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Sanofi (NYSE:SNY)

Q3 2012 Earnings Call

October 25, 2012 9:00 am ET

Executives

Sébastien Martel

Christopher A. Viehbacher - Chief Executive Officer, Director and Member of Strategy Committee

Hanspeter Spek - President of Global Operations

Olivier Charmeil - Senior Vice President of Sanofi Pasteur - Vaccines Division

Jerome Contamine - Chief Financial Officer and Executive Vice President

Analysts

Luisa Hector - Crédit Suisse AG, Research Division

Mark Dainty - Citigroup Inc, Research Division

Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division

Richard Vosser - JP Morgan Chase & Co, Research Division

Vincent Meunier - Exane BNP Paribas, Research Division

Peter Verdult - Morgan Stanley, Research Division

Seamus Fernandez - Leerink Swann LLC, Research Division

Graham Parry - BofA Merrill Lynch, Research Division

Operator

Ladies and gentlemen, welcome to the Sanofi 2012 Third Quarter Results Conference Call. [Operator Instructions] I now hand over to Mr. Sébastien Martel, Head of Investor Relations. Sir, please go ahead.

Sébastien Martel

Thank you. Good afternoon, and good morning. Welcome to our third quarter conference call.

As always, I'd like to draw your attention to the Safe Harbor statement. I must advise you that the information presented in today's call will contain forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to differ materially, and I would suggest that you refer to our Form 20-F on file with the SEC and also our Document de Référence for a description of those risk factors.

So with us today on the call are Chris Viehbacher, our CEO; Hanspeter Spek, our President of Global Operations; Olivier Charmeil, our Senior VP for Vaccines; as well as Jérôme Contamine, our Chief Financial Officer.

Without any further ado, let me turn the call over to Chris.

Christopher A. Viehbacher

Thank you, Sébastien. Hello, everyone. We'll move straight to Slide 5, where you can see the quarterly sales and the year-to-date sales. As you could see, on a reported basis, sales were up to just over EUR 9 billion. On a constant exchange rate basis, that's a decrease of 3.1%. Versus the prior 2 quarters in the year, this is a quarter where we've had a new product come in to the list of those facing generic competition, and that's namely Eloxatin, which faced generic competition, really, from early August onwards. On a year-to-date basis, the sales continued to grow, even at CER. That's also because we consolidated 2 quarters of -- sorry, 3 quarters of Genzyme last year, or if I look at a 9-month basis, 2 quarters of Genzyme in 2011 and 3 quarters in 2012. Obviously, the lower euro had a very favorable effect on our accounts again in the third quarter. Jérôme will cover that in a little bit more detail.

If we look at the profit, that number is on Page 6, there, we see that quarterly business earnings per share declined at 14.5% at constant exchange rates. This is, of course, to a great degree driven by Plavix and Avapro in the profit line and Eloxatin but also the fact that we no longer have Copaxone sales revenues in our numbers. On an year-to-date basis, the decline is 8.4%.

A look to Page 7. This is a slide that we have used before and really over the last 3 years and really tells the detail of the transformation of Sanofi. In the second quarter of 2009, the products that really added up to EUR 2.2 billion really represented the patent cliff for the company on the sales line, remembering that Plavix and Avapro in the U.S. are consolidated in sale. And if we look at what happened to that EUR 2.2 billion over the last 3 years, we can see that there's been a steady erosion, and what's left is essentially EUR 400 million sales or above 4.4% of total sales. So what you really see is that with the generic competition for Eloxatin, this is really in a lot of ways the last step in the decline of those former glory day blockbusters. The real effort, of course, has been on the right side of the page. These were the growth platforms that we had defined in 2009. At that time, they represented EUR 3.3 billion of sales and really were less than 40% of sales. As you can see that really over the last 3 years, we've been able to almost double those growth platforms, and today, they represent EUR 6.4 billion on a quarterly basis and 70.9% of total sales. So what I would say if I -- before we go into too much detail on the underlying results, is that I think Q3 is completely in line with the solid progress that the company has been making through, getting through the patent cliff and preparing for a new future. These results are completely in line with our expectations, looking out towards 2015, the guidance that we gave back in September of 2011. So a very satisfactory performance really on all fronts.

Now if we look a little bit in detail on Page 8, you can see the growth platforms. They grew 6.4% in the quarter. I think -- I'm not going to all of them because Hanspeter will talk about some -- I'll just point out a few, Emerging Markets of 6.8%, I would just caution everybody about not overanalyzing Emerging Market quarterly sales. We have a pristine situation in the United States where we have 3 wholesalers. 90% of the business goes through them, we get daily stock levels, we get weekly prescriptions. That contrasts with the Chinese market where you may have hundreds of primary, secondary, tertiary wholesalers. In some countries, you got tender businesses. So we're not going to see the nice, smooth evolution always on a quarter-to-quarter basis and why we prefer to guide you around performance for -- on a full-year basis. And Hanspeter will be able to give you a little bit more detail. Diabetes is clearly a star performer here, a very satisfactory performance. But I think Hanspeter will also point out a number of things that really show the company orienting itself to a diabetes franchise in Emerging Markets. I will point out new Genzyme. This was clearly an important step in the company's history as Genzyme joined the Sanofi group. The critical element was being able to have recovery in the manufacturing, and I think when you see the very robust growth of 22.5%, this is a very strong indicator of how the manufacturing has rebounded, clearly driven by the recovery of Fabrazyme but also very high single-digit growth on a constant exchange rate basis for Myozyme and for Cerezyme. I remind you that new Genzyme is essentially the rare disease business and also will be the launch company for AUBAGIO and for Genzyme. Innovative Products, when you look at it from a growth platform point of view, is still very low. But I think when I come on to some of the things in the pipeline, I think this is an area where we can see significant growth for the future.

Looking at Slide 9, this just gives you a little bit more detail again of the Genzyme performance. On the Fabrazyme, clearly, this was related to the approval of the new Framingham plant in January. We are subsequently getting other countries on board from U.S., Europe and all the way out into Japan. The withdrawal of Shire's product, Replagal, which was present in the compassionate release program as they had their BLA outstanding, has obviously allowed us to convert patients from them to Fabrazyme. But we're also making good progress at regaining market share outside United States.

Turning to Slide 10. This is a -- we announced results for our third quarter study called ENGAGE. This is a new oral therapy in Gaucher disease, and you can see that the -- this first set of Phase III results demonstrated an absolute difference of 30% in spleen volume, which is a key marker for efficacy of a product. What we have seen, these are 9-month results. What we have seen with Cerezyme as well is that as you begin to treat patients, there is a progressive decrease in spleen volume. So our own first -- our own interpretation of this is that eliglustat is demonstrating comparable efficacy to Cerezyme but, obviously, with the convenience of an oral form. These, of course, need to be validated with the results of a second Phase III study called ENCORE, which will be a study versus Cerezyme, which will be expected in early 2013.

