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Sanofi (SNY)

Q2 2015 Earnings Call· Thu, Jul 30, 2015

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Transcript

Operator

Operator

Ladies and gentlemen, welcome to the Sanofi 2015 Q2 Earnings Call. I will now hand over to Mr. Sébastien Martel, Head of Investor Relations. Sir, please go ahead. Sébastien Martel - Sanofi: Thank you, Laura and good morning, good afternoon to everyone. Thank you for joining us to review Sanofi's second quarter results. As always, the slides of this call have been posted on the Investors page of our website at sanofi.com. With me on the call today are Olivier Brandicourt, our Chief Executive Officer; and Jérôme Contamine, Executive Vice President and Chief Financial Officer. All the members of our company are also around the table. We've got Olivier Charmeil, Executive Vice President, Vaccines; Peter Guenter, Executive Vice President, Global Commercial Operations; Carsten Hellmann, Executive Vice President, Merial; David Meeker, Executive Vice President, Genzyme; and Elias Zerhouni, President of Global R&D. First, Olivier will discuss the key highlights of the second quarter and then Jérôme will review Sanofi's financial results during the quarter. After that, as always, we'll open for Q&A session. Before we begin, as you can see on slide two, I'd like to remind you that information presented in this call today contains forward-looking statements and 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 document, on file with the SEC, and also our document reference for a description of these risk factors. With that, I'd like to turn the call over to Olivier.

Olivier Brandicourt - Sanofi

Management

Thank you, Sébastien. Good morning, good afternoon to everyone. I'd like to welcome you all to our second quarter earnings conference call today. So starting with slide four, let me start off by saying that I'm very pleased with our results in the second quarter. Our performance continues to be solid across the board and while we are introducing a series of promising new products for future growth, we are also advancing our late-stage pipeline. Sales were up 4.9% at constant-exchange rates, reflecting the strength of our diversified businesses. We delivered growth across all regions and businesses except for Diabetes. We also reported solid financial results, despite the expected higher operational expenses driven by the investments in our multiple new product launches, business EPS was €1.41 per share, up 5.1% at constant-exchange rates. Importantly, our second quarter was also strong in term of innovation. Beyond our solid operational performance, we once again made significant progress in bringing innovative medicines to market. First of all, I'm excited to highlight our great success in achieving FDA approval of Praluent, the first fully-human monoclonal antibody targeting PCSK9 approved in the United States. Together with our partners like Regeneron, we are now ready to launch Praluent in the important U.S. market. In addition, we also received earlier-than-expected positive opinion on Praluent from the CHMP in Europe a few days ago. We also expect to achieve further R&D milestones before the end of the year with the three regulatory submissions in the U.S. of lixisenatide, LixiLan and sarilumab. Of particular interest is, of course, our recent announcement of a new alliance with Regeneron in the fast emerging field of immuno-oncology, and I will introduce this important collaboration shortly. Now turning to slide five, let me provide you with some of the key figures of the…

Operator

Operator

Thank you. The first question is from Florent Cespedes, Société Générale. Florent Cespedes - Société Générale: Good afternoon, gentlemen. Thank you very much for taking my question. Two quick ones. First a question for Olivier on the simplification. Could you elaborate a bit on your plans and on the impact of the simplification strategy? Notably in terms of potential cost avoidance, given that we understand that you are planning to have some globalization of the support function. My second question is for Olivier Charmeil on the dengue vaccine. Could we have an idea of the ramp-up profile of this product? And what could be the impact on the vaccines margin? Do we have to anticipate higher COGS and higher marketing costs? Thank you very much.

Olivier Brandicourt - Sanofi

Management

All right, Florent. So you are talking about the reorganization which we have announced a couple of weeks ago. Yes, the aim is focus and simplification. It has to do with marketing a portfolio which has increased now very substantially, believing that in pharmaceuticals today you need specializations. It's very different to try to defend an established product portfolio versus launching a new mAb in a very specialized area. So, that's the reason why the first intention is really to build those specific BUs on the pharmaceutical side which are joining the two other BUs we have already and which have clearly demonstrated the value of being vertically aligned. On the other side, we are creating global functions which aims will be to support those global BUs optimally and for each leader heading those global functions to have a clear understanding of deployment of resources across the world and those different businesses. So again, in simplification, making sure we are executing our globally strategies from global to local and bringing the best potential support to those business. The aim ultimately is to simplify, as I said, and focus. We think the consequence, to your point, will be to generate some saving where we'll see redundancy when we will build those new businesses from bottom up. But it will be very difficult at this point to tell you what those savings will be, and I would add, if any, to be honest. So that would be my answer. Olivier?

