Earnings Labs

Sanofi (SNY)

Q1 2011 Earnings Call· Thu, Apr 28, 2011

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Transcript

Christopher A. Viehbacher

Management

All right. Thank you, Sébastien. And good morning/good afternoon, everybody. So we had a lot going on in the quarter and obviously I think the context is important to understand. I mean I think the first factor we need to get out of the way is of course the H1N1 sales that were incurred in the first quarter of 2010. I think last year we signaled very clearly that this was non-recurring revenue. I seem to remember answering a question last year from someone who said, how should we value the sales of H1N1? And I think my response was put a multiple of one on it. So I think we were pretty clear last year that we weren’t likely to see those sales come about and that’s the case. So if, obviously we can come back to it, but I think for the sake of simplicity, for all of the numbers we present, we’re going to assume that H1N1 is out of it, to give a better sense of what the underlying performance is. Obviously, as Sébastien said, this is also the first quarter where we’re consolidating Merial sales, but then of course we’ve always done the comparators on that. So with that out of the way, when we look at the business, I mean, welcome to the patent cliff. We’re right in the middle of it. And yet actually if I look at the first sales we’re still moving ahead as a company. And I think that’s an important achievement, and I’ll show you a little bit what the effect is. But there is clearly the transition going on. We’re moving away from the sales of the traditional growth drivers and more and more this company is looking like our growth platforms. So again, that first slide says,…

Hanspeter Spek

Management

Yes, thank you, Chris. Good morning or good afternoon to everybody. I would like to guide you through the chart as of page 14. And on 14 in the headline you read, that shows approximately 60% of our today’s sales representing as growth platform, delivered a growth of 15.5% during the first quarter. In absolute sales, we nearly made the sales result of last year, €7.8 billion. And you see then from the bar – we’ll describe H1N1 effect of approximately €400 million. But more importantly, you see that the growth platforms a little bit overachieved what we had lost during the first quarter due to generification, which was €569 million. Also of course, important to mention that we had a positive ForEx effect of €289 million. Now, the emerging markets. The first of the important growth platforms, we continue to perform strongly on the basis of our market leading position. We had a growth of 14.6%, up to €2.4 billion nearly, coming from those markets, which represent now nearly 31% of our total shares and became the most important part as you see, in comparison to the USA is 28% and Western Europe is 29%. So nevertheless, I think it worth to be mentioned that cardio-thrombosis which is more a historical part of our business largely consisting out of Plavix, continues to grow with 10.4%, mainly due to a very strong performance of Plavix in Asia, especially in Japan, but also due to the fact that Lovenox is continuously growing in Asia and in Western Europe, (inaudible) well in the USA in front of the generic competition, where we still achieved more than 50% of our previous sales in the United States. We thought it would be adequate to give you a picture on the Japanese situation which of…

Olivier Charmeil

Management

Good morning, good afternoon, everybody. We are having a good start. That was a strong first quarter, showing a growth of 9.6% excluding the pandemic sales. The strong growth comes mainly from the emerging markets where the first quarter showed a growth over 37%. The growth stems from a very strong (inaudible) campaign with regard to flu. We show on (inaudible) a growth that is above 170%. It’s the best ever season we have made in terms of flu in Latin America, with a very, very strong season in Brazil due to the change recommendation, which impacted pediatric sale as well as pregnant women. We maintained an extremely high market share. We have also had a very strong delivery now regarding the (inaudible) sales, where our market shares have gone from 35% to more than 85%. In terms of price uphold, we have seen very minor erosion in terms of price. Our growth in the emerging markets, those have been driven by a strong growth of our combos and more specifically of our plant vaccines that we continue to roll out internationally. In the U.S., our growth continued to be driven by our good performance on our combo, our Pentacel sales, as well as our Adacel and our booster, following the recent outbreak of pertussis in California, which has increased significantly the level of (inaudible) and the need to be immunized. We are happy to report that the FDA has granted us a license for Menactra for infant and toddlers for the age group between 9 months to 23 months, which puts us in a situation as we are the only one today to have this indication. I now hand over to Dr. Elias Zerhouni for the R&D highlights.

