UCB SA (EBR:UCB)

Earnings Call: H2 2012

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Feb 27, 2013

Good morning. Welcome to UCB annual results 2012 presentation. If I summarize the year 2012, clearly it's a year where we smile. Even as you know when I think I can't smile, on this one I can. Clearly, we're pleased with the momentum that we have now with Cimzia, Vimpat, and Neupro driving our growth, and indeed for the first time, indeed exceeding the sales of the other top-selling UCB molecules. That's clearly an important milestone in 2012. The other one is the progress in our pipeline. Thinking about the late-stage pipeline. While being decisive, I think we've shown in the year 2012 our decisiveness and our ability to focus on what we believe will make the difference into the life of patients, and the solutions that we have in development that do not fit the bill, then kill them early and move on to the next one. We're pleased, of course, to have delivered on our financial commitments, and you'll hear more today about it. But overall, it feels good to enter as of 2013, a period of long-term growth with no major patent expiry on the horizon. I'm sure you've read all the disclaimer and know it by heart now. Let's move to the agenda of this afternoon. After me, Marc will focus on Cimzia, Vimpat, Neupro, and Keppra, which remains an important franchise for us. He will answer later on all the questions you have on emerging market also, as this is one of his key responsibilities. In the Q&A he's joined by a few colleagues. In the room, Kozo Balluch, who you know. Kozo is our Chief Marketing Guru, and moved a few weeks ago to become the head of Europe and reports to Jean-Christophe Tellier who is on the line from the U.S. together with Jeff Wren, who is heading North America. Both Jeff and Jean-Christophe's technology allowing are there for the Q&A. Then we'll have Detlef focusing on the finance, and then Iris bringing up to speed with the latest developments that we have on our pipeline, and then I'll conclude before the Q&A. This is the slide that summarized the year really 2012, the famous crossover, and you saw even some nice acceleration in Cimzia, Vimpat, and Neupro in the latter part of the year. So, very strong momentum there. I have to say that Keppra made it more difficult to reach this because clearly Keppra resisted better than anticipated to the generic erosion. Keppra also performed better in Asia, mostly in Japan. Overall, the financial highlights were met, and I will let Detlef mention them. We have to notice the strong growth of Cimzia, Vimpat, and Neupro. Over 40% if I exclude exchange, and the strong Keppra performance in Japan. I thought it may be a good idea before we drill into the results as we're now entering this period of long-term growth to put some color on how do we see this growth and what will be the key drivers of growth. You know that we have set a strategy in place where our beliefs, our resource allocation, our energy is being focused on delivering superior and sustainable solutions to patients. All our resource allocation is being done in order to meet that goal, deliver superior and sustainable solution to patients. The belief indeed is that if we do that well, then we bring innovative medicine to the market, payers pay for it. We get market shares because it is superior solutions to patients. We get sales. Sales bring profitability. Profitability bring returns to our shareholders, and we are able to invest in R&D more than our peers. This is the anchor, the belief, and on which we focus all our energy. We have a few hows and enablers behind it. If you are interested, we can go into the Q&A. This strategy and the implementation of this strategy is driving our growth. There are really five key growth drivers as of 2013 moving forward. It will not be a surprise that clearly growing Cimzia, Vimpat, and Neupro is on the top. We have new territories, we have new indications. We still have huge untapped opportunities with each one of the three molecule. I am going to highlight each one of them into more detail. Building emerging market, and this is somewhat new, but you see that emerging really, no pun intended, in the 2012 results where you see our strong performance in the emerging market, clearly superior than the local market performance. Advancing our rich late-stage pipeline is clearly a focus for Iris and her team. Delivering breakthrough medicine to the clinic is the focus of Ismael and his team, and altogether improve our competitive profitability. Again, let me cover each one of them into more details. First growth driver is Cimzia, Vimpat, and Neupro. With the performance, the trend, clearly our peak sales guidance of at least EUR 3.1 billion is, I would say, a target that we are all aspiring to exceed and beat. Combined sales for the year 2012 exceeded EUR 900 million, EUR 934 million in fact to be exact, +49%. We made progress in the competitive differentiation reflected in the new label of Cimzia both in the U.S. and Europe. Extensive progress, investment, and achievements in the life cycle management. We filed for two new indications for Cimzia, ankylosing axial spondyloarthritis and psoriatic arthritis, both in the U.S. and Europe. Both have been accepted for review by the authorities. Just to remind you that the prevalence of these two diseases combined is more or less close to the one of rheumatoid arthritis, with less intense competition in these two new indications. Life cycle management, we are working hard to get Vimpat monotherapy U.S. results in the next coming weeks. Life cycle management also with Vimpat started its clinical development in Asia and new territories with the approval of Neupro in Japan, in the U.S. last year just starting with Neupro with the approval of Neupro in Japan on Christmas Day, the launch of Neupro yesterday, the approval of Cimzia in Japan on Christmas Day also, and the launch of Cimzia in Japan together with Astellas in the coming weeks. A lot of life cycle management, and we continue to work on innovative solutions, and more will come on this. But to really provide indeed superior value to our customers, which are the patients, their caretakers, the physicians, and payers as a whole. So big, important growth driver. The second one is emerging market and Japan. We are focusing on six countries, which are listed on the slide, and these six countries derive 75% of the firm's emerging market growth. The last block that we did not have in the 6 countries was Brazil. You all know that we acquired the majority stake in a small Brazilian company last year, which indeed provides the base for fueling our growth in Brazil. Very nice momentum, very nice growth so far, and indeed a base to launch over the coming years our new molecules also in the emerging market. UCB Japan is performing very dynamically with E-Keppra, the new launches that I cited, and the Vimpat phase III that have started. For us, Japan is a new market and an emerging market indeed. We built our presence and the first new product that we launched on our own is really E-Keppra just a couple of years ago. Third big driver is of course our late-stage pipeline. I will let Iris comment on it. You see a new addition here, which is tozadenant, and also Iris I am sure will comment on this. Very nice momentum last year with romosozumab entering phase III. We are focusing our efforts on bone loss disorders, mostly post-menopausal osteoporosis. Nice momentum with epratuzumab, and indeed you see that also we filed for the new indications of Cimzia on this slide. The fourth one is the breakthrough. Ismael is also in the U.S., so this is a summary slide of how do we pick our breakthroughs and hopefully from this slide will fuel many new molecules that will come into the clinic. We have announced that we have one new immunology compound coming into the clinic at the end of last year. This is really what drives us. First of all, our decision-making is based on 4 key criteria, which we complement with the inputs from payers. We are talking about the medical needs, so the higher the medical needs, the better. We are allocating our resources to indeed the solutions that provide the strongest medical needs, unmet needs. The second one is the ability to measure the target from a proof of concept. A high proof of concept in human would be anticrosin where we have a human knockout or a positive phase II-B would be a high proof of concept in humans. The higher the proof of concept is, the more we will allocate resources to. The clearer the proof of concept in humans is, the clearer we allocate our resources. Robustness of endpoint. If we have the choice between allocating resources to a disease where there are soft endpoints, lupus and pain are 2 examples of soft endpoints. Hard endpoints would be tremor, movement disorders, epilepsies and hard endpoint of fracture in the post-menopausal osteoporosis or BMD is a hard endpoint, and that is easy. We still have a product for lupus, but clearly when we allocate our resources, this gets less points for less robust endpoints or more points for more robust endpoints. Clearly our competitive differentiation. I just felt that I wanted to share that with you because this is just a guide that show you that the same discipline that you have seen in the clinic and decisiveness of allocating our resources applies before the clinic into our ability to kill early the compounds that do not match, basically, these grids. We do that with, that is what you have on the left, by focusing on the excellence of science ourselves and complementing the science by super network. You've seen us over the last three years really turbocharging our alliances with top universities in the world, whether it's Harvard or Oxford, or with top biotech companies in the world. You saw an example of UCB being the one company that basically partnered with one of the latest Nobel Prize winners. This notion of building this super network, nobody can harness the power of the science today on their own, and it's really aligning ourselves with the ones that have the technology and being able to harness them and be the consolidator of all these technologies together with our unique science. We match that with unique patient insight. Patient insight is not only a patient talking to us. It can be that. We have some scientists that are combining their science excellence with a deep customer insight, we're able to rediscover what could be potential breakthroughs, but it's also patient insights, such as what we've done with romosozumab, understanding indeed what happened in subpopulation and their gene pool. That would also be unique patient insight. All this effort is really focused on delivering superior and sustainable value for patients right from the beginning with the input of patients and of payers, too. The last big growth driver, of course, is the improvement of our competitive profitability. We have as a goal to reach the 30% around the year 2017. Gradually you will see between now and 2017 our revenue to total revenue ratio going up. This is done by rigorous resource allocation, ruthless elimination of what is not core, what does not make a difference into the life of patients, once more, to focus our investment on delivering sustainable and superior value. You've seen that indeed, we've taken advantage of that to invest more in R&D. These are the big five growth drivers that will move us moving forward. You all know this graph. We've shared it with you over several years. I'm pleased that we're leaving the block on the left to enter this intense company growth. Now this graph really describes the future as we see it, which is growth from emerging markets, growth from things you have impact on Neupro, growth from our late-stage pipeline, and growth from our breakthrough medicine, all that while improving our competitive profitability gradually in order to deliver superior and sustainable value to patients and hence to all stakeholders, including, of course, our dear shareholders. I hope you didn't mind that I wanted to take this helicopter view, but I felt that as we're now entering this new growth phase, it was important to share with you what is driving our energy and our focus. In fact, it's also why we have aligned our organization. We've announced that a few weeks ago, and if you pair the five growth drivers together with this new organization, you clearly see a complete match. Every single one of the top four is one of the quadrants here. Number one is grow CVN. This is a priority of Jean-Christophe Tellier, who is heading Biopharma Brands and Solutions. Number two is drive emerging market and Japan. This is a priority of Marc, who is heading the Established Brand Solution and Supply. He has a few more than just the emerging market, as he is also accountable for our supply chain and corporate business development. The third priority is bring the late-stage pipeline to patient as soon as possible. This is Iris' responsibility and focus, and she leads the Biopharma Development Solutions. Last but not least, is