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Sanofi (SNY)

Q3 2012 Earnings Call· Thu, Oct 25, 2012

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Transcript

Operator

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

Analyst

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…

Hanspeter Spek

Analyst

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

Analyst

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

Analyst

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…

Jerome Contamine

Analyst

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…

Operator

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

Analyst

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

Analyst

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

Analyst

Exactly.

Olivier Charmeil

Analyst

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

Analyst

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

Operator

We have your next question from Mark Dainty from Citi.

Mark Dainty - Citigroup Inc, Research Division

Analyst

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

Analyst

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

Analyst

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

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

Analyst

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

Hanspeter Spek

Analyst

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

Analyst

Do we have any updates about...

Hanspeter Spek

Analyst

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

Analyst

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

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

Analyst

Jérôme and Olivier then?

Jerome Contamine

Analyst

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

Analyst

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

Analyst

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

Operator

We have your next question from Vincent Meunier from Exane.

Vincent Meunier - Exane BNP Paribas, Research Division

Analyst

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

Analyst

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

Analyst

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

Analyst

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

Jerome Contamine

Analyst

Above $5.

Operator

Operator

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

Peter Verdult - Morgan Stanley, Research Division

Analyst

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

Analyst

Chris, you want me to go first?

Christopher A. Viehbacher

Analyst

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

Hanspeter Spek

Analyst

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

Analyst

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

Operator

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

Seamus Fernandez - Leerink Swann LLC, Research Division

Analyst

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

Analyst

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

Analyst

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

Operator

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

Graham Parry - BofA Merrill Lynch, Research Division

Analyst

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

Analyst

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

Analyst

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

Analyst

That's, again, lower dose Lantus patients?

Olivier Charmeil

Analyst

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

Analyst

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…

Operator

Operator

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