Elias E. Zerhouni

Management

Thank you. And good afternoon, everybody. I think in terms of R&D, I’m just going to highlight the significant changes that have occurred in the past quarter. And the latest one is the news on ZALTRAP, or aflibercept, which is a vascular endothelial growth factor trap, which is a fusion protein that essentially captures the ligand and prevents the activation of the receptor, which is a well-validated anti-angiogenic approach. And we’ve had positive Phase III results in the second line metastatic colorectal cancer trial called VELOUR with, essentially the trial has met its primary endpoint of overall survival. We’re obviously looking at the details as we speak and full results will hopefully be presented at ASCO and we’re expecting regulatory filings in the second half of 2011. This will be followed by final results from the VENICE trial, which is a Phase III trial in first-line metastatic [Audio Dip] cancer with an accrual completed already and final results to come. And this is obviously also complemented by the AFFIRM trial, a Phase II trial in first line metastatic colorectal cancer. Again I’ll remind you ALLURE is the second line and we have this trial, which is really trying the molecule in first line with the results expected in the second half of 2011. So this is a novel anti-angiogenic agent. We’re certainly carefully looking at the implications of the positive results we’ve had on this class. Other news, as you know, lixisenatide has been a major project in terms of our opportunity to expand in the GLP-1 market. And the benefits are very clear. First and foremost, I think from my standpoint, it’s an effective GLP-1, it does reduce HbA1-C and prandial plasma glucose. It does demonstrate low incidence of hypoglycaemia and obviously has a positive impact on weight. But…

Jerome Contamine

Management

Thank you, Elias. Before we end with the financials, it’s sort of been said already on the sales, is at slide 29, so I will just add a few comments. A, the contribution of Merial, because as you know, we have presented pro forma figures for 2010. So the contribution of Merial in 2010 for the first quarter would have been on a pro forma basis €513 million, which is to be compared with €594 million for 2011, showing by the way as was highlighted already the strong growth of Merial during the first quarter. The rest of the slide basically shows that on one hand we have had, excluding H1N1, neutral growth, so clearly showing that the organic growth of the growth platform (inaudible) the decline of the genericized products. And on top of that, we had positive headwinds from currencies on exchange rates and if there is one thing to note is that – I’d like to repeat again that is not only the U.S. dollar, which is the euro – versus the euro which is rising our actual figures on the current exchange rate basis. But it is also the Japanese yen, which has become very strong since the crisis in Japan, as well as the real, the Australian dollar and of course the renminbi. So it just highlights how, I mean, the diversity of exposure to various currencies, which is another way to look at the diversity of the growth in terms of geographic – expansion. Now if I move to slide 30, the P&L and maybe I will not spend too much time on this slide, but give more some details on the next slide. So as you know, we have on the consolidation basis, a 5% decline on net sales, but this of course…

Christopher A. Viehbacher

Management

Thank you, Jerome. We’re indeed now ready to answer any questions you may have.

Operator

Operator

We have a question from Mrs. Alexandra Hauber from JP Morgan. Madam, please go ahead. Alexandra Hauber – JPMorgan: Yes. Hi. I – of course more than one. So I’m trying to – I had actually five. This LANTUS 14% growth in the U.S., prescription growth was about 7%. So is the rest price or is prescription growth not a good measure for volume growth? And the other question is, if you really plan to file Teriflunomide in the third quarter in the U.S., what data will be included in the files, is that just TEMSO? Sébastien Martel: You want to take --

Hanspeter Spek

Management

Yes. Your assumption is right. The rest of the growth evidence is price, we have the last price increase in the first quarter 2010. Sébastien Martel: And Teriflunomide...

Christopher A. Viehbacher

Management

Well, we’re looking at including actually the TOWER, the interim TOWER studies in addition to TEMSO, and we have already interacted with the FDA, and that seems acceptable. Alexandra Hauber – JPMorgan: Is that just a safety look at, from the TOWER from interim or is that any efficacy also?

Christopher A. Viehbacher

Management

No, the interim is actually understanding the safety better. Alexandra Hauber – JPMorgan: Okay, thank you.

