Medincell Aktie

Hello, everyone. Thank you for joining MedinCell's Annual Results Call for the fiscal year ended March 31, 2026. Our press release and presentation are available on our website. Before we start, I invite you to refer to Slide 2 for important information regarding forward-looking statements. Joining me today are Christophe Douat, our CEO. Hi, Christophe.

Hello, everyone.

And Stephane Postic, our CFO. Hi, Stephane.

Hello, everyone.

And with that, I can now leave the floor to you, Christophe, to start the presentation. Christophe?

Thank you, David. Let me start with MedinCell's trajectory. Our shift to growth strategy is built around 3 engines of growth, all powered by MedinCell's innovation. The first is risperidone LAI with UZEDY successfully marketed in the U.S. since 2023 by our partner, Teva. The second is olanzapine LAI and the third is AbbVie #1, together with our broader pipeline and innovation platform.

What is important here is that these are not isolated assets. There are 3 complementary engines supporting both near-term execution and long-term value creation. As you may recall, 1 year ago, when I introduced our shift to growth strategy, I said that the coming 2 years would be the most transformative in MedinCell's history. One year later, I can confirm that we are exactly in the middle of that transformation. In fiscal year '25, '26, we delivered strong execution across all our growth engines. We saw continued ramp-up of UZEDY, which is driving royalty growth. Olanzapine LAI progressed toward its expected U.S. launch in the fourth quarter of 2026. And on the third engine, we advanced our first IV program toward the clinic while continuing to expand our pipeline and further strengthen our innovation platform. So this was a year of broad execution, not just progress on 1 product but progress across the company.

Starting with UZEDY, momentum continued to build during the year. Net sales by Teva reached $215 million compared with $141 million in the prior fiscal year, while royalties increased to $10.9 million from $7.1 million. At the same time, prescriptions in the U.S. continued to trend upward and the product benefited from an FDA label expansion into bipolar I disorder for the 1-month formulation in October 2025.

So the key message is simple. UZEDY is gaining traction, and that traction is translating into growing revenues for MedinCell. Beyond the pure numbers, UZEDY provides an important proof point for our business model. It combines innovation for MedinCell, enabling differentiated products with strong commercial execution from our partner. These differentiating features such as ease of use, flexible dosing, rapid onset, are directly driven by our technology. At the same time, our partner demonstrates strong commercial execution. Teva's initial 2026 guidance is $250 million to $280 million with $63 million already delivered in the first quarter of the year. So what UZEDY shows is that differentiated long-acting products, combined with strong commercial execution can deliver meaningful market adoption. And this gives us confidence as we prepare for the upcoming olanzapine LAI launch, which is built on the same combination, innovation and execution.

Turning now to olanzapine LAI. The regulatory path is clearly defined. In the U.S., the new drug application was submitted in December 2025 and accepted by the FDA in February 2026. In Europe, the market authorization application was -- sorry, has been submitted this year. We are expecting U.S. launch in the fourth quarter of 2026, subject, of course, to regulatory approval. So we are now entering the final phase before what could be a major inflection point for the company.

The opportunity of olanzapine LAI is driven by a clear unmet medical need. Olanzapine is one of the most widely used oral antipsychotics, both in the U.S. and in Europe. It is often prescribed for the most severe and refractory patients, typically, those who would benefit the most from a long-acting treatment option. And yet today, there is no practical LAI options available.

Let me show you this slide again. On the left, you have Johnson & Johnson; Risperidone on the right, Eli Lilly and olanzapine, both follow the same life cycle strategy with LAIs. Johnson & Johnson was highly successful, building a $4.8 billion franchise, Eli Lilly failed commercially. UZEDY is targeting Johnson & Johnson's franchise. But look on the right, there is no large multibillion green box. Eli Lilly failed commercially. FDA imposed a 3-hour wait after injection. And MedinCell gave Teva the keys to grab this potential.

This is where differentiation becomes critical. Existing olanzapine LAIs are constrained by PDSS-related monitoring requirements. PDSS is an overdose like reaction that can happen at each administration if the injection is made into the vein by mistake. With MedinCell's subcu formulation, more than 4,000 injections have been performed across clinical studies with no PDSS observed. This is supported by in vitro data showing a controlled release profile even in plasma, in contrast to the rapid release observed with intramuscular existing formulations.

Plus, there is only 10- to 20-micron wide blood vessels in the subcu space when they can reach 1 to 2 centimeters in the muscle. This could significantly expand the use of olanzapine in long-acting injectable form.

