UCB SA (EBR:UCB)

Earnings Call: H2 2010

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Mar 3, 2011

Welcome to UCB's annual results presentation. We indeed published yesterday the 2010 results for UCB, as you saw, strong results. When I look at the year 2010, I really feel that 2010 was the year where all the elements of the strategy that we had set 7 years ago came together. First of all, from a financial standpoint, clearly we met, in fact, we exceeded the expectations, so that's good. What is very exciting behind that is that clearly our new products are taking off in a very dynamic way, so very promising launches of Cimzia, Vimpat, and Neupro. What is also very exciting is that we're building a late-stage pipeline and a mid-stage pipeline to fuel this late-stage pipeline. Also, you will see some of that today, the excitement of our science that is delivering some new innovative product into this pipeline. Last, also, we continue to refine and strengthen our financing. Overall, when I look at all these elements and these achievements, indeed, 2010 was a strong year and an important year as all the elements of our strategy are coming together. I will let you read this forward-looking statement and disclaimers that you all know by heart. For those of you that do not know UCB yet, if I have to summarize who we are, we are clearly a mid-size biopharma company. We are focusing on 2 severe disease areas: central nervous system and immunology disorders. We feel that we have the size in these 2 severe disease areas to compete with company of whatever size, be more innovative, and deliver superior value to patients and hence to shareholders. The testimony of that, clearly believe, is clearly what we invest in R&D. You see 22% of our revenues or 25% of our sales, which is significant. Clearly this R&D is delivering results. The testimony of that, the measure of that result, is the fact that, in 2010, more than 200,000 patients benefited from Cimzia, Vimpat, and Neupro, which is almost double from the previous year. We are operating in 40 countries, and 40 countries in a very focused manner. Really our footprint, remember, since the beginning of 2009 is really focused on North America, or I should say NAFTA, because we do operate also in Mexico. Strategically, that's one important block. Europe and large Europe, and then Asia, basically. So in large Europe including Russia, and then Asia, clearly, where we operate by ourselves in countries like China and India. Today, UCB is about 8,500 colleagues after the divestment of our 3 plants. Just to put that into perspective, 3 years ago, UCB was over 12,000 employees. So that gives you an extent of the magnitude of the focus that we have provided the company. Out of these 8,500 colleagues, in fact, almost 2,000 joined in the last couple of years. Also an element of the transformation that we have gone through. Back to 2010. You know these results now by heart. We delivered revenues of over EUR 3.2 billion, up 3%, and this was driven by the strong growth of Cimzia, Vimpat, and Neupro, but also Keppra holding very nicely. The underlying profitability measured by our recurring EBITDA reached EUR 731 million, up 5%, and core EPS reached EUR 199, and that was up by 15%. So very dynamic growth also on the adjusted net profit. Beyond the finance, new products, very strong growth, very promising launches for Cimzia and Vimpat, both in the U.S. and in Europe. For Neupro, very strong growth in Europe, and not yet in the U.S. Overall, these 2010 numbers clearly confirm our strong belief that the peak sales for Cimzia is at least EUR 1.5 billion, for Vimpat at least EUR 1.2 billion, and for Neupro at least EUR 400 million, and of course, for Neupro, the access to the U.S. market is important to get there. The menu of this afternoon, you just got the appetizer, and now we will move into the new products update and also an update on Keppra, which will remain an important franchise over many years to come for UCB. I will have Greg Duncan, who is the President of North America that will update you as well as Kouz Obeidullh, who is our Chief Marketing Officer. He doesn't like when I call him Guru, so our Chief Marketing Officer. That will update you on the new product performance and on Keppra also. Then Detlef will update you on the numbers more precisely than I just did, of course. Iris will provide you with the exciting momentum that we're building in our late-stage pipeline and mid-stage pipeline. Then Ismaïl will start to give you a sense of why we're so excited about the breakthrough period and why we're confident that our momentum to bring new medicines beyond what we have in our pipeline into the pipeline and eventually to patients that suffer from severe diseases is very strong. That's the venue. I now have the pleasure to introduce Greg. For those of you that are on the phone, the cool guy that is on this slide is not Greg, although Greg looks very cool also and has about the same accent as Brett. Maybe you can introduce Brett. I'm pleased to. Brett is on this slide, but who is a patient that lives with Crohn's disease. But I'm pleased to introduce Greg to update us on Cimzia and Vimpat in the U.S. Thank you, sir. Thank you, sir. Appreciate it. My mom thinks I'm cool. I'll tell you that. My kids, not so much. Good afternoon. My great pleasure this morning, or this afternoon, excuse me, I'm still on U.S. time, to give you an update on how Cimzia and Vimpat are doing in North America. Before I start, I think Roch mentioned our cool patient here. This is Brett. I've actually met Brett. He is a patient living with Crohn's disease. He is actually a pretty cool guy. He's now a chef, a very successful chef in the Atlanta area. Interestingly enough, he actually got his interest in food because of his Crohn's disease. Perversely, he had to become his own chef because he had to figure out which foods he could eat and which ones he could not eat. He's been successfully treated with Cimzia, and he's taken what I can only describe as kind of a defensive interest in culinary skills to become a professional in the area. Effectively, that's what this is all about, right? Getting it right with patients, and the business will get it right. This is Brett, certainly one of our successful patients, and this is the power of what happens when we actually get this right. We're pretty excited about that. Let me start off with Cimzia, then I'll transfer to Vimpat. Suffice it to say that you probably know we launched the Crohn's disease indication back in April of 2008. In June of 2009, we introduced Cimzia for the treatment of rheumatoid arthritis. Our sales last year were EUR 166 million, which represents 137% growth over 2009. Obviously, a full year of CD and half a year of RA. All told, we have 18,000 patients currently in the U.S. on Cimzia. We're quite excited about that. Other patients like Brett. Wanted to give you a little bit of a sense of how we're positioning the product. In the introduction at lunch, I got to meet a few of you, and you guys are obviously very well-versed in the details of the marketplace. I'm going to hit the big themes. We can certainly get into the more refined details during the Q&A. But I thought I might give you a sense of how we're positioning the product from a value perspective so you can get a sense of how we're competing in the marketplace. We'll start off with Crohn's disease. You can see with Crohn's disease that we're targeting both bio-naive patients, as in first on a TNF, as well as bio-switch patients, those who may have started on Remicade or on Humira. What's important, I think you're all familiar with this, we have two formulations: a prefilled syringe, which is, generally speaking, a prescription you pick up from a doctor, you go to the retail pharmacy, you fulfill that prescription, and you take it home and inject yourself. We also have a lyophilized version of the product, which physicians actually purchase themselves, and they actually introduce the product to the patient in the doctor's office, administered in-office administration, almost like an IV. That's important for us because there's two modes of administration, and some physicians in the U.S. feel like to maintain compliance with their patients, they want to administer the drug in office. That's very, very important because you can use Cimzia for bio-naive patients for Crohn's disease, but if you like subcut Humira or you like in-office administration with Remicade and you want to switch from either one of those, we have a path you can get to. For subcut, you can go to the prefilled syringe. If you're used to Remicade, you can use the lyophilized version in the office. So really exquisitely positioned versus our competition. We have a position which is called sustained stable dosing. Very importantly, Cimzia works fast, and the dose you start with is the dose you stay with, which is in sharp contrast to Humira and Remicade. Both of those drugs you see roughly 15%, maybe as high as 25% of the time, based on U.S. claims data, you see an increase in dose, which substantially ramps up the cost. All right? We have a proposition where we talk about fast action, sustained stable dosing. You get to the dose you want right away. All told, we have penetrated approximately 4,000 prescribers, which represents about 50% of our target. Although we're quite happy with the progress of Cimzia in the CD space, there is certainly room for growth there because we need to convince the other 50% of the marketplace to start administering the product. On the RA side, we have what's called fast and predictable response. If you know the history of rheumatoid arthritis, you'll know that physicians have been trained to treat this as an acute disease. Try one product, use it extensively until you've proven it does not work, then move to the next product. In our case, our proposition is you can make a choice at 12 weeks. That's very, very important given the severity of this disease, and you do not want a patient on a drug at this cost and with the potential side effects of TNF drugs that are not responding. I'll talk a little bit about how we're competing with that proposition in the marketplace. We have 2,200 prescribers. Again, very similar to the Crohn's space. That's about 50% of our target audience. Roughly speaking, our breadth of prescribing is about 50% of the target to this point. I'd like to dial a little bit more into the RA position because it is truly unique. I think you may have seen some of this, but just to express it, when we go in to talk to our customers, we talk about the fact that you hit your maximum response with Cimzia at roughly 12 weeks, be it an ACR 20, an ACR 50, or an ACR 70. At 12 weeks, you will get that peak response, and importantly, you get that sustained response in rheumatoid arthritis. On the right side of the slide, you'll see what's the probability analysis of responders. This is a cumulative graph, so if we start at the first point, you'll see that roughly 25% of our patients respond within a week. If you go to the next dot, you get to 20% and so forth and so on, down to roughly 60% response rate. What's important is once you get out to 12 weeks, you only have a 1% chance of responding if you maintain therapy. This is very important because when we go talk to our prescribing customers and payers, very importantly, we tell them, "Guys, we know the marketplace is moving into using two or three TNFs maximum." In the old paradigm, they used to use all TNFs. Now you see 90% of physicians use one, two, or three. In many cases, they're only using two TNFs. This proposition, when we're walking into physicians and saying, "You can make a choice at 12 weeks," which has important clinical benefits and important cost benefits, is really starting to resonate in the marketplace. Particularly if you think about using only one or two TNFs, the chance to make a choice within 12 weeks becomes a very attractive proposition. Very importantly, we've actually tested this proposition in the marketplace, and as you know, there are five TNFs in the marketplace, plus the T-cell and B-cell inhibitors. If physicians understand our message that they can make a choice within 12 weeks, if that message resonates with them and they start to believe that as part of the Cimzia proposition, which it certainly is, we're the only company in the marketplace saying make a choice at 12 weeks, in contrast to our competition, which is saying use it four months, five months, six months. You see that their preference, their motivation to prescribe because of the uniqueness of the drug actually goes to the top of