Earnings Labs

Sanofi (SNY)

Q4 2015 Earnings Call· Tue, Feb 9, 2016

$45.95

+0.11%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-0.98%

1 Week

+1.18%

1 Month

+6.66%

vs S&P

-2.68%

Transcript

Operator

Operator

Ladies and gentlemen, good afternoon. Welcome to the Sanofi Full-Year Results 2015 Conference Call and Live Webcast. I am Shire, the Chorus Call operator. The conference must not be recorded for publication or broadcast. I would now like to turn the call over to Mr. Sébastien Martel, Vice President, Head of Investor Relations at Sanofi. Please go ahead, sir. Sébastien Martel - Sanofi: Thank you very much. Good morning and good afternoon to everyone on the call. Thank you for joining us to review Sanofi's fourth quarter and full-year results. As always, the slides of this call have been posted on the Investors page of our website at sanofi.com. As you can see on slide two, I'd like to remind you that information presented in this call contains forward-looking statements that involves 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 de reference for description of these risk factors. With that, please advance to slide three, and let me introduce our speakers on the call today. With me are Olivier Brandicourt, our Chief Executive Officer; Jérôme Contamine, our Executive VP and Chief Financial Officer. Also joining us today for Q&A are the heads of the five global business units. Olivier Charmeil, Executive VP Sanofi Pasteur; Peter Guenter, Executive VP, General Medicines & Emerging Markets; Carsten Hellmann, Executive Vice President, Merial; David Meeker, Executive Vice President, Sanofi Genzyme; and Pascale Witz, Executive VP, Diabetes & Cardiovascular. We also have Elias Zerhouni, President of Global R&D with us for Q&A. So, first, Olivier will discuss the key highlights of the fourth quarter and full-year 2015, and then Jérôme will review Sanofi's financial results. After that, we'll open the call to Q&A. Just before we start, I'd like to draw your attention on the fact that as a result of the announcement of exclusive negotiations with Boehringer Ingelheim on the potential assets swap, certain changes in the way we report and present our results are required. On the current IFRS accounting standards, we need to report Animal Health separately as a discontinued operation. However, to help you with the year-over-year comparisons, we will use the term aggregates, which simply means that our Animal Health business is included in our financial results line as before. With that, I'd like to turn the call over to Olivier.

Olivier Brandicourt - Sanofi

Management

Thank you, Sébastien. Good morning and good afternoon to everyone. Welcome to our fourth quarter earnings conference call. So before I comment on our 2015 results in detail, please turn to slide five and let me review some of last year's key accomplishments. Over the last 10 months, we have worked hard to lay the ground work for our future success and I'm pleased with the achievements we have made so far. Since driving innovation is at the core of what we are doing, I'd like to highlight the significant successes in R&D which we delivered in 2015. We've launched three key new products Toujeo, Praluent, and Dengvaxia, and their worldwide rollout is underway. Also in 2015, we submitted three new products for regulatory review in the U.S. and they are expected to become the next wave of launches in 2016. Additionally, we advanced our pipeline and concluded a number of new significant R&D alliances. This include two in-licensing agreements for late stage assets in diabetes, which underscore our continued commitment to leadership in this large therapeutic area. We also took several important steps to progressively rebuild our oncology business, the most important of which is a new collaboration in immuno-oncology with Regeneron. Especially in November, we announced our strategic roadmap for 2020, designed to create long term value for our shareholders. Ahead of this, we began implementing the new organizational model based around five global business units, which came into effect on January 1. This will simplify the company and be a key enabler of our strategy. Lastly, in December, we made progress on our strategic objective of reshaping the portfolio and announced that we are in exclusive negotiations with Boehringer Ingelheim on a business swap, which would bolster our CHC business in exchange for our Animal Health business.…

