Sébastien Martel - Vice President of Investor Relations Chris Viehbacher - Chairman, CEO Jérôme Contamine -EVP, CFO Elias Zerhouni - President, Global R&D.

Michael Leuchten – Barclays Graham Parry - Bank of America Merrill Lynch Peter Verdult – Citi Tim Anderson - Sanford Bernstein Mark Clark - Deutsche Bank Steve Scala - Cowen & Co Philippe Lanone - Natixis Steve McGarry - Société Générale Alexandra Hauber - UBS Florent Cespedes - Exane BNP Paribas.

Ladies and gentlemen, welcome to the Sanofi Second Quarter 2014 Results Conference Call. I will now hand over to Mr. Sébastien Martel, Vice President, Head of Investor Relations. Sir, please go ahead..

Thank you and good morning, good afternoon to everyone. Thanks for joining our call today to discuss our financial results for the second quarter and first half 2014. As always, the slides to this call are available on the Investors page of our website at www.sanofi.com.

Before we begin, as you can see on Slide 2, I'd like to remind all of you that information presented in this 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 document on file with the SEC and also on our document reference for a description of these risk factors. On Slide 3, you can see the agenda for the call. With us on the call today are Chris Viehbacher, our Chief Executive Officer; as well as Jérôme Contamine our Executive VP and Chief Financial Officer.

First, Chris will discuss key highlights of the second quarter and first half, and then Jérôme will review our financial performance during the period. After that Chris will return and make concluding comments and then we will take your questions. Dr. Elias Zerhouni will also join us for the Q&A session.

As you all know, Elias the president of R&D at Sanofi. I will now turn the call over to Chris..

Thank you, Sébastien. Good morning, good afternoon everybody. So I think we’ve got a good set of results here. You all know, of course, really we’ve come out of the patent cliffs since September of 2013 and we’ve seen shabby [ph] growth of the company and the second quarter of this year is no exception. It continues that trend.

Net sales up 6.4% on constant exchange rates, obviously helped to a degree by the comparative period where we had the Brazilian situation and we will show you what the impact of that is, and certainly in the press release. That also coupled with some pretty tight expense controls led to business earnings per share up 13.4%.

We’ve played an awful lot of attention to cash flow, working capital management. So free cash flow was up actually faster than earnings, so we had an increase of 33% in the first half.

That has also allowed us to return €4.8 billion to shareholders, €3.7 billion with the payment of the dividend and we have year to date bought back about €1.1 billion in share buybacks. The growth platforms have the story for the last five years. We started five years ago at about 38% of sales, they are now 76.3% of sales.

It clearly doubled as a percentage of our sales partly through the organic growth, partly of course because we lost the old blockbusters. Very good execution in emerging markets. Very pleased to see Merial back to growth. What I think is really interesting now about Sanofi is that we are, I think, becoming an R&D story.

Most of you do not see Sanofi as an R&D story and I know we’re going to have to change that. But we will come back and talk to that -- about that a little later in the presentation. We got three significant products under regulatory review now.

There are another four projects with Phase IIb/III that will readout in the second half and we have two new collaborations. So moving to the next slide, you can also see, though, that one of the headwinds that we have faced in the first year is strong euro and the resulting foreign exchange impact.

With foreign exchange not quite eliminating the growth of net sales, so we had an incremental sales of €0.5 billion offset by 440 million in foreign-exchange and about €0.10 a share on the earnings-per-share line.

Largely I think this should be behind us, one never knows and if I could predict the exchange rates are probably doing something else but we are starting to see, I think, some weakening of the euro and it’s nothing else, at least just the stability of that such that there shouldn’t be such a major impact on the second half.

So when we take all of that together and moving to Slide 7, we obviously had a good performance even when you eliminate Brazil up high single-digits. So we decided to adjust the guidance narrowing it from 4.7% to about 6% to 8%. So essentially moving this to the upper range of our guidance from the beginning of the year.

When we look at slide – the next slide on buybacks, one of the things that we have faced over the last couple of years was an awful lot of issuance of shares.

Due to the performance of the share price, a lot of our employees have not been able to exercise any stock options, and so really about five years ago, we were faced with quite a backlog of stock options and given the strong share performance up until the 2013, a lot of our employees have been able to exercise so well.

We've been buying back shares, this has largely been to offset dilution. That has now stabilized and so we actually have a higher net share buyback having bought back about 1.1 billion in shares with only 252 million in issuance. Next slide is, I think really what we have been trying to do with the growth platforms, this is a risky business.

If I even look at where the environment is today versus as little as three years ago, it wasn’t that long ago when biotechs were all looking for money, now everybody is flushed with money. Three years ago, emerging markets were growing rapidly, now we’re seeing more strife in the world and who knows where we’re going to be in three years.

We certainly see a much more challenging payor environment, for example, in the US. And to me the way you deal with that is that you’ve got to have a business that can weather these storms, and that’s what we try to do with the growth platforms. These are businesses that really have some level of competitive advantage, they don’t have a patent.

Now because of their nature and because of the variability of these businesses they are little bit more variable than some of our pharma investors are used to.

But when you actually look over the last couple of years they’ve largely been between 5% and 10%, so the average is kind of the mid to high single digits which is exactly what we've been trying to achieve.

This provides a longer-term cash flows and a predictable growth outlook that we’ve been trying to achieve, and principally the reason for this is to be able to really exercise our core mission, which is research and development, which by its very nature obviously requires big upfront investment and some big risk.

So I think when I look at that I would say the strategy is clearly working. If we look to the next slide and look at these platforms individually you can see emerging markets up strongly but of course obviously helped by the weaker comparative period.

When we strip out Generics in Brazil, growth platforms grew 10.7%, so still double-digit growth instead of the 14.5% in the second quarter. And that same number is 9% in the first half. Looking at emerging markets, if we also exclude Generics in Brazil, emerging market growth was still 8.6% in the quarter and 6.5% in the first half.

So again we’re still in that range of upper single-digits on both emerging markets and on the growth platforms. Diabetes continues to do well with the US up 20%, emerging markets up 16% and Europe which obviously doesn’t benefit from any price increases, up in upper single-digits.

Consumer healthcare is up 9.2%, really across-the-board but particularly helped by a very successful launch of Nasacort. The whole category has inhaled corticosteroids has actually – nasal corticosteroids has actually grown as a result of the launch of Nasacort and so we are very happy with that launch.

In our vaccines business, as we said at the end of the first quarter, we expected the quarter to be flat and it was, and it’s really rocket science. The lead times involved with vaccines mean basically we can sell everything we can make and therefore it's really a matter of looking at releasing in vaccines.

We had that supply issue last year but the vaccine supply chain is one that takes a long time to fill, you have a lot of long lead times in some of these antigens. So that's why as we look to the second half we are going to be confident of getting back to growth.

Genzyme goes from strength to strength, up 29%, not just because of the rare disease franchise which is clearly doing well, particular driven by a 44% increase in Fabrazyme but also I think Aubagio, and as we have said before, you don’t have to beat [tech for there], you only have to get your share of a clearly growing oral segment.

Aubagio has its role, every patient is different, you’re talking about patients who are going to be on medication for decades, physicians are looking for options, not everybody has the same risk-benefit profile. And so Aubagio is clearly gaining its share.