the list vis-à-vis the competition. So it's a very important proposition, which is beginning to resonate with our customers. We're quite excited about that. How is that translating into the marketplace? Let me walk you through our prescription data here. In the blue, you have new prescriptions. In the red or maroon, you have total prescriptions. What we've done is we've indexed both market and Cimzia prescriptions back to January. The market in the hashed lines, the solid line is actually Cimzia. What you can see for the rheumatoid arthritis marketplace is on average, it's bouncing around a little bit from January, but by and large, you have probably 7.5%, 8% market growth over the course of the year indexed back to January. Take a look at new prescriptions for Cimzia in the blue and total prescriptions in the red. You'll see substantial growth vis-à-vis that market growth differentiating in the marketplace. So the proposition is to make a choice in 12 weeks. It's tested quite well in market research, moving it up to the top of the preferential list, preferred most amongst those prescribers of TNFs, and in fact, we're starting to see that resonate in the marketplace. We're quite excited about the in-market penetration for Cimzia. Right now, we're running at about a 3.5% market share for rheumatoid arthritis on new prescriptions and a 3.2% share for total prescriptions. If I were to switch over to the CD performance, again, same graph. You have the market in the hashed lines, new prescriptions in blue, total prescriptions in red. What you see is throughout the period, in fact, a little bit of a different story, is a frank decline in the CD marketplace towards the back half of the year. Notwithstanding that decline, you see substantial separation between the blue lines and the red lines, suggesting that Cimzia is continuing to grow even in the face of a declining marketplace. In fact, all told, our prescription share for Crohn's disease is about 20% or 21%. Importantly, I know several of you guys asked me this previously, how does this compare with the other near-term launch, which was Simponi? I figure I'll head off that question before you ask it at the Q&A. In fact, you see the three indications for Simponi and the two indications for Cimzia. You see the products virtually overlapped since launch, which is pretty impressive given the J&J folks in the U.S. have been there for about 10 years. What's important, that lyophilized version that I referred to before is not captured in the prescriptions. You probably have another 10%-12% volume on top of those prescriptions. All told, I can safely conclude conservatively that in fact, we are outpacing Simponi in the U.S. marketplace. That said, the competition is very clearly Humira and Enbrel and Remicade, and that's where we're focused as we move forward. Switch to Vimpat. Sales last year, EUR 96 million. That's growth of 220%. We launched the product in June of 2009. A long heritage here in the epilepsy space, which we'll talk about. All told, we have 58,000 patients who are now benefiting from the Vimpat molecule. A terrific medicine, really terrific medicine. That EUR 96 million makes it the most successful launch in the epilepsy space in the U.S. by value in history. Outpacing Keppra's value-based launch by about 20%. We're quite excited about this launch. Our basic proposition here is when monotherapy is not enough, add on Vimpat. As you probably know, one out of three patients with epilepsy are not controlled, and there's an increasing body of data. In fact, there was just a New England Journal of Medicine article suggesting that the mortality rate, not just morbidity, but the mortality rate for seizure patients who are not controlled is seven times that of patients who are controlled. Seven times the mortality rate. We've all known about the morbidity challenges. That's very important because we are trying to educate the market on the importance of tighter control. This is an outstanding drug, not just because of its efficacy, but because it is clean. If you know the epilepsy marketplace, you will know that most patients are on anywhere from 3.5 to 4.5 meds, some patients on 5 and 6 medications. The idea that you get a drug that works and does not interact with other medications is a very important proposition. Currently, we have 11,000 prescribers, which represents about 85% of our target universe. We have primarily focused on neurologists and epileptologists and are now expanding into the hospital and long-term care sectors. Very importantly, I will not belabor the point here, we have moved forward with what is called the optimized combination therapy. Traditionally, physicians prescribe first-generation products and added second-generation products. We have actually taken a look at our data, working with the key opinion leaders across the globe, and come up with a very novel way to look at this molecule. If you think about the class, there is basically two types of agents, those that work in the sodium channel area and those that do not. These are the data we got the drug approved on. The orange line is a 44% response rate, reducing seizures by 50% for the 400 milligrams. You have about 34% for the 200 milligrams. If you add Vimpat to other agents that work in the sodium channels place, like Lamictal, for example, you see that that efficacy of roughly 40% holds up. Very importantly, if you add Vimpat to a drug that is a non-sodium channel activating drug like a Keppra, like a Topamax, in fact, you take that seizure freedom rate all the way up to 62%. I have actually been in focus groups with key opinion leaders who literally get out of their chair and say, "That is probably the most impressive seizure freedom rate I have seen or reduction in seizure rate I have seen." Basically what we are educating the marketplace on, getting to those 1 in 3 patients that are not well-controlled, and importantly, you can add Vimpat on basically anywhere, and in particular, if you add it on to non-sodium channel agents like Keppra, like Topamax, which are amongst the most frequently prescribed, you can take that percentage of populations who have a 50% reduction in seizures up to 62%. A really fantastic proposition for providers and their patients. A very powerful proposition, importantly, married up with a very good reputation in the marketplace. This maroon line, which represents UCB reputation in the marketplace, significantly outpaces all of our competitors. Every 6 months, we ask 200 high-volume prescribing doctors in the U.S. who is the company they want to partner with, who has got the most credibility in the marketplace when it comes to treating epilepsy. As you can see by that maroon line, we are best in class relative to our reputation. It is a very powerful proposition, married up with a very long history of trust with our customers. What does that translate into the marketplace? Again, similar format. What you see with the hashed lines for our new NRx and TRXs effectively that the AED marketplace, the antiepileptic marketplace, is flat. It has been the case for many years. What you do see, however, is a very substantial growth for our new prescriptions and our total prescriptions in that flat marketplace. We are on the verge of besting 2% share within NRx. Our latest weeklies were at 1.9%, and we expect to pass the 2% share barrier in the next couple of weeks. Very excited about the product. Great reputation, great proposition, a really great product, and so far outpacing Keppra from the value perspective. There is one more piece of information which makes me probably most excited about the future, and that is this. This is recently completed market research. This is asking physicians what is their preference for add-on therapy. If an existing therapy doesn't work, be that monotherapy or combination therapy, which is the most likely add-on product that you would add? What you see in the red chart now is Vimpat listed clearly as the number one choice add-on after only 18 months in the marketplace, outpacing even our own Keppra as the add-on of choice. A very good start, and importantly, this indicator of the future is something I am quite pleased about. I will get in to answer any specific questions during the Q&A. It gives me great pleasure at this time to introduce a good friend of mine, our Chief Marketing Officer, Khoso Baluch. Kosa? Thanks. Thank you, sir. Good afternoon. Let me start by talking about a patient called D. This is an individual that is living with rheumatoid arthritis, training to be a teacher, and this is neither Belgium or England with this weather, just so you are aware. It is Ohio in the U.S. Similar to Greg, what I am going to do is cover the CVN, Cimzia, Vimpat, and then I am going to cover Neupro because in the United States, we do not have Neupro. Then I am going to look and cover Keppra worldwide. Let me first begin with Cimzia. All my discussion will be outside of the United States and Canada. Outside of that territories, the rest of the world, we launched Cimzia in 15 countries. As you can see, clearly the growth as we have started our launches in these countries. We are now at 4,000 patients, and we have basically got Cimzia now in the five major European countries. Our message is consistent with the message that is in the United States, and we rolled it out in the second half of 2010, which is again, the message about having the 12-week and the predictability of Cimzia. In addition, we have Cimzia for Crohn's disease in Switzerland. In early 2008, we launched Cimzia in Switzerland with Crohn's disease. As I was mentioning, Switzerland, early part of 2008 with Crohn's disease, all the way till Q4 of 2009. In October of 2009, we launched Cimzia in Germany for rheumatoid arthritis. You can then see the healthy growth that we have got through the period. The countries we have launched Cimzia in are these countries, and three countries stand out a little bit. One is Cimzia in Italy, in France, and then in Spain. For those of you that know Spain, you know that although you launch it in June, July, nothing happens there during the summer till September. So technically, you have got three of the five major countries in the second half of 2010 launching Cimzia. If I move on to Vimpat, we launched in 6 more countries during 2010. Vimpat message is the same, add-on where monotherapy is not enough. Clearly, you can see we have got now 49,000 patients on Vimpat outside of the U.S. and Canada. If you take the 58,000 patients that Greg covered in the U.S., we have passed the magic point of 100,000 patients on Vimpat. It is a critical point because physicians want to see you pass that point to have more confidence in the product from a broad usage. We have passed that magic point, and we announced it publicly on February 14, which is Valentine's Day, but it also happens to be the day of epilepsy worldwide. Again, taking you through our quarterly data as we have continued to launch Vimpat, and outside of the U.S. and Canada, it is in 20 countries. You can see the growth that we have had through the quarters. These are the countries that we have launched Vimpat in, the 6 countries that we have launched Vimpat in through this period. Going to Neupro. I would like to spend a little bit more time on Neupro. Clearly, Neupro is a transdermal patch. The value proposition here is that you have got stable drug delivery over 24 hours. It helps improve the symptoms of sleep, of morning, irrespective of the GI condition, which is one of the issues several patients with Parkinson experience. Clearly, what you will see here from the sales growth, because we do not have Neupro in the U.S., we have had a 34% growth in sales for Neupro. For those of you that were not around here during 2009, you know that we started active promotion of Neupro in the middle of 2009, June, July timeframe. At that time, we had about 32,000 patients on Neupro. So since the middle of 2009 to now, we have more than doubled the number of patients on Neupro. As you can see, we started the re-acceleration of Neupro, both with Parkinson and RLS, which is restless leg syndrome, in the middle of 2009, and we have shown healthy growth in the marketplace, a marketplace that has evolved with generics and a marketplace that has evolved with the introduction of extended release products. These are the countries that we launched Neupro in. There are 3 countries in the latter part of 2010. The one good news that we have up here is that in the last country in Europe, major launch in Europe, was France in January of this year. This shows overall now Keppra on a worldwide basis. You can see healthy