Olivier Brandicourt - Sanofi

Management

Thank you, Jérôme. Let me conclude by reminding you of our strategic priorities. At our recent Investor Seminar in November, we set out four strategic goals along our 2020 road map. First, we had started to reshape our portfolio around core businesses and we are in the process of executing on the proposed business swap to become a global leading in CHC. At the same time, we are focused on delivering our growth objectives for existing leadership businesses such as diabetes, vaccines, rare diseases, and emerging markets, and on building competitive positions in multiple sclerosis, oncology and immunology. At this point, I'm pleased to tell you that effective as of February 22, Muz Mansuri has been appointed as Executive Vice President, Strategy and Business Development at Sanofi, and he will be a new member of our executive committee. Muz joins us from Gilead Sciences and has a deep understanding of business development and strategy of global biopharmaceutical organizations. Moving on to our second priority, we are executing on very important product launches. As we showed you in the presentation, we are working on accelerating the uptake of our key new products, Praluent, Toujeo and Dengvaxia. We also expect to deliver further important approvals with LixiLan and sarilumab. Third, we continue to build momentum in R&D in order to sustain innovation for the long term. In 2016, we expect key late stage readouts particularly for dupilumab and six Phase III starts. At the same time, we continue to pursue new pipeline opportunities through external collaborations and other business development activities. And fourth and in parallel, we have already taken significant steps to simplify the organization with the objective to achieve savings, which we intend to largely reinvest in the growth of our business. Focusing on these four strategic priorities, we will lay the groundwork for Sanofi's success in 2016. I would like now to turn the call back to Sébastien to open our Q&A session. Sébastien Martel - Sanofi: Many thanks, Olivier. We're now ready to open the call to questions. As always, I must remind you that we will like to have you ask only two questions at a time so that we allow as many participants as possible in the Q&A session. So, just two questions at a time. Thank you. Operator?

Operator

Operator

We will now begin the question-and-answer session. The first question is from Richard Vosser, JPMorgan. Please go ahead.

Richard Vosser - JPMorgan Securities Plc

Analyst

Hi. Thanks for taking my questions. Richard Vosser, JPMorgan. Just on Praluent, could you talk through in a bit more detail your expectations for the development of sales ahead of the OUTCOMES data? And specifically, what proportion of patients do you have on assistance programs at the moment so we can see what the rollover might be? And then a second question just on the Diabetes guidance, your comment suggested operational effectiveness. And I suppose Toujeo, you're improving the development of that business. So, should we be thinking of a slower decline in 2016? Just some more guidance there would be very useful. Thanks very much.

Olivier Brandicourt - Sanofi

Management

All right. Thank you, Richard. Pascale, do you want to answer both questions maybe?

Pascale Witz - Sanofi

Analyst

Sure. I'll start at least. Richard, so first of all on Praluent, what we have focused on in 2015 is really on access, and we at this stage very pleased with the level of access and coverage we have obtained. We have now more than 172 million lives covered. And as you could hear Olivier talk about, this is really a very good start and that was really the focus of 2015. Now, on your question of the proportion of the patients on PATH and bridge program. In our case, actually a majority of patients are in those programs. And as we have now a good position on the coverage, we do expect that it will ramp up and we'll see an acceleration of the prescription throughout the Q1 of this year.

Olivier Brandicourt - Sanofi

Management

Yeah so, Richard, we think we're going to have a very good coverage of Medicare Part D patients by the end of the first quarter and we expect a fair amount of patients coming from that part, that channel where we have obtained the best coverage. So again, to confirm what Pascale was saying, we expect to see patient being transformed in commercial prescription after that first quarter.

Olivier Brandicourt - Sanofi

Management

On Diabetes.

Pascale Witz - Sanofi

Analyst

Then on Diabetes, yes. So, in terms of, your question was on the operational effectiveness and the evolution, the slower decline. Now, you can, and this was on one of the slides of Olivier, we do expect the first half to still see some pressure given the Medicaid extension and the backfills and the year-over-year comparison. But as we move throughout the year, we do think that those factors are going to relax a little bit. And meanwhile, we'll see the acceleration of the Toujeo ramp up, which we're very pleased with. Sébastien Martel - Sanofi: Okay.

Richard Vosser - JPMorgan Securities Plc

Analyst

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

Operator

Operator

The next question is from Alexandra Hauber, UBS. Please go ahead.

Alexandra M. Hauber-Schuele - UBS AG

Analyst

Thank you. Sorry. Just a follow-up on the Praluent. Since you seem to be focusing on the Part D coverage, what is the average co-pay a patient has on Praluent given that you can't give co-pay assistance in the Part D? And secondly, on the U.S. insulin market, can you comment on volume growth there? I mean, there's IMS data seem to suggest a slowdown. Is that correct given that we don't see all the channels? And if there is a slowdown, have you got any explanation where that's coming from and whether that's potentially temporary? Thank you.

