Christopher A. Viehbacher
Management
Good afternoon and good morning, everybody. Thank you for the savings, Sébastien. I could probably add that actually, as part of our overall cost reduction measures, reorganization of Paris-based office space will have eliminated 100,000 square meters of office space of an annual saving of EUR 50 million. So you can see that we continue to be cost conscious and focused on growing the business. As I present to you today, I'm thinking about the very first time that I did this in the name of Sanofi, which was in February of 2009. Back in 2009, we were looking forward to the patent cliff, and actually on that day, that was the very first time we, as a company, admitted there was a patent cliff and announced, really, a strategy about how we intended to deal with the patent cliff. This morning, I was on TV, and the journalist was very kind in saying, "You've never deviated a single line from that strategy." And I think that's true. It hasn't always been easy. Not everybody's believed it. But I would say today that we have successfully navigated through the patent cliff because if you look at all of the products that we lost, we have had certainly the most concentrated and deepest patent cliff of anybody in the industry, and I'll show you some numbers on that. The objective is, as we laid out 4 years ago, it wasn't just to replace the sales of those products we were going to lose. It was to put the company on a completely different path. It was meant to provide long-term sustainable growth of the business, and you can't do that if you're really only ever going to be focused on R&D and patents. So what we were looking to do were to create these growth platforms that had different barriers to competitive entry, whether it be capital investment, brands, know-how. But the idea was that, really, unless you got that long-term predictability of earnings, you were never going to get to a higher multiple. This industry has now, for at least a decade, underperformed the broader market in terms of multiples. In the last 2, 3 years, last 2 in particular, Sanofi has closed the gap to its peers on multiple. But I would say that on an average multiple of around 11x, 12x, this industry is still at a discount to the broader sector, and largely, that's around the perceived risk of R&D and the lack of long-term predictability. So what we are really looking to do with these long-life assets like Vaccines and the Consumer Health Care and Animal Health and Emerging Markets was to provide a platform of predictable long-term earnings. Now it never was meant to eliminate innovation as a core of our business. But if you are doing research and development in the context of a company that can grow long term without patents, then imagine the leverage effect that you could get if one of these products actually makes it out of R&D. And imagine actually the predictability of a business that knows that it can grow even if in a particular year, a particular product doesn't make it. And imagine the discipline that you can have in R&D if you are no longer dependent on meeting your 2014 number because a certain product has to launch. Because I can tell you, in my career, the thing that really drove me nuts the most was that we took compromises. We made compromise along the development path because we needed to hit certain expected net present value calculations on our portfolio, that we needed to have certain number of projects in every stage of development, and I think that has led to poor quality pipelines. And so the objective we have, and Elias will talk more about it, is to really be a growing company on a long-term basis and known for the science. Now we're not entirely there yet, but I think we've made a significant amount of progress. And I would submit that today, the company is stronger than it was 4 years ago. Largely because back then, we had a significant amount of our sales and an even bigger percentage of our profits that were threatened by generic entry. And today, we have probably one of the lowest exposures to generic entry of anybody in our industry. Now we all know that Plavix had a big impact on our business in May of 2012, and it's going to take a year from May 2012 for all that to wash out. 18 months ago, we told you that the impact of losing Plavix and Avapro in the U.S. was about EUR 2 billion on an after-tax basis and on a 12-month basis. That would be split roughly between '12, 2012 and 2008 -- 2013. In actual fact, because of exchange rates and a few other things, it's actually about EUR 2.1 billion. And so the effect in 2012 was EUR 1.3 billion, and it'll be EUR 800 million next year, so it's about EUR 100 million more than what we had expected. So as a result, we're going to be affected by comparisons to last year, when we still had Plavix, until the middle of the year. But once we're back into like-for-like comparatives, we expect to be able to show growth in our business on both top and bottom lines. And of course, everything that we are looking at in the business completely confirms what we thought 18 months ago. All of the businesses are performing as we had thought, and so we are completely confident in being able to meet our 2012 to 2015 objectives for sustainable growth. Now what we've done, and I think you've known, we moved from the blockbuster phase. We've just finished 4 years of extensive transformation. This -- a lot has gone on in the company that you'll never see and is completely invisible, but it certainly has included investing in the growth platforms and diversification, cost management. And I think as we stand here today, I would say we start a new chapter. I mean, really, the major impact on results is finally getting rid of the generic drag on the business and just letting the growth platforms continue to perform as they have over the last 3 years. The other aspect that is quite exciting this year is -- and most of you don't know Sanofi as a pipeline company, but if I've had any surprise over the last 12 months, it's really that the pipeline has kind of crept up on us. We have not had the attrition we've expected. We've had interesting assets, like the IL-4, suddenly come through and come through faster. I think the partnership with Regeneron, for instance, drives us at a pace that's probably faster than your typical Big Pharma pace. And as a result, I think we're