Slide 11, we've had 2 major approvals here, particularly with AUBAGIO, and had very good conversations at the EC Terms conference in León a couple of weeks ago with key opinion leaders. And I was very satisfied with the favorable reception that key opinion leaders have for the product. Clearly, this is an oral and has a huge implication for people who are going to be on treatment for 20 or 30 years. And given that this has been able to demonstrate strong efficacy against interferon but with the convenience of an oral, that we believe that this will be a very strong performer. I would just point out one thing on AUBAGIO. The neurology community in multiple sclerosis is, by nature, a very conservative community. The Fabry situation a number of years ago clearly enhanced that conservatism. The interesting -- and so new products are still looked at with some degree of caution until a safety record has been established, and that's why we still see 80% of patients being treated with interferon or Copaxone. However, given that this is a metabolite of leflunomide, there is actually quite a long safety story with this, and I was actually hearing that there is a little bit more confidence given this history. So we'll have to wait and see how the uptake is on that. On Zaltrap, clearly, approval for second line metastatic colorectal cancer. Again, initial results seem to be promising, but it's early days. We've had sales of EUR 7 million since late August of 2012.

Looking forward to regulatory milestones over the next 6 months on Slide 12, the first thing I'll say is that we are starting to get regular news flow now on the R&D story. So I think this is -- when I kind of look out towards 2013 back in 2009, we were projecting out on the growth platforms and on where sales and profits were going to go, but our mission was also to have a decent late-stage pipeline by 2013. We knew that would take time. And I would say when you start looking at the news flow and the number of molecules we have now in Phase III, I think there's 17 molecules in Phase III, I think Sanofi's R&D outlook is looking much, much more robust. On the specific milestones, Zaltrap, clearly, we're expecting CHMP opinion in the fourth quarter, along with Lyxumia. We are on track to submit to the FDA by the end of the year. You've seen the advisory committee, which voted in favor of KYNAMRO for Homozygous Familial Hypercholesterolemia just last week, PDUFA date in January and a European opinion in the fourth quarter of this year. Equally, the CHMP opinion on AUBAGIO is expected in Q1. The refiling of LEMTRADA is nothing new on that. It's exactly as we said when we announced that we would be refiling. I would alert you to the fact that we're going to revert to past practice, which is that we will announce filings at the time of FDA and acceptance of a file. We have made originally an exception with LEMTRADA because of the proposed buyback for the CVR. Now that the -- sort of that modified Dutch auction has taken place, we're going to -- we'll be making a statement once we've had a decision by the FDA on the acceptance of the dossier. And, of course, we're actually having a nice upside in the sense of being able to now awaiting approval for the hexavalent vaccine in Europe, which we would hope for in the second half of 2013.

Looking out for the year on Page 13. Now if I look at where the business is going, I think, again, this is very solid progress, very good performance of our growth platforms, in particular, Diabetes and Genzyme. We continue to be disciplined on cost, but I would also point out that we have used some of that discipline on cost to reinvest, which you don't always see. I mean, a significant investment has gone on to create a whole new multiple sclerosis team, for example. Phase III programs on things like the PCSK9, the dengue vaccine. So we have discipline on cost, but largely, what we're trying to do is take out nonproductive costs and make sure that growth drivers for the future are also well-funded. So and that's led to good operating margins. There are -- I'll let Jérôme talk about some small tax rate improvements. What's going on in the marketplace is what you see with our -- some of our competitor results. The EU is not getting any easier, and I wouldn't expect the EU to be an easy environment for a number of years to come. There is the global macroeconomic environment, although I would caution that the health care costs tend to track GDP growth on the way up. If there is a slowdown, you don't see the same tracking on that, largely because people get accustomed to a certain level of health care. And really, what drives this is not so much GDP growth but the increase in middle classes and urbanization of populations, and, of course, we have the competition. So if I take the tailwinds and the headwinds, we're very -- we're confident in the outlook for 2012, and that's why we've moved our guidance to the top end of the range that we announced at the beginning of this year and would predict that, therefore, the business EPS will be around 12% lower than 2011 business EPS. And I would remind you that the constant exchange rates because, clearly, the exchange rates have had a significant effect.

With that, I'll pass over to Hanspeter Spek.

Hanspeter Spek

Thank you so much. Good morning, good afternoon to everyone. I propose to switch on Page #15, where you see a chart, which you have seen in a similar outline already for the last quarter. It is illustrating our overall performance now for the third quarter. First thing to state, we had a relatively strong quarter in absolute sales, with sales north of EUR 9 billion. In comparison, last quarter was at EUR 8.8 billion. So we sold about EUR 140 million -- EUR 170 million more in this quarter. More pronounced in the third quarter is the loss due to genericification. You see we have lost EUR 448 million in the third. As a comparator when, again, the second quarter was EUR 163 million. As we have heard already from Chris, this is mainly due to the loss of exclusivity for Eloxatin. The other position is nearly identical, EUR 190 million to EUR 187 million for the lot. The growth platforms as well, EUR 364 million compared to EUR 386 million. And yes, we have an even stronger headwind in the third quarter coming from the positive ForEx impact, with EUR 561 million compared to EUR 486 million. So overall, I think we can summarize, it is a good, it is a solid quarter, absolutely in line not only with our forecast but also what we have seen in the previous quarters.

Now to look into more details of the overall portfolio, I pass on to Olivier Charmeil, who will give you some insight into vaccines first.

Olivier Charmeil

Good morning, good afternoon to everyone. So vaccine sales for Q3 showed solid underlying performance, despite supply constraints. Our Q3 sales have reached EUR 1.5 billion, up 0.7%. Our growth for the quarter has been very much driven by a strong pediatric franchise. Vaccine sales up 16%. We are very happy about the performance of Pentaxim in China and in Mexico. We launched in China a little bit more than 1 year ago, and we are really impressed by the uptake. With regard to our recent launch in Japan, Imovax has been launched a little bit earlier at the end of the quarter, at the end of August. We have been able to record sales of EUR 65 million, and it is the best launch ever of a pediatric vaccine. We have submitted a new hexavalent combination in Europe.

Looking to the U.S., our sales are down 6.9%, reflecting a different phasing for Flu. The delivery of Flu between Q3 and Q4 in 2011 and 2012 is different. We are expecting to continue to ship Flu those in Q4. We managed to ship in Q3 54 million doses, and since the beginning of October, we continue to ship. And as we speak, we already have shipped 58 million, which means that we are on track for 60 million doses.

With regard to our differentiation strategy with regard to Flu, we are starting to show positive signs to maintain our leadership position and to grow the market that is otherwise suffering from competition found at those presentations.

With regard to supply limitation for Pentacel that we discussed extensively in our July call, there is nothing new from what I told you except that we have now 3 batches that have been released since the beginning of the summer. Our objective, we remain then to get back out to full supply early next year.

So to conclude, solid underlying performance for Q3 despite supply constraints, and we are expecting a strong fourth quarter with double-digit growth.

