how fast you get out the market on market access. The most important is I think that we’re going to be putting all of our promotional effort behind Toujeo in next year. And I think there are a couple of strategies that will be different in terms of promotion that we're doing but we will be able to tell you that more close to launch. Steve Scala - Cowen & Co.: Thank you.

Operator

Operator

Thank you. Our next question from Philippe Lennon from Natixis. Please go ahead.

Philippe Lennon - Natixis

Analyst

Good afternoon gentlemen. Thank you for taking my question. I'd like to ask the last question in another way. You’ve given half of the guidance for 2015 with the diabetes indication. But in Q3 2014 the rest of the business has compensated for that. And you’ve been at 5% growth organically which has been kind of guidance overtime, it's not to speak on one figure but the question is will you be so far away from that level in 2015 for the whole group? And can we anticipate, in your view, for the few next years this kind of level? And maybe a second question on Lemtrada which is still not taking off. So is there any hope here or is it a lost cause?

Christopher A. Viehbacher

Analyst

You know the big we have always is, you know the minute you start trying to provide some transparency on some major aspects of the business everybody wants to know about the rest. We will be giving guidance for 2015 in with the fourth quarter results in February. And so the idea was just to say look, we have seen a shift in market dynamics in part of the business. And I would just say we've seen a shift market dynamics trying to help quantify that for you. But obviously the rest of the business continues to develop. We have our growth platforms, we have launches of new products. There are cost cutting maneuvers ongoing. All of that is going in to a budget process for 2015 that has not yet been finalized and will typically be finalized for another four to six weeks. And you know we will be able to provide a guidance for the whole business with the earnings announcement in February.

Philippe Lennon - Natixis

Analyst

Okay. And on Lemtrada

Christopher A. Viehbacher

Analyst

On Lemtrada I think, let's -- lets first wait for the FDA decision and where that is. The FDA -- Lemtrada is a first I think -- you know targeted to extrapolate from Europe sales because if the FDA doesn’t approve a product straight away even if you get it approved elsewhere, there's still a waiting to see what the FDA does. So I wouldn’t use that and you have seen it with other products. I mean if you looked at the InterMune product for example. I'm quite certain that that Roche when they bought InterMune didn’t extrapolate from the European sales. So there is that impact. What we have seen and I went to ECTRIMS just a few weeks ago in September, which is a Global MS Conference. There are an awful lot of opinion leaders that have used Lemtrada, loved Lemtrada. A lot of them are believing that it is actually going to end up being patient driven but it is very clear that this is a product that has had a history and it is going to take time for people to really get used to using it. But for those who have used it, we are seeing people, we had a patient actually address our top 300 meeting at the beginning of September. This is a person that had the -- had Lemtrada seven years ago and is back to running 5K runs and living a normal life and taking no medicines. So when I was talking a number of KOLs in Australia for example where we have been really trying to use this in a big way, very positive but it will take some time for that patient experience to be seen by enough physicians. And so I think overtime this is an important medicine but I would not expect this medicine to rapidly take off out of the shoe. But let's wait and see what the FDA decision is before we think of anything definitive.

Philippe Lennon - Natixis

Analyst

Thank you.

Operator

Operator

Thank you. Our next question is from Michael Leuchten from Barclays. Please go ahead.

Michael Leuchten - Barclays

Analyst

Thank you. It is Michael Leuchten from Barclays. Just taking the changing dynamics, Chris you mentioned a little bit broader, I think your methods around pricing is a clear on the volume side of the story, however, in the past you have commented about how this market is relatively stable and sticky on the insulin side. Do you see changes on that side of the coin as well, is managed care able to drive a more dynamic momentum into this market that historically has been quite sticky? And then secondly on the government programs that you have mentioned, there is a potential threat that you get the best pricing kick in on a franchise like Lantus is, I just wondered whether that is part of your assumption on the pricing side or whether you are clear off having that negative collateral damage? Thank you.

Christopher A. Viehbacher

Analyst

Do you want to take on the…

Peter Guenter

Analyst

Yeah, so on the markets question, you see in these an uptake of roughly 1% to 1.5% of the insulin clause as a whole. Most of that increment goes however, into Medicaid. There is a channel which is of course the least profitable channel. Your second part of the question was…

Michael Leuchten - Barclays

Analyst

In terms of the changes of the dynamics in the market, obviously your pricing side was very clear, but relating to market?

Peter Guenter

Analyst

So, that's -- the best price in Medicaid is baked into the assumptions. Next question please.

Operator

Operator

Our next question is from Luisa Hector from Exane. Please go ahead.

Luisa Hector - Exane

Analyst

Thank you, good afternoon. So, first on Toujeo, I noticed on the timeline that the U.S. decision has moved into Q1 which seems a little bit earlier versus the first half and I just wondered if there is any particular reason for that? And just to confirm that whether or not you are expecting an advisory panel, I am assuming if you could just update us on that? And then Chris, you said the key to the success of Toujeo will be the market access, so in your recent rounds of contracting, have you been discussing Toujeo, does it form a separate conversation, you know how far advanced are you in discussing that product with the payer? And maybe I could ask on dengue, how many doses do you expect to have at launch and as you have been around Asia recently, is there any clarity on how you could incorporate this into the vaccine schedule, would it be a particular age cohort, and how you can ensure that everybody's got the three doses over the quite wide time frame, any color there? Thank you.