Lemtrada off to a slow start, unsurprisingly we always said Lemtrada was going to be off to a slow start, this is a paradigm shifting drug, it’s not going to be for everybody. People need to get used to using it but equally this medicine has demonstrated unprecedented levels of efficacy up against the gold standard comparator treatment.

Animal health growing up 6.2%, really the turnaround is not only as a result of the successful launch of NexGard, but really I think stabilization of Frontline. Frontline, as you all know, is the biggest product in the entire animal health market.

It has been off patent for about four years, we have been losing about 6% market share every year but not until last year we were doing that in a growing market such that we can still grow Frontline on a net basis. Last year the seasonality was such that the whole market decreased for the first time which really exacerbated the generic erosion.

This year we’ve been able to stabilize Frontline sales and the launch of NexGard then has been accretive to that growth. So we’re expecting animal health now to stay on track for some time here. Other innovative products, this is an area that's really going to grow over the next few years and I will come back and talk about that.

Moving to Slide 11, you can see the geographic sales mix. Here you can see, our single biggest region is still emerging markets, grew at 11%, obviously with the Brazil effect in there. Africa and Middle East, a little softer this quarter largely in Africa largely due to just some movements in the distribution channels.

Obviously there is quite a collection of countries. Some of this also related to some of the turmoil in parts of Northern Africa. You can see Eastern Europe, Russia and Turkey up 4.7%, so far Russia continues to perform well for us.

Asia up 5.4%, really the pharma business growing at solid double digits behind that and that’s just largely where some of the shortfall in vaccine supply has brought that number down to 5.4% and Latin America growing a very robust 14.6%, when you exclude the Brazil and Generics.

So emerging markets are always going to be a little bit of a variable phenomenon but this is where 80% of the world lives, and I don't think anybody can really exclude that part of the world as a key part of their market. U.S.

doing well largely on the back of Lantus and Europe actually coming out of patent cliff and actually if you strip out the older products, we’re seeing very satisfactory performance in Europe as well.

Merial, I have largely talked about, clearly we’re moving from a product with Frontline where you put drops on the back of your dog or cat’s neck and NexGard is for dogs.

Here you can just toss your dog a beef flavoured chew once a month and any of you have dogs know that anything you feed them makes them pretty happy, and so it’s got pretty good marketing appeal. Moving on to the next slide, this is where we’re really moving into R&D. So first is we have three medicines under active review.

The first is obviously extremely important Toujeo. This has been filed in the US, in EU and also recently in Japan, so it’s a global filing and a global launch. This is a medicine that offers the efficacy and the confidence and safety of Lantus while offering lower hypoglycemia – glycaemic events.

I was with some of our colleagues of the ADA this year, you talk to key opinion leaders, the number one concern that doctors have, even though these things are vanishingly rare, there’s still always a worry about hypoglycaemia. You talk about something that offers hyperglycemic events and you’ve got a physician’s attention.

So I think it's really as simple of that in terms of positioning. Lemtrada has been approved in 31 countries, the FDA has accepted re-review of this and we will hear later on in the year. As I said this is a product that clearly is working for patients and I think will grow ultimately to a big medicine but it’s going to take some time.

Cerdelga, I think is being lost sometimes in the limelight of all of the other new product launches but this is actually a very important medicine to this for Gaucher. These are people who have perhaps been taking an infusion every two weeks for their entire life since childhood, you can have adults.

In fact, Genzyme has people that they started off as children and patients and now these people have children themselves. I was talking to a key opinion leader in São Paulo recently who has got about 60 patients there.

Her words to me was – her patients are extremely excited about this, not just because of the convenience of an oral but if you have been going to an infusion center every two weeks for your life and now you simply have to take pills for you, it makes you feel "normal”. So I think this will be an important launch for ourselves.

Now moving to alirocumab or the name we submitted to the agency is coluent [ph].

There is a lot that can be said about this and to be honest I think this is an area where we’re really going to have to work, I would say, we clearly are looking differently inside the company about how this drug is going to be used and which segments, and the investment community.

I think we have two opportunities to help better get the utilization understood. We will be presenting all of these data in detail at the ESC in Barcelona at the end of August and we also have an investor call planned at that time. So that will build into really what’s in the medical and the science.

And then we plan to do a new medicines day on 20 November. This is really an opportunity to bring not only what we understand medically but some of the aspects of our market research. For us there are -- this is a market that is going to be segmented. This isn’t a product that’s going to replace all statins.

But I think there is a huge underestimate of the unmet need that exists in this category.

Someone who's had a heart attack, who still got high LDL despite high statin, has hypertension, has diabetes, and you offer a product that can reduce their cholesterol by 50% to 60% beyond where the statin has taken it and you’ve got what appears to be a pretty benign safety profile – do you really think that they’re going to wait for the outcome study to actually prescribe this product? The second thing is that even without the outcome study, we were extremely encouraged by this interim look at the long-term safety study, Elias can comment on this afterwards but I think those data that have already shown a imbalance between cardiovascular events between the treatment arm, the non-treatment arm, augur well the longer-term outcomes study.

We do plan to file by the end of the year and as we announced last evening Regeneron and Sanofi acquired a priority review voucher from BioMarin. These types of vouchers are to encourage and motivate people to do research in rare pediatric diseases. A company can either use that voucher itself or sell it in this BioMarin sold it to us.

What you should understand is that the voucher can be used against any products for any indication, that is not to be used just for other rare disease type products. So this is an opportunity potentially to be able to get an accelerated review in the United States, it only applies to the United States but [indiscernible].

Now behind that, going to the next slide, there were other new products, Dengue vaccine, we’re expecting the second phase 3 study.

Now again I think one has to remember when you’re talking about vaccine efficacy, this isn’t drug efficacy, this is about not only protecting the individual but reducing the reservoir of infected people who are available to infect others. Now unlike flu, this doesn’t transmit itself, you need a mosquito to go from person-to-person.

But the more you vaccine – so this is why the more you vaccinate the more you reduce the pool of people who are infected. And that’s why the regulatory agencies set a hurdle rate of 25% efficacy, because this isn’t drug type efficacy, this is really trying to reduce the pool.

In fact, the WHO is looking to reduce morbidity by 50% in – by 2020 and mortality by 25% and this dengue vaccine will be critical to it. Most of our investors unfortunately live in the northern hemisphere and -- largely unaware of the significant public health issue in the southern hemisphere, this is also an urban-based disease.

If you are in Singapore and Sao Paolo or in Kuala Lumpur, all of these cities have incredible difficulties with this.

These field hospitals -- when you have an epidemic there is no treatment available and people – these are largely children, adolescents, people live in fear of this, and of course we have seen an 88% reduction of the dreaded haemorrhagic fever in this and 67% reduction in hospitalization.

So I think I’d encourage everybody to look little differently at the efficacy rates because I can tell you when I talk to health ministers, they’re pretty excited about this actually. Dupilumab, I think, is going to be another game changer, we’re talking atopic dermatitis.

I’ve had our executive committee spent half days with patients and physicians for all of our new products.

Once you really see how difficult atopic dermatitis is for people to live with, you really understand where the opportunity is, if you go to IMS and look at what the market is don't be surprised because there really isn't much that people can take with this. We’re talking about people whose bodies are often at least 50% covered by this.

