Sanofi SA (SNY) 2007 Q1 法說會逐字稿

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  • Operator

  • Good day, ladies and gentlemen, and welcome to the Sanofi-Aventis Group first quarter 2007 sales and earnings conference call. For your information, this conference is being recorded. At this time, I would like to hand the call over to your host today, Mr. Sanjay Gupta, Head of Investor Relations. Please go ahead, sir.

  • Sanjay Gupta - Head of IR

  • Thank you, Claudia. Good morning, everybody. Thank you for joining us this morning. On today's call, the participants from Sanofi-Aventis will be Laurence Debroux, our CFO, Jean-Claude Leroy, our Executive VP Finance and Legal and Hanspeter Spek, Executive Vice President of Operations.

  • I would like to begin by just taking care of legal requirements. During this conference call, we may make projections and forward-looking statements, which are based on our current expectations, but actual results may differ materially due to various factors. For additional information about the factors that affect our business, kindly refer to our forward-looking statements on our 20-F.

  • The format of today's call will be the same as previously. We'll begin by a small presentation, which will be followed by a question and answer session. Mr. Spek will make a presentation on the Company's business during the first quarter.

  • Hanspeter Spek - EVP Operations

  • Yes, good morning, everybody. Thank you for being with us so early today. Well, we [have] to report the first quarter 2007, which we consider to be a good quarter. Why? Mainly for two reasons. First, because it's in line, even a little bit reinforcing, what we have seen for the fourth quarter 2006. And second, because it shows a growth which is in line with pharmaceutical markets, even a little bit stronger.

  • Now, more in detail, if you go to our presentation page three, you will find then that the top 15 products have been growing in two digits by 10.5%. You see further and I will comment more in detail that the base business nearly has been stable. It's a small decrease of 1.8%, giving overall Pharmaceutical sales a growth of 6.2%. Vaccines continued to be a strong contributor to our growth with 16%, giving overall sales performance, then, a growth of 6.9%.

  • From a geographical breakdown, you see - and I believe it will be not a real surprise to you - that Europe has been difficult, with slightly negative sales growth of 1.3%, largely due to the situation in France and Germany - I will get back to this, of course, also, more in detail - but also to a new issue we had in Turkey, where we have been struck by reforms and by negative currency impact, which is a rather new situation but, for us, significant, given the importance we have as market leader in the Turkish market.

  • In contrary, very strong growth, 16.4%, in the United States. This is by far more than twice the market growth in the same period. And in the rest of the world, which will be definitely tomorrow our main marketplace, continued two-digit growth with nearly 11%.

  • If you turn to the following page, page four, then, you see the leading 15 products overall. You see, of course, again, those 10.4% in terms of overall growth. And now perhaps a little bit more in detail. Lovenox, a growth of 8.2%, which seems to be modest on first glance, if you keep in mind that the overall prescription growth is two-digit. So what happened there is a change in the ordering schedule of one of the major wholesalers. So we are totally confident that the growth in the second quarter will go back to two-digit.

  • The Plavix result, to be commented also in more detail, is of course under the influence of the appearance of the generic coming from Apotex in the second half of 2006. [Also there] more details, but [upfront] you see, if we take out already the sale of active ingredients for the United States to Bristol-Myers Squibb, corrected sales growth would have been 6.4%.

  • Very strong growth Stilnox, Ambien and Ambien CR. We will give you more information of this. In any case, the 49%, definitely spectacular. Taxotere, finally, I have to say back to a two-digit growth. I have [committed to] this for quite some time. I am happy to report that the first quarter growth now shows two-digit growth. I believe that we have a positive future ahead of us.

  • Eloxatin, negative, minus 3%. We will see in more detail the product is continually doing very good, very positive in the United States. But in Europe, we are now hit by the end of patent situation, which progressed during the first quarter, mainly in the United Kingdom and in Germany. In France, we still have no generic competition, but of course this will come during the year, [next month].

  • Lantus continues to grow extremely strong, given the level of sales - plus 27%. The product is now the more or less unchallenged leader of the insulin market. We are very content with the Copaxone performance, 17.5%, largely driven by newer data which has been published during the second half of 2006. Aprovel, 7.8%, I believe nothing in detail to be reported.

  • Tritace, minus 6%, a product which had lost its patent protection already during 2005, 2006, has now direct competition from generics in Canada. This was the remaining major market for this product. Allegra, plus 22%, largely driven by an extremely positive success of Allegra in Japan - and I will get back to Japan overall in a couple of minutes - but also supported by a continuous growth of Allegra-D in the United States.

  • Amaryl and Xatral are products equally struck by generic competition, Amaryl all over the world, Xatral, so to say, only in Europe. We are not content with the development of Actonel, which you see is minus 10%. Why? Mainly by appearing competition, indirect competition through generics for [fulcromas], which is the European market. And we have to see, together with our partner Procter & Gamble, how to better address the situation in the future. No further comments, then, to be made on Depakine and Nasacort from my side.

  • Now to page five, a little bit more in detail on a number of major products. I start with Acomplia. You see that, when you look at the headline, 130,000 patients already being treated in Europe. We continue to see an encouraging starting success. On the left side of the [slide], you see a comparison, for the 11 markets where the product has been launched, [inaudible] compared -- in comparison with the major and most successful launches from our competitors and you see that Acomplia behaves very well.

  • A little side note on a report you may have read in the press, which was referring to prescription data in the U.K., which are called PCA. The report, in short, said that the sales would be not satisfactory. I have to correct this. The report is stating only a selected part of the overall market, which is the NHS market inside England. So it's not reporting everything which happens outside the NHS market and outside England, which means Scotland, Wales etc.

  • We are equally content to report that we target very well our patient population, as you see from the right side of this chart. We have everywhere patients between 84 and 95% exactly inside our target group, which means with a body mass index superior to 27 and risk factors such as diabetes.

  • Nevertheless, on page six, we are very well aware of that the Acomplia battle will be long-lasting battle, driven by life cycle management and [step wise] improvement of reimbursement. We have encouraging steps and, most recently, are of course very happy to report the reimbursement we have obtained in France. It is too early to give very detailed data, but we tend to believe that we have a very, very good start also in France.

  • And in Switzerland we have obtained the reimbursement, which we consider, on the database we have as of today, as very positive, covering obesity alone and obesity -- or overweight patients which have an accompanying disease of diabetes. Our life cycle management is very well in place. You know that we have submitted Serenade to the authorities in Europe and the U.S. And we expect to hear from them, within the weeks or months to come, concerning our labeling.

  • Of course, the big event in context with Acomplia for the second, the ongoing quarter will be the FDA advisory committee planned for June 13. We are, of course, actively preparing for this meeting. We welcome the opportunity to show all our data and to discuss it in public. We believe that this, in fact, is the best way to find the right decision for this very important product.

  • On page seven, then, Plavix. What you see is positive. It's very positive. It's encouraging. You see, in short, on the right side that, in terms of new prescriptions, the trademark Plavix, by the end of March, has been back to 90% of the previous market. This is perfectly in line what we see in terms of ex-factory sales, as you may have read in the publication of our partner Bristol-Myers Squibb.