Now I hand over to Hanspeter.

Hanspeter Spek

So continuing with the other growth platforms. You'll find then on Page 17 a closer look to Emerging Markets. Emerging Markets sales have been growing by 6.8%, based on first glance, may look a little bit soft. Now if you look to our major competitors, you see then for the same quarter growth of 6% for AstraZeneca and 6% for Novartis, and only Roche has been better this 11%. Keeping in mind what Chris said before concerning the relative volatility of sales in Emerging Markets from quarter-to-quarter, nevertheless, what can we state? If there is a little bit of softening, it may be in Latin America. We have in Latin America only 1 minor issue, which is a tax situation in Brazil. I believe to know that we are not the only pharmaceutical company facing it. We have on top a strong concentration of our Medley sales in the state of São Paulo, which underwent a major tax restructurization, and the hope to overcome this is in the upcoming quarters by reallocating our forces in other parts of the country, moving partially out of the state of São Paulo. The Asian performance is very much in line with the previous quarter. There may be a little bit of slowdown in the Chinese sales, which is partially due to season. You know that our CHC sales mainly driven by cough and cold products and sales at different seasonality, and we hope to compensate this in the 2 upcoming quarters. There is absolutely no change in trend concerning Eastern Europe and Turkey. We had in the previous quarter exactly the same sales and exactly the flat growth rate, same explanation as last quarter. Those markets become more and more closer in their growth pattern to the Western European ones. We have a clear difference now in Africa and Middle East, where we had previously very strong 2-digit growth rate, 17% in the last quarter -- second quarter 2012, now only 2.8%. This is entirely due to technical reasons. So you may know that the African market is largely dominated by tenders, which vary from quarter-to-quarter, and [indiscernible] on the strong acceleration of our sales for the upcoming and ongoing fourth quarter in Africa. So overall, we feel confirmed in our extremely strong position for overall Emerging Markets. You see they represent 31.2% of our company sales. And as such, we are and we continue to be, by far, the leading company in Emerging Markets, AstraZeneca achieving about 21% of company sales and Novartis 25% and Roche 26.8%.

Chris has mentioned the really excellent performance of our Diabetes franchise, which you see in more detail on Page 18. We have a growth of 17.5%, achieving nearly EUR 1.5 billion of sales in the quarter. Within Lantus, of course, plays the role of a kind of engine, which close to 21% growth. And yes, we are content and proud to report now the seventh consecutive quarter. This is a very strong growth. And as you see on the right side of the chart, this is true for all parts of the world. If nothing else is growing, even in Western Europe, it is at least our [indiscernible] in diabetes with 6% growth, while all the other segments are in high 2-digit numbers.

We continue to build on this. As you see on Page 19, we do it, of course, in all dimensions, in a geographical dimension. If I start with the bottom of the page, we have started to launch a specific device for Emerging Markets. It's a device that's produced at low-cost by us and produced locally in India. We are convinced that with us can make an adequate offer to those populations. This high-tech device, which nevertheless is affordable, we continue to build up new products. We expect for the weeks to come to see approval of Lyxumia, our next-generation product, as they launch in Europe approximately 1 year after. We are apt to launch in the United States, waiting for the resize of the ongoing CV outcome study. And yes, we also continue to work on the successor of Lantus. The so-called insulin glargine formulation is a high concentration, which is currently undergoing 6 Phase III clinical trials, which are all right on track and perform accordingly to plan. So also, the midterm future for our portfolio should be safe. We, of course, follow with a lot of attention, the ongoing launch preparation of Novo Nordisk. We have taken out all the labeling in Japan. We see that there is no difference at all to the existing labeling of Lantus, which makes us relatively confident and relaxed for eventually upcoming launches in Europe and later on in the U.S.A., where we have a couple of [indiscernible] coming from the upcoming hearing with the FDA.

On Page 20, information on Consumer Health Care. We have good and very solid sales, EUR 733 million in the quarter, up by nearly 6%. Also, once again, in Emerging Markets, very strong growth, above 16%. We continue to build on this business by internationalizing our major brands. You see an example here the box of Allegra to be launched within weeks in Japan. We have concluded a joint venture with Hisamitsu, a very experienced OTC company in Japan. And if you compare the box, this, let's say, is a box we sell through [indiscernible] very successfully for nearly 2 years now. You will see a high degree of similarity between both [indiscernible]. Allegra will be our real first worldwide brand, and other brands will, of course, follow.

A word on Page 21 then on Merial. Although Merial is very nicely on track, it's performing exactly to expectations. We have in the quarter close or very close to 4%. You see the comparison with last year, which is, once again, favorable. We have benefited to a lesser degree from problems of our competitors in terms of quality and production. We see well to the fipronil Frontline generic competition, especially in the U.S.A. but also in Europe. And we do this in a very -- the business of Merial continues to perform extremely well, also in terms of profitability, is a business operating income of 33.6% after 9 months, which means absolutely comparable to all our other activities and far ahead of our competitors inside Animal Health in terms of profitability.

Last but not least, I wanted to make you familiar with an upcoming launch in the United States. It's a very specific segment. It is a device, it is a product indicated for those people who are hyper allergic to any kind of allergy, being it from insects, being it from nutrition. It is a very often underestimated market. In fact, it is a market of approximately USD 600 million, and it is totally dominated by mostly 95% today by a product called EpiPen from Mylan, which today has no competitor or nearly no competitor at all. We believe that our product, Auvi-Q, presents significant advantages. It is a small device, it is a talking device, which is extremely easy to be used in a nevertheless very dramatic, sometimes life-threatening indication. We will bring this product to the market. It is already approved by the FDA, and we will bring it to the market by the end of this year or very early next year, just right in front of the upcoming season.

Once again, we feel it's a good example of how we carefully diversify our portfolio. We have a sound experience, of course, in allergy, being it due to Allergan, being it due to Nasacort, and we diversify here together with a licensor into a new device, which combines our expertise with the expertise of others to the best of our customers.

So I close here and pass on to Jérôme.

Jerome Contamine

Thank you, Hanspeter. So I move to Slide 24 on the P&L. Well, you see the P&L impacted this quarter by the loss of revenues coming from Plavix and Aprovel in the U.S., impacting those lines, other revenues and share on profit of associates, which both are declining strongly. Of course, this is -- this was expected, and I will give some more detail on the next slide. You may notice as well that we've reached a business operating income margin of the quarter of 33.9%, which put us well in a position to reach at least the high end of the 31%, 32% operating margin, which we gave as a guidance now at the beginning of the year.