Olivier Antoine M. Charmeil - Sanofi

Analyst

So thank you for the question regarding dengue. It's a little bit premature to give you a precise answer about the ramp-up. As we speak, we have filed in seven countries. We will have filed in 20 countries by the end of the year. That represents roughly half of the worldwide population at risk of dengue. We are expecting to get the first registration by the end of the year. Regarding the ramp-up for 2016 and 2017 onwards, it will be very much dependent on the objective country-by-country in terms of getting the impact of dengue reduction. This will be a combination of routine immunization and of catch-up (38:59). Some countries might decide to move fast in order to get a better protection within a short period of time. With regard to cost of goods, we can say that the gross margin for dengue is going to be above average, so we should expect an improvement in terms of gross margin due to the launch of dengue. With regard to the commercial cost, we are planning a moderate increase of our commercial cost. I remind you that a significant portion of our sales for dengue are going to be public market sales. For the private market sales, there will be an increase in terms of commercial cost, we will focus in the countries that are going to put in place all catch-up program (39:55). And we will synergize also as much as we can with our colleague from Pharma to leverage the group. Florent Cespedes - Société Générale: Thank you very much. Sébastien Martel - Sanofi: Next question, please?

Operator

Operator

The next question is from Tim Anderson, Bernstein. Timothy M. Anderson - Sanford C. Bernstein & Co. LLC: I just wanted to clarify your earlier comments on the recent reorganization. Did you say that it would not necessarily lead to any cost savings? That's my first question. Second question is on M&A. The company obviously has a long history of doing deals. Nothing substantial has happened since Genzyme a few years ago. I'm wondering how the company is viewing the landscape at the moment, along the lines of current valuations of potential targets. And is M&A potentially on hold for the company, given the recent change in leadership and also the reorganization and the need to reassess the direction of the company? And then my last question is on biosimilar Lantus. You note on one of your slides that it has launched in two Eastern European markets. I'm wondering if you can tell us what the effective price is of the biosimilar relative to Lantus in those two markets.

Olivier Brandicourt - Sanofi

Management

All right, Tim. Thank you for your questions. So, again, I'd like to come back to the aim of achieving this transformation first. So, I mentioned focus, simplification; it will increase speed of decision-making. During the first quarter, I insisted that we need to have single point of accountability to improve governance and that's part of the equation, overall decreasing complexity across the organization. And because of what I mentioned about specialization, I think that should lead to engaging more deeply our customers in those different lines of businesses. And one point is to allocate resources more effectively and efficiently. So, if we do that and if we do the last one, then we should logically see some savings. That should lead to some saving that could be reinvested in the business and R&D. So, that's the answer. The second is M&A. M&A, yeah, it's part of the tools we may use for the right opportunity. I think that's what we are saying for a little while. We have not been engaged in M&A in the last two or three years. But before that, as you underlined, Sanofi was involved in midsize like Genzyme or bolt-on acquisitions such as Merial and Chattem. And this is definitely part of what we can continue to do or start again to do. Our balance sheet is pretty strong and our debt level is low. And that would be my answer. On the biosimilar Lantus, yes, we do have some information and Peter Guenter will give you that.

Peter Guenter - Sanofi

Analyst

Yeah. Hi, Tim. So, as we speak, we have three countries actually in Europe. We have Czech Republic, Slovakia and Estonia where the product had been introduced and the price differential compared to the Lantus price varies between 15% and 20%, one five and 20%. What is also already known is that we expect Lilly to launch in the UK, which would be their first significant market, obviously. We expect them to launch in September and we know that the price differential there will be 15%, that is one five percent to be precise. Sébastien Martel - Sanofi: Thank you, Peter. Next question, please.

Operator

Operator

Thank you. The next question is from Michael Leuchten, Barclays.