There is an awful lot of other allergic diseases with this autoimmune disease. It’s often associated with asthma, so when we see the phase 2b results, I can certainly tell you that the reaction of patients has been extraordinary for this drug.

Sarilumab with rheumatoid arthritis, despite the fact that you’ve got a number of TNF alpha drugs out there as well as ACTIMA, there is still clearly significant unmet need. Again we spend all the time with key opinion leaders.

You saw the phase 3 mobility trial data that we presented a little earlier, with very clear significant improvements in all three core primary endpoints. Now we’re also always looking for things to keep our business fresh. We have an licencing agreement with Lily.

The switch business in the OTC category is the most exciting part of that, we’ve been successful with the leg, we’ve been successful with Nasacort. I think that's the part that gave Lily the confidence to provide us with the opportunity to switch Cialis and we have the rights in US, Europe, Canada and Australia.

So now the ambition is to really get this ready for launch probably around the time of patent expiry. And the other of course is Medtronic, we talked about this on the investor call that we did at the ADA. Really looking at two things, how do we look at drug device combination and how do we better leverage some of the care management.

Type II diabetes is not just a question of medicines or devices, it is really trying to help patients cope with their disease and I think with the partnership of Medtronic we can make a real difference here.

Looking to the second half, we’ve got a lot of news flow, we talked about the expected regulatory decisions with Cerdelga in Q3, and then Lemtrada, the EU Cerdelga decision and the Fluzone Quadrivalent intradermal in the US all in Q4. We are planning to submit the hexavalent vaccine the PR5i in the US in Q3.

We already talked about probably [ph] in Q4 and we will be presenting in Barcelona the nine ODYSSEY trials, the dengue trials should be in Q3 as well and we're starting phase 3 for dupilumab in atopic dermatitis, rotavirus vaccine with Shantha in India as well as our Insulin Lispro in diabetes.

So I will just close with this Thursday, November 20 to which you are all invited. We will be doing this at Genzyme headquarters in Cambridge Massachusetts and I think we will also have a satellite theater set up in London for people who prefer to stay in Europe.

So we are going to be discussing the market opportunity, the shift of our portfolio to Biologics and further progress of our innovative R&D assets. So with that I will turn it over to Jérôme..

Thank you very much Chris. Good morning, good afternoon everyone. I will now take you through a bit more of the details of the financials for the quarter.

So I will start with slide 20, so as Chris mentioned earlier, we delivered both strong top and bottom line growth at the constant exchange rate this quarter which reflects consistent execution on our strategy, which is roughly €8.1 billion which are up 6.4% and the business EPS which is reaching 1.7 billion, is up 13.4%.

Therefore our results were primarily driven by strong performance across our growth platforms with selective investment on product launches, on late stage pipeline.

However the strength of the euro as mentioned by Chris continued to impact our account, when they are translated into euro into the second quarter, the impact on earnings by a similar amount in the first quarter, so this quarter more precisely sales were impacted by €443 million, or 5.5% negatively and the business EPS level, we expensed a negative currency impact of 8.9% or $0.10 in the quarter.

The currencies impacting sales in the second quarter were primarily the US dollar and the Japanese yen but also the Brazilian real and the Russian ruble. Of course we cannot predict exchange rate movements, but we assume that the June 2014 exchange rates remain stable until end of 2014.

The negative foreign currency impact on the full year 2014 business EPS would be limited to approximately five percentage points which is roughly speaking €0.25 in absolute demand. Therefore we would expect a significantly lower impact on the second half of 2014. If the exchange rate remained stable at the level of June 2014.

With the same assumptions, the negative FX impact on the business EPS in Q3 is expected to be around 4 percentage points while the negative FX impact would become much smaller in the fourth quarter of 2014 at around 1 percentage points.

Of course, we can always hope toward a stronger – as example, US dollar over here, this is something that’s very hard to predict.

For additional information with currency sensitivity, two key challenges which may help you refine your modelling, as the exchange rate evolves during the year, I invite you to refer to the last slide in the appendix of our Q2 slide deck. Now I move to the next slide, Slide 21.

Before I dive into the details of the P&L, you can see here that we managed to keep our all cost items going slower than our sales in Q2. As a result, our business operating income increased by 15% CER. We posted a business operating margin of 26.6% which is 1.3% higher than last year.

Before we move on to the expense line of the P&L in the next few slides, I would like to point out a couple of other elements. First of all, the second quarter marks the first time that we are actually consolidating our ownership in Regeneron which was 20% in the quarter. We now own 22%, we have consolidated 20%.

We had highlighted to you last quarter that we expect to benefit from our investment in Regeneron by approximately 45 million on a full year basis for 2014 which is three quarters. The contribution form Regeneron on this book on the share of profit and loss associates line reached a bit less than – of this 45 million during the quarter.

Additionally I'd like to remind you that last year we recognized a gain on the other current operating income line of €165 billion of the sale of some US tail products to Covis. This year we have booked a again of only €62 million which having from the return of our US rights for Eligard to originator TOLMAR.

Now I move to Slide 22, so we see here the cost of sales increased by a limited 2.2% on a constant exchange rate basis, €2.6 billion in the quarter. Due to a significantly stronger sales growth, our gross margin improved by 0.9 percentage points in this quarter, versus the same quarter of last year.

This favourable evolution mainly reflects a recovery in Brazil of course, but also strong improvement from Genzyme representing at the Genzyme level around 5 percentage points, for the gross margin of Genzyme itself and diabetes also, which was partly offset by unfavourable currency effects as well as slightly negative mix impact from vaccines and animal health.

For the full year, I can confirm that we continue to expect an improvement in our cost of sales ratio at constant exchange rates versus prior year, despite some competitive pressure at the payor level in the US impacting gross to net pricing.

I now turn to next slide, Slide 23, we continue to control our R&D expenses rigorously, while increasing investments in multiple phase 3 programs at the same time. This quarter our R&D expenses grew 3.2%, to almost €1.2 billion which is in line with the full year guidance which we provided earlier in the year.

The slight increase largely reflects higher investments in development programs for mono-clonal antibodies, more than offsetting internal cost of sales. As already guided, we confirmed to expect R&D expenses to slightly increase during 2014 while staying below the €5 billion threshold.

Due to investments in our strong late stage development on post marketing programs, we continue to project a slight increase in R&D expenses in the coming two quarters. Now I move to Slide 24, we see that SG&A expenses increased slightly here again by 2.6% at the constant exchange rate in the second quarter to €2.3 billion.

This modest increase in SG&A largely reflects incremental investments in our product launches specifically for [indiscernible] franchise as well as the launches of Nasacort OTC on our next generation flea and tick product NexGard.

In the second half of the year, we will be investing in the launches of Cerdelga and Lemtrada as mentioned earlier by Chris. Overall we expect to keep the ratio of SG&A to sales basically stable compared to last year which is in line with the guidance we communicated last February.

Looking at the lower part of the P&L, on the Slide 25, we again highlight that business EPS was up 13.4%, in the quarter on almost close 10% of the first half. Of course all these on the constant exchange rate basis.

Net financial expenses also decreased in the second quarter to €94 million compared to €137 million in last year’s second quarter, firstly as a result of a capital gain of €31 million before tax, resulting from the sale of several financial investments. At the same time our cost of net debt continued to decrease by 30 basis points.