Christopher A. Viehbacher

Analyst

So, the filing -- so approval date for Toujeo is Q1 for the U.S. and Q2 for EU. So I think it has been a short form to stay both in H1 but there is no real change on the expressive timeline for Toujeo. When I talked about fair market access, it is principally a question of when you start trial, okay, start looking at cannibalization rates. You have to make sure that you are starting from the point where you get a broad coverage and today we just don’t know but it is not -- I mean it is important for the longer term but it will be more of a factor about how big your shelves get to be in 2015. You know we haven’t -- I mean you have discussions with payers at a medical level, at a very general level but you really can't go into any detail with payers until the product is approved. You can orient the product with your medical people but you can't actually engage with the pharmacy benefit people until you have an approval. On dengue, dengue we have actually built a model that we work with ministries of health on. It takes the past 10 years of data typically for a country of dengue incidents. In some countries it depends on the level of surveillance data that is there. I mean if I take Malaysia for example, I have excellent tracking data and so you can look at the incidents by state in Malaysia and also by age cohort. So you can actually model and say if you vaccinate so many people, here is what you would expect the incidents of dengue to do. So, is it this age group or that, and what you find is actually there is…

Luisa Hector - Exane

Analyst

Okay, thank you.

Christopher A. Viehbacher

Analyst

We are going to take a couple of more questions operator.

Operator

Operator

Thank you. Our next question is from Fabian Wenner from Kepler Cheuvreux. Please go ahead.

Fabian Wenner - Kepler Cheuvreux

Analyst

Hey, good afternoon and sorry to come back to the dominating question. I guess you are not going to give us any detail on what the extent of the rebates that you have given for 2015 are, but I want to come back to Mark's question about how much of the impact on the sales level you can actually compensate on the bottom line and I think Chris you did say that you do see flexibility on the cross plans to at least counter some of the effect. I just wondered if you can give us any indication how much you can reign in actually given that most of the impact is going to be on pricing and not on volumes, whether you can actually reign in some of the sales force, what other cost items you can flexiblize? Thank you.

Christopher A. Viehbacher

Analyst

I think first of all no, we can't give you any details on the rebates mostly from I am sure our competitors would like to know that. So, we can't really do that and for the rest it comes back to we don’t really want to give guidance for 2015. There are going to be cost reductions that we can do, we have got launches of products that we can do. We could be investing in new medicines. So, we will be happy to put all of that together for you there. You know again the real objective was we wanted to give you a heads up because we had perceived some change in market dynamic already at the half year and that became more crystal in the third quarter. And that is really all this is meant to be is to help get at least some level of about fund information so you can do more modeling.

Fabian Wenner - Kepler Cheuvreux

Analyst

If I can just try follow up to that, are you surprised somewhat about the timing of the competitors behavior. Couldn’t that competitor have behaved this way basically year-over-year or even earlier than that, was that kind of pricing pressure?

Christopher A. Viehbacher

Analyst

All I can say is that actually you have to go ask the competitor. I think if you look at -- markets are dynamic places and I would say that this is a change in our own expectations, there is no question about it.

Fabian Wenner - Kepler Cheuvreux

Analyst

Thank you.

Christopher A. Viehbacher

Analyst

We are going take the last question operator.

Operator

Operator

Thank you very much. Our next question from Seamus Fernandez from Leerink. Please go ahead.

Seamus Fernandez - Leerink Swann

Analyst

Thanks very much for taking the questions. So, just two questions, first on your views on the prospects of a directly substitutable generic in the insulin space, is this something that one of the generic manufacturers Mylan specifically has commented on. Really the question surrounds where you think breakeven pricing might sit for a smaller participant in the market in that context and how much room there is for price thresholds and where you see the challenges for a directly substitutable generic in that regard? And then the second question is, as we think about the launch trajectory of a product like alirocumab without outcomes data, how should we think about the launch trajectory of alirocumab in the context of both another competitor who may help grow the market but also the absence of the outcomes data?

Christopher A. Viehbacher

Analyst

You know it is Mylan Biocon is number of years behind, so I think it will be difficult to speculate on what the market is going to be by the time they get there. By then you have got Toujeo out there, you got probably a Tresiba, probably a Lilly Biosimilar, possibly a Lilly novel basal and I think by the time that comes you are going to have probably have seen a market between first generation basal insulin and second generation. So, I think we will wait and see. We know that Lilly has not gone for a substitutable Biosimilar. And I think trying to do a substitutable and doing the clinical studies, you just have to question about what economics of that are for the company wanting to do that. But I think it is too early to speculate on that today. On alirocumab we will give you a whole lot more but add two more of these questions through that and after 20th of November I think what we will really be trying to communicate on is what are physician attitudes. Do physicians believe that lowering cholesterol is a good thing. And if you particularly have patients who have multiple risk factors, if you have someone who has already had a heart attack and who despite high statin use has still got high cholesterol, maybe overweight, maybe still smoking, possibly have diabetes, and you can offer a product that dramatically reduces their cholesterol by 60%. How many physicians would be willing to treat that patient with or without outcomes data. And I think we will be able to give you some more indication of that but I am sure if you go ask your favorite cardiologist, that cardiologist whether he or she thinks it is good idea to reduce LDL, I think you will find at least nine times out of ten or 99 times out of 100 that they think it is a good idea. I think you are going to be really in this period of really looking at a number of targeted populations between the SH population, the statin intolerant population, the secondary prevention population. You are not going to be out there to try to replace statins but there is probably a bigger unmet need than most people think. But let's try to distill this a little bit more for everybody as we have got a little more time till 20th of November.

Christopher A. Viehbacher

Analyst

Thank you Chris. So with that we would like to conclude the call and thank everybody for your interest in Sanofi today. We look forward to having you follow the IR Thematic Seminar on new medicines and vaccines which will take place on November 20th in Cambridge, Massachusetts. With that bye-bye.

Operator

Operator

Thank you. Ladies and gentlemen this concludes the conference call. Thank you all for your participation. You may now disconnect.