Olivier Brandicourt - Sanofi

Management

Okay. So, do you want to take the Praluent co-pay question, Pascale?

Pascale Witz - Sanofi

Analyst

I can take the market as well. Sure. In terms of a Praluent co-pay, I mean at this stage I don't think we comment on this one. I don't know. I think at this stage, Alexandra, really at this stage, I don't think we can comment on this one. We have, as we said, we're proud of the coverage both on Medicare and on commercial. We are very satisfied with the starting point that we have here. I think that's all we can say here. On the insulin market, for your second question, as you remember in 2014, the market growth was 7%, 7.2%, if I'm recalling correctly. We saw a slowdown in 2015 in the range of 4.9%. And we do think that some of it may come from what we have seen historically, which is when there is a growth of a different class in diabetes, it is slowing down on insulin. And in this case, we have seen an acceleration of the SGLT2 and the GMP1 class, which may explain this slowdown. Now as far as 2016 are concerned, we are expecting or we have modeled the low single digit market growth.

Alexandra M. Hauber-Schuele - UBS AG

Analyst

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

Operator

Operator

The next question is from Graham Parry, Bank of America Merrill Lynch. Please go ahead.

Graham Parry - Bank of America Merrill Lynch

Analyst

Great. Thank you for taking my questions. Just I wanted to run through a couple of other assumptions that are built into the guidance. Specifically, how many Dengvaxia doses you think you might be able to ship during the course of this year, and roughly what kind of sales estimate that would give you? What are you assuming for Renagel generic competition? And do you have a target buyback level for the year given you've already bought back quite a lot of stock already? And then my second question is on M&A. You commented at a recent conference that you'd consider M&A to address the flat EPS profile in 2016 and 2017. So, what sort of thing would you have in mind that would be so immediately accretive? What sort of business or therapeutic areas and size of deals would you consider? And what ROIC hurdles would you put in place to ensure that you're not destroying value just to chase EPS accretion? Thank you. Sébastien Martel - Sanofi: Thank you, Graham. You managed to put four into two, but that's okay. Jérôme Contamine - Sanofi: Dengvaxia, Olivier you want to answer? And Peter, Renagel. And I'll take M&A.

Olivier Brandicourt - Sanofi

Management

So, as we speak, we have Dengvaxia licensed in four countries. And we are expecting some new licenser in the upcoming months. We have shipped, for the first time, for the public and private market and to the Philippines, 1 million doses. And we are expecting to get the first dose arm on the private market by the end of February. And we are expecting, in the upcoming weeks, the public market to start in the Philippines. We are discussing with the Filipino authorities on a tender of 3 million doses that we should get in the upcoming days. You probably saw that it was reported that the price that is considered is €20. For the ramp-up for the upcoming months, we don't guide product-by-product, but I would have to say that based on everything that we know today, everything that I see in your model, in the consensus that is roughly in the range of €200 million, makes a lot of sense to us. The upcoming months are going to be important because we are starting the design of the immunization program with the various countries. But so far so good. Sébastien Martel - Sanofi: Thank you. Peter?

Peter Guenter - Sanofi

Analyst

Yes. So, Graham on Renagel, as you know, we have generification already since 2015 in Europe. Still a little bit supply-constrained, so. But you see it accelerating. And actually Western Europe down in the last quarter by 36%, but still with some fluctuations. In the U.S., as you know, we have a pretty different situation. We have multiple ANDA filers with approval pending now since 83 months to be precise and still no approvals or tentative approvals in U.S. despite patent expiry since September 16, 2014. Now, it is obvious that we are not devoid of risk in that respect. And I can tell you that we have baked into the budget a scenario of progressive arrival of generics also in the U.S. market.

