Sanofi-Aventis
SNY
Sanofi (SNY)
Q4 2009 Earnings Call· Thu, Feb 11, 2010
$46.04
+0.21%
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+0.25%
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+2.77%
1 Month
+9.19%
vs S&P
+1.53%
Sanofi-Aventis
SNY
Executives
Management
Sébastien Martel – VP, IR Christopher Viehbacher – CEO Hanspeter Spek – President, Global Operations Wayne Pisano – SVP, Vaccines Jérôme Contamine – EVP and CFO Marc Cluzel – EVP, Global R&D Laurence Debroux – SVP and Chief Strategy Officer
Analysts
Management
Sébastien Berthon – Exane BNP Paribas Graham Parry – Bank of America/Merrill Lynch Jo Walton – Credit Suisse Eric Le Berrigaud – Raymond James Philippe Lanone – Natixis Securities Alexandra Hauber – J.P. Morgan Norris Shirhan [ph] – ICAP Jean Jacques Le Fur – Oddo Securities Sébastien Martel: Okay. There we go. Hello, everyone, and welcome to the Sanofi-Aventis full year 2009 annual results. It's a pleasure to have you here. As always, I'd like to remind you that today's conference is actually also available through live webcast, and the slides that we'll show today are available on our Web site. I must remind you that today's conference would contain forward-looking statements. And these statements will involve known and unknown risks and uncertainties and other factors that could cause actual results to differ materially. We can find details on – about those factors in our Form 20-F on file with the SEC as well as in our Document de Référence. Today with us is our management team with our CEO, Christopher Viehbacher; Hanspeter Spek, President of Global Operations; Wayne Pisano, Senior Vice President of Vaccines; and, Jérôme Contamine, our Executive VP and CFO. The presentation will be followed by a Q&A session. And at this stage, I will actually hand the conference over to Chris.
Christopher Viehbacher
CEO
Thank you, Sébastien. Good afternoon, everybody, welcome to Paris. In some ways, it seems a lot long ago than one year that I think I stood up and presented the first set of results for Sanofi. And it's certainly a pleasure to think back now after, certainly, my first year in office. And I think a lot's changed. I think a lot's changed in the industry, and a lot has changed very positively within the company. So what's changed in the industry? I think one of the things that's getting interesting is that the famous cliff is now getting on to the spreadsheets. This is no longer something that they'll stay in the future. We're now into '11, '12, '13, and beyond. And I think the entire industry is starting to recognize that really share price is not being driven by our quarterly results anymore, but more of the long term. I was talking to one of the bigger biotechs out of the J.P. Morgan conference. And it's incredible, we don't have any patent expiries before 2017, but we've already got people asking us how we're going to replace our patent cliff in 2017, and this element where the cliff gets anticipated. And what people are really looking for is this sustainable growth. And so, it's great and we need to have regular quarterly earnings. But I think the whole industry is now recognizing we need to address this issue beyond the cliff. I think we are innovative the last year. We put out a floor guidance for 2013, which was really meant to have people focus on the fundamentals of Sanofi-Aventis and to really dispel some of the myths. Like for instance, if we can commit to the same level of profit as we did in sales in 2008,…
Hanspeter Spek
President
Thank you, Chris. Good afternoon. As Chris said, I will try to guide through our performance slides in 2009. Evidently, let me start with the sales. You see the overall sales peak of EUR29.3 billion and an overall growth of 5.3%. You've heard that these – that there has been a growth in all parts of the world, 3% in Europe, 2.8% in the United States, 12% in the rest of the world. It also states that the fourth quarter brought an acceleration of growth with the exception of Europe, due to the increasing general application of Plavix. But our sales in the United States accelerated to nearly 10% growth, and in the rest of the world, sales accelerated to 18%. This is partly, but not only explained by what you see then in the fourth quarter for vaccine sales. A 65% of growth, which has largely considered it to increase of sales in the United States, but to a much lesser extent, that would be acceleration of growth in the rest of the world. Overall, I think it's fair to say that we have well resisted the generic competition. I dare to remind you that this is the kind of competition, which we had originally not planned for 2009. We were not supposed to lose the protection of Plavix in Europe, and we continue to fight against this on various levels. And we were not expecting to lose by a court decision the protection of Eloxatin in the United States. It's the point of time when it happened and also against this we continue to litigate. Now how has this been construed overall by a process of strong growth rates and by established Lovenox and Lantus? Both products have now overpass EUR3 billion of annual sales. While this may…
Wayne Pisano
Management
Okay. Taking a look at the vaccine division, 2009 was both an exciting and overall an excellent year in terms of our performance. Revenue was slightly over EUR3.4 billion, up 19%. We had strong performance across all of our franchises. As Hanspeter referenced, we had an exceptionally strong fourth quarter, over EUR1 billion of sales. A lot of that is linked to H1N1 and the pandemic. And I'll address that in a moment. But before that, we'd like to look at our basic business. In our Polio/Pertussis/Hib franchise, our pediatric franchise, we had over 20% growth. The business today is over EUR0.75 billion. And this is business is being driven globally. In the US, the first of the Pentacel launch – Chris referenced that our market share against one other competitor is now at 70% after our first full year in the marketplace. Our product, Pentaxim, another pentavalent vaccine that is used throughout the international markets, continues to grow significantly. This was introduced in 2005 in Mexico and Turkey. It is now being introduced throughout the Latin American region, throughout Eastern Europe and the Middle East. Our pneumonia and meningitis franchise was up 6%. The catch-up market for bacterial meningitis is – has probably – has reached its peak in the US. We continue to grow the greatest opportunity for bacterial meningitis now will be in the international marketplace as long term and new indications in North America. The emerging markets was up 16%. Our business is approaching EUR1 billion now in international markets, and so a strong growth there. Now, total sales on H1N1 in the fourth quarter were EUR440 million. This was in line with the guidance that we gave where we had projected sales to be about EUR1 billion between the end of 2009 and 2010. So…
Christopher Viehbacher
CEO