If you move to this -- well, details on Slide 25, here, you see the impact of Plavix on the quarter. So the net impact on the business net income after tax is EUR 469 million, after around EUR 330 million, which we lost during Q2. So this is clearly in line with the guidance we gave for the full year to be around EUR 1.4 billion of negative impact of the loss of Plavix and Avapro. And as we know, there will be another EUR 700 million to lose in the first and second quarter of 2013. So we'll feel the impact over the coming 3 quarters, obviously. There is going to be some further comments, a, these lines, during the third quarter, benefit from a one-off payment made by BMS, in connection from -- with a litigation we had with them on the supply of Avalide, which, well, it had some shortage last year. So it has a positive impact on this contribution of $80 million, which, of course, will not be repeated in the coming quarters. The second thing I can mention is that on the income of assets, which goes down to EUR 6 million, this includes also the contribution of the Sanofi Pasteur MSD JV in Europe. This JV for the quarter the previous research expenses to Sanofi Pasteur. Therefore, the contribution of SPMSD has been negative over the quarter as a result of this one-off payment.

If I move to the next slide, well, we are now aware that for this year, we benefit from a very significant positive headwind from currency exchange rates. In particular, in Q3, in U.S. Dollars the exchange rate has been, again, the Euro 1.25 when it was 1.41 in the same quarter of last year. So the impact from sales has been EUR 561 million, out of which, EUR 354 million is due to U.S. dollar, EUR 82 million due to the Japanese yen versus euro and EUR 40 million interestingly due to the renminbi versus euro, which shows also the importance of our Chinese operations. This also was a positive impact on the business operating income, as long as we have a cost base, which is more euro-denominated than our sales base, obviously. And as you notice, I mean, we have a positive impact of the exchange rate on our BOI of around 8% for the quarter. Well, you'd be aware that when probably we could expect that in the coming quarters here, the Euro remains not very strong against the U.S. dollar, there is still high volatility. If I just look at the present exchange rates for the present quarter versus the same quarter of Q4 2011, we will not see the same positive headwind on a like-for-like basis.

Now on costs, well, basically, I think the main message is that we have somewhat concluded our EUR 2 billion cost savings objectives, which is a mission for the period 2012 to 2015, i.e., over 4 years. As a matter of fact, I think that we can say today that if I include the synergies associated to addition of Genzyme, which is close to be completed, will be completed in the first quarter of 2013, we will have reached around 40% of the overall objective over the year 2012. So this clearly impacts positively our different ratios at different levels. We'll start with cost of sales. You remember that we gave at the beginning of the year a guidance of around 31.5% to 32% ratio. And so the first 9 months at 31.1%, which clearly says that we are well in line with the objective to be on the high end of the guidance, i.e., around 31.5%. Of course, there is still some dilution arising from the evolution of the portfolio, including in Q3, the loss of Eloxatin sales. But if you compare Q3 2012 to Q3 2011, the difference has to be pretty minor, and we could say that around '12 should be the bottom in terms of cost of sales to sales ratio around the bottom.

On the next slide, 28, which is R&D expense, well, clearly, I mean, we have reduced significantly our R&D expense over the quarter by 10.7%. Part of it is due to the same event, which I mentioned earlier, which should be repayment by the JV of the -- having the expenses incurred by Sanofi Pasteur over time in connection with accelerant. So this impact is EUR 44 million. But even if I don't include this element, then the -- we continue to have a close on tight control of R&D expense, which a significant side of internal expense, while we are starting to spend more on external studies, on trials in particular, in connection with our Roche Phase III trials we recently launched, in connection with our new formulation of insulin glargine or in connection with the launch of the studies for the PCSK-9 product. So all in all, over the year, for the first 9 months, we reached a decline of 0.6% of the R&D to sales ratio, which is clearly showing the impact of the efforts we are doing to optimize our cost base and also as a result of the reorganization, which has taken place in the sales force in the U.S. and in Germany and other European countries at the beginning of this year.

SG&A, the message is pretty much the same. Our overall SG&A expense declined by 2.7%. On a quarter-to-quarter basis, this reflects the positive impact of Genzyme integration synergies on a tight control on G&A expense, which is down 4.1%. It reflects as well a further decrease of expenses in mature markets, whether in Europe or partly in the U.S., and some increase in new markets, whether it's emerging market or behind new launches. And we have started to increase our expenses clearly behind AUBAGIO, as well as Zaltrap and also preparing for the launch of Lyxumia.

On the net income, which is Slide 30, here, I like to mention 2 elements. So the first line is that the net financial expense benefit from the capital gain we've made on the disposal of Yves Rocher, which is, I mean, an element of the explanation of the decrease of the net financial expense for the quarter. And also, we benefit from a lower expected tax rate for the year. And this lower expected tax rate is connected to an agreement we've signed with the Japanese authorities, which, at the end of the day, reduce the overall taxation of the profits we generate from our Japanese sales. So we now, as a result of this agreement, expect an effective tax rate of 27% for the full year, and this is what has been taken into account in Q3 for the 3 first quarters. So thanks to these 2 elements, we post EUR 1.68 per share, earnings per share, which is clearly ahead of consensus, and we would have been ahead of consensus without these elements, of course, slightly less. And this is 14.5% below the level of last year on a constant exchange rate basis but thanks to be a positive exchange rate impacts I mentioned before. On the published basis, it's a decrease by only 6.1%.

Cash flow, clearly, the company is continuing to generate strong cash flow despite the loss of revenues coming from Plavix, which, of course, was not only profit but also cash flow. As you see from the slide, our free cash flow generated has been EUR 5.8 billion, pushing it down 10.7%, so pretty much in connection with the decrease of profit. However, it allows us to more than pay the dividend, which represented EUR 3.5 billion, as well as a share repurchase, which represented for the first 9 months EUR 825 million, including EUR 375 million over the third quarter. As a result of that, we see a decrease of debt. We are now below EUR 10 billion, and we have decrease of debt by around 1 -- net debt by around EUR 1.5 billion over the first 9 months and by EUR 2 billion versus end of June.

So clearly, I think we have posted today solid results, slightly better than anticipated for the first 9 months. They benefited from the solid growth and the solid performance of our growth platforms, also in the first quarter from the consolidation of Genzyme, which was not considered in the first quarter 2011, as Chris mentioned early on. We've seen, I would say, as expected, the competition on our legacy blockbusters, and we've seen that in Q3, the last one has come to a genericification, being Eloxatin in the U.S. And, well, let's be frank, I mean, the austerity measures have hurt the company as expected, with maybe some tendency to intensify here and there in southern European market. But, as is true as well, as Hanspeter has showed to you earlier, that our exposure to Europe start to decrease. We are now around 22% when we were 3 years ago around 33% of our overall sales being in Western Europe. We have showed continued discipline on costs and have front-loaded our EUR 2 billion saving plan. At the same time, we are progressively increasing our investment into new product launches. So this will continue and probably somewhat amplify in the coming quarters as we prepare for the launch of Lyxumia and, thereafter, for the launch of LEMTRADA. While the first 9 months have been impacted by some specific items, some of them being positive but some of them also being negative. The net has been slightly positive and clearly is also helping the overall evolution. But with all that and with solid performance, I mean, we manage today to feel comfortable that we will be on the high end of the year minus 12%, minus 15% guidance we gave at the beginning of the year. And we expect to end the year at around minus 12% versus last year despite the challenging global environment that the economy, in general, but also our industry, is facing.