Olivier Brandicourt - Sanofi

Management

All right. Thank you, Peter. Sébastien Martel - Sanofi: Buyback

Olivier Brandicourt - Sanofi

Management

Buyback, Jérôme. Jérôme Contamine - Sanofi: Yes, Graham, good afternoon. So I think that you could assume – I think we don't give a guidance on the level of buyback. Now, looking at the last three years, I mean, we have bought back in the rage of €1.8 billion per year. As you said we have, let's say, accelerated early in the year this buyback program as we have already bought back €1.3 billion shares, that's around 17 million shares. And you could assume that these programs would be in the range of €1.7 billion, €2 billion as we had in the previous years. Keep also in mind that this doesn't take into account the potential cash payment that we could receive from the Boehringer Ingelheim transaction is closed which will more impact 2017.

Olivier Brandicourt - Sanofi

Management

All right. Thank you, Jérôme. Graham, just I want to reassure you first, our solid focus is, of course, on transacting BD deals including M&A, which will create shareholder value, right, and help to position Sanofi for long-term growth. That's what we said in November. I want to make sure that everyone understands that we are not interested in deals for deals' sake. Now, it's true that the valuation of biotech companies has come down in the last six months. It is also true that the valuations were very high and have risen very dramatically in the former three years to four years. And we're not sure that the expectation of boards and shareholders of this company may actually be realistic even after recent price falls, so. Having said that, you remember what we said in November, that we have refined or redefined our priorities for the next five years in our 2020 road map. And we have highlighted areas and TAs where we want to be active. We are actually vigilant. We are agile and our M&A team is assessing different opportunities. And as you know and as you've seen, we are in a situation where we have flexibility as we have said in the last few months and we would act on opportunities if they present. So, that's what I would answer. Next, please? Thank you, Graham. Sébastien Martel - Sanofi: Next question, please.

Operator

Operator

The next question is from Jo Walton, Credit Suisse. Please go ahead. Johannah H. Walton - Credit Suisse Securities (Europe) Ltd.: Thank you. I'll try two questions. Again, I'm not sure how successful I'll be. For Praluent, we understand that there is very good access that you have. But I wonder if you could talk us through what you think the issues are that may be blocking doctors from prescribing. So, is there a heavy level of testing that you have to do to show that you have failed a number of statins before you could initiate? Is there some sort of step edit, if you could just – prior authorization, if you could just tell us some of the blocks that happened before you come to getting a prescription. And on the insulin side, I wonder if you could talk a little bit about why we're seeing a slowdown in the new-to-brand. So, having seen throughout all of last year a very strong move towards Toujeo and away from Lantus, from December onwards, that's been much more stable. And it seems that Toujeo is finding it more difficult to gain new patients. So, I wonder if you could just talk a bit about the dynamics there. Thank you very much.

Operator

Operator

Ladies and gentlemen, please hold the line. The connection with the moderator has been lost. The conference will begin shortly. Thank you. Sébastien Martel - Sanofi: Hello. Johannah H. Walton - Credit Suisse Securities (Europe) Ltd.: Hello? Sébastien Martel - Sanofi: Thank you. So we're connected again. Johannah H. Walton - Credit Suisse Securities (Europe) Ltd.: Did you hear my questions? Sébastien Martel - Sanofi: Jo, sorry, we lost the connection, Jo, while you, just at the time you started to ask your question. So if you don't mind repeating, please? Johannah H. Walton - Credit Suisse Securities (Europe) Ltd.: Of course. Very quickly. I wonder if you could tell us a little about some of the barriers that doctors may have in prescribing Praluent in terms of issues like prior authorizations, step edit, proving you have to have failed five previous statins. And on the insulin side, I wonder if you could also address why we might have seen or the reasoning behind the slowdown in the trend in new-to-brand. So there was very strong growth in the Toujeo new-to-brand through to December, and then since December onwards, it seems to have plateaued?

