Good morning everyone, and thank you for joining us on this very special day for MedinCell. Today, as you can imagine, we will discuss what WELTRUZA U.S. approval means for MedinCell, the market opportunity, and the long-term financial impact for the company. Then we will take questions from analysts. Joining me today are Christophe Douat, our Chief Executive Officer. Hi, Christophe. Hello, everyone. Hello, David. Stéphane Postic, our Chief Financial Officer. Before we start, I want to remind you that today's presentation and our comments include forward-looking statements involving risk and uncertainties. Actual outcomes may differ materially. Please review the important notice on slide number two of the presentation. I remind you also that all information speaks only as of today. Christophe, that said, I leave you the floor. Thank you, David, and welcome everyone. WELTRUZA's approval is a decisive step in our shift to growth strategy. Our three engines are now progressing in parallel: UZEDY, WELTRUZA, and our partnered and internal pipeline, including our first program with AbbVie. Together, they illustrate the model we are building: multiple differentiated long-acting medicines supported by multiple partnerships and capable of generating recurring value over time. WELTRUZA is transformational for MedinCell across three dimensions. Innovation, the first and only once-monthly subcu olanzapine LAI for adults with schizophrenia. Financial impact, a second potential stream of recurring royalties alongside potential milestones. Platform validation, a second FDA-approved product demonstrating the repeatability of our technology and business model. Schizophrenia is a chronic, progressive, and debilitating disorder, and long-term adherence remains a major challenge. Missed doses can lead to treatment failure and relapse. By reducing the burden of daily dosing, long-acting injectables can support adherence and lower relapse risk. This is the patient need WELTRUZA is designed to help address for appropriate patients treated with olanzapine. Today, long-acting injectables are the core of schizophrenia innovation. LAI penetration in schizophrenia is expected to increase from approximately 13% in 2025 to 18% beyond 2030. Within this growing market, around 300,000 U.S. patients are already treated with oral olanzapine. Olanzapine is a well-established treatment option, including in more complex patient populations, but LAI penetration has remained minimal because of the post-injection monitoring requirement associated with the previous option. WELTRUZA is the first olanzapine LAI approved in the U.S. without a post-injection monitoring requirement. This removes a major practical barrier to the use of long-acting olanzapine. It is administered subcu once monthly, requires neither loading doses nor oral supplementation at initiation, and is available in three doses corresponding to commonly prescribed oral doses. In Teva's phase III SOLARIS program, WELTRUZA demonstrated efficacy across symptoms, illness severity, and personal and social functioning. Its systemic safety profile was consistent with oral olanzapine, and no cases of PDSS were observed during clinical development. No cases of PDSS were observed during clinical development. Commercial adoption will depend on launch execution, reimbursement, physician adoption, and patient access. UZEDY and WELTRUZA are complementary treatments based on different active ingredients and addressing different clinical needs. Together, they cover the two most widely prescribed atypical antipsychotics in schizophrenia and have the potential to address roughly 75% of schizophrenia patients in the United States. As you can see on the slide, the contrast is clear. Long-acting formulations are already well established for risperidone and paliperidone on the left, while olanzapine remains widely used orally, but largely untapped in long-acting form. WELTRUZA removes a key barrier that historically limited olanzapine LAI adoption. Teva expects to begin making WELTRUZA available in the United States in the coming weeks. Patient access will depend on market access processes and discussions with payers, which will take time. Teva brings deep expertise in the U.S. schizophrenia market, an established commercial infrastructure, and recent experience launching and growing UZEDY. This provides a strong foundation for WELTRUZA, while outcomes will depend on execution, reimbursement, physician adoption, and patient access. Stéphane, I leave you the floor for the financial framework. Thank you, Christophe. Now with UZEDY and WELTRUZA, MedinCell has two approved products under the same economic terms, assessed separately for each product. For each of the two products, MedinCell is eligible to mid-to-high single-digit royalties on worldwide net sales. Up to $108 million of milestone remains for UZEDY, and up to $112 million for WELTRUZA, including the $4 million milestone that we will get right at approval, which will be payable in the coming weeks. Commercial milestones depend on specified annual net sales thresholds. Royalties, as you know, are the principal driver of the long-term value. Teva currently estimates combined peak sales of up to $2 billion for the two products, UZEDY and WELTRUZA. This is Teva's publicly stated expectation for the franchise, not MedinCell guidance. At that level, MedinCell's annual royalties could approach $150 million, depending on the product sales and applicable rates. This is an illustration of what it can represent and definitely