With that, I think that -- I turn to -- turn back to Sébastien, maybe to handle the question on the Q&A session.

Sébastien Martel

Thank you, Jérôme. So we're indeed now ready to open the call to questions. As you probably know, we have 38 analysts covering us. So I will keep on asking you to ask 1 question at a time, 2 maximum, so that we can allow as many people as possible to participate in the discussions. Operator, we're ready to take questions.

Question-and-Answer Session

Operator

[Operator Instructions] You have your first question from Luisa Hector from Crédit Suisse.

Luisa Hector - Crédit Suisse AG, Research Division

So I'm wondering if you can give a bit more color on the outlook for the R&D spend. Clearly, there was a decline in spend during the third quarter, and you've quantified the reimbursements from the vaccines JV. But how do you see this as we move into 2013? And linked to that, we've seen some pipeline disappointment today in the press release, and these come partly from products, which you've in-licensed or acquired. And this was a key strategy to be more external-looking. So I don't know if you can give any color on what you've actually spent on upfront for Fovea, Metabolix and BiPar. I mean, they stand out as being 3 that have failed. And are there some write-downs we should expect for the fourth quarter? Obviously, none of this is going to be captured in your business net income. So how should we think about the R&D disappointments in terms of the financial side? And are there any lessons to be learned here? I mean, you wanted to be more external-looking in your R&D, and we're seeing a lot of the disappointments come through now. So was it not enough due diligence? Is it just we should expect this to happen? And as much I've highlighted the negatives, there are positives that are also happening. So any color that you can give us on that, please.

Christopher A. Viehbacher

I'll take the R&D. I have to say, Luisa, I haven't got a clue what you're talking about on negative. I mean, Metabolix is kind of an older story, iniparib is an older story and iniparib we'll make some conclusions on next year in terms of having them work on mechanisms of action. There is a non-small cell lung cancer study ongoing that we'll read out next year. We have a Phase II in triple negative breast cancer. So I would say the overall story in R&D is extremely positive. The external development of the 17 projects that we intend to launch between now and 2015, all but 2 of them are external. Just because you do external development doesn't mean you're going to change anything necessarily on attrition. You do this in a sense of trying to broaden your -- diversify your source of product and, to that extent, that you can expand your portfolio. At the end of the day though, we all live with R&D risk, and there are going to be some things that work out and some things that aren't. I wouldn't say that those 3 items, especially since they've been around for a while, have any particular reflection on whether or not the attrition rate is up or down. So I would say if I'm looking at the PCSK-9 and look at the dengue vaccine and I look at even our otamixaban and look at LEMTRADA and look at AUBAGIO, I look at our U300, look at Lyxumia, I would say the -- I'm actually very satisfied with where the progress is going, and where I sit, I think there's a complete -- continue with the strategy that we've laid out. But perhaps, Jérôme, you can give some color to Luisa's question on R&D spend.

Jerome Contamine

Yes, I don't have all figures. So I don't know all figures by heart, but I will give some color. When it comes to Fovea, well, first of all, I mean, the Fovea was not just 1 product, and we have built also ophthalmology unit. It's ongoing, with a handling of a few projects coming either from Fovea or from other sources including one from from [indiscernible] as well as one coming from Genzyme. So if I recall properly, we -- I mean, the beauty of in-licensing is that you pay by steps or by milestones. So I think that we initially invest EUR 90 million in Fovea to acquire not only the products but also the team, and there is no impairment to be expected. Metabolix, I mean, as Chris said, it's an old story. It was a preclinical investment. I mean, the write-off has been taken already, and I think it was in the range of EUR 10 million. And BiPar, I mean, we'll see, I mean, iniparib a few studies are still ongoing. So the value of BiPar in our book, and we never paid anything since the very beginning. And I think that the outstanding amount on the balance sheet is something like $350 million. But once again, I mean, as Chris said, I mean, even if we take some external products and say that you reduce the rate of attrition, and once again, I think iniparib there are still ongoing studies, although we'll see later on what we do with that.

Luisa Hector - Crédit Suisse AG, Research Division

Okay. So specifically on Fovea, there's still some technology behind that, so you're not exiting here despite the 2 changes from the Phase II results that were in the press release today?

Jerome Contamine

Exactly.

Olivier Charmeil

And maybe to clarify on the status of the Fovea 1,101 project, we basically decided to look for a sub-licensee that will potentially develop the compound further.

Jerome Contamine

On your question of R&D expense, I think we gave a guidance that R&D expense should be flat declining, with a ratio of around EUR 5 billion. This year, clearly, it will be somewhat below the EUR 5 billion. Of course, depending upon the base case study, in particular, we embark on in next year, I mean, this will -- may vary a lot, remaining below this ceiling, and we'll see exactly where we stand when we review our books, I mean, set priorities.

Operator

We have your next question from Mark Dainty from Citi.

Mark Dainty - Citigroup Inc, Research Division

Just a couple of specific ones. Just on teriflunomide, I noticed the only protection you have is in the exclusivity act until 2017. So I just wondered if there's a chance of a patent term extension there. And then just on Merial margins, obviously, impressive progression. Is that kind of reaching a peak now? Or do we think that continues to progress further?

Christopher A. Viehbacher

Just on AUBAGIO, there will be work ongoing in the U.S. There is a patent, but there could be a patent term extension, which could take it out towards 2019. Otherwise, we've got roughly 7 years of data exclusivity between the usual 5-years-plus pediatric exclusivity, if there is available, and the time for generic approval. But -- and, of course, in Europe, we would enjoy pretty much a 10-year data exclusivity period. Jérôme, do you want to talk about margins on the business?

Jerome Contamine

Yes, on Merial, I believe that we have little room to drive this 36% margin even higher. I remind you, market's mainly driven by our high share in pets, and inside pets, it is, of course, affected. We have this Frontline, the only nearly blockbuster-sized Animal Health product on the overall market, which is a unique thing. As more as we balance the portfolio from a strategic point of view, between production animals and pets, as more -- as less chance we have to drive this margin even higher. So I believe if you keep it stable, it's already a significant achievement over.

Operator

We have your next question from Tim Anderson from Sanford Bernstein.

Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division

Lantus, in the new formulation, can you tell us when you'll likely be on track to file that for regulatory approval? My guess is that it could be around 2014, but hoping you can confirm that. And related to Lantus, any update or perspective on Novo's degludec in the upcoming FDA advisory panel. Our thought is that it may relate to the hypoglycemia claims they're trying to make against your product. And then second question, Chris, can you describe Sanofi's current plans for M&A over the next couple of years just in terms of deal size?

Christopher A. Viehbacher

Hanspeter, do you want to start off on diabetes and I'll pick up on the M&A?