actually looking at an extremely robust late-stage pipeline. You've seen the number of approvals we've had even in the past week, and of course, all of those need to be properly funded. And so I think in addition to the growth platforms, you're going to see us increasingly become a story of launching new products and having a sustainable pipeline. Now on all of this, of course, we've been able to grow our sales. We started -- 2008 was the first year I presented. We had EUR 27.5 billion in sales. I'll show in a minute that had we done nothing, we would have certainly lost EUR 5 billion because of generic entry. We're showing close to EUR 35 billion in sales, and so there's been a significant increase in sales, and of course we all know that at least part of that is through acquisition. But I will tell you that it's at least a 50-50 split between what we've acquired in growth and what we've been able to do organically through our growth platforms. If you look at what has really left us over time, it's a pretty impressive list of products, from Allegra all the way through Eloxatin. And you can really see this concentration. Sanofi, really, before 2010, had never really been faced with any significant patent expiry. And after 2012, as I'll show you later, really isn't faced with any, at least in the small molecule, patent expiry until the end of the decade. But in those critical 2 -- 3 years of 2010, '11 and '12, you saw an awful lot of business at risk. So when I look on the right side of that graph, of course, you see this, the 9 products that were really facing patent expiry and generic entry, had sales of EUR 7.6 billion roughly in 2008. EUR 5 billion has walked out the door, and so that perimeter is now EUR 2.2 billion. Of course, we all know that, that never really goes to 0, but there will be some marginal impact in 2013 of some of that business. In the meantime, the growth platforms that we just talked about have grown from EUR 11.8 billion to EUR 23.5 billion. They were 42% of sales, and they're roughly around 70% of our sales today. By 2015, as we already said 18 months ago, they'll be roughly 80% of our sales. In other words, the emerging new Sanofi is really the growth platforms, and as you'll see also later on, we were able to grow those growth platforms at close to 10%; 9.9% to be exact. Individually, Emerging Markets grew at 8.3%. We didn't achieve our double-digit target in 2012. I don't think that's for any fundamental market reason. This is principally as a result of, for example, Eastern Europe, which is growing slower. We describe Emerging Markets essentially as those countries that spend less than 5% of GDP on health care because we know that that's an underinvestment in health care. However, Eastern Europe continues to be principally affected by macroeconomic trends in Western Europe, and Hanspeter will go into more detail. You'll see that the key regions of Asia, of Latin America and Middle East, Africa continued to grow at double digits. My personal view is, and I have not changed one iota on this, I still believe that Emerging Markets is the single biggest growth lever that this industry has. Diabetes continues to perform extraordinary well at 16.7%, Vaccines at 5.7%, Consumer Health Care 9.9%. We were nowhere as a consumer health company 4 years ago, and today, I have to say I'm extremely proud of our teams in being able to say that we're the third OTC company now worldwide after J&J and Bayer. Animal Health, an extremely important business. I think we continue to drive value since the acquisition of Merck's half of the business. If you think about Frontline, 4 years ago, the patent expired. It is still a $1 billion-plus brand. And there's a very exciting pipeline. We never talk about the pipeline because in this business, you test the products in animals, and therefore, it's pretty fast for the competitors to chase you. So we tend to tell you about what's in the pipeline about 5 minutes before we launch it, as I say, largely for competitive reasons, but I think you'll see that growth accelerate in the future. New Genzyme, and I'll go into some detail later, really a success story in the past year. Innovative products at EUR 611 million grew at 10%, but we all know that, that part really has been historically a weakness of the company, and I think you're going to see that strengthen over the next couple of years. We were busy on external growth. It was one of our key pillars in strategy. EUR 23.7 billion in acquisitions. We acquired 32 companies, but of course the most notable was Genzyme; 91 in-licensing agreements; and we entered into 3 joint ventures. Genzyme really was a -- had a remarkable year. And this was a very, very delicate exercise. The biggest issue we had was how are you going to integrate an iconic biotech company. We're talking about 1 of the 4 original biotech companies ever created in the world suddenly being merged with a Big Pharma. People who work in biotech generally work there because they don't want to work for Big Pharma. Now we're going to take a French-American cultural exchange, we had a hostile bid to acquire the company. So the stars were really aligned against us in being able to integrate it. And I think one of the first tests was the ability of the Sanofi team to work with Genzyme team. We've been working day and night for 2 years to really get that production back on track. And I think the fact that they were able to work together, get Framingham approved by both the EMA and FDA within 4 days of each other in January is an extremely important event. We also then saw that Shire did not get Replagal approved in the United States. And that really allowed Genzyme to take advantage of the renewed manufacturing capacity and the open market in the United States and now also to reconquer market share in Europe. And so we close to doubled the business in Fabrazyme. All of the other business is performing well. The other, of course, is that we decided to make New Genzyme. Remember, we took the oncology, the bio surgery, the renal business, put that into Sanofi where we had the marketing muscle to do more with those businesses. New Genzyme is rare disease and multiple sclerosis, and I'll show you a little later on. But they've already launched Aubagio with success. We have Kynamro approved, and of course, Lemtrada has been filed in the E.U. and in the U.S. [Audio Gap] So