Pascale Witz - Sanofi

Analyst

Okay. So I'll start with the Praluent question. As you know, I mean, this is a new type of medicine here for the target physicians. So this is why the coverage was so important and this is why actually focusing on the access was really our only – I mean main focus in 2015. Actually now the only one, because the other focus was really on driving awareness and adoption. Now, this is for the label of Praluent. This is a medicine that is indicating for patients who are actually still at high level of LDL cholesterol despite the current regimen. And of course, we're working with the payers to make sure that this is – I mean, this is addressing the patients that it is intended to. So, as part of this process, there is a first set of ensuring the coverage. And then the payers have different formularies to allow the prescription. So, some of them do ask for some settings, prescription before or ask some – check before the Praluent is prescribed. But, as I said, because it is a new medicine, it's a new thing and new type of treatment for the patients that these cardiologists are treating. And therefore, we think that this is something that is going to iron out as we are going through. And again, because we have this large amount of patients around the PATH and Bridge program, we think that actually, as people are going through a number of patients, they will become more at ease with what are the criteria under which the patients are covered. In terms of the insulin question, your question related to the slowdown, I think to the NBRx. And actually, when you look at the analogs, this is something that we see. There is actually a couple of months. There is a plateauing effect of the NBRx. And I think this is something that is quite normal. Besides that you probably have seen that a little bit of ramp up of the Toujeo shares, TRx being above 4% and the NRx is following the same trend.

Olivier Brandicourt - Sanofi

Management

Yeah. No. No. I just can add, I think that's an important phenomenon that Pascale is. So, Jo, you're right. I mean, we've seen NBRx moving from – to the point we're making, 15% or around 13.5% share of NBRxs. And when you look at this flattening, it is consistent with the trends we have seen with other analogs like Victoza or Bydureon where, in fact, NBRxs are very close to peak value after (61:31). So, that's where we are and that's what we think may be the explanation. The important aspect of all of that is our sales in Q4 were about €100 million globally. So, it's a very good pickup and a good run rate of about €400 million entering 2016. So, we're very encouraged by the pickup on Toujeo. Thank you very much, Jo. Next, please.

Operator

Operator

The next question is from Florent Cespedes, Société Générale. Please go ahead. Florent Cespedes - Société Générale SA (France): Good afternoon, gentlemen. Thank you very much for taking my questions. First, on the consensus, you said that you are quite comfortable with the consensus for Dengvaxia for 2016. I would like to ask the same question for Praluent. How comfortable are you with the consensus we can see for 2016 on your website which is around €400 million. My second question is on emerging markets. Could we have your comments on the situation in China, which is performing quite well for Lantus and some thoughts on the overall pricing environment in this territory? And if you could add also something on Brazil and on Russia? Thank you.

Olivier Brandicourt - Sanofi

Management

Thank you, Florent. As you know, we gave you that indication for Dengvaxia. We not choose to guide on products. And I would not like to deviate from that rule for Praluent next year. Now, having said that, the second question is for you, Peter.

Peter Guenter - Sanofi

Analyst

Yeah, Florent. So, let me take them one by one, so let's start with China. Actually, you're right. We have a very encouraging performance, significantly outperformed the markets. And I think there were a couple of reasons for that which make me comfortable also that in the future, we will continue to outperform the market in China wherever that market growth will be. And I will come back to that in a second. So, basically, what we have as competitive advantage is number one, a very adaptive portfolio to China. You know, we are really in chronic diseases, cardiovascular, diabetes, but also, oncology, also CNS, and of course, with a very good result of the Vaccines portfolio also in the fourth quarter. You will remember that we have been a pioneer in going to the counties that we have now a pretty significant striking force of close to 1,000 reps. And I can give you the number for the Q4 in the county segment, actually, we grew our business by 25%. So, that is definitely contributing. And then, last but not least, we're just gaining share in markets where we compete. You mentioned it yourself, Diabetes, a very good performance, and Lantus is actually now the number one basal insulin in the Chinese market. Now, where this market is going is a little bit more difficult. You know, of course, that there have been a couple of measures taken which actually put additional pressure on prices in China. You know that the NDRC ceiling price is actually abandoned. So, you go into a model with regional tenders, with hospital tenders, with much more pricing transparency between provinces or between regions. You also come into new tender categories. So we have also of course baked into our budget assumption some additional…

Olivier Brandicourt - Sanofi

Management

Thank you, Peter.

Peter Guenter - Sanofi

Analyst

All right. Florent Cespedes - Société Générale SA (France): Thank you very much.

Olivier Brandicourt - Sanofi

Management

Well, my answer was short. But I think you got a good answer on emerging market. Hopefully, it would balance mine. Okay. Next please?