Hanspeter Spek

Yes. The new Lantus, the intent to file by 2014, being ready for launch in 2015 then. The second question in context was?

Christopher A. Viehbacher

Do we have any updates about...

Hanspeter Spek

No, on degludec, we really have no update to give. As I mentioned before, of course, we have taken note of the labeling in Japan, which confirms our conviction that the product, by no means, is better than Lantus and Lantus really is the gold standard. But we all wait as you for the upcoming FDA outcome, and we have no further knowledge.

Christopher A. Viehbacher

Tim, on M&A, I mean, if you were to take Genzyme out, but look at everything else we've done, it's pretty much an indicator of what we want to do. Genzyme was a unique transaction in the sense of really trying to get that credible scientific platform in the U.S., as well as boosting our own portfolio. But I think most of what we've been doing has been gradually building up on these growth platforms. On a practical basis, compared to what you can buy, obviously, given the fairly high concentration in Animal Health, most of what we can do from an anti-trust point of view is going to be smallish. So we acquired a company earlier this year in the United States, which really was designed to expand our swine vaccine business. Emerging markets is clearly an opportunity. The difficulty with Emerging Markets has been -- is that where we started in 2009 and we didn't have too many of our competitors looking at that. Obviously, everybody now is interested in Emerging Markets. The advantage of our footprint is that we can actually go therefore into emerging markets where fewer of our competitors are actually present. And what you're actually seeing is a lot of countries that are non-BRIC, really experiencing some pretty significant growth. I mean, if you take a country like Vietnam, for example, 100 million people in Vietnam, we acquired a business there, we already have a significant business, 2 factories in Vietnam. We acquired a business in Nigeria. Nigeria is one of the fastest-growing populations in the world, as is the whole African continent. A lot of money going into Africa, particularly from China and investments by China in education and health care in Africa. We bought, as Hanspeter already said, the business in Colombia. Colombia is probably one of the most exciting economies on the Latin American continent these days. So we'll continue to look for that -- for those types of acquisitions and try to find value where we can. CHC is clearly another area. We've been able to essentially almost double our business in 3 years, largely on the back of acquisition such as Chattem and Sunstone, and we'll be on the look. But they might be individual brands or smaller businesses. So that's pretty much what we're going to do. We've, I think, guided at around EUR 1 billion to EUR 2 billion per year on average in terms of our M&A strategy.

Operator

We have your next question from Richard Vosser from JPMorgan.

Richard Vosser - JP Morgan Chase & Co, Research Division

It's Richard Vosser from JPMorgan. First one, just following up on the comments on the R&D spend being flat, if I work through looking at the operating margin for 2012, even with the fourth quarter impact from Plavix and Eloxatin, I think it seems like you've so far surpassed the 32% original guidance for the operating margin. So could you help us understand sort of any uncertainties that might impact this view around the margin for 2012? And then secondly, just thinking about the positioning within your Diabetes franchise, you've got the new formulation coming in 2015. You said this -- the combo of vaccine that potentially will be hitting the market after similar time, maybe slightly after. How do you think of the positioning of these products within the market, within -- geographically within different markets and also within the same market and, of course, Lantus as well, the original product? Any help there would be useful.

Christopher A. Viehbacher

Jérôme and Olivier then?

Jerome Contamine

Yes. So Richard, well, there is no, I mean, uncertainty as such. I can just make a few comments. For the first one, in terms of cost of sales, of course, I mean, as you mentioned, to start with, I mean, we'll see the impact on Plavix on Q4, and this will be the full impact of being a bit more than the EUR 470 million because we came down -- won't have the onetime payment we got in the third quarter from BMS, so you could say around EUR 525 million or EUR 530 million on a constant exchange rate basis. Now in terms of cost of sales to sales ratio, addressed, recall that because we are going to sell more vaccines, and the cost margin vaccine, it's more in the range of 60%, which is some dilution, as usual, when we sell more vaccines on our cost of sales to sales ratio in the fourth quarter, which you also see the full impact of the loss of revenues from Eloxatin, which still have some positive contribution in Q3. So this where you understand why we are expecting around 31.5% over the full year. And when it comes to R&D, I mean, we discussed that already, the one-off event will not be -- will not impact the gain, and at the same time, we will probably spend a bit more on external R&D expenses, in connection with the late-stage Phase III studies, in particular, PCSK9. We should be back more in the segment of where we were in the previous quarters. When it comes to SG&A, we'll continue to pay -- I mean, to closely monitor our cost base. We will, however, invest a bit more in Q4 than in Q3 in MS, in particular, in terms of SG&A in order to, as I said before, to accompany the launch. And I would say, traditionally, there is always sort of seasonality on our expenses on a quarter-to-quarter basis, and we spend a bit more in the first quarter than in the third quarter, as an example. So this will probably replicate as well to a certain extent. So with that, I mean, there is not more -- I mean, I can't do in more detail than do your own calculation, and I think this clearly is totally in line with the guidance we gave for the full year.

Hanspeter Spek

The positioning is perhaps a little bit far away to be really final on it, but we strongly believe that this market, which is already today an enormous market and will be even more important tomorrow, is a paradise for product differentiation and say our number of x is where you can position being it the time to insulinization, being it a question to be in parent and/or oral. I'll remind you that beside AMARYL, Sanofi today is not at all an actor in the oral field or being it in the field of combinations, products having synergistic effects. And so talking just about the 2 we are working concretely on. U300 will be positioned depending on the outcome of the ongoing Phase III trials based on the much flatter, much longer levels U300 produces, and beside, it is an excellent opportunity to take advantage of the growing market segment of those patients who need high doses where, of course, we can play the fact that the product has a high concentration. So it presents a clear convenience. You said that there would be a vaccine under development. Probably, you were talking -- Olivier confirms to me that this is not the case. So you probably referred to the combination of Lyxumia with Lantus. So there is a final combination once again will be more in the convenience area because, as you know, we launched Lyxumia today as lixisenatide in mono presentation, and it will be freely combined with Lantus because the intent positioning is on top of insulin. And this is where it is established that we hopefully will have the fixed combination, which then has a convenience of giving just 1 injection instead of 2. So I'm really convinced there's a lot of opportunity to segment the market and to position very successfully.

Christopher A. Viehbacher

Did we get your question, Richard? Because I've heard kind of vaccine 2, and I wasn't sure whether...

Richard Vosser - JP Morgan Chase & Co, Research Division

No, it was on the combination product. Hanspeter was exactly right. That's where...

Operator

We have your next question from Vincent Meunier from Exane.

Vincent Meunier - Exane BNP Paribas, Research Division

The first one is on eliglustat. Can you please explain to us what will be the positioning of the drug, well, assuming that there is, again, 1 trial ongoing, ENCORE? But I would like to know if you consider the drug as -- is likely to become a new standard of care, i.e., first option like Cerezyme or Reprieve or if the drug is likely to become sort of a companion drug for Cerezyme or Reprieve. The second question is with regards to Lantus. I would like to -- I want information, if possible, on the evolution of price and volume, especially in the U.S. and in Emerging Markets where it was up by 22% and 35%, respectively.