Beyond UZEDY and olanzapine, we are building our third growth engine. This includes developing a portfolio of long-acting injectables, mainly with blockbuster potential. We are continuing to expand our technology platform and leveraging partnerships to scale development and commercialization. So we are not just building around 2 products, we are building a broader engine for sustainable growth.

And this third engine is already supported by concrete progress. With AbbVie, our first program is progressing toward clinical development with CMC work expected to complete this year, supporting a clinical start in 2027 by our partner. For mdc-CWM in post-TKR pain, Phase III preparation is ongoing with initiation still expected in 2026. More broadly, we now have 15 active programs at formulation stage across internal and partnered assets with increasingly focused on high-value indications.

So this is a pipeline that is both broad and actively advancing. Underlying all this is the continued expansion of our innovation platform. As highlighted during our recent R&D Day, our capabilities now extend across a broader range of molecules from small molecules to increasingly complex peptides. This expansion enables us to address more opportunities and support the growth of our pipeline and future partnerships.

So overall, we have strong execution on UZEDY, a clear path toward olanzapine launch, and the growing third engine driven by our pipeline and platform. With that, let me now turn to the financials, Stephane.

Thank you, Christophe. So as already mentioned by Christophe, we are really entering into a new era, and that's specifically true in terms of business model as we are now scaling a portfolio of innovative products generating royalties.

Let me highlight 3 key messages here that illustrate this change. First, we are generating strong and regular revenues, which includes a massive growth in UZEDY royalties. This will continue to drive the expansion of our recurring revenue base and to support our path to operating profitability. Second, we see a strategic voluntary increase in the operating expenses to support future growth and value creation. And third, we have a much stronger balance sheet with EUR 85 million of cash available that provides clear long-term financial visibility.

Now starting with UZEDY. We all see that UZEDY's strengths are really exciting. We continue to see the strong commercial momentum reflected in sustained growth in net sales reported by Teva. They reached $250 million during our fiscal year from April 1, '25 to March 31, '26. This translated into a very significant increase in royalties, up 54% in U.S. dollars and slightly lower once converted in euros, but still a very nice increase of 42%, reaching EUR 9.3 million.

I'd like also to remind everyone that we really see a regular acceleration in UZEDY sales. Q1 '26 net sales reached $63 million, up 62% compared to last year. Q1 '26 was the strongest quarter ever for UZEDY, confirming strong underlying demand and continued adoption by doctors and patients. Ahead of olanzapine launch, UZEDY remains the short-term key driver of our expanding royalty base.

Now moving to the revenue dynamics. Total income for the period was EUR 24.3 million, slightly lower compared to the EUR 27.7 million posted last year. Why that? There is some variability coming mainly from the milestone payments. In fiscal year '25, '26, we did not get any milestones versus a EUR 4.8 million milestone linked to olanzapine Phase III result the year before. Milestones are triggered by one-off events, and they happen in certain years, not in others.

Of course, they are valuable when they occur, but they are not the best way to read the underlying trajectory of the business. What is most important and relevant is illustrated on this slide. We are clearly switching into a more royalty-driven revenue model. Royalty income continues to increase as a share of the total revenue, reaching 38% this year versus 22% last year.

When excluding the milestone effect, the underlying revenue increased from EUR 22.9 million to EUR 24.3 million, reflecting the continued progress in our core business. Even more striking when you look back at the revenue evolution over a longer period, you can clearly see that our revenues, excluding milestones have been multiplied by 3 over the last 2 years.

Now a couple of additional words on the revenue -- of the revenue items. So AbbVie collaboration is progressing well and as planned. As Christophe said, we are now getting closer to the IND. And the revenue recognition, which is based on the received upfront, reflects the activities performed during the fiscal year and represented EUR 6.4 million last year.

Among the R&D partnerships, you find also the early-stage collaboration revenues. They nearly doubled last year to EUR 1.6 million, and they cover 8 partner-funded programs. That's very promising because it means as many potential future opportunities for licensing deals with pharma or large biotech companies.

And finally, one comment on the research tax credit contribution, which has also doubled year-on-year. This is actually a nice transition to the next slide and the continued R&D effort that I will comment on in a minute.

Moving to the operating expenses that have increased to EUR 45 million compared to EUR 38.5 million last year. This reflects a deliberate and disciplined increase in the expenses to support our future growth. So we'll start with R&D. First, a comment on R&D instead of talking of operating expenses, I would rather call them investment because a big portion of them is there to create value in the long term.