Operator

Operator

We have a question from Mr. Mark Dainty, Citigroup. Sir, please go ahead. Mark Dainty – Citigroup Global Markets Ltd.: Thank you. Just very quickly, Jérôme, I wanted to touch on something you mentioned at the end of your comments. With respect to capital structure you made a hint that more debt might be more efficient. Should we assume that in the future you will maintain a structure that has more debt than you have in the past, and therefore that your repayment of the Genzyme debt might not be very rapid? And then the derivative of that therefore is the use of free cash flow may go to greater returns for shareholders? Thanks.

Jerome Contamine

Management

Okay, Mark, thank you for the question. So let’s go step-by-step. A, I mean, may depend upon which debt you referred to in the past. I mean, clearly it’s not our objective to reimburse the full debt associated to Genzyme. Now, I mean, let’s just keep in mind that if we have no debt by the end of Q1 and then we will add, roughly speaking, $20 billion by construction, let’s say $20 billion by the first of April, and then we have also to pay the dividend. So I mean, we need to monitor that over the coming two years. But you are right that we’re, I mean reviewing how we can optimize the return to shareholders and the cash return to shareholders by optimizing the capital structure. And I will say yes, I mean, keeping a level of debt which could be in the range of, I mean in the range of, we’re gearing of around €10 billion is something that we can definitely sustain. €10 billion. Mark Dainty – Citigroup Global Markets Ltd.: Okay, thanks very much.

Operator

Operator

We have a question from Mrs. Luisa Hector from Credit Suisse. Madam, please go ahead. Luisa Hector – Credit Suisse Securities: Thank you. Chris, you touched upon the potential revenue synergies with Genzyme, so I wonder if you could just add some color to that and perhaps within that maybe a comment on Renagel where we have the patent expiry looming in 2014, so your thoughts around that? And then I noticed specifically on Renagel in the Genzyme press release that there was this Q1 new tender in Brazil where I think we already have a generic presence. Perhaps you could tie in the generic situation on Renagel with that. And then the second question would be just to get some guidance on the other operating income. Because it did look a lot more positive in Q1 despite the Genzyme bankers’ fees, so I just wondered what the full year outlook is there?

Christopher A. Viehbacher

Management

Well on the revenue synergy, I think the most obvious is to look at the geographic footprint of Sanofi. There are a number of products, you mentioned Renagel, there’s a number of others where either the products are approved and there isn’t enough resource to be able to allocate to promote those products, or if there has been some resource, it’s significantly underfunded. I think it’s fair to say for example on the Biosurgery business, which includes particularly Synvisc, Synvisc-One and the SEPRAFILM, that Genzyme has been in a resource constrained environment and has not always had the resource to allocate to that business. So I think if we look at Synvisc-One in places like India we can clearly put some more – simply put more people behind those things and gain some synergies. The other is a little bit longer-term but they are clearly some late-stage assets in research and development that have not been funded due to lack of resource. And I think one of the first decisions that we were able to make was to be able to fund three projects that hadn’t been. And I have to credit Elias and his team because funding these was important from a number of reasons. One is because they’re good projects and deserved to be funded. Two is that it was a good thing to be able to show that, to demonstrate in real money, our commitment to invest in the business. And three, I think it also demonstrated that even a big pharma company can move nimbly and make some timely decisions. And those three projects were for example the progress of the project in Niemann-Pick, which is a rare disease and obviously right at the core of what Genzyme has been doing. We also are going to…

Christopher A. Viehbacher

Management

Okay. So now, I’ll turn that over to Jerome.

Jerome Contamine

Management

So maybe I can take it, I mean this is typically the line when you see a lot of plus or minuses, which may vary from one quarter to another. Last year, I mean we did have some exchange rate losses last year, which were linked to our hedging policy on the high volatility of currencies. This year, we have a slight profit, so this is probablyh one of the explanations where you don’t match exactly what you would expect just by the cut of revenues from Copaxone. We still have on these lines the revenues from (inaudible) and on Actonel. And we had last year the accretion cost of Chattem, which were also the same magnitude (inaudible) enzyme but was also chopped short. Basically on the like-for-like basis, this explains the gap beyond the loss of revenues from Teva on Copaxone. Luisa Hector – Credit Suisse Securities: Okay. Thank you.

