Sanofi

Sanofi

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Sanofi (SNY) Q1 2014 Earnings Call Transcript

Published at 2014-04-29 18:09:05
Executives
Sébastien Martel - Vice President of Investor Relations Chris Viehbacher - Chairman, CEO Jérôme Contamine -EVP, CFO Elias Zerhouni - President, Global R&D
Analysts
Michael Leuchten - Barclays Vincent Meunier - Morgan Stanley Mark Clark - Deutsche Bank Graham Parry - Bank of America Philippe Lanone - Natixis Eric Le Berrigaud - Bryan Garnier Peter Verdult - Citi Alexandra Hauber - UBS
Operator
Ladies and gentlemen, welcome to Sanofi First Quarter 2014 Results Conference Call. I now hand over to Mr. Sébastien Martel, Vice President, Head of Investor Relations at Sanofi. Sir, please go ahead. Sébastien Martel: Thank you. Good afternoon and good morning for those in the U.S. Thanks a lot for joining us today to discuss our Q1 2014 financial results. As always, I remind you that the slides are available on the Investors page of our Web site at www.sanofi.com. Before we begin, as you can see on Slide 2, I'd like to remind you that information presented in today’s call will contain 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 on file with the SEC and also our document reference for a description of these risk factors. On Slide 3, you can see the agenda for the call. With us today are Chris Viehbacher, our Chief Executive Officer; and Jérôme Contamine our Executive Vice President and Chief Financial Officer. First, Chris will discuss key highlights, and then Jérôme will review our financial performance. Chris will return and make concluding comments and then we will take your questions. We also have Dr. Elias Zerhouni with us. Dr. Zerhouni as you know is President of Global R&D. He will be with us for the Q&A session. With that I will turn the call over to Chris.
Chris Viehbacher
Thank you, Sébastien. Hello everybody. So we will start off with key highlights for the first quarter. We have top and bottom line growth inline with our expectations with sales up 3.5%, business earnings per share up 5.8% all at constant exchange rates. Jérôme will take you through the exchange rate impact which of course continued from last year and which will likely continue at least until the first half of this year. New product launches Nasacort Allergy 24 HR those in U.S. I hope you seeing it on the shelves in pharmacy, its going extremely well. NexGard the chewables in the United States is also going extremely well mostly just in the South of the United States obviously because of the weather. But actually, the stock in has gone well in the first quarter as well. We have – I think it's an extremely strong progress in our R&D pipeline and in fact inside the company significant effort is going on to ramp up all of the launches that are facing us really starting from the second half of this year. We will talk about the dengue vaccine results from yesterday, but obviously a lot of significant advances with Lemtrada alirocumab, LixiLan and dupilumab. And finally, our open innovation model was strengthened, we have strengthened our collaborations with Regeneron and Alnylam and we have two new collaborations with UCB and SK Chemical. So we look at sales, pharmaceutical sales which is essentially everything but vaccines and animal health and which is how we present the numbers in the actual official accounts. Pharmaceuticals were up 4.7% at constant exchange rates. You see a decrease of 4.2% at constant exchange rates for vaccines that is not a continuation of the supply issues that's really just a number of timing issues and toxin going into emerging markets as well as one-off sales in the prior year you may remember that the flu season actually continued quite late into the first quarter in United States last year. We not only have been able to address the issues in Toronto and Marcy-l'Étoile near Lyon. But, we have actually just received official confirmation last night from the FDA that we have addressed all of the concerns raised in their warning letter and that therefore the warning letter has been officially lifted. And that's a result of the very strong effort that we have taken to really go after those issues that have caused us difficulties last year. We would expect vaccines to be probably flat in the second quarter, again, largely because of timing issues and comparison to last year with a significant growth in the second half of the year. The animal health business actually performing quite well. The NexGard launch is off to a – actually a very strong start. It's down 1.6% principally because again of the comparative period, one of our competitors had supply issues last year with Zentonil which lead to higher sales of Heartgard. When you actually are looking to like-for-like basis, our animal health business is actually back to slight growth and we expect that business to be growing for the course of the year. Look at – now, we look around the world how we're doing, emerging markets grew at 5.5% actually here again the pharmaceutical business actually grew at over 8%; this is largely around those timing of those Pentaxim sales vaccine in the emerging markets. This is just a function of emerging markets and when the timing of tenders occurs and the like and the timing of shipments it's not as smooth. So there is nothing in particular but it does have an impact on the overall growth. If you see the Latin America, was growing strongly at 13%. Asia at 4%. This is where most of the Pentaxim was occurring, but Asia is growing at double digits without that effect as well. And Middle East, EU, Russia, Turkey is at 4%, Africa is around timing largely in North Africa. This is just around some timing of price -- pricing of governments and therefore shifts in distribution patterns; U.S. growing strongly at 7.5% largely driven by our diabetes business. Western Europe actually flattish, actually a good result for us in Europe and the rest of the world is largely Japan and that's related to the price – to the generics – [general observation] (ph) that we saw already last year. So if you look at the growth platforms, really growing at 7.9% reaching 73.7%. And this is the benefit of the emerging market – of the growth platforms. I mean you are always going to have something going on whether it's timing of vaccine sales or some of the animal health or some of the emerging markets. But, actually if you go back over the last several years, these businesses have really been growing between 5% and 10% every quarter and the whole idea of these is that in this business, if you are always going to have some things that are going well and some that are not and that the downward side going to achieve really the medium term growth in sales that we have always said we would be able to achieve. Couple of points on diabetes. There has been a trade shift with some of the wholesalers in the U.S. this is not just affecting us. There have been a couple of others. These are largely as a result of new distribution agreements that we have already signed last year. This has led to lower inventory levels in a couple of big wholesalers that effect on Lantus in the U.S. was about €70 million. So and that was an affect but nonetheless its still diabetes grew at 13.2% worldwide. And again, very strong sales of Genzyme particularly happy with continued growth in market share for Aubagio. Some of the feedback that we are hearing from the AAN actually just this week is that now that Tecfidera has been out there for a week, it's still a very successful product. But, I think a number of physicians are seeing an unexpected number of breakthrough cases in their mass, which really goes to show that in this oral space, I think they are going to be – it's going to be a space for multiple players. If we look at now, new launches for the quarter Nasacort, you can see it's the first and only 24 HR full Rx strengthened nasal allergy spray available. This is extremely important for a number of allergy sufferers who aren't able to be satisfied with tablets. Enormously this is a huge market and growing with 60 million people. So we got 36 million sales in the first quarter a lot of that in stock in. And of course this is really the prime season for allergy medicines today. Down below you see NexGard, this is the successive to Frontline. Frontline is a product – you drop, drops on the back of the animals neck to protect it for treating fleas and ticks in dogs. This is a chew that you can give to your dog once a month. So easy, you just toss this to the dog and the dog – it's a deflavored and so the dog eats it pretty quickly. And it's just – it's a whole lot more convenient for customers in the U.S. €23 million sales in the first quarter. Now we come to the dengue. And I will just spend a quick minute here on vaccine efficacy. Vaccine efficacy is not the same as in medicines because obviously you get protection directly through the vaccine, but what we are really trying to do is eliminate a lot of these infections by reducing the number of people who can infect others. This is a disease that is transmitted from human-to-human by a mosquito. And obviously, the more people you vaccinate, the fewer people that there are who can infect others. And so actually the FDA establishes a minimum efficacy level 25%. So now you can see that the 56% is pretty good and when you actually project this over time with regular vaccinations you can see that the pool of people who can affect others is going to grow. Now, this is particularly important because mosquito doesn't really go very far. One of the most interesting things about