R&D remains the largest component of our expenses, representing around 60% of the total. We shared more information on our innovation strategy during the recent R&D Day. Accelerating innovation is at the heart of MedinCell strategy. We have 2 core priorities in terms of R&D, the product pipeline and the technological platforms behind them, advancing our pipeline to generate high-value data is really key to our business model. It enables us to engage with partners under attractive economic condition. We currently have 15th program in formulation, 7 internal, 8 already partner funded.

For all of them, the aim is to generate high-value data to support future licensing discussion, like we did in the past with AbbVie where we started to work on one of their assets before the deal execution. And secondly, we are continuing investing to strengthen our technology platform to BEPO, BEPO Star and other future generation. And this is mandatory if we want to expand our capabilities to formulate more and more molecules.

Beyond the R&D, business development expenses have also increased. It's reflecting our willingness to intensify partnership activity and to expand globally. And finally, G&A are increasing to support the scaling of the company, mainly with personnel-related costs and also expenses relating to IT and cybersecurity infrastructure.

On the next slide, you have the income statement. So MedinCell is really today at an inflection point. Christophe has been telling our investors repeatedly that the current years are the most transformative ones, and they are. We anticipated that fiscal year '25, '26 would be a transition year from a financial perspective because of the absence of any milestone and some variability in the R&D revenues. We end up with an operating loss, representing EUR 20.8 million.

Below this line, the financial result is a loss of EUR 10.6 million, including a EUR 5.4 million of noncash impact related to the EIB warrant revaluation. You know that we have successfully negotiated with the EIB a waiver on the put option in March '26. So this cash -- non-cash impact should disappear in September '26 once we get the final approval at the general meeting on the revised terms for these warrants.

And this will definitely ease the reading of our accounts when it will be done. Total annual net loss was EUR 31.3 million. And again, as a conclusion, I'd like to say that this loss reflects a deliberate acceleration. We are building scientific, technological and partnership assets that will drive future revenue growth and value creation.

Next slide is on the balance sheet, and I guess it speaks by itself. We continue strengthening our balance sheet to support our growth strategy. We ended the period with EUR 80.8 million in cash and financial deposits and more than that, our cash position net of debt is also positive for the second year in a row at EUR 15.3 million. This really highlights that we are gaining the financial flexibility needed to support our growth strategy.

Now let me conclude with the growth outlook for the next years. So we are really building a clear multi-engine model. First, UZEDY is already generating and scaling royalties. The current sales expectation for '26 are close to $300 million. If you compare the sales figure to other existing products on the market, UZEDY is already on track to become a blockbuster by the beginning of the 2030s, meaning tens of millions in royalties for MedinCell by then.

Second, olanzapine LAI should be approved in the coming months in the U.S. and then in the EU. This will trigger nice milestone payments and even more important, first royalties are expected as early as Q4 '26. Given the strong expected demand and the current competitive landscape, we anticipate that revenues could become meaningful from the second half of '27 with a faster ramp than for UZEDY. And third, we are building a broader pipeline and more partnerships, including AbbVie and others. So all exciting things ahead. And that's it for me. So Christophe, back to you for a word of conclusion.

Thank you, Stephane. To conclude, I will repeat what I said earlier. One year ago, when I introduced our shift to growth strategy, I said that the coming 2 years will be the most transformative of MedinCell's history. One year later, I confirm that we are exactly in the middle of that transformation. Thank you.

Thank you, Christophe, and thank you, Stephane. We can now open the call for questions. And with the first question, coming from Ram Selvaraju of Wainwright.

I cannot hear you. But I wanted to ask 3 quick questions. Firstly, I wanted to know if it would be possible for you to comment on the guidance that Teva has historically been providing regarding UZEDY, which clearly appears very conservative. And if you expect this pattern to continue, not just with UZEDY in the future, but also once olanzapine LAI arrives on the market. And also, if you could give us any granularity regarding how rapidly you expect Teva to be able to make olanzapine LAI available in the United States?

Secondly, I was wondering if you could clarify business development expenses delineated in one of the slides that Stephane showed, what do these consist of precisely?

And then lastly, I was wondering if you could comment on the level of exposure to foreign exchange fluctuations and the degree to which you might be able to hedge against these in the future, especially given the possibility of future depreciation in the value of the U.S. dollar versus the euro and/or if there are any specific provisions made in the agreement between MedinCell and Teva to take account of this potential eventuality?