Thank you, Jérôme. Again, so what does 2010 look like? I'm not going to apologize. It's going to look like 2009. We've got a strategy. You don't change your strategy every year. I think well we really are focused on execution. I think I've said before, strategy is actually the easy part. Execution is the hard part. So our formula for growth remains unchanged, and we'll going to continue to pursue with the same passion and energy that we did in 2009. In R&D, as I said, I think whereas we were looking more at the clean-up and change, getting some cultural change to occur, we're going to put some runs on the board now in terms of actually bringing in more innovation in the research and development. We clearly have an opportunity to accelerate high potential late stage candidates, like our PARP inhibitor. There are some exciting things in early stage. I think our policy is not going to be to say, "Let's go do big pipeline reviews and everything else." From my experience is that you can a mouthful about R&D structures, you can talk a mouth load about R&D portfolio, and you get zit for it in your value and you give an awful lot of information to your competitors. So we'll probably not talk enough a lot about anything that's in early stage, and really wait until what our company hears from the market. But there are some interesting things. I was talking with one investor recently and let slip that we had our PC SK9 in there. "Why? Do you have a PC SK9? This is hot property in the pharmaceutical industry." And, "Yes, we have one of those." And these are things that we will clearly be looking to really accelerate and bring forward.…
Christopher Viehbacher
CEO
All right, Sébastien. Sébastien Berthon – Exane BNP Paribas: Yes, hello. This is Sébastien Berthon from Exane BNP Paribas. Two quick questions please, one on diabetes and one on emerging markets. I noticed your target have overtaken Novo Nordisk within the next year in diabetes. There's a 25% gap on sales as you mentioned. How do you see how you can gain market share against Novo given that they are launching their own GLP-1 in probably two years before yours, and also have a next generation wave of insulins, which is probably three or four years ahead of yours? So should we assume that this gap will be by acquisitions? That's the diabetes question. And regarding emerging markets, obviously, growth has picked up over the year. If you think – I mean your growth still seems to be slightly below the emerging markets pharma sales growth. Any particular regions where you see particularly intense competition? And should we assume in the future that as a big leader in emerging markets, which you are right now, you will have to give a little bit of market share to your competitors or you're still confident you can grow actually in line with the market there?
Hanspeter Spek
President
In diabetes, you may have noticed that I didn't give a year when we take over Novo Nordisk. It's a target. It's overall a target. Evidently, Novo Nordisk will continue to grow. It depends on various aspects. I believe that we have a certain attention to developing costs as opposed to where we are, usually, stronger even, much stronger than Novo Nordisk. So it will largely depend – we can take advantage of it into the – even in large business. The second element is definitely new products. They have tried to launch a new product in the US. This took them some while with this – we all know we have to see how this product and how in class it will perform. In any case, they have a new product. For the time being, we have managed the products we have on (inaudible) let's say, three years from today. We believe we are in a better position once again. We have a number of single agents under development. And yes, I personally have quite some expectations of the combination, which I've already mentioned earlier today by this – of GLP-1, this Lantus. We also work, as you know, on a long-lasting Lantus. So it will be based on new products, which will contribute. And to circle on these – the environment of pharmaceuticals, which means mainly blood glucose monitoring, and also devices like pens, I believe that everything is, for the time being, open. But I'm confident that we will be a little bit faster than Novo Nordisk on the actual post monitoring. This is not a simple blood glucose monitoring, but it is who will succeed to connect best those devices with the individual pharmaceutical product offer. Who comes up with this first will have definitely, once…
Christopher Viehbacher
CEO
And I will just add on that, to me, it's not a market share thing. Market share is really, if you have a developed market and you got to go steal share from somebody. There is going to be an element of competition in those markets. But the real issue is really the growth in those markets. So you take China, for example, there's pretty much everybody on the East Coast of China. But the further you go inland, and in particular as you go west of the Szechuan provinces, not everybody is there. And so, you're not interested in whether your market share is bigger or smaller than Bayer or Pfizer at that point. It is, how do you find reps, train them up, get them in the finer positions. We have a range of products that you can use to match that. You take up Brazil, there is more of a market share game, and in Mexico. But you've got other markets where it really is market expansion, market development issue. So for me, I think one of the core things is how well is that business is growing. And if it's growing at nice strong double digits, then you do want to benchmark yourselves in some ways. But it is also all about growth. We also know that not all of the products – not only do you not have the issue in IMS because of the rebate mechanisms, you also have a whole range of products that aren't always covered. I mean vaccines are actually very poorly covered even in places like the United States. We also have very poor coverage of some OTC in that regard, so. It is a benchmark. We have a kind of a look at it. But personally, I'm looking at…
Christopher Viehbacher
CEO
All right. With Lovenox, we don't know anything more than the chatter. The FDA talks to the generic applicants, not to us. So we're just prudent and listening to that. And we've heard the rumors that they're talking to wholesalers in the like. We have a fire drill early in December, where there's all kinds of chatter that this is going to be a Christmas present to Momento, and Santa Claus did not deliver. We've had another fire drill in the second week of January. So we just said, "While there's lots of chatter out there, it seemed to be more intense than typical chatter, but we have no information on that." In terms of IRRs and things like that, I mean to a degree – and I'll let Laurence and Jérôme take a crack at this. It depends on, to me, a little bit about what type of business to this you're buying. An IRR makes no sense on a – to me, on a biotech company, to tie they're invaluable investment is a total waste of money. And there is no medium happy ground in there. If you're buying an OTC company, however, then I think you termed it into a more traditional return on investment criteria. But Laurence, maybe you'll give it a crack, or Jérôme, if you'd like to answer that?