dengue versus malaria is that this is a disease that you find in a lot of big cities. Malaria is out there in the country side; dengue is actually in major cities so we are talking the Singapores, the Sao Paulos, the Rios of this world. And that's important for a couple of reasons. First of all, in cities people have much easier access to care and therefore an ability to be vaccinated. Secondly, this is where the hospitals are when you have a dengue epidemic, this fills the hospitals. You got people in the isles, in the corridors, and this is a huge burden on the healthcare system. Third, this is where the jobs are. And this is where the income levels are. So you are going to have both a public health motivation but you have an economic motivation actually to vaccinate. So this is just probably the first Phase III study, this was 10,000 children in Asia. And we got a second one going on in Latin America 20,000 children in adolescences. Remember dengue is really something that affects people up to the age of 25. And it's really amongst children that we see the most number of deaths in dengue. So we expect the results of the second trial in the third quarter and an ability to file some time towards the end of the year possibly at the beginning of 2015. This vaccine is really going to be a major weapon in the WHO objective of reducing dengue mortality by 50% and morbidity by at least 25% by 2020. So really within five years of the launch of the dengue vaccine. Now, if I move along to a couple of other products Lemtrada. As you know, we received a complete response letter at the end of 2013 at that time we said that we would appeal that decision. This is a product that has been approved by over 30 countries in the world. It is clearly demonstrating and continues to demonstrate value and important therapeutic advance for patients. Before you can actually launch an appeal process you go back to the division and you have a discussion with them about the consent decree letter and you consult about the process going forward. That discussion, we consider to be sufficiently constructive that we decided that at this time we would initiate an appeal process and that would make a resubmission in the second quarter of this year under the FDA rules and the FDA will take a certain time to review that file, as if the file was acceptable then the FDA will either review this on a two month timeline or a six month timeline. Today, we don't know which timeline the FDA will pick. But that is what the process will be. If we look at Alirocumab, we present a positive Phase III monotherapy trial results, we will have nine additional Phase III top line read outs. Here are just a couple of thoughts for all of you because reading some of the notes I'm seeing the number of interesting things out there. First is, a lot of people really not understanding or not being able to figure out really what is the potential before the cardiovascular outcomes trial. Obviously, we won't know until we get there. But, here is a few things for you to think about. If you look at Amgen's statin-intolerant trial and we can certainly confirm that the number is very similar in our own statin-intolerant trials. People who are in ezetimibe came into those studies as statin-intolerant with a baseline LDL cholesterol of 190. So over twice the recommended level of LDL and that's on top of ezetimibe. If you are looking at people who had already had a cardiovascular event and still have high cholesterol, I think what we are seeing in our market research high propensity to treat patients with something else. And of course, then you have the familial hypercholesterolemia population. So this is all before you see a CD outcomes trial. So our view is that I think we are going to see actually very strong interest in the product you are seeing a side effect profile that today as far as we have seen is pretty benign. And obviously, some extremely important reductions in LDL cholesterol and I think if you ask most cardiologists, most of them will certainly continue to believe that reducing LDL is a good thing for patients. On LixiLan, this is our combination with Lyxumia and Lantus. We are actually slightly ahead of where we thought we would be. So we have now initiated two Phase III studies in the first quarter of this year, one in patient insufficiently controlled on orals and second one in patients who are not at go on basal insulin. And we also have Dupilumab, our IL-4. We have strong Phase IIa results in atopic dermatitis that we presented back in March. We should have Phase IIb results in atopic dermatitis in the second quarter of 2014 and asthma in Q1 of 2015. I will just tell you that I had the pleasure attending a meeting with some experts in atopic dermatitis. Both of whom actually described the results in the Phase IIa “mind-blowing” this is the first time that any drug has demonstrated any benefit in pruritus or there would be itching and the scratching. And in case some of you actually think that is a benign condition, I learned actually from some of these experts that we have patients in severe cases who actually commit suicide because of this disease. The patients in this Phase IIa study were on average 37 years of age had suffered from this disease for 30 years and had over 50% of their body covered with eczema. So this gives you a sense of not only the significant or the condition clearly there is no real treatment today, so no real market. But, we are starting to see, I think not just from Sanofi but I think from a few other companies some real innovation coming along in products and we are certainly excited about these. If I move along to Regeneron. As you know, we had renegotiated the covenants agreement with Regeneron in January. We have been able to reach 20% of the ownership in Regeneron. We have nominated and the Regeneron Board of Directors has accepted, Mr. Robert A. Ingram, Bob Ingram as a member of the Regeneron Board of Directors, under IFRS, this provides Sanofi with the conditions to achieve significant influence and that means we will be accounting for the investment in Regeneron using the equity method from the 4th of April 2014. And I'm sure Jérôme can tell you more if you are interested in some of the details behind that. I think the other one was back in January. We extended our collaboration in rare diseases with Alnylam. This of course in RNA interference technology. I think – it was clearly some investors posing questions because Novartis actually pulled out of their collaboration with this. And I would point out that really I don't think it's a question of judgment of Novartis versus Sanofi. I think the real interest is that in this type of technology rare diseases really lend itself to evaluating this technology. And that was really because of Genzyme's expertise in this, both in the understanding in the marketplace, but also a lot of the science behind rare diseases that really made this an ideal way to really develop this technology. And in fact, I think there are two areas in the world, one is oncology and other is rare diseases. We are really seeing a lot of the ground breaking cutting edge science being developed. And here of course, you got some much more clearly genetically identified targets here that lend itself really to this type of technology. We have expanded our collaborations in the first quarter, first with UCB in Belgium. Here we have a strategic collaboration for oral anti-inflammatory products. And we are going to be focusing on some of the diseases as you see on the slide with rheumatoid arthritis, ulcerative colitis and Crohn's disease. And the other is extremely important for us with SK Chemicals in Korea. This is a long-term strategic cooperation to co-develop an innovative pneumococcal conjugate vaccine. And this is interesting from the point of view of being able to complete our own vaccine portfolio. But this is also provides us access to some new manufacturing capacity so that we actually would be able to produce as well as develop the product through SK. Lot of news flow coming through the year, we expect the pre-qualification from the WHO in our Shan5 pediatric vaccine eminently. This is Shantha in India. This was our strategy a few years ago to have actually a low cost, high quality vaccine portfolio out of the 110 million babies born every year. 100 million are born outside of U.S., Europe and Japan. We would not be able to access that population without Shantha, we redeveloped that vaccine. And we now are expecting to be back in the game this year with this pre-qualification. We expect news on Cerdelga. This is eliglustat in Gaucher disease. This is the oral for adults. Lemtrada, we talked about. We have the QIV ID in the U.S. towards the fourth quarter in time for the flu season. And then we have got a number of other regulatory submissions. We got – obviously we talked about Lemtrada. Toujeo is our brand name which we – is the provisional name that we are – we'll file with for our U300 product we'll be expecting to confirm submissions sometime in the second quarter both in U.S. and Europe. We have our hexavalent PR5i in the U.S. Alirocumab as we talked about. We will be ready for filing certainly by the end of the year in both the EU and the U.S. As you know, for the EU it's pretty straight forward. The U.S. is gated on the progress of the ODYSSEY outcomes trial and discussions with the FDA. Until those discussions are ongoing, we really can't give you any more precise guidance at this time. Nonetheless, we would expect the U.S. regulatory requirements will be consistent with different