Michael Leuchten - Barclays

Analyst

Thank you. It's Michael Leuchten from Barclays. Two questions, please. Just sorry, going back to the GBU setup and just asking you about potential conflicts between disrupting the organization and the launches. Some of your launches will have to reach across the GBUs. I'm just wondering, why you think the timing of setting those GPUs up now when you are going through the execution phase of those launches is the right timing. And then the second question on Toujeo, you stressed the access of the product both in the commercial plans and also in Medicare. Yet the NRx share of IMS is still relatively low compared to Lantus. So given you have the access certainly in the Tier 2 – or from a Tier 2 perspective, what's holding the NRx share back since launch? Thank you.

Olivier Brandicourt - Sanofi

Management

All right. Thank you, Michael. Good questions. For the first one, of course, the aim is to put in place a transformation or reorganization in the next six months without disrupting the launches. But it happened that two of our main launches are happening in one division, right, which is Diabetes and cardiovascular team and global teams, regional teams and local teams are actually not changing as they're going to be part now of the same organization. Before that, global teams may not have had the same impact in terms of guidance to the local ones, so that's what we are improving. But overall, verticalizing those teams should not disrupt our launches. But again, good question and we are keeping that in mind. We are involving the minimum number of individual in planning for that transformation, and we're trying to be least possible disruptive. To the question on Toujeo in the U.S., NRx, TRx, Peter?

Peter Guenter - Sanofi

Analyst

Yeah, Michael. So the access data, which are actually excellent, of course, is also something that gradually build up over the second quarter and the data that are on the slide are of course the situation as of August 1, 2015. So, it is not that we have that kind of access as from April 2015, which was actually the first month of the launch. So that's one element. The second element I would say is that the latest data we have now, weekly data, we have an NRx share of 2%. But I would also like you to take home that if you look at the so-called new to the brands prescription for the month of May, which is the latest data we have, we actually have 15.7%. You should know that in the NRx data, there's a lot of actually renewal of TRx, which is counted for us as NRx. So the NRx is not really a fully reliable reflection of what is the market share we take with Toujeo in the dynamic segment of the market. And then last, I would add that if you compare the absolute TRxs and NRxs and you compare it with recent launches in the field of Diabetes in U.S. that we're actually tracking on par or better compared to a couple of these launches. And allow me also even if you don't ask it, we have some first data coming in from the European launches, so Germany, obviously a very important country. I remind you that when we launched the product in the price list, which was June 1, actually, we had the good situation that we had a full reimbursement as of day one when we were listed. And the other latest weekly data already indicate that we have an overall market share of 3.5% in volume after six to seven weeks, which indicates, of course, that the combination of good access, a very competitive label really allows you to make apparently again early days, but by far the most successful launch in Diabetes over the last years in Germany.

Michael Leuchten - Barclays

Analyst

Thank you. Sébastien Martel - Sanofi: Next question, please.

Operator

Operator

The next question is from Tim Race, Deutsche Bank.

Tim M. Race - Deutsche Bank AG

Analyst

Hi there, gentlemen. Tim Race here, Deutsche Bank. Just a couple of questions on – following on, on diabetes first. Just if you could you spell out which patients you are actually getting those NRxes with for Toujeo, are you getting the low-hanging fruit or is this active switches really that you're seeing? And just perhaps any comment on what your competitor has done in this segment in the last few months, seeing the uptake they are getting. Then switching tracks to dupilumab, will we be seeing any published data of the long-term follow-up from the Phase II anytime soon this half of the year? Will you actually press-release that information? And then what does a breakthrough status actually allow you to do in terms of filing, given that you will get the pivotal data at the end of this year or start of next year? I will leave it there and get back in the queue.

Olivier Brandicourt - Sanofi

Management

All right. Thank you very much, Tim. David is here again, on who are those patients we are capturing today.

Peter Guenter - Sanofi

Analyst

Yeah. So the first data we have, of course, Europe is extremely early but probably it's not going to be that different from the U.S. In U.S., we have a bit more data, obviously. So, roughly, I can say that 60% is switch from Lantus, 25% are real new patients to insulin and roughly the remainder of the – the 15% are switches from other basal insulins. So, Levemir and NPH. Again, early data, of course, probably because this can vary a little bit in the next couple of months, but that's an early trend. In terms of what the competition is doing, well, you know the situation is quite different between Europe and U.S. In U.S., there is no degludec. In Europe, there is degludec, at least in some markets. Although you also have seen that Novo has decided to withdraw degludec in Germany because of an insufficient value assessment of the IQWiG or the G-BA. And actually if you look at the other European countries where degludec is launched today, the in-roads are actually extremely limited, which probably also has to do with the premium pricing strategy in Europe. So, so far, we haven't seen a lot of impact of this product.