this is just what I've said before. This is largely what we said. We've had -- because of some tweaks to exchange rates and some other things, it's a slightly different mix from the EUR 1.3 million and EUR 700 million. It's EUR 1.3 billion and EUR 800 million, but largely, this is a predictable event. We've seen it coming, and I think we've managed through it. Now of course, we shouldn't forget that we live in an extremely difficult environment. On the U.S. side, of course, we had health care reform from President Obama. These are mostly taxes that have impacted us. Those are expected to reach almost $500 million in 2013 for us. On the E.U. side, things are no easier, and you all know about the austerity measures in Europe. These are measures to either increase generic utilization, decrease prices or increase the difficulty of getting new medicines approved. I would say Europe is probably the most difficult region in the world for the pharmaceutical industry today and is likely to remain so for a couple of years. That's about EUR 300 million for us in the 2010, 2013 period; on an annual basis, I would add. And of course, because we are a traditionally-rooted European company, we have a fairly large tail product business that gets affected by these measures. Now this is the EPS picture, 12.8%. But if you went back to the EUR 5.59 in 2008 and you calculate the generic impact, you would have seen that we would have lost 50% of our EPS had we not employed the strategy that we did. 12.8% is clearly down. It's nothing to write home about, but it's certainly a lot better than it could have been and, I think, a credible performance given what we've faced in terms of patent expiries. Now as we look forward, I think this comes back to this notion again. I think a huge amount of progress has been made on the R&D front. I mean, 9 regulatory approvals in the last year. And certainly, we've seen a couple that are already off to a good launch start. We've got 6 new drugs and vaccines which have been submitted, so we're going to have other decisions, and Elias will tell you what's in Phase III. Well, all of these are progressing well, and as I say, we've had certainly less attrition. In terms of progression to Phase III, we've got the PCSK9 inhibitor, and Elias will talk about the big ODYSSEY study. We've got our new insulin glargine formulation. We've got the JAK2 inhibitor. We've got the Fluzone quadrivalent ID, the Synvisc-One for hip, and you've seen the Lyxilan [ph] device. Because of a recent technical glitch, it's not probably going to go into Phase III this year. For Phase III results reading out this year, we'll have the Lemtrada, and this was back in 2012. We had Lemtrada. We had Lyxumia. We had eliglustat, and we've just announced that the ENCORE study, which is the second Phase III, met its primary endpoint in efficacy. And one of the most important events, I think, was the ORIGIN study and the epidemiology study. I mean, we not only put to rest any concerns around safety, but now as we look at competitive entries, I would submit to you that there isn't a product that has a more robust safety profile and efficacy profile out there on the marketplace. So what are we going to see in 2013? Well, we've already ticked the box for ENCORE. We've got the JAK2 inhibitor. And you can see these products. I won't go into them in detail because Elias will cover the pipeline a little bit later. But you can see that actually, there's an awful lot going. What is also good for me is I've been a skeptic on R&D for many years now, but I will say that when I look at a pipeline and I say, "Do we know mechanisms of action. Do we have a robust proof of concept? Do we have a high percentage which are biologics?" and I can answer all 3 -- to all 3 of those questions a yes, that gives me a whole lot more confidence about this pipeline's ability to make it through to the marketplace. Now the dividend has been an important part of the value story of our stock, particularly as we've been going through the transforming. We wanted to make sure that investors continued to believe in our company, and so the best way that we could communicate our own confidence in the business was a steadily progressing dividend. And you've seen since 2008, we've increased steadily the payout and steadily increased the dividend regardless of, actually, the development of EPS to EUR 2.77. That's a compound annual growth rate of close to 6%, and we intend to -- we still are intending to achieve a payout ratio in 2014 with the payout of the dividend in respect of this year. One of the untold stories of the company over the last 4 years, it's not only just a question of transforming the business, of dealing with the patent cliff, we obviously had our key shareholder, for very legitimate strategic reasons, exiting the company. And they certainly did it on a sensitive way, trading every day. But nonetheless, we had 1% of the capital coming into the market every quarter, and depending on the market cap, that's anywhere from EUR 500 million to EUR 800 million every quarter, and that has meant that we've had to go around and find new shareholders. And the shareholding of the company has dramatically changed over the last 4 years. And that's why it has been extremely important for investors to believe in the long-term story of the company but also in the dividend. Because I think we've actually been able to manage this part of the cliff now equally well, and I just want to confirm that, of course, that TOTAL is no longer a shareholder of the business today. So to wrap up my part, if I look at 4 years, sales up to EUR 34.9 billion from EUR 27.6 billion. Key genericized product sales were 28.4% of sales 4 years ago. They're now 3%, probably, again, one of the lowest rates in the industry. The growth platforms, which were fledgling businesses back in 2008, now 70.4% of our business. Emerging Markets business, from EUR 6.5 billion to EUR 11.1 billion. Biologics, we've clearly been behind in biologics, and I'm very happy to see that 48%, close to half of our pipeline, is in biologics. And you may remember me setting that as a target 3 or 4 years ago. Earnings per share, clearly not up as much in sales but still up from EUR 5.59 to EUR 6.20 in 2012, and of course, the dividend, up to EUR 2.77. So with that, I will turn it over to our Chief Financial Officer, Jérôme Contamine. Jérôme?