products in the same class. So dengue vaccine, we talked about and the other so – you got quite a strong news flow with some more Phase III starts towards the end of the year. We have got LixiLan. We got Dupilumab and we got Rotavirus vaccine from Shantha starting in the fourth quarter. Finally, in terms of return to shareholders, we have been buying back shares on an opportunistic basis. Largely, the tremendous increase in the share price over the last two years really meant that we had an awful lot of exercise or share options which had not been exercised during the many years of lower share price. We have moved away from options and gone to restricted share units. But that's meant a lot of the buybacks have really been absorbing some of the dilution of those. The buy backs that we have done for the year-to-date of €583 million have largely been without any dilution from share option exercise. So they will actually help to reduce our outstanding share count. With that I will turn it to Jérôme. Jérôme Contamine: Thank you very much Chris. Good morning, good afternoon everyone. So now I turn to Slide 18, so as you can see from the slide, you have seen that already. We already got both top line and bottom line growth at constant exchange rate, which were inline with our expectations. We have both – say they are roughly 7.8 billion up from 3.5% at constant exchange rate. And business EPS being €1.17 gain up 5.8% at constant exchange rate basis. However, we are negatively affected by those trends of the euro, which also affected the first quarter; I will then explain more in detail the current feedback, moving to the next slide. So on the Slide 19, we currently see, I mean for another quarter the strength of the euro which continue to solve the quarter to impact both outside on our profit. So it impacted our sales by 6.2% during Q1 on a business EPS level, we expense a negative currency backlog of 9.1% in the quarter. Currency impact on sales in the first quarter were of course primarily due to the U.S. dollar almost to the Japanese Yen, but also emerging market currencies mainly the Brazilian real and the Russian ruble. Assuming and this is also important, assuming Q1 2014 exchange rate, we remained at the same level for the full year 2014. If I assume the exchange rate for each and every currency remain the same for the full year and during the first quarter to a negative FX impact interest of 2014 business EPS would be approximately 6% i.e., around €0.13. So as you can see we have had an impact of €0.11 during the first quarter, our business being equal, we expect this impact to continue to be roughly speaking the same in the second quarter and then starting to diminish based on the lower reference. While the impact during the third quarter everything being equal could be in the range of 5% instead of 9%. And in the fourth quarter should be between 2% or 3% i.e., around €0.03. If you need some additional information on (indiscernible) sensitivity to key currencies and help refine your model inviting to use the Slide 38 in the appendix of our slide deck, which give more detail but wouldn't be across it, happy to comment, if you have any further question. So now I move to Slide 20. Looking at the gross margin we saw a sequential improvement in Q1 2014 versus the last quarter of 2013. The cost of sales in the first quarter was €2.5 billion up 4.3% at constant exchange rate compared to last year at this time. Cost of sales ratio for the group was down 0.5% from last year affecting a positive impact of 0.4% at constant exchange rate due to enhanced margin of our growing pharmaceutical business including Genzyme on diabetes. However, again, this positive trend, we saw an offsetting impact of the Group cost of sales ratio of 0.3% for each the vaccine and the animal health business. Specifically low sales as traditionally in the first quarter of higher margin vaccines as compared to last year whereas possible we produce it back. In addition, there was a decrease in Frontline sales at (indiscernible). And talking about our current generation is contributing slightly negatively as well. For vaccines, we continued to incur some manufacturing costs in Q1 due to the reservation of supplier issues and Chris commented earlier today that we got that lifting of the warning letter. And we will continue to impact the following quarters as they have been properly capitalized and you will see the unwinding on that – on improvement of the coming quarters. We continue overall to expect that our cost of sales ratio will improve at constant exchange rate under full year basis in the full year 2014 versus 2013. I will now move to R&D expenses. So once again, you can see that we continue to control our R&D expenses and be very selective we control these R&D expenses vigorously. While increasing investments in activities related to our multiple Phase III trial programs at the same time. A significant increase investment in late stage trials was partially offset by the completion of our last Fluzone High-Dose study in the third quarter of 2013, which contributed to lower R&D spend on a comparative basis in the first quarter. Consequently R&D expenses were up €1.1 billion slightly up by 1.1% over last year put inline with the guidance we provided at the time of the full year report last February. And I will now move to SG&A, which is in next Slide 22. We see that SG&A expenses increased slightly by 2.5% here again on a constant exchange rate basis for the first quarter, well, a bit less than €2.1 billion, which is a modest increase which is spent largely in the commercial investments in our product launches specifically for Aubagio, but also for Lemtrada, the multiple-sclerosis franchise as well as for the launches of Nasacort OTC, our next generation CHC product NexGard. So overall, I want to point out that the modest increase in our SG&A expense in the first quarter remained lower than the percentage increase of sales in the top line which is within the guidance of parameters that we have indicated here again in February. Now, I will move to Slide 23. So I'm looking at the lower part of the P&L. Again, I highlight the business EPS up 5.8% from a constant exchange rate basis consistent with our full year guidance. Net financial expenses decreased to €76 million compared to €140 million in the first quarter of 2013. This includes the capital gain of €41 million associated with partial sale of our financial investment. Our tax rate was 25% in the first quarter, we can now confirm that our tax rate for 2014 will be around 25% i.e., in the low end of the range which was provided in last February. Also we are going back to Chris comments earlier during this call. We can see a slightly lower average number of shares outstanding in the first quarter slightly less than 1.320 billion shares. Of note, as of April 25, just now we have bought back shares of total amount of €583 million and this share buy back took place since full year release beginning in October. I will now move to the Slide 24. We are very pleased to report increase in the free cash flow by 20.6% up to close to €1.4 billion after CapEx expenditure. I mean clearly, this is a good result in the circumstances and the reasons for this is due to good management of our cash flow and the better management of our working capital spread evenly across inventory receivables as well as payables. As you can see on the right side of the slide, our net debt has slightly increased to €6.7 billion this is of course of the result of the investments we made in acquisition of the extra shares we acquired Regeneron as well as the acquisition of our stake in Alnylam. The total amount amounted to €1.556 million. By the end of the quarter, we add good back spend on our €55 million but I confirm that we continue to buy back share, which is why I gave the overall figure of €553 million which is made by the 26th of April. I will remind you also that we are going to pay the dividend of €2.8 per share which will be proposed at the coming AGM on May 5th which will present around €3.6 billion expense to be paid on May 15th. I now turn on to the next slide, which gives some comments on the Regeneron relationship on the financial side. So we have here some details regarding our increased investments in Regeneron, the most striking clearly the growing importance of this relationship. As you know Sanofi has recently reached 20% ownership of Regeneron's outstanding common stock and we have nominated member who was appointed to the Board of Directors of Regeneron and which should now allow us to account for investment under the equity method of accounting on precisely effective as of April 4th. Importantly these consolidations of Regeneron financials include some development we can do with the International Financial accounting standards highly related to deferred tax assets on revenue commission. Going forward, the accounting was for Regeneron investments will lead to changes in our income statement as well as our balance sheet. On the income statement, we will recognize the contribution from Regeneron underlying shareholder profit of associates as expected. On to the balance sheet, we will consolidate our ownership in Regeneron as an investment in partnerships. So following these changes accounting for our investments in Regeneron, Sanofi's business is expected to benefit during 2014 by approximately €45 million for the quarter based on Regeneron consensus estimate of (indiscernible) in U.S. GAAP that's why we are going to consolidate on the IFRS. So with that I will now turn back to Chris to conclude.
