Hello, and welcome to Ipsen's Q1 2023 Sales Update Conference Call and Webcast. I'll now hand you over to David Loew, Ipsen's CEO. Good afternoon or good morning, everyone. I'm delighted to welcome you to our Q1 sales update. As you just heard, I'm David Loew, Chief Executive Officer of Ipsen. It's a pleasure to take you through our performance in the first quarter. Please note that our 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. 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 going to take you through our brief presentation after which I'll be joined for the Q&A session by our CFO, Aymeric Le Chatelier. Please turn to slide four. Today's headlines illustrate how we are continuing to deliver on the strategic roadmap. In the first quarter, we produced a total sales increase of 5.7%, with our growth platforms delivering another double-digit performance led by Dysport and Cabometyx. The acquisition of Albireo completed at the start of March, meaning one month of bill-to sales for Ipsen in the quarter. Following regulatory submission in H1 this year, we look forward to communicating on filing acceptance. Based on the priority review, we await a decision by the FDA on June 15 for Bylvay in Alagille syndrome. The decision date for Palovarotene in FOP is set for August 16th. Finally, given Ipsen's continued sales momentum, we are confirming today our full year guidance on total sales and the core operating margin. Please turn to slide 5. With total sales increasing by around 6%, our growth platforms, which now represent almost two-thirds of sales, are continuing to outweigh the gradual decline of Somatostatin. After delivering growth of 21% last year, these growth platforms of Dysport, Cabometyx, Decapeptyl, and Onivyde were up by a combined 15% in Q1. Somatostatin now representing only around 1/3 of sales declined by 10%. I will now go through the performance of our medicines in more detail. Please turn to slide six. Dysport's momentum from 2022 carried through into Q1. Growth of 25% reflected a strong aesthetics performance by both Ipsen and our partner, as well as continued therapeutics growth across the regions. Cabometyx, up by 31%, was supported by the growing contribution from the first-line renal cell carcinoma combination with nivolumab, including in Europe and a number of other new markets, such as Brazil, where we have recently launched with reimbursement. The region in strongest growth for Cabometyx was the rest of the world, where sales were up by 86%. The momentum in second line monotherapy also continued as we launched and gained reimbursement in more markets. The limited growth in Decapeptyl sales was a function of the impact of increased stocking in China last year, done in anticipation of COVID-19 restrictions. Outside of China, the performance was impacted by the phasing of inventory. We did, however, continue to take market share in a number of geographies. Finally, the 12% decline in Onivyde sales was purely a reflection of the phasing of shipments to Ipsen's ex-U.S. partner, which was partially offset by solid underlying growth of 19% in the U.S. Please turn to slide seven. Somatuline sales fell by 10%. This was further evidence of its gradual long-term decline profile. In North America, sales fell by only 3%, benefiting from a favorable wholesale inventory comparison to Q1 last year. Volume demand remained in solid growth, but pricing continues to be impacted by the level of commercial rebates and adverse movements in channel mix, driven by the increased effect of 340B. Europe now represents less than 1/3 of Somatuline sales. Here, the volume and pricing impact from generic competition was most keenly felt in Q1 in France, Spain, and Italy. The rest of the world, solid underlying growth continues, with several geographies performing well, including Latin America. Please turn to slide 8. Turning to our recently acquired medicines, there were encouraging sales of Bylvay in March, reflecting momentum in both North America and Europe, as we saw an increasing number of patients treated for PFIC. As we prepare for a potential launch in Alagille syndrome, we look forward to forthcoming regulatory decisions in this indication in both the U.S. and the European Union. Sales of Tazverik amounted to EUR 9 million in Q1, with commercial sales up by 21% year-on-year. We are in the process of relaunching Tazverik in the all-comer population in the U.S. The March update to NCCN guidelines advocating the use of Tazverik irrespective of EZH2 mutation status. Further strengthens our new positioning. Our focus on new patient starts and the duration of therapy in all comers is already yielding early signs of progress, while with increased reach, we're beginning to see an uptick in the breadth of the therapy prescribers. Please turn to slide nine. Looking to the major elements of our pipeline, this chart continues to build nicely thanks to the progress of our external innovation strategy. The major changes since our full year