So maybe I'll answer the first two questions. And then Stephane, you can answer the others. So it is Teva's policy to be very conservative on guidances. The first year of UZEDY, the initial guidance was $80 million. They ended up at $120 million. On year 2, it was initial guidance of $160 million and ended up at $191 million. So we expect them to keep being conservative. That's Richard Francis' strategy.

On the next question, when do we expect olanzapine LAI to be available? Teva said clearly that they would launch right away upon approval.

Right. And to answer your question on the BD expenses, they cover personnel costs for our business development and market insight people. So we've built up a very nice team. And as I say, the will of the company is to expand globally. So we have now people all around the world looking for additional partnerships and opportunities.

And on the second question regarding the exposure to USD fluctuation. It's only versus USD that we have a small difficulty. No other currency at the moment. So indeed, all the royalties are labeled in USD. The best way to hedge against that is to repay as much as we can in USD. So I'm trying now to sign agreement with suppliers that are also issued in USD. Apart from that, it's a bit difficult because indeed, a good portion of our expenses are in euro.

Next question comes from Shan Hama of Jefferies.

I've got three, if I may. So firstly, I know in the release, it states that for the AbbVie first candidate, the initiation of clinical development will be in 2027. So to be clear, we'll know the candidate in 2027, not in 2026.

And then secondly, I saw a bit on the potential delayed initiation of the 6-month contraceptive program due to change in the regulatory pathway. Could you expand on what those changes are, please?

And then finally, of course, it's very sad to hear that Richard has retired. Obviously, we wish him the best. Obviously, he was very valuable to the company in his role, given he's previously been at Teva within the psychiatry team. So just wondering what sort of candidates are you looking for? And are you looking internally and externally?

Thanks, Shan. So yes, the AbbVie #1 program should start clinical in '27, and we expect AbbVie to disclose the name of the underlying drug at that time. So as we said, there is a change in the expected regulatory path for WWM. And we do not comment on that.

On the third point, as you noticed, Richard, which has been my [ companion on the road ], as I say, in France for many years is retiring, but still consulting for us, especially in the psychiatry field. And we are getting very close to get a new CMO on board which is -- actually, it should be a woman who will be adding a lot of value to MedinCell with all the core competencies that we need in -- especially in preclinical and opportunity identification.

Next question comes from Michael DiFiore of Evercore.

Congrats on the continued progress. Two questions for me. Number one, you've spoken about becoming more selective and generating more data internally before partnering. So today, is the challenge primarily finding technically feasible opportunities or finding opportunities that are large enough to justify the level of investment and economics you are now targeting? That's question number one.

Number two is that at the R&D Day, you showed progress with larger peptides, GLP-1 type molecules and highly soluble compounds. So as you look at the platform today, what remains the biggest technical challenge you're still trying to solve and what would solving it unlock in terms of new partnership opportunities or addressable markets?

Thanks a lot, Mike. So on the first question, yes, so about half of our formulation early-stage pipeline is made out by internal programs that we have identified like with AbbVie #1. We look at the pipelines of big pharma, large biotechs. And then we evaluate the potential as LAI and look at technical feasibility on a paper-based. And if we think it's positive, as we explained during the R&D Day, then we move into early formulation and with the objective to trigger licensing. And some of those programs are quite exciting and have significant potential as long-acting injectables.

So on the second question, the biggest challenge in the formulation. So I should remind that BEPO and BEPO Star are -- their sweet spot is small hydrophilic molecules and we definitely have the best technology in the world for those molecules, which are mostly -- all of the molecules in psychiatry are small hydrophobic molecules. And we are making some very nice inroads into more hydrophilic molecules and the large hydrophilic is definitely 1 objective that we have, obviously, GLP-1s fall into that category.

And the second direction in which we want to expand our technology is higher doses. When you inject a depot under the skin, you are limited by the volume. Usually, we inject at most 1.5 ml. And then you have to take out the volume by the pharmaceutical solvent, the polymers and so what is left is the volume for the API. And so in some cases, we are limited by the dose as well. So as we said, there is innovation in the lab ongoing, as I speak, innovation, which is, I think, generating the most excitement I've seen at MedinCell in the last 15 years.

So there's things we need to confirm in the next few months, but we definitely will use that as the next generation. We just need to define the scope -- confirm the scope.