Chris Viehbacher
So we had a good start to the year with results inline with expectations and guidance. I think we are making significant progress in key pipeline assets. We continue our collaborative model and we continue to be attentive to the shareholder returns as you may remember the dividend will achieve a 55% payout ratio for 2013. And we continue the opportunistic buy back of shares. So that will – operator we will turn it open to questions.
Operator
(Operator Instructions) We have a question from Michael Leuchten from Barclays. Please go ahead. Michael Leuchten - Barclays: Thank you. It's Michael Leuchten from Barclays. A couple of questions. One on Lantus, the €70 million that you mentioned can you clarify that the net change from Q1 to last year Q1 this year or is that a high inventory level that is carried in Q1 lower inventory level that's carried in Q1 and hands were washed out? Then related to that U300 filing strategies, U.S. versus Europe and also the related regulatory requirements around and particularly in cardiovascular side effects, if it is an NDA in the U.S? And if I could tempt you on dengue the press release was fairly limited in terms of the details, if 56% reduction in cases, can you just put that into perspective from a regulatory perspective I understand that this is meaningful from a health economic perspective. But, for filing is that enough, what you need to show what does regulators really want to see? Thank you.
Chris Viehbacher
We will start on dengue which was – yes, I mean the FDA required a minimum efficacy level of 25%. So 56% is a very good result and we expect this to be very filable. Just to give you an idea of the Phase IIb study was only around 30% but that was just because the Phase IIb study was a 4000 patient study and here we had 20,000 patients. So clearly you got enough a lot more patients and you can really understand the statistical significance of where we are in the vaccine. Well, with the second question on the cardiovascular, I didn't get that.
Elias Zerhouni
It’s on Toujeo, we will mean to cardio…
Chris Viehbacher
Oh, yes. We have definitely – we had definitive of FDA guidance that we will not require at cardiovascular outcomes study. Remember we did the –
Elias Zerhouni
Yes. This is Elias Zerhouni. I mean as far as cardiovascular outcome study for Toujeo it’s not in – not what we expect – we know for sure that the FDA is looking at Lantus is the competitor and so as far as all of our interactions have been with the agency. There is no expectation to conduct a cardiovascular outcome study in the U.S.
Chris Viehbacher
All right. So on the inventory thing Michael; it was a higher inventory level last year, the lower inventory level this year because of the stock – the difference being the €70 million. So it's about 60% related to the higher inventory level last year and 40% related to this year. Michael Leuchten - Barclays: Thank you.
Operator
The question comes from Vincent Meunier from Morgan Stanley. Please go ahead. Vincent Meunier - Morgan Stanley: Hello, gentlemen. Thank you for taking my questions. Starting with capital allocation. There is currently a waive of M&A in large pharma and also shrink-to-grow approach which seems to be more trendy currently. What do you think about this? And would you still prefer diversification and then in which area? And then I have a question on Alirocumab, you said that in the U.S. the FDA is likely to have the same position for the different products in the same place with regards to the requirement of the CD trial. Can we assume that if Amgen files and the filing is accepted then Sanofi will be ready to do it almost immediately or will it take a few months for you to prepare the dossier? And the last question is on the buyback, it seems that now the buyback is becoming a more regular and is it still then an opportunistic buyback or is it switching towards a more classical and sustainable program?
Chris Viehbacher
Right. Just on Alirocumab, I mean, as its difficult to compare exactly where Amgen is at – the only thing we would say is that from what we understand there is no real reason to suggest we would be ahead or beyond Amgen at this stage. So we would expect that these are all roughly the same time line as far as we can tell from public explanations by Amgen. There is an awful lot of elements we are going to hear but we prefer at this stage not to do that. We just – there is the outcomes study in there – discussions are ongoing, so we prefer not to anymore precise. Coming back to capital allocation, I mean, I think I said this morning for the press, I mean I think there is – the transactions can be grouped into two different camps. I think you have seen some companies – unless they have been building for some time, I certainly heard it on the road myself from investors. That there are some companies who are diversified in terms of having a number of different businesses, but which don't have critical mass. Also, if you start looking at what is the percentage to total sales of some of these diversified businesses, you see that there is actually some pretty dramatic differences. I mean, if you looked at Lilly for example 90% of its business is in pharma and Elanco really only represent actually less than 10%. With the acquisition of it’s – of the Novartis business it starts to significantly increase as a percentage of total sales and this will of course be accelerated by the fact that the pharma business at Lilly is declining. But, it's really a 85% to 90% pharma company. If you look at Merck, Merck is a little bit more diversified, I think if I remember it's probably 75% pharma and 25%. You can't contrast that with the Novartis and the Sanofi. My calculations are that roughly 55% to 57% of Novartis prior to its divestments were pharma. Sanofi is about 62%. So we are in the kind of a different position. We have a much greater percentage of our asset than sales base actually in more diversified businesses. Now, Novartis is a little different because it has significant presence in ophthalmology and generics. And therefore, it had two businesses in OTC and animal health. That really weren't contributing to the overall diversification of the company and I think – certainly looking after animal health business was something in subcritical mass. And although, the OTC business is in nice size, it really was not going to ever move the needle on Novartis. And so I think what you have seen is, is a way for Novartis to participate in a bigger OTC business. We didn't want to abandon it anyway the diversification. But have a little bit more critical mass and then to say okay, let's sell-off the animal health business. And then that was – and enabled them to have more cash to go buy an oncology business which is more in their core business. So you got an awful a lot of what I would call portfolio optimization but all company's are not all in the same position. What I would draw from that is, when I look at the prices that are implied in some of these transactions and are being paid and some that are rumored for Merck's OTC business. You can see that these are pretty highly priced assets. So nobody is – I don't think walking away from the importance of diversification. I think I think it’s largely a function of how does this weight in my overall company profile. And do I have critical mass. And if I look at Sanofi, we have already much greater degree of diversification in some of our peers. We have been one, two or three in each of the markets that we are in. So for us to try to do swaps and bring a note, then there is not an awful lot of – reason or not the same motivation to do things we clearly are interested in and looking at how we might build up on these things. So that is really one camp. The other camp is of course, there appears to be some bigger deals out there. And I think that's going to be driven by really other factors part of those are pipeline some of those might be specific to American tax situations. So I'm not so sure how much of that is going to be a change in the real landscape of the industry. It doesn't really affect us in any case. I mean, we are sitting there as a company with a growth profile out into the future. We got a lot of new products to launch. We got really I think a good diversification profile. So we clearly continued to monitor that situation when we look at it. But, I don't really see any need at this time to really change what has been our strategy. Buy backs; we are below our €10 billion target for net debt. And then we have always said, our first inclination is to invest in the business. But we can really only do that where we find transactions that benefit our shareholders and not simply someone else's shareholders because we paid a very high price So we haven't been able to find those transactions. And so in the mean time, in addition to the dividend, we will continue looking at things like a buy back. I have always been reluctant to make long-term commitments to buy backs because it sort of says at that point management is giving up on looking at how it can invest in its own business. So it's something that we will evaluate over the course of a year and years with our own Board of Directors as we have always said that's why we set the €10 billion benchmark, it is not the job of management to accumulate cash on the balance sheet. But equally, I think it's also the job of management to look at growth both internally and externally and that's how we are going to continue to do. Vincent Meunier - Morgan Stanley: Thank you very much.