Operator

Operator

And we have a question from Mr. Michael Leuchten from Barclays Capital. Sir, please go ahead. Michael Leuchten – Barclays: Thanks for taking my questions. Question number one for Dr. Zerhouni. On the TEMSO study, despite a good tolerability, the completion rate was quite low, be interested to hear your view on that. And then a quick tricky one for Hanspeter. Going back in time, Taxotere at peak, what were the revenues in prostate cancer in U.S. and in Europe?

Elias E. Zerhouni

Management

Well, I’ll take the first one. And as far as TEMSO, I don’t think it was any lower than the usual. Remember this is a two-year study. I have to check, but I don’t think it was remarkably lower, let me see. Yeah, I think it was well-tolerated, very similar number of patients reporting treatment immersion adverse events. So I’m not sure exactly what you are referring to, but I’m not aware of a significantly different --

Christopher A. Viehbacher

Management

We’ll check because, the whole value proposition here is you’ve got nice efficacy and probably one of the most interesting tolerability profiles. And this is not a space where low side effects has been very common amongst competitors. So it’s quite an interesting drug really because of the combination. But we’ll check and get back. Hanspeter, do you have --

Hanspeter Spek

Management

On the Taxotere, I just have to give you an estimate and I would say that it was approximately 50% to 60% of sales. But we get back to you with a more precise figure in – which of course has to be in volume and in terms of value because the treatment and substance use is different between the 7 or 8 indications Taxotere has in the USA. But it’s definitely more than half. Michael Leuchten – Barclays: Thank you.

Elias E. Zerhouni

Management

I just have, just a little more information, I was looking at my notes here and so in terms of long-term use, the open label extension of the Phase II study, which we presented showed that Teriflunomide was well tolerated for over eight years of continuous use in that open label study initially. And there was no real difference between the eight years and the 36-week. So I’m not sure exactly what you’re referring to, if you could just e-mail me and I’ll look into that. Michael Leuchten – Barclays: Okay. Thank you.

Operator

Operator

We have a question from Mr. [Phillip Allen] from Natixis. Sir, please go ahead.

Unidentified Analyst

Management

Good afternoon. Two quick questions. One on Menactra which is down 40% in the quarter, so when do you expect the sales to stabilize and what can we expect of the new line extension? And also on the sales that we adapt the (inaudible) product on the growth platform, there are about €2 billion in the quarter of sales, which are, let’s say, tail products, and we find here some old product that they’re back in, et cetera. it’s basically flat in the quarter, but what can we forecast for that midterm, shouldn’t we take some minus 205% in the models? Thank you.

Jerome Contamine

Management

So I’ll start with Menactra. So there are a couple of after effects in our Q1 sales due to large order from CDC at the end of December, December 2010. And secondly, some orders that have not been shipped in the first quarter that I believe will ship at the beginning of the second quarter. When we look to the data in terms of use, we see that overall the use is at the same level, 2011 versus 2010 for the first quarter. Regarding the price, the price remains at the same level and we maintained our market share at the very high level between 85% and 90%.

Christopher A. Viehbacher

Management

I mean, the rest is in on the tail products and I’ll let Hanspeter comment.

Hanspeter Spek

Management

I would say you are on the safe side if you assume flat sales over time of course those products will continue to diminish due to price, let’s say, in Europe. But referring to the product you mentioned (inaudible) is a product which still has growth in, let’s say, in Latin America and Africa and in (inaudible) I think if you estimate, zero growth you’re on the safe side.

Unidentified Analyst

Management

Okay.

Operator

Operator

We have a question from Mr. Damien Conover from Morningstar. Sir, please go ahead. Damien Conover – Morningstar Research: Great. Thanks for taking the question. Just regarding the Consumer Healthcare division, given the strength in the quarter, I was wondering if you could comment on the competitive position of this division in emerging markets, particularly relating to potential synergies with the rest of the business being branded and generics. And then secondly if you could comment on your comfort level with the current scale of the business in the U.S.? Thank you.