Next question comes from Marc Goodman of Leerink.

So with olanzapine LAI coming into the franchise alongside UZEDY, can you help us think about how you'd segment the 2 products commercially. Specifically, what patient profile do you expect new to LAI patients to opt for an olanzapine LAI versus risperidone-based, like UZEDY, and then to what degree do you expect switches from UZEDY to olanzapine LAI?

And then secondly, on the AbbVie collaboration, should we think about the 2027 clinical start as a single lead candidate moving forward first and then the rest of the collaboration programs progressing stepwise behind it or multiple candidates moving forward in parallel today?

Yes. The first question is a very good question. Both compounds, risperidone and olanzapine are not in competition. They are complementary. Risperidone is a standard treatment in first intention. Olanzapine is for the most severe and refractory patients and there is no overlap or very little overlap between both, which made Teva say that with both products, they could cover 80% of patients.

On the second question, so AbbVie #1 should start its Phase I in 2027. As a reminder, the agreement with AbbVie allows AbbVie to do 5 more programs with the same financial metrics. But I cannot comment on the status of discussions with AbbVie on the other programs.

And next question is Nicolas Pauillac of Kepler Cheuvreux.

Maybe just three questions from my end, too. Just first to come back on a previous question about the kind of gap there is between Teva's guidance on the potential of the 2 drugs? And what you kind of imply like the blockbuster potential for it, UZEDY, for instance, when you look at the consensus on Teva today, I think it's sitting around [ 506 million ] of sales for UZEDY. So what is making you so much more confident that you can almost double what the market is seeking today in terms of sales for this asset?

And also for the world franchise, I think Teva has been pretty vocal about this EUR 1.5 billion to EUR 2 billion cumulated sales on that. So just trying to understand why -- what is making you so much more confident than what Teva has guided for in the past and has kind of consistently guided for. So that's my first question, just to come back on what was asked before. And then just much more easier question, let's say, on the OpEx, any guidance on how things evolve into next year? And then kind of linked to this AbbVie disclosure, when we think about modeling, should we put some upfront into this fiscal year, so '26, '27 or will it be rather, let's say, smarter to put it next year? That would be the three.

Okay. Thanks a lot, Nicolas. So on the first question on UZEDY. So as I said earlier, Teva's strategy and its CEO, in particular, is to always underestimate guidances to always provide good news to the markets. What we know now after 3 years of commercialization, as Stephane said earlier today, is that it follows the same curve as some LAI in psychiatry, which have reached the $1 billion mark. And the third point I would say is, I think UZEDY was underestimated by analysts, by Teva's analysts at first because it was one product among many others.

At Teva, UZEDY has Johnson & Johnson across the street with all its power. And not many analysts try to understand the differentiation of UZEDY, which is an amazing product, the ideal LAI, it ticks all the boxes and the -- its profile, combined with Teva's execution, is showing that it can take a dent from the $3.5 million (sic) [ $3.5 billion ] out of the $4.8 million (sic) [ $4.8 billion ] from the U.S. part of the Johnson & Johnson franchise. So there is room to go.

Olanzapine, similar scheme, although olanzapine, I think, was better understood by analysts because here there is no competition. It's an open road in front of olanzapine. We think that those guidances will be updated as the ramp-up goes. The initial guidance of UZEDY was extremely low at first. Here, we have a product that has no competition with the most used oral antipsychotic as the underlying drug and -- for patients that are the most severe that need the long-acting injectable the most.

Here, we also have a benchmark. We know that Johnson & Johnson is doing $4.8 billion with risperidone LAIs. We know, as we said earlier, that olanzapine is used more than risperidone. So in theory, of course, in theory, Teva could exceed what Johnson & Johnson is doing today on risperidone. So time will tell. It will depend on execution. But we know that Teva has done great execution on UZEDY in the U.S. that they are getting aggressively worldwide, fighting into Europe and conducting some trials in China as well.

So right. The second question you had, Nicolas, was on the OpEx for next year. So I'm not going to comment or give any figure for next year. But what I can say is that everyone has to bear in mind that 2 things that first, a good portion of our R&D expenses are covered by our partners. So we have many collaborations with AbbVie, with the Gates and with also some undisclosed partners for now that cover the R&D fees.

And the second thing I'd like to reemphasize on is the fact that we have clearly this willingness to build this portfolio of programs. It is the way that we are going to create value on the long term. So definitely, the OpEx will reflect this strategy of going to the next stage.