growth in Europe, double-digit sales growth in Europe for Keppra. In spite of the fact that the U.S. has a patent expiration, which has taken place, we can still show 3% growth for Keppra on a worldwide basis. The interesting part is we are now entering in Europe with the LOE for Keppra. We already know that there are 2 generics being approved in Germany for Keppra. We have also introduced an authorized generic of Keppra in Germany, and it is already available now for physicians to prescribe. The other exciting news is that we introduced Keppra in Japan at the end of 2010. If you compare the first few months of launch of Keppra in Japan versus Topamax and versus Lamictal, we have had by far the best launch in Japan for an antiepileptic product. Let me summarize now the key takeaways for CNS worldwide and bring closure to it. We have had great introductions now for CNS on a worldwide basis. We have launched in all of our countries, the G6 countries. Other than Neupro in the U.S., we now launched everywhere. The other exciting news to share with you is the seventh country, largest country, which is Japan. We have signed an agreement in January of 2011 to develop and commercialize Vimpat in Japan. So we now have complete Vimpat on a worldwide basis. Keppra is doing very well, and as I have shown you the data, we expect Keppra going forward to still be a significant product for us. With that, let me hand it over to Detlef. Thank you. I hope you feel for me. It is getting more and more difficult for the finance guy in this company. Years ago, everybody was so focused on the numbers, and it was an easy run. Now, when you are between the exciting new products on the market and between the new products to come, which are equally exciting, it is really difficult to make a story. I will try my best. Antje told me if I explain the taxes well, then I made the day of most of you. I already got some questions on that. I try to make it easy. It is really easy. I understand it, so you should be fine. Let me just go on the summary again. I think we are quite happy, I have to say. If you are coming in in a year and have beaten all your guidance parameters, there is no reason to feel not good. When you have in mind, and this is something new that you have here on that slide, that we still increased our spend into the new products and into our pipeline, and you will see that something is coming out of that. We saw already that something is coming out of our marketed products. They are growing really nicely, well on track on our guidance. We will see from Ismaïl and Iris that there is something coming out of our R&D spend too, which we all know is not a given in this industry. Net profit is around EUR 100 million. More telling is the adjusted net profit when you take all these extraordinary things out of the equation, and this was up 6%. If we look to the products, I think we have elaborated the strong growth of our new products. Let me focus a bit more on the other mature products. Also, here, we cannot complain. It is down 5%. If we have in mind that there is still a little bit of that apple-to-apple comparison with the selling of the GSK product portfolio, that deal that we did last year, first quarter was still in the numbers for the year before, then this is quite a good performance. These mature products are still giving a good pass and paying a lot of bills. As you know, we have been very successful in also doing it with an infrastructure which is vastly reduced and Roch alluded to that in terms of mentioning what we did in terms of the employee size, and that is meaning it is more profitable. This is a picture that everybody wants to see. We are happy that we can show it. The new products are overcompensating the loss of your mature product portfolio. If you have in mind that the loss of the products portfolio, the mature product portfolio, has seen in the last two years, two blockbusters going off patent, and that is still shining a bit on these. This is a very solid performance. Let's go a bit in the details. We see good revenue, 3% up, and we see that it's mainly driven in the sales line. Everything else, royalty income, other revenue, very stable, so not a lot to tell. Sales we just talked about so very nicely. When we told you last year, this will be the start of the product growth, the intense product growth, I think you have seen it. If you look into the expenses in the different areas, not a surprise, marketing and selling, second year of complete launch for major products, relatively stable. But if you really look into the quality of that spending, this has vastly enhanced. We have taken out money on the non-core, have moved out of infrastructures for U.S., Japan, Turkey, for general practitioners, and moved all the spend in the productive side of the specialist area. This has been enabling us to drive these products, and this is important for us, and we will continue to do so if we have an opportunity. The second good news is, and you might wonder when a CFO says it's good news when we spend money, but the second good news is that we have been able to still spend significant amount of money. 22%, first of all, I'm happy that it is within the 20%-23% that I'm always guiding on. But secondly, I'm very happy that we have been able to drive the pipeline further. We have a number of products, and we will see that going into phase III now. We have enhanced pipeline and good quality. Iris and Ismaïl will be much more convincing in saying that than I am. Oops. If we look into the G&A, it is more or less stable, and if we would not have the financial crisis and the interest rate going down, which does mean just from accounting purposes to increase the pension cost a bit, then this would be even looking much better. We are quite happy with this, what I would say, expense development because the expense is going into the right directions and into the right areas. You might wonder what is happening here. These numbers are fluctuating in the amortization depreciation. Let me just explain that. Amortization is mainly linked to products. If you bring products to market like we have done with our new products, amortization is increasing. That is the explanation to the first line. You remember that we wrote off last year the plant in Shannon, quite a significant one. You do not have to depreciate anymore. We also had a number of other areas like usage of equipment where we have contractually prolonged that usage, and we are able, therefore, to have this amortization or depreciation in that case over a longer period of time. Very stable. Nothing that cannot be very well explained, and you should not really take too much time on that. Like to show this one. This is not a surprise. We already in January explained what we are doing. Fizikoterdin, the big part, the second big part in the numbers in, if you look into the details, is you know that we disposed of three sites in Europe, two in Germany and one in Italy, and we wrote off the remaining asset value of these sites. These are the two big items, and there is a third one, which is taking care of a coming settlement with the DOJ on Keppra, and you have seen that in the releases. Also this, we have been able in putting into the results of 2010, and therefore, we have no expectation for seeing more of that in 2011. Now we come to the favorite part of this P&L for this year. Financial expenses look up, and you might wonder, and you rightfully wonder, because there are some extraordinary expenses in due to the change of our financing structure, which is a positive change. As you remember, we did an adjustment in our financing so that the facility is now maturing in five years, which is good news, because it is giving you flexibility. What is even nicer, we also were able to get a lesser interest rate. This will benefit us, but it came with some extraordinary amortization of expenses, which is now in this line and will benefit us in the coming years. If you think along the lines for the coming years, if you stay around the EUR 160 million level, you are not too far off, I guess. Now we come to the hurdle for today. EUR 86 million credit. Years ago, and Antje is smiling at me. Years ago, I was a CFO that had to explain tax rates of between 70% and 90%. Now I am the CFO to explain tax credits, quite sizable. I seem to be on the edges all the time with the damn tax rate. Let me explain how that works. It is three parts. The first one is, if we would not have all that extraordinary stuff, we would have paid EUR 73 million of tax. The second part is, we had that extraordinary stuff, and out of the difference that you see, EUR 73, EUR 86, roughly EUR 160, EUR 159, out of that, EUR 78 million is related to that extraordinary stuff. If you write down, you get the credit in the tax line. Very easy. What is left? EUR 81 million, and that is really something that we feel not too bad about. It is driven by two factors. Number one, you once in a while disagree with tax authorities about whether the taxes you have to pay or they want you to pay are correct or not. You go for litigation. When you are conservative, and I trust you to believe that we are conservative, then what you do is you reserve for that. If you win the case, you can reverse it. That has happened. The second thing that has happened is once in a while, these guys are not coming. You have an idea what you might have to pay. You are, again, conservative. You put it on the books. They are not coming before the statute of limitations are running out. If that is the case, you reverse. Then there are a smaller portion of what I would name accounting-based adjustments. That is the explanation. I hope it was not so difficult. With that, I come to the cash flow, and this is good news, too. EUR 500 million of cash flow. This is a nice number. For the ones, and I know you do that, for the ones that have already looked into the details, you have seen that we have worked very well on our working capital. I told you last year that that would be an area of focus, and I am happy to report that it also has granted something. Usually, when we put some focus to something at UCB, we are also getting some results. Here we have roughly got EUR 200 million out of this. This is very nice because it has done a lot of things for us. First of all, it has helped us to pay down debt, and you will see that on the next slide. It has also given us the flexibility on paying the dividend and proposing a dividend that is EUR 0.02 higher for this year. It is a good buffer for us going forward. We have invested not as much as in the normal years. You always hear me saying EUR 80 million to EUR 120 million, and we are on the lower range of that, mainly because we have not invested too much anymore in the existing sites because we are on the verge to really invest into biologics. I think you have heard that we will have a pilot plant in Braine-l'Alleud in Belgium, and we will have a bigger plant for Cimzia in Switzerland. I hope that gives you also an indication how confident we are about Cimzia going forward. This is a nice picture. This is a net debt development. The trend line is the right one, significantly dropping. That leads to the leverage ratio also significantly dropping. This is important for really going forward in being flexible and being able, not only for the Today's investment, but also for tomorrow's investment. You have seen that we have done a few investments throughout this year. Coming to the guidance, my last chart, my second to last chart. The guidance is impacted clearly by what we will see with Keppra in Europe. That is the bad part of the news, and it is also impacted by the strong growth of Cimzia, Vimpat, and Neupro. Because if you lose a Keppra in Europe and you have, what I would say, a very slight decrease of your parameters guidance, then this is good news. What is our expectation? We think we can deliver revenues between EUR 3 billion and EUR 3.1 billion. We feel that we will be able to keep a very nice EUR 650 million to EUR 680 million of recurring EBITDA, and this then translate into a core EPS between EUR 1.6 and EUR 1.7. Let me come to my favorite picture that we share more or less since years with you. I start here, where you don't see anything anymore. Because what I want to make sure you leave today with an impression is that we deliver. Here was the first block, which was the transformation and the integration. I think you would be with me, we delivered. This is the second block, and we are in this part of the second block, and it will last until mid of 2012, when the generic erosion will plateau. It is a phase of intense product growth. Cimzia, Vimpat, Neupro. This is what we are driving now, and this is where the company then will also be able, starting the middle of 2012, to go into an intense company growth with all the scaling effects that we all know about. This is also driven by line extensions and is complemented when we get into the mid of this decade by new breakthrough products being able to come to market. When we look into that breakthrough element, I hope that when Iris and Ismaïl are finished, that you will be with me and say, "They deliver on integration and transformation. They deliver on product growth. They can promise at least today, and I hope next year, we will say we will be able to deliver again on company growth coming, but we believe there's a good chance that they also will deliver on breakthrough innovation." With that, I hand over to Iris, and you are really getting to the exciting part. Thank you very much, Detlef. Good afternoon, ladies and gentlemen. Time to talk about the pipeline. I would like you, first of all, to take a helicopter view with me. There are two elements which should really stand out. One element is that we are still working very hard on the life cycle activities for Cimzia, Vimpat, and Neupro. We have demonstrated the therapeutic value that resides in these products, and we are convinced that in reaching out to additional patient population, we can bring additional value and therapeutic benefits to patients. So we are investing heavily in terms of effort and resources into the life cycle activities for these products, and we deliver. The second element that stands out is, and I hope that you agree with me, that we are witnessing the next wave of phase III, phase II, and early-stage projects. What is particularly exciting about this is that on one side, we have innovative, very attractive mechanisms, which again hold the promise of additional therapeutic value for patients in need. We match these promising mechanisms with indications and diseases where patients are still suffering because currently available therapies are not satisfactory. I hope that you will agree with me, these are two very important elements of our pipeline, and I now will walk you through the details. This is a look at our CNS pipeline, and it starts with Neupro. We are making progress on the development of our reformulated room temperature stable patch. This will satisfy the requirements from FDA, and we are confident that we will be able to bring Neupro back to patients in the United States suffering from Parkinson's disease and restless leg syndrome in 2012. We are in dialogue with the FDA, and we are confident, pending approval by the FDA, that we will be able to stick to this timeline. In Europe, we are in the regulatory review process for Xyrem in the indication fibromyalgia. The next block is dedicated to Vimpat, and you see a lot of activities around Vimpat. First of all, monotherapy is the next big building block. Monotherapy is the way by which we reach patients with newly diagnosed epilepsies. Very important to have Vimpat available as the first treatment for these patients. You might remember that the regulatory requirements are very different in the United States from Europe. We have an ongoing program in the United States, and that is on track. We have started just in the end of last year, the European program in monotherapy. We are progressing in this very important area. You are also aware that we have a phase II study ongoing in primary generalized tonic-clonic seizures. That is next to partial onset seizures, another big population of patients suffering from epilepsy. Of course, we also want to make Vimpat available to these patients. This phase II study is important. We are getting so far positive signals from this study and are encouraged to prepare the phase III in primary generalized tonic-clonic seizures. We, of course, are also caring about children with epilepsy, and we have received first results from our pediatric program, which also encourage us to continue moving in the direction of late-stage development for pediatric population with Vimpat. Kosa has already mentioned to you that Vimpat now really goes global. We have the development and commercialization rights now also for Japan, and we are in the process of designing the development program and getting agreement with the Japanese authorities on the path forward. Of course, we are hopeful that with the richness of data that is already available, we will have a very focused program for Japan. brivaracetam is the next in our epilepsy pipeline. brivaracetam has just started in December, the phase III study in partial onset seizures and is on track. The youngest addition to our CNS pipeline is a pre and post-synaptic inhibitor. Again, a very innovative, very strong therapeutic principle aiming at patients suffering from therapy refractory resistant epilepsy, so really the toughest disease in epilepsy, and where we hope that with this new principle, we can also bring therapeutic benefit to these patients. It is early stages. We're just in phase I, but high hopes that we continue to deliver important therapeutic value to patients suffering from epilepsy. Let me move on to the immunology pipeline, and you see that there's still a lot of effort going into Cimzia. I'm delighted to report to you today that the phase III development program with Cimzia in rheumatoid arthritis in Japan has been successfully completed. Together with our partner, Otsuka, we have run two clinical studies, one with Cimzia as a monotherapy, the other one with Cimzia in patients who are partial responders to methotrexate, and we have seen positive results in both studies. It's still early days, so we are still in the process of analyzing. We will have intense discussions with the PMDA, the Japanese authority, and will prepare for our regulatory submission, which is currently targeted for 2012. Cimzia truly on its way to go global. Of course, we are also delivering on the additional inflammatory arthritis indications ankylosing spondylitis and psoriatic arthritis. You know that we have phase III programs ongoing in these indications, and they are on schedule to hopefully give you first results before the end of the year. We are working hard on a juvenile program with Cimzia to ensure that with minimal effort, in Europe and in the U.S., we can bring Cimzia also to patients suffering from juvenile rheumatoid arthritis. Epratuzumab is next on the list, and epratuzumab has started its phase III program in systemic lupus erythematosus just before the end of the year. Very exciting program for us. Innovative mechanism of action and patients suffering from lupus are still in need of effective therapies, and we have high hopes for this program. I will give you more details in a few minutes. A very exciting element in our pipeline is our sclerostin antibody. You might remember that we are talking about a novel principle that will give patients quality bone formation. That's at least the hope we have generated with our non-clinical and early clinical data. The program is currently in phase II in two indications, post-menopausal osteoporosis and fracture healing. And post-menopausal osteoporosis is still a significant burden to the individual patient with pain, with frequent hospitalizations, with increased mortality due to the sequelae of extended hospital stays, and it affects a large number of patients. And all of the currently available therapies are primarily preventing further bone resorption. So you can imagine what a principle that actually builds good quality new bone could do for this patient population. It's too early to say anything. We are in the middle of phase II, and we will have phase II results in post-menopausal osteoporosis before the end of the second quarter this year. The same molecule is progressing also through a fracture healing development program, where we are looking at the safety and efficacy of our sclerostin antibody, of course, always together with our partner, Amgen, on the healing effort and the healing efficacy in difficult fracture populations. We also have progress in the mid and early-stage pipeline in immunology. Olokizumab is our IL-6 antibody, which has just started the phase II development program in rheumatoid arthritis. So progress there also in terms of moving from phase I to phase II. And with our CD40 ligand antibody, we are offering another innovative therapeutic principle potentially to patients suffering from SLE. Very exciting mechanism, which works on B cells and T cells and could really provide an important addition to the physician's armamentarium for this very difficult-to-treat disease. I wanted to give you a little bit more detail on the phase III programs which we have started recently so that you get a flavor of how do the studies look like that we have started. Let me begin with the monotherapy study in Europe for Vimpat. It's a very big study. It's about 1,000 patients. We are in more than 120 centers engaged, and we are talking about the recruitment of freshly diagnosed patients, either with partial onset seizures or with primary generalized tonic-clonic seizures. It's a study that's designed to show non-inferiority of Vimpat versus carbamazepine. It's a standard design that's required and validated with the regulators. Our primary endpoint is to show, once patients have stabilized on their therapies, that we can maintain them for at least six months seizure-free on the treatments. We expect to see results during the year 2014. brivaracetam, I've mentioned that before, has started a new phase III trial in partial onset seizures. This is an adjunctive therapy study, 720 patients. Again, more than 100 centers around the globe will be involved in this program. Our confidence in brivaracetam is strong, and we have seen a very benign, very good safety profile of brivaracetam, which has encouraged us to expand the dose range to include 200 milligram per day, which will allow efficacy to shine. This study is ongoing. You see that we have two different primary endpoints, one for the U.S., one for Europe. This is in line with the requirements by the regulatory authorities. This is checked with FDA and EMA. These are the endpoints of the Vimpat development program. They have worked for us with Vimpat. They will also work with brivaracetam, and we are looking forward to provide results to you in the first half of 2013. The EMBODY program is the phase III program with epratuzumab and systemic lupus erythematosus. We have shared with you our phase II results, which we find very promising and encouraging. We have also shared with you our concern that phase III development in this indication bears substantial technical risks, and we have tried to mitigate these risks to the extent possible by staying very close to the design of our phase II studies in terms of the patient population that's being enrolled, but also in terms of the primary outcome variable. Of course, we have validated our approach with FDA and EMA and are in line with expectations from both authorities. The phase III program will enroll around about 1,600 patients in 160 centers, will be patients with moderate to severe disease activity. We will compare two different dosing regimens of epratuzumab with placebo. Our primary endpoint, again, is the one we have used in phase II, which is a composite endpoint with a heavy contribution from BILAG. We are currently looking at results in the first half of 2014. This has given you an overview of the current pipeline. I hope that you share with me that we are delivering on our programs, and we have exciting life cycle activities for Cimzia, Vimpat, and Neupro. We have a very solid, very interesting, hopefully also very engaging early, mid, and late-stage pipeline coming through. In case we wanted more projects to join our pipeline, we are building on our partnering capabilities and try to reach out to other companies to be networked and to get access to potential additional projects. We have signed a deal with Synosia, now Biotie, in October 2010, which will give us access potentially to two Parkinson's disease drugs. The deal allows Synosia Biotie to continue the development program through phase II. Then in case this is successful, UCB can take on the further development and commercialization. You are very familiar with our partnership with Wilex. Wilex is currently moving the early-stage UCB oncology compounds through development, and we have opt-in rights at certain time points should we wish to take these molecules back. So a partnering approach which will allow us, if we wish to enhance our pipeline. Of course, our most important partners to enhance our pipeline are our friends and colleagues in NewMedicines, and it is my pleasure to hand over to Ismaïl Kola, who is going to explain to you what is going on in NewMedicines. Thanks, Iris. Thank you. Okay, so it's my pleasure to stand between you and the end of the session. Roch is going to be with us just to finish off. What I'd like to do is share with you my 470 days at UCB and what we've been doing in NewMedicines to advance the pipeline. Now, how many of you will turn around and say, "He's counting the days, therefore, he's not having fun"? It's actually different. All my teams will tell you what I tell them is every day for a billion-dollar drug late to the market is $3.3 million every single day at the end of its patent life. UCB NewMedicines strategy and business model, we actually have two major pillars. One is internal innovation, and we've developed a five-pronged strategy for our internal innovation, which we believe heralds a new R&D paradigm to deliver innovative and differentiated molecules. First of all, molecules that must be differentiated, either they're first in class, so they'll be innovative or they're best in class where they'll be differentiated. We need to show that, not have wishful thinking. We want to increase the success rates because the problem that plagues our industry is low success rates, especially in development. I'll show you some data on that. I personally believe that scientific excellence is the most important thing that makes a pharmaceutical company successful. When drug companies are at the top of their innovation peak, this is when they actually bring new medicines to patients, and that's critical for us. We want to increase the efficiency. That's key. Although you've heard from Detlef and from Iris and from Roch, we invest 22% of our revenues in R&D. EUR 674 million is still an infinitesimal part of the amount of R&D that is being funded throughout the universe. UCB should be a preferred partner to access that innovation irrespective of where it occurs. That leads on to our second pillar. In fact, one of your ex-colleagues, Erica Whittaker, who's in the room here joined us on the 1st of November as Vice President for Strategy and Licensing and Business Partnering, where she actually has already been very successful at driving deals for us, including the collaboration we announced on Monday with Harvard University, where we get access to Harvard University's innovative programs. Now, if you look at our second part, which is partnering and virtualization, because we believe in this open innovation model and that one can access innovation virtually, we have three major thrusts here. One is to feed our own internal pipeline, which you will see later on, and I alluded to already. Secondly, to access innovative targets and use our core technologies and bring these medicines, even if they're sometimes a little bit out of strategy, because we believe as other companies are pulling out of research, there will be an appetite and a demand, right, for people to partner with companies like us that actually bring this to proof of concept in men. Then the third piece, which is innovate or innovate our molecules with other partners such as Wilex. So those are the two major streams that we have as our operating strategy and our business model. Now, here's the problem. If we look at the central panel, and this is some data that we published in 2004 in Nature Reviews, out of every 10 drugs that enter the clinic, only one is successfully registered. In fact, we compared two decades from the top 10 drug companies in asking the questions, why do drugs fail in development? The major reason they fail is lack of efficacy. In fact, even when you come to phase III, where you have expensive investments and you have an opportunity cost because you don't have the bandwidth to develop everything that you have in your pipeline, one in two molecules fail in phase III, and 67%-80% of those molecules fail because they don't have efficacy. Even if you're successful in getting regulatory success, commercial success, which is where you recover your investment made in it, is only 30%. So it's critical for us to ensure that we have both regulatory and commercial success. It's in trying to solve that problem that we've built our strategy because when we analyze that data and said from the top 10 drug companies, some 674 clinical trials, what could be the two levers that we could pull? The major levers turned out to be on the bottom axis, proof of concept or POC, proof of concept in man, and the second one is the objectivity and robustness of your endpoints that you use. If we now take these data and repopulate this two by two graph by putting things that are high on POC and high in terms of the endpoint, and we come to the top green quadrant, you will only get 25% of failure as opposed to 42% on the aggregate portfolio pipeline failure. So what that means, what that translates to is a 40% increase in productivity. With current cost of bringing a drug completely, the cost of bringing a drug to the market of being somewhere in the region of about $2.4 billion, a 40% increase in productivity is a significant return on investment. Now, to show you this example, if we took our anti-sclerostin molecule that Iris told you is in phase II with our partners Amgen, we know that there's a human genetic disorder where people don't have sclerostin. They don't make it. They have thicker bones, and there are no mechanism-based side effects. So there's genetic evidence to prove this concept. We've got a biomarker, which we've shown already with Amgen, where bone mineral density is modulated. So in some ways, there's an element of PoC. That compound would fall into that top quadrant. So we've significantly de-risked that mechanism and that molecule already by the types of trials we carry out. If we take that concept and start translating it into an operational paradigm, then what we have is on the front end of the funnel, testing the theory, what we call the learn phase, and then when you get into phase III, our proof of concept in man, the confirm phase. If you do it really well, you should have very few failures in the confirm phase. We have some strict gates whereby we measure and decide whether a molecule will go forward or not. First of all, is the molecule good enough to engage the target at the level that it showed efficacy in preclinical species? Does it, in man, engage the target the way it did in preclinical species? If the answer is yes, you go to the next gate, which we call PoC lite. Here, the PoC doesn't stand for proof of concept, but it stands for pull out the checkbook. Because it's an investment decision for us whether we want to prioritize this program, and we want to put our resources behind it and eliminate something else that doesn't have the same degree of evidence to take forward. Then we come to the final point, which is actually proof of concept, where you modulate the registrable endpoint that the regulatory authorities want you to have, and you show in a small population that you actually hit those endpoints, and then you go into phase III, because then the only risk you're taking is in scale-up in terms of going from 250 to 2,000 patients. That's the operational paradigm. Using that, what happens is you pick winners early, and you eliminate the losers. As an example, here's a molecule we showed you last year this time, which was UCB's H3 inverse agonist or antagonist, which was being put into the clinic for cognition or cognitive dysfunction that occurs in diseases such as Alzheimer's. Whilst many other drug companies have this molecule in development, what we were able to show in early human studies is that this molecule has an unacceptable clinical profile and, in fact, that the toxicity that would arise is mechanism-based. We no more invest in that molecule because it's not a molecule-based toxicity, and neither do we invest in the mechanism because the mechanism is fraught with something that will not give it a respectable profile. We eliminate this compound, and we announced it in our press release, and it took 37% of the time that a normal cognition study would take you and 36% of the cost to get to this no-go decision. That, in our minds and in the culture we're getting out in the laboratories, is success because it liberates resources to put behind our key programs that are coming into the pipeline. As Iris showed you, we have a very busy pipeline, and I'll show you some data on that as well later on. Now, the flip side of that is we took a molecule, which is UCB's anti-IL-6 monoclonal antibody, olokizumab. In phase I studies, we measured the biomarker for rheumatoid arthritis. It's acceptable biomarker C-reactive protein, and we were able to show that this antibody significantly reduced CRP levels in human patients. It was well-tolerated at all doses. It had a very good half-life of 31 days, and it had a low incidence of immunogenicity. On the basis of those data, we advanced this molecule ahead of time into phase II-B. We skipped phase II-A, went into phase II-B, and are doing a subcutaneous dose trial, which already has enrolled, and there are greater than 200 patients who have active RA and have failed TNF blocker therapy. In that trial, we are comparing against an active comparator, Actemra IV, which has already been approved. The headline results for this are expected in the third quarter of 2012. So as a result of this paradigm, what does it look like, and how does it impact our pipeline? We'll show you an evolutionary story here. This was our pipeline at last year's analyst meeting, January 2010. This is what you saw, where you had the H3, and that was CNS on the top, immunology at the bottom, and the Wilex incubator completely at the bottom. I'm not showing the phase III because that's what Iris focused on. I'll just show you the sphere of influence where NewMedicines operating. So what happens, in the first quarter, we moved in the anti-CD40 ligand for systemic lupus erythematosus. In the second quarter, we brought in the two molecules from Synosia, phase II molecules for Parkinson's disease. We brought in the epilepsy molecule, the pre and post inhibitor, and in fact, this was in patients just before Christmas. The teams were incentivized to get it done, and they did. They executed flawlessly. We advanced our IL-6 into phase II ahead of time. With that, and having given you some insight into our strategy and our business model, I hand over back to Roch to close out the session. Thanks, Roch. To summarize again, great 2010. Exceeded financial target, Detlef showed you that. We had Greg and Kozo sharing with you the CVN. We exceeded the EUR 400 million milestone for CVN in 2010. So dynamic launches there. In terms of patient reach, more than 200,000 there. Clearly, you, I think, shared my excitement hearing both on the late-stage pipeline, the mid-stage pipeline, but also what's going on in UCB NewMedicines, that we clearly are building a very strong pipeline behind Cimzia, Vimpat, and Neupro. That is clearly, as Detlef summarized better than I could, is preparing for a fantastic future at UCB. We're in the last phase of the first part of this graph, which is the intense product growth. As Detlef reminded you, starting the second half of 2012, clearly the intense company growth is going to be driven clearly by CVN, but beyond that, clearly also by our pipeline. I think you start seeing some sign that the breakthrough phase is indeed something that we will talk more and more about as time will go through. With that, I will ask my colleague to join me on stage, grab a chair, and we will answer all your questions. Antje, you will play the master of ceremony. Two very nice microphones here. Thank you. Yeah, sure. Why don't you sit here? Hey, I cannot see you. Alice, you want to sit here? Okay. Since you asked for your forum, is that okay? Yeah, thanks. Do you want to use this? Here. Hi, it's Richard Parkes from Deutsche Bank. I've got a couple for Greg and maybe one for Detlef. Firstly, on Cimzia for Greg. I'm just wondering if you could talk about where you're at in terms of formulary coverage and particularly tiering relative to your competitors, and what maybe you can do to improve that, and what the inflection points are there. Secondly, a similar question on Vimpat. I'm wondering what percentage of payers in the U.S. will reimburse Vimpat as a first add-on therapy rather than requiring patients to cycle through other drugs. Then one for Detlef. I'm just wondering, is the period of cost savings now, has that been completed? Should we look at operating costs as more of going into a period of investment or kind of flat outlook? What should we be looking for? Detlef, you want to start? I can start. First of all, I think we will see still in 2011 and probably into 2012 that we have to drive this growth for the future, both on the R&D and marketing and selling. But I still believe there is opportunity of improving the quality of the expense. We are still working on increasing efficiency. This will not be as easy as it was before because we have, with the SHAPE program and the transformation and integration, already done a lot, I think, if you compare us with others in the industries. But we think we have a few more things that we can pull off, and we are working on that. When we feel comfortable, as usual, as you know me, if I feel comfortable that I have something that I really can promise, I'll let you know. I would not give up on more efficiencies. Greg, managed care of Cimzia, Vimpat? Sure. Let me start with Vimpat and go back to Cimzia. If you have watched the epilepsy marketplace in the U.S., you will know that the three big products, Keppra, Lamictal, and Topamax, have actually gone generic. So in fact, although that has been sad for us from a Keppra perspective, effectively what it has done is it has taken a lot of the expense out of epilepsy off the radar screen of managed care formularies. As a consequence, and because this is still a disease with high unmet need, we actually see that we have very good formulary coverage for Vimpat. Just to give that a little bit more specificity, you generally speaking have three tiers of coverage in the U.S. for co-pay. Tier 1 is generics, tier 2 and tier 3, tier 2 being a preferred brand. You will see that Vimpat is accessible in about 28% of cases on tier 2 and probably 60-so percent of the time we see it in tier 3. That is a co-pay that is about $50. So a little less than $2 a day for an epilepsy medicine. By and large, the evolution of the anti-epileptic marketplace in the U.S. has actually in some regards worked to our advantage because there is not as much tight management there, and they recognize that one out of three patients still needs access to therapy. So we have relatively strong freedom to operate in that sector. If I move over to Cimzia, we have the two versions, as we mentioned, the 1,000 units version, which is in office administration that is covered, generally speaking, under a medical benefit. There you will see we have parity to Remicade about probably 75% of the time, 80% of the time. If you forecast over to the pre-filled syringe, we have access on par with Enbrel, Humira about probably 50% of the time, and we are about equivalent to Simponi in the relative access. The important news, and I can share this with you because it is public now, this 12-week proposition is resonating, as you can imagine, quite well with our prescribing customers. It is also resonating quite well with patients. This is a chronic disease. In many cases, they have been on multiple medicines. They want to know in 12 weeks if we are arresting the progression of this disease. Importantly, the payer community is very interested in the total cost of care for RA. And as you move to using one, two, sometimes three, but primarily two TNFs, the idea that you can actually make a choice with Cimzia at 12 week, either for a bio-naive patient or for a switch patient, is a very compelling proposition. In fact, we have just been added to the SilverScript formulary, which is CVS's Medicare Part D, which is treatment of the elderly, which is about 25% of the RA population, as a preferred agent with Humira, with Enbrel and Simponi now being double-step edited behind our product. That is a publicly available formula. You can see it through the Internet. So that proposition, which we're quite excited about, is not just resonating with our prescribing customers and our patients, it's actually resonating with the payers. And we are engaged, as you can imagine, with many payers who are looking at that total cost of care model, which is effectively where the payment model in the U.S. is going. And they're quite excited to get into a dialogue about how that model might actually work for them. So news to come as we continue to engage to improve that access. Decent access right now, very good on the medical side, decent on the pharmacy side for PFS, and improving literally as we speak. Hi, I'm Keyur Parekh from Goldman Sachs, and I have three questions. Greg, first one for you. I think the Cimzia charts look great. The message certainly seems to be resonating from a qualitative perspective. But when I look at numbers, the U.S. Cimzia numbers appear virtually flat second quarter, third quarter, fourth quarter. Can you talk a bit about what's happening in the marketplace, either in sense of sampling or discounting, or what is it that we're missing in the numbers? Yeah. So if I were to bring your attention to that prescription chart which I showed you, it had the blue and the maroon line, the prescriptions over time. You can see growth going up through the third quarter. In the fourth quarter of last year, we introduced a program called the 12-week free trial program. And effectively what we said to our customers are, we want to put our money where our mouth is. And that is to say, we will tell you to make a decision in 12 weeks, and we're so comfortable with this that we'd like to try it on your next two or three patients, and actually put that program into the marketplace. So what you see is a bit of a muting effect of the new prescriptions, because in some cases, patients that might ordinarily have gotten product are getting the 12-week free trial. What you see, however, if you take a look at the weeklies in the first five weeks of this year, so January 1st of this year through the latest weeklies, is that we are now getting those patients who ordinarily would've been on prescription drug, paying patients, are now cycling back into the system. You've seen a pretty substantial delta between us and the marketplace over the first five weeks of 2011. In fact, on an RA basis, we're growing a new prescription around 13% or 14% on a four-weekly rolling basis. On the CD side, we're growing about 10%. That program, although very exciting as a proposition and allow us to bring new prescribers into the marketplace, because you can imagine if you've never prescribed Cimzia and we say we're willing to put our money where our mouth is, put that test to your patients, we're bringing some of those prescribers in. It also has unfortunately muted that fourth quarter growth in NRx. TRXs have continued to grow, but the NRx were flat, and we're starting to see those rebound back into the marketplace. Would that be the case for reported sales dollars as well? Yes. In some regards, yes. It does have a compound effect on the reported sales dollars. That's correct. Detlef, can you talk a bit about the tax rate on an ongoing basis for the next few years and how we should think about that? Yeah. I still stick with my around 30%. I know this year it looked quite a bit different from that, with 23%, but you have these major changes on where you make the money and the product portfolio mix behind that. I would stick, if I would be modeling in your shoes, around 30%. Lastly, Iris, can you remind us what the doses were for brivaracetam in the first two phase III trials? If my memory is correct, you are trying a new dose in the new phase III trial. What gives you confidence that the FDA might be happy with just one positive phase III trial at a particular dose? The dose range that we have covered so far for brivaracetam in phase II and in phase III is between 5 milligrams and 150 milligrams per day. We have seen efficacy in the existing phase III program between 50 and 150 milligrams per day. In discussions and in negotiations with FDA, it has become obvious that we are in agreement with the agency that the safety profile is so good that it really warrants to optimize for efficacy, and this has led to 200 milligrams as an additional dose in the phase III study, which has just started. It is in concurrence with the agency and really built on, if you go through the entirety of data, there is room for more efficacy based on the very good safety profile we have seen so far. Thank you. Thank you. Good afternoon. Nicolas Gingener from Exane. First, one question about the guidance. The middle range of your guidance implies 5% revenue decline, 9% recurring EBITDA decline, and 17% core EPS decline. Can you please explain us why this deterioration all the way down the P&L, and walk us through the main reasons behind this? I appreciate that Keppra generics in Europe are obviously a key moving part, but are there any other item that we should look at carefully, such as sustained marketing effort behind CVN? Secondly, one product question about brivaracetam, a follow-up. The phase III program just started. Could you just walk us through briefly the design and the reason why this one should work? Specifically, am I right by thinking that you better selected the patient in this trial, and that you now exclude non-responders to Keppra? Are there any other exclusion criteria? Ultimately, how do you plan to position it versus Vimpat? Thank you. So Detlef, guidance? Yeah. Let me just run through that. The math is absolutely correct, I am sure. It is just if you have a high number at the top and you have 5%, let's say on EUR 3 billion, it is EUR 150 million. If the numbers get smaller, percentage-wise, that is increasing. That is just the reason. That would be the first one, part of the question. Second part of the question is, if you look into Keppra Europe, then I think you should also have in mind Keppra XR in the U.S., which will go generic in the last quarter of 2011. You should still have some impact on venlafaxine and Trulicity, which went generic in late of 2010. So you have these major effects that are coming together, really to build this basis for the guidance. As I said before, the strong growth of the new products is stemming against that. But it is quite a sizable chunk of generic erosion, as we said, I think continuously, also in the past. Iris, brivaracetam? Yeah. The brivaracetam phase III study design is a 12-week maintenance period with an appropriate baseline run-in period. You have all in all, six months therapy within the study. I have shown to you the primary endpoints. You might remember, we had identified three potential areas of improvement compared to the existing program. One, as you very correctly mentioned, is that we see additional efficacy if we add brivaracetam to individual levetiracetam patients. This effect is not so pronounced in large patient populations, and the previous program included 20% of patients on levetiracetam. We have changed this to no concomitant levetiracetam in the current study. The second comment we had made was, that we can enhance the dose range, and we have done this with the inclusion of the 200 milligram dose, and we are starting with 100 milligram in this study. The third area was, we had been very ambitious in our recruitment efforts, which has resulted in inclusion of sites all around the globe to really be fast in terms of patient recruitment. We have now selected the best of the best, if you wish to say so, to be sure that we get the right patients and the right sites into the study. So three distinct areas where the current study might be differentiated from the previous program. I think you will understand if I am not commenting on positioning versus Vimpat today. There are some obvious differences, like for example, the mechanism of action. For the remainder, let us look at the data and come back to you when the right moment is there. Thank you. Brian, and then follow-up. Good afternoon. Thanks very much. It's Brian Bordeaux from Barclays Capital. Thank you very much for your presentations. A few questions. I think Detlef, they're mostly for you, but we'll see. Firstly, I think you had a press conference yesterday, which I believe you made some comments about the profile of growth in 2012. I think there were some comments about the second half versus the first half. I was wondering if you could elucidate those for us, please. Second question on your guidance for this year, could you further detail what your thinking is around generic Keppra? I think you've previously mentioned that your working assumption is for a 50% decline in European Keppra revenues post-generics. But of course, generics are coming country by country, and I just wanted to ask you if you are thinking of that effect being staggered throughout this year and next year. If you could share your thoughts on that with us, please. I guess lastly, I think I caught a comment from you talking about Keppra XR going generic maybe towards the end of this year. But I notice you seem to have had a new patent granted towards the end of last year, which is listed in the Orange Book. I'm not aware that anybody has filed a Paragraph IV against it. Does that mean that genericization could potentially be delayed in the U.S. for Keppra XR? Thank you. Okay. We are going obviously, let's say, the conservative route in terms of generic erosions, because it is very rare nowadays that products run out of exclusivity without having a generic. That is the answer to the Keppra XR question. The other two are related. I think we talked about the crossover year, if you remember. What that means is, there is a certain period of time you need or when you get generic competition until you plateau with the remaining branded product sales. In the U.S., that is somewhat between 6-9 months. In Europe, it's more 12-18 months. If you apply that to what we have seen in terms of the products that I mentioned for generic erosion, that does mean that probably the plateauing effect will need until mid of next year. As you said, there will be generic erosions throughout this year on Keppra in Europe and Keppra XR for the U.S. late in the year. That will bring you into that plateauing effect into mid of next year, which does mean that the first half of that year will still have a negative impact on these product families, while at the same time we'll see that strong growth. Now the real question is how much at any moment in time, and nobody can predict that because we don't know when all of these will happen this time. That is really why we talk about that. But what we feel reasonably comfortable with, if you look into the second half of 2012, that you should have seen most of that plateauing effect, and that in this second half, you should see substantial growth on the new products that is not any more, to that extent, limited by the generic erosion. So I hope that makes it clear. Yes. Thank you. Thank you. Thank you. Peter Welford from Jefferies. Two, I think, for Detlef, quick ones, and then two on the products. With Detlef, first of all, how happy are you going to be to keep R&D between 20% and 23% this year? You mentioned that was your target, but obviously, clearly, with the top-line decline, is that possible this year? And also with regards to the financial expenses of EUR 160 million you're guiding to, is there a reason why you're not paying down the short-term credit facility, which clearly is fairly onerous? Why not just pay that down given the current interest environment for your cash? Secondly, for the products, just wondering, Xyrem in Europe, there's not been any mention of that. Are you assuming any investment in that this year, and what potentially could be the timeline for that? Rest of world Xyzal was very strong in the second half of this year. Did anything happen at all in the rest of world that helped Xyzal? Thank you. Shall you take the product one? Do you want to take the- Yeah, in terms of the financial expense, I think I feel reasonable comfortable that it should be in that range because what I assume is that with reduction in profitability and having a stable dividend policy and investing into some of the sites that cash flow generation will be a little bit less than what we have seen this year. That is the question why there is a reasonable stability. In terms of, help me on the first one of your questions, please. The first one was- R&D the cash- R&D. The R&D. No, I feel very comfortable on the 20%-23%. You asked also whether I. I'm comfortable on that guidance, and I'm happy also, as long as we are bringing something out of it, and I have the feeling from what I see more or less day by day, that we are getting something out of it. I'm very happy because I strongly believe that you can't save your way to health in this industry. You only can innovate your way to growth, and that will be success. Also, Xyzal, Japan. Was it Xyzal, Japan? I thought it was Xyrem, Europe. Xyrem, Europe, and Xyzal, I don't know. And Xyzal. Xyzal, Japan is the answer. First, Xyrem in Europe. Today, we do actively promote Xyrem in Europe with our current field forces. That is going on. What Iris shared with you is that we do have a fibromyalgia indication right now with the European authorities. We're waiting to hear on that, so that will decide if we do anything else in Europe. In terms of Xyzal, we have an agreement in Japan with GSK, and in December, we launched Xyzal in Japan very successfully. Hi, thanks. Richard Vosser here from JP Morgan. Just a couple of Cimzia related questions, please. Just wondering on additional countries for Cimzia in terms of ex-U.S., whether any are additional targeted for rollout in 2011, and if you could give relative size of the markets relative to the G5, so the five big European countries. Secondly, could you contrast the market share you've got in the recently launched markets such as France with market share that you've got in Germany or the U.K. in Europe, so that you can put that into perspective for us versus the U.S. And then finally, just a question on maybe future competition for Cimzia. Are you concerned at all by the JAK inhibitors that we are going to see data of in the second half, and how could that impact your long-term growth aspirations for Cimzia? Your views on that would be very useful. Thanks very much. You want to take the questions? Okay. Cimzia in Europe, your question on France, we launched in France just recently, so we are very happy with the launch and how it has gone. The market shares, it is too early right now to talk because we have got a split of hospital and retail. In France, basically, when you first launch a product, the first prescription has to be given by the physician in the hospital setting. Right. It goes out into the retail. Yeah, I think it's important to say that the accuracy of data that we see in the U.S., as you know, in the U.S., we see that every week. In Europe, you don't have that. For example, in this country, there is no market data at all because it's not distributed through IMS, so through pharmacy. It's direct distribution. That's frustrating. We have anecdotal data. We do market research, et cetera. But the accuracy in Europe of market share or even the availability of data in Europe of market share is very limited. France is still a little early to talk. But if you talk of our countries that we've been on the market for a while, and based on some of the comments that Roch made, when we do snapshots of market research, when we look at the opportunities out there, we appear to be capturing a good chunk of it. As an example would be in Germany, of the opportunities, we'd be getting close to about 10% of the opportunities. In the U.K., on the other hand, we're getting about 20% of the opportunities. That just gives you a piece of where we are going. And what we are seeing in Europe in general, our uptake at the moment is either above or pretty close to where Simponi is. The question on the JAKs, of course, we consider the JAKs as competitors. I think we know more about their profile, both from an efficacy and safety profile probably this year, but we have included in our assumption that the JAKs will make it to the market. When we give the big sales estimate of at least EUR 1.5 billion, we have assumed that the JAKs will make it to the market. Hello, Bridget De Lima from Bank of America Merrill Lynch. I will start off with three questions, please. First one is on the manufacturing facility you decided to build. I have to say I was a little bit puzzled given that there is a lot of capacity out there. Companies like Lonza are struggling to fill their own tanks. Given that, in line with Peter's question, I think you are better off paying down some of the debt. I am not quite sure why you are spending so much. Perhaps you can comment on how much better the margins might be for you once you start producing Cimzia there versus what you have producing with Lonza. Then also on the facility, how flexible is it? How easy would it be to switch in between products, or just fill it with a whole bunch of pipeline products just in case Cimzia doesn't quite get to your expectations? Second is on your Keppra franchise. I think you seem to be quite confident on the declining Keppra franchise. Looking at erosion in the U.S., it does look like it is plateauing. I am just wondering, are you assuming that Keppra in the U.S., I am talking about the IR formulation, is currently reaching a plateau, and it is probably going to stay fairly stable there? The last one just for modeling purposes because I am trying to get your recurring EBITDA correct. Can you give us some guidance on the amortization for this year, given that it was quite a big jump versus 2009, 2010? Thanks. I think amortization, and I look to Carlin, will probably increase a bit more but not too much. Decrease? Ah, because of the phase up. Thank you. It will be stable or slightly decreasing as I just learned from the people that know better. In terms of Keppra, I think Gregory can say that there is a plateauing effect for the immediate release. Yeah. If you were to use general analogs in the U.S. marketplace, the market has become brutally efficient, right? You are down to 4% of branded molecule within six months. Interestingly enough, with the AEDs, they are hanging in around the 15% share. So 15% units continue to be supplied at a branded product. There are a lot of dynamics out there, certainly in the U.S. marketplace, including the federal government now tagging the states with picking up the tab. So they are pulling back some of those grants they were giving out. So Medicaid, which is where a lot of antiepileptic drugs are used, will certainly be on the horizon of most state governors. Although we are plateauing at that 15%-16% range, there is some market dynamics there we just need to be mindful of from a U.S. perspective, and I think the assumptions have been brought forward in our European forecast on a relative basis. Which leaves the manufacturing facility for Cimzia. One thing is clear. With Cimzia, our expectation for Cimzia, we needed additional capacity. It is a very easy make or buy analysis. I can promise you that before we put a big check out, there is significant benefits, and that is the case. I think that answered it probably. It is clearly, as Detlef mentioned, we looked at make or buy, of course, and it is cheaper for us to buy it by a significant amount. One should realize that the manufacturing process for Cimzia is bacterial and not mammalian cells or other techniques there. We have the flexibility to change from a bacteria to mammalian. You cannot change, don't ask me why, but you cannot change from mammalian to bacteria. We will be able to switch if and when needed the Cimzia facility to a mammalian cell facility if we need. But the others that have mammalian cell cannot switch to bacterium. Got you. Does that answer your question? Good afternoon. This is Sachin from Kampen. My question is regarding 2,500 people you have hired. How many of these are actually dedicated specialist sales in U.S. for Cimzia? Were you able to grab some of the specialist sales from J&J or Abbott, the star salesmen who could sell your product? Another thing is why to go for 1% margin in COGS in manufacturing facility when you can invest and get most of the star salesmen in marketing from other franchises where you will make 90% of your money? This is what I'm not able to understand there. Second is regarding the graph which you showed two by two, POC and biomarker, how mutually exclusive it is, because according to me, it's related, so it's actually not two by two for mutually exclusive. If we look at the trend today, we are going for companion diagnostics, and that's pretty much it. We still don't see companion diagnostics in this concept yet. If I have to ask you one of your favorite products where you have the most conviction in phase I and phase II, which one it would be? You have taken five in last years, but there is a conviction on one which you would say, "Yeah, this is definitely going to make it." Thank you. Ismaïl, I'll let you answer the last question, but you have the right to play a joker on the latter part of the question. You can love all your babies equally. Yeah. Maybe I'll answer the question since it crosses really across the company about the 2,000-plus new colleagues that joined us. They really joined us in all areas. five years ago, we didn't have any skills in biotech manufacturing. We have a great partnership with Lonza in manufacturing, and it's a joint partnership, so we are active there. This is just one example. Sales force is clearly three years ago, we didn't have sales forces that visited rheumatology across the world. Some of them are our internal development, so salespeople that were doing other products, but a lot of them are hiring, you're absolutely right. And some of them, yes, from the competition. So these 2,000 people, it's really all across the company, including And region the President of UCB NewMedicines, and across all region. In China, we hired significant number of our growth is very dynamic in China, and a lot of these numbers that you saw in the rest of the world are also driven by China and Russia. We expanded also sales forces there. On the question on the 2 by 2 matrix. So what we were measuring at the bottom is in these trials, did they establish proof of concept in that? That was the bottom axis. So did they modulate the registrable endpoint? And so that was the parameter. Yes, no, and to what extent, and what was the PoC? The objectivity and robustness of the biomarker was an endpoint we used when we said in depression trials, for instance, you use an HAM-D score. And the element of subjectivity on a HAM-D score is greater than when you read out a LDL or HDL or blood pressure or HbA1c thing. So that was a continuum of grading how objective and robust was the endpoint. Was it a cumulative score, et cetera? So that's why they were actually mutually exclusive. The part about the diagnostics. People have been opining, and clearly, this is something that's confronting the industry about whether you're going to move into segmentation or not in terms of stratification of disease. The Royal Society under David Weatherall actually put out a publication which I largely agree with, and I wrote an editorial from an OECD meeting about when pharmacogenomics is going to hit. The answer there was pharmacogenomics in its classical sense or personalized medicine is a long way off. What is more important and which we think should occur, and we're partnering and Roch sits on the board of governors of the IMI, et cetera. What we think the academic and the medical community and the industry has to do is to first of all redo the taxonomy of human disease. Because right now when we take a disease, we take it on diagnostic criteria, and we introduce a lot of sub-diseases in one, and then we do our large trials on that, and we get a lot of noise, and we tend to handle that noise by just increasing the number of subjects, playing with the failure rate as we see it. That's what you see in the industry-wide. If we can go in and redo the classification of disease into sub-diseases as a first step, that would be the way to go to tailor make specific drugs with specific diseases. Then, obviously, the diagnostics about what's the molecular signature that puts you in one classification versus another becomes important. What do I love? Clearly what we say there is we're going to pick winners and we're going to eliminate losers, and we're going to do that objectively and have that at governance. We have great robust debate, and we apply these criteria. So for me, the olokizumab will make it. If I was a betting man, clearly, and that's been de-risked. It's a precedented mechanism. The A2A receptor antagonist, I've got experience with that, and I think that has a very high chance of making it. The PPSI is really a robust mechanism, and I would be surprised if that doesn't make it. So I think the bottom line is it would be hard for us to pick one because these guys have gone through the robust scientific review and they fulfill the criteria for why we're advancing them in the pipeline. Thank you. I'm going to give you a little secret, but you made that secret public, Ismaïl, so I can share it, I think, with the team, is that, first of all, Ismaïl is not a betting man, but more importantly, when you enter his office, there is a sign on his door that says In God we trust. Everybody else, bring data. It is all going to be data-driven, the love, in that case. Yep. Jan van de Bossche from Petercam. Two questions for Detlef, if I may. First of all, on the gross margins, I am looking always at the cost of sales and services, so the pure number, if I say. That gross margin has gone up in the second half. Was there anything specific? I have seen the comment in the notes saying higher yields of biotech production, but was there anything else specific? I do not know, maybe there was something interesting there. Then secondly, on the gearing, you have shown a very nice trend move. What is the ambition for the gearing target, for the financial leverage target for UCB? Thank you. Second one has not changed. It is still 1 to 1. 1 times EBITDA. The second one, in terms of the gross margin, what we always have said, and that should resonate with you very well, the new products have a much better gross margin in average than what we have as a gross margin today. If the new products are growing significantly, and we are not seeing the generic erosion of Keppra at the same time to the same extent, then you should see some improvement. That is watered down a bit by products like venlafaxine, which was roughly a 50% only. In that regard, I think you see, if you stick with what we said before, looking a little bit more on the medium term and eliminating that window of generic erosion, then you should see high gross margin product, Cimzia, Vimpat, Neupro, driving the gross margin line upwards. Okay. Thank you very much, Jan. The next question is coming from Jan De Kerpel over the telephone. Go ahead, Jan, please. Okay. Jan, please go ahead with your question now. Okay. Thank you for taking my questions. I have three questions. First one on Cimzia, maybe for Greg to answer. I am hearing from a lot of rheumatologists that actually they are administering the product more frequent than the four weeks, those which is on the label, and I wonder if you could comment a little bit on that. And related also to Cimzia is, if there would be some pressure from biosimilars coming, what kind of flexibility do you have on the price and the guidance that you give? Second question, maybe for Iris. Just wanted to know with respect to Xyrem, what is the status of the discussions that you are having with the EMA on the fibromyalgia indication? What are the themes in fact of the discussion over there? Is it about efficacy or what else? And then finally, maybe for Ismaïl. I really liked your conversation and your discussion on first-in-class and best-in-class, and there are plenty of good reasons to go for first-in-class. However, you see that even very big pharma companies have an ambition on working in first-in-class, but when they found a molecule in phase I and phase II, they get afraid and actually drop these first-in-class molecules because they will have to change the paradigm on how doctors treat patients today. I just want to know what your view is if UCB is big enough, in fact, to go into that change of paradigm in diseases. Thank you. Greg, Iris, and then Ismaïl. Just to clarify, Jan, also, that the label of Cimzia is different in the U.S. than it is in Europe, where in Europe, it's- Biweekly dosing biweekly dosing, and in the U.S., you have the flexibility of biweekly and monthly. Yep. If I were to compare the two indications, CD is administered once monthly almost all the time. From an RA perspective, we've gotten really great feedback from our customers about the flexibility in administration, and sometimes you're a little bit worried about this. For those of you who've been in pharmaceutical marketing, you like simplicity of a very clear dosing, and you're always on the fence about whether or not you want to promote the flexibility in dosing, because that can lead to confusion in the marketplace. We have a number of docs who are saying for specific patients, they like the biweekly dosing. They prefer to use that for patient administration and compliance reasons and to avoid the double injection on a once-a-month basis. You take one injection, obviously every two weeks as opposed to two injections every four weeks. I would contrast the feedback we've gotten, which is exclusively through the market research, that they like the flexibility for specific patients to that which we get for Simponi, for example, where the feedback is pretty resoundingly that they do not think it's a once-a-month drug, that the efficacy's not holding up over the once-a-month period. We have not heard any of that for Cimzia. My response would be very clearly that some physicians for specific patients actually like the flexibility of every two weeks rather than every four weeks, and it's actually proved to be a nice benefit in the marketplace. Thank you. Iris? Yeah. Jan, thanks for the question on Xyrem. I think you will understand that I can't comment with details on an ongoing regulatory review process. But just to remind you of the facts, we have gone into this review process with two solid, robust, positive phase III studies together with our partner, Jazz. We are, and you know that from the historical evidence, confronted with an environment which is not recognizing fibromyalgia as a disease. I think that's part of the European reality, and so we see part of the work we are doing during the review process also trying to pave the way for this recognition of fibromyalgia as a disease. But I think it gives you an idea of the magnitude of the obstacles we are confronted with. Yeah, being French by background, unfortunately, fibromyalgia has no translation in France, apparently, for the medical community. That's a little barrier. Ismail? Yeah. This is a very important question you've asked, and I think everybody in the industry is struggling with it. Let me make two points about the overarching thing and then get into the first versus best-in-class. Firstly, at UCB, what we've and the teams came up with us when we did the transformational change offsite, the NewMedicines offsite. They came with a concept of best for patient value. Which means that in reality, if you have that, then you're agnostic about whether it's first or best in class. But what it really means is you need to provide evidence that it will provide significant value against standard of care, which is existing treatment paradigms. Now, if you take that down, then what you say, well, it means that you can have both first in class and you can have best in class. But in best in class, you need to show true differentiation. That's why you see with our olokizumab, we actually designed the trial where we go up against the comparator and make a go, no-go decision based on those data. Of course, innovative mechanisms, especially if it differentiates from standard of care, will be rewarded by payer pressure. We believe that payers are going to not reward incremental innovation as they do true innovation. But the risk then is always if you go for innovative mechanisms, unprecedented mechanisms, your attrition risk might be higher. Well, that's why we've created the paradigm exactly as we have, which is to de-risk innovative mechanisms, to interrogate the molecules very early on for proof of concept in man. That's where we've come up with a paradigm, and we think that serves the innovative first in class mechanism really well, and why we will not be afraid like some other pharma companies. I should also say that UCB, given that we have new products in the pipeline, we've navigated a lot of the patent expiration, and we're doing some of that now. The last bit does give us the horizon to make these genuine breakthroughs and bring them to the market, which will be of significant value for patients. Thank you, Ismaïl. I think, Jan, also the other thing is behind that also, remember that UCB is focused on severe diseases at this stage of central nervous system, mostly neurology, with as much as possible hard endpoints, as Ismaïl said, and immunology diseases and clearly with product like anti-sclerostin, also trying to also go for the hard endpoint. So it is all about the metrics that Ismaïl shared with you and the fact that indeed maybe we can be more daring because we go into severe diseases with large unmet need. Do we have any more questions? If not, then I want to thank all of you for your participation and numerous questions, great questions, and sharing the excitement more and more. Thanks very much. Have a good day.

Data Source: Quartr Last updated: Mar 3, 2011

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