Operator
Question from Mark Clark from Deutsche Bank. Please go ahead. Mark Clark - Deutsche Bank: Yes. Good afternoon gentlemen. Couple of questions. Firstly, on the dengue, I appreciate that the Tecfidera is still to be presented at Scientific Congress. But, is there anything you can tell us on the reduction hospitalizations, which I think is the key issue. And also can we impute from the 56% efficacy that it was effective in all of the four serotypes? And the second question is on animal health, I mean it sort of follows from the previous question about capital allocation. It's sub-10% of your sales, it's a drag on your growth for the last year. Although, you think it will return to growth, but my suspicion is it won't match the overall growth of the rest of the business, simply because of the drag effect of Frontline. Is there an argument for divesting oral alternatively looking to do a sort of Glaxo, Novartis OTC partnership deal here? Thank you.
Elias Zerhouni
Well, yes. I will take the dengue question. This is Elias. I mean, in terms of the specific results, I don't want to really prevent the publication in a top journal which – journals are really anxious to publish this before the end of this quarter. So the results will be out there. But it's trending all in the right direction. Hospitalization definitely down, I don't want to give you specific numbers. But I think that from our standpoint, this is really a landmark event in terms of developing in dengue vaccine. We will have to wait obviously for the second Phase III, all parameters are moving in the right directions.
Chris Viehbacher
So coming back to animal health, I mean I think when we acquired the other half from Merial from Merck. We always knew that that Frontline was going to be a drag on the growth in the near term. And you may remember that I actually when we acquired the other half of Merial, the objective was actually to merger it and create a new joint venture with Merck and really to dilute the effective Frontline. Frontline is the only and by far billion dollar blockbuster in the animal health business. I mean a big product in animal health is typically around $100 million. So we have a huge product here. Heartgard is another product, which went off patent many, many years ago. And which is still, I think the fourth biggest product in the animal health industry. But obviously, which doesn't have as much growth. Now, we have got new products coming in. We couldn't do the merger with Merck at the time because of anti-trust. And in fact, it's very limited what you can do in animal health, it all depends on where you are and vaccines in different diseases. I mean they are not just looking at market share as a company, they get into the granular details, we don't have IMS in animal health or something called Vetnosis. But the actual categories and how you define a market is a lot less clear and in particular in Europe, this can be quite challenging. Our approach to animal health has been, this is part of our diversification strategy that actually as a business it's much bigger than other people's business. It's not as big now as a Elanco or Merck's business. But it's still is a pretty big business. And we have a number of new products to come in. Obviously, this is something that has to contribute to Sanofi's growth over time and we expected to do so. And so there is no thought process about doing anything today. I mean, if we could acquire something to make it bigger, we would do so. But, again, there are quite a number of constraints on them on this from an anti-trust point of view. Mark Clark - Deutsche Bank: Okay. Thank you.
Operator
Question from Graham Parry from Bank of America. Please go ahead. Graham Parry - Bank of America: Thanks for taking my questions. I'm just picking up on the Regeneron consolidation, the 45 million is about 1% benefit to EPS this year that's if you were to just pay 20% of that non-GAAP earnings it would probably yield more like 3. So can you just help us more through, how you – or what the practice are that bring the number down to just 1% decrease, how much of that looks like it was one-off this year and perhaps appeal for sort of accretion you are thinking about in 2016 – sorry 2015 and beyond? Secondly, on the Lantus destocking, can you just give us a feel for what level inventories are at now they – actually at a very low level. And is that at a level of that stage because of the changes that you are seeing in the inventory pipeline? And also, any comment you put on rebate pressures, how they turn to be as hard as you are flagging at the beginning of the year? And then finally, on Lemtrada, can you just expand on the constructive discussions you had with the FDA given its emphatic view on non-approval in the briefing documents, what's triggered do you think that allows you to actually refile? Thanks.
Chris Viehbacher
Well, let me take them in reverse order. On Lemtrada we really can't give you a much more detail. It's generally pretty bad form to talk about discussions with the FDA in public. So we have been – we tried to give you factually what's going on. But really can't go into any more detail on that. Considering, sorry, what's the second question?
Elias Zerhouni
Lantus inventory.
Chris Viehbacher
Of the inventory, we are down to 12 days. At the end of the quarter it was about 14 days. We are obviously at a pretty low level of inventory. And then, there is a kind of a trend actually obviously in the industry, there is a question always of how things are managed in cash flows. And I think we got to quite a low level of inventory. We have to wait and see where that goes. I suspect that over the course of quarters that could go up and down a bit. But, I think it looks like it’s – as far as I can – as we can tell it’s washed out. Rebate, not a significant impact in this quarter. I think it’s fair to say that the diabetes market is becoming increasingly competitive. And I think some are pushing harder than others for market share. So far we haven't seen anything on the horizon that would cause us to change our business outlook for the year. But there is definitely an increased competitiveness in this field. Jérôme Contamine: On the Regeneron, Graham, so if I'm not wrong, I mean check what was the U.S. GAAP net profit of Regeneron in 2013 and I think it was $524 million. So if I take this net profit maybe not – it could be around $500 million. So if I take 20% of that that's $100 million of the (indiscernible) that $75 million i.e., in the range of €50 million plus or €55 million. So we are very close in fact to what I just mentioned, we showed €45 million in the expense area. The main detailed analyses are mainly coming from deferred tax accounting and to a lower extent the timing of some revenue provision. So now, I mean they are – underneath – dig into the consensus for 2014 and I gave this €45 million. But if you look ahead, I mean currently this is the contribution of (indiscernible). So if I just take 2015, (indiscernible) consensus figure, I don't have any more information. We should be at least at €100 million in 2015 on this trend. And this will continue to increase and of course it depends upon the assumptions they take on the P&L on the sales of Regeneron. Graham Parry - Bank of America: Okay. Thank you.