Operator

Operator

The next question is from Vincent Meunier, Morgan Stanley. Please go ahead. Vincent Meunier - Morgan Stanley & Co. International Plc: Good afternoon. Thank you for taking my questions. Two please. The first one is on Praluent. Can you please give us an update on the legal disputes versus Amgen? What are the next steps? And is there a risk of triple damages here? The second question is on the disposal of the European generics unit. What is the favorite option for you? And can you update us on the proceeds, the use of the proceeds of such disposal? Thank you.

Olivier Brandicourt - Sanofi

Management

Okay. Thank you, Vincent. So Praluent, it happens that we have our General Counsel in the room. And I'm going to ask Karen to give you the answer.

Karen Linehan - Sanofi

Analyst

Thank you, Olivier. I'm pleased to be here. Considering the fact that I've been watching the Amgen patents well before they issued in 2014, I'm not so happy for the question. Needless to say, we don't believe that the Amgen patents are valid and we are confident on the law and the facts that will support our petition. Some of you may have realized that we are stipulating to infringement to simplify the issue at the trial. That's an indication that we have strong invalidity arguments. What's the next step? There will be a seven-day jury trial beginning on March 7 of this year. We will of course monitor it very carefully and be present. And needless to say, both Sanofi and Regeneron are vigorously defending any claims from Amgen.

Olivier Brandicourt - Sanofi

Management

All right. Thank you very much, Karen. The second, Vincent, on the disposal of Gx. We are working on it. We are assessing different options. It would be premature to tell you what the decision is and what we would do eventually with the proceeds. So, more to come. You remember in November, which was only three months ago, we basically said we would come up with a final decision within a timeframe of a year. We're only three months in. We're working on it. And I can't give you much more than that as of today. So thank you, Vincent. That's all. Next, please.

Operator

Operator

The next question comes is from Tim Anderson, Bernstein. Please go ahead. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC: Thank you. On U.S. drug pricing, is diabetes really the only area where you see pressure on pricing in the U.S.? As you look forward into 2016 and maybe 2017 too, are there other disease areas where you see this sort of thing starting to build? And then, your guidance for 2016, again kind of focusing on the U.S. market, qualitatively what have you built into your forecast about assumed price increases in the U.S.? Is it at a lesser level than what you were able to realize in 2015 due to voluntary price moderation?

Olivier Brandicourt - Sanofi

Management

Okay. Thank you, Tim. So, do you want to answer the guidance question, Jérôme? Jérôme Contamine - Sanofi: I think my understanding was about what did we bake into the guidance in terms of price increase in 2016 in the U.S., really basically no further. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC: Yeah. Jérôme Contamine - Sanofi: So, we have not. No, we have not baked any significant price increase or nothing different from what we had in 2015, actually. And of course as you know, I mean, in diabetes the Lantus situation is somewhat specific. So in that respect, I don't think it's very comparative, the question is more when do we stabilize. And I mentioned that as from the second half of 2016, we should see a stabilization of the channel mix impact versus 2015, not exactly in the first half of 2016. For the rest, we had been very conservative, but very much in line with what we did in 2015.

Olivier Brandicourt - Sanofi

Management

And your question, Tim, on pricing, I think the answer is no. We're not, Diabetes is certainly, at least in our portfolio, the area where we have seen and we described it several times, pricing pressure. We're not observing anything similar in other area we are in, either MS or rare diseases. So, that would be the answer. And we don't see any new trends outside the U.S. with the exception which was I think described by Peter for China, where the old pricing system is under review and has moved from central government to provinces. But that's what I would say. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC: Thank you, Olivier.

Olivier Brandicourt - Sanofi

Management

Yes, we have time now to take two more participants, operator. Next question, please.

Operator

Operator

The next question is from Philippe Lanone, Natixis. Please go ahead.

Philippe Lanone - Natixis SA

Analyst

Hello, gentlemen. One question on Lantus. I just wanted to know that what in the Q4 has been the, in the 31% decline in the U.S. sales, has been the part of the true-up of discounts especially for Medicaid and how much you've baked in your guidance for 2016? And another one on consumer, consumer was not up, up only 1%. There's the Nasacort effect, but there is a number of other drugs in consumer that seems to have declined. So could you make a comment on what we can forecast for 2016?

Olivier Brandicourt - Sanofi

Management

All right, thank you, Philippe. So, first question is for you, Pascale, on Lantus Q4, the 32% Lantus in the U.S. And then on consumer, Peter will answer.