Laurence Debroux
Management
Well we do calculate the number of metrics, including IRR on every project. I cannot tell you there is a magic number that we apply, and we discuss each project on an individual basis, and based on its merits, and based on the types of projects that you're looking at, whether it's more R&D oriented or totally OTC types of projects. And we discuss that to Jérôme to see what should apply on a project-by-project basis. So I don't think we will give you a target at the company level. Jérôme Contamine: We can say that, of course, all projects have to be – or acquisitions, let's say, have to be – have to have an IRR, which is significantly involved in the cost of capital of the group. Then you need to think about what is the cost of capital risk you'd take. And here, you have to weigh that with the area that you (inaudible) you are in so that you would do that with the expected IRR for a project in Thailand is right or not, much higher than the one we will get in the US. One important issue is also to what extent is it wrong to have – do we have a wrong perspective or not? So here, I would say, because very (inaudible) of the question one, when do you get the risk on the capital, which is above your cost of capital? And here, I would say, if you are into a (inaudible) like Chattem, where you have five generations of production, you have a very, very long horizon, you could really accept what return of capital, which is above the cost of capital, let's say, after you are seven or you're eight. And if you go a more a high risk project, well you have to assume that you need to have a cost of capital – your return on capital above the IRR three or four. And that means you will be around five or six, that could it be arranged and we will accept to go this type of range when going for business, which offers a long term visibility.
Christopher Viehbacher
CEO
Personally, I think if you ever make an acquisition decision on that type of analysis, you're not going to get very far. I think I'd like to look first at a company and say, "What do we bring as management that current management isn't doing? What can we do in terms of sales growth? And where is there a good business rationale opportunity?" If you can really come up with a good equity story around that, then the numbers will generally work if it's a good margin business. If you go and decide on an IRR, quite honestly, I'd rather not touch the business, so it's probably too close to the line to call. On the growth rate of the 19-point whatever in the– Jérôme Contamine: The emerging markets, the overall growth rate was already at 19%. There is no currency effect at all. This is at the constant exchange rate – on the constant exchange rate basis. If I recall properly, the organic growth rate for the full year has been 7.5%, keeping in mind that this includes the impact of the economy crisis at the beginning of the year, specifically in Latin America. And you remember that during the first quarter, I would say, – the two first quarters, the growth in Latin America was slightly lower, particularly in Mexico and to some extent in Brazil. We are really recovering from that. So the first quarter organic growth rate has been (inaudible) the average growth rate of the year, so we are catching that to the 10% average we are aiming at. Once again, I mean this year, people tend to forget. But when we're in Q1, we are still at the end of the currency crisis, and we will – I mean the concession was going down. So yes, the key thing I'd like you to get from that is we are seeing an increase in organic growth rate around emerging market sales over the year, and in particular in Q4 as I compare to the previous quarters. And I think on average, the 10% objective, which we had, organic plus acquisitions, is definitely advancing, which remains our objective on the remainder of the year though.
Christopher Viehbacher
CEO
You want to add to that Hanspeter? I mean you had a slide that actually showed–
Hanspeter Spek
President
That's the only thing you will see again. You'll definitely see a strong difference in the first quarter – second quarter, which was at least on the level of the previous one. It's not an acceleration. It's (inaudible).
Christopher Viehbacher
CEO
It wasn't actually just the economic crisis, and in Mexico in particular, was hard hit, also because they suffered particularly hard from the H1N1 crisis. They went through a two-week where they shut down travel and businesses. And I think the Mexican economy was down something like 7% at the beginning of the year. Brazil, it started also in negative territory, and moved into neutral zone as halfway through the year, and came back into growth in the second half. When you consider that we have a huge exposure to Latin American economy, in particular, we have over billion euros of sales certainly in Brazil, and close to that in Mexico, that will actually start to weigh on the results. But I think Jérôme is right that we would be expect to be growing in double digits in those markets, enhanced by acquisitions. Oh my, other side. Jo Walton – Credit Suisse: Jo Walton from Credit Suisse. I've got a couple of general questions and a few other public ones. The general one though is really to do with R&D expense. I wonder if you can tell us, of your EUR6 billion of licensing and acquisition spending, how much of that was effectively buying R&D externally, but other companies who did the same work internally would have put through the P&L? I'm particularly concerned that we see a reduction in the R&D as a percentage of sales, but not actually seeing a reduction in spending. And I wonder how investors are supposed to mark you to this because now you're not even including the amortizations that might ultimately come out of it. It seems to be getting a free ride on the spending that's never going to appear in an earnings number that you've asked investors to look at. Could you also give us some help on the profitability of Lovenox in the US, just very, very prudently? If it does it go in the US, is it a more than averagely profitable product, a less than averagely profitable product? Do you have any – a variable cost that you can remove from it in terms of promotion or will the loss in sales pretty much go through in the short term to the bottom line? And then, I'd like to just ask on Multaq, can you tell us where the 34% Tier 2 for the PARP fees is actually accessed? Is that good or bad? I don't know. It doesn't sound brilliant, but I guess you feel that it is. So what could that go up to? And a final one for your flu product, you talk about your high dose flu for the elderly. Can you give us some sense of what proportion of the market for flu vaccines is delivered to the elderly? Is that like a big opportunity? And could you get a price premium, any ace-type endorsement that would actually drive the market share towards that product?