Our tax rate was 25% which is consistent with our full year guidance but an increase of 3.8 percentage points for the same quarter last year, as you remember that we had a 24% expected tax rate for the full year 2013 but as a result of that 21.2% during the second quarter.

I also should point out that due to our share buyback activity this year, the average number of shares outstanding declined by approximately 11 million relative to the same period of last year. As of July 15, we have bought back shares for a total amount of €1.1 billion.

On the next slide, Slide 26, I should highlight that our EPS growth at constant exchange rate this quarter was largely organic, that’s the message, while adjusting for the various other elements. Indeed, you can see on this slide the breakdown of the business EPS impact resulting from – Generics in Brazil.

From the lower contribution, from the other operating income line, versus last year and from the very low tax rate we had in Q2 2013, so clearly we foresee the solid business EPS growth of 8.9% on a recurring basis this quarter excluding these elements.

Moving on to next slide, Slide 27, we can see that free cash flow was highlighted by Chris, increased by 33% faster than profit and reached almost €2.4 billion in the first half of the year. This is a result of tight control of working capital and capital expenditures.

This increase in free cash flow largely from business acquisition of Regeneron shares in the amount of 1.4 billion total including what acquired in July, up to July 15 as well as 1.1 billion was the repurchase of company shares since the beginning of the year.

The cash flow statement also included a dividend payment of about €3.7 billion paid in the second quarter as well as significant investments in our biotech partnerships, Regeneron of course and also Alnylam during the first half.

As you can see our net debt at the end of June was approximately 10.2 billion which is in line with our net debt medium term target. In summary, we are pleased that we continue to execute our strategy of the strong financial results in this quarter.

as we look to the second half of the year I just want to remind you a few items for your modelling considerations. First, we expect the continued progressive improvement of the supply situation of vaccine, on the strong flu season as underlined earlier by Chris.

Second, recall that last year increased the payment of 92 million before tax following the amendment of the [indiscernible] agreement with Hoechst which was booked in Q4 2013 as well as an income of €93 million before tax resulting from the Rituxan arbitration between Hoechst and Genentech in the first quarter.

We also will continue to invest in our late stage pipeline which we look forward to discuss with you at our seminar on new medicines on November 20. So all these things considered, we increased slightly our guidance and we expect business EPS to grow between 6% and 8% this year. Before we turn to questions I will now hand over to Chris to wrap up..

Thanks, Jérôme. So I guess just to summarize 75% of our sales are now generated by growth platforms and you’ve got three years of experience where you’ve seen that these growth platforms really growing at high single digits on average. They can be lumpy because of the nature of them but over a long period of time, I think they have proven their value.

Our business earnings-per-share has been adjusted from 4% to 7% growth to 6.8% growth, largely on the back of a good performance in the first half which we simply expect to continue despite a more competitive payor environment in the US.

Our late stage pipeline as you’ve seen is moving now to launch execution and we would expect actually new medicine launches to further redefine Sanofi as a biopharmaceutical leader, 45% of our sales today are already in biologics, 80% of our pipeline is in biologics and I believe today that we would rank second or third in terms of biggest biologics producer in the industry.

So with that I will turn it over to Sébastien for questions..

Thank you, Chris. Operator we are now ready to open the call to questions. As always I will ask participants to limit their questions to one or two at a time so that we can allow as many people as possible to participate into our Q&A session.

You can always get back into the queue if you have further operations, operator?.

(Operator Instructions) Our first question is from Michael Leuchten from Barclays..

Two questions please, one for Chris, you have mentioned in the press release the increased payor pressure and Jerome mentioned that as well in terms of gross to net conversion in the US.

Just wonder whether you could add more color why that is specifically mentioned now and where you see that pressure within your business particularly? And then a question on the ODYSSEY trial given you put the test in the press release yesterday in the long-term trial in the post [ph] analysis, just wondering if Elias could talk to us about how those patients look at baseline maybe their baseline area level, what those severe event rates were post hoc that you're looking at post hoc and whether there's any comment on the different time points where those events occurred say one year versus 24 weeks and 18 months or any color you can add in overall?.

I think on the increased payor pressure this is an industry phenomenon. I think I’ve certainly seen notes out from various companies who held the panels on this, this is partly due to the pressure from some new medicine, it’s partly due to some of the pressure that some companies are facing from the ACA.

And partly quite honestly just due to our own competitors, you’ve got a number of people out there who are being much more aggressive in contracting to try to gain market share, and I think seeing this in some of areas, largely I think I am trying to seize upon the payer pressure to see whether there's an opportunity to gain share.

Clearly Sanofi is not about to yield share on anybody and so I think that's normal, I think as I say you’ve seen it with other companies and it’s just sort of something to keep an eye on.

Nonetheless I think this comes back to the diversity of the company, that yes it is there but even though we know it's there we can still I think maintain and probably we slightly increased the outlook for the rest of the year.

Elias, do you want to say a few words about the long-term safety study?.

Sure, so the long term safety study of about 2341 patients and in terms of what the baseline levels were – as you know we started every patient on statins. So all of them are on statins and their baseline level are no different than the population that would be selected upon this criteria.

I can’t be specific about levels because I don’t want to jeopardize publication of rights and presentation at the DAC [ph].

In terms of the points, clearly what’s in the [piece trial] analysis we were looking at the major criteria which are the exact same criteria that you would look at in the cardiovascular cum study which is the study that is ODYSSEY is continuing on 18000 patients, the time points, there were pace test defined analysis where we would say the first analysis would be at 50% patients, having been exposed more than 12 months and 25% 18 months.

So the analysis that we are reporting, what we are surveying – less than 0.5 difference in favour of alirocumab, it’s based on this plan interim analysis..

We have a new question from Graham Parry of Bank of America Merrill Lynch. .

So firstly on the alirocumab priority review voucher, i.e.

some conditionality in your statement of intent to use – phrases like potentially usual plan to use, so is there any risk at all that you might not be able to use it and to what extent, would that voucher purchase the result of any broader discussion with Bio-Marin? And then on pricing, there is a lot of discussion around pricing above GLP1 level for these agents, possibly more towards the TNF agents, the commercial players are seeing that GLP1 is great, it’s been hampered by a premium price level to Lantus, so could you just talk us through any rationale as to why these agents could be priced above GLP 1 analysts? And then finally on additional data we could look at, are there any DSMB interim look on the cardiovascular outcomes trial, or should we expect any pharmaco-economic data at upcoming cardiology meetings?.

So on the voucher, let’s say, at the end of the day until you see ink drying on the NBA, I think anything is possible but generally you have to give the agency 3 month notice, now there is two types of about voucher, one is related to the rare pediatric disease, the other is to tropical diseases.

Tropical disease one actually requires a longer notice period and that’s why the pediatric voucher is – the rare disease voucher is considered more valuable. This is a request to have an accelerated review.

Obviously you back into the normal review cycle then, you can be awarded an accelerated review for any type of product even without a voucher, that doesn't always mean you’re going to get it but at this stage all we can do is say we’ve acquired the voucher and at this stage our intention would be to try to use it for that.

In terms of pricing, I don’t want to get into this pricing today but I will say that I do not consider – certainly all our market research does not consider the GLP1 market as a relevant comparator or an analog.