And lastly, you had a question on AbbVie and if we should expect another upfront for the coming year or when it should come. So I'll just state again what Christophe said a couple of minutes ago, we cannot comment on the next AbbVie program.

Thank you, Stephane. So this concludes the Q&A session. Christophe, last word?

Yes. We are really excited at MedinCell. We're in the middle of what should be the most transformative years of MedinCell's history. UZEDY is growing significantly. Olanzapine is about to be approved. The countdown has started. It's a matter of months. And the third engine is accelerating both on its pipeline and the technology progress. So very, very, very exciting times for us at MedinCell.

Thank you, Christophe. Thank you, Stephane, and thank you all for joining us and for your continued interest in MedinCell. So a replay will be available shortly on our website just right after this meeting, and we look forward to speaking with you again soon. Thank you. Goodbye.

Hello, everyone. Thank you for joining our online R&D Day. If you wish to follow along the presentation, the slides are available on our website. Before we start, I would like to draw your attention to Slide 2, which contains important information regarding forward-looking statements.

Please note that today's discussion may include projections and assumptions, and we therefore encourage you to review this information carefully. After the presentations, we will open the floor for a Q&A session.

And with that, I am very pleased to invite Christophe Douat, our Chief Executive Officer, to open today's meeting. Christophe?

Thank you, David. This is a very special moment for us. Good morning, everyone. Welcome, and thank you for joining us today for our R&D Day. Today is about one fundamental idea: how we turn science into long-term value creation. At MedinCell, innovation is not an abstract concept. It is something very tangible, something that reaches patients, supports physicians and ultimately transforms lives. And what we are building here is much bigger than individual products. We are building a platform, a model, a company designed to create value over the long term.

We are deeply proud of what our teams have achieved, from a strong foundation in polymer science rooted in world-class research to a company that now operates at a global level. We have built an exceptional R&D organization, bringing together talent from more than 30 countries, creating one of the highest concentrations of expertise into the world in our field. And what excites us even more than what we have done is what is now ahead of us. At the core of everything we do, there is a very clear ambition: unlock the full potential of long-acting injectables, improve adherence, enhance treatment efficiency and ultimately transform patients' lives. This is what drives our R&D teams every day. Because in our space, success is not measured by technical achievement alone it is measured by real-world impact.

Now let me step back and remind you of our strategy. We are executing what we call our shift-to-growth strategy, built around 3 engines operating in parallel. First, UZEDY, our risperidone LAI already demonstrating very strong adoption in a very competitive market. Second, olanzapine LAI, waiting for regulatory approval with the potential to unlock a very significant market opportunity. And third, Innovation and R&D, which is the focus of today because this third engine is what will define our future.

This third engine is about disciplined and focused investment. We invest in R&D to broaden our innovation platform, to expand our portfolio and extend our network of partners. Approximately two-thirds of our operating expenses today go into R&D because we see innovation not as a cost, but as the core driver of long-term value creation. And most importantly, we do this with discipline, allocating capital where we can create real differentiation.

Our approach to value creation is very clear. We are building a long-term royalty engine. Each successful program adds a new layer, what we call a string of pearls, stacking revenue streams over time. UZEDY is the first validation. Olanzapine will be the next one, and more will follow. This is how we build sustainable, scalable growth.

Now to explain how we execute this third engine, how we turn science into products and products into long-term value, I'm joined today by 3 key leaders of MedinCell: Adolfo, Head of R&D; David, Head of Intellectual Property; Sebastian, Chief Business Officer. Together, they will walk you through our technology platform, our innovation strategy and our IP and partnering model.

With that, I will now hand over to Adolfo, who will take you deeper into the evolution of our technology.

Thank you, Christophe, and hello, everyone. My name is Adolfo Lopez-Noriega, and I am the Head of Research and Development at MedinCell. Over the next few minutes, I'd like to share how we are building our R&D roadmap for long-acting injectables and how it supports MedinCell's growth, future products, partnerships and long-term value. My objective today is not to go into organizational details or scientific depth. I would like to explain how our R&D choices reduce risk, open up new opportunities and support sustainable value creation.

Let me start with 3 clear takeaways, which will structure everything I will show you today. First, adoption drives value in long-acting injectables, not duration alone, and adoption is something we intentionally design for. Second, our platform strategy enables us to scale innovation across products and indications rather than depend on individual assets. And third, beyond the platform, we invest selectively in focused internal and external R&D to accelerate development and solve product-specific challenges. These three points form the backbone of our R&D roadmap. I will come back to this message through the presentation.

