You remember last year we had to wait like 10 minutes or 5 minutes for Brian and everyone was here? Yeah. Brian got lost. I can't do this. Brian got lost, yeah. Good afternoon, everybody. Welcome to this afternoon's session. My name's James Wayne Tempest. I'm Jefferies' European Specialty Pharma analyst. Delighted to host a hybrid session, actually, this afternoon with Recordati, joined by the full senior team here on stage, which is great. We've got Rob Koremans, who's the CEO. We've got Luigi La Corte, who's CFO, and Scott Pescatore, who's Head of Rare Diseases. I guess the format will be just a very kind of brief few slides, just given some of the developments of the company, and then we'll jump straight into some moderated Q&A. With that, I'll hand over to Rob. Thanks. Thanks, James. And thanks for joining all. Let me just start off with a couple of general remarks before we hand over to Scott to show us some of the exciting update for us and for patients we'd like to think on Esteresa. The first nine months of this year have been really good. We've seen fantastic performance throughout the business with strong revenue growth of 12%, also translated into really nice EBITDA growth of 11.8%, and seen that throughout the business. We're off to a couple of really good months. What was also very encouraging, and Scott will talk a bit more about, is in Quarter Three, we've seen really a nice pickup of Esteresa, specifically in the US, on the back of a label extension that we got in April of this year. We're very happy with the performance. On our pipeline, all of our projects are moving in line with plan, and exciting opportunities and potential around Karziba, around Signifor, and new indications. We are very committed and pleased to continue to drive those at low investment rates with R&D levels of, what, 6%-7% of our net revenues in R&D, but they are really getting quite nice productivity out of that so far. We are happy. Very, very nice to see the increased peak sales expectations to more than double the range at now EUR 1.2 billion for Isturisa. It was also good to be able to confirm our guidance for the year to the lower end of the guidance, notwithstanding very strong currency headwinds that we were facing. Our business is really, on the back of that good performance, able to continue to perform. We have been able to confirm as well the guidance that we gave for 2027 earlier in this year, also again, notwithstanding strong currency impact that we see over 2025 and 2026. I will leave it at that and hand over to Scott to give a little bit of background on Isturisa. Thank you very much, Rob. Good afternoon, everybody. Just to give everybody a little bit more color on the market landscape for where we're operating Esteresa today and moving forward to achieve the peak year guidance that Rob just mentioned. Currently today, we're operating on the left-hand side of the slide, which is what's called the overt patient or the severe Cushing's syndrome patient. I'm not going to go into too much detail on that because this is where we've been seeing the uptake for Esteresa. As Rob had mentioned, we have a very positive performance this year up through Quarter Three. That's on the back also of our positive expansion of our label in the US from Cushing's disease to the full breadth of Cushing's syndrome after the FDA approval in April. Where we see additional opportunity to grow the brand is on the right-hand side of the slide, which is so-called the non-over or the mild patient population. Just to give you a little bit of color on the difference between those patient populations, typically these patients are they present with comorbidities such as persistent, difficult-to-treat hypertension and/or diabetes. They are seen more in the community centers, typically by community endocrinologists who prescribe and treat these patients today, and also a bit in the cardiologist centers and select primary care physicians as well. As I mentioned, I mean, these patients present with much more mild forms of Cushing's syndrome, not as obvious to the presentation in terms of their physical presentation, but also their lab. They have cortisol levels, which tend to be much lower than the severe. The severe patients tend to have three to five limits, the upper limit of norm. These patients can have one to two limits of the upper limit of norm, presenting with comorbidities, and then allowing the physician to then make the differential diagnosis of Cushing's syndrome. The dosing with these patients in terms of Esteresa is on the lower end of the spectrum in terms of if you compare it to the overt patient population. Overt patients are on a higher dose because they have a more severe disease. Today, we're seeing lower doses of that, but we'll understand better as we enroll more of these patients and we get more experience in how these patients titrate up to levels that control their cortisol levels. If I just go to the next slide, how are we going to achieve, excuse me, how are we going to achieve these goals? There is a bit of investment that's going to be made, about EUR 40 million-EUR 50 million per year, starting already now or starting now. We're starting to build that up in several areas within the U.S., expanding the field force. It is very important that we expand the number of not only the sales reps that we have, but of course our medical science liaisons and our medical teams. There is a lot of education that's needed in this space. This is a market that still is under development. It is a market that's still a bit immature, and there is a lot of insights that need to be gained there. We're also generating real-world evidence, additional real-world evidence trials and studies to help physicians better understand how to diagnose and treat these patients. We're running a phase four trial, again, to provide physicians with more information and more data on how they can manage this population of patients. All that being said will allow us to really continue to build on the momentum that we've had from Isturisa. We're very pleased that we're able to increase our peak guidance to more than EUR 1.2 billion. I'll hand it over to Luigi. To the next slide. Yeah, very briefly to close it off in terms of the outlook. First of all, Rob already said it, very happy that once again in 2025, we'll be able to deliver results which are in line with that guidance range that we gave at the start of the year. Despite the adverse effects of about 3%, our start of year guidance was around minus 1%. We do expect those headwinds to continue into 2026. Very excited about the Esteresa opportunity. We are going to start, and you've already seen the number of patients on the drug stepping up, and we expect Esteresa to help drive rare disease to high teens growth in 2026. Obviously a step up versus the mid-teen growth rates that is achieving this year. That, as Scott has said, will require some investment to the tune we said of EUR 40 million-EUR 50 million, which will weigh on margins for 2026. We guided this year in 2025 for margin to be EBITDA margin to be around 37.5%. EUR 40 million is roughly 140-150 basis points. Of course, as the mix shifts to rare disease, that gives a positive uplift to margins. Effects, on the other hand, will go against. Obviously, we will, as always, give more detailed guidance for 2026 at the beginning of the year in February, but we wanted to start giving an indication of where we're heading. Of course, despite that, very happy that we're able to confirm the 2027 guidance that we gave earlier this year. With that, I guess back to you, James, for Q&A. Brilliant. Thank you very much for giving us a brief overview of where we are, Esteresa, and the expectations laid out. Maybe just to start off with that, if I can. You have raised Esteresa peak sales to north of EUR 1.2 billion. Can you just touch on the cadence of the ramp-up of that EUR 40-50 million investments you flagged, and also how long those are expected to be there before they potentially start to step down? I can take the first part. We are very excited about this, right? It is within label, so that I think is important. We are starting early next year with a phase four trial. I think equally important, more MSLs, field force, and generating real-world evidence. We have already started to do these things now. I think for next year, 2026, you should expect towards the lower end of that €40 million-€50 million in additional expenditure on Esteresa behind the wonderful opportunity that we are really excited about and is a fantastic opportunity. We are very committed to do that. The trial should end in 2029, and some of these investments. Of course, the buildup of MSLs and sales force is not something that is going to step back, but as the sales really further accelerate, as a percentage, that is going to be more attractive in that sense. That is why we called out 2026 as an investment year. Thank you. Since you kind of disclosed this to the market earlier around results, some investors have also kind of wondered the cadence in terms of when we could start to see the inflection in this sort of additional population you kind of highlighted. What can you say, at least in terms of to help us think when that might start to come through? Yeah, sure. Thanks, James. I mean, we're already seeing that today. I mean, we do have a subset of our patients in our Quarter Three results that are the so-called mild patients. There is a referral pattern that does take a bit of time, as I had mentioned. A lot of these patients are sitting in cardiologist and PCP offices. They need to be diagnosed. They need to be referred on to endocrinologists. Then the endocrinologists need to then, of course, begin to treat them. There's a bit of a backlog at the moment in the U.S. in terms of endocrinologists. There's a lot of activity within their offices today. There's a lot of, as you can imagine, there's other things that they're working on. I mean, even if you have a more severe patient with Cushing's syndrome, there still tends to be a bit of a wait. That cadence is a gradual ramp-up based on the education and the fact that there's just only a finite number of people that are treating these. Even though the community endocrinologists are treating them, there's still a lot of work to be done in order for them to see these patients. Maybe I'll just add to that, just building on that, that you should expect sort of the rate of growth of the number of patients to be steeper than the revenue curve, simply because these patients may well start at a lower dose and titrate a little bit more slowly than the Cushing's disease. We are starting to see already an inflection and expect that to continue. Thinking about the ramp-up of the cost and then the inflection of the patients, you also kind of reiterated the guidance in 2027. What are the sort of the put and takes in terms of why that was a reiteration and not changed? Because when we set 2027 guidance, we did it also on the basis of what exchange rates were at the time. You recall in Q1, I think we were looking at the US dollar, which was around 1.03, 1.04. It is now, you have added a one decimal to that number. That is obviously a headwind. We are quite happy that despite that, thanks to the higher growth that we are expecting in rare disease, thanks to Esteresa, we are able to still aim for that same objective. For those who are newer to Recordati, of course, 2027 does include a contribution from BD and M&A in terms of the target that we set. We are very happy and confident around the organic growth momentum and opportunity, but we will continue to complement that with BD and M&A as we have always done. Thank you. Maybe talking a little bit about the competitive environment for Cushing's. I mean, there's quite a few more drugs in clinical development. I guess of note, Corcept, Relacorilant, has its PDUFA at the end of this year. I know you sort of touched on this before, but perhaps for people in the room today, how are you thinking about the competitive landscape if and when that's approved? Sure. No, again, you see a theme to sort of the responses here. There is a lot of education that needs to be done in this space. I think the more people that are involved in this space, the better it is for everybody, including the patients. If there are other players, which we know there are in Corcept and ZERUS and others are investing a lot in this patient base, it is good for all of us. There is still a lot of work to be done. They are going to be out there probably in January, depending on their approval, with investments. This is a positive environment for all of us. Thank you. The business is obviously a lot more than just Isturisa in rare diseases. Perhaps just in the essence of time, touching on one other product. Enjaymo, cold agglutinin disease, was acquired from Sanofi last year, which I think from memory was your largest deal. How is the launch progressing there? Super happy with it. We're getting to learn how to work and best plan with this product. The name already says it, cold agglutinin disease. In summer, you don't get as many people suffering from the symptoms. We always expected that they would take a bit of a therapy break, which indeed they have done, but we see them coming back. By the end of the year, we should absolutely be in line with our expectations in terms of number of patients and penetration. The lower dollar will make us land a little bit shy of EUR 150 million, which we put as a target for this year, but in terms of patient market penetration in the U.S. and Japan and also in Europe, we're very happy with how this has gone. It's been a very successful integration of the team and very smooth in that sense. So happy. Thank you. And then maybe finally just on rare diseases before sort of switching to the other kind of parts of your strategy, perhaps a brief outline in terms of the opportunities in Cardicor. I know you've also initiated recently a proof of concept study in Ewing sarcoma. So what kind of prompted interest in this indication and how should we think about that opportunity? Sure. Enjaymo is a phenomenal product for us. Not only are we looking at other indications like Ewing sarcoma, we are continuing to pursue the approval of Enjaymo in the U.S. We had very positive interactions with the FDA over the last couple of meetings. There is a path forward there. We understand the requirements they need from a data perspective. We are fulfilling them, and we anticipate bringing that product to the U.S. as soon as possible. It is a very exciting product. We have seen tremendous uptake in Europe and other parts of the world. We really look forward to bringing that to the market there. Ewing sarcoma offers another opportunity for us as well. I mean, there is activity within those patients for anti-GD2s. This is something that we are beginning to invest in, and we are kicking off now. Thank you. Switching gears to the specialty primary care segment, it is incredibly diversified both by geography and sort of by segment. Perhaps just to highlight a couple of the sub-units within SPC and which perhaps are best positioned to support the growth of the business. All three key therapeutic areas actually have done really well in the first three months. To remind everyone, that's cardiovasculars, that's urology, and also GI. We've seen fantastic growth where we've been outperforming the reference markets by and large in SPC. Also, our consumer or OTC business is doing well with products in Italy, for instance, Magnesio Supremo. That is an incredible, nice contribution and shows very nice growth rates. Going forward, I think also the recent acquisition of Vascepa is going to be an important one in the cardiovascular space. It's uniquely positioned to help patients on statins to still overcome some of these significant cardiovascular risks when they still have the high triglycerides. That's something that we're excited about. We're launching that now as we speak in Italy. It's already in Spain and in the U.K. in the market and doing well. That will help to offset the loss of Cardicor that the licensor after 10 years is taking back this specific product, which next year will be a EUR 35 million. It is on a yearly basis, actually EUR 35 million loss, but Vascepa is going to help and offset that and be a growth driver after that, right? It will be important. When we think about the margin evolution of that business as well, it's literally gone from the mid-20s some years ago and now kind of in the mid-30s. What have been kind of the main drivers behind that, and how should we think about that from here as well? I think to give credit to the team, they've done a fantastic job continuing to grow what is essentially a mature portfolio, I guess, on the back of a very strong brand equity and obviously benefiting also from good underlying market trend. Doing that whilst at the same time right-sizing the business and really focusing the resources on those products which we thought had more growth potential. I think we've said when asked in previous occasions in terms of future margin progression, rest assured, 2026 is an investment year, but underlying sort of opportunity for the business is to continue to see margin improving because we do see opportunity, particularly on the rare disease side, as the business continues to sort of increase and accelerate. Of course, as the mix shifts more to rare disease to support that. As far as SPC is concerned, of course, it can never be satisfied, but I think they're doing a pretty good job already. Maybe to add to that, if you look at our business, we're now about 4,500 employees, which is more or less the same as three, three and a half years ago, but we've doubled our revenues. That's because of putting resources behind the opportunities and right-sizing constantly. We've been downsizing and refocusing from primary care to specialty care on the SPC side, decreased our sales forces in countries like Italy and Spain, but we've been increasing also within SPC behind urology, behind in some countries where we saw opportunities and significantly increased, more than tripled our presence in the US for rare disease, right? It's been a constant shift, and you can expect our company to continue to make that choices to not only guarantee the growth, but also protect our margins and make sure that we keep our profitability good to be able to do the investments we want to do and the acquisitions, finance the acquisitions that we continue to plan for. I guess leading that on to M&A then, I mean, M&A has always been a core part of the strategy, I guess, the sort of search and develop rather than kind of core research and development. Luigi, you mentioned obviously 2027 includes a little bit of M&A, but I guess if you can help sort of remind people the cadence of when you kind of look to do and the type of assets which you're looking to do. I can maybe Luigi will add some, but we do not really look at a specific cadence, right? We look at for rare disease, we now have a much better organic growth opportunity ahead of us than we have had a couple of years back. The immediate pressure to do a deal is not there, but we really would like to find opportunities that address unmet medical need where there is a clear patient segment where we can offer something where the science makes sense and where the finances also make sense and where it fits to our strategy. We'll continue to drive and look for these opportunities in rare as we do on the SPC side where we look more for promotion-sensitive mature products, but also like we've shown with Vascepa, we do a deal that still requires to be launched in, for instance, in countries like Italy, and we can expand in further countries in Europe, but builds on our existing infrastructure of cardiovascular, salesforce, medical, and the entire infrastructure we need to drive that. We'll continue to look at these deals, smaller ones, single country, bigger ones, and I don't think we'll slow down. If I look at the opportunities and the projects we're working on at the moment, that is as good as any time I've been in this company now, four years, and it's good as ever. I'm optimistic there. Thank you. We touched on Enjaymo, I guess that was over $1 billion, which he did. I guess when we think about the number of deals he's done over the years, as we've got bigger, the deals have kind of also got bigger. I guess some people in the market wonder, do you have to continue doing sort of bigger deals? I mean, you've just alluded that there's going to be sort of a flavor and kind of a mix of everything, but is there, I guess, access to sort of different types of deals has changed as you've sort of executed on the strategy? Perhaps you can give a sense on what we should expect in terms of size. I don't think it's changed. Good deals have always been difficult in the sense that there was a lot of good competition, good assets create attention from not just Recordati, and that I don't think will change. We are still fishing in ponds where the big pharma is not interested, right? An asset that would do €200 million-€300 million for us is very important. The big pharmas are really not focused on that. It shows with, for instance, what we're able to do with Isturisa or Enjaymo, this is because big pharma doesn't want to continue or focus on this or change their strategy. These opportunities will come, will continue to come. We've been a company that is known to be good at BD and M&A, a good partner. Competition will be there, and I'm optimistic on our ability to continue to deliver on it. We will continue to also do other types of deals, right? I mean, with the most recent one, Vascepa, EUR 20 million-odd upfront for a product that we said will deliver potentially up to EUR 100 million, subject to having exclusivity out to 2039. We do not just look for those bigger transactions. Thank you. In the last few minutes, perhaps a few questions on financials. I mean, obviously, we'll get sort of guidance of full year, but I guess you sort of mentioned that rare disease is approaching 50% of the top line, whereas it's currently around sort of 40%. Can you sort of give a little bit more color what that means at this point? Yeah. I'll apologize. Approaching perhaps was interpreted in many different ways by people. I think you saw on the slide today, we sort of fine-tuned it to continuing to trend towards whilst delivering a high teens. I mean, the momentum is there, right? If you run the maths, you plot those growth rates in, it won't be too long before those businesses, if you just look at the organic growth of the current portfolios, start being closer to 50-50. We will, of course, continue to invest, and we have said we'll continue to invest in both businesses. It also kind of depends on where the next investment is. We don't know. We seem to be in a pretty good cadence of doing one year rare disease, the next year SPC. Let's see if we continue, but it'll also be a function of what deals we do. You've given 2025 guidance and obviously 2027 guidance. We're going to look for the one in the middle as we get to full year. When we think about profitability, you've obviously talked about the step-up of investments, which is coming next year. Is it fair to assume a bit of margin pressure next year or other kind of underlying improvements which can offset that? No, for sure. I mean, we said that 2026 will be an investment year. Again, we need to still review the budget and discuss it with the board. But the rough indication that we gave, if you just assume the bottom sort of end of that range of €40 million extra incremental investments, that's worth roughly 140-150 basis points at the EBITDA level. Mix is positive because rare disease is increasing, but effects, we said on the call, you should probably with a minus 3% on revenue, roughly assume a minus 2% on EBITDA. Again, we still need to review the budget and confirm a proposal for next year. We'll give the full guidance as we always do in February, but hopefully that gives some direction of travel, which we thought was appropriate to give at the same time, once we agreed that we should go ahead with those investments and at the same time as when we were updating the market on the opportunity that we see, which far outweighs the investments that we'll be making. Thank you. Maybe to close, Rob, people in the room might be looking for ideas coming into next year, so why should they consider Recordati? We have a wonderful track record. We've delivered every single quarter and have generated what? A fantastic return for our investors. One of the stronger return on capital employed, always between 15%-20%. Very solid. We tend to be conservative and deliver on what we promise. We have even more opportunities now coming from some of our organic part on the rare disease. I'm very happy and proud to be here, and I think we can really do something amazing going forward and continue to deliver.