So we’re looking at much different levels of efficacy and a much different type of market, in a much different set of treatment alternatives, as well as a much different set of outcomes. So I personally don't really pay much attention to GLP 1 when it comes to alirocumab.

But this is where I think we will come back, our teams have done market research now, we obviously know more about this product today than we did even a week ago.

And the robustness of the results is something that we will be exploring with physicians and patients and you can – just so you have a first look in Barcelona and then we will try to bring all of that together in November.

Elias, do you want to take Graham’s third question on other aspects of the outcomes trial?.

Yeah this is a good question, so as you know the long-term cardiovascular outcome study called ODYSSEY outcome is an event driven design. In other words, we are basically dependent upon the event rates, number of events observed that are adjudicated amongst the patients who were treated.

Now in terms of those studies there always are a planned interim analyses that are performed during the conduct of the trial by DSMB and to which were blinded. During those times, so the DSMB has total discretion to assess the risk benefit on both sides of the equation, if there are less events or more events in one arm versus another.

So we do have planned interim analysis at a certain number of events as agreed upon with the agency at which point the DSMB has discretion to continue or terminate the trial depending on what is observed. That’s pretty much all I can say now..

Just trying to follow up that, have any of those events possible, can you give us any kind of feel for when they would be, and also the question on pharmaco-economic data?.

So in terms of timelines 2017, 18 is our timeline. There is plus minus 6 month is possible on those dates. So I can't really predict more than that at this point, it’s recruiting at the rate that we expected to recruit, and the event rate is what we expect. So I would say that we should hold ourselves to those timelines at this point.

In terms of pharmaco-economics let me say this -- there are two fundamental questions that affect this year, one, is our PCSK9 inhibitors are capable of increasing the better outcomes that we see with statins and there is a central question which is that statins per se have a solitary effect that others drugs have not proven.

I think the results that we reported yesterday in our long-term study with the 2341 long term patient cohort, are the first evidence in my views that in fact that notion is not correct that in fact lowering LDLC is having an additional impact on top of optimal statin therapy.

So because of that, that will change the pharmaco-economics to a large extent given – it’s confirmed obviously by the ODYSSEY long term study in terms of the ability for us to lower morbidity, mortality of the disease beyond that of maximum statin treatment. So I think there is the first evidence.

So in pharmaco- economics terms now you can see a baseline an and upside that is essentially trending towards the upside given the recent results.

In terms of the other positive pharmaco-economics I would I would say that if they are still evolving, we absolutely believe that there will be – as Chris said, a need for addressing unmet high risk cardiovascular patient needs early in – after the launch of this product even before the full cardiovascular outcome study is published, because I don’t think the risk benefit is something that you would want to weight towards the risk in these patients, you would probably want to error on the side of giving the benefit of the doubt to the patient given what we know today..

And just as an add to that, because I agree with everything Elias just said, and this is why I think we need to spend some time with what we have learned.

I think there is an assumption out there, that there is statins and everybody's well-controlled and the problem solved but in actual fact it’s pretty astounding when you look at the number of people who despite statin use are nowhere near goal and I think that when you couple that with patients who have other risk factors is one, one cardiovascular – KOL described it’s the gang of four between smoking, between high cholesterol, hypertension and diabetes, when you have those four conditions this is the four controllable elements of cardiovascular disease.

And this is really why cardiovascular death is still one of the leading causes of death. So that's why I would say that we don't really look at the GLP 1 which is looking at a broad spectrum of patients and a broad spectrum of treatment.

And here you’ve got essentially – I mean LDL-cholesterol is a factor in itself but it is also effectively a biomarker for identifying patient options and I think so you’re going to see a much more targeted approach. And then we don't really do that in the GLP 1 segment.

But again this is something where you actually have to spend a fair amount of time, this is a fairly granular analysis, but I think you will probably be surprised that at the numbers also involved. We will talk more about that at another time. .

Next question is from Peter Verdult from Citi..

I have got two questions, one for Chris, one for either Jerome or Chris.

With GO and PCSK9, XGS, pretty big potential launches, if we then go and assume that you do kind of broad label full PCSK9, how should we think about the incremental commercialization efforts of both assets? If we were to just simply assume there is a significant expansion in both diabetes and the primary care sales force, is that the right way of thinking about it or can you help us think about it a bit more intelligently? And then secondly, Jerome or Chris, lots of noise in the market regarding big pharma looking to divest established products, can you just update us as to how much for product this is for you to explore these options for your EP business and if it is on the cards is it technically feasible to sell out vehicles for tax conversion purposes?.

Yeah, I can tell you inside company, I think we are pretty busy. We are in pretty much every business we’ve got new product launches either underway or about to get underway, I mean Genzyme and Cerdelga, Lemtrada we only talked about the others here, we got Toujeo, we’re still rolling out lexy lean [ph], PCSK9 now.

The interesting thing I think is that clearly Sanofi -- when we talk about this gang of four and you hear the diabetes as one of the four risk factors, obviously we are exploring what kind of synergies we might get them between these two. And I think next year we're already putting more money into the business.

Last year we had a big investment in building up our MS platform this year, we had a significant net increase, so you don't necessarily see them in the numbers because we're busy driving savings out of the rest of the business but we put well over €700 million of new investment into the business just because of this burgeoning pipeline.

And next year I think we’ve got both continued pipeline investment and commercialization cost, I think it’s too early to tell what impact that will be. I don't think we’re looking at PCSK9 initially as a primary care product.

However I think we’re going to be focused to probably more on specialty audiences, so I think the field force expansion will not necessarily be there but you do have two big blockbusters here, even to try to launch.

So I think what we've also seen is that we’ve been able to try to manage new investments while squeezing costs out of the rest of the business. Just on the mature products I will let Jerome talk a little bit about some of these.

I think the reality is that the mature product question has been around as long as I have been in the industry, it comes and goes largely with patent cliffs. And so as the industry has gone through a patent cliff yesterday’s blockbusters become today's mature products and we’re all sitting there with the hopeful of these.

The conundrum has always been as long as I have been in this industry, we would like to eliminate the dilution of our sales growth but we don't really want to give up on the cash flow that those bring. And in particular there is an awful lot of cash flow from those older products that go into funding research and development.

So there's a everybody think it’s discussing in the industry, I think finding a solution that is not dilutive for our shareholders is critical. But when you look at the past there have actually been that many deals done in this area. .

No, nothing is if anything to that, Chris made that on the one hand, these products are dilutive on your growth on the financial standpoint, to a an extent, I mean focusing the company versus to focus on new launches but at the same time and cash flow on to profit, which had financing direction of the business.

I mean the holly grail is not that we just have to find them, you hear a lot in the press about all these established product stories but very few transaction actually take place, so I don’t think we have much more to say – and it’s normal that in this industry which speaks about that but at the end of the day I mean not much takes place..

It is something everybody is actively looking at and we can do something that would create value for shareholders. There are whole host of technical issues that I will spare you with on this but if we can create value we will try to do something here..

Next question is from Tim Anderson from Sanford Bernstein..