Olivier Brandicourt - Sanofi

Management

Thank you very much, Peter. Elias, dupilumab?

Elias E. Zerhouni - Sanofi

Analyst

Yes. Sorry. Dupilumab, as you know, we have a program ongoing in atopic dermatitis and we should be – we are already in Phase III in atopic dermatitis. We should be reading out next year second half. In asthma, we already talked about our Phase IIb, I don't know if that's what you're referring to, and it will be essentially presented at next scientific meeting. We already talked about our Phase IIb in atopic dermatitis, which is what got us into the Phase III programs. So, if you look at the impact of the accelerated approval, if you assume that our Phase IIIs which are recruiting quite well in atopic dermatitis work out, we will be able to essentially submit towards the end of 2016. And acceleration under a breakthrough designation certainly gives you the opportunity to accelerate that. Although the agency really is not committed obviously, but we do expect a four-month acceleration given the track record of breakthrough designations. And again, the AD results will be presented in the first quarter of 2016.

Tim M. Race - Deutsche Bank AG

Analyst

Thank you very much, Elias.

Elias E. Zerhouni - Sanofi

Analyst

Thank you, Tim. Sébastien Martel - Sanofi: Next question, please.

Operator

Operator

The next question is from Seamus Fernandez, Leerink Partners.

Seamus C. Fernandez - Leerink Partners LLC

Analyst

Thanks very much for the questions. Just a few here. First off on Aubagio, can you just update us on any strategies for potentially extending the Aubagio patent life? And you are seeing good success in the U.S. Can you just give us an update on where those patients are coming from, specifically? And second question is on the Praluent opportunity. As we think about your updates on the recent conference call, you mentioned that you anticipate that the outcomes trial would complete, I think it says by 2017. Does that actually mean that it's by the end of 2017, or no later than the end of 2016? Just wondering for a little bit of clarification there. And then the last question. As we think about the second half of this year, I think some may have hoped that a guidance increase may have been attendant to today's earnings upside report. As we think about the spending in the second half of this year, how much of that is really driven behind the increased support behind the launch of Praluent in particular? Thanks a lot.

Olivier Brandicourt - Sanofi

Management

Very good. Thank you, Seamus. Question on Aubagio. David, can you answer the patent question and the U.S. patient question?

David P. Meeker - Sanofi

Analyst

Yes. So on the patent, the method-of-use patent, which is issued and gives us coverage up through April 2022, and then the opportunity for patent extension out through 2026. So that's the situation there. There's no other additional filings, per se, that would change that picture. With regard to the overall market situation, again, Olivier highlighted the brand campaign, which I think is noteworthy because I think it speaks pretty directly to the way Aubagio has been growing and the brand campaign is quieting MS quietly. It just speaks to the fact that this is a drug that in a real world setting has been incredibly well tolerated. And the efficacy results have been very consistent with what we expected coming out of our clinical trial development program. And so it just highlights the importance of real-world data. The consequence is that we've been growing market share. We're up 2 points year-on-year and we're about 3.5% at the end of quarter two last year, we're at 5.5% share in the U.S. Perhaps more interesting that the new brands starts are up most recently in the month of June to 12%. So, again, we see steady increases. And the European experience is even more robust. In certain countries where there's strong double-digit market share ranging all the way up to a high of 20% in Denmark, for example. So, it's just a drug that people are discovering. The patients that are coming, the majority are coming from switches, over two-thirds, and the majority of those actually come from Tecfidera. And so we're getting, just as you expected, good uptake and the switching is coming from other therapies.

Olivier Brandicourt - Sanofi

Management

Thank you very much, David. Praluent, the cardiovascular outcome study, Elias?

Elias E. Zerhouni - Sanofi

Analyst

Right. So the answer, really, as you know, the cardiovascular outcome trial is an event-driven trial and so you cannot really fix a date by which you're going to be able to finish. We have projections. We're really on target to complete recruitment over the next couple months, two, three months, by November, probably, we hope, given the recruitment rate. And then everything depends on the accumulation of events and the event rate because this is a trial that stops at a certain number of events that are adjudicated. That's why we have such a large window. We do have an interim analysis at the 75% point. Again, I cannot tell you when that will happen, but I think the window between 2016, the end of 2016, beginning of 2017 or the end of 2017, I can't tell you more, but it is within that window that our modeling estimates that we will reach the number of events needed to analyze the data.