  • The first quarter of sales increased to $789m, after less than half in the fourth quarter. And this is a trend we continue to observe in the ongoing quarter, in terms of prescription, in terms of ex-factory sales. So we are convinced that the generic stock will be finally exhausted during the ongoing second quarter of 2007.

  • And then, if you turn to the next page, number eight, we believe that we have an excellent base for future growth. Why? Because the increase of the prescription for the total molecule, I believe, is spectacular, given the size of the product. As you see, the sales -- the prescription growth rose to 22%. We had reported, in the previous quarter, a number of organizational changes, new allocation of resources. And yes, finally, we also benefit from the relatively recent FDA panel on the Drug Eluting Stents, but not only - as you see on the lower part of the page, we finally also succeed in peripheral arterial disease, where sales very nicely increased to 35%.

  • An additional comment on Plavix in respect to Japan. We had a very slow launch of Japan with Plavix. We have given the reasons. There are a number of hurdles in place which limit prescription, which limit the number of patients. Those limitations have been lifted partially and what we see is a very, very consequent increase of sales every month.

  • And the last hurdle will be lifted now in the [ongoing] month of May. And we are developing increasing confidence in the situation of Plavix in Japan, also supported by the fact that we have taken back the rights of Panaldine, which means we are now in a better and stronger position to manage both molecules, ticlopidine and clopidogrel. And, as you have also noticed, we have terminated our promotional activities together with Daiichi. So overall, we are in a stronger, more direct position to manage both molecules in the best interests of the patients. So this gives us increasing confidence.

  • On the next page then, some information on Lantus. You see that the overall growth of 27% is a growth which is driven by all markets - the United States, Europe and the rest of the world. And then, on the right side, you see that Lantus by far is the leading insulin. You see also the development of the other products, which are either [decreasing] [inaudible] like premix or natural insulins. And you see then, also, the performances of the more recent launches, like Levemir and Byetta, which we consider as not impacting directly our performance, as it is obvious from this chart.

  • We believe that there is much more opportunity to grow with Lantus in the future and you see this more details, then, on page 10. There are new guidance, therapeutical guidance, for the use of insulin. And on the left side of the page, you see that, according to the most recent guidance, insulin, basal insulin, should be immediately added to the regime if lifestyle intervention and metformin have failed. And then consequently, on all three steps, insulin plays a leading role.

  • And we believe that [in] insulin, mainly given the significant advantage of easy dosing, that [within] Lantus has an excellent position. This is confirmed when you look to the right side of the chart, where you see that the usage of insulin in Type II diabetes patients is continuing to grow from only 40, 41% in October '05 to November '06 by 10 points, and consequently diet alone and the oral products are in regression.

  • We have further invested into the product, launching a new device. On page 11, you see picture of both devices, both devices for Lantus and Apidra. We could report that, before yesterday, that the FDA has registered Solostar. This is very encouraging news. The role of devices in the U.S. still is relatively low, but we believe this is a device, which we consider as being superior, [this will change], will give us additional opportunities. We have, as I said, invested into this program heavily. And we have internalized the production of devices to drive innovation and, of course, to better control quality of this very essential part of an overall insulin program.

  • On page 12, some additional information on Lovenox. I have commented on the sales growth, which is a little bit [short of] [inaudible], but will be back to a two-digit growth during the second quarter. You see that the product, for us, remains an important product, also, in terms of life cycle management. We have excellent data, which will continue to drive this product. I believe, in a short term perspective, most important data will be ExTRACT. ExTRACT, in short, has reconfirmed the superiority of Lovenox over unfractionate heparin, which still represents about 60, 70% especially of the American market. So there's still a large room to grow and we are confident to do so.

  • Then, on the next page, 13, information on Ambien. Yes, the month of April saw the end of the patent protection for Ambien IR. This does not at all mean the end of the success story of Ambien overall. Why? In short, because we managed to drive Ambien CR being the leading brand in this market. You see on the chart on the left side that Ambien CR holds, currently, a market share of approximately 15%, as compared to 11% of Lunesta.

  • What we try to achieve is approximately 50% of sales. And I'm honest to admit that I would have preferred to have a higher [switch] rate than the 32% we have obtained by the end of the patent. But, in the same time, we succeeded to drive the overall family of Ambien products much stronger than we had anticipated when launching Ambien CR, which was in August 2005. You see that, if you annualize today Ambien CR sales on the right side of the chart, we are very close to have a new blockbuster in our portfolio, which will do everything to step into the shoes of the previous blockbuster, IR.

  • Now, first data to the market, we have to see this with extreme prudence, because we have nothing but one week. And this is daily prescription data, which is perhaps not the most reliable insight. That's the data we have access to. But what we see today is [similar] impact on the growth of Ambien CR, which is of course, today, our major objective in driving this product and we have concentrated, evidently, all our efforts on Ambien CR. And we have increased our investments in this transition period, especially in the field of DTC. So we are confident that Ambien CR will continue to make its way, being the leading brand in this very important market.

  • Page 14, as usual, short report on our activities for the base business. You know which importance we give to this base business, especially in the international [zone]. And, as you see, we've succeeded there to continue to develop this part of the business positively, with a sales growth of nearly 7%. In the U.S., the base business plays no role.

  • In Europe, we were a little bit suffering by 2.3%, which is driven by, I would say, two facts. First, yes, the intervention -- the continued intervention especially of the German and the French government hits those products, first because most of them are not patent-protected. Second, the negative sales development of Ketek, which is according to our in-house definition in this segment, so called base business, also contributed to the minus 2% for the first quarter inside Europe. But overall, if you will exclude Ketek, you see that worldwide sales of the base business are de facto stable with minus 0.4%.

  • I said in my introduction Vaccines continued to contribute strongly to overall performance and you find more details, then, on page 15. [Other facts] to be explained upfront is the development of influenza vaccines, with minus 17%. It is a seasonal thing. We have less [stockage], especially in the United States, to be reported for the first quarter. We are convinced that this will be equalized during the year. You see that, besides, boosters are growing extremely strong with 65% and meningitis and pneumonia with nearly 50%, so overall giving them those 16%.

  • Page 16 gives a short summary on, so to say, our part to be reported on Gardasil. You know that this is a product which has been invented by Merck. We share it inside our joint venture in 18 countries in Europe, where we contribute also promotional resources from our pharmaceutical activities to this joint venture. And Merck, with its pharmaceutical [resources], is doing the same.

  • We see a good beginning in Europe with Gardasil. We progress step by step. And you know that, as with any pharmaceutical product in Europe, the market is largely depending on reimbursement, where we continue to progress, where we have very encouraging news in terms of reimbursement coming from France, but also from Italy and partially from Germany.

  • To close on my part, here you find on page number 17 some information concerning business development. We have been challenged in this respect during recent quarter presentations. So as you see, we have concluded a number of agreements, which we consider as being very promising. This is true for Pharmaceutical products. It's equally true for Vaccine products.