On your M&A plans, the first question -- you generally continued only do smaller share buybacks and you’ve been pretty consistent in the past saying that you're looking mostly bolt on acquisitions, but when I take those two things together, so if you would have cash are coming on the balance sheet, so my question is really whether it's realistic to expect that you will continue to look primarily bolt-ons for some time, does the window open up here for you to consider larger targets? And second question in keeping with what seems to be Sanofi’s goal which is to be a diversified company, can we expect Sanofi to push in the brand-new area, would it likely just build out existing areas, for example, with something like medical devices or diagnostics, it will be of interest to the company, but would the company be interested in becoming more of a global generics player?.

Look, I mean acquisitions are kind of in the DNA of this company, this is the base on which this has been built. And I think by nature we are – we like to hunt - the issue is I think that the that market situation has dramatically changed over the last 3 years, I am particularly happy that we did our acquiring two three years ago than today.

The basic problem is that by the time you pay a premium and the premium is often driven by awful lot of cash by some non-healthcare specialty investors now are looking for higher returns.

And then if you kind of couple that with the people who were are trying to do inversion deals, who are willing to pay more premium because you get a synergy on the tax side, valuations are pretty robust and by the time you pay the premium and you sort of say well what value am I creating for our shareholders? You’re left saying there isn’t really much left there for us to do that with.

I was like to say -- I don't get paid for making someone else's shareholders happy which is pretty easy to do here but it's a lot tougher to find shareholder value for us.

But the thing about this is that the wind has changed pretty quickly, so we continue to look, we continue to play this kind of on a half by half basis on the year, we’re back to 10 billion in our net debt target, as we look and we don't find anything to do beyond the bolt ons, then we buyback shares, so we don't want to say that hey, we will never find something to add value and so we prefer to keep some of the strategic flexibility.

I will say that we’re prepared not only to be evaluated on the deals we have done but also on the deals we haven't done.

And I have to say most of our shareholders when I talk to them are not keen for us to do anything, you do get a lot of bankers telling you that when everybody does an acquisition the share price goes up, and I have a lot of investors coming to me saying we hope you’re not listening to all this.

And because you how long is that really going to last especially if you end up with companies that where you got a lot of new balance, you are not generating return on.

On the diversification, I think where we said et in the past, I will say – will certainly confirm again today Tim, we’re happy with the perimeter, there is a balance to be struck between the diversification and management bandwidth quite honestly.

I think we've got our hands full on this, so I would expect us to be building out versus expanding, I have to say I really don't know anything about multiple devices and even where we want to be in devices we will prefer to partner which is why we decided to get together with Medtronic, for example.

We recognize that, we have some competencies and some products that can be useful to Medtronic but Medtronic knows a lot about things that we don't know about and so where we need to be in the broader area we will do through partnership.

So and for the rest of it, yeah, I mean pretty much everything is open in terms of build out, subject again to creating a value for Sanofi shareholders. .

Vincent Meunier [ph] is on the line. Sir you have the floor..

The first one is a follow-up on alirocumab, and [indiscernible] on the post hoc analysis of the ODYSSEY long term trial, can you please tell us if you think the results of that study can be paths of the label of the product? And then that would give you an advantage before the publication of the ODYSSEY outcomes trial? And the second question is another follow-up on the situation currently in the industry.

Is it fair to assume a marked deceleration of Lantus in 2015 because of the flattening price in the US and a growing rebate and assuming that what's happening is an industry event as you said?.

Sure, so in terms of the long term study, which involves 2341 patients, one thing I'd like to stress to you all is that we have been extremely careful to design quality over speed in our trials, we have 5000 patients, we didn’t go to 12 weeks, we wanted 24 weeks, we didn’t go to 12 months follow-up, to 18 months follow-up, we have 75, 150, and 300 mg doses, so the quality of the program allows us in fact to submit the data at the time of submission will be in the label obviously, we need the cardiovascular outcomes study, 18,000 patient study to make it in the label but it will certainly I hope be in the clinical section.

The impact obviously is that this is the first solid quality evidence of a differential effect on cardiovascular outcomes of alirocumab on top of statin. So I'm pretty confident and hopeful that it will make it to the clinical section, but not in the label itself from the first trial, as it needs to be confirmed by the larger study.

Is there going to be an advantage? I think in generic terms there will be a significant advantage, I believe, in having shown some definitive or strong early evidence of better outcomes with PCSK9 and in particular one of the things that we have been very careful in our design is to focus on high risk cardiovascular populations, the ones most in needs of intervention.

So my answer is obviously attending to puts this data in our submission for inclusion in the clinical section in the second – yes, on the scientific and medical standpoint, there is clearly an advantage in having demonstrated through this very careful more long-term program that we have done, where we have really explicitly quality over speed I think this would make a significant difference in my opinion and I hope so.

.

I would just add I think one particular area where we might have some benefit is actually in Europe because I think obviously economic hurdles for new drugs are much higher in Europe and we might've anticipated some payer saying, well that's great, you would do LDL, but we want to see outcomes.

I think it might be interesting to see well this wasn’t the primary endpoint by any means and we do need to be prudent about we look at this.

Nonetheless, I think it is an important signal and I think just from a medical ethics point of view at that point I think we will certainly get some European payers to potentially look at this differently than they might have otherwise done.

The second question was – the Lantus trajectory, so there is a number of factors that go in obviously in 2015, first is does the biosimilar arrive – as you know there's a Markman hearing scheduled for this fall and there is a court hearing, the trial is scheduled currently to take place in September 2015.

Unless there's a summary judgment one wouldn't expect a biosimilar until the decision on patent infringement has been taken, which would probably take you out into 2016. And of course obviously with the launch of Toujeo we are going to considerably deprioritize Lantus because we believe Toujeo is a much better product.

So you are going to in any case see a decline in Lantus as we ramp up effort behind Toujeo. Difficult to predict on the rest in the market, the whole diabetes space is clearly a very competitive space.

Equally I think we have put a lot more focus in our US business on sales force execution and we've actually seen in NRx share gain now over the last seven or eight weeks and actually TRx share gain again.

The other fact – a very modest at the moment is that it does appear to be some benefit from the ACA, we are seeing the overall diabetes market grow little faster in 2014 than it did in 2013.

Now we all know that those who are enrolling in the exchanges to a great degree of people who previously had healthcare and insurance and are now just switching but there is probably 20% to 30% of new patients coming in that didn't have healthcare insurance before. There's also some evidence that some smaller employers are starting to get insurance.

Now the offset to that of course is the new insurance often comes with much higher co-pays and coinsurance, so that’s why I think we have to be extremely prudent about actually seeing any real benefit in volume but there appears to be some.

What we can also say for our diabetes business that we have just hired a new head of our diabetes business unit and the person formerly used to work for Novo Nordisk. So we’re looking for some new energy in that part of our business in the US. .

I just want to add one little detail that I don't think I made clear – the statement was this was in terms of the long-term study that we also reported on, the statement was made that this was a post hoc analysis.

I want to make sure everybody understands that we actually pre-specified that analysis in the plan submitted to the FDA, so it’s not a discretionary post hoc second look, it’s a pre-specified analysis on the maintenance criteria, the same ones we use in the long-term cardiovascular outcome driven study of the 18,000 patients that we are continuing.

So I just want to make sure it’s a prespecified analysis which really means that it has a high likelihood of being taken into consideration and hopefully included in the clinical study sections at least of the label..

Next question is from Mark Clark with Deutsche Bank..