Olivier Brandicourt - Sanofi

Management

All right. Thank you very much, Elias. Seamus, on to the last one, I understand what you're saying. We had a very solid financial performance during the first half of 2015. However in the second half, we expect that we face exclusivity losses and higher OpEx, and those will impact our financial performance. So as anticipated, among those challenges, we have the initial launches of insulin glargine biosimilar in multiple European countries. And we've seen already, as we mentioned earlier, some of that happening in small country in Eastern Europe. And the onset of generic competition to Plavix. And Plavix has been one of the most successful brand in Japan. So that genericization happening there will have an impact on our P&L in Japan. And Renagel in Europe, where we've seen very little genericization until now, as well as possibly at one point in the U.S. So, that's for the top line. When it comes to the OpEx, I think Jérôme covered most of what we're going to face during the second half. R&D funding of our newly-announced IO alliance with Regeneron. We also are working on a series of very important Phase IV program studies for Toujeo in order to generate the data which may have an impact on our U.S. label ultimately. We also have Phase III trial, which you heard Elias mentioning, on dupilumab in asthma and our continued investments in new launches. And you mentioned Praluent. Until now, it was pre-launch. Now we are in full-scale launch. And of course, I'm not going to give you any number, but it's much more significant. And again, at the same time I want to send a message that we are obviously remaining rigorous in the way we manage our cost. And we're always continuing to look for opportunities to become more efficient. But we'll face a series of additional expenses and, as a result, we have decided to reaffirm our existing financial guidance for the year and, therefore, reiterate our outlook for 2015 with our EPS to be stable to slightly growing at constant exchange rate.

Seamus C. Fernandez - Leerink Partners LLC

Analyst

Thank you, Olivier. Jérôme Contamine - Sanofi: Maybe I can just add one point, Seamus, for you to understand the guidance. If you look back at our 2014 second half, we had two one-offs, which were disclosed, actually. One was a gain associated with termination of a license in the U.S. for one product in Q3 for €40 million before tax. Another one was a capital gain following the sale to a third party of some products, mainly in France and Italy, in Q4 for €79 million. So it helps you also in understanding from a financial standpoint what leads to guidance. Sébastien Martel - Sanofi: Thank you very much, Jérôme. Next question, please.

Operator

Operator

Next question is from Graham Parry from Bank of America.

Graham G. Parry - Bank of America Merrill Lynch

Analyst

Thanks for taking the questions. Firstly on Diabetes and the pricing outlook into 2016, presumably you are quite far through the contracting process now for Lantus and Toujeo. So can you give us a feel as to whether you expect similar or smaller price declines in 2016 in the basal insulin franchise? And perhaps how many of the current Lantus and Toujeo contracts already extend into 2016 flat pricing. Secondly on the dengue vaccine, the three-year pool data from the Phase III trials recently published in the NEJM seem to throw some conflicting results around the under nine-year-old population that suggests vaccination may only be in the older population over nine. Could you give us any thoughts on whether that dampens the enthusiasm of governments looking to purchase the vaccine and whether you still see the ability to supply the vaccine as the biggest determinant of sales, rather than demand? And then thirdly on OpEx growth, bearing in mind the increased OpEx growth we are looking at in the second half, to what extent should we expect that to continue into next year? Should we think of OpEx growth in 2016 at a similar rate to 2015 or potentially even faster? Thanks.

Olivier Brandicourt - Sanofi

Management

Thank you, Graham. I'll take the first one on Diabetes. So, for 2016, as you can imagine, future pricing in the U.S. will be a little hard to predict, given the fact that there are many elements which might have an influence, so biosimilar being one, degludec launch being another and all of that has to be considered. However, I mean to the point you were raising, we can confirm that the majority of Lantus and Toujeo contracts in commercial and Part D are multiyear. However, they do have a standard language included in the agreement where terms and conditions may be changing or may change. So, further price erosion on insulin glargine has been embedded in our 2015 to 2018 guidance for Diabetes, which, by the way, we are changing, right? So, I just want to make that point. It is – that price – additional price impact has been included in our guidance on Diabetes for the next two years. All right. Second question on vaccine and dengue, Olivier.