  • And last but not least, we widen our economic presence in Japan. We have taken back the rights of Acomplia, Plavix, Panaldine. We are in the process of concluding other agreements in the same direction. So we believe that, overall, the two-digit growth you have seen in the first quarter in Japan will continue by internal growth, first of all, and [within] of course Plavix plays an important role but not only, because also because of external growth.

  • So to sum it up, we see a first quarter which is perfectly in line with our previous results for the end of 2006. It is clear that 2007 in the second quarter will become a little bit more difficult, because of the out of patent situation with Ambien IR. But as said before, we believe to have, with Ambien CR, a strong growth driver to maintain our market leadership in this market segment in the United States. And saying so, I pass on to Jean-Claude Leroy.

  • Jean-Claude Leroy - EVP Finance and Legal

  • Thank you, Hanspeter, and good morning, everybody. I propose, as usual, that we keep an eye on page 18 and 19 and then we skip through the next pages to our comments on the P&L of this first quarter.

  • First, all of you know that, talking from a comparable basis growth of 6.9% on the sales, we are posting 2% growth on a reported basis, mainly because of the currency impact. And as you can see, this is a 4.6% decrease that we are posting this first quarter, two-thirds of which being the U.S. dollar parity evolution versus what happened in the Q1 2006, namely the parity to the dollar was 1.20 in the first quarter of 2006, when it was 1.31 in the first quarter of '07.

  • If we go down to the gross margin, you see a stable ratio to sales, 17.7 -- 17.6% -- sorry, 77.6%, as in the first quarter of '06. This is due to two factors going different directions. First, there is an improvement of 0.5 -- of a point -- 0.5% of a point to 26% of the cost of goods to sales ratio and this is totally due with the favorable product mix. You've seen that the first [inaudible] fifteen products grew 10.5%, which is obviously higher than the global portfolio. So this explains this improvement in the gross margin and, I should add, despite the fact that most of our production are in the euro zone.

  • The other way, in the other revenue, there is a small decline versus Q1 '06 and this is mainly due to two factors. The first is a small diminution in Q2 [of] Plavix in the U.S. And you've seen the figures from Hanspeter's presentation. And the other one is the discontinuation of the royalty income coming from Merial on Fipronil. This was, by contract, ending at the end of 2006. Obviously, losing that, say, 100% revenue, we recouped 50% of it, because through our consolidations, through the equity method, 50% of Merial net income, we are recouping half of what we lose on this line item.

  • If we go down to expenses, now, I guess that is where we see the main evolution, an evolution which, in a sense, is in line with what you've seen during the fourth quarter of 2006, which is a close monitoring of the expense. Even though through these figures, you can imagine that there is currency impact, but that's not all of the explanation.

  • Just to give you a comparison, you see R&D growing by 3.3%. At the end of the day, when we do that on a more comparable basis - I'm talking of currencies - I can tell you that we posted a 7% increase of these R&D expenses, excluding this currency impact.

  • The next item, which is Selling and General expenses, is probably the one where we see the most important impact, since we are diminishing by 8.6% during that first quarter. And I can tell you that the exchange effect is by far not the only explanation. The real explanation of this trend is the continuing adaptation of the measures we've taken after, you will remember, August 31 of '06. We've seen that through the end of the third quarter, continuing in the fourth quarter. And obviously we are continuing monitoring the expense during this first quarter of '07.

  • You see the result of all of that through the operating income current, which, by reaching EUR2.7b in this first quarter, is showing a 3.5% increase in the ratio to sales, coming from 34.4 up to 37.9%, and showing a 12.4% increase, which is directly to be compared to the 2% increase in net sales, reported sales.

  • Going down to the second part of the P&L now, what do we see? A small amount in this quarter which is the continuation of the impact of the restructuring plan in France, with this EUR22m. And the other important item which is to be compared with were these gains we made last year under sales, the disposal of Exubera to Pfizer, which was the main item. And the second one which was the Nutrition business we disposed of the remaining 30% stake. Obviously, this year, there was no such main disposal. So the calculation, when it comes to the operating income level, is a little bit more difficult to read. But then I will be back later on the results before selected items for a better understanding.

  • Going down to the net financial expense, let me tell you that within these two amounts '07, '06 of close to EUR30m, you see an interest charge which is decreasing to EUR56m, coming from EUR73m in the first quarter of '06. And this is definitely due to the reimbursement of debt we were able to achieve during the first quarter, as well as a reverse effect because of the increase in the interest rate in the euro zone as well as in the dollar, when you compare these two quarters.

  • Now, the next line item, which is income tax, deserves a special comment, since you can see that the rate which is posted - 22% in Q1 '07 - is not the usual tax rate, as well as it was not the one with 28%. It was the same situation in the first quarter of '06. Now, you would remember, in '06, we had that disposal of Exubera I was just mentioning before, with a low income tax [attached]. So you may remember that, last year, we had an effective tax rate, excluding this kind of special item, of 30.7%.

  • Now, I can tell you that, in the first quarter of '06, we also had same 30.7% effective tax rate, the difference being a net profit of EUR223m, which is the result of the net of reversal of provision for tax risks and resolution of tax audit. And definitely that's the last part of this sentence, resolution of tax audit, which is the reason for this big profit of more than EUR200m in this line item.

  • Going down to the share of profit and loss from associates, not that many comments. And it was mainly -- The difference comes from the consequences of the sales of Plavix. And now, in the U.S., unfortunately, we are talking of the conversion in euro, so even though the decline in sales between the two quarters were rather slow, as Hanspeter showed to you, when it comes to conversion to the euro, it adds up a negative impact. And minority interests, the other way around, are increasing simply because the management of Plavix and Aprovel in the rest of the world, the part which is managed by Sanofi-Aventis, is improving.

  • I said that, page 26, we would give a word on selected items, which are of so much importance for the better understanding of the performance. As you can see, in '06, mainly gain and loss, mainly gain on divestment, and I was mentioning Exubera and Animal Nutrition. In this first quarter of '07, mainly provision for tax and resolution of tax audit, this EUR223m profit I was mentioning.

  • So for this good reading, we would have to exclude [EUR200m] of profit in the Q1, when we have to exclude EUR466m [out] of the 2006 first quarter profit, which three drivers to report on this adjusted net income before excluding selected items. And as you can see, starting from an adjusted net income which is posting down 3.1% at EPS level, when we exclude selected items, we are showing an EPS of EUR1.41 per share, which is up 11% as compared to last year.

  • I said that we were continuing to reimburse our debt. This is shown in slide 28, where you can see that the first quarter generated a net cash flow of EUR1.8b, the same amount as we did last year. And obviously the gearing of the Company is below, now, 10%.

  • This very good performance we had during the quarter, the first quarter, drove us to increase, to raise, our yearly adjusted EPS growth guidance. And we have decided to increase this guidance by 3% for the full year, bringing it from around 6% to now around 9% expected growth for the full year. Now, obviously, this is calculated by keeping the same exchange rate, the same parity between euro and dollar, which is the 1.25, you may remember, which is the average of 2006.