Firstly a question on the pipeline product, the CD38 antibody for multiple myeloma, so it’s a shame it doesn’t start with the – because everyone would put a billion in front of it but would you be planning to file on the phase 2 study you’ve started in the way that Genmab potentially with it daratumumab, if not, when will you be in a position to start the phase 3 combination studies? And then second question about Toujeo, just a follow on from previous comments Chris about, de-prioritizing Lantus and you think about a product, clearly when we talk to investors the feedback from many other – from many in the market is they are not convinced Toujeo is a better product.

But financial contexts doesn’t determine prescribing, what is your market research coming back from actual prescribing physicians on Toujeo versus Lantus?.

So on the CD38 assets, obviously your point is well taken, this is exactly what we’re working towards, we’re hoping to be able to accelerate the plan, we’re already from both optional – and essentially on the results and at this point we’re just accumulating the results.

In terms of [indiscernible] we hope to definitely go in phase 2 concurrently and we hope phase 3 in 2015, I can’t tell you exactly when..

Toujeo, Mark, I think we will come back on November 20, the one thing I will say is that there are still number of people in the company who launched Lantus and it seems that the financial community didn't really think much of the prospects of Lantus either.

So I think as you say it’s probably pretty good thing that you listen to prescribing these products. .

Next question is Steve Scala from Cowen & Co..

First, Chris, can you help us create an expectation for the rollout of Toujeo and alirocumab in 2015? The company clearly is excited and optimistic and your experts apparently are as well, should we conclude that payer adoption will be brisk and the rollouts will be very strong, or would you urge us to lean more cautiously on the rollouts? Second question is in the past the company has noted its early efforts in immuno-oncology and how there is improvement opportunity for PD 1 or improvement activity upon PD1 activity, so will this be a topic at your thematic seminar and if so would you care to give us a preview of what you may say at this point?.

On rollout I think rather than answering the question because I have to say that on particularly alirocumab this is actually -- we are talking about a paradigm shift in treatment here, just because of the extraordinary level of efficacy, I mean when you are talking to key opinion leaders and nobody really knows what happens when your LDL goes below 70.

And so on the fact that we just had these phase 3 results as well as the long-term study we are going back and updating our market research on this, but – and then there is also a whole lot of other questions because there are for instance two doses here, you got a 75 mg and 150 which actually Amgen does not have and you’re going to have two schools of thought here about lower is better faster versus this is a new class of drugs, let’s do what cardiologists have tended to do which is to titrate up, so there are a lot of moving parts in how this is going to take place.

So we’re doing a lot of work on that and I really rather give a more detailed answer on November 20 because it's pretty rich. Toujeo I think is a lot simpler, we do think this is a better medicine, we are going to be driving to get a maximum rollout. On alirocumab I just think it's just early days to give you some sense of that.

But Toujeo clearly is we want to actually really get behind this next generation instrument.

On immune oncology I will let Elias comment a little bit more on this, the only thing I will say is that every expert I have talked to in this – no matter what they think about how immune oncology is going to develop, will always say that we are just really at the beginning here.

It’s obviously an area of significant unmet need but this is going to be a major area of research and development for at least next decade and so we’re all looking at position ourselves in this area but nobody should think that the train has left the station on that..

I was going to echo that, and just a second, I would say also that you should know that we have probably one of the largest most active antibody drug conjugate program with four assets and late preclinical and early clinical, which give us a basis to understand in fact key aspects of immune oncology which is the targeting on the cancer cell, in addition to that we have a very active collaboration with Regeneron on checkpoints and our view is that as Chris said, this is not a sprint, this is going to be a marathon, and I think based on our understanding of the science and as I said before really our teams are favouring quality over speed here.

We believe that some of the outcomes will be driven by combinations because the immune system is not a one brake one accelerator system but many brakes many accelerators and that depend on the tumors. Clearly we are in the field and we intend to, as Chris said, be part of this marathon is much as anybody else.

And we have some unique assets that we will present later on perhaps at the November session if things are mature at this point..

Our next question comes from Philippe Lanone from Natixis..

Could you give a bit more color Merial going forward because Q2 was quite spectacular and even shifting out the NexGard is only a slight decline, so what will be the situation, what should we model for the rest of the year and for 2015? And quick question on Aubagio because it's becoming -- it will become quite a significant drug, and that has an exclusivity through in 2017, should we stop the story here or do you have any possibility to go beyond that especially there is a -- another patent to up until 2031?.

So Merial, it did get back to growth, as I said there is at least a part of this related to Frontline and that’s clearly because the weather conditions for the flea and tick season is much better which has had an impact on both NexGard and Frontline.

I think the other is that we’ve brought new leadership into Merial last year, we have reprioritized resources and I think they are doing a great job on really getting the Merial rejuvenated and energized, much better advertising, much more of a focus on getting promotion going.

Merial management believe that they are going to be able to continue mid single digit growth certainly in the next quarter and the end of the year. Longer-term NexGard is extremely important but clearly we need to expand that and we’re really looking at building upon the Pet franchise.

We've had a few setbacks from some of our biologic vaccine production which I think we’re sorting out. So I actually think we should be able to keep the momentum going in Merial. Aubagio, yeah, you are right, I think Aubagio is running at almost €400 million run rate today.

My recollection is that while we first have 10 years of data exclusivity in Europe, so that takes us to 2023 and the last I think that takes us out to 2017, September 17, we will also have some method of use patents that goes into 2022 and further patents on formulation as well as process that actually go beyond that. .

I mean our teams today are looking at this for the US beyond 2020 because of the additional patents, how much beyond 2022 I think is still yet to be added to the terms..

Our next question is from Steve McGarry from Société Générale..

Just a quick questions, firstly just given that payer pressure you had, given that it affected in zero play with Lantus, do you still believe that you have scope for price increases now? And secondly on the Regeneron stake, when Sanofi stake was 20% you added the direct general [ph] on board, so what’s the overall strategy for the Regeneron stake, is that to ensure that third party doesn’t acquire your partner, and given that Sanofi increased its stake so far this year, that caused to Regeneron’s all time highs, when you could have allocated capital elsewhere, does that include time sensitivity for Sanofi to get its stake to its target level?.

On payers, I think lot of the -- there's the two types of the price increases obviously, there's the whack pricing, the list price changes and then there is a net price changes. Largely the list price changes are a function of competitor activity.

To a great extent I think Lantus was seen as being lower-priced to compared to its value, therapeutic value if you compare it to for instance GLP-1 or DPP-4s even and I think we’ve got better price alignment with that, Lantus today, it has a daily treatment cost of around $8, so still less than the GLP1s but one aligned with the DPP4s.

Then question is how much of that price increase can you translate to the bottom line and I think that's where there is increasing pressure and also we need to keep volume moving.

We need to do also I think continue to work with payers to really show how do we get the better outcomes because the real target is not lower-priced medicines but it's better outcomes for patients at a lower cost.

And I think actually doing a better job of partnering with some of our payers could actually help us on that and that’s largely why we moved on this path of integrated care and moving beyond the pill.

I think outcomes are going to be much more important in the payer environment and I don't think as a company we could just continue to supply a medicine, I think you have to try to think about what can you combine this with the devices with education, with the program, with information to actually help patients cope with their disease, because in type II diabetes is probably one of the number one cost drivers for the whole healthcare system.