Olivier Antoine M. Charmeil - Sanofi

Analyst

So, the global dengue burden is high in the population of nine and above as presented in the IR seminar in Boston. In countries like Brazil, Mexico, Malaysia, 90% of the case reported with dengue are in the population of nine plus. So, we do not intend to revise our internal forecast. We will continue to generate data in the upcoming years as with the ongoing surveillance study of the below nine population with the objective of seeking an extension of indications. In vaccine it's not unusual to go step-by-step, especially for the children population.

Olivier Brandicourt - Sanofi

Management

All right. Thank you very much. OpEx growth, Jérôme? Jérôme Contamine - Sanofi: Yes, so, hello, Graham. So, as you can imagine, Graham, it is too early to give you any guidance on the OpEx evolution for 2016, and we have not even started our budget process. Well – and the only thing I could say that – well, it's fair to consider that if we are going to invest on a full year basis beyond these new launches. I also mentioned the investment in connection with the IO agreement for 2016. We should be in the range of $200 million. So, altogether, there could be some increase of OpEx, but clearly, the magnitude is something we'll discuss later back – later – when we give again for 2016.

Olivier Brandicourt - Sanofi

Management

Thank you, Jérôme.

Graham G. Parry - Bank of America Merrill Lynch

Analyst

Okay. Thank you. Sébastien Martel - Sanofi: We'll take a couple more analysts on the Q&A session, please, operator.

Operator

Operator

The next question comes from Alexandra Hauber, UBS.

Alexandra M. Hauber-Schuele - UBS AG

Analyst

Thank you for taking my questions. Firstly on Lemtrada, can you please give us some dynamics on new patient adds in the U.S., but also in Germany, where it's been on the market for longer, are you still adding patients month-on-month or are you reaching plateau somewhere? Secondly going back to the question of the second-half performance, given that you alluded to Plavix as probably one of the bigger LOEs you've seen in Japan, and that will be probably everyone who is focused on Japanese generics will jump after this, what sort of erosion should we expect here for Plavix in Japan? And I have not seen very many authorized generics. How much share do you think you can hang on to? And is that authorization over a certain period of time? And the third question just very quickly. Yesterday when I read the press release on LixiLan, I was a little bit confused about the language you were using, that you are considering next step in the regulatory plans, and then you define those plans. Does that mean those plans are subject to change? And is there any risk that the filings will be pushed out? Thank you.

Olivier Brandicourt - Sanofi

Management

All right. Thank you, Alexandra. So, David, on the Lemtrada question first.

David P. Meeker - Sanofi

Analyst

Yes. So, the way I would think about Lemtrada is first and foremost this is a therapy that requires a bit of a mind shift, the paradigm shift for the community. So, there's been that lag in a sense as people get their heads around a new way of treating MS. Secondly, there is significant logistics for this product, which include training in REMS, enrolment in the REMS program to ensure that the drug can be used safely and effectively. And then, third, of course, the usual reimbursement challenges. So, I think the way I would look at the current Lemtrada launch, the patients who are enrolling in the REMS program, which is the leading indicator, if you will, as to future, has been accelerating. We've essentially doubled the number of patients enrolling on a monthly basis. Going back to earlier this year, coming out of February, remember we put the sales force fully in place only at the beginning of February. So, we are seeing a ramp. And again, I would expect it to continue but we're so reasonably early.

Olivier Brandicourt - Sanofi

Management

Thank you, David. Plavix, LOE, Japan impact, authorized generic, and all of that, Peter.

Peter Guenter - Sanofi

Analyst

Yeah. Hi, Alexandra. So, what I can tell you is that we have 30 companies who've launched in total 66 generics, so it shows, of course, the magnitude of the pie, I would say. Now, there is one specificity you should know is that actually Plavix is the only one who has the full spectrum of, what I would call atherothrombotic indications. So, post-MI, post-ACS, post-stroke, and PAD. Whereas the generics do not have that yet to the extent that both ACS and PAD are still protected. So, we have worked very, very hard and diligently with the team to make that very clear to both physicians and pharmacies, which makes me believe that probably we'll have a gentrification curve, which might be a little bit better, if you will, than other recent examples that we have seen in Japan. What I can tell you is that the generics erosion rate, we have to be careful. It's only four weeks. But let's say that after the initial stocking, so let's say week three and week four, we are around 20% gentrification rate, which is actually a little bit better than we thought. And which is actually also better than recent gentrification of big blockbusters like, for example, the Diovan.