not a MedinCell forecast. The U.S. patent portfolio covering WELTRUZA includes multiple granted patents extending to 2044. Patents may be challenged, and this should not be interpreted as guaranteed exclusivity through that date, but intellectual property now provide an important foundation for the long-term value creation. Back to you, Christophe now. Thank you, Stéphane. I would first like to thank Teva and all the teams who contributed to this approval. It reflects years of persistent scientific rigor and close collaboration between Teva and MedinCell. Let me close with three key outcomes. WELTRUZA addresses a major treatment gap and opens a significant opportunity in a large established oral olanzapine population. It creates a second long-term royalty stream and expands MedinCell's recurring revenue base and growth potential. Last, with two FDA-approved products, MedinCell's platform is now established as a proven engine for differentiated long-acting medicines. One last thing I would like to say. WELTRUZA is more than a second approval. It opens a new growth chapter for MedinCell and contributes to a broader transformation driven by execution, growth, recurring revenues, an expanding pipeline, and world-class partnerships. We believe MedinCell is entering the most transformative years in its history. Thank you. We are now ready to take your questions. Thank you, Christophe. Thank you, Stéphane. As you suggested, Christophe, we can start questions, and we'll start with Mike from Evercore. Mike? Great. Thanks so much for taking my question, and much congrats on the approval. I know this is a long time coming and well deserved. Three questions from me. I wanted to get your thoughts on what you expect the maximum conversion from oral olanzapine might be and how this may differ in the U.S. versus the E.U.. I have two follow-ups. The conversion rate at MedinCell, we think it could be higher than risperidone and paliperidone because of the higher need for compliance with the population that takes olanzapine. The second point I would make is since there is no appropriate LAI of olanzapine on the market, it's a wide open road for WELTRUZA, which should experience a faster ramp-up than UZEDY. Thank you, Christophe. Next question from Shan Hama from Jefferies. Hi, Shan. You can unmute. Okay. Yeah. Okay. Hi there. Thank you so much for taking my questions. I have two, please. Given that Europe is, of course, waiting for that decision at the moment, could you help us understand how significant the PDSS monitoring guidance is in Europe and how that looks versus in the U.S., just to get an idea of the potential uptake in Europe, if and when it gets approved? Then secondly, I guess earlier on Teva's call, management noted that expansion into bipolar mania would require additional clinical studies. Given that WELTRUZA's approval without monitoring requirements has been achieved, how are you thinking about future label expansion opportunities for this asset, or do you think this is a primarily severe schizophrenia asset? Thanks very much. Yes. When you look at the existing product, which has PDSS, if you look at the existing patient population, I believe there is around 300 patients in the U.S. as we speak that use the existing product which used to be Eli Lilly. There is a wide open space for WELTRUZA. In Europe, same situation. PDSS has really scared clinicians and patients from using the existing LAI product. We expect a very strong, significant shift from oral olanzapine to the WELTRUZA olanzapine long-acting, in the upcoming months and years, both in Europe and in the U.S. We can't disclose Teva's plans on indication expansion. But it's certainly, obviously, given the very significant potential of olanzapine LAI, something that Teva is looking at in the same manner as they looked at it for UZEDY and expanded into the bipolar disorder indication. Thank you. Thanks. Yes, Shan? You want to add something, Shan? Oh, sorry. I just said thank you. Thank you. Thank you, Shan. Next question is from Nicolas Pauillac of Kepler Cheuvreux. Nicolas? Yes. Hey, guys. Hopefully you can hear me, and congrats on the big news. It brings back 2023 memories. Big congrats. Maybe two questions on my end. One is going to be pretty fast, was just maybe a clarification on what you said, Stéphane. When you mentioned that these are Teva's target for. Were you implying, sorry, that you think they are kind of too conservative, or it's just to, let's say, repeat that you only get royalties on that? So this was just a quick clarification there. Then the second question, how should we think about this ambition of MedinCell to reach the operational profitability, knowing that Teva in their call were, let's say, pretty vocal in the fact that they were highlighting that we should expect a slow ramp-up into H1 2027 and then probably an acceleration of the sales into H2. How should we think about that when we look at, let's say, MedinCell angle there? Okay, thank you for the question, Nicolas. On the first part, indeed, I emphasize on the fact that it is Teva's guidance that I was mentioning, with this $2 billion franchise for the two products. As you know, since you are following MedinCell for a long time, all of you, we believe that there's indeed more room to play on the two programs. UZEDY is going to achieve almost $300 million, maybe even $300 million this year. So it means that it's on target to become a blockbuster product by the beginning of the 2030s. And we all know that the potential of WELTRUZA is even