Pascale Witz - Sanofi

Analyst

Yeah. So, indeed, I mean Q4 Lantus was down 32%. But actually, although it looks greater than the 20% decline of the previous quarter, you remember that in Q4 2014 we took a price increase in mid-November. And actually, that accounts for about half of the differential, the decline. The remainder of that is actually the adverse gross to net effect of the clawback and the incremental Medicaid rebates. When you took those elements out, actually we are in line with the Q3 decline.

Philippe Lanone - Natixis SA

Analyst

All right. Thank you. Thank you, Pascale.

Peter Guenter - Sanofi

Analyst

Yes. So, Philippe, on the question on CHC, indeed the fourth quarter growth of 1% again taking into account Venezuela there. So, if you would normalize the fourth quarter for Venezuela, it would come to 2.5% actually in the fourth quarter. So, much more in line to kind of a normalized growth rate for the year. It's also true you will have noticed in the Q3 that we have a very good quarter in the U.S. with 11% growth where it's actually more to do with phasing of invoices than anything else. So if you would normalize it for those two factors, you would actually look at a pretty, quote-unquote normal CHC quarter. Last point is that in France, we have two price decreases of Doliprane, which is of course a very important product of our CHC franchise. We had one in January 2015 of 7% and another one in November, so which of course hits then the fourth quarter of 5%. So I think that those are the elements which kind of flush out the fourth quarter.

Olivier Brandicourt - Sanofi

Management

All right. Thank you very much, Peter. Next please? Sébastien Martel - Sanofi: That would be the last question.

Operator

Operator

The last question is from Steve Scala, Cowen & Co. Please go ahead. Stephen M. Scala - Cowen & Co. LLC: Thank you. I have two questions. First to clarify, the company said on December 15 that the business swaps would be neutral to EPS in 2017 and accretive thereafter. May I ask neutral and accretive to what? Is that with Merial in the base or is it without Merial in the base in 2016? And then the second question is what could you tell us about the event rate and pattern in ODYSSEY OUTCOMES? Sanofi expects to have 1,200 events by year-end, but isn't saying when you will see 50% of events or the 800 for the futility look. So any color on the rate and pattern would be helpful. Thank you.

Olivier Brandicourt - Sanofi

Management

All right, Steve. Yeah. We will give you the answer to those two questions. So Jérôme, do you want to talk about the swap? Jérôme Contamine - Sanofi: Okay. So, thank you, Steve, for the question to (78:16). So our guidance for 2016 includes Merial. And we include Merial as long as we believe our best assumption is that the transaction with Boehringer Ingelheim should close during Q4 as it was announced back in mid-December. And I can confirm that's a timing for closing taking to account earlier steps we have to go through. So now when it comes to 2017, the neutrality is, should we keep Merial or should we get rid of Merial, get CHC plus use of part of the proceed to do buybacks, this will be neutral of EPS. So, I compare Merial in versus Merial – or with CHC and plus some share buyback. And that's the same going forward when I look at 2018, of course, is assuming that we just have CHC.

Olivier Brandicourt - Sanofi

Management

All right. Thank you very much, Jérôme. Elias, do you want to answer the 1,200 question?

Elias E. Zerhouni - Sanofi

Analyst

Sure. As you know, this is an event rate-driven trial, so it's really not possible for us to have a fixed date. However, what I can tell you is that we completed enrollment ahead of schedule in November. I also can tell you there are two interim studies, one there's a 50% event rate, which will be a futility study to determine whether or not we have any effect. Second, a 75% event rate is for overwhelming efficacy. At this point, what we have predicted from the planning of the study is that we would have all the results by the end of 2017. However, when you look at our event rate, we think that we have the first analysis within the first half of this year, the end of Q2, probably, and then second within the second half. So, you can do your math. And depending on statistical projections, you can see where those results might be. Again, I'll remind you that the interim analysis are not under our control. They're under an independent data safety monitoring board. And what they decide is really fully under their control.

Olivier Brandicourt - Sanofi

Management

All right. Thank you very much, Elias. I think that concludes our call. And thank you very much to all for attending.

Operator

Operator

Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call and thank you for participating in the conference. You may now disconnect your lines. Good-bye.