Christopher Viehbacher
CEO
So let's take the R&D question first. And then, first in terms of where do you put the amortization. And I know this is not going to make a difference for quite a while because you don't start amortizing until you actually launch a product. And if we get there, we'll all be happy. We actually do disclose the number as far as I understand. We're not putting it in that number just to be consistent. And we've actually looked at what our peer companies do, so we want to be in line with that. And sometimes, by the way, that amortization number, in my experience doesn't actually land up on the R&D line. It lands up on the cost of sales line, for example. So I think we will try to do that. We have had a net reduction in R&D spending internally, and we have added back on projects. So if you see a reduction in the minus 7%, it's actually a net reduction in spending. Yes, you buy in R&D, but if it was R&D that you didn't spend from the past, I think that number loss was also around 600. Jérôme Contamine: We have invested in-licensing EUR325 million. That's for 18 partnerships. So I think you have to compare what you can compare. The thing about what it means in terms of the range of products coming from (inaudible) to Phase II, this doesn't include investment in BiPar. And BiPar as you now recall, it has been disclosed that the overall spending, if we go to approval to (inaudible) is EUR500 million. But we are not yet there, by far, from there. So if I put all that together, I mean as – because that's originally with Marc, I think the cost of external R&D versus internal research front and bringing the product in NFA to (inaudible), remains definitely quite competitive.
Laurence Debroux
Management
And also, as we've done some early agreement on R&D, which are really research collaborations, you put in the – in your assets what you say as milestones. But then, after that, our R&D is going to work on this product and that's going to flow through the P&L. So what you put in the assets, of course, will only be amortized when you launch a product, or if you're not lucky, getting (inaudible) from points. And that's going to be below the business net income. But then, when you get the amino portfolio, they'll continue the life within portfolio, so you have the expense.
Christopher Viehbacher
CEO
And I think, so if you take Regeneron as example, Regeneron flows through Marc's budget. If you take BiPar, the cost of developing now this asset in Phase III is sitting actually in R&D expense. What we're also doing is say, "We're going to do an R&D partnership. Wonderful." But that doesn't necessarily come on top. So we're also looking at allocating resources according to where the best project is. And if we're going to do this. We will probably stop doing something else. I don't know any other way to actually present it. We can certainly look at how we do it. For me, the biggest advantage is, if you cap – if you buy this, it's a different thing than if you spent it yourself because by the time you buy it, you discharge a huge amount of risk. Whereas, if you've been extending, you've got a lot more risk because you're still in that process of not having discharged risk. So for me, net-net, you're in a better situation. And what?
Hanspeter Spek
President
Lovenox.
Christopher Viehbacher
CEO
Lovenox, yes.
Hanspeter Spek
President
So we don't probably say individual profitability of products. So I ask to remain a little bit in quickly. Lovenox is a very profitable product for us in the US. But we have even more profitable products. Now you can guess. We have significant costs allocated. We have massive sales force behind it. We promote the products, of course, in the hospital, and we also promote it in the retail segment, which depending on the outcome we would have. I think we discussed this issue before and said it's a huge difference between a substitutable and a non-substitutable. I heard today that somebody from Novartis seems to have said this thing would have a substitutable. It's actually a big opportunity if we want to have non-substitutables, there would perhaps even hesitate to commercial it. This perhaps is a little bit accelerated because (inaudible) we would have survived so far the situation in Momento. So it's very difficult to say. But if we would have a non-substitutable, we would very, very moderately adjust our spending. If we would have substitutable, we would radically, of course, reduce headcount and also variable expenses. So the 4% commercial are reasonable, are reasonable given the fact that we have less than six months to achieve it, and that we have launched in the second half. I understand that it is getting more and more difficult to get on the coverage as more – as the year is progressed because you have more difficulties to get access. I think our maximum coverage would be 70% across, which is what we have with our top product. I am much more proud about the fact that we have nearly 60% coverage in managed care, which is definitely a very good result.
Christopher Viehbacher
CEO
Yes, I'll echo that. Pretty much now, most managed care organizations will want to have an experience with the product for six months before the PMP [ph] committees meet. And to the extent that you are on Part D formularies, that's even worse. And when you think of the average person with A-fib [ph] is already the age of 70, you've got quite a bit of exposure to Part D. Now, 57% is not good, compared to, say, a product that is – that's been on the market for three or four years. I mean, the big blockbusters typically get to 80%, 90% Tier 2 coverage. But to do that before that even fixed-month window is actually pretty good. The numbers on one of our sites is usually good seriously.