results reflect the completion of the Albireo acquisition. IPN6260 is in phase I development in viral cholestatic disease, while in phase II, IPN6250 is being investigated in primary sclerosing cholangitis, complementing the PSC trial of elafibranor. Outside of rare disease, we look forward to the forthcoming move to phase II development for our longer-acting neurotoxin in therapeutics alongside its phase II development in aesthetics. We have a number of milestones for the pipeline in the next few months, which I'll address on the next slide. Please turn to slide 10. Firstly, we await the decision by the FDA on 15th of June for Bylvay in Alagille syndrome, while a decision by the EMA is expected in the second half of the year. Following a regulatory submission for Onivyde in first-line pancreatic ductal adenocarcinoma in H2 this year, we look forward to communicating on filing acceptance. We also anticipate the unblinding of the ELATIVE phase III trial for elafibranor in primary biliary cholangitis, likely around halfway through the year. The PDUFA date for the resubmitted new drug application for palovarotene as a potential treatment for FOP will be on 16th of August, while we have requested a re-examination of the negative CHMP opinion for palovarotene. While we await PFS data from the phase III CONTACT-02 trial for cabo atezo in second-line metastatic castration-resistant prostate cancer in H2, it's worth noting that for Ipsen's territory, approval and reimbursement may well require mature overall survival data. Please turn to slide 11. Before we go to questions, please let me conclude. We are continuing to deliver on the strategic roadmap. Our growth platforms are performing well and are consistently ahead of Somatuline's gradual decline. The newly acquired medicines are set to augment our growth journey, and it's this progress that supports the confirmation of our 2023 guidance. We're happy to have completed the acquisition of Albireo as we expand the scope in rare disease. We're working at pace to integrate Albireo into Ipsen. The pipeline is advancing, and we are making good progress in the number of trials and the assets we are developing. We have clear opportunities across the three therapy areas, and in the near term, we look forward to several key milestones. Our focus on external innovation continues as we look for further opportunities to drive long-term sustainable growth. Please turn to slide 12. Thank you for listening to our presentation. We now have time for your questions. Operator, over to you. Thank you. As a reminder, to ask a question, please press star one one on your keypad and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we open the first question. The first question comes from Brian Balchin at Jefferies. Brian, your line is open. Please go ahead. Hey, thanks for the questions. It's Brian from Jefferies. just a few on elafibranor. Just firstly, what's the bar for the phase III in June? Is it fair to assume 36% placebo adjusted from Ocaliva's POISE? On the incremental opportunity, not sure if you mentioned this before, and I couldn't actually catch it on slide nine, but what's the plan for the first line PBC, or is the plan just to focus on TSC now? just on BD, if you could give us any update on that, if any, just given current focus on launching Tazverik, Bylvay, and the phase III data in June. Thank you. Sorry, Brian, can you just repeat the last question because you came in and out? Oh, yeah. Just on any update on business developments, if you had any on that, just given focus on launching Tazverik, Bylvay, and the phase III data that you've got in June. Right. Okay. Let me start with the first question on elafibranor and what is the bar we set ourselves for the phase III, and you link it to Ocaliva, but actually, you know, our trial is against placebo, just as a reminder. We are not really benchmarking versus Ocaliva because Ocaliva actually versus our primary endpoint, which is, you know, a composite endpoint of ALP, being inferior to 1.67, the upper limit of normal or, a larger or equal, of 15% in ALP or, patients achieving, you know, smaller than the upper limit of normal. Ocaliva didn't show very impressive results, and also Ocaliva actually showed an increase of pruritus. We have a higher ambition. We are comparing ourselves against placebo, and we are also assuming that we're gonna see a positive effect on pruritus, which is what we have seen in the exploratory analysis on the phase II. Regarding your second question on first-line PBC, we do not have an intent to go into first-line PBC. UDCA is pretty well installed there. There might be exploratory trials, you know, given the very long timelines to go into a first-line, we rather bank on expanding the second-line pool for faster switches from UDCA, because there are several patients who do not derive the benefits on UDCA and also do the trial in PSC. Having said that, in PSC, we would also have to go to the FDA after our phase II we are currently conducting, which should have a readout next year, and have a discussion with them if we can also register it on a surrogate endpoint and then have a confirmatory trial behind, like in PBC. Today, that's not the case in the current environment, but I think there is rationale to actually have that discussion with the FDA or EMA. On BD, we communicated that for larger deals, let's say phase III or, you know, acquisitions or on-market compounds, it's probably rather gonna be towards the end of the year, given your point on the integration of Epizyme and Albireo, which we need to now really do. Epizyme is done, but the relaunch needs to happen now. On Albireo, we are still in integration activities. For larger deals, it's rather gonna be end of the year, beginning of next year. Having said that, of course, we still wanna license in or acquire other compounds which might perhaps have less impact on Ipsen in terms of organizational setup, and those are more like the earlier compounds in pre-clinical phase I, phase IIs, for example, which we are currently screening. Thank you for your question. Next question. Thank you. Please stand by for your next question. Your next question comes from Charles Pitman-King at Barclays. Charles, your line is open. Please go ahead. Thanks very much for taking my questions. I've got two, please. Maybe first on Bylvay. The implied quarterly revenue was around EUR 15 million, and I'm just kinda wondering how we should be thinking about this on an annualized basis, how sales tracking versus your expectations so far, and what have you noticed in terms of any accelerated uptake since the acquisition closed, and maybe an idea on kind of penetration that you're already seeing for PFIC. Then second question on Dysport. Do you have any market share data that you can share with us for the aesthetics portion of revenues? Could you reiterate what the split of aesthetics versus neurological revenues are for Dysport? Yeah. Thanks a lot, Charles. On your first question. it's early days. I mean, we shouldn't extrapolate from one quarter of sales, of course. On the other side, we see quite a nice dynamic in the U.S. and in Europe on Bylvay. I wouldn't take credit for that first month because obviously it was the Albireo organization which was still conducting that, and we are now integrating Albireo into our organization, which is advancing nicely. but so far, so good. Regarding penetration figures, I would say that's too early. We have to sit down and look more carefully at market research data. We are gonna come back to you probably in the future with a bit more information there. Regarding Dysport, the aesthetics proportion on our sales, which, as a reminder, includes the therapeutics, it includes aesthetics on territories that we have, and it includes the sales that we do to Galderma. The aesthetics versus the therapeutics is about a 60/40 split in it. That's about the ratio. Thank you. Next question. Thank you. Please stand by while I prepare the next question. Your next question comes from Richard Vosser at JP Morgan. Richard, your line is open. Please go ahead. Hi. Thanks for taking my questions. A couple of follow-ups there. Maybe on Dysport. There was some weakness in the U.S. that you may have covered, but just could you give us an idea of what's going on there and whether the asset market is saying any changes in consumer behaviors outside of that this year with the recessionary concerns, or is it plowing on ahead? How confident are you in double-digit Dysport growth for the year this year? Second question, maybe just how should we think about the ramp in Alagille syndrome for Bylvay? Livmarli is already approved and has first-mover advantage there. You have first-mover advantage in PFIC. How should we think about a change in, you know, uptake of the product or growth of the product as you get approval in Alagille syndrome? Thanks very much. Thank you, Richard. What we see is that the aesthetic sales to Galderma, there was a bit of phasing, so there was a bit less sales to them. However, the data we got from them in terms of sellout shows that their sellout data is developing very nicely and they're gaining some market share from what we understand. It's more like a phasing thing. In the treatment space, we are growing also in the U.S. In terms of double-digit growth for the year on Dysport, as you know, we don't guide per brand. On the other side, I think we see a very good development of Dysport overall in aesthetics and in the treatment of spasticity mainly. That's our main indication. We are positive on the development on Dysport. Regarding your question on Alagille, for Bill, A, of course, you're right. Livmarli has a first-mover advantage, and I mean, in pharma, that's generally true if you're not completely different as a drug and having massive superiority on efficacy. Usually, the first mover has an advantage in terms of market share uptake, so it will take some time in Alagille, for the uptake. Having said that, we believe that the difference in the galenic formulation with them having a liquid and we having granulars, granulates and capsules, especially for the older babies or older patients or teenagers, can be an advantage. We have to observe how this is gonna pan out. Thank you. Thanks. Question. Thank you. As a reminder, to ask a question, please press star one one on your keypad and wait for your name to be announced. Your next question comes from Matthew Weston at Credit Suisse. Matthew, the line is open. Please go ahead. Thank you very much. Apologies if you touched on this in your opening remarks. I joined the call a little later. I'd be very interested to discuss Tazverik. David, it's probably disappointing investors' expectations in terms of where we are now. I would love to know whether it's matching what you anticipated in terms of relaunching the product. If not, what is it that's different than you expected, and what can you do to re-accelerate the growth of the franchise? Hi, Matthew. Thank you for your question. The question was not asked yet, so no worries. Regarding the uptake of Tazverik, as we said at the acquisition is that Epizyme, given their structure, was positioning this drug mostly in the academic setting and in mutant patients. We actually think that's the wrong positioning. The drug should be positioned in more elderly, frail patients and in all comers. We have seen now that NCCN expanded the recommendation from mutant only to mutant and wild type. That was a very important step that we had to achieve, and we have recently achieved that. You see two underlying dynamics playing against each other. Since the drug was mostly used in these mutant patients in academia, where Lunsumio is launching, it is logical that we see a bit of a pressure there on the new patient pickup in academic centers. That was to be expected, and that's in line with our expectations because we really believe the drug is gonna be ideally positioned for office-based physicians. That is where we are seeing now an increased prescriber base. We go from 500 to 600 physicians now prescribing Tazverik. We see longer treatment durations coming in, and we also start to see earlier use of Tazverik. Having said that, since these two dynamics play against each other, you see this gradual ramp-up of Tazverik with a 21% growth quarter versus quarter. It is gonna take some time to really see Tazverik grow because when you look at office-based oncologists or hematologists, they typically treat between two and four follicular patients which are eligible per year. You know, it's not gonna be a massively fast ramp-up. It's gonna be a gradually, you know, recovery on the repositioning and also because of the number of patients that you can put on the drug, and then you need to keep them on the drug. That is really where we are today. It's slightly below our expectations, but we were anticipating that this dynamic is gonna unravel as I just described it. Can I just ask one quick follow-up? Yeah, sure. Apologies. We'll bring Matthew back shortly. He disconnected there. Your next question is being prepared. Please stand by. Your next question comes from Manos Mastorakis at Deutsche Bank. Manos, your line is open. Please go ahead. Hi, thank you for taking the question. Quickly, I just wanted to ask about Tazverik initial feedback from doctors and patients on the market. Secondly, again, on Tazverik, just how you're thinking about the clinical development program and further indications that you plan to study. More specifically, in terms of CRPC, given the highly competitive landscape there, what level of efficacy or How are you thinking about, you know, the data that you're gonna get there and how you're gonna move forward? What do you hope to see in that study? On your first question, feedback from physicians, so obviously, office-based physicians, they see that the drug is very well tolerated also in the elderly and frail, which is perceived as being an advantage. Of course, when you compare it to bispecific antibody and CAR-Ts, it doesn't have most probably the same complete responses. That's why we believe it's gonna be reserved more for the elderly and frail, and the younger fitter are gonna be treated in the academic hospitals where they can also handle the cytokine release syndrome that you might have. Patients, we do not interview patients quite honestly, because, I mean, you know, when you have lymphoma, patients actually trust what their hematologist or oncologist are prescribing them. It's really pertinent what physicians think. Regarding the clinical development program, as you might have seen in the appendix to our slides, which are on our website, we are conducting the second-line indication in follicular lymphoma that is expected to unblind in 2027. We also have a couple of phase I or two trials, one of them being in prostate cancer in combination with enzalutamide. We have also one in DLBCL in combination with Monjuvi and REVLIMID, and we have one in follicular lymphoma in relapsed refractory in combination with Lunsumio. These are, you know, first exploratory trials. We have to really see how the data is gonna look like. I don't wanna speculate what the results are gonna show because, you know, when you do these early combinations, well, it's different. You just wanna wait for the data and then take it from there. I think then we come back to Matthew again. Is that right, operator? Matthew had still a question, and I think he was cut. Correct. Matthew, if you can still hear me, please press star one one on your keypad to join the queue. In the meantime, please stand by while I prepare your next question. Your next question comes from Michael Leuchten at UBS. Michael, your line is open. Please go ahead. Thank you very much. Similar to Matthew, if I'm asking something that's been addressed already, I apologize. I was late to the call. Two questions, please. One, just your observation what's going on in China at the moment. The message coming out of the peer group is a little bit mixed, with some companies benefiting from inventory buildups as inventory, wholesalers were expecting the reopening to deliver more demand, which may or may not be coming through. It looks like Decapeptyl was a little bit soggy in China. Just your read, what are the dynamics at the moment? If there is distortion, when would you expect it to normalize? David, in the past you've been quite happy to comment on reform proposals. Just interested in your view of what's been proposed in Europe now. Is it a good idea? Is it a bad idea? How long will it take? Any color would be interesting. Thank you. Yeah. On your first question on China in general, as you know, I mean, our main drug in China is Decapeptyl. We also have Somatuline. We are starting to see that China is coming back to normal. There was a backlog obviously. We did not see, let's say, an inventory buildup that we had this year. In fact, the inventory buildup was as we communicated in Q1 last year before COVID-19, that is why the sales that you have seen in Q1 this year didn't compare favorably to the Q1 last year. However, our Chinese team believes that Decapeptyl is gonna reaccelerate now in the quarters to come in China. The distorted effect, if you want, is the comparison to this inventory build versus Q1 last year. Regarding your question on the pharmaceutical legislation reform, the, you know, paper that now we have seen since yesterday, published by the commission. The pharmaceutical legislation reform should be an opportunity for Europe. There are some aspects in there, which I think are positive. We see that the commission and therefore the council and the European Parliament, which will have to discuss this, is striving to accelerate the approval timeline. I would say that's a good thing. There is something which is quite concerning, and that is the definition of the patents, and especially the data protection and the orphan drug protection. What we are seeing there is on the data protection, it goes down from eight years to six years, and then you can get additional years if you fulfill some conditions. Some of these conditions, in our view, and we're totally aligned with EFPIA here, do not make a lot of sense, or they are ill-defined. I'll give you an example. It says that we have to launch in all member states, but of course, launching is dependent that you actually submit and you get accepted. We believe it should not say launch, it should say submission. We have, you know, given that feedback, but we have not really been heard, and I think that's a discussion which should be ongoing. The other one is you can get additional prolongation, for example, if you hit a high unmet medical need. It seems, you know, kind of strange to say EMA would approve drugs which do not satisfy an unmet medical need. That definition of unmet medical needs is not precise, and I think it would also require some more work on, you know, what does this mean? We would actually think it would be better to leave the eight years, not go down to six years because we need to remember, you know, that with other regions like the U.S., which are very attractive, and China, which is clearly a very dynamic region as well. Europe is getting in a bit of squeeze and has lost, you know, for example, on biotech towards the U.S. Making reforms which are hampering the industry are certainly not gonna help Europe. This is something as an industry association that we want to discuss further with all the countries in Europe and with the European Parliament. Thank you so much. Next question. Thank you. There are currently no more questions. Matthew is not in the line anymore? He was, but then he switched off again, so maybe Michael Leuchten's question was similar. Okay. Very good. Good. Thank you. That concludes our presentation and our response to questions. Thank you very much, everybody, for joining. Have a good day. Bye-bye. That concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.