Olivier Brandicourt - Sanofi

Management

Very good. Thank you, Peter. LixiLan, Elias?

Elias E. Zerhouni - Sanofi

Analyst

Yes. Our expectations on LixiLan are the same. Clearly, we have very good results in LixiLan-O in this quarter. We should be getting the final results in LixiLan-L. And as you know, you need two Phase IIIs to be able to determine your regulatory approach. And this is what we met. So, we are still on line for the fourth quarter of 2015 in the U.S. and for the first quarter of 2016 in the European Union.

Alexandra M. Hauber-Schuele - UBS AG

Analyst

Okay. Thank you very much, Elias. Sébastien Martel - Sanofi: We're going to take one last analyst please, operator.

Operator

Operator

Thank you. The final questions are from Vincent Meunier, Morgan Stanley. Vincent Meunier - Morgan Stanley & Co. International Plc: Hello. Thank you for taking my questions. The first one is on the IO. The combinations are becoming a priority for all the players. Can you explain how you think you can differentiate versus much more advanced projects? And also, can you explain how and when you will make combinations? If for instance you consider acquisitions at some point, who will decide and who will pay between Sanofi and Regeneron? And I have a second question on Praluent. Can you explain what is the difference in terms of positioning between the pen and the prefilled syringe in terms of pricing, profitability and maybe market access? Thank you.

Elias E. Zerhouni - Sanofi

Analyst

(1:11:18)

Olivier Brandicourt - Sanofi

Management

Yeah. No, no, you definitely, Elias. Why don't you answer the IO questions?

Elias E. Zerhouni - Sanofi

Analyst

So I think in the IO question, we evaluated the field. And because we have actually current assets in the current discovery alliance with Regeneron, we have several multiple assets in the IO field that we have evaluated or we're very familiar with, of which three are the late preclinical stage and one is already in a clinical (1:11:51) stage. Also, our analysis of the field showed this is early. If you look at the response rate for current therapies of IO, you see that there are some patients who respond extremely well, but many others who do not, and on top of it, you have a significant toxicology effect. So, in terms of combination with other products, we have in our portfolio several assets which we evaluated and which we think can be very early combined with the clinical assets that we currently have, the PD-1 is a backbone to combinations, but also LAG3 and maybe PD-L1. So, we're looking at a strategy whereby having this agreement, we can speed up and scale up our ability to explore a fast field of combinations with the antibodies that we are jointly working with Regeneron, other combinations with assets that we internally have such as BCG vaccine, as just one example, which is well-known to stimulate the immune system, but others that we'll certainly be able to discuss later. In terms of acquiring from third parties, obviously, we will consider significantly strategic assets from third parties as we know that combinations not with just antibodies are going to be important because as you want to modulate the immune system both to remove brakes on the immune system, but also activate it, certainly opportunities will come, which will then be discussed by the partners. And the contract, actually, contemplates these acquisitions, obviously at a 50%/50% cost, 50%/50% benefit generally is the principle that we will follow. So, when you look at that, you realize that our choice here has been an expansion of an existing collaboration with the clinical and pre-clinical assets that can be combined with existing clinical assets in our own portfolio and that of others, and that all of those considerations have been taken into account before really triggering this renewal, an extension of our effort with Regeneron, combined with our internal efforts as well.

Olivier Brandicourt - Sanofi

Management

Okay. Very good. Thank you very much, Elias. So Praluent positioning of the pen versus the syringe.

Peter Guenter - Sanofi

Analyst

Yeah. So, Vincent, the pricing is exactly the same, so, there's no difference between the PFS, the pre-filled syringe and the auto-injector. I think the whole principle that – which is around Praluent is the choice. We get the choice for the patient, for the physician between the 75-milligram and the 50-milligram. We give the choice between the pre-filled syringe and the auto-injector. Of course, it is fair to assume that the majority, or if not, the vast majority of patients will opt for the auto-injector. But that's basically what I can tell you around this topic.

Olivier Brandicourt - Sanofi

Management

Okay. Thank you very much, Peter. I think we are closing the call now. Thank you very much, all, for joining us. Just reminding you that our Q3 results will be on October 29 and we hope to have the pleasure to host you at our Meet-Management meeting on November 6. So, thank you very much everyone.

Operator

Operator

Ladies and gentlemen, thank you for your attendance. This call has been concluded. You may now disconnect.