Wayne Pisano
Management
We would high dose (inaudible).
Christopher Viehbacher
CEO
Oh yes, high dose.
Wayne Pisano
Management
Okay. So the high dose formulation in the US, (inaudible) to the population, over 65 is in the (inaudible) from foreign in the US. So like most developed countries, that is the large market segment. US market varies in size year-to-year because of the supplies and shortages. But ballpark, 120 million in the United States, at least half of that is the elderly population. We have been in discussions with regard to reimbursement with Medicare. It will be reimbursed. Your question on premium price, yes, it will have a premium price. I'm not ready to give you the specific price, other than to say more than double the intramuscular vaccine. And in terms of the ACIP, ACIP is scheduled to meet in June. That's when they make their recommendations to the upcoming influenza season. And we feel very strongly that they will be recommending this product to the elderly population. But the data comparing immunogenecity is absolute. This product provides a secure immune response. And that's irrefutable. I think that the elderly is pretty excited about that.
Christopher Viehbacher
CEO
Someone over here, let's take this side of the room. Eric Le Berrigaud – Raymond James: Eric Le Berrigaud, Raymond James. Three questions, first on operating cash flow. It seems that in 2009, the operating cash flow was flat versus 2008 at EUR8.5 billion in the back of working capital negative EUR550 million. Could you talk about what you're doing in terms of working capital to make it – to make some improvements there, especially in terms of inventories, for instance, for the years to come beyond profits? Second, on Merial, is it fair to expect that you would exercise the second option to merge Merial and Intervet if and only if accretion is larger than the 3%, 4% points EPS accretion that you mentioned for Merial as a stand-alone company? Or is there any other metrics that you're looking at to whether or not to exercise a second option? And lastly, on diabetes, could you elaborate a little bit further on the next generation insulin that's entered into Phase I, the concept behind it in terms of very long-acting, and also on PN2034, just to tell a bit more of what kind of mechanism of action it is?
Christopher Viehbacher
CEO
Do the operating cash flow. Jérôme Contamine: On operating cash flow, well first of all you should – well, I don't like to enter in too many details, but first thing is that the operating cash flow takes into account the research costs as we are going to – we are just spending. So if I exclude this element – I mean you can use it or not, but you know that we have embarked just a number of restructuring. So this impact is around EUR500 million plus, EUR550 million. If I exclude that, you would see an improvement of operating cash flow by EUR500 million. The second thing in terms of working capital. Yes, you're right to say that the working capital has increased by EUR840 million, if I recall properly. Well first of all, the activity has grown by – so we should think the inventory towards save ratio – actually here, you have some variations because we took some provisions on some tax line last year linked to – so I mean you should compare on a net – on a gross basis, it varies. But to remain that we have inventories in the range of nine months. And I think Philippe could comment on that industrial activity. But we have some plans to reduce that. I mean, in this business what I learned is that the first thing is never be short of product when you're able to sell it, so let's get on to other businesses. We have always a balance to keep for many reasons, first, for public care reasons, some business reasons. So that's my comment. In terms of receivables, we are – we see a slight decrease of receivables to sales. And this is basically due to the expansion of activity of different carriers, such as generic business, typically the Zentiva. So we have some plans to work – always to work together with Zentiva to reduce the – to reduce their receivables. Now let's be clear, I mean there are some countries where the payment timing is decided upon by states. So I mean we can't do much around that, but here with hospitals. So last thing we shall be negative this year on the – the other area because we are spending much less – sorry, we are spending less. We have less debt to our suppliers, which is negative in our working capital. So in short, we are working on our receivables. We have some plans to reuse our inventories, but still I think this will remain an advantage or so to have product available. So under that concern, all in all, we see a working capital level. But we have some plans to reduce it in 2010.
Christopher Viehbacher
CEO
So concerning Merial, obviously, it is going to be a factor as to what is the combined would look like versus a Merial stand-alone. And I'll let (inaudible) comment a little further. I mean I think you would say that if you look to the Merial with a significant part of its business really in two products in pets sectors, particularly in the US, that we don't expect to see generic activity in animal health like you see in human health. But there are some generic activities, which will be expected to affect growth. If you look at an Intervet business, this is a business that's really production animal based. And in fact, in that part of the business, even when you think of themselves as being in – part of the animal business, it's protein production. And essentially, if you look at the emerging markets opportunity, the fact that you've got a growing world population, a population that is expected to expand by 3 billion people over the next few decades, there's a huge interest in productivity around food supply and food chain, which also has a direct factor related to that as being the underlying health of the animals that generate the protein. Also, as you have emerging market macroeconomic growth, people tend to want to have better food. And what you see as people gain more money, they want more protein. So you have to look at, first of all, a strategic element and come to some conclusions about the relative the value propositions. Perhaps, Laurence, you'd like to comment further.
Laurence Debroux
Management
To give you an idea of the accretion of the step one, if we say that's step one. It's obviously quite a short term metric. And whenever you compare two projects, you see one of them include – combining with someone else still having to divest some products immediately for competition reasons. And the other one is savings on the loan, if you compare only on these kinds of metrics, you handicapped the combination project if you look very short term. And accretion is by definition something that you look short term, which is the sanity check, which of course we will say – and we are taking when we look at these projects. But I would say it's definitely not the driving metrics. Driving metrics is the generation of value long term serenity of the business, and long term growth that we can have with this project.