We know if you take a more proactive intervention that you can actually reduce the cost of patient while giving them better help. So I think there is a big price to be had actually in diabetes and we probably need – we need better collaboration within that.

On Regeneron, the logic of buying more shares of Regeneron is simply that we believe in the products that we’re developing with them. Whether you look at alirocumab, you look at sarilumab, you look at dupilumab, plus we see a whole range of other compounds coming down the path.

We believe that Regeneron has not only an ability to generate antibodies but their ability to have replicated human immune system inside of a mouse really allows you to validate targets on a quicker basis and the way the arrangement has been historically set up is that we not only fund the research but we fund the hundred percent of the development and then we share the profits with the reimbursement model for the research and development.

So our believe is that we’re creating an awful lot of value inside of Regeneron, we get a piece of that through the profit share, if we want to expand Sanofi shareholders participation in that value creation. The best way to do that is to increase our own shareholding. And that's what we have done.

So we actually do see it as a very good use of capital largely because as I said the phase that we have in the products that we’re jointly developing. .

We have question from Alexandra Hauber from UBS..

On R&D, you hinted on potentially on the R&D budgets in the second half, and potentially be on, can you just quantitatively describe what is driving that? I can see we did a new phase 3 programs that should be coming on, but there is on the other side probably at least not increasing costs anymore, PCSK9, dengue, MS is probably coming down, diabetes, looking like is probably just replacing what you are winding down on Toujeo, so is it all in the early stuff that we normally don’t see much – that doesn’t drive R&D budget so much, so if you could just describe the key drivers, what you see the key pressures? Second question for Chris, you said on Lantus, you’re not going to yield share to anybody yet, in the first half at least you have been, not going in terms of marketing, long acting with analog [ph], so question is -- 4% TRx and market grew 7%, why is that? Is that due to disciplined contracting? I am asking because obviously at the end of the day, the issue for Avaya [ph] because it was good while it lasted but the big issue is the sector, when you finally do except to lower price, just wondering whether that could be similar issue here.

And then final question, M&A I recall that for the change of acquisition usage, that you had a limit, from the board, and does that limit still exist or do you just need to fulfil all the user criteria that you seek to return for shareholders?.

Alexandra, I wish the reality was what you described, I mean if you really look at it, I mean first of all, the long-term study for alirocumab continues although it’s 17-18, 18,000 patient study, so it’s quite a driver.

In terms of PCSK9, I don't think you’re going to see a reduction year on year even though we finished all the early – all the phase 3s, we have a couple more ongoing.

Second, IL4 is going into its phase 3, IL4 is not just the single molecule, single indication, it's actually a class of indications, so it's going into phase – we’re going to read the phase at the end of this year and it goes to phase 3 in asthma, we have nasal polyposis as well, that are up-and-coming.

We’ve launched LixiLan in phase 3 which is ongoing at this point.

In addition to that we're looking at the early portfolios you mentioned which I think is very vibrant, we have seven projects there that have again what I call the high quality lower attrition index that we have directed and driven the R&D organization at Sanofi to focus on quality rather than quantity and our attrition rate if you really look at it over the past three four years has been very low.

So we believe that's going to be important. In addition to that I think something that perhaps is not well appreciated a significant portion of the R&D budget has to go, once you are successful like in Toujeo for example and submitting a drug, you have to continue to spend behind it for two reasons.

One is the regulatory requirements imposed by regulatory agencies are actually quite so significant and increases every time you succeed, so Lemtrada for example, I expect that with the approval hopefully in the US there will be some regulatory requirements.

And third, as you well know today payers and payer driven studies are extremely important to build within the R&D budgets. So all in all I don’t see pressure lowering on our budget, in fact the opposite, because of all the needs of both the prelaunch, post launch activities, regulatory activities and the pretty rich portfolio we have today.

I can give you more details and outside the point and hopefully in November, that also covered for you..

On Lantus, we’ve got – TRx growth is certainly growing at about – the last two quarters is 4.5 and the first quarter 4.6, we compare that a selected insulin market that grew at 4.1, so we've been out growing that now. That demand out-performed Lantus a little bit in some of that period but we’ve got a 20% market share to our 80% market share.

So it's hard given the amplitude of the numbers. Largely what we have been focusing on is field force estimates. I would say that I think when you got 80% market share there is always a risk of not being as energized as one could be and I think a lot of effort has gone into that by our US team.

And we’re not -- we don't see anything really in terms of our performance in the marketplace. In terms of pricing this is something that's affecting everybody. But again I think there is an element here of not necessarily getting into price wars but really getting into the battles with payers -- this is the most expensive part of healthcare.

We can give all the great medicines that you can but if you don't really have a change in diet or exercise or other lifestyle elements, you’re not necessarily going to get to better outcomes, that’s really again coming back to why we want to get into integrated care is to really to try to have some influence on the overall patient treatment experience – the insulin.

On M&A, I am not sure what limit was that you were talking but we've never had a limit. Those consider to be a limit, the only thing that we do as I said accretion is not the only investment criterion which can often be the case in our industry historically.

We also look to achieve a return on investment that at least meets and probably exceeds our WAC requirement, cost of capital, and in fact we as management believe that allocation of capital is a core part what management is supposed to do.

So for our executive committee, in fact, it can be all of senior management who get equity compensation, 50% of the performance criterion -- all of our equity compensation is – has performance conditions, there is no equity compensation without performance criterion, and half of that is actually return on asset to that calculation.

So in other words doing something that is not generating return even if it’s accretive actually would cause us to miss our own equity compensation target.

If you actually went back to the Genzyme acquisition, one of the reasons that we held as long as we did was, the acquisition is clearly accretive at a much higher price, but at a much higher price we wouldn’t have been able to meet our return on investment criterion..

We have our last question from Florent Cespedes from Exane BNP Paribas..

Two quick ones, first on dengue vaccine, could you remind us the timing and the ramp up you see for the products and remind us also which are the priority countries? And second question is a quick clarification on – sales are no longer declining but when you said earlier that you expect mid single-digit growth, is it for the division or is it for Frontline?.

For Dengue, we would expect in the third quarter the second phase 3 results and on that basis we would be expecting to do a filing in the first quarter of next year.

And at that point this will be a question of countries choosing to give this priority access, we would expect the first launch countries to be in Latin America, Mexico, Brazil, Colombia and possibly if I look at Asia, Singapore and Malaysia as the priority countries.

We are actually already ramping up production, so the initial production comes out of a pilot plant and we're creating stock, we are currently running validation lots in our new facility, assuming those validation lots are qualified then the validation lots are also available-for-sale.

So I think you’ll probably start to see the initial sales possibly as early as the fourth quarter of 2015 and should be going for full-year certainly 2015.

On Frontline we’re looking at – around the mid single-digits, roughly around 5% for the whole of Merial, I think it's a strong result that we have got Frontline stabilized but clearly the growth in the flea and tick business will certainly come more from NexGard but given the size of Frontline and the importance of that, it’s important that we maintain the sales of that as well..

We would like to conclude the call now, and obviously thank participants for their attention. As we mentioned during the call, there will be an IR thematic call around ESC on alirocumab and we will send shortly the sales data of that.

And we will also – I am sure you’ve noted already the date of November 20 for our IR thematic seminar on new medicines, we will also be sending a save the date for that. With that, I wish everybody a good end of day..

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