  • So to -- If I may summarize in a few words this first quarter performance, I would insist on three items. The first is the good leverage of the P&L through continuous close monitoring of the expense, driving an improvement of the operating income current of 12% and bringing it at 38% of sales.

  • Second, I would mention that EPS before selected items increased, up 11%. And let me tell you that it would have been even plus 17.6% at constant 2006 dollar euro parity, which is probably a better way to compare with peer results mainly denominated in U.S. dollars. And therefore we can post -- trust in our '07 performance, which led us to increase this expected growth of EPS by 3 percentage points, as I just mentioned.

  • Thank you very much and now the floor is yours.

  • Sanjay Gupta - Head of IR

  • Claudia, can we open it up to questions, please?

  • Operator

  • Thank you. Ladies and gentlemen, the question and answer session will be conducted electronically. [OPERATOR INSTRUCTIONS]. We will take questions in the order received and we will take as many as time permits. [OPERATOR INSTRUCTIONS]. We now move to our first question from Tim Anderson with Prudential Securities. Please go ahead.

  • Tim Anderson - Analyst

  • Thank you. A couple of questions. Eloxatin in Europe is facing some generic competition in the U.S. Realistically, when might we expect generics to launch and how comfortable are you with your intellectual property on that product in the U.S.?

  • And then, second question is just an update on Lovenox generics. Can you comment on your degree of confidence that FDA will not approve AB-rated generics against the product either this year or next year?

  • Hanspeter Spek - EVP Operations

  • Well, Tim, let me start with the FDA. So I think you phrased your question very prudently, because you said what is the degree of confidence. So we are talking, really, about something which is today not material. But nevertheless, what we see, if we look to the recent events during the first quarter, we understand there is a trend in the sense that the U.S.A. starts to tend to follow the European attitude concerning biosimilars.

  • And the European attitude is clear. It is fixed. It has been expressed by the EMEA, saying that biosimilars or bioequivalent products need to show clinical proofs that they are really therapeutically equivalent. And we believe that this, for the time being, is best reflected in the outcome of the Congressional hearing and in a paper Senator Kennedy has issued later, in which he says he believes that biologicals should prove to be equivalent not only in terms of pharmacokinetic data but also in terms of clinical data.

  • And what we tend to understand is that this is something which generic companies also start to incorporate into their strategy. So once again, this is what I tend to believe today. There is nothing really material coming out of the FDA, besides the fact that several people outside the FDA have expressed themselves in the same direction. I hope this is satisfying for you, but I cannot give you more.

  • Now, on the protection of Eloxatin in the U.S.A., please remember that ANDA can only be filed after data exclusivity has expired. In the case of Eloxatin, this was extended six months to February 2007. And as of today, we have not received any notice of certification from a generic competitor to date. Independently, the ready to use form approved and marketed in the United States is covered by patents running as late as 2015. And yes, we feel very comfortable in the respect of Eloxatin's protection in the U.S.A.

  • Tim Anderson - Analyst

  • Thank you very much.

  • Sanjay Gupta - Head of IR

  • Can we have the next question please?

  • Operator

  • We move to our next question from Gbola Amusa with Sanford Bernstein. Please go ahead.

  • Gbola Amusa - Analyst

  • Hi. Thank you. Good morning. Gbola Amusa at Sanford Bernstein. I have three questions on Acomplia, the experience in Europe. Your internal data, first of all, are showing that 90% of Acomplia patients have risk factors. What is the average number of risk factors for those patients? Secondly, of those 130,000 EU patients, what percent are paying out of pocket?

  • And then lastly, it's perhaps a bit too early for this question, but maybe you have some data from the U.K. I'm just wondering what the drop out rates for patients on Acomplia are and if that's influenced by reimbursement at all.

  • Hanspeter Spek - EVP Operations

  • I'll start with the last of your three questions. The drop out rate we see is significantly lower than what we see in the clinical trials. So you remember that the drop out rate in the clinical trials has been between 40 and 50%. Now, let's keep in mind we are not in a comparable situation and the quality of data we have necessarily is also not comparable, because in [inaudible] clinical trials, of course, the quality is higher. Nevertheless, what we see is significantly lower and I would estimate it between 20 and 40%, depending on the market and depending on the reimbursement situation.

  • This leads to your second question. What we see as of today is that approximately 40%, in average, pay for the product out of their own pocket. Now, again, we have to read this with care. We have nearly 100% reimbursed patients, let's say, in Scandinavia, where we do, by the way, extremely well in Sweden. And of course we have today zero, or close to zero, reimbursed patients in Germany. So the situation varies strongly, but, as an average for the 10 or 11 markets I gave you in my presentation, 40% is a good estimate.

  • Then, last, on the accompanying risk factors, they vary between two or three and [they are] the classicals you may expect - first of all, diabetes, second, dyslipidaemia, and third, hypertension.

  • Gbola Amusa - Analyst

  • Thank you.

  • Operator

  • Moving to our next question, Mr. Richard Woodman with APM Health Europe. Please go ahead.

  • Richard Woodman - Media

  • Good morning. Do you still see a certain logic to a merger with BMS?

  • Jean-Claude Leroy - EVP Finance and Legal

  • As you know, we've been constant in our answer. We don't comment on this. And I'm sorry to be consistent with what we've always said on this kind of subject.

  • Sanjay Gupta - Head of IR

  • Thank you. Can we have the next question please?

  • Operator

  • Thank you. The next question comes from John Murphy with Goldman Sachs. Please go ahead.

  • John Murphy - Analyst

  • Yes, good morning, gentlemen. Hanspeter, could you tell us, please, if you had any pricing benefit at all in the U.S.? And Jean Claude, a couple of questions, please. First, any stand out or sizeable components in the other operating income line of EUR191m?

  • And second, you talked about continued close monitoring of expense and we certainly saw that with a very strong performance in SG&A in the first quarter. Can you maybe talk a little bit more about the moving parts of this line item going forward? I'm wondering really how indicative the first quarter may be of the full year performance here.

  • Hanspeter Spek - EVP Operations

  • John, so I start with the pricing policy. Overall, we have increased our prices as usual during January, with two exceptions. We had a very small price increase in March for Taxotere of 1.5%. And we had a price increase for Ambien, given the out of patent situation, of course, of 9% in February, which means we have driven up the prices of Ambien IR in respect to two references.

  • First, of course, the reference Ambien CR. At the moment when patent went off, Ambien CR is significantly lower priced than Ambien IR. And the second reference for our pricing policy, of course, has been Lunesta. And we are positioned today that we are approximately 10% less expensive - I'm talking on a [VAT] basis - than Lunesta with Ambien CR.

  • Besides this, our price increases in January have been, with some exceptions, in the neighborhood of 5%. This is true for Lantus, Lovenox, Actonel, Apidra, Avalide. Avapro has been slightly above 6.9%. Copaxone, we took a price increase of 9.9%, given the competitive environment.

  • John Murphy - Analyst

  • So it would be fair to assume sort of mid single digit benefit in terms of pricing in the U.S.

  • Hanspeter Spek - EVP Operations

  • Excuse me, I didn't understand you [phonetically].