Christopher Viehbacher
CEO
For the diabetes.
Marc Cluzel
Management
So our products from which (inaudible) its efficacy in the mid term, it is an insulin sensitizer. To give you an idea of its potency, it's exactly as the potency of the BiPar, but without the side effects of BiPar. And it is definitely not the BiPar. We have a – is the continuation on this site, and it's extremely active on diabetics to restoring sensitivity to insulin. And at the same time, we have proof of activity on this compound, on top of most of the active antidiabetic – oral antidiabetic compound with a very good activity. Before we go into Lolar [ph], which is our long acting insulin, we'd like to go back a little bit to what was already said by Hanspeter, under the association of our GLP-1 and Lantus. We have more and more the feeling – speaking with – we're stepping a little bit on (inaudible), that what is, to me, important is not the best control of HbA1c, but in fact it's also the control of the peak of glucose during the day. And that we can achieve that only with the good association of a relativity short-acting GLP-1, which is our case, and tie that also to GLP-1 without too much side effects. And we actually said that in terms of mitigating effect, we are really at least, with what you have said so far, in the low-end of side effects. So it's really an association, which is willing to address not the problem of HbA1c, but the problem of control of HbA1c and the peak of glucose. And so it is interest of the once a day GLP-1 because you cannot achieve that with the once a week in GLP-1. And for Lolar, which is the long-acting, you have to consider two points, that one day is perhaps not enough so we are looking to increase the duration of insulin. So we do not know exactly how long it can leave it, should be definitely more that one day. And at the same time, you can always white-wash – whiter than white, so we have very few hypoglycemia with Lantus, but have still some kind of hypoglycemia with Lantus. And so, we are aiming with a longer duration of action to reduce the – as a maximum – as a possibility of hypoglycemia with an insulin, which is quite an achievement again.
Christopher Viehbacher
CEO
Can we try this side of the room? Philippe Lanone – Natixis Securities: Philippe Lanone, Natixis Securities. I have three quick questions, sorry. First on the combination of Lantus with the GLP-1, what time – can you elaborate a bit more on the timeframe as it is a combination it would actually be fast to go to the market, while we're looking at three to four years before in the market? Second question on Taxotere, when – did you file for the pediatric extension? Are you confident that you will get it in time before the generic arise in May? So should we put in the model actually generic Taxotere in November? And last point, I noticed that the others line in the sales model, which is EUR6 billion in sales, was only declining by 2%, which is better than the past, and actually in the fourth quarter it was up. So does it mean that generic – that emerging markets are catching on here? And should we project growing or stable states here versus declining before that?
Christopher Viehbacher
CEO
Okay. Jérôme? Jérôme Contamine: For Taxotere, it's really basically I think we did our job, so I expect we'll have that extension until November. For the GLP-1 versus Lantus, we started already in the past the work, not with definite in device. So as your reason, I would say, it's closed to 2013 for the combination of the GLP-1 versus Lantus.
Christopher Viehbacher
CEO
So the GLP-1 will get approved and be launched first and then the combination will follow. On Taxotere, we've answered, and then the other revenue?
Hanspeter Spek
President
Yes. You're right, that the (inaudible) comes to the fact that we are – I mean we benefit from a higher sales in emerging markets. But looking forward, I mean you have always to know, you have to wait to make your positions. And one is to early look by products, another one is to look by growth platforms and try to combine these two to see where we're heading. Because we are really – another way to look at the metrics of sales, which is to say, “Well, see how the growth products, how the other main product, which are due to be generified, and then there is a fake product in mature countries, and then the same in mature countries." I mean, still doing really well, but probably still continuing to decline. So that's basically your answer is you have (inaudible).
Christopher Viehbacher
CEO
Now, one of the reasons I think it's good to look at emerging markets, and you're going to have products that are going rapidly, some that aren't, but there is a portfolio effect in some of these markets where you need to a have range of products. Some of them will grow well. And so, it depends on which matrix you're looking at. If it's part of the growth platform, it'll get lost because the high growth products are offsetting that. But you need those other ones to be present in the marketplace. But that's why we also show you the line-by-line so you can see that, yes, there is still a part of the business that is stable, but it doesn't decrease much in some cases in growth. Next, Alexandra. Alexandra Hauber – J.P. Morgan: Thank you. Alexandra Hauber from J.P. Morgan. First question is just a follow-up question again to the GLP-1 combo product. When I first saw it, I said, "Well it's probably going to do – once the GLP-1 is approved, you can probably do some paper NDA, so that's going to go quite quickly." But then you were talking about potentially looking at this one end point as in the glucose piece, so I thought that's going to delay. But still you talked about 2013, so should how should I reconcile the two things? Is it that you're just going to try on the market and then generate the data later on potentially on that end point? Second question is on – turning back to the Fluzone high dose, let's assume you've got tremendous recommendations from the Asec, could you – would be able to ship something like 30 million doses of that? And could you just go through how we should think about this, what's happening on the distributor versus the doctor level? Because I understand the typical flu vaccine you actually sell to the distributor, but to this one you probably would market to a doctor. So maybe you could win them both from this year, but how would it look like next year? This definition completes the difference, I think one of the reasons why the pet numbers got so bad because all of a sudden they include the healthcare payables. So I was just wondering, given that – do you know it's particularly high risk and bigger than the hospital business? And since you have Taxotere and Eloxatin, what's your exposure to risk, if anything, and how you deal with this? Have you been taking very new vitals? Is this the number we should worry about sitting at some point now?