bigger than for UZEDY. All in all, $2 billion for the two products seems indeed a bit conservative. But at the moment, it is indeed the public guidance from Teva. We are sticking to that guidance. But hopefully, we'll have some more good news to share in the coming years. Now on the operating profitability, I would say that definitely the news of today is a good one because it triggers, first, a milestone of $4 million. It also means that we are going to receive royalties from Teva on the WELTRUZA net sales on top of the UZEDY ones. So things are definitely going in the right directions in terms of revenues. Does that mean that profitability is going to happen in 2027? I'm not going to comment on that. And as we've said during different occasions, as of today, we are clearly focusing on accelerating the growth on the rest of the pipeline. Christophe mentioned very briefly the third engine that we have with the first AbbVie program as the first program in the pipeline. That's definitely something that we are looking carefully at, and we are making to have all the resources rightly allocated. Thank you, Stéphane. Next question's from Damien Choplain of Stifel. Hello, Damien. You can unmute. Yeah. Hello. Sorry. Can you hear me? Yes. Yes. Hi. Congrats on the approval. I have one question regarding weight gain. Is there evidence of any metabolic difference versus oral olanzapine, or should we assume the same profile? Would it make sense to combine WELTRUZA with obesity drug to offset the side effects and in the end, limit potential treatment discontinuation? Hello, Damien. Yes. It is a similar profile between oral and WELTRUZA. However, I was at the Psych Congress in New Orleans just two weeks ago, and something we will watch very closely is the impact of the use of GLP-1s on olanzapine, because the early data shows that the weight gain can be mitigated by using GLP-1s. We know that soon, like in 2031, semaglutide will get off patent and could provide a boost to the use of olanzapine. So we plan to evaluate this potential more closely, because from the early information we have, weight gain is what is limiting the use of olanzapine. It is still the most used antipsychotic, but it could do a lot more if it had less weight gain. So more to come on that subject, but it is really on top of our agenda here at MedinCell. Thank you, Christophe. Next question is from Marc Goodman of Leerink. Hi, Marc. Yes, Marc? We cannot hear you, Marc. Marc, we cannot hear you. You are on mute. Yeah, but you are on mute. Maybe try again. Hello. How about now? Yes, we can hear you. It's not Marc, but we can hear you. Yes. Okay. Hi, everyone. This is Alyssa in for Marc. Congrats on the approval, and thanks for taking our question. I was wondering if you could give us an update on the BEPO Star platform and when we might get some more data on how the progression is going for the next generation approaches. Thank you. Yes. Just to remind everybody, within our three engines of growth, UZEDY is number one, WELTRUZA now number two, and innovation and pipeline are the third engine. At the R&D Day of May 12, we said that we were switching all programs to use of BEPO Star, which is our new generation with patent life moving from 2033 on BEPO linear to 2040 on BEPO Star. This is just the technology patent life because, of course, on products like UZEDY and olanzapine, we have additional patents on method of use and composition of matter. Yes, BEPO Star is moving into all our new collaborations and internal programs. Beyond that, we also said in May that we had early innovation that was creating the most excitement I had seen at MedinCell in 15 years. Today I can confirm that the excitement is growing after additional data, and that we are starting to accelerate the scale-up of this third generation as well, and contemplating its use in selected partnerships. Thank you, Christophe. Next question is from Martial Descoutures from Oddo. Hello, Martial. Hello, hello. Do you hear me? Yes. Great. Thank you very much for taking my question. Maybe just a follow-up question of Nicolas previously asked. When do you expect royalties and milestone from WELTRUZA to become a meaningful contributor to MedinCell? Maybe a clarification on the milestone expected. Are they linked to the geographical expansion, or is it only linked to the sales of the drug? Thank you. Okay. To answer your question, Martial, first maybe on the milestone. We are entitled indeed to receive today $4 million from Teva thanks to the U.S. approval. We are also entitled to receive $3 million once the product gets approved in different E.U. countries. That should come next year, probably end of 2027, beginning of 2028. On the contribution that you mentioned, we expect to have a much faster ramp-up on the WELTRUZA than on the UZEDY because of the simple absence of any competition. Probably the ramp-up to peak sales will be much faster for the second product, for WELTRUZA. We will see. Thank you. I think that was the last question. There is no more question. Thank you, everybody. Thank you for joining us. Christophe, I leave the user floor for conclusion. Well, thanks to all. We all know how important this news is for MedinCell, of course, for patients. We have been looking for this. We have been looking for the approval with no monitoring requirements, and we have it. It is amazing news. A historic moment in the life of MedinCell. We will be talking soon and watch this ramp-up of this amazing product.
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