  • John Murphy - Analyst

  • So it would be fair to assume that, within the U.S. growth, there will be at least around about four or five points of pricing.

  • Hanspeter Spek - EVP Operations

  • For the overall year, yes.

  • John Murphy - Analyst

  • Thanks.

  • Jean-Claude Leroy - EVP Finance and Legal

  • Okay, move to next question. First, the other current operating income and expense, I have to mention that there is a slight change between '06 and '07 in the way to book a certain income and expense. Now, upon the recommendation and, I have to say, the recent request and recommendation of IMF in France and SEC in the United States, we've been obliged, as other companies, to change [only] the posting of some [inaudible] some charge and profit, in the sense that, now, within the three following line items, such as restructuring costs, impairment of PP&E and intangibles, gains and losses on disposal and litigation, we can only report significant amounts, which is a difference with the past, where there was a possibility [inaudible] to report each and any amount in the same area.

  • The difference it makes between the two quarters is such that we've had some minor [operations], like some small disposal and gain on disposal of assets, some small amount of litigation which had solutions during the quarter, which were posted above the operating income current line item, namely in this other current operating income and expense line item, where it was posted below.

  • Now, to make this as clear as possible, I have to confirm to you that, first, any of these --- each and any of these items are small. And then, when you take the [full average], you make the addition of the plus and minuses, this comes to a very insignificant amount when it comes to make the comparison between this and the result for even the operating income at current. So yes, a minor change in the presentation, but which has no influence in the reading of the performance of this first quarter of '07.

  • Your second question is related to the trend in the expenses. Well, once again, I suspect that I can say that, indeed, when it comes to R&D expense, you know that we don't monitor R&D expense lines. We spend the money which is necessary to go on clinical trials when they are ready to be made. And on the other line items, fair to say that there has always been room for monitoring of the level -- of the global level of expenses of the Company in the selling, SG&A line item.

  • Now, I am not very much in favor of giving you too much, too many precise figures. [Say] that we are not going to [inaudible] trend, the trend but not the figures, up to the end of the year. And this is one of the -- I mean, what you've seen during the first quarter, this rather important decrease, is one of the reasons for which we were capable of raising our EPS guidance for the full year.

  • John Murphy - Analyst

  • Thanks very much indeed.

  • Sanjay Gupta - Head of IR

  • Claudia, the next question please.

  • Operator

  • Thank you. From Citigroup, we move to Amit Roy. Please go ahead.

  • Amit Roy - Analyst

  • Hello. Thank you. Amit Roy from Citigroup here. Just three questions. Firstly, on the Plavix litigation, I just want to make my understanding clear. If the judge rules in favor of Apotex, would they be allowed to launch at risk before any decision from any appeal that you'd carry out, firstly? And secondly, is there any update on the timing of that?

  • The second question surrounds the advisory panel on Acomplia. I see the title of the advisory panel includes the usage for obese patients, i.e. BMI of greater than 30, as well as BMI of greater than 27 plus a risk factor. Is that indicative of a use of rimonabant in the U.S. for just BMI of 30 alone?

  • And my third question is a small one. The trade name Zimulti that's mentioned on the advisory panel, is there any reason for the change from Zimulti to --- from Acomplia? Thank you.

  • Hanspeter Spek - EVP Operations

  • I'll start on Zimulti. Zimulti is a request by a subdivision of the FDA which is in charge of trademarks. This subdivision is challenging trademarks from several angles, from a consumer angle in general. And this division considers that Acomplia could be too descriptive or eventually misleading, indicating that a patient taking Acomplia would accomplish his [inaudible] [target].

  • To give you another example, we had a similar case some years ago, when we tried to register irbesartan in the United States under the trademark of Aprovel, where the FDA indicated that they thought Aprovel would be too close to approval.

  • So it has, in short, nothing to do, absolutely nothing to do with the medical, clinical evaluation of the product. There were reservations from the FDA from the aspect I've described. And then we commonly decided on Zimulti. We had proposed others trademarks and the FDA agreed finally on Zimulti. So that's all for this.

  • Now, as far as the headlines of the commission or the advisory panel are concerned, we are not in a position to make any conclusions the way the FDA has set up this. And my only advice would be to be extremely prudent to [interpret] it too much into what you can read today on the web of the FDA in this respect.

  • Jean-Claude Leroy - EVP Finance and Legal

  • On the U.S. Plavix situation, now, I will try to answer your question, even though your assumption is not one we favor. And I would observe that, if there was a negative outcome of the trial for us, it is likely that a generic would be re-launched, if I could put it this way, even though of course we would consider our own legal actions at that time.

  • As far as the agenda of the trial is concerned, as we've already said, there is no official agenda in such a trial. So we -- Again, sorry to repeat, but what we've observed in similar cases is that it takes generally between three and nine months between the end of the trial date and the date the judgment is rendered. So that's the best we can imagine. We have no other clue of this [actual] date.

  • Amit Roy - Analyst

  • Thanks very much.

  • Sanjay Gupta - Head of IR

  • Next question, please.

  • Operator

  • Thank you. We move to --

  • Amit Roy - Analyst

  • You answered two of the questions, clearly.

  • Sanjay Gupta - Head of IR

  • I'm sorry, Amit, do you have another question?

  • Operator

  • Pardon the interruption. Mr. Roy, have your questions been answered?

  • Amit Roy - Analyst

  • Yes, thank you.

  • Operator

  • Okay. We now move to Michael Leuchten with UBS. Please go ahead.

  • Michael Leuchten - Analyst

  • Yes, just going back to the SG&A line, would you be willing to quantify the currency impact benefit that you experienced on the SG&A line?

  • Jean-Claude Leroy - EVP Finance and Legal

  • Well, what I can tell you is that, starting from the decrease of 8.6% of this line item on a reported basis, with a constant U.S. dollar euro parity, the decrease would be in the order of magnitude of between minus 4 and minus 5%.

  • Michael Leuchten - Analyst

  • Thank you.

  • Sanjay Gupta - Head of IR

  • Next question, please, Claudia.

  • Operator

  • Thank you. We move to Michael Leacock with ABN Amro. Please go ahead.

  • Michael Leacock - Analyst

  • Thank you very much for taking my question. Just on your adaptation program, I wonder if you could just give us a little bit more comment, perhaps, on your progress there, what you've achieved in terms of headcount reduction and savings, and perhaps a little more about the overall timing and scale of that program.

  • Jean-Claude Leroy - EVP Finance and Legal

  • [Inaudible] I am not back to what we could call the French program. Remember that we posted, at the end of the year, a reserve for this program, which is mainly early retirement program plus some part which is dedicated to volunteer departures. This started really after negotiation at the beginning of the year.

  • You've seen that we posted an additional reserve in Q1. I can tell you that there will be another small amount in Q2, when -- because the rules in accounting is that you can only post when decisions are firmly made by the people. So we will see the impact of this French restructuring plan mainly a bit during the second quarter and definitely in the second half of '07.