Hanspeter Spek

Management

I would start with the U.S. because that’s an easy process, we are, we have a high comfort level because as I mentioned earlier, Chattem is establishing its position by the launch of Allegra, which is probably announced at an event in our business. If Chattem continues to perform like this we have a very nice leading position in CHC, which of course always is a question of definition. if you really define it in the very, very large sense including Coca-Cola and other consumer products. Or are you really defining it as, more stringent sense as consumer health. We’re then amongst the leading five companies in the U.S, which I consider as a good position especially for a company which has been absent in the U.S. three years ago. Now for the other markets, the answer is a little bit more complicated. I think we have to say that today we cannot be entirely satisfied with our position in Europe. And we have some good positions, one of course is here in France. But we have absence in let’s say in the United Kingdom and nearly absence in U.S. – in Germany, which we have to look over time, if there is opportunity, opportunity to switch products or evidently also to make bolt-on acquisitions. And if you go to Latin America we have a market leading position in CHC, which is so far, for Mexico, which is so far Brazil, which is to some extent also true for all of the – more smaller markets in Latin America. And then again in Asia is a position, is mixed, you have made a significant progress in China though the two acquisitions of Sunstone and Minsheng. We have good traditionally strong positions in let’s say Philippines and Indonesia and in other smaller markets, Thailand for example. We have totally redesigned our business in Australia, which has been 100% prescription business 3 years ago. And today it’s depending to 40 – on 45% on CHC sales. And once again a soft spot in Japan, where we have today no CHC position, but where we see significant opportunities and amongst them of course, an analog switch of Allegra into OTC, as following the example of the United Sates. So overall we have made a very, very significant progress as outlined in one of my charts. But we have to continue to work. But if we keep the speed of the last two years we don’t worry.

Christopher A. Viehbacher

Management

I think there was an element of your question which was around the synergy with the rest of the portfolio. I think it would be fair to say, as you go into emerging markets, market segmentation is not nearly as crisp as it is in, say Europe and the US. And certainly a broad portfolio in the pharmacy is both a key success factor and a strength of Sanofi. And so I think given the importance of the pharmacy to that chain that shows the demonstration of the importance of CHC and ability to communicate directly to the consumers to build up branding. So for example in Brazil we actually sell CHCs under the Medley brand, but we also sell unbranded generics under the Medley brand as well. So there is some synergy, not necessarily in having branded generic OTC products but, although that may be possible. But I think there is an element of a portfolio effect in that business. Sébastien Martel: Operator, we’re going to take one last question, please.

Operator

Operator

We have a question from Mr. Graham Parry from Bank of America – Merrill Lynch. Sir, please go ahead. Graham Parry – Merrill Lynch International Ltd.: Great, thanks and just a quick question on the LANTUS manufacturing. Following the warning letter, wondering if you had any further communication with the FDA, or do we just have to wait the six months for their response? And also if you could clue us in on what was in the remediation plan that was submitted in March that wasn’t in the two that the FDA had previously rejected. The second question on the EMA multi benefit risk assessment, any expectation on timeline, when we should get a result for that? Thanks.

Christopher A. Viehbacher

Management

So on the warning letter, I mean I’m not sure what you’re talking about remediation, I mean we certainly submitted a remediation plan with the FDA and the FDA has accepted that and the FDA has indicated they’re quite happy to come and do the inspection when we feel that we’re ready. I think you have to recognize that the FDA has something like doubled the number of inspectors over the last two years, and has clearly and correctly, I think, become much tougher and even tougher than they have been in the past. So I think their willingness to escalate to warning letters or their willingness to look at things critically and to make sure they’re sending signals to industry has evolved over time. So, because you remember this inspection was to come in and look at the fexofenadine primary production related to the Allegra switch, and actually the inspectors decided not to look at that and looked at Apidra, which was not what the usual inspection practice has been. That doesn’t change anything about the nature of the letter but we – I think Sanofi has actually got one of the better records in this industry on manufacturing quality. Frankfurt is one of our star sites, so it’s something we’ve taken extremely seriously. We’ve got resources all over this and I think we’re extremely confident that we’ve got this issue resolved. In terms of MULTAQ --

Elias E. Zerhouni

Management

Yeah, as far as MULTAQ is concerned, the review of all data is still ongoing at this point in terms of the risk of liver injury and, associated with MULTAQ and we’re still evaluating this as we go. We are trying to get epidemiology data and we expect the team to deliver their assessment in the coming month. We can’t predict what date that would be. Graham Parry – Merrill Lynch International Ltd.: All right. Thank you.