Operator
The question from Philippe Lanone from Natixis. Please go ahead. Philippe Lanone - Natixis: Good afternoon, gentlemen. Maybe a question on emerging markets because we have decline in Africa, some specific factor here and how would you see emerging markets going forward especially with China recovering? Second question on tax, the tax guidance for the year was 25% to 26% in the low part of the range. So is there something we can forecast for a year. Maybe a last question on animal health because we have very strong from NexGard and there was another product to be launched, will it be the test in Q2 and when we will see the next launch understand there were others coming? Thank you.
Chris Viehbacher
So in Africa. This is really – its Algeria and Morocco principally. There is also a tender in Libya that has a change. So this is all really just one-off effect. So there is nothing fundamentally different we have solid double-digit growth in Africa over the past number of quarters. And we don't see any reason for that to change. In general, our emerging markets was affected a little bit by some of the timing on Pentaxim. This is our pentavalent emerging markets vaccine not produced in Toronto. So it's nothing to do with others just really timing issues. If I take the vaccines part out of that sales of pharmaceuticals in emerging markets were up 8.6%. So you can see that emerging markets from quarter-to-quarter is going to be affected by here and there. And of course, it’s only got one quarter. So you are going to have more of a quarterly impact as we start to see a year-to-date impact with multiple quarters. These one-off effects and have a less impact as you go through the year. I have to say, I had been in China twice this year already. One of things I keep telling people is that just because you see a decrease in the growth in GDP, doesn't necessarily mean that you see a change in the fundamentals of what drives healthcare markets. One is, the emerging middle class. So this continues just because growth slows down doesn't mean, the middle class stops being creative. And the second is, that you see this in general across emerging markets a significant migration of people from rural areas in the cities. And this is extremely important because not only do people make more money in the cities, not only the people suddenly start eating differently and having different activity levels which causes certain diseases. This is where the doctors in the hospitals are. And you are seeing actually quite significant investment in healthcare infrastructure really across most emerging markets because this is the way that governments are able to convey to everybody in the country that they are benefiting from the economic growth of their country. So I think the fundamentals of emerging markets in healthcare continue to be attractive. You are going to always be subject to here and there government decides to do a price increase – decrease sorry or there is a tender that doesn't get made or that there is some buying patterns in this market or that market. But I think, as I look over the year and the coming years, I think emerging markets are a big area. Have to say, when I talk to other CEOs in different meetings, I mean, we are all of that view, I don't think this is a Sanofi view. I think most people are of the view that emerging markets for healthcare will be a fundamentally important market for industry. Jérôme Contamine: On tax, I mean yes, Philippe, I mean as you know when you start you have to run down many information to try to assess between the effective tax rate value and really generate profit (indiscernible). Now, I can confirm that hopefully you can take 25%. Philippe Lanone - Natixis: And what about 2015, the 28% you guided on, is it still valid? Jérôme Contamine: No change. Upcoming can we do better. This is something we are working day on day. But I think 28% guidance remains for 2015. Philippe Lanone - Natixis: Okay.
Chris Viehbacher
Next question please.
Operator
A question from Eric Le Berrigaud from Bryan Garnier. Please go ahead. Eric Le Berrigaud - Bryan Garnier: Yes. Good afternoon. Three questions actually. First, if we put together everything that is expected to be better later in the year and cost of good that deteriorated into Q1 that will improve over the full year animal health and vaccines that will improve quarter-after-quarter. Comp present basis in Brazil and China that will get better also in the second half. The stock in Lantus being negative in Q1 Pentaxim delays and the tax rate being lower than expected. And with Q1 already well in the middle of the range, how could you explain the maintenance of the – of your guidance except that you, you usually are reluctant in moving the guidance up to the first quarter? And also having some more share buy backs potentially on Regeneron? Second question, more general one, as to oncology business, what kind of statement would you make about your position in oncology, would you say that that could be a future for some pharma companies outside oncology or you are not pleased with where you are and you would like to find a partner or find a solution to be back into the game? And thirdly, on LixiLan are you happy with the way LixiLan is going excluding the situation in Germany or do you, would you say that its taking more time than you expected to make this drug a significant drug for you?
Chris Viehbacher
Well, Eric, I think you answered your own question. I mean we have never looked at guidance at the end of a quarter. I think it's always a good idea that you give guidance at the beginning of the year and then you look at things again in the mid-year there is still lots of time left in the year. And I think it's good to have a better sense. So the guidance that we gave a few weeks ago was still valid and if you look at oncology, oncology I think is an extraordinary interesting area. We usually had a look at it internally. The classical oncology market is not going to go away anytime soon that's absolutely clear. But, I think we are seeing a real I think shift here in how cancer is going to be treated, we are seeing for the first time with immunotherapy on opportunity that actually cures some cancer patients and we are really just at the beginning of that. So you got a CTLA-4, (indiscernible) that's first out there. That really can help 6% of patients according to clinical trials. You got the PD-1 path coming along that would appear on cancer types such as melanoma, non-small cell lung cancer, renal cancer to have benefit of about 10% of patients. Then obviously, there is going to be thought processes around combinations of these so called checkpoint inhibitors. Then you got other types of transfer cell technologies that are coming on. So I think the cards are going to be redistributed here in oncology and there is an opportunity to be involved in it. We actually happened to have a portfolio of assets and then I think – we will hours to play in this market. We are not going to talk about those toady. But, I think we do feel that we could with some existing compounds get into this. We also have our CD38 which is looking very good. We got some new data coming on with Jevtana. We got €1.5 billion oncology business. This is not the size it's used to be. But, it's already bigger than the business that GSK just sold. So I think they doesn't have the same growth opportunities GSK's business in the near term. But I think with immunotherapy and the ability to get into that I think we are developing some real competencies in immunology as a company not just in oncology, but in other areas. So I think for us oncology is an important area to be. On Lyxumia, obviously this is a European launch to start with. We've had good success in Japan and our market share across Europe depending on where we are as anywhere from 10% to 20%. So yes, actually we are on track, clearly the situation in Germany is something that as frustrated a number of companies, you got, you've got an (indiscernible) law that suddenly subjects some new products, subsequent to that law that have to be evaluated in a way that products from the same class reimburse before that law came on didn't have to be submitted to. And then the curious thing is in true German style and speaking similar with the German passport, there is a very black and white view to this and hardly enough you can even purpose pricing less than existing products in the same class. But they are absolutely geared to looking at some other competitor versus actually drugs that they are already paying quite enough lot of money for. So it's a very non-economic way of looking things, but there are certain facilities in Germany. The big opportunity is clearly going to be in the U.S. and we are rising to finish our safety study and to be able to file next year. Japan has got about a 12.5% market share. Mexico is in there at around 16%. We expect to be launching France in Q3. So obviously, there will be a whole lot nice if you could launch in the U.S. and get Japan and then Europe, but we've kind of done that in reverse order. But, I think everything we're seeing is we are very happy with it the progression of Lyxumia. Eric Le Berrigaud - Bryan Garnier: Thank you.