  • For the rest, there is not something spectacular to announce, except that we go on monitoring, managing. You've seen that, when it comes to external forces [inaudible], when we consider that we have to do something, we take them out of the Company, which means that that's the explanation for which you saw so quick and rapid decrease in the SG&A line, even during the fourth quarter of '06.

  • [Say] that we are continuing to adapt mainly in Europe and for parts of the States when necessary. You've seen that, now, the States are back to a good situation of the sales of the main products. And that we do, I have said, to the contrary in the international zone, the rest of the world, simply because, as you've seen, we've been able to post very interesting growth in these areas. So we go on sustaining this growth by feeding with the necessary promotional efforts in order to keep the kind of pace we've been seeing in these areas for over a year, now, a very interesting one.

  • So again, a dedicated and targeted not program but adaptation, here and there, when we feel that there is a need, because the measures taken by the authorities have [altered] very much the business of the Company.

  • Michael Leacock - Analyst

  • Thank you very much.

  • Operator

  • Thank you. We now move to Sebastien Berthon with Exane. Please go ahead.

  • Sebastien Berthon - Analyst

  • Could you tell us what are the financial [inaudible] impact ---

  • Hanspeter Spek - EVP Operations

  • Sebastien, we don't hear you at all.

  • Sanjay Gupta - Head of IR

  • Hello, Claudia, [are you on] the line?

  • Sebastien Berthon - Analyst

  • Hello, can you hear me?

  • Hanspeter Spek - EVP Operations

  • Yes, that's much better.

  • Sebastien Berthon - Analyst

  • Okay. Hello, gentlemen. I was wondering what are the financials behind your giving back the rights on Alvesco to Nycomed. And also, could you update us on the situation for this product and the situation for the combination product with formoterol in the U.S. please.

  • Jean-Claude Leroy - EVP Finance and Legal

  • As you may remember, this is an association with, now, Nycomed, which belonged to the legacy Aventis. We decided to withdraw from the mono form of the product and it has no other consequences than to stop the ongoing program with a six months period. And then we still go on on the combo form, and I mean by that that we're keeping the pace in the co-development of the program with a view to launch this product if the trials are positive.

  • Hanspeter Spek - EVP Operations

  • Perhaps I may add two thoughts to this. The first one is that, prior to the acquisition by Nycomed, Altana had decided to withdraw from the co-promotion of the product as a mono product in the United States. And this is a policy which, overall, seemed to be confirmed by Nycomed, which has clearly communicated that they see no priority strategically in the United States.

  • The consequence would have been that we launched mono alone. And given the market, which is a market which clearly goes -- more than clearly goes into combo products, we have decided, then, to refrain also from launching the mono product in the United States. Having said so, it is clear that we maintain our interest into the combi product, which, in terms of development, is several years behind the mono product.

  • Sebastien Berthon - Analyst

  • Any financial impact from this settlement?

  • Jean-Claude Leroy - EVP Finance and Legal

  • No, no impact.

  • Sebastien Berthon - Analyst

  • Thank you.

  • Operator

  • Thank you. We now move on to Graham Parry with Merrill Lynch. Please go ahead.

  • Graham Parry - Analyst

  • Good morning and thanks for taking my questions. Starting off on Ambien CR, I was wondering if you could give us an update on formula repositioning, in particular what proportion of lives you have covered compared to proportion of lives covered with the IR version, and how much of the CR coverage is in tier two. Also on the Ambien IR, did you see a significant reduction in rebates in the first quarter as well as price increases helping sales for that product?

  • Then, moving on to flu vaccine, just wondering if you can give us an update on capacity and pricing trends for the '07, '08 season. It may be a little early, but hopefully you'll have some view on that by now.

  • And then, just finally, on SG&A, just could you give us a little bit more clarity on the cost reductions, particularly from a geographical point of view? So are we really looking at Europe still being the key driver of reductions here? How much of this is rep reductions versus different selling techniques?

  • And then, looking into the future quarters, should we be expecting to see a significant up-tick if you can launch Acomplia in the U.S.? Or do you still believe you can launch Acomplia using existing resources such as transitioning Ambien reps on to the product? Thank you.

  • Hanspeter Spek - EVP Operations

  • So if you like, I start with Ambien CR. Now, the Ambien CR situation is extremely dynamic, because everybody, of course, was waiting for the very, very last minute. So what I report is what we have according to [mainly media] information as of February 2007. So in February 2007, 76% of lives have tier two and tier three access to Ambien CR. Approximately 20% of HMO, PPO and [DOS] total lives are enrolled, which is approximately 170m lives have tier two access.

  • We see a very, very strong progress in the overall access period and we have gained, during the last days and even hours, a number of very, very important accounts. There, of course, the purchasers also waited until the very last minute to see how things would go. So overall, we are very content with this. We have made no major changes in our overall commercial policy before the end of the patent protection for Ambien IR, except those which I described earlier concerning price.

  • Sanjay Gupta - Head of IR

  • [Inaudible] vaccines?

  • Hanspeter Spek - EVP Operations

  • Sanjay, yes, [if you could take] the vaccine question.

  • Sanjay Gupta - Head of IR

  • Essentially, the Q1 2007 sales are lower than the 2006 sales, but this is not because of any pricing impact whatsoever. In 2006, the CDC has placed an order for vaccine, [tactical] flu vaccine stockpile of about $24m, and they purchased only $10m in 2007.

  • So in 2006, Sanofi-Aventis supplied 170m doses, out of which 55m doses were for the U.S. In 2007, we forecast to supply about 200m doses. And so far, we have not experienced any pricing erosion for seasonal flu vaccines. So I cannot speak about the 2007, 2008 season now - we shall comment upon it later. But in our experience up to date, we have not seen any pricing erosion.

  • Hanspeter Spek - EVP Operations

  • Now, the question on economies or synergies, it's a little bit difficult to answer and I don't want to give you a precise dollar or euro answer. But what did we do overall? Overall, our [progress on] worldwide is stable. But what we did [change is] we have reduced in the United States, in France and in Germany and we have increased approximately the same number of people, which is approximately 2000 people, in the fast-developing segments, which are of course Asia Pacific, to a lesser extent Japan and South America.

  • What we reduced in the U.S. is G&A, where we have made significant reductions beginning of 2006 and we continue to do so. What we have kept stable is the number of reps in the United States. Where we have reduced in Europe is, in contrary, largely sales force, but not only. We have made reductions in general administration. In our French subsidiary we are in the progress of reducing significantly our headcount in terms of sales force in Germany and in France once again.

  • So overall, it's a balancing effect. But as Jean-Claude has indicated earlier, we reduce [further] where we see less opportunity and we increase where we see continued an increase in opportunity.

  • Graham Parry - Analyst

  • And on Acomplia launch impact in the U.S. on potential SG&A expenditure, do you still think you can transition using the existing resources that you have, or would you need to be looking to hire again?

  • Hanspeter Spek - EVP Operations

  • From what I see today, I maintain this position, and once again the most important element in this game is the timing of the availability of Acomplia - which, if things go fine, should be in the second half and probably more in the fourth trimester than in the third trimester - and the continued development of Ambien CR. If what I indicated earlier, which is that we see no impact -- no negative impact by the out of patent of Ambien IR and CR, is being maintained, we will reduce our forces on Ambien CR when we have successfully managed the transition. This should coincide with the availability of Acomplia.