Christopher A. Viehbacher

So starting on eliglustat, I mean, as you point out, we have to wait for the ENCORE study and get, obviously, a full picture of, first of all, safety. This is clearly an oral, which is convenient and appears to have comparable efficacy to the Cerezyme. At the same time and certainly at least at the start, the product will not have a pediatric indication. So we're talking about adolescent/adult patients, principally. I think you're also going to find that physicians have had a long experience done on not only Cerezyme but Ceredase before that, and I would be surprised if eliglustat rapidly moved Cerezyme up from a primary physician, especially because if you're starting on this drug as a child, switching at some point, maybe a decision about how confident the physicians feel. That having been said, there clearly are going to be a number of settings where an oral therapy is going to be extremely important. I was recently talking to our General Manager in Malaysia, who talked about a patient who needs to bring her 4 children with her on the bus every 2 weeks to do a 50-kilometer trip for infusion, obviously, in such settings, and you could be in rural areas where infusion centers are far and few between. So I would say it's a good tool for us to gain back market share from Reprieve, and I think we'll certainly provide a benefit for a number of patients. But I would see it -- at this stage, I would say its market position is gradually taking place rather than anything revolutionary.

Hanspeter Spek

On the Lantus price and volume, we have a growth of 22% in terms of -- well, half of it -- on a worldwide basis, half of it comes from price, the other half comes from volume. If we look into 3 market segments, we see very, very controversial trends, we have a relatively high share in terms of price, once again, 50% of total development in the U.S.A. Inside the market, we have, once again, very controversial trends, depending which customer and which channel you look to in the U.S. In Europe, we have a process you have seen before of approximately 6%, and this is entirely volume, we have even a little bit of a negative price effect coming mainly from Germany, to a lesser extent, also from France. And in the Emerging Markets, it's nearly entirely volume what we see. So to sum it up, yes, there may be some potential risk on the price element in the U.S., but I'm convinced that for the years to come, this will be overplayed by the strong volume increases, which we have in all market segments, being it in Emerging, in the U.S. or in Europe.

Vincent Meunier - Exane BNP Paribas, Research Division

Can I have a last question? In the U.S., can you tell us what is the daily average price per patient?

Jerome Contamine

Above $5.

Operator

We have your next question from Peter Verdult from Morgan Stanley.

Peter Verdult - Morgan Stanley, Research Division

Pete Verdult here from Morgan Stanley. I just wanted follow-up on the Lantus pricing question. Hanspeter, in terms of going forward, regardless of where you stand in the debate, there's a new competitor in the basal insulin space coming aboard for sure in Japan and in Europe and potentially U.S. at some point going forward. Wherever you stand on the debate there that the pricing of that product is going to be a significant premium to the current basal insulin analogs that are currently available. So I just want to know, is that an opportunity for Sanofi in terms of how we should be thinking about pricing flexibility going forward, given the comments you've made about how you believe the products stack up against each other? And then shifting one for Chris. I mean, you've beaten consensus by 5%, 10% each in Q1, Q2, Q3. You've mentioned some of the potential headwinds you might be facing in Q4, but I was just wondering whether the reluctance to change guidance further or be more positive on the outlook. Does that reflect some sort of political situation in France in terms of what you can do in terms of the productivity initiatives you're trying to push through in France and, at the same time, potentially raising guidance in that climate?

Hanspeter Spek

Chris, you want me to go first?

Christopher A. Viehbacher

Yes, sure. Go ahead on the -- on that, Hanspeter.

Hanspeter Spek

So it's a little bit difficult to say. I mean, you may have heard before, it means that Novo Nordisk has always claimed to go for a superior pricing for degludec in respect to Lantus. I am not very optimistic, in this respect. I have said earlier and I'll repeat it, and now I repeat after I have seen the labeling in Japan, that I don't see any room for superior pricing definitely in the Emerging Markets and in Europe and the U.S., we would have to see depending also probably on the channel. Second, the real issue is not the issue for Sanofi, it is an issue for Nova Nordisk in first instance because they have to position the new product in terms of price against their present partner products, which are there for many, many years and representing 60%, 70% of the total insulin sales. And on top, they have to position it against Levemir, which probably will suffer, anyway. So besides having market shares in the analog segment of 60%, 70%, I believe we have really eaten every reason to look what will Novo Nordisk try to do and what they will effectively achieve. And then, yes, there may be an upside for us. I believe that you can exclude any downside on us, which nowadays is already very positive.

Christopher A. Viehbacher

Peter, concerning outlook, no, it's not really related to French politics because in any case, the general opinion would be looking at published numbers versus constant exchange rates, which are clearly better than where we are on a current exchange rate basis. No, I think the beat really in Q3 was to a degree driven by some nonrecurring items, the payment from BMS, some reimbursement here and there. I think broadly, when I look at the business is that the growth platforms are really performing well but performing consistently and in line and consistent with our more medium-term guidance. Obviously, every quarter, we try to do the best we can. But I think we are plugging along pretty solidly and pretty well through it, and being up at the top end of the guidance kind of reflects that.

Operator

We have your next question from Seamus Fernandez from Leerink Swann.

Seamus Fernandez - Leerink Swann LLC, Research Division

Just a couple of quick questions for Jérôme and then a question on Merial. Jérôme, can you just update us on your thoughts on the sustainability of the tax rate as we see it this year? Post 2012, it sounds like some of these changes may actually be structural. And also, Jérôme, did I hear you right that you believe that 2012 will really be the bottom or the worst for the positioning and the cost of goods? And then separately, maybe 2 additional questions quickly. On Merial, we're actually hearing that there may be some new products in Merial, particularly on the flea and tick side, that may be breakthrough in nature. Just wondering what your enthusiasm is for the Merial pipeline. And then the final question on the Lantus, the new Lantus. How should we think about the opportunity there? Is this really more of an extension or improvement of the franchise and -- or really more an extension of the franchise with IP protection that allows you to be incrementally competitive? Are there any production benefits that could be seen so that gross margins could even improve to some degree?

Jerome Contamine

Okay. If I can take the 2 questions, 2 financial questions. On the tax rate, well, as you know, the share of our profit, which is derived from royalties being taxed as a low tax rate under the French taxation scheme, is decreasing significantly. So we have been working on compensating for that through various means, including some renegotiation. You heard about the renegotiation with the Japanese authorities, which [indiscernible] number 1. However, I think that we are heading on a sustainable basis to tax rate, which will be around 30%. We are still working on having something better. There is some room for improvement, but I will not at this stage commit from -- for a better rate than the 30%, let's say, on the medium term than say that next year, we would still maybe get some optimizations, which would get us to a lower rate than 30%. On the question of COGS -- on COGS, yes, I mean, I strongly believe that on the basis of our existing business, that we should be able to somewhat, of course, it would be huge in the first [indiscernible] but somewhat increase or improvement, let's say, of COGS to sales ratio, in other term, decrease of COGS to sales ratio. As for next year, of course, it may vary on a quarter-by-quarter basis depending upon the mix of business, I mentioned before the contribution of vaccine as an example. But on average for next year, we should see a slight improvement of COGS to sales ratio.