Christopher Viehbacher
CEO
GLP-1, Lantus.
Marc Cluzel
Management
I will reassure you still for the situation in diabetes, HbA1c is still a good standard, so we'll just – GLP-1 and HbA1c were (inaudible) study, which are needed now at the present time. It is for – in terms of positioning, which is a little bit different than registering. We will try to position the association Lantus and GLP-1 as a treatment of choice in order to control, in fact, the daily peak of glucose. And we will do a study to demonstrate that we are good – we are the better control of the peak of glucose, and with any kind of association. But I think, I'm not sure that we need – definitely to have that into label at the time of the launch. Definitely, we need to have data to support our assumption that we need at the same time to have a better control of HbA1c, but also better control of the peak of glucose. There is a lot of that happening into this direction, by the way.
Christopher Viehbacher
CEO
And high dose flu?
Wayne Pisano
Management
Hopefully, you're not going to settle 30 million doses in 2010. I think it's going to take a couple of years to build this product in the US. So will it be 30 million at peak sales? We believe so, which is one of the reasons why we built the new flu facility in the US because the high dose IM consumes four times the amount of antigen as a typical IM influenza vaccine. So you have to have the capacity to handle that first. And in terms of the distribution, you may recall, maybe not, but 10 years ago, there was a severe influenza vaccine shortage in the US, and the entire industry shipped through distributors, and the stock market for flu vaccines went from $5 a dose to $25, $30, $40 a dose. After that year, we took all of our distribution direct because we bore the brunt of the complaining of the price gouging. And yet, it really was – it was in the distribution channel where that occurred. That's given us a couple of advantages, one is we have a much closer customer intimacy because we do ship direct, so we have a more consistent loyalty with customers. We know who cancels orders. We know who basically sticks with us, good year and bad year. And obviously, we rank those customers, and so a loyalty that builds both ways. So I think in 2010, it will be the launch year, and peak sales probably three years out. And that'll be when the facilities are fully on line and operational to support that kind of volume.
Christopher Viehbacher
CEO
And Jérôme, on the Greek hospital debt? Jérôme Contamine: Well first of all, the beauty of the sanity model is that we are presently aware. So we are not different specifically for any country or for any IRR, or whatever. So actually Greece represents a bit more than 1% of those ERE [ph] sales. We of course – sorry?
Laurence Debroux
Management
(inaudible). Jérôme Contamine: Sorry?
Laurence Debroux
Management
And so, you have been – possibly accumulated over many years those payable systems? Jérôme Contamine: Yes, I mean, in term of sales, it represents a big loss at 1%. So I maybe made a mistake, 1% of our overall sales. In terms of outstanding receivables, actually, I think the ratio of outstanding receivables to sales, it has even slightly decreased last year. All in all, it came to the public and the private sector much below one year. And we have improved the situation right again at the beginning of this year. And I think that Laurence, Hanspeter, myself, and the private people, we are following that very carefully. Well we have taken some provisions – some reserves against that, but not much because these figures are showing that we have already – already in debt. So the exposure is – at the end of day, runs unlimited. And I think as well even there is some concerns about the future of the Greek economy, I mean, should you still believe that you are logging to be paid by Greek hospitals, I doubt it means that it would be the case because at the end of the day, it would mean back to all the questions around the risks of that country belonging to the Euro zone. So yes, this exists. I mean, we are all going to face – we have been facing crisis in Venezuela, or in Russia, or maybe one day in India, or one day here and there. But at the end of the day, I mean the risk is really very, very mitigating. And once again, the overall outstanding receivable is around EUR200 million, which we have taken already on reserve. And within that (inaudible), part of it is hospitals.
Christopher Viehbacher
CEO
Back row? Norris Shirhan – ICAP: It's Norris Shirhan [ph] from ICAP. A question on emerging markets please, GSK said they've had to walk away from a number of emerging markets because the price had become too high and I know it's got a lot of activity. Your 2013 guidance includes further emerging markets. Our positions, as you just said – how do you plan to extract more value than your peers so you don't destroy value in emerging markets? And then a question on the debt level and of the CapEx, and debt, you have around EUR4 billion left, if you plan to continue acquiring, should we assume the current debt level is one which you are comfortable with?
Christopher Viehbacher
CEO
I'll start off with the emerging markets. I can certainly say that we've look at a few deals, the GSK did that – we didn't get anywhere close to even looking at. So I would say, if anything, our hurdle rates are much lower than when they where because we were scratching our head as to how they could justify doing the ones they did. You want to think the – the reality is that there's an awful lot of stuff out there. The deals that you're talking about are things, for instance, there's another Big Pharma company like DMS have been selling off. There are other deals out there and you do have to go looking. And for us, I think you've heard we put higher hurdle rates on some of these investments. If it's in an emerging market, it's got a much higher hurdle rate to achieve than elsewhere. And we haven't actually done that many deals actually in emerging markets, not because there weren't any companies, there are 4,000 companies in China alone. There are 400 pharmaceutical companies in India. But you do have to find those ones that really do add value. And I would say that when you look at what we have done, I think we actually have met what shareholders would expect us to do in terms of driving value. Do want to take a bit question Hanspeter?