clearly bring the breakthrough into Iris' hands as soon as possible. This is Ismael's responsibility who leads the New Medicine organization. All this focusing our resource allocation to deliver superior value for patients. This is a good introduction to present you Marc. Marc will speak with his old hat today as he presents the results of 2012. But also his new hat, I am sure he will give some exciting colors on the emerging market and the remarkable performance in Japan. Okay. Thank you, Jean-Christophe. Good afternoon to everyone here, and if you are in North America, good morning, and if you are as far east as Asia, good evening. I am very pleased to be here. To clarify what I do, again, my name is Mark McDade, and I am now responsible in the new organization for the established brands, which means everything except for CVN. It is really easy. Or in another way, it is the mature products, the off-patent products within our portfolio sold on a global basis. Responsible for the geographies that cover others, but encompass the emerging markets, plus Japan. Responsible for supply chain manufacturing, what we refer to as technical operations, and then responsible for our global business development. The team keeps me very busy, but speaking of the team, I am very proud of talking about the 2012 performance of core products in markets E, V, N, and K, as you guys know them quite well in terms of our acronyms. Let me start with Cimzia, because it is the biggest of our new core products. Clearly it is our most important new growth driver and has continued to meet our expectations, and we hope to continue to meet yours. You can see that we had more than 50% growth year-over-year for the brand. On an adjusted basis, this was just slightly under that, at 41%, adjusted for currency. Strong growth in all the geographies. Obviously, on an absolute basis, tiny in the emerging markets, not yet established in Japan, but we got approval at the end of the year. Strong growth both in North America and Europe. Overall, we are pleased. We have continued to expand market share on a global basis, and we are, as you have seen, and as you will hear more about from Iris, expanding indications as well as the geography that we cover. We have 34 countries approved and 33 of them selling in RA. The 34th will be Japan. We have seven countries approved for the sale of Cimzia in the setting of Crohn's disease. That is a quick overview. This slide just highlights that we have been on the market in the U.S. since 2008 in one indication, Crohn's disease. That was matched at the same time by a Swiss approval right around the same time in early 2008. Launched in 2009 in the U.S., and then late in the year, and really the following year, in Europe in the rheumatoid arthritis setting. All 34 of those countries have been rolled out since the 2009 timeframe. Let us start with the U.S. market performance, which this slide represents treatment share, TRX, as we call it. What you should note is really steady, almost Swiss watch-like growth of this brand quarter over quarter. This represents quarterly TRX growth since the launch of the product. You can see pretty steady state uptick. This represents significantly greater growth than the market. The RA market, which this represents, grew last year at around 4%. We are considerably above that with our growth rate in the U.S. of nearly 50%. On top of that, what this does not show is Crohn's disease, but we are growing above the Crohn's disease market rate as well, which is in the low double digits. Overall, handsome growth. I think that has really been generated in the U.S. by a number of factors, some of which are not represented on this slide, which I will talk to. First of all, highlighted on this slide is the fact that even though UCB is new in the immunology field and certainly new in the rheumatology field, now present in that market for just over four years in the U.S., we have roughly half of the U.S. population, in terms of lives covered for Cimzia. Jeff Wren, who up until recently was responsible for our managed care activities in the U.S., and his team have really done a terrific job in getting lives covered with half the population. As you can see on a preferred position basis, roughly 10% of the U.S. population covered. What is not included in this slide, because there is no easy way of tracking it, is that obviously the Medicare business for all the anti-TNFs and of course Cimzia is important. We have gone from 62% Medicare coverage across the states to 94%, representing 47 of the 50 United States now having so-called MAC coverage, which has really enabled us to drive growth of the second of our two formulations, as well as obviously PSS. What is also not covered in any of our IMS data is the fact that we sell a lyophilized version of Cimzia, which is used and administered by the healthcare professional, either in the office or in a hospital setting. That is not easily tracked by any audited system. The 50% improvement in terms of MAC coverage will impact sales in 2013, we think pretty importantly. The growth of our lyophilized formulation, which represents roughly 20% of U.S. sales, it is not sold anywhere else, is not captured, again, in the audit data. Just for clarity. I do not have any slides in terms of overall European performance, but our European performance in terms of market share, in terms of the EU4, we cannot track U.K. for reasons of the unique distribution system here. EU4 market share for Cimzia on a TRX, so comparable basis to the United States, is actually slightly higher at about 5.7%. You saw the growth rate was also higher in terms of 60 some odd percent for Cimzia in calendar year 2012. Overall uptake for the brand, quite strong. Cimzia in Crohn's disease grew roughly one percentage share in the United States, which is the major market in which we are selling it today. That is a snapshot on our number one drug in the CVN core product group. Number two is Vimpat. Vimpat is near and dear to our heart because I will give you a few snapshot pieces of information as to how strong UCB is in the setting of epilepsy. The aggregate data, we are sold in 36 countries, and we grew by more than 50%. This should be a common theme that you are feeling pretty good about. I am certainly smiling, and I know my colleagues are. You can see the geographic representation. I do want to highlight that there is a big difference in price between North America, Vimpat, and the rest of the world. That certainly puts emphasis on the importance of the U.S. marketplace relative to anywhere else. With this slide, I would just like to highlight a few elements on the slide and not on the slide. Number one, we take epilepsy very seriously as a company. We are committed to the treatment of patients, and as you will see from later slides, roughly a third of patients all the time are refractory to drug treatment, which means we have a big job as UCB to do. That takes a lot of people and presence from all functions of the company around the globe to basically instill confidence and trust in UCB. We monitor that constantly around the globe in major countries and in the newer countries in which we operate. We take surveys with questions like this one, which basically asks, "Which company do you feel has the best reputation in the treatment of epilepsy?" This is just one of the many questions in the survey that give us the confidence that we are a trusted provider of product. Basically, we try to then leverage that as we introduce new products or new indications into the marketplace. Behind this, what you should also understand, Decision Resources is a group that we trust for their data. Their 2011 data suggests that in Europe and the U.S., the treatment value in epilepsy of AEDs, sorry, in the G6, not in total Europe, was roughly $2.9 billion U.S. The treated patient population in that same area was 5 million patients. I mention that because, just take our numbers, Vimpat, Keppra, way over EUR 1 billion. So we treat on a value basis more than a third of the patient value in the U.S. and Europe. We are proud of that. It also means we are committed to doing things right and very well with our providers and for our patients. Okay, so a little background information that is not widely advertised, but we think it is important for you to know, because it is that kind of strength that has leveraged the launch, as you can see in these curves, of Vimpat on a worldwide basis, starting in Europe and the U.S., and now we are starting to expand it in the emerging markets later in the decade in Japan. Again, U.S. market share, Swiss watch-like growth performance quarter-over-quarter. This is TRX data, very steady growth. Proud of what the team has accomplished. This again does not reflect the use of other forms of Vimpat which are not necessarily tracked, such as IV sales in the hospital setting. In addition, in Europe, I mentioned before the price difference, so that is important to take into account. But we are proud of the fact that we are matching toe-to-toe the previous best-ever launch, which was Keppra in the European marketplace, which is very price sensitive, roughly one-third the price of the United States on average on a treatment day basis. This kind of performance, we think, is a testament to the quality of the drug and the basic importance that UCB has and the trust that we have in the setting of the providers that treat these patients. The same neurologists, in general, other prescribers prescribe products for epilepsy. But many of those same prescribers use Neupro. Neupro is our patch formulation, 24-hour sustained-release formulation of the drug called rotigotine, which is patent protected roughly until the end of the decade and is approved in many countries for its use in Parkinson's disease, both early and late, as well as in RLS in a number of fewer countries. As you can see, the growth was not quite 50%, but there was an important uptick in 2012 that was caused by two important events. Number one, we were successful in reformulating a room temperature stable product, and that led to then the approval in two markets, U.S. and Europe. Then a third good event happened at Christmas Day, which was the approval of Neupro in Japan. So I think 2012 represents certainly an uptick growth year based on solid performance from a regulatory standpoint as well as solid performance in the marketplace. You can see the uptick that really occurred from the United States. There is no impact yet for Japan. I am pleased to say our partner, Otsuka, which has the exclusive rights, exclusive even as to us in Japan, launched yesterday at a very fine price. So we have high hopes and expectations for 2013, but those numbers are not reflected here. That is CVN, Cimzia, Vimpat, and Neupro in a snapshot. Let me switch quickly to our biggest drug, and it is the leading drug in the established brand portfolio, and that is, of course, Keppra. I think many of you, and we, were pleasantly surprised by the fact that we achieved less decline, if I can be happy about less decline. We had less erosion than we expected to the tune of about 13% drop, most of which was precipitated in Europe on a real exchange rate basis. We actually nominally grew in the U.S., although on an exchange-adjusted basis, we slightly declined, as you can see from the figures. Importantly, as Roch pointed out earlier, the E-Keppra launch has been the most successful Keppra launch in the world, and it has been the most successful AED, anti-epileptic drug launch in Japan. At the end of last year, E-Keppra surpassed Lamictal, which was launched two years prior to us, as the number one valued drug in Japan. Our target is to take over the number one slot on a treatment day basis, but that will take a little while longer. We are pleased about Keppra as clearly a linchpin and an important sustainable product for the future. I will wrap up on the note that Roch already highlighted before. I would say based on 2012 performance, we are as confident as ever, maybe more so, in the projections that we make in terms of peak sales of more than $3.1 billion for the total of CVN. While we do not guide to Keppra, we feel good about its resilience and its strength and our ability to maintain high patient levels for Keppra going forward. That growth is going to be underpinned for Cimzia by new indications, starting with ankylosing spondylitis, also axial spondyloarthritis, as well as psoriatic arthritis and possibly other indications. In Vimpat, the most important new indication is the one we will hear about in the next month, and that is monotherapy in the U.S. and later monotherapy in Europe for reasons that Iris will talk about. Neupro is going to be more geographic expansion, launch full year in the U.S., launch first year ever in Japan. With that, Detlef, I would like to turn it over to you, and thanks again to all of my colleagues for the great job in 2012. Yeah, thanks too, because if top line is going well, usually the numbers are not that difficult to explain either. Let us just take a look through it. You saw that too. I got that young dynamic. That was a grumpy old man before, so they gave me an uplift. Looking into the overview, if there are green arrows, then usually that means things were going well. We heard about the revenue and the strong performance of our products, whether it was a mature product, and we come to that, or CVN. You also have recognized that there was a strong FX component to it. If I were to take that out, the 7% increase would be a 2% increase. Still better than what we would have expected before we went into the year, but we want to leave it where it is. In terms of the operating expenses, they have been going up too, 5% of this 9% also due to FX. That is making sense. The remainder, I think the quality of our spend is improving year by year. We are investing where it's really the way to invest, whether it's in the new product launches or whether it's in R&D. R&D costs, we'll see that later, are where I guided you to around the 25% mark. I'm really happy about it because it's a great pipeline. Recurring EBITDA is on the high end of the guidance, so as expected for you. Net profit is much higher than the guidance as well as core EPS because you saw the tax again. I never will get that right. I think as a CFO in my life, I was the 70%-90% guy when I was with Schwarz. I'm now the 3%-10% guy when I'm with UCB. I still stick to my long-term guidance. For your models, stay with the 28% because these are temporary effects, and we can go into that. The core EPS is EUR 2.14 is a very nice number. When we look into the sales, I leave CVN out because everything was said by Marc, but the mature product is another highlight. 