  • But you see, overall, we have about 7,000 reps in the United States, so we have a lot of opportunity to do. And if we would need, even short term, let's say, another 400 or even 800 people, we can do so relatively easily with external sales forces, which are available and which are of, in general terms, good quality.

  • Graham Parry - Analyst

  • Thanks very much.

  • Operator

  • Thank you. We now move to Deutsche Bank, Mr. Paul Mann. Please go ahead.

  • Paul Mann - Analyst

  • Thanks very much. Yes, I've got a couple of questions. Just looking at the Lantus, the new pen you're launching, could you talk just about the pricing premium of this pen versus, say, the [syringe and] vial formulation? Also, what proportion of your current revenues are sold in a pen? And what proportion of U.S. insulin prescriptions are sold in a pen, maybe giving some color on disposable pens versus, say, fixed pens? And also, do you have a target of what percentage of your current Lantus patients you hope to shift on to this pen? That's my first question.

  • Second question is on Plavix. I believe you said, about 12 months ago, maybe nine months ago, that you don't expect to achieve a similar price in Plavix in the new environment versus, say, the old environment. Perhaps you could just update us on where the price of Plavix is or where your realized price of Plavix is compared to, say, 12 months ago?

  • Hanspeter Spek - EVP Operations

  • Let me start with the Plavix situation. Overall, we have a very homogeneous pricing for Plavix in the world, with a significant difference, of course, between -- of course -- still, of course, between the United States and the rest of the world, so to say.

  • The United States, as usual, are superior to the rest of the world. The rest of the world average price [I would see shape] today at approximately [EUR1.60]. And this is true for Europe and, of course, it is true for Asia. In Japan, we have a price which is approximately between [EUR1.80] and [EUR1.90], so it's superior, evidently. And in most Asian countries the price is between [EUR1.60] and [EUR1.90].

  • Now, perhaps you are alluding to the recent discussions we have with the government of Thailand, where we evidently became under pressure, given the fact that, in an economy like the economy of Thailand, unfortunately, not everybody can afford to have this product at such a price. To stay in this example, today about 25 to 30% of the population have access to Plavix.

  • We have signaled to the government of Thailand that we understand their concerns and that we are open to go into special programs. And we get first signs from the Thailand government that this is being appreciated and we have to finalize, if possible, this in the upcoming weeks.

  • But overall, once again, we have a very homogeneous price policy for Plavix all over the world, if you accept that they are two parts, the United States and outside the United States. And we have not made any significant concession in this respect since the launch of the product.

  • Now, the question on the pen is really a difficult one, because there are very, very different usages from market to market. First of all, there are markets where the pens are being sold. They are usually being sold at cost and they don't present a real economic interest in this respect.

  • There are other markets, especially in Europe, where the pens are given away for free. So, yes, they are a burden for the overall presence in insulin, but they are very, very important element in the competition. And so, if one of the leading competitors, historically, has started to give the pens away for free, the others usually follow, for reasons which I believe are evident.

  • Third, there is a strong difference, then, in terms of usage. In the U.S., only approximately 10% of insulin patients are using a pen and this is exactly what we have for Lantus. But there is a new trend, then again, which, for Apidra, for example, which is a rather small product -- still rather small product in the U.S., pen users are about 40%.

  • Why? Because I believe the usage of a product like Apidra is very different. You inject it once. You inject it during meal time. So you are in a different situation as a patient and you appreciate to have a pen with you, while, when you inject your insulin at home in the morning and in the evening, you can do so more easily with cartridges.

  • So, to sum it up, there is no really homogeneous situation for the pens all over the world. In general terms, it's fair to say that they present no direct economic interest. They are a service product and we think they are very significant in terms of importance for the pharmaceutical product which is manufactured with it.

  • Paul Mann - Analyst

  • So just to confirm, you don't expect to get a pricing benefit from launching your new pen over, say, a syringe and vial, which is where the bulk of your Lantus revenues are at the moment?

  • Hanspeter Spek - EVP Operations

  • Definitely no.

  • Paul Mann - Analyst

  • Okay. And then, just to confirm, on the Plavix, you didn't really talk much about the U.S. market, which is where I'm more interested in. What's the price of Plavix now in the U.S. that you're selling versus, say, 12 months ago?

  • Hanspeter Spek - EVP Operations

  • Well, you see, I think that this is premature to answer to your question, because I believe to understand that the background of your question is has there been an impact from Apotex generic on our prices. We believe that this is still too early, as there is still some stock [outside] in the market. We see pressure. We see requests to make concessions to get back to previous [second tier] positions. We resist for the time being. We tend to believe that we will have to make concessions, but it is still too early to give you precise figures in this respect.

  • Paul Mann - Analyst

  • Okay, thank you very much.

  • Operator

  • Thank you. We now move on to Alexandra Hauber with Bear Stearns. Go ahead.

  • Alexandra Hauber - Analyst

  • Thank you very much. I've just got four questions. Firstly, you said earlier, initially, that, of the top line effect from the currency, two-thirds was from the dollar. Is there any -- Would it be wrong to assume that, therefore, the effect from the other currencies on your SG&A line would be different, so, if the dollar effect was 3 to 4% on SG&A, the total currency effect would be 4.5 to 6%?

  • Second point is a follow-up question to earlier. I think, Hanspeter, you said that -- if I understood you correctly, that there will be a transition period for Ambien CR where you keep the current promotional effort. And then, depending on how it plays out, you will allocate that to Zimulti. And from the timing, should we therefore assume that about -- in a period of three to four months you would see how the Ambien CR market would play out, because that would be the timeframe when ideally you make that resource reallocation decision?

  • And then a quick question on Eloxatin in Europe. From the -- Is the figure we see now a new run rate or is it still declining? You have obviously a much better visibility month on month. Any color on that?

  • And then a very quick question on Clopidogrel script acceleration. Is there any? Have you done any work at all to be sure that this is not related to the availability of cheap Clopidogrel? Looking from the recent trend, it doesn't seem to me to be particularly [void], because you would have [seen this] to level off, but have you done any work on that at all? Thank you.

  • Hanspeter Spek - EVP Operations

  • So I try take the first three, which gives time to Jean-Claude to calculate the currency effect. Clopidogrel, yes, I believe, frankly, that there is some impact from cheaply-available Clopidogrel, but what we have in terms of figures indicates that it is minor.

  • There are a number of other elements which we believe play much stronger, which is first of all the readjustment of our promotional resources, especially to hospitals, where cheap Clopidogrel did not play any role, I dare to say. Second, we have, during the appearance of the Apotex generic, not at all reduced our investment. We even have accelerated in our investments, which means we have spent more in the second half of 2006 than in the second half of 2005.