Hanspeter Spek
President
Yes. I mean we're stuck into the very low level basically of EUR1.8 billion net debt. As you said, because of acquisitions, we have increased our net debt up to EUR4 billion. Still, take this EUR4 billion and think about the EUR4 billion of free cash flow we are going to generate with one year after dividends. It means basically that if we were not to do any deal in 2010, which won't be the case, we have only Chattem, we would be able to bring that debt to zero by the end of 2010. So I really feel that we are definitely still very comfortable. All the rating agencies share this view. We the regular discussion with them. You that we have AA rating with Standard & Poors, and A1 ratings with Moodys. And they both agree that we have headroom to do some – to do those acquisitions. And of course, this will depend upon which acquisitions we would do, how stronger the cash flows generated by these acquisitions, how visible also is the cash flow that we are going to generate. But clearly, I feel and if we compare to the competition, a lot of our main competitors, a lot of competitors have debt to EBITDA ratio, which are much beyond 1%, even 1.5%, or even some of them 2%, not speaking about smaller companies. So I don't say we are going to go to 2%, but I feel that it's a 0.3% ratio of debt to EBITDA, we are really on the lower end of the level of that as we can be. So once again, I think it will not definitely – we should not limit our ability to do these acquisitions. We'd extend if these deals make sense for us on strategic point of view, which was not discussed today, but also from the (inaudible) point of view on a case-by-case basis.
Christopher Viehbacher
CEO
All right, another question in the back? Jean Jacques Le Fur – Oddo Securities: Jean Jacques Le Fur, Oddo Securities. Some question about BSI-201, the first one is, if what I understood Hanspeter was saying that the filing date is expected to be late this year for breast cancer. So my question is, is there any chance to try to file with the phase II data earlier than late this year, so that means a few weeks or months? The second question is, will we have a chance to see the phase II that (inaudible) in the next few weeks, and in which manner we can see this data? And last question on VSI, could we have an update on the patent situation? If I remember well, the patent is to expire in 2013. So what is your expectation for the US to get probably a five-year additional extension? And I have another question on the combo Lantus with GLP-1, just to try to understand the advantage of the GLP-1 is not to have any dosage of glucose in the blood. So when adding an insulin, you will have to do such dosage? So don't you think you will lose the advantage of having a GLP-1 – of the GLP-1 with combining with an insulin? Thank you.
Hanspeter Spek
President
It's a good question, but I think you need to look the other way. Either, once you need insulin, in fact, the risk with the quick-acting insulin is in fact is to get rid of the peak of glucose, but at the same time you expose your patient to hypoglycemia. So if you are able to add – in-patient, we need insulin, Lantus first, then GLP-1, you get rid of the upshot peak of glucose without hypoglycemia, and on top of that, with a potential advantage on weight because you know that with insulin you are getting weight. In terms of the VSI for submission. No, it's based on an interim analysis of the ongoing study, which is in fact doing more factors than expected. But still I do not expect it will be possible to do as – internalize this also. We need to be absolutely sure whether this is going to give an advantage in terms of survival. And so, because it might be – the drug is active, we have lesser than expected, and so we are increasing a little bit of the time in order to get these events. And the second question that I do– Jean Jacques Le Fur – Oddo Securities: It's the Phase II data.
Hanspeter Spek
President
On breast cancer remission or on lung cancer? On lung cancer, this research is starting.
Unidentified Participant
Management
(inaudible).
Hanspeter Spek
President
Sorry? For that I apologize. I don't know exactly when it's supposed to be published. So I cannot answer this question now. But I'm sure that Sébastien can tell that. And the sub-question–? It is true that we have one certain in 2017, but we have many also patents, so we are not commenting, and we will submit, so I'm not commenting on that patent we are submitting (inaudible). But we are expecting in 2011 – in fact making this large life cycle management program, that patent would be extended after 2020.
Christopher Viehbacher
CEO
We know that the 2013 date is absolutely relevant anywhere because you will have at a minimum five years to data exclusivity from launch, plus the fact you can't launch – you can't file for generic in that five-year data exclusivity period. So you typically are going to be working with at least seven years from launch. We know that there is a patent extension that could take you up to 2018 depending on what indications, and general counsel is sitting right over there. But I think you could even imagine a patent situation that goes beyond 2018. But I think, what we certainly said is we're going to have those seven years in US, and then obviously in Europe, we've got the 10 years in (inaudible) everything.
Marc Cluzel
Management
We have a patent for the use in cancer, which goes up to 2018, plus the extensions there.
Hanspeter Spek
President
We have also – I would not go into all the details, but we can – because when – since all the patents are not still registered, but we have patent which is covering some product likely above 2020. It's why we are making stock – staffing a life cycle management.
Christopher Viehbacher
CEO
Right. So you've been very patient. We thought we might – if you would like to continue the discussion and questions in a little bit more convivial fashion, we'd like to invite you to a drink outside afterwards. We certainly like to celebrate our first year as a management team together. I think we had a great year. We appreciate the support of investors and analysts alike, and look forward to having a drink with you. So thank you very much everybody.