As Christophe said, our R&D is built around a world-class team in polymer science and drug delivery. However, expertise alone is not enough. What matters most is how R&D connects to value-creating functions across the company. We work hand-in-hand with our IP team to ensure that innovation is protected at the right level and at the right time. David Martin will provide details around this after me.

We also work closely with business development to ensure that R&D priorities are aligned with real market needs and partner expectations. This tight integration reduces downstream development risk and ensures that innovation translates into commercially relevant, partner-ready products. This slide is especially important because it explains why some long-acting products succeed while others do not. When long-acting injectables are discussed, attention is often focused on duration: one, two or three months or even longer. Our experience shows that duration alone does not drive adoption.

In practice, adoption has two dimensions. First, physician adoption, driven by ease of initiation, safety, predictability and integration into clinical workflows. And second, patient adoption, which is driven by comfort, confidence, convenience and adherence. If a product is difficult to initiate, if it's challenging to administer or uncomfortable for the patient, adoption will remain limited no matter how long it lasts. That is why adoption and not duration alone is the true commercial differentiator.

Let me illustrate this with a concrete example. We have demonstrated the critical importance of adoption through the outstanding success of UZEDY. UZEDY offers several differentiating features beyond controlled release over one or two months. One key example is immediate onset of action, which is a very tangible illustration of adoption-driven design. Immediate onset means that therapeutic concentrations are reached shortly after administration, as shown in the graph illustrating risperidone concentration over time. For physicians, this simplifies initiation protocols because no oral supplementation is required. And for patients, it provides early confidence that the treatment is working.

Beyond onset of action, UZEDY integrates additional features that remove common hesitation points in real-world use. Subcutaneous administration under the skin rather than intramuscular enables thinner needles and easier injections, which improves patient comfort. No need for loading dose or oral supplementation simplifies treatment initiation for both clinicians and patients, and ready-to-use formulations reduce preparation errors and make administration more straightforward in care settings. Consistent performance regardless of injection site increases flexibility and predictability. Individually, each of these features may appear incremental. But taken together, they have a minimum meaningful impact on prescribing behavior by reducing complexity and building confidence.

Another essential factor for adoption is trust in safety. With olanzapine long-acting injectable, our objective was to address the safety limitations that constrained earlier products. As you may know, a previous olanzapine LAI developed by Eli Lilly was associated with rare but serious overdose light reactions following injection, which are known as PDSS. These reactions were likely due to the unintended intravascular administration of the product, and this resulted into heavy regulatory restrictions and ultimately limited commercial adoption.

Using BEPO, we demonstrated a fundamentally different safety profile. In clinical studies conducted by our partner, Teva, approximately 4,000 injections were administered with no overdose like events observed or suspected. This outcome is not only technical. It can translate directly into physician confidence, regulatory credibility and real-world usability. But how did we manage to avoid the PDSSs? There are 2 main reasons.

First, the product is administered under the skin rather than into the muscle, and this reduces the risk of unintended intravascular exposure. Second, we precisely control the release of olanzapine from BEPO, thereby avoiding high initial plasma concentration, as you can see on the image. This is what we refer to as burst control. A successful long-acting injectable must deliver the right duration, the right dose across patient populations and critically robust and predictable release behavior. And this is exactly what we have achieved with olanzapine. I often say that the profile that you are seeing here is a dream profile for anyone working in drug delivery.

Now designing a single successful product is very important as sustainable value creation requires platforms. Our strategy is to continuously extend our innovation platform so that knowledge, data and development effort can be leveraged across multiple products, indications and partnerships. This platform-driven logic has been the foundation of our R&D activities over recent years.

Okay. I will now take you through our innovation road map, and we should start by the foundation, which is BEPO. Let me briefly remind you how it works. BEPO is an in situ forming depot technology based on solvent exchange. When a solution of our proprietary copolymers in a biocompatible solvent containing the drug is injected under the skin, solvent diffusion causes the polymers to precipitate and form a depot that drops the drug and injection site. Drug release occurs through diffusion and polymer degradation, both of which we can precisely control.

What you see on the video is exactly what happens with UZEDY under the skin. One of BEPO's strengths is its simplicity from a manufacturing perspective. The drug product is composed of just 3 elements: the API, a biocompatible solvent that ensures injