Good day, everyone, and welcome to the Ipsen's H1 2022 results conference call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star one on your telephone keypad. You may withdraw yourself from the queue by pressing the pound key. Please note this call may be recorded, and I'll be standing by if you need any assistance. It is now my pleasure to turn the conference over to Ipsen's CEO, David Loew. Please go ahead, sir. Good afternoon or good morning, everyone. I'm delighted to welcome you to our first half results call. As you just heard, I'm David Loew, Chief Executive Officer of Ipsen, and it's a real pleasure to be here today to run through our first half performance and upgraded guidance. Please note that this presentation is available on ipsen.com. Please turn to slide two. This is our safe harbor statement, which outlines the routine risks and uncertainties contained within this presentation. Also, any commentary on growth you'll hear today will be based on constant exchange rates, unless stated otherwise. Please turn to slide three. I'm joined today by our CFO, Aymeric Le Chatelier, as well as Howard Mayer, Head of Research and Development. Howard will be with us for the Q&A session later. Please turn to slide four. Here is the agenda for today's call. I will start our presentation with an overview of our business, after which Aymeric will take you through our financial performance in the first half of the year, as well as our upgraded guidance for 2022. After concluding our presentation, we'll be happy to take your questions. Please turn to slide five l et's begin with the business overview p lease turn to slide six. Strong financial results in the first half of the year t otal sales growth of 10.5% at constant exchange rates was accompanied by a core operating margin of 39.6%, representing an increase of two percentage points. We continue to replenish our range of brands and the pipeline. In the first half, we announced the acquisition of Epizyme, expanding our presence in oncology from currently solid tumors to now include also hematological tumors. We also delivered on the divestment of our consumer business, and I'm delighted to say that this transaction closed yesterday. Finally, given our performance in the first half of 2022 for total sales and the core operating margin p lease turn to slide seven. Our growth platforms of Cabometyx, Dysport, Decapeptyl, and Onivyde performed very well in the first half, growing by 19.5%. Cabometyx sales grew by 25.4%, with good levels of uptake in renal cell carcinoma as an increasing number of patients on IO progressed to second line. The launches of the first-line combination with nivolumab in a number of countries were encouraging. For example, in France, where we have launched in March and we have already 12% of new patient share in first line with the combination of nivolumab. Dysport delivered a strong performance in both aesthetics and therapeutics. Growth of 15.5% was somewhat limited by supply phasing and aesthetics that was impacted by the preparations for an increased capacity given the strong demand. Decapeptyl sales grew by 15.9% as we gained market share. The ongoing impact of COVID-19 restrictions in China slowed our sales growth there, but I would like to thank our colleagues in China who have done so much this year for patients under very difficult circumstances. Finally, Onivyde sales were up by 30.4% as we gained further market share in the U.S. while there were increased sales to our ex-U.S. partner. Please turn to slide eight. Somatuline sales grew by 1.1% in the first half. This was a robust performance, though we are aware that increasing levels of competitive activity in both the U.S. and Europe will continue to increase. Turning firstly to North America, stable Somatuline sales were helped by demand growth in the U.S. that was reflected in market share gains. We saw only limited volumes so far from lanreotide competition, with around 5% volume market share by May. Somatuline pricing was adversely impacted by increasing levels of commercial rebates, and channel mix continued to be affected by the growth of 340B. In Europe, sales declined by 4%. Where there was no generic competition we gained further market share. Where the generic has launched, however, sales of Somatuline have been adversely affected. Varying by country the impact has been on volumes and or pricing. We anticipate further launches of the generic in Europe. At around 10% of the total rest of the world sales were up by 33.7%, with volume growth supporting strong performance in all geographies. Please turn to slide nine. Turning to external innovation, I'm excited by the acquisition of Epizyme we announced last month. The transaction gives us global access to Tazverik, which is already approved in the United States, generating sales and which has also a patent life in the U.S. extending to 2032. Given our strong U.S. market presence and capabilities, we will leverage our infrastructure to accelerate its growth. The addition of Tazverik will enhance our long-term performance, particularly through the potential approval. If the early clinical data recently presented at ASCO are replicated in phase III development, favorably impacting progression-free survival and overall survival, there is the potential to take Tazverik sales to around EUR 800,000,000 million. The deal is in line with our priority of replenishing our pipeline with programs at both clinical and pre-clinical phases of development in oncology. The acquisition comes with Epizyme's first-in-class oral SETD2 inhibitor, EZM-0414, which was granted FDA Fast Track status and is currently under evaluation in multiple myeloma and diffuse large B-cell [lymphoma]. This deal is a great strategic fit for Ipsen, strengthening as it does our portfolio in oncology and our early and clinical stage pipeline. Once we close the transaction in the coming weeks, we will focus on fast integration and the acceleration of the growth of Tazverik. Please turn to slide 10. Yesterday's closing of the agreement to divest our consumer business to Mayoly Spindler was a significant moment for Ipsen. We're now 100% focused on specialty care. The transaction, representing an enterprise value of EUR 350 million, including an earn-out contingent payment of EUR 50 million, was a major step forward in the execution of our strategic roadmap towards building a more focused Ipsen. Please turn to slide 11. Turning to the pipeline, given the recent approvals of Dysport's NDO indication and Cabometyx in second-line differentiated thyroid cancer, they are now in launch phase. The rest of the pipeline is unchanged, though I want to draw your attention to our longer-acting neurotoxin candidates which are progressing nicely in phase I and phase II development in both aesthetics and therapeutics. I will now focus on the pipeline milestones coming up. Please turn to slide 12. We have a number of pipeline milestones between now and the end of 2023. We await phase III trial data from the combination of Cabometyx plus atezolizumab this year in second-line non-small cell lung cancer, as well as from Onivyde in second-line small cell lung cancer. We now anticipate phase III trial data for Onivyde in first-line pancreatic ductal adenocarcinoma this year. phase IIb data are expected in 2022 for mesdopetam in levodopa-induced dyskinesia with Parkinson's disease. Finally, tHe review date has been set for the by the FDA for the end of the year for palovarotene in FOP. Turning to 2023, there are three major milestones to consider. We await phase III data from the combination of Cabometyx plus atezolizumab in second-line metastatic castration-resistant prostate cancer. Elafibranor is also expected to read out its phase III data next year, while a European regulatory decision for palovarotene in FOP is assumed in 2023. Please turn to slide 13. We have refocused our company social responsibility strategy. The new generation Ipsen identity centers on four key pillars, namely environment, and people, and governance. I was very pleased with the progress we made under every pillar in the first half of the year. Firstly, we reduced carbon emissions by over 20% year-over-year, driven by the switch of European-based manufacturing and R&D to green electricity in 2021. With the move to renewable electricity and the significant reductions in refrigerant gas emissions in recent years, our last big obstacle to decarbonize our manufacturing will be to address the use of fossil fuels at our sites to produce heat and steam for the manufacturing process. We have already invested in heat recovery projects at Dreux and Signes, who utilize waste heat to reduce fossil fuel consumption. Dublin is the most recent site to complete the installation of a new chiller system that uses a lower global warming potential refrigerant gas and incorporates waste heat recovery to reduce site fossil fuel consumption. The project is expected to deliver a 7% reduction in site greenhouse gas emissions. Our patient focus has included support to people in Ukraine in medical need. On top of donations to the Red Cross and Tulipe, we have donated medicines and supported nearly 100 patients with three months of supply of their necessary treatments, including with Decapeptyl around 30 children with central precocious puberty. Access programs have also been extended in geographies with underserved patients. You may remember that our revolving credit facilities includes a key ESG element. Favorable ESG results are rewarded with charitable donations, and one of these was awarded to International Health Partners, a charity supporting people in some of the world's most challenging places to get the medicines they need. Within the people pillar, we are targeting a balanced gender ratio for our global leadership team by 2025, and we are very proud to report that ratio has already reached 45%. Ipsen was also recognized as an employer of choice in 21 countries. Finally, our focus on governance included the renewal of anti-bribery certification by ISO. I hand over now to Aymeric Le Chatelier, our Chief Financial Officer. Please turn to slide 14. Thank you, David. First half of the year, as well as the detail of our upgraded 2022 guidance. Please turn to slide 15. As you can see, the first half financial highlights are showing a strong performance with a strong sales growth of 10.5% at current exchange rate, as presented by David. The record level of margin at 39.6% of total sales, which I will detail in the following slide, driving a growth in core EPS over 20% and an increased level of free cash generation to fuel our ambition for external innovation. Please turn to slide 16. Looking at the detail of our core P&L the growth in total sales was impacted by the positive evolutions of the currency, especially the U.S. dollar boosting our total sales by an additional 4.7 points to 15.2% growth. Other revenues increased by 24% primarily reflecting the increase in royalties received from our partner for this quarter. Given the unfavorable mix of sales with flat Somatuline sales the gross profit margin was slightly down at 87.6% of total sales. R&D costs increased by only 1% with lower investment in the existing oncology program, and despite the higher level of investment in neuroscience and rare disease, including elafibranor. SG&A expenses increased by 14% or 9% at constant exchange rate reflecting the commercial investment to support our growth, as well as preparing for the several upcoming launches. We also see an increase of the impact of post-pandemic spend on travel and expense, as well as on medical and marketing activity, all of that being more than offset by the cost efficiency across the entire organization. As a consequence, our core operating income grew by 22% and our core operating margin improved by more than two points to 39.6% of total sales. Please turn to slide 17. We also continued in H1 to increase our cash flow generation with free cash flow growing by 17%, driven by the enhanced profitability as well as the sound management of working capital and capital expenditures. After the payment of dividends and net investment from business development Ipsen is now fully deleveraged with a closing net debt of only EUR 2 million. Our capital allocation priority remains to increase our firepower for our external innovation strategy. I'm very pleased to say that at the end of H1, on a pro forma basis, which means after the proceeds that we just received from the sale of the consumer healthcare business and the expected closing of the Epizyme transaction we have a total firepower of EUR 2.2 billion available for further transactions. Please turn to slide 18. Based on the strong momentum of H1 results, we have announced upgraded expectation for total sales and the core operating margin for full year 2022. This new guidance assumes a closing of the Epizyme transaction in the third quarter and excludes, obviously, any contribution for our consumer healthcare business. We now anticipate total sales growth at current exchange rate to exceed 7% this year, which represents a 5% improvement as compared to our initial guidance of a growth greater than 2%. Compared to our H1 performance we expect in the second half an increasing adverse impact from the competitive activity for Somatuline in both Europe and in the U.S. We assume also a larger favorable impact from currency of around five points based on the average level of exchange rate in June, meaning that we anticipate to grow our top line by more than 12% in this year 2022. The core operating margin is now expected to be greater than 36% of total sales as compared to greater than 35% in the initial guidance in February. Assuming first the dilutive impact of the Epizyme transaction, which will be integrated and which will remain limited given the expected timing of the closing. It is worth noting also that beyond Epizyme, we anticipate a higher level of expenses in H2, given the level of additional pre-launch activities, notably for palovarotene and elafibranor, but also the pressure from inflation on raw material and salary costs, as well as the traditional seasonality as we see more activity in the second half of the year. To finish this guidance on margins excludes any potential impact of incremental investment from external innovation transactions. With all of that, I will now hand back to David. Please turn to slide 19. Thank you, Aymeric. Please turn to slide 20 for the conclusion. To summarize, we are successfully executing on our strategy and delivering strong results, advancing the pipeline, and focusing on more external innovation opportunities. We have upgraded our 2022 guidance, reflecting the strong progress across the four strategic pillars. The pipeline is advancing nicely, and over the next 18 months, there are a number of potential milestones, including lifecycle management for Cabometyx and Onivyde, as well as new molecules, palovarotene and elafibranor. Finally, our focus on external innovation as the main capital allocation priority has generated over EUR 2 billion of current firepower. We're moving at pace with our preparations to integrate Epizyme, and we will have a real momentum at H2 to do more deals. Thank you for listening. Aymeric, Howard, and I will now be happy to take your questions. Please turn to slide 21. Operator, over to you. At this time, if you'd like to ask a question, please press the star and one on your telephone keypad. You may remove yourself from the questioning queue by pressing the pound key. Once again, that is star one to ask a question, and we'll pause for a moment to allow questions to queue. Our first question comes from Michael Leuchten with UBS. Thank you very much. Two questions, please. One, just the implied margin for the second half, Aymeric, forget my math, but it is about 35%. How good of a jump-off point is that as we think about 2023? You talked about R&D being sort of flat in the first half because some trials are coming to an end. Is it a good benchmark to use H2 as we think about 2023, or is that too premature to think about that? The second question is, have you changed any of your assumptions around Somatuline? Again, your implied guidance for the second half. Your guidance seems to imply the second half for Somatuline, a fairly flattish trajectory, so no significant deterioration. We've seen a slight incremental negative impact in Europe, which I presume is mostly the pricing that you talked about before, but it doesn't seem to assume an acceleration of those trends into the second half. Have you changed any assumptions for Somatuline, as you now have a bit more experience in Europe? Thank you. Thank you. Thank you for the question on the margin. We'll address the question, and David, you're gonna address the Somatuline. Clearly, as I said, we are assuming, and you're right a lower margin a significantly lower margin in H2 as compared to H1. A big chunk of that is really related to the impact of Epizyme. Epizyme will be only consolidated for a few months this year. Answering to your question for 2023, you should assume that there will be a more significant dilutive impact from Epizyme, which will offset the declining R&D spend on the existing portfolio, as we've said, which is part of our overall trajectory to clearly replenish our pipeline. Beyond that, I think that there is also, in H2, some pre-launch activity that will impact the margin. I think it's too early to take any conclusion on the level of margin for 2023. Michael, regarding your second questions on the assumption on Somatuline, actually, you know, we have always said this is a gradual erosion product holding up pretty well because the production is quite complex. Actually it confirms what we have communicated to the market. Of course, we will see some further launches in some of the countries. When we look at the total list where, you know, our competitors are registered they could have launched in many many more markets since a long time, and they have not done so y es, we will see some more impact from somewhat more volume w e will see also pricing pressure. We have not seen an authorized generic yet in the U.S. which certainly is good news for us. In that sense we stick to our assumption that this will be a gradually eroding product over time. Thank you. We'll take our next question from Keyur Parekh with Goldman Sachs. Hi, thank you for taking my questions, two if I may please. The first one is, as you kind of are highlighting you're gonna bring forward the readout for the first-line kind of pancreatic cancer study. Just wondering kind of how we should think about the factors that have enabled you to bring this forward, and how would you kind of characterize your optimism kind of ahead of this readout? That's kind of question number one. Question number two, kind of just talking to your broad kind of M&A strategy. You clearly just did Epizyme, but as we look further into kind of 2023, can you characterize kind of some of the areas that you would like to kind of strengthen further? Is this kind of going to very much be focused on kind of the oncology part of the business, or should we expect a further broadening of the specialty business here? Thank you. Perhaps, Howard, you can take the first one. I'll read on pancreas. Yes. Thanks, David. Thanks for the question. I think you know we expect to have data in the second half. I wouldn't read too much into bringing it forward because it's only really by a couple of months and enrollment went a little better than expected. You know we're obviously cautiously optimistic w e've gotten this far. You know the trial has a DMC or a data monitoring committee that monitors the data and the study has continued as planned w hen we look at the data from phase II, we're encouraged by the fact that we saw a median OS of over 12 months. When we read through with that and what we've seen with [gemcitabine/Abraxane], we're obviously cautiously optimistic that we're going to see a clinically meaningful difference in median OS. Obviously the data will bear that out in the second half of this year. Regarding your second question on M&A clearly we have a very strong focus on M&A. As we have communicated since our capital markets day, we are gonna be very active in that space, so you're gonna hear more announcements on deals that we're working on either licensing deals or acquisition deals. In terms of the areas to your question we are really open for the three therapeutic areas that we have signaled. Obviously, you know, we can still leverage more our oncology or hematology platform that we have built up, but we also believe that rare disease is an area where we're gonna start building up a portfolio, as you have been seeing, as well as CNS, where we have a good footprint also with our Dysport business. We are really gonna look at the right opportunities in these three areas. Okay, we'll take our next question from the line of Thibault Boutherin with Morgan Stanley. Hello. Hi, thank you for taking my questions. Just the first one on Dysport. I'm not sure I really understood the comment on the capacity increase. Is the phasing benefiting H 1 or H 2? Just if you could give some clarification on this. Second question, just on Onivyde. It's been, I think, the second quarter in a row where we have good contribution from ex US, so basically as a shipment to Servier. Just wanted to know what's the kind of what is stocking elements in this? Or is it just that there is an underlying good performance in Europe, and so you're just supplying on a regular basis to Servier? Maybe last question on Somatuline, rest of the world. It's been second quarter in a row where we see a good performance. You know, just trying to understand what is the scope to see more growth, you know, in other countries and the ability to kind of offset the erosion in U.S. and Europe to some extent. Thank you. Thank you, Thibault. Perhaps on the Dysport and your question on the capacity b asically, we had a little bit less capacity this first half because we were actually investing into increasing significantly our capacity for the future. That means that there is a bit of a phasing if you want where you have a little bit less supply this first half of the year. It's gonna significantly increase in the second half of the year as the new line is starting to really be able to produce much more because we are actually seeing very strong demand in the market in both aesthetics and therapeutics. We have a real big increase in capacity to be ready for the future to see Dysport growing also very strongly for the future. On your second question on Onivyde and the stock, and Servier, I let Aymeric answer. Yeah. On your question regarding ex-US sales, as you know, there is always some shipments from one year to another one, and clearly H1 last year was very low in terms of shipment. Beyond that, I mean, Servier has a pretty strong performance in a selected number of markets, including Japan and China. I think we are very pleased with the momentum from Servier. You should not underestimate the impact of shipments, which is impacting the performance ex-US of Onivyde. To your third question on Somatuline and the rest of the world markets, we anticipate strong growth of Somatuline in these rest of the world markets. You know, our competitors have not yet registered in almost any of those markets, and we see very strong growth in these rest of the world markets. Yes. Is it gonna offset it completely? No w e have to assume that, you know, the Somatuline is gonna gradually erode in Western Europe and in the U.S., as we have always communicated. Of course, this erosion is gonna be dampened by actually the very strong increase of sales in the rest of the world market and also in Western Europe markets where the competition has not launched yet. Thank you. We'll take our next question from Elizabeth Walton with Credit Suisse. Hi. Thank you so much for taking my questions i have two. Firstly on Somatuline y ou previously talked to some quite large price cuts in Europe which don't seem to be having a meaningful impact just yet, although they happened at the start of Q2 as I understand. Perhaps you can talk us through the cadence that you anticipate there to be an impact to your European growth. Can you share any insights from what you're seeing on the market today? Are there any additional geographies where your competitor have launched? Then secondly, on Cabometyx, we're looking forward to seeing the data for the combination with atezolizumab in second line non-small cell lung cancer. Assuming this study works and it's positive, how should we think about the incremental revenue opportunity building in Europe, given your need to take a mandatory price cut for the additional indication? Thank you. Thank you, Elizabeth. On Somatuline we had, of course, in the markets where our competitors have launched seen varying degrees of price cuts. You know, for example, Nordics are tender markets. The price cuts there were very significant and that's where the competitors have taken the biggest amount of market share. In other markets, you know, for example, in Germany the price cuts have been somewhat less and we are holding up extremely well our market shares on volume. In France, as you know, there was a price cut of 40%, and even somewhat more in Spain. There as well, you know, the penetration was not that strong i would say all in all, you know, we are holding up relatively well where the launch has happened. So far, we have only seen launches in small markets, so the most recent ones were the Netherlands. We anticipate that the next one could be Portugal, and at one point also perhaps then a larger one with Italy. This remains to be seen when exactly it happens. To your second question on Cabometyx in second-line non-small cell lung cancer, we are not guiding yet on the incremental revenue. I mean, as you know, of course, non-small cell lung cancer is quite a large indication, but we have to see first the quality of the data. There is, of course, also competition on blinding. We have to really see what's gonna happen on the clinical data there. You know, non-small cell lung cancer is, of course, always a bit of a tough indication, as we all know. Regarding on the price cuts, we also can't communicate on this because this is, of course, sensitive information. We'll take our next question from Simon Baker with Redburn. Thank you for taking my question. Two, if I may, please. The first one really continuing from Elizabeth's question on Somatuline. It sounds like from what you said, most of the revenue impact at the moment is price rather than volume. I just wonder if you could sort of give us any color on how you see that evolving, not just in terms of the mix between the two, but the potential impact on gross margin going forward. A second question on Tazverik. The more I read about Tazverik and EZH2, the more I see this is a drug having potentially very broad utility well beyond hematologic cancers. All I was particularly thinking of was in non-small cell lung cancer in combination with PI3K inhibitors. I'm just wondering if, given that you already have exposure to lung cancer, if that's an area that you're looking at. Thanks so much. To your first question on Somatuline., I mean, there is a bit of both, I have to say, on price and volume, but it's a mix, I would say, country by country. I just told you on Germany, where we are seeing that the competitors have almost no market share. But then, as I said, in the Nordics, they took almost like 80 or 90% market shares in the tender market. There it's price and volume. But these are small markets if you want. It's gonna be a bit of a mix. The same for the United States, I would say. We have seen our competitor with the pharmaceutical alternative take about 5% market share in volume in the U.S. You have seen that the U.S. kind of is now relatively flat in sales on Somatuline and of course, therefore, there is a price effect coming from commercial discounts and also a little bit from the 340B, which is increasing, as we know, for all, you know, drugs in the United States i t's also a bit of a mix effect of price and somewhat of the volume. Regarding Tazverik, it's a bit early days, I have to say, and I don't wanna get ahead of myself. We haven't even closed there, so we need to do the closing. But I do agree that there could be potentially a broader utility. I think it's too early to speculate on the lifecycle management and the indications there. We have to now sit down with the people from Epizyme and our teams to really go through the lifecycle plans and see which are gonna be the priority indications that we want to develop. Obviously, you know, we have several trials already ongoing, so we also have to see how they are gonna read out and how we're gonna pace the lifecycle management. Again, if you do have questions, please dial star one. We'll take our next question from the line of Delphine Le Louët with Société Générale. Hello. Hi, good afternoon and congratulations everybody for this outstanding first half. I had three questions. The first one deals with U.S. performance, and especially can you detail us the pricing impact that you had over the semester for the major drugs? So we're talking about Somatuline, Cabometyx, Onivyde, and of course Dysport. Thank you. Second question will deal with can we get the breakdown between Cabometyx revenue first line second line in RCC? And finally, a follow-up regarding Epizyme, sorry, and Tazverik. How do you see the commercialization and the marketing effort to be put in place in next year versus what it has been already made by Epizyme? How do you see a sort of convergence of the two teams or a full onboarding from Ipsen marketing team? What's the plan there? Thank you. Thank you, Delphine. A lot of detailed questions. I'm not sure I can answer to all of them, I have to admit, because when it comes to the pricing impact, you know, this is very sensitive information, and we're not giving that out to the market, obviously, because our competitors are listening to the call as well. I just wanna attract your attention that Cabometyx, we don't commercialize that in the U.S. This is Yeah, yeah. question to them. We are not communicating the pricing impact in detail, obviously, you know, because we don't want our- Can you say they were only single digits or, you know, like for Dysport you have some double-digit increase, or can you make probably a more broad vision? No. The pricing on, for example, Dysport and Onivyde is, I would say, broadly flat. There is a little bit of 340B, but then we have also taken a bit of price increase on some of them, in line with inflation. It's, I would say, basically a bit of a wash, there. On Cabometyx first and second line breakdown, the vast majority for the moment of the sales is coming from second line sales. The higher penetration that we're getting in the markets where we have already launched, as more patients are moving from IO combinations into second line, and Cabometyx has not been launched in many markets yet in first line. You see a very strong effect of the sales that we are seeing right now from the second line. That's the vast majority. We have launched so far Cabometyx in first line in Germany and in France. In France, we have basically just launched in March. That's where I said, you know, we are happy with the 12% new patient shares that we have started to take. You will see a gradual increase of the first line penetration and the sales coming from the first line pool over the next coming years, because that dynamic really needs to play out. Then you have a little bit of a price decrease on Cabometyx, obviously from the markets where we are launching. Short-term, you have a slight pricing impact, long-term, that's gonna wash out. A larger proportion in the countries where we're launching first line is in the longer term gonna come from the first time setting, most probably. On Tazverik, so there, the question is on the commercialization. As you know, we believe that Epizyme did not have enough footprint to really see the office-based hematologist. This is very important because most of the elderly and frail patients, which are representing the majority of patients in follicular lymphoma, are actually being treated by office-based hematologists. That's where our belief is that bispecifics play a little bit less of a role because you have the cytokine release syndrome, which for an office-based hematologist can be a little bit of a challenge. We have to see how this is gonna develop. Definitely we think Tazverik has an ideal place with the office-based hematologist, and therefore we are gonna use our field force in addition to the field force of Epizyme, you know, to really increase significantly the footprint. That's true also for the MSLs, because we need to really relaunch this drug. Epizyme was launching in the midst of COVID-19. That was a very suboptimal environment to actually launch a drug for any company. Epizyme being a pretty small company, it was even harder to actually do that. That's why we believe this drug has a nice potential, and we are gonna ramp up the field force. In fact, as soon as the deal closes, we are gonna deploy our field force. They are being trained on hematology right now. In a second step, of course, we're gonna train them on Tazverik. Once the close has happened, we can immediately deploy the two field forces together. Okay. Thank you very much. We will take our next question from Richard Vosser with J.P. Morgan. Hi. Thanks for taking my questions. A few please j ust on Somatuline, I think there was maybe a little bit of restocking in the U.S. post destocking in Q1. Maybe you could quantify the impact that had in the quarter. Then just back on Somatuline pricing in Europe it sounds like because Advanz can't supply very much, you haven't had to cut your price at all very much in Europe. Is that the right sort of understanding at this point in terms of Somatuline for Europe, say, in France? Then just one last question, just going back to NAPOLI. Howard, it sounded like there'd been an interim analysis of the data from the DSMB, the Data Safety Monitoring Board. Can you Is that right? Anything you can share in terms of the idea of interim analyses? And maybe also in terms of the pull forward of the trial results, are you seeing the events coming in faster than you had expected? Is that also a contributory factor? Thanks very much. Thank you, Richard. On your first question on Somatuline, on the destocking effect, I'll let Aymeric elaborate because you need to actually dig into details to really understand what's going on there with this destocking effect. Yeah. We are talking here about Somatuline in the U.S., and as you can see, I think it's more the Q2 performance that has been impacting by stocking impact. As we said in Q1, the level of inventory has decreased following the entry of competition. The inventory have remained pretty stable in Q2, so there is no impact on the Q2 of this year performance. Last year there were a lower level of inventory during the second quarter, which in a way has boosted the performance that you see in the Q2. As David explained before, I think that there is a sequential gradual erosion, which we see that the product continue to grow in terms of volume. There is some pricing impact, which are a combination of challenges and commercial rebates, and clearly inventory will remain the same. It's more the comparison quarter to quarter that make up the Q2 performance. On your second question, pricing Europe. We know of course that they must have a bit of a lack of volumes because if not, they would have launched a long time ago in many more markets, so they are launching very gradually. Obviously then when you look at the pricing, that means that, for example, in the markets where they have not launched, there is basically no pricing question, so that's already good news for us. In the markets where they have launched, there is sometimes, you know, like guidelines from the government, how much you need to decrease the price, like in France, for example. For example, in Germany it's a discussion sickness fund by sickness fund. In Spain, you know, it's the product which is lower priced, is actually the most favored product and needs to be distributed by the pharmacist. It's depending on the strategy that they have. Typically what happens is actually, you know, they took a pretty big price cut in Spain and we aligned. What happens is that if you are aligned on the same price, then there is not a favoring of the generic. You can protect also the volume by eventually following on the price. There is really a mixed market by market, so it's different market by market. Obviously there is the good news for us that they don't seem to have that much volume because if not, they would have launched in many more markets much faster. To NAPOLI, I let Howard answer. Yes. Thanks, David. You know what I had intended to say before, and what I meant is that, you know, we have an independent DMC that's reviewing the data on an ongoing basis, and they've consistently told us that, we should continue the trial as planned, you know, which is always a better sign than the opposite view. We're encouraged by that. Again, in terms of the, you know, second half versus very early, you know, first quarter, originally it really in the grand scheme of things doesn't represent a tremendous acceleration of time, considering how long the study's been going on. You know, we're not overly concerned about it, in the context of, you know, more rapid OS events, et cetera. It's really, you know, doesn't really represent a large period of time in our view. Obviously, again, you know, this will all be borne out by the data from the study which we expect in the second half of this year. Great. Thank you. We'll take our next question from Sachin Jain from Bank of America. Hi there, Sachin Jain. Thanks. My questions, I've got three, if I may, all of which are follow-on questions. First on Somatuline, answer prior question referenced U.S. volume growth. I think that's obviously been aided by Cipla supply constraints. I wonder if you could just update us on your competitive intelligence as to where they are with supply and whether you think there should be any material shift in their supply levels into the back end of this year. Second one for Aymeric on margins into 2023. I understand not giving guidance just after, if you give us some high-level building blocks as we think about 2023 margins. Obviously full-year Epizyme dilution seems to be the main factor with them being roughly a EUR 200 million cost base. Is that the major driver of how we think about year-on-year change in margins for 2023? Or can you offset some of that? The reason for the question obviously is you've taken 2022 margins up despite a couple of months of dilution. Just wondering if that can be a thematic into 2023. Final question on Cabometyx in lung. Just follow up from prior commentary. Some of our physician feedback on the phase I data you presented at the ASCO update was that response rates are very solid, but questions on durability of responses which were in the low single digit months. Just as we think about the phase III coming, and you referenced, in your answer, David, I think competitive landscape, what PFS do you think you need to reach to be competitive? If you could reference that relative to the duration of response in phase one that I just commented on. Thank you. Thank you, Sachin. On Somatuline, regarding the U.S. volume growth and competitive intelligence, do we see material shift? First of all, of course, we have to be very humble and modest, you know. I mean, it's hard to get kind of very detailed information on this. I think what we can say is that Cipla is also sourcing from Pharmathen. You see that Pharmathen, who is sourcing Advanz in Europe, is not having that much supply, and in the U.S. so far, they have only taken 5%. So far, I think we therefore need to assume that it's gonna be a gradual erosion that we're gonna see, and we don't think, you know, there is gonna be suddenly a huge amount of drug coming into it. As we always communicated, it's very difficult to produce. You need to have really stable production, and you can't have too much write-off, you know, in the production of this because the write-off has a significant impact on your margin. Therefore, we really stick to our guidance that we are gonna see a gradual erosion. Regarding your second question on margins 2023 and Epizyme, I'll let Aymeric elaborate on that. Yeah. As you say, Sachin, I'm not gonna provide you the guidance that I will give you in February. As you said, yes, we are starting from a higher starting point. Clearly, as you know, the diversity of the [CHC business] has significantly improved our profitability. The strong momentum that we see this year in 2022 will get us to a higher level. I will say the component of that will impact the margin going forward are first the top line, I think the cost, and as you point out, Epizyme. Clearly on the top line, we continue to see that the dynamics, we're gonna be able to continue to grow, even if Somatuline will continue its gradual erosion. We're confident that our growth product will continue on the strong momentum that you see here on the first half, and we'll see also in the second half. On the cost base, I think we're gonna have more launch activity. We are managing also the inflation environment, but basically we are also working on efficiency. We do not expect any significant increase in our cost base. Clearly, Epizyme, as we said during the announcement of the transaction, will have a more significant impact, and any additional BD could also impact the R&D. While at the same time, as we know, the end of a lot of the significant phase III and a lot of them which will read out in the coming months will have also a positive impact on the level of R&D. Epizyme, I think the message is the same. We talk about a moderate dilution. That we mean that we expect to be able to recreate some momentum on the top line. We integrate and get synergy, but there will be clearly a much higher level of investment given the study for Tazverik and also for the pipeline once we have fully reviewed through the integration. On your third question on Cabometyx and, you know, extrapolating from the phase I ORR and durability onto phase III after two decades of working in oncology, I have given up on doing that. I have to say, I'm just waiting for the readout because the primary endpoint is overall survival. To your question on PFS, what we need to see is definitely three months on PFS, and we should also see two to three months on overall survival. If not, it's mostly in oncology not considered clinically meaningful. That's where we are, and we are just waiting for the readout now in the second half of this year. Thank you very much. That is all the time we have for questions. I will now turn the floor back over to Ipsen CEO, David Loew, for closing remarks. Very good. Thank you very much, everybody, for joining us today, and I wish you a pleasant rest of the day and a pleasant holiday for those of you who can, take them. Thank you very much. Bye-bye. Thank you everyone for joining the Ipsen's H1 2022 results conference call. This does conclude the program. You may now disconnect. Have a great day.