  • Third, what we see in PAD is definitely a fruit of our continued investment into this otherwise relatively difficult field of indications. And lastly, the communication of the FDA concerning Drug Eluting Stents once again placed, so to say, only in favor of Plavix, because Clopidogrel as a generic has not been really present in the [stents room]. But I believe, yes, with the average [GP] there was a little positive effect and, yes, we have to do them, as we say, to keep this.

  • On Eloxatin, very difficult to say what are a little bit the facts behind what you see today. We have a different impact from market to market concerning price. We see a main competitor, which is [main], which is the most aggressive what we see as of today in terms of price policy. And we see prices which are up to [50%] lower than the previous Eloxatin prices from us. Nevertheless, through our own measures and our own price flexibility in all markets, we maintain volume of 70, 80% in the case of Germany, even 90%.

  • So this is an [on-struggling] rate and we have to see, but we maintain our clear position that we see no reason to be fatalistic. We have the prime objective and products [for] generic to keep the volume and we succeed, but you need press for that and we have to see how this continues during the next months.

  • The most important factor for the growth rate in the second quarter and in the third quarter will be when and under which conditions generics will appear in France. We have today, now, as I speak, no generic in France, so our sales in France are relatively stable and the French market is a key market. It is, together with Germany, the largest Eloxatin market by far in Europe. And we have to see how the French market reacts.

  • So I am hesitating a little bit, but I would say that what you see this trimester should not be worse in the next trimester. But this is nothing but a guess.

  • Alexandra Hauber - Analyst

  • Thank you. That's very helpful.

  • Sanjay Gupta - Head of IR

  • We just have time for --

  • Jean-Claude Leroy - EVP Finance and Legal

  • No, I was [inaudible]. After a lot of work, I came to the conclusion that -- No, coming back to the SG&A line and the currency impact, I said that, with the impact of the U.S. dollar to euro taken into account, we could say that, starting from a minus 8.6% in SG&A line, we were back to between minus 1 [but] minus 5%. Because of the very great importance of the U.S. dollar in this area, I can confirm that, when you do the same work, including all the impacts of each and every currency, you come to the same conclusion. We are still within minus 4 and minus 5%.

  • Alexandra Hauber - Analyst

  • Okay, thank you.

  • Sanjay Gupta - Head of IR

  • Thank you. Claudia, we have time for a couple more questions, yes?

  • Operator

  • Thank you. We move to the next question from Jerome Berton with Aurel Leven. Please go ahead.

  • Jerome Berton - Analyst

  • Yes, good morning. Thank you for taking my question. Just really quickly, could you update us on the generic challenges on the CR version of Ambien? Have you [viewed] the generic challenges there?

  • And also, could you update us on the Japanese situation? If I remember correctly, Philippe Fauchet said in April that you could be interested in acquiring a mid-size company there. Could you confirm that or not?

  • And lastly, sorry if you already answer that, but could you explain or remember me the reason why Acomplia sales in the first quarter were a little bit, in my view, disappointing and lower than compared to the Q4? Thank you.

  • Hanspeter Spek - EVP Operations

  • I start with Acomplia. We had some stocking effects in the fourth quarter, coming from a relatively intensive launch phase, really, at the end of the fourth quarter in various small markets, but it was more the number of markets. [We see them] in Europe, but not only in Europe. We had a number of launches, technical launches in December 2006, also, in South America, such as Mexico, Colombia and [Argentina]. So it is, to a certain extent, an [odd effect] and I believe that you will see much stronger figures, then, in the second quarter, of course, driven by the launch of Acomplia in France.

  • Concerning Philippe Fauchet's statement on an acquisition policy in Japan, yes, we confirm this. We believe that, despite the recent up-tick of our own internal performance and the additional external growth by products we are taking back from our Japanese partner, we still are under-represented in Japan. And, yes, of course, we are actively looking in Japan to opportunities which fit our needs. And those opportunities are more in the mid cap than in the large cap.

  • Now, on the Ambien CR, what we have done so far, we brought [suit] against Watson on January 26, 2007, against Synthon on February 5, 2007 and against Barr on April 5, also for 2007. We have received, paragraph four, notices for two other products coming from Anshun and [Aprica], but we have received those notices only in March and in April 2006, which means -- in 2006, which means, yes, we are fighting those applications.

  • We are going not further into details, but you may be aware that they are technical effects, which means that it is not useful to fight each and every applicant. So we have a selective legal strategy in this case, but we defend our rights, which we feel are solid. We have data exclusivity that precludes that the approval of any generic until March 2009 is literally impossible. And besides, we will defend our valid patents on the formulation, which will not expire before 2019.

  • Jerome Berton - Analyst

  • Okay, thank you.

  • Sanjay Gupta - Head of IR

  • Last question please, Claudia.

  • Operator

  • Thank you. The last question comes from [Jo Walton] with Lehman Brothers. Please go ahead.

  • Jo Walton - Analyst

  • Good morning. I wonder if you could give us a little more help on Taxotere. You say that you've seen growth there, but it's still minimal growth in the U.S. If you could perhaps split out demand and price and give us some help?

  • And looking at restructuring, the EUR22m you had in the first quarter, you've alluded to some more to come in the second quarter and the second half. Is it fair to say that we should perhaps use this as an ongoing run rate for your continuing restructuring efforts?

  • Jean-Claude Leroy - EVP Finance and Legal

  • I'll take the last one. Just to tell you, yes, I mentioned that rather small amount of Q1. And I said that we expect that [inaudible], which is going to be rather small, too, in Q2, but that doesn't give no guidance as to what you should see or you might see on this line item of restructuring on the ongoing year. So, no, it's not predictive of anything. It's just a conclusion of the total cost of this French restructuring, which, if we add up what happened in '06 and in the first quarter, brings the total to around EUR150m before tax.

  • Hanspeter Spek - EVP Operations

  • And then, finally, Jo, on the Taxotere growth rate, yes, what you say is true. We have a much stronger growth still outside the U.S. with Taxotere. But let's keep in mind, if I remember correctly, our total in the U.S. for total 2006 has been close to zero. So in this respect, I see it as absolutely encouraging to report, now, a growth for the U.S. isolated of between 4 and 5%. So I see it as a good beginning and, yes, the international part, which is growing by 14% this year, is the right direction. But overall, I'm very much encouraged by what we see in the U.S. now.

  • Jo Walton - Analyst

  • But the U.S. sales are still sequentially lower in the first quarter of this year than the fourth quarter of last year. So it doesn't look as if -- in dollar terms, so it doesn't look as if you've actually managed to turn the corner there.

  • Hanspeter Spek - EVP Operations

  • Well, I see here a figure of EUR174m in the fourth quarter and EUR168m in the first quarter, so I think [inaudible] that it is, in absolute terms, on the same level, which, from quarter to quarter for a product which is centrally purchased like Taxotere, is, I believe, okay.

  • Jo Walton - Analyst

  • Thank you.

  • Sanjay Gupta - Head of IR

  • Thank you, Claudia, and thank you for participating in today's conference call. As usual, if you have any further questions, please don't call the IR team. Thank you. Goodbye.

  • Operator

  • Ladies and gentlemen, this will conclude today's conference call. Thank you for your participation. You may now disconnect.