Operator
Question from Peter Verdult from Citi. Please go ahead. Mr. Verdult your mic is open. Peter Verdult - Citi: Hello, hello.
Chris Viehbacher
We can hear you. Peter Verdult - Citi: Yes. It's Peter Verdult here from Citi. Chris, just a couple of views on terms of the capital allocation there we've touched on few other points. When your communication of M&A is being pretty consistent over the past year, you've reiterated again today, yet at the same time you're sitting at one of the stronger balances sheets in the sector. I was wondering given the recent industry activity and attempts by some companies to resist Lantus, do you see scope in the current climate and paying opportunities other than tuck-ins. And then just one add-on to that before you answer it, and I think is just being asked on oncology. I'm happy for you Elias, should be down here, from my perspective it's difficult to see (indiscernible) into credible platform organically given the current pipeline and developments elsewhere? So I just want to get thoughts on that and then I have two follow-ups.
Chris Viehbacher
Well, let me just talk about oncology, because there is also kind of seeing in some notes around even on the IL-4 in asthma that, there is kind of an attempt to translate small molecule marketing into large molecule marketing. And I'm not so sure that that's really going to play. Generally for example in a small molecule business there is a huge benefit to being first entry into the market. And that it makes sense when you think about it, because all drugs are relatively inexpensive. We're talking about a couple of dollars a day, four or five dollars a day. And with small molecules you're never too sure around the safety profile and therefore a product that gains physician, gains physician confidence is not overly expensive. It's makes a hurdle much higher for anyone else coming in as a second and third line. A contrast that was a biologic drug, which is by definition a lot more expensive than the small molecule. A biologic is unlikely, or certainly less likely to have some unknown side effects up on it. And so there I think you’re going to be in a model, if you're going to pay enough an awful for drug and you are not as concerned about side effects. I think you are going to have something that really then depends on efficacy. And I'll tell you, I would use this as an analog the years I spent in HIV, and, these were relatively expensive drugs as well. And when you looked at HIV, actually the entry in was a lot less relevant than in some other areas. So whether you're looking at IL-4, or you're are looking at some of these checkpoint inhibitors. I actually think that people coming in potentially where the larger portfolio ability to combine could actually have an opportunity to compete. So it's not visible to you today, but I think some of these immunotherapies could move actually pretty fast. I think if there is an opportunity to do something externally, I think we have to look at it, but I'm not sure that we want to go and invest in an awful lot of technology that we think is probably going to obsolete over time. I mean, when you look at it all of the things that we have been doing on angiogenesis and targeted therapies really are still only pushing out to be progression free survival. But, we haven't really seen any curative therapy. This is why I think immunotherapy will over time really become the dominant form, now, a lot more has to be designed and having spent half day with Elias and some of the answers of top leaders in immunotherapy and other oncologists. What we are seeing first, although everybody is excited about a PD-1 and everybody is excited about a CTLA-4. There are other checkpoint inhibitors and, you're still talking about 80% of people dying in this class, because we don't really know why they work with some and versus another and I think that will be decoded over time. And so yes, I think we are not going to be seeing much evolution I think in our oncology business between now and 2018. But I do think you could see some inflection point post 2018 and what we're looking at. Coming back to capital allocation, the last major deal we did was really Genzyme. And that was in 2011. I think we were the first one to put $20 billion in cash on a major deal when everybody was thinking about doing this string of pro-type acquisition. So I think we demonstrated that where we see an extraordinary value creation for our shareholders, we're willing to be bold. But, I get paid by Sanofi shareholders not by someone else's shareholders. And so we are typically, I think a disciplined house in terms of acquisitions. We'll continue to be that, equally if we did see an opportunity that we saw could really drive value for Sanofi shareholders. We have a balance sheet. And we've demonstrated our ability to use it in the past. Equally when you think about all the deals that have been done since Genzyme, we have looked at each and everyone of those and have chosen for various reasons either not to compete, or certainly not to compete at the level that it took to get those deals done. So I always say we're happy to be evaluated not only on the track record of the deals that we have done, but also on the track record of the deals we have not done. So I think you're going to see some pretty consistent behavior on ours, the guidance we give is basically based on an environment as far as we can see and what we would be looking at, should something change in terms of valuations and attraction of other assets, nobody is going to be rigid in how it looks – how we look at things going forward. But, if you ask me today, I can only really tell you as far as what I look at, we don't see anything today that would cause us to fundamentally change how we look at capital allocation. Operator, we are actually going to take one last question, please.
Operator
The last question from Alexandra Hauber from UBS. Please go ahead. Alexandra Hauber - UBS: Thank you for taking my questions, I actually got three. Firstly, is there anything in your, I'm looking at the pharma cost of goods, not at group cost of goods, is there anything special about your product mix in the first quarter that left you – that lead to report always low cost of goods in the first quarter that's certainly was the case last year, the third quarter 2013 cost of goods were 200 basis points below average of the year. And now we're seeing again very, very low cost of goods is that something that is sustainable or we are going to see the same creep of the cost of goods in trauma for the remaining quarters? Second question is on dengue again, I was wondering whether you could educate us a little bit about serotype distribution of Asia versus Latin America and also whether that distribution is relatively stable. And would it be fair to assume that in the Phase III you actually had a similar serotype distribution in the Phase III (indiscernible) results, you had the similar serotype distribution as you had in the Phase II? And third very quick question, just coming back one more time on (indiscernible) counting. Should we assume that your, the IFRS number is actually also going to be the number relevant for your adjusted – for your business net income numbers. So there is no further adjustments or no adjustments it's whole of the U.S. GAAP figure to come to the right number which is your business net income which is guidance basis?
Chris Viehbacher
All right. Let me just say on Q1, remember there is a big difference between pharmaceutical manufacturing and biological manufacturing and that you generally have a big fixed cost in biologics and not very much variable cost. And first quarter tends to always be a small quarter for vaccines just because of the nature of our business. Alexandra Hauber - UBS: I'm talking about pharma cost of goods, I'm sorry if I interrupt.
Chris Viehbacher
Pharma cost of goods. Alexandra Hauber - UBS: Same thing in pharma, even if I take on vaccines entirely out of the equation. Jérôme Contamine: So what is your point that if…
Chris Viehbacher
The cost of goods is higher in Q1, the only… Alexandra Hauber - UBS: It's lower, it's actually lower. Jérôme Contamine: The answer is lower by 0.2%. On the published basis, the cost of good of pharmaceutical is 29.7% ratio in Q1 2014 versus 29.9% in Q1 2013, it is an improvement by 0.2%, which is of course, I mean which is good improvement and of course the equation is, it's sustainable over time. And I think that this is the type of improvement we should see quarter-on-quarter in the coming quarters. Now, we need to think that the mix of business that was with them in coincidence to this month – this quarter we have sold, we have sold Lantus in the U.S. if we don't have any modest, this effect in the U.S. inventory this would be favorable to the to the ratio. On the country, I mean we have sold more Plavix in Japan as we've noticed linked to the impact to the [V8] (ph) issue that as led the trade to be that inventory, which will stable in a little bit ratio. So I mean we cannot look at the ratio on a quarterly basis too precisely, but I can just confirm that over time on for the full year, we will see an improvement of the ratio on the constant exchange rate basis versus last year all in all including vaccines and animal health. And as we know I mean we roughly follow the path that Chris has described as a big quarter, small quarter and this as some impact on their cost of sales ratio, so hopefully it helps. So there will be improvement, provided improvement and we expect to have the cost of sales ratio to be better on a full year basis 2014 versus 2013 as we said already being, anyway when I say better its between (indiscernible) this is a bit where the – having done something light depending directly upon the pattern of what we are going to sell. On your second question, U.S. GAAP IFRS, I mean no, I think that now in the P&L originally its (indiscernible). So P&L is original on these revenues from cost, pre-tax profit impact of stock options on back of tax. So if you look in detail, you will see that because, I believe that's the question, communicates on the non-GAAP U.S. basis which exclude those – the stock option impact or equity remuneration impact as well as some tax impact. If I understand well, the reason why they do that is relevant are not cash. We communicate after cash, along cash elements when you counting tax of anything means remuneration. So basically that fits. So the rest is minor issue, so don't expect a big significant disturbance between IFRS figures on business net income figures on this matter for various reason which I just described.
Chris Viehbacher
And I think it’s fair to say there is a non-cash remuneration items, it’s a practice of most of the biotech, it's actually to do below the line where is on the pharma side it tends to be above the line. Yes, just on the margins, I think there has been significant effort done on the pharmaceutical side, as we've seen some significant shift in the mix of business to actually achieve efficiencies. Our real next target is going to be on the biologic side, we've certainly seen some improvement in gross margin on Genzyme as the cost goes down every year of consent decree, the consent decree plan takes us into 2015 and we've been trying to bring cost of that consent decree down every year and we have been able to achieve that. Vaccines have been first and foremost to ensure that all of the issues raised in the warning letter have been adequately addressed. But, I think that's going to be the next biggest area for us to really examine over time as to how we can get a better cost of goods out of our vaccines business and biological manufacturing on a broader basis. You asked about dengue, so I will turn it over to Elias.
Elias Zerhouni
This is Elias. So again, I'm not going to give you very specific answer that could jeopardize the prompt publication of a comprehensive paper. I think we owe this to our investigators hoping to do this by the end of this quarter or if possible so that information will be given. But you are asking a very crucial question, was there a difference between Phase II and Phase III. And this is a question that I will answer two ways. One, the Phase III was conducted in the exact same region, in fact Phase III was filed before Phase II was completed. And so there shouldn't be a difference. And I can say that being in the exact same geographic region there is no reason to expect difference between the two in this distribution. But, again, the specific details and the specific numbers I would like to defer the investigators who are writing this paper.
Chris Viehbacher
We are already seeing, we don't think its necessarily, I mean, we don't really know until we see the Phase III study whether there is a big difference between Asia and Latin America.
Elias Zerhouni
Right. So that's a good point that Chris is making again. I think its really important to realize that we can interpret constantly this Phase III because its conducted in the way we conducted the Phase II. So we have the baseline data. The second Phase III is obviously going to be conducted in eight different regions of the world. And those data obviously will inform us even further about the distribution. But we cannot say that the distribution will be the same in Latin America as it is in Asia. But we can certainly say that it should be similar between the Phase III conducted in the same region as the Phase II.
Chris Viehbacher
I think let's not get caught up in the serotypes. First of all, remember the FDA – the Phase III studies were not design to actually examine the statistical significance of efficacy by serotype largely because that agency is looking for overall efficacy because from a public health point of view what you really looking to do again is not only protect people but also reduce the number of people who can in fact others. And this level of efficacy is extremely for serotype circulate and regardless of where you got variations in the serotype. It is really public health people are looking at the overall impact on herd immunity and populations. Most of our investor base lives in area where dengue doesn't really occur. If you travel to dengue endemic areas and this could be Vietnam, this could be Singapore, this could be Brazil, this could be Mexico, this could be all kinds of parts of Africa, India. This is a major, major health issue. When you travel around, I was at APAC last year in Indonesia, you see big signs out, warning people about dengue. You got 100,000 cases of hemorrhagic fever in the Mekong Delta. You got major issues in Singapore with dengue. And because this is particularly in populated areas you can see a rapid increase in the epidemic area when it occurs. So for us this is a major advance in public health in the Southern Hemisphere. Our industry hasn't typically developed drugs for this Southern Hemisphere but this is a real incidence where we have really tried to address that. And I think that's you are seeing some – such strong interest on the scientific community, from governments in all of the Southern Hemisphere. And that's why we are cautious about the results. We are conscious of our needs to talk about this is a major investment in the company. But, with such strong scientific interest that we really want to make sure that these data are – have an opportunity to be published in the peer viewed journal. Let me just wrap up here. We are off to a great start I think for the year, results are – from our point of view in line with our expectations and they are largely unremarkable from that point of view. I don't think that we talked about some of the shifts here and there, and some of the inventory on Lantus. We talked a little bit about some of the shift in timing of some of the Pentaxim sales. But, when I look at the business from a management point of view, on the way the executive committee looks at this. This is proceeding as, marching as we expected. When your inside of Sanofi, the biggest thing is, is really been trying to get ready to launch a major new medicine that will take LDL cholesterol to unchartered territory. We are looking at entering into a $20 billion injectable treatment market for rheumatoid arthritis. We are looking at making a major difference here atopic dermatitis and severe asthma. We have Toujeo, which is our next generation insulin that will be rolling out next year. We've got dengue vaccine, which will also rollout sometime next year, making a huge public health difference in an area where there is going to be an awful lot of economic motivation to see this kind of vaccine come in this Southern Hemisphere. We've got a whole new oral therapy coming for Gaucher's disease. And we've got a lot of Phase III studies ongoing, we're about to go into Phase III on a number of other programs. So for us as a company this is a big deal, we have not actually launched that many new products in 10 years and so we have been really building up our capability in this area. But I think in the meantime, while we're doing that we're still demonstrating very tight cost control. If you look at the number of people that we have been recruiting, the competency basis that we're building a global marketing and market access and data analytics in bringing a whole different approach to medical affairs, because we are a much more, we will be a much more specialty focus company the fact that we are largely a big biotech today, 45% of our sales from biotechnology, 80% in the pipeline. A lot of these biology products demanding significant attention to biological manufacturing and the need for recruitment all of that you are not really seeing in our OpEx, largely because we keep pulling out expenses out of other areas of the business. Now, as I've always said we're reaching some limits to that, but I think we are – we have shown that we are able to really build up the platforms to really launch these products without actually putting us off for a path on protecting our margins and building the bottom-line and not just the top-line. But, it's certainly its still - its still pretty exciting times in Sanofi as a result of the new products, plus launches of Nasacort and NexGard, which I think provide an awful lot of growth opportunity to our consumer business and our animal health business. So we look forward to updating everybody as we go along through the year, I think we've got some good news flowing. We'll talk to you all again at the end of the second quarter. Thanks very much for listening. Take care.
Operator
Ladies and gentlemen, this concludes the conference call. Thank you all for attending. You may now disconnect.