Hanspeter Spek

Well, on Merial, yes, it's true, we have, over the last year, significantly invested into a replacement strategy and not only replacement expansion strategy for Frontline. We intend to deposit those products with the authorities, which means in the U.S. with the FDA during 2013. It is a group of new products for cat and dog. It is products against flea and tick and also endo, EXO, which means also against parasites like heartworm for dogs. It will be product in a totally new form, chewables, which means orals, and not only spot-on. And yes, it is safe to say that we, in fact, plan a major offensive into this field where we have this terrific heritage franchise around Frontline, which, of course, will give us an excellent starting phases, even more as it will be built around a new set of molecules. We will launch those products as of 2014, 2015, and it's therefor that we also expect for 2014 and '15 an acceleration of growth. Now on the new form on Lantus, I think it's really too early to say. I said earliest that we had today, 6 Phase III trials going on, and I don't want to be premature. It's clear that beyond this product will present us interesting aspects in terms of patent protection or IP overall, as more as we will be able to replace as better off we are. And yes, at least, theoretically, there is also potential upside for the cost of goods because this product will be coming out of our Frankfurt insulin fermentation and filling plant. And whatever we produce more in Frankfurt is absorbing overheads and, therefore, good for the overall portfolio. But I cannot be much more specific for the reasons I gave in context with the ongoing clinical trials.

Operator

The last question is from Graham Parry from Bank of America Merrill Lynch.

Graham Parry - BofA Merrill Lynch, Research Division

So just first question, just the thought process on expanding new glargine to compare with non-insulin agents, which would be an arguably milder patient population when you haven't gone for patients on mid to low doses of Lantus, and a rough date timeline for the data from those trials. Second, you say you've seen no scope for differentiation of degludec pricing, so I just wonder what your thoughts were on the fact that the CHMP statement in the approval document said that degludec has a better high profile than Lantus. And then just on the 32% growth on Lantus in Emerging Markets. Just trying to work out if there's anything lumpy in that. Is there any tender or new reimbursement in any specific country or region that would have led to do that?

Hanspeter Spek

Yes, I take the degludec pricing, first, well, I mean, there is a statement which is one thing of what will be finally on the label is another thing. And once again, I'll refer to what has been published and issued from the Japanese authorities. But even beyond, I doubt, given our experience in authorizing prices and access for Lantus in Europe, I remind you, that it took us nearly 10 years to get access in major countries like Italy with Lantus where we had very, very, very good arguments. And I remind you, that even today, we have Bundesland in Germany, which unfortunately is the second most important buyer where Lantus still is not being reimbursed. So I'm extremely doubtful if you would have something in the labeling with a little advantage in terms of high [indiscernible] in Europe, which justify a higher price. But ready to look to the opposite, then it should be proven by Novo Nordisk. I take the opportunity also to express the thought. We have -- I mean, overall, we have a clinical program for degludec of approximately 16 or 17 trials. Out of those, 2 are published as of today. And once again, we will see what comes out of the remaining 15 or 14 at the upcoming ad com conference of the FDA.

Olivier Charmeil

Maybe just, Graham, on the question about testing the use of the new formulation of Lantus in known insulin patients. There has been a study from the addition program initiated just over the summer in August, and I can forward you the details of that trial. It's listed in clinicaltrials.gov.

Graham Parry - BofA Merrill Lynch, Research Division

That's, again, lower dose Lantus patients?

Olivier Charmeil

Yes. [indiscernible] patients.

Sébastien Martel

So maybe, Chris, at this point, if you would like to say a few words to wrap up the call?

Christopher A. Viehbacher

Yes. No, I think it's pretty much like the reply I had to Peter. I mean, I think the company is progressing well through the patent cliff. Pretty much everything that is going to face generic competition in U.S. and Europe is now in that process. The impact, I think, has been pretty well-signaled really for almost 2 years now. What is important is to look at the growth platforms. We gave medium-term guidance out to 2015 where the growth platforms are expected to get to 80% of sales. I think the fact that we're at 70.9% shows that, that's not an unrealistic target. So I think the business continues to perform really in line with both short-term, as well as medium-term expectations. There are some headwinds notably in Europe, as we said. But equally, I think the diversified nature of our business positions us well. When I look at the last 2 or 3 quarters, I would have to say that those companies who bet only on R&D have had some difficulties, and I think having a broader range of more sustainably growing franchise is a way to deal with the difficult world. There's really no question that we've got very strong leadership in Emerging Markets versus most of our competitors. The Diabetes franchise is shaping up well and I think really reflects the enormous size of this market on a worldwide basis. So I'll say I think we come through the quarter and feel very confident in the outlook, and we'll continue to really closely manage costs, obviously. I think the R&D portfolio is shaping up, and we need to get those products to market now. And we are making those investments. On R&D, clearly, we do have some major programs coming along, and the approach thus far has been really to, let's say, transfer a nonproductive spending into more project-related spending, continue to reduce our fixed cost percentage of our R&D spend versus the more project-driven costs. And I think the very extensive restructuring that has been undertaken over the past year in research really is an example of that, and that was largely enabled by Genzyme. And perhaps I'll close with Genzyme. I think, today, I think Genzyme is clearly contributing strongly to the company and very much in line with the benefits that we had forecast when we completed the transaction. So to say, I think we continue to go through. There's choppy water here and there, but there's opportunities elsewhere as well, and I think the company is well-positioned to deal with both.

So I thank everybody for listening, and we'll see you out there on roadshows. I'll turn it back to Sébastien.

Sébastien Martel

Thank you, Chris. Maybe just before closing, I'd like to remind you of 2 upcoming IR events for November. First, Sanofi and Regeneron will host a conference call during the upcoming AHA congress, which will be focusing on our anti-PCSK9 antibody, with the launch of the Phase III program, ODYSSEY. This will take place on Monday, November 5. The webcast will be available as of 4:15 p.m. Paris Time or 7:15 a.m. Los Angeles Time, where the congress is taking place. And the next event will be in South America, where we will be organizing an IR schematic seminar in São Paulo on the 29th and 30th of November. You will have a chance to meet with Hanspeter Spek, as well as Heraldo Marchezini, who is in charge of the Lat Am region. There will also be opportunities to meet with the local management for Diabetes, Vaccines, Animal Health, Generics, as well as Industrial Affairs and we'll visit Pharmacy and Plants.

So with that, I'd like to thank you for your participation and wish everybody a good day.

Operator

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

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Source: Sanofi Management Discusses Q3 2012 Results - Earnings Call Transcript
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