5%, if you have in mind that Keppra erosion happened, is a very strong number, and it is supported by the emerging markets growth. Looking through the P&L in a bit more detail, the one number in terms of the revenue parts that you might stumble upon is royalties. Is something missing there? No, it's really not because it's royalty income and fees, and you know that our new products are partly at least royalty-bearing. While it seems counterintuitive, negative numbers might be good because it means we are paying more royalties on the new products, which means we have strong growth there. That is really the only one to explain there. If you go to cost, I would point your attention to the constant exchange rate numbers. You see that cost control is very well done. Our marketing and selling is flat, although we had significant launches. SG&A, the G&A part of it is 2%, and I can promise you if we would not have seen the share price soaring so well and share-based payments would have to be accrued for, this would be also a lower number. That all went very well, which leaves us with R&D expenses and they are on the high end of what we guide, which does mean we have a very strong pipeline to support. You have seen throughout the year that we are not making this job easy for us. If there is something that is not creating the value, it's going out of the portfolio. If there's something that we believe can create more value, it's coming into the portfolio. We are very rigorous on that. In terms of the amortization and depreciation, not too much to add. It leaves us with what I believe are very good numbers in EBITDA for this year with EUR 655 million. Looking into that a bit more in detail down the line, you might stumble upon the net financial income and expense. This number seems high compared to last year. It is, and the 2 major reasons are, we have done an impairment on the Wilex participation that we have. As you know, one of their key products failed, and that's bad data. Therefore, the stock tanks, and this is a reflection of it's EUR 15 million, and there was another EUR 9 million because we purchased back EUR 70 million of our convertible bonds because it seemed like a very good thing to do in terms of investing our money. Having said that more or less leaves the financial expense in the area that you would expect, and so there are no surprises other than tax. Why do we have tax numbers being low again? Because we have recognized formerly unrecognized losses in some countries that are now going into profitability. These are temporary effects, as you can imagine, and they have not so much to do with the underlying profitability. If you want to do your model, please stick with me on the 28% for the longer-term range, and I keep you updated, and I see that more positive. In terms of core EPS, we'll just give you another slide to have a bit more transparency how that is calculated, but the number is strong with EUR 2.14, quite significantly above the guidance as well as your expectations, but also, here tax plays a major role. Cash flows have been strong, but also when you look into that we are heavily investing. We talked about the CapEx for this year, but also in the next few years going forward, being somewhat suppressed, increased by the bio plant investment that we have in Belgium and in Switzerland, which will be a very good investment for us in the long term as it will help us to be reducing our costs. This leads also to a slight increase in net debt, but still in a very solid range in terms of the ratios. I just want to mention on top, we don't have any restrictions on our ratios. All our financing has no ratio. I'm just putting that out because I think from a hygiene factor, it is important to keep that in mind. Leaves me with the financial outlook. I'm happy to say that what we have promised that the company is growing with C here too. We talked about the FX effects on revenues in this year. We see a single-digit increase from EUR 3.3 billion to approximately EUR 3.4 billion that we foresee if you take out the FX effects. This is represented also in the recurring EBITDA with a nice increase into the range of EUR 680 million-EUR 710 million that we predict. Core EPS can follow that, and here, against my usual way of doing, I have given myself a push and reduced the tax rate for this year because we can see that some of these effects that I mentioned before, unrecognized losses being recognized, will be taking place also in 2013. So the tax ratio is around 20% that we guide at this moment, and this gives us a core EPS of EUR 1.90-EUR 2.05. All in all, I think I'm quite happy, as you can imagine. Not only that we have a strong operational performance, both from our core products, but also from the pipeline, but also the financials look very benign and achieve or overachieve towards what we have promised. Having said that, the exciting part next to the growth of our products is our pipeline. Who could better do that than Iris? So I hand over to Iris. Yeah. Good afternoon to all of you. Good morning. I would like to invite you to review our late-stage pipeline together with me and to have it all on this slide. The first message to all of you is we are turning regulatory submissions into approvals. You have already heard about our happy moment in Japan. I will just add that we looked into the annals of pharmaceutical industry in Japan, and that we have not come across any precedent where two new molecular entities coming from the pipeline of one company were approved on the same day in Japan. So a very unique moment in time for us. Of course, we are also determined to turn the most recent Cimzia regulatory filings into approvals. The review is ongoing at FDA and at the European Medicines Agency for the two new inflammatory arthritis indications, psoriatic arthritis, and axial spondyloarthritis. Again, we are determined to turn these into successes. We will talk about the phase III project in more detail. I would also draw your attention to the early-stage part of the pipeline. As you see, we have taken a molecule from our internal pipeline in the immunology space into phase I. Of course, as of last night, we have added tozadenant into our phase II/phase III portfolio. Together with our partner, Biotie, we will develop tozadenant for advanced Parkinson's disease patients. It is a very innovative mechanism we are looking at. If you look at current treatments in Parkinson's disease, they are typically all dopamine-based. It is either levodopa or dopamine agonists. Tozadenant is an innovative molecule with a new mechanism of action. It blocks adenosine A2A receptors, and these receptors sit in the striatum in the brain and play a key role in the motor function. So we are deeply convinced that we will, with this molecule, provide additional treatment options for people living with severe Parkinson's disease. Our hope is based on solid phase II data that were released recently in an advanced patient population. The worst that can happen to patients is that they are off. Off time means that they can hardly move, and this is really the lowest quality of life moments every day. The patient population that was investigated in the phase II study was a patient population with advanced disease, with an underlying treatment regimen of levodopa. Most of these patients were also on concomitant dopamine agonists. On top of this very thorough treatment regimen, patients experienced a statistically significant and clinically relevant improvement in off time. Great start to get ready now for phase III. Again, we are looking forward to intensify our partnership with Biotie, who will drive the development in phase III. Let me tell you a little bit more about what else is going on in our CNS pipeline. I start with Vimpat, because the next big data point that we want to deliver is the results of the U.S. monotherapy study with Vimpat. As you might remember, it's a historically controlled study. We are looking into a patient population who are on a number of antiepileptic drugs, then Vimpat is added, and the concomitant antiepileptic drugs are sequentially withdrawn until patients are maintained on Vimpat as a monotherapy. Then we are looking into what's the withdrawal rate from this regimen. The complexity of the study comes from the historical control aspect, because you cannot put a patient population like this on placebo. Our comparison has to be the success rates of a number of monotherapy studies that were conducted in the 1990s. One of the challenges of this study was to find a patient population that matches this patient population from the 1990s. You can imagine this has not been easy because a number of antiepileptic drugs has been added since then, also the characteristics of the patients have changed. But now we are only a few weeks away from being in a position to present data to you. We have a European monotherapy study ongoing with Vimpat as well. This study started later than the U.S. study, for regulatory reasons, it has a different design. In this study, we are looking at patients who have a fresh diagnosis of partial onset seizures who are receiving their first antiepileptic drug. It's a comparative protocol. Patients are put either on Vimpat or on carbamazepine. We expect results from this study next year. Let's move on to brivaracetam, which is the phase III molecule in our pipeline. As you all know, we are running one large-scale phase III study with brivaracetam in a highly refractory patient population. We are recruiting almost 800 patients in more than 100 sites. You remember that for this program, we had some lessons learned to be implemented from a previously completed brivaracetam program. There were three key lessons learned. One lesson learned was go to a higher dose, we have done this by including a 200 milligram arm. There were two other lessons learned, namely, please focus on the best clinical centers in the best regions. Do not try to go everywhere just to be fast with regard to recruitment. The third lesson learned was exclude levetiracetam as a concomitant antiepileptic drug to optimize the delta between placebo and active. The last two lessons learned have confronted us with a delay in recruitment, again, our commitment to patients and to you is that we want to do everything to ensure success of this study. On top of these requirements, we are confronted with a highly competitive environment. There's a lot of antiepileptic drugs in development. There are a lot of studies ongoing, we feel this competitive environment. As we are a learning organization, we of course have learned from this situation, and we are in the process of revamping our recruitment tools. We live in an age of big data. There are new means to identify opportunities for recruitment. So kind of a blessing in disguise that will benefit our future clinical trials. We expect now to bring results from the phase III brivaracetam trial to you in the second half of next year. Sorry for that. Many of you are asking, why are you still investing so much work and effort in epilepsy? Is there still an unmet medical need? Of course, my message to all of you, yes, there's huge unmet medical need. If you look at the graph, on one side, you see clearly that about 50% of patients are controlled on an initial monotherapy. There are other patients who are controlled on a number of antiepileptic drugs. There's definitely always 30% of patients who are refractory to any antiepileptic treatment, and these patients are definitely in need of new therapeutic options. If you ask for my personal perspective, I'm deeply convinced that also patients who are showing up in this chart as controlled are still suffering from seizures and still have suboptimal quality of life. So I believe as long as there's people living with epileptic seizures, we have a big medical need, and we have a big job to do as a company that's deeply committed to epilepsy and to people and their families who are suffering from epilepsy. If you ask yourself why are we building step after step the portfolio of indications for our molecules, then the graph on the right side gives you a good feel for how important it is to go into different indications. Vimpat right now serves patients who fit the criteria in the upper right quadrant. Vimpat is approved for adjunctive therapy in partial onset seizures. You see that when we move impartial onset seizures into the monotherapy space, we are more than doubling the patient population that can benefit from Vimpat. Then, of course, if you go to the lower two quadrants, you see that also primary generalized seizures are an important field to take care of, and you know that we have completed a phase II program as adjunctive therapy in primary generalized tonic-clonic seizures, and that we are preparing for phase III. Again, coming back to Vimpat, very obvious that of course, the U.S. is a major part of this unmet medical need. Is there unmet medical need in epilepsy? Yes, definitely. We're working hard to serve patients living with epilepsy. This gives me the opportunity to move to the immunology side of our portfolio, and I start with epratuzumab. As you know, we are developing epratuzumab currently in phase III in systemic lupus erythematosus. We have a large program underway, two clinical studies, EMBODY-1 and EMBODY-2, in moderately to severely active patients living with lupus. In essence, what we want to do is repeat the success of our phase II study. We are looking for a combined endpoint, BICLA, which is a very granular and sensitive instrument that measures the change of disease activity, but also includes physician's assessment and patient's assessment of disease activity. We have a 48-week duration of these studies. Again, as I said before, in essence, want to repeat the highly clinically relevant effect that we have seen in our phase II program. If you look at the details of the studies, they are, in essence, identical, placebo, and then the two best treatment regimens that we could identify in phase II. Both treatment regimens are 2,400 milligrams per quarter. Patients receive the doses either as a weekly infusion during the first four weeks or as a biweekly infusion, again, during the first four weeks, then have a break for eight weeks, and then the cycle starts again. Again, we are very excited about epratuzumab. It provides a unique opportunity for the treatment of patients with SLE. You know all that the real risk of SLE development resides in the technical hurdles. SLE is a disease which is highly fluctuating. We have instruments that are less robust than we would wish to be, and that is the reason why we try to be as confined to our phase II criteria, which has worked for us as we can be. A quick view of the mechanism of action of epratuzumab, and of course, there is a lot of work still to be done to understand the mechanism. You can imagine in a disease where little is understood, we also have to work hard to understand the mechanisms of our molecules. Epratuzumab blocks CD22. CD22 is a surface antigen of mature B cells. What we see from our laboratory experiments, it is very clear that the blockage of CD22 results in a loss of activation and migration of mature B cells. Epratuzumab does not deplete B cells, it modulates, which in our perception means that the immune response is intact where you need it, and it is about combating infections. We have intact immune response, and it is modulated and down-regulated to avoid hyperactivity, and that is, of course, what is a contributor to SLE manifestation and maintenance of disease activity. So, so far, our scientific insights into the mechanism of action of epratuzumab. Moving on to romosozumab, our sclerostin antibody. Some of you have asked me what excites you most in the pipeline, and I said I love all of our molecules, but if I can be honest, this is the most exciting. Why is it so exciting? Number one is we are in this very rare and fortunate situation that we have a genetic validation of the target. We are all aware of the sclerosteosis population in the south of Africa, a patient population that experiences constant lifelong growth of strong, good quality, solid bone. We know, and researchers in UCB have identified this together with colleagues from academia. So we know that there is one single reason for this lifelong solid bone growth, and that is the lack of a gene that codes for a single protein called sclerostin. So if sclerostin is missing, you have lifelong solid bone growth. We know that. That is no longer hypothesis, that is proven in the sclerosteosis population. If we look into post-menopausal osteoporosis, which is the most important and most obvious bone loss disorder, on top of this genetic validation, we have wonderful results from a phase II study where we have compared romosozumab with placebo, but also with standard of care, alendronate as a frequently used bisphosphonate, and teriparatide. And we have seen in the results that romosozumab compares extremely well against placebo. That is not a surprise, but also extremely favorable compared to standard of care. That is, of course, a very solid basis to go into phase III, and that is why we were very happy last year to go into phase III starting as of second quarter. My colleagues have asked me to share with you the latest schematic of the mechanism of action of sclerostin. We go a little bit in detail here. Sclerostin is typically produced by osteocytes. These are the mature bone cells. The function of sclerostin, as mentioned before, is to suppress the formation of new bone. So sclerostin has a negative feedback on osteoblasts maturing and producing bone. When you now go to the effect of romosozumab, it of course blocks a blocking principle, which results in removing the blockage of the underlying mechanism. So if you block sclerostin, you mobilize osteoblasts and you get the formation of new bone. Simultaneously, you also get a stopping of resorption of bone. Both are mechanisms which, of course, are very valuable in bone loss disorders like post-menopausal osteoporosis. You have stimulation now of the formation of new bone, and you have no further bone resorption. Both add to the building of new bone. This is a schematic of the ongoing phase III program. Just to give you an idea how the two studies look like. All in all, it is a huge program. It is about 10,000 patients. We have 6,000 patients included in a placebo-controlled phase III study. Patient population is, of course, women with post-menopausal osteoporosis. We are comparing romosozumab treatment with placebo, and we have endpoints after 12 months and after 24 months. After 12 months, patients are switching from romosozumab or from placebo to an anti-resorptive therapy, denosumab in this case. Now we have a second study ongoing that is looking into clinical fractures. There is vertebral fractures in the first study as endpoint, which is the classical regulatory endpoint. In the second study, we are looking at all clinical fractures as particularly relevant for payers. 4,000 patients, again, with post-menopausal osteoporosis, and it is an event-driven trial, which we expect also to read out after 24 months. You should also be aware that we are continuing to observe patients in our phase II study. You might remember the data that we have released so far are one-year phase II data with bone mineral density as the primary endpoint, and patients were either on romosozumab or on placebo or on the standard of care. Patients in this study continue for a second year on romosozumab or placebo or standard of care. Then in the third year, we will see a switch. Patients can then go either on placebo or can go on an anti-resorptive, and then in the fourth year, we will switch again. The reason why I am mentioning this is this treatment regimen in phase II will, of course, inform us about how to utilize romosozumab in practice. I hope you all bear with me, but if you bring innovation to treatment regimens like we do with romosozumab, we need to explore what is the most efficacious, what is the most effective treatment regimen then in the hands of physicians. That is work in progress, and that will require some auxiliary work to the phase III studies, which will be guided by the phase II results. The place of romosozumab in the armamentarium of physicians in osteoporosis can be before anti-resorptives, can be after anti-resorptives. We will provide guidance on that as we move forward in the development program. This is the news flow, and we are already in the middle of the 2013 news flow. As we have heard, the launch of Cimzia and Neupro in Japan is ongoing as we speak. We will deliver the Vimpat monotherapy U.S. data to you in the next several weeks, and we will start the phase III in the pediatric population with Vimpat later this year. 2014 will be a big year in terms of data to be released. We will have the results from the brivaracetam phase III study. We will have the results from the epratuzumab phase III study, and we will read out the data from the Vimpat European monotherapy study. Again, big year in terms of data then coming up. With that, I leave you with a view of the pipeline. I am very passionate about our molecules. I hope you feel it, hear it, see it. I hope you are at least excited about it, and I hope you continue to believe that we are committed to deliver high-quality data as timely as we can. With that, I thank you very much and hand over to Roch. Thank you, Iris. Time to conclude. Now that the crossover year is indeed behind us, it is time to focus on all our energy on the long-term growth of UCB, as well as improving our competitive profitability. We all understand that the world is changing big time and more and more rapidly, and clearly the pharmaceutical industry and the biotech industry is probably at inflection point. The pressure of payer has never been so big, and yet when you provide indeed superior solutions to patients, you can thrive in that environment. Just to give you a few data points in 2012, you saw that in Europe, which is a tough environment, was a tough environment, is a tough environment from a payer standpoint. You saw Cimzia growing at over 60%, Vimpat at over 33%, and Neupro in fact accelerating from the previous year at 22% growth. It is all going to be in this changing world about indeed delivering superior value to patients that payer are willing indeed to fund or reimburse. That is why we are focusing ourselves, and this is why we are focusing on, A, severe diseases, large unmet needs, and focusing all our energy, all our efforts, all our activities into this mission of delivering superior and sustainable value for patients. You have here our growth drivers, emerging markets, Cimzia, Vimpat, and Neupro, the late-stage pipeline that you saw from Iris, and hopefully more will come in that late-stage pipeline from the priority of bringing breakthroughs into the clinic, as well as gradually improving our competitive profitability. We have summarized, and you will see more of this as time goes, because we have summarized really what UCB stands for by this tagline, which is really the results of actual colleagues at UCB coming up with these taglines, but also the perceptions from patients, providers, and payers about how they perceive UCB. It is all about doing well for patients, focusing on severe diseases, being excellent and exquisite at science, not by ourselves, but also by super network. So that is why we call about us being a doer and facilitator of super network in the research field in order to provide superior and sustainable value for patients. That is why we say UCB, inspired by patients, driven by science. And now, not only inspired by patients and driven by science, but listening to your questions. Okay. Ladies and gentlemen. If I may now ask the operator to open the lines to Orlando, and we are starting the Q&A session and yeah. Natalie, if you start with the gentleman first and go to Brian, and then we go through the lines. Unless you go back there as well. Okay. Ladies and gentlemen, the line to Orlando is indeed open. This is two questions. First one on the emerging markets, which is quite huge in your long-term projection. Today it is only mainly on your old product franchise. Could you elaborate on when you will be launching the big three Cimzia, Vimpat, and Neupro in emerging markets, and how you will do that through acquisitions or partnering, and which countries, and especially in China, what you will do? The second question for Ted live from the cash taxes. If you look at the cash flow statement, we have EUR 180 million in cash taxes. If we have virtually no taxes accounting-wise, you have been recognizing previously unrecognized tax going forward. At one point in time, we will use them, and we should see the EUR 180 million disappear from the cash flow statement. So when will that be? Is that right to think so? We have EUR 180 million more in our cash flow next year. Yes. I can tackle the first multiple-part question. Emerging markets, you are correct. Overall, aspirationally, our goal is to grow faster than market in local market terms in every single one of the emerging markets. That typically translates into high single digits or double-digit growth rates or more. Our goal is above the local annual growth rates for each one of those countries. Overall, aspirationally, that is our aim. You are correct. Today, in most of the countries, and let us focus on the six that were highlighted in the slide, the so-called BRICK MT that Roch talked about. So Brazil, Russia, India, China, Mexico, and Turkey. In Brazil, we have launched through our partner, AstraZeneca, because I will remind you, we partnered and launched Cimzia before we had an operating affiliate in Brazil. We have not yet launched Vimpat or Neupro or even Keppra, and we expect to do that, I would say, within the next 2 years. Correct me if I'm okay in giving that kind of guidance. In Russia, we have just launched Cimzia, and we have just launched Vimpat, and we have not yet launched Neupro. But we will as soon as possible. In India, we have not launched any of the three CBN. We are obviously a major player in the epilepsy market with Keppra, but there are approximately 70 levetiracetam generics in a very low-price market. So stay tuned for us bringing the products to market. I don't think it's in the next couple of years for any of the core brands. China, we have not yet launched any of the three core brands. Keppra roughly doubled year-over-year in China in terms of sales, but that's from a small base, but we do expect growth of Keppra, and we expect to launch by the second half of the decade, all three of CVN. So that takes care of BRIC. Mexico, we have launched basically all three drugs just very recently, CVN, and Keppra is the market leader in the treatment of epilepsy in Mexico. There's a common theme there. Then finally, the T stands for Turkey. Very challenging low-price market, similar in their economic governmental policies to Korea, which believes even though they've both got highly successful and dynamic GDPs and growth rates, they don't like to spend it on healthcare. We're having some challenges in terms of gaining a reimbursable price that does not threaten and really provides value for patients in the Turkish market. That being said, I do expect we will launch Cimzia within the next 12 months, and we'll likely launch Neupro within the next 12 months in Turkey. So hopefully that gives you the specific template. Keppra is again, the market leader in Turkey in epilepsy already, so it's wonderfully established there, and we have quite a sizable neurology field force present. Hopefully, I've guided to the rough dates in each one of those countries. Asia is very important to us in general. We, for the rest of the world, don't think we're schizophrenic. You might recall in 2009, we sold the smaller emerging market country operations, which were about 50 countries, to GSK. So actually, in those countries, GSK now sells Keppra for us. They buy it from us, and we're very happy about it because they've been growing Keppra. But our focus is on those six countries plus a few more, and then we work with very good distributors in the rest of the world. CBN is in the process of being launched in virtually any market where it's justified to bring it to patients over the next couple of years. So leaves me with the cash taxes now. Let's just think through how taxes work. The first thing that you can think about is where you sell the product, you usually make profit. After a few years, that is happening now. We are selling most of these products, however, in high-tax countries. So your tax rate and your cash taxes are high. Second impact that you have in all of these countries, they are non-deductible. So your cash taxes and percentages are even higher than the normal tax rate. Then when you think about where you are creating these losses, it is usually where you invest heavily in R&D. That takes a while before you get eaten through these unrecognized losses. Before you, at that moment in time, then get the benefits of either an Irish tax rate that is very positive or Belgian patent box tax rate that is very positive. We have not achieved that. Therefore, for the coming years, the cash taxes will stay reasonably high. Only when you come into a certain mass of profit in the countries like Belgium, like the U.K., like Ireland, where we have invested heavily before in R&D, and then get the benefits of these growing products, then you really see some of these cash taxes in average coming down. That is also the reason why I advise you for your models to just stay with an average tax rate that I guide you on, with that 28%, because that takes out some of these cash elements, and therefore your cash flow elements. And gives you an average that I believe for your modeling would get you to the most truthful answer on the value proposition. And can I add one point? Go ahead. Because I forgot to answer your partner question. In China, it's not our intent. Ladies and gentlemen on the telephone, if you wish to ask a question via the telephone, please press the code 01 on the keypad now and you will enter a queue. When you are announced, then you can ask your question. So once again, please press 01 on your telephone keypad now. Thank you. Working with us to launch Cimzia in the next couple of weeks. Brian, followed by Richard, and then Nicolas. Good afternoon. Brian Porter from Barclays. Thank you very much for your presentation. One question for Marc, please, and two questions for Iris. Firstly, Marc, you showed us a slide showing your progression of market share for rheumatoid arthritis prescription for Cimzia. Just wondering what your share of dynamic new and switch patients is, please, in the U.S. And for Iris, one question on brivaracetam. Will you, in the study, be doing a pre-specified analysis of patients previously treated with Keppra? Just wondering what proportion of patients currently enrolled in the study fall into that category. Lastly, on romosozumab, you mentioned some auxiliary or further work that may be added onto your phase III program based on what comes out of the extensions of your phase II. You highlighted that you expect the first phase III results to be available around the end of 2015. Just wondering how we should be thinking about a reasonable timeframe for filing submissions with regulators, whether 2016 is a reasonable assumption or whether we should be modifying that. Thank you. We will let Iris answer your question, and then we have Jeff and JC on the line from the U.S. So if the technology works, we will get the direct answer on your India question dynamic. I start with your romosozumab question. The expectation is that we will follow, how should I put it, the ordinary process. When we have positive phase III results, we will proceed to regulatory submission immediately. We do not expect that beyond the 10,000-patient program that is ongoing, we will have to do anything else for regulatory purposes. My point was more to say we, of course, also need to inform what is happening in the life of a patient with romosozumab, and that is where we will have additional data from the phase II that will inform the different cycles of romosozumab and how they are orchestrated during the life of a patient. This has nothing to do with the initial regulatory approval. With regard to brivaracetam, we do not have a pre-specified analysis on previous Keppra users. That will be a subgroup analysis. The expectation is that we will have round about, and please, this is a very rough number, it will be round about 40% of patients who have been on Keppra previously. Concomitantly is excluded previously. Jeff, can you hear us or something? Jeff, can you hear us? Yes, I can. I will be happy to answer this question. It is a good question. You have seen our TRx growth, and one thing I would like to point out is our new Rx growth. The best way to look at this is just looking at the growth rate from fourth quarter 2011, where our new NRx share was roughly 4%, and we have grown that to 4.7. Although quarter by quarter, we see a little bit more variability in our new NRxs. As far as the overall trend, it is matching with our Ts. Once again, some strong growth with new Rx share. I think it is still with us. Back with Jeff. Richard Parkes from Deutsche Bank. I have three questions, one for Detlef and then a couple for Iris, mainly. Detlef, it is quite simple, really. Just wondering if you can give us some directional guidance on royalty and other revenue. I think we would expect to see declining Servier as well, due to maybe some of the top secret sellers, Marzone will not be reproduced in 2030. If you could just help us there. Secondly, for Iris, on Vimpat in generalized seizures, I wondered if you could talk a little bit more about the plans for the phase III program. Excuse me if I am incorrect about this, but I think I remember from the phase II data, there was a bit of a feel or concern about whether some patients did worse relative to baseline. I am wondering if there is any risk that you have to do any additional phase II work before going into phase III. I am just wondering how important is that setting to achievement of your peak sales guidance. The last question, just on epratuzumab. Maybe you have done some more work on the mechanism of action. Can you update us on what your thoughts are about the potential biological rationale for the loss of efficacy at the higher dose in the phase II? Iris. I can start. With regard to epratuzumab, we continue to work, as I said, on the mechanism of action. Of course, we continue to work on the data that are available. With regard to those response that we have seen, we have a number of theories that are still being evaluated. There are questions about when you go to higher doses, is there a different pattern of response in different B-cell types? There is a question about do we induce trafficking of B-cells into other compartments in the body. There is also very recent evidence that the efficacy of epratuzumab requires bivalent binding, and that as you increase the concentration of epratuzumab, you shift this curve towards more monovalent binding, and that might have an impact on efficacy. Take this as a testimony that we are really working on the topic. There will be not an easy explanation for that. I have said it before and I continue to say it, we have agreement with the regulatory authorities that we have picked the right doses and that the study that we have been doing, the EMBLEM trial, satisfies all of the criteria for phase II dose-finding study. We have doses where we see minimal efficacy, and we have a dose where we see no additional efficacy. On Vimpat and primary generalized tonic-clonic seizures, you remember the phase II study that we were undertaking was primarily a safety study to find out whether there are any potential issues around absence seizures, myoclonias, and the answer from this study is clearly no. There is no hint for that, and this has given us the confidence to proceed to phase III. In our discussions with regulatory authorities, there has been no request for additional phase II work. The work that we are currently doing together with regulatory authorities in Europe and the U.S. is really harmonizing the different regulatory requirements. This is all informing the design of the phase III program, and we are close to finishing this. There is no request for additional phase II data, and there is no safety concern for Vimpat in primary generalized tonic-clonic seizure. Yeah, I just add on the peak sales guidance, we are very confident. It is at least EUR 1.2 billion. Remember, peak sales with Keppra was EUR 1.3 billion. Keppra never got the monotherapy approval in the U.S., and you saw from Marc's presentation the trend of the uptake with those products. Keppra, EUR 1.3 billion, and the peak sale was really just because we got generic erosion. Otherwise, it would have continued to grow up. Fortunately, today we have more life line. Leaving the royalty question, trying to help in a number of fields. First of all, take the biotech royalties, and if you take the net number, you see that it is starting to be marginal. There is still a bit left, but that is in the low double digits millions. I think that will be further decreased over the coming years. In the longer term, just forget about it. Then you see a second bucket that is the royalties from other products. I expect that to be, at least for the medium term, reasonably stable because these are mainly older products that we have sold to partners where we are benefiting from a royalty on their success in the marketplace. This might be slightly decreasing or staying stable. Which leaves you the third bucket that is really making the impact, which is a negative bucket, which is the royalties for our new core products. As we know, there is very little royalty on Neupro because we purchased it back at an earlier point in time. There is roughly, I think we guided around 10% royalty on Cimzia. There is a royalty in the double digit area for phase II products in license for Vimpat. I do not think that we have given more guidance on that up to now. What we have done for you is to take that out of your system or have said that all of these products will have a gross margin that is higher than the existing one, higher than 70%, and that all of them will be improving that gross margin when gaining. If you take this information together, I think you probably are very close to what you need for your modeling. Good afternoon. Nicolas Gantzer, Exane BNP Paribas. Three questions, please, for me. The first one is with regards to the strategy and the new organization. Could you come back on why you decided to set up five new priorities with a new business organization? Emerging market surprisingly comes second, while profitability only comes last. Any comments on that? The second one is on Romo. What have you learned from the two phase II trials in fracture healing? The very last one is about the defensive warrants that are held by the Janssens. They will expire in April. Could you discuss the potential scenarios from here on, whether or not they might be renewed? Thank you. Take it. The first one and the last one. Let me I'll jump in on the strategy because that is a little bit of a hobby of mine, as you know. It is not that these strategies are new. I think we are just pointing them now out, and in terms of the alignment with the organization, which is now really giving an opportunity, having for each of these strategies, the first four, and that is the only reason why profitability is last, because all the four will drive profitability. For the first four, you have now people that are solely responsible in driving that, and their organization is solely responsible in driving that, which in a regional organization like before, you didn't have that to the same extent. That is the question, and that is why profitability comes last in that one. But second one is really having in mind that we want to drive that in that changing environment makes it more important to make that step now that you have gone through that first phase. All right. Oh, the warrants is an easy one. We will not ask for renewal on that one. This was an instrument that was very good for us in the past, because it gave us some additional stability in a time when we were really undervalued to a large extent. I leave it up to you to decide whether we are still undervalued to a large extent, but I'm not going into that. We are not using that anymore. We are using other instruments that are more typical in the market in terms of capital that you can apply, and we will ask for that in the coming shareholder meeting. You asked about the lessons learned from the phase II in fracture healing with romosozumab. The biggest lesson learned is not a new one, it's a very old one. Mainly that regulatory guidance can change overnight, and usually it only evolves in one direction. Mainly, there's requests for more. We were very surprised when FDA informed us that the expectation for a fracture healing submission are two adequate and well-controlled studies for each fracture site. So two for tibia, two for hip, two for any other bone you want to explore. The duration for each of these trials, two years, because it's no longer about fracture healing, it's about long-term functional outcome. Four key variables would have to improve simultaneously. Improvement on pain, improvement on physical functioning, improvement, of course, radiographic healing, that's obvious, and you would have to show a reduction in revision surgery. If you take all of this together, you end up with a huge package. You end up with enormous complexity. You end up with heightened risk because these are quite demanding outcome variables. To be honest, when we saw this, we felt very strongly that's probably not the best investment. You have heard it today, that we really try to invest our resources where we can provide superior and sustainable value for patients. We felt that this is not the case under these circumstances. Jo. Thank you. Jo Walton from Credit Suisse. I have got a few questions, please. On the foreign exchange, we saw a benefit of 5% in sales and nearly 20% in profit in 2012. If we were to start the year or surprisingly keep the year at the same rate that we have today, can you give us some sense of what headwind we would be looking at? Would it be much more substantial at the profit level than at the sales level to unwind in that very strong profit base of currency? The second question I have is regarding Cimzia. If I look at just the sales in the U.S., up 32% or so. If I look at the list price rises, you have got a 20% price rise. I also see 20% prescription, and I know that there is lots of prescriptions that are not captured because of the lyophilized element. That all adds up to more growth than you have got. So this must be the highly competitive pricing and rebates, et cetera. I wonder if you could tell us a little bit more about that, and perhaps give us some sense of whether you are seeing any impact at all from Xeljanz. On the basis that you have got an oral product with methotrexate, can generalists give methotrexate and another oral and perhaps not refer people on to the specialists who are the key providers of injectables? So any sort of help around there? I am sorry, I have got two more very briefly. In Japan, you tend to get limits on the number of prescriptions when you first start a product. I do not know whether your products are so specialist that perhaps that is not relevant, so I was looking for what sort of rate of uptake we could get from Vimpat and Cimzia. And one final one on the romosozumab product. Just to be clear of this, is there any different regime of perhaps more frequent use of romosozumab that you could see in phase II, that the regulators, when they see your package of one year use and then denosumab say, "Well, that is really interesting, but actually couldn't you use it in a different way? Please go back and do some extra work before we approve it." So is there any danger that they see an alternative and better regime before they get the option to just approve what you have done in phase III? We have Ari start, then Detlef for the foreign exchange. We will try the technology again with Jeff for the how do you reconcile the price increase and NRx increase with the sales increase, and then Marc on the rest. The phase II study in post-menopausal osteoporosis has explored a number of dosages and treatment regimes. We had monthly and quarterly treatment regimes, and we had different dosages. It is very clear that the doses and the dosing regimes that we are taking forward into phase III, 210 milligram every month, is the absolute best regime that has come out of the phase II study. As usual, we have done our diligence, have presented the phase II results to relevant regulatory authorities, have agreement with them on the phase III program. Based on everything we know, based on everything we have heard in our regulatory interactions, we believe this is the dose. Foreign exchange. It is a very good question. First of all, you are absolutely right. The impact of foreign exchange on the top line is much bigger than on the EBITDA just because the same impact is on the big amount of operational expense. I feel very comfortable on the guidance as we have given in the range of $130 to $135 for the U.S. dollars, and in reasonable fields for the other currencies. Because that is something that I feel with the hedging that we are doing, we can manage in the range of that. If that is a help. Thank you. Jeff, reconciliation of the growth rate and one word on the JAK. Sure. Let's start with the JAK. You can imagine we're keeping a very close eye on their growth rates and just a couple of things to point out. They're in line with our expectations, number one. Number two, their growth rates seem to be in line with previous anti-TNF launches. One thing that we have done is we've looked at the growth rate 8 weeks pre-launch and 8 weeks post-launch, and our growth rate has not declined. We are just as strong. In fact, we even came about it from a different view and looked at the first 6 weeks of growth 2013 compared to 2012 with Xeljanz being in that market basket. The market during that time grew 8.5% and we grew 17.7%. Many questions to come on their growth rate. Will they be expanding the market or taking away from the market? For us right now, our growth rate is very strong, and we're very pleased with that. Now giving into the gross to net questions and looking volume growth and price. Our price increases have been consistent with the market. The majority of our growth, looking at 2011 compared to 2012, has been on volume and not on price. Don't want to get into the exact specifics on the price increase and amount, but I will say that at least 17-plus percent of our growth has been due to volume. A lot of this has been due to channels that aren't recorded by IMS, as well as some of our new contracts that we were able to solidify in 2012. Okay. On the last question, the two products you asked about, you are correct. In some disease areas, there are defined limits, usually not so much on the number of prescriptions, but on the length of a prescription for a given disease. In epilepsy, for example, in the first year of a drug's introduction, a patient cannot receive more than 60 days of a prescription. That was somewhat growth limiting, but we're past that with Keppra since we're now slightly more than 2 years into the launch. Okay. You can actually see an inflection in our market share post that 12-month point. You can see it in Lamictal as well. That's restricted in certain drug classes and definitely in epilepsy. To my knowledge, for Cimzia, we do not have any current restrictions for the launch, which should take place sometime in the next several weeks. Hello. Amit Roy from Nomura. A couple of questions for Iris, please. On epratuzumab, CD22, clearly. You talk about modulation of the B-cell, which should be a good thing compared to say, rituximab, for example. So a couple of questions. First, why SLE first? There's obviously quite a few large major B-cell indications, so I'm interested in your thinking around that. Secondly, for example, with rituximab, the regulate had issues of delayed neutropenia. It wasn't an infection, but you could see there was a neutropenia. Are you having an improvement on this particular aspect? You did mention there's less infection quite well. I'd be interested in that. Secondly, on generalized seizures, the phase II data that you were talking about. Any chance you will publish that data? There's quite a lot of insight we can gain from seeing what your thinking is if you publish it. When would you expect the phase III roughly in terms of timing of it? I might guess at 2017, but just like to take that miles off mark or not. Thanks. I'll start with the epratuzumab question. First of all, when you have a B-cell modulating agent, SLE is a disease that comes to mind, right? It's one of the few diseases where I think we're all in agreement B-cells play a major role. If you then combine this with the major unmet medical need, if you think about it now, there haven't been new therapies in a long period of time. It's a disease that affects mainly young women at a very important time in their life, namely very early. It fluctuates. It really impairs quality of life tremendously because patients are so fatigued that they really can't lead a normal life. It was very clear for us that this is a perfect combination, right? The huge unmet medical need and then a B-cell targeting agent that's more modulating than depleting. For us, the translation is efficacious and also very safe. We are not seeing any depletion of B-cells based on all of the clinical data that we have. So that's consistent with the hypothesis. We see a slight decrease, but it's really 20%, 30%. So by no means anything that should translate into clinically relevant experiences. There's no neutropenia, and when you look at the overall adverse event profile, it's almost at placebo level with epratuzumab. Again, early days, we are still growing our database as we recruit patients into phase III, but so far an extremely benign safety profile. I apologize, help me with your other question. Sorry. No, publication. Just around the phase II generalized seizures. Any chance you'll publish it as well? I think it'll give a lot of insight, and when would we expect phase III? I don't see it on your pipeline, so. Yeah. No, thank you for reminding me of the question. Primary generalized tonic-clonic seizure data to be published at one of the upcoming epilepsy congresses. We follow our old rules. When we have data, we first work hard to take the next step for the molecule and then go into publication mode. So it will be at one of the upcoming congresses. I can't tell you out of my fingertips. We expect to start phase III still this year. Again, we are finalizing discussions with the regulatory authorities, and the key here is really to harmonize expectations in Europe with the expectations in the U.S., because we would like to address the regulatory needs with one clinical trial instead of having to do two in a not so big patient population. Guidance on when we expect results will come once we have started. Thank you. Okay. The next one is for the target. First of all, it was Peter. Thank you. Keyur Parekh from Goldman Sachs. Just a couple of questions for you on the sclerostin antibody. You mentioned you are doing extension work on the phase II. If memory serves me right, we got the headline data on the phase II in April 2011. So presumably you have the 2-year data at this point of time in-house. Is that something you plan to share with us? Have you looked at it and anything you can share on the side effect profile as you dose it further? Secondly, on the phase III and the timelines associated with that, you start getting full data in the second half or late 2015. Are you going to get data from both the studies at the end of 2015, 24 months data then? Or do we get the 12 months data from the first study in 2015? I am just trying to figure out how we should think about the potential filing timelines in 2015, 2016, or 2017 that we should think about. To start with your last question. We expect the first results from the 24 months data in the end of 2015. That would be, if positive, the package that would go into submission. And with regard to your first question. Are you going to publish- Oh, the publishing. Yep. The data extension? The phase II data, long-term extension, second year, are consistent with what we would expect. We will release data at upcoming ASBMR meetings like we have done last year with the one-year data. You can expect to have releases from additional time readouts at upcoming ASBMR meetings. Just if I might push you on that. Given that your dosing on the phase III is 1 year, does having patients on dosing for 2 years in the phase II make an impact, either from an efficacy perspective, or can you get to the same efficacy you've seen at year 1 without incremental dosing? The phase III dosing is based on the biomarker data that we have seen, biomarker data in terms of bone formation and in terms of bone resorption. What we see is a peak in the increase of bone formation biomarkers in the first 3 months of treatment. Then they return to baseline, and we see the same, but inversely with resorption biomarkers. This is consistent with the scientific hypothesis that you initially form a collagen matrix that requires the absence of the sclerostin stimulus, and that's then calcified later on spontaneously. That's a very consistent theme that we have seen across studies. Thank you. Thanks. Richard Rotter from JP Morgan. Three questions, please. Just on the Biotie compound that you've just opted in on. I wondered if you could compare and contrast the safety profile that you've seen in the phase II versus the older A2A drugs that failed and had, I think, blood pressure issues. What you've seen here, what's different about this compound would be great. Second question, just back to sclerostin. Just an idea of how recruitment's going into those trials, when recruitment might finish. I'm probably wrong, but whether there's a slight delay here into the end of 2015, maybe it was H1 or H2 2015 before. So just any idea on recruitment would be great, how is that going? Then finally on Vimpat. You stated again that Keppra achieved its peak sales without monotherapy, so and- In the U.S. In the U.S., and you said again, that there is a big opportunity for monotherapy in terms of the potential patients. Just some idea in terms of how much upside we might see to that peak sales guidance of $1.2 billion if the monotherapy data is positive would be useful as well. Thanks very much. To start with your question on tozadenant, again, we were very happy with the efficacy data that we have seen in phase II, which as I said, are clinically relevant and statistically significant even on top of levodopa and the dopamine agonist. Quite substantial for patients with advanced Parkinson's disease. On the safety side, we have not seen anything that causes us concern. You asked specifically about hypertension. There was nothing that would have prevented us to embrace the molecule and take it into phase III. So far, and again, please keep in mind it is early days. We have data on 400 patients. That is a very limited safety database. But so far it looks very promising. In terms of guidance. Yeah, in terms of the guidance, I feel compelled to answer. I think you have seen that Lynparza is doing extraordinarily well. Statement number one. Number two, our guidance is at least EUR 1.2 billion. We feel very comfortable with that guidance. Again, number three, we have very important data points coming up in the next more or less 2 years in terms of enlargement of the patient pool that we can serve. I think when we have these data points, with more data points of the commercialization that is ongoing, I think we will look at the guidance again. The room to the top is open in any case, so no need for us to do anything today. You know that we always want to base our guidances on some facts and some good experience. We will take that time to get this. Peter, and after Peter, we will take questions from the phone. Just a moment. Yes. Recruitment. Recruitment in any clinical study is tough, particularly if you want to control the quality of the study. So far, we are confident that we can have the first results from the 2 clinical studies in the end of 2015. Recruitment started about 8 months ago, so we still have a way to go. So far, no alert in your direction. Peter, and then after this. Three questions left. Start with romosozumab, the active activity. Just on the phase III trial, wondering with regards to the design, is the assumption here that in the year 2, you will see any preservation of the drug's effect, or is the assumption you will create a delta in year 1, and then the lines essentially proceed in parallel, if you like? Is there any theory as to why we should expect any difference in year 2 data with denosumab versus use, whatever is very mechanistic rationale for a difference there. Secondly then on the Biotie collaboration, what is the rationale for waiting until the first half of 2015 starting phase III? Is that further regulatory requirements, or is there something else behind that sort of gives us a 2-year delay? Thirdly, just coming back to olokizumab. The Crohn's trial, obviously we still have not read out yet. Is there anything that you can see or could see in that Crohn's trial that would persuade you that that is still an opportunity worth pursuing inside UCB? Or is this really more to create a partner? Thank you. Just to start with the last question. The Crohn's disease trial has been stopped. We will not see and do not expect to see any data from that would change our mind. With regard to romosozumab, again, we will have to see how the increases in bone mineral density that we have seen in phase II after 12 months, and that we continue to see in the second year, will translate into a fracture risk reduction. The expectation currently is, but we're doing the study to confirm that, the expectation currently is that there will be at least maintenance of the fracture risk reduction that we will see in the first year when we move to an anti-resorptive principle in the second year. Do not forget what we are seeing with romosozumab, and take it with a grain of salt because it's based on historical data. What we are seeing with romosozumab, is an effect size in one year that you see with other treatment regimens in five years. There's quite high hopes for the first year. On Biotie, the answer is very simple. It's CMC work mostly that needs to be done. We just need to do the work. We do the regulatory consultation together, but that's not the critical path. The critical path is the plain simple CMC for it. Sorry. Can I ask first that, yeah. Tino, were you ready with the line? After this, that's it. Can we have the question from the line, please? Okay. Our first question from the line comes from Fabian Schmitz from ING. Please go ahead. Yes. Thank you very much. Two questions from my side. I saw yesterday you did a nice deal with Biotie. I was wondering how exactly does such a deal work in case of a corporate takeover of Biotie or, maybe something we would certainly not want, a bankruptcy. On your phase III brivaracetam studies, I was wondering why are you exactly excluding patients who are also being treated with levetiracetam? I can start with the brivaracetam question. You remember that we have a previous phase III program with brivaracetam, where we had allowed up to 20% of the patients to receive concomitant levetiracetam. What we have seen in individual patients is that adding brivaracetam on levetiracetam may add to the efficacy overall. But we do not see this in large trial population. So in essence, we have diluted our efficacy of brivaracetam when levetiracetam is added onto that. This may be due to the fact that the mechanism of action of both drugs is close to each other. It's not identical, but it's close to each other. Again, one lesson learned from this program was we do not allow concomitant levetiracetam just to keep our efficacy data clean and just to keep the delta between placebo and active treatment as big as possible. There's no drug interaction reason for that. There's no safety reason for that. It's really the tactics of ensuring success of the clinical study. Yeah. Can I add just one point to acknowledge that, because I have seen actually in some of the recent reports that just came out this morning, there may be a misnomer that people are not enthusiastic about brivaracetam. Remember that 30% roughly of patients are refractory, not well controlled by a drug. So that is an important factor for any physician, and they will look for new mechanisms and new safety opportunities to treat the patients with a different drug. So that is important to highlight. The other important thing to think about with levetiracetam is there are many countries where now more than 25% of the patients literally treated, not 25% share of treatment in epilepsy can be levetiracetam or Keppra or both. So that is a pretty large objective to surmount, and we really want to generate data without the impact of levetiracetam to show the benefit for patients. Sorry. Go on. Sorry. On Biotie, the deal is reasonably easy. We had an opt-in right and we have taken the opt-in. So that is the first part of the deal. Second part of the deal is because they have done a very fine job in developing the compound. They have the personal resources and the financial resources to do that. We have engaged into a development cooperation that is giving them the opportunity to continue with the winning team on the good work while for us to focus on other work that we have to do. I think Iris made clear there is a lot to do. This is success-driven, milestone-based, as you would expect in a collaboration like that. We hope to do these type of arrangements with more companies because we want to benefit, as we have done with other companies before. Also with Biotie, we want to benefit from these capabilities that smaller companies can bring to the table while staying focused on our core focused assets, especially in the later stage of the development. I think that is more or less it is about, and I do not see any reference to any other capital-related issues. As everybody knows, we hold a stake in Biotie, and there is no direct link between that stake and the development efforts that we are doing together. Do we have further questions on the phone? Yes, our next question comes from the line of Jan de Kerpel from KBC Securities. Please go ahead. Thank you very much for also taking my questions. Sure. I would like to follow up, in fact, on the discussion of the Biotie deal and want to play a little bit devil's advocate. It is clear that this is of benefit for you as a company. Yet on the other hand, you put your fate of this molecule in a small biotech company for doing the phase III, while you, in your organization, have skills and capacity and capability of developing a phase III program in Parkinson's. So the point of devil's advocate is, it feels like you are already very stretched financially in your R&D capabilities. Is this a way of mitigating that stretch? So it is really kind of a provocative question here. Second question is, in your fifth objective, improve competitive profitability. Roch, you clearly stated rigorous resource allocation, ruthless elimination of non-core. If I look at the sales of UCB today, there is something like 500 or maybe more million EUR in sales coming from what people could say is non-core. Are you hinting that some of these kind of second or third-tier products are close to the door and leaving the company, or are you thinking of other items which you consider non-core? If you could just clarify us a little bit on that angle, what you mean by that. Then thirdly, I would like to spend a few moments on Vimpat, the monotherapy trial. The results are expected soon. Iris, I was wondering if you could educate us a little bit in what is the risk, where lies the risk of not meeting the primary endpoint in such a trial. I understand it is difficult from trial design. That is very clear. You are aware of that. In your experience, where lies the risk of not meeting it? Roughly speaking, how much of these monotherapy trials of products have not met their primary endpoint? It is more of an educative question I have over here. Then if I may, a fourth question on olokizumab, the IL-6 compounds. You stated again you want to partner this project. How far are you in these discussions? What are the partners giving you as a feedback on the product? In your decision-making process of partnering it, how much was the current competitive landscape in IL-6 playing a role? Thank you so much for your answers. I can start with Vimpat monotherapy. I think it is fair to say that an anti-epileptic drug with strong efficacy as an adjunctive therapy should also work as a monotherapy. I think just from a medical perspective, that is something that can be expected. Of course, every clinical study has a technical risk of failure, and that risk applies to every clinical study and also applies to monotherapy studies. I have tried to allude to an additional complexity for the historical control studies because, as I mentioned before, we need to mimic the patient population of 15 years ago, which is not that easy, but which is controllable by very tight monitoring, of course, which patients can access the study and which not. I think these are the key risk factors with regard to monotherapy studies. They are basically not different from the technical risk of any study, plus the complexity that comes in by the historical control. As such, and I cannot give you a precise number on that. There are successful monotherapy studies. The eight studies that we are referring to that were conducted in the 1990s are successful. There are recent examples of successful trials, but there is also, of course, examples of failed studies. I would assume same proportion as in other epilepsy studies. I'll let Detlef answer the non-core. Just first of all, on lecanemab, we'll let you know clearly when we have a deal, and at this stage, several parties are discussing, but too early to tell. Your question on Biotie, I referred to it in my strategic presentation, that this is really a core part of UCB strategy, is this notion of partnering in and out. We call it the super network that I mentioned. If we look at probably the most productive and impressive example in our industry, it's really the Roche/Genentech relationship, where Genentech has been extremely productive. At the same time, I think the industry has struggled as companies have grown to keep the innovation momentum. There is clearly a belief that we have, which is now shared, I think, by most of us in the industry, that indeed as you grow, how do you manage your innovation so that you continue to thrive? The short answer is, keep it small, keep it focused, and let partners, if you have partners like Biotie, do the work and then share the benefits, as I think Roche has been doing very successfully. I have to say just to be clear, that we don't intend at all to end up in the same way that Roche has ended with Genentech, because we have no role with Biotie. You want to- On the non-core? Yeah. That is a very broad concept, and perhaps I can, to best explain it, give a few examples on that. If you just look into the product ranges, there are products that we feel we are not the best party to drive growth of these mature products that because we don't have the best access to the target group, because we don't want to invest the money, because we see better investment someplace else. We hand over to somebody else. That is a nomination of non-core and getting benefits for that. If you look into other areas like finance, 3 years ago, 100% of finance people more or less were within UCB. Next year, probably 40% of finance people will be outside of UCB. Same is true in Iris' shop, where we have a very strong relationship with two leading CROs that are doing a lot of the execution work on clinical trials. We are really asking for each activity, is this an activity that we want to do in-house? Can we do that better? Or can somebody do it less expensive for the same quality? Then we decide on that. So it is a very broad concept going across all the different parts of the value chain. Supply chain would be another one that I could mention, and it is more a mindset. You want to do the right stuff. You want to do it as efficient and effective as you can. And you use the capabilities of others when you are not the best party to do it. That is more or less how to look at that. Okay, Sachin. My questions are 3. Commercial potential of brivaracetam. Do you think if we are delayed already by almost 3 years in this patient life, what is left is commercially attractive enough? Or are you really positioning it to be the best one for a generic company to target? Second one would be, survey is very interesting. I remember asking this question last time. Can you share that this survey you did for RA also, where do you stand in that ranking? And the third one is, what discussions are you having internally to maintain your differentiation or differentiating edge on Cimzia, especially in immunology in second half of this decade? Thank you. We let Jeff, if technology allows, I think answer your question also, where do we stand with rheumatology? That is your question, right? You are showing neurologists that we are leading and how do we stand, what is our perception with rheumatologists and their staff, which they have an important role in the U.S. Sorry, your last question was on? To maintain the differentiation of Cimzia in second half of the decade when you are going to hit the B trails, what are the discussions you are having around that? What are you doing now in New Medicines, which is going to help you there? Do you want to take Briv, Roch? Let me start with Briv. In terms of Briv, and you have seen the charts previously, we still have about 30% of the patients that are refractory patients. So clearly there is a need for other AEDs to come to the market. When we look at Briv and look at the timings that it will come and what we have forecasted in terms of its uptake, we clearly see there is a commercial product here that we have. So we are not looking at it for a generic company. It is very much for UCB. We have a great presence with the neurologists. Clearly, we are the epilepsy company. You have seen what Mark has shown to you, and we believe with Briv, we can make it a very successful commercial product. I can give it a start with the Cimzia. Of course, we will disclose data as they become available. So, it is hard to be precise what will happen in the second half of the decade at this stage. But of course, we are increasingly building on the uniqueness of the molecule. Do not forget, Cimzia is not a full-blown monoclonal antibody. It is a pegylated fab. There is no FC portion. And we have just last year, received label changes related to the absence of FC and the resulting lower transition through the placental barrier. So we expect to see more of that differentiation built on the uniqueness of the molecule. Nita, do you want to add on how we are perceived in the U.S. by rheumatology? I think Marc wanted to add on the- If I can just add one element, because I think it is important to think about this, as you raise the second half of this decade for Cimzia. By the end of the decade, we and Simponi will be the only two patent protected anti-TNF, and we are the only pegylated. We think the field will be quite substantially changed by the emergence of biosimilars and impacting the major bigger brands. We do have high expectations as being, one, if not the strongest brand by the end of the decade. I think the continuation of that differentiation, possible new indications that continue to build on that, are the ways we expect to build. For Jeff? Sure. Jeff, tackle the question on rheumatologist survey results and how it might differ from our neurologist survey results that I portrayed. Sure. So number one, just time in industry, of course, associated with Keppra. We have very strong results in the CNS front. Our results and reputation with rheumatologists continues to increase every single day. One of the things that we continue to outline for our physicians is that we are unique. We have rapid onset of action that leads to predictability. We are one of the only products on the market that allows the physician to decide if it should be in-office administrated or by a healthcare professional. Then likewise, looking at the reimbursement, both on the medical and pharmacy side, there are additional opportunities. As we continue to highlight these differentiating points, our reputation continues to improve. We measure that just by, for example, using Gallup survey. This is not just words. Right. It's a great point, Roch, and looking at the last Gallup survey that came through, our most recent scores show that the rheumatologist rating of our sales force, especially compared to our total, is one of the fastest-growing and strongest as of today. So we're very pleased with these new Gallup scores. If I may add to that, more globally within the new organizations, we plan to do on a regular base, both in Europe as well as in the U.S., regular feedback from our customers about how satisfied they are with our services and our activities in order to put that as a metric for the future to evaluate our progress. Thank you, guys. Thank you. Do we have any further questions in the room? Jo? Just a quick question on Vimpat. I am assuming that there is already some off-label use in monotherapy in the sense that a patient is established on it and takes the other drugs away. I just wonder whether that is true or not. Secondly, let's assume that it does get monotherapy. What proportion of patients do you think it could ever be used as first-line therapy or for the foreseeable future, would first-line therapy always be something like generic Keppra? If that fails, move on to Vimpat. I am just trying to get a sense of what the market share or if there is a reason why you might put a patient at first presentation onto Vimpat or whether you would always use a generic first. I can take it. Yeah. In terms of answering your question, is there any Vimpat being prescribed beyond the add-on indication? Clearly, physicians around the world have a right to prescribe a product as they consider fit. It's not something that we are advocating in any way, and there is some that goes on. What exactly the numbers are, it varies country by country. There's a small amount, but very small. To your question about should physicians in the future, once we do get the indication for Vimpat as monotherapy, be used as first line? As a marketer, I'll tell you, they should, yes. They should use it all the time as first line, and it should be the choice. Clearly, Vimpat does show what we believe, and hopefully, the data will come out when the clinical studies are done, that there is a benefit of using Vimpat first line on these patients and ensuring they come under control. The only thing I would add to that, in first add-on, which is our target today, since it's POS add-on, in many countries, since we do track all the segments, we have very strong share already in first add-on. I think that bodes well for the confidence in the drug if we do get monotherapy approval. Do we have any further questions from the room? Thank you. With that, we're going to close the meeting. Thanks for your interest in UCB, and I'm looking forward to sharing the journey of this long-term growth with you and sharing the different milestones coming from Jean-Christophe, Kozo, and Jeff. Coming from Marc on the emerging market, Japan, and all the surprise it will bring us on the positive surprise of the established brand. And the deals. And the deals. And coming from Iris in bringing romosozumab, icatasumab, brivaracetam, and tozadenant as soon as possible to patients. Coming from Ismail Sharp to make Iris busy in the next 10 years and more, and our dear Chief Financial Officer keeping everybody on track to deliver on the competitive profitability by around 2020. Thanks for all the updates. Thank you very much, all, and thanks for your great questions. Thank you.

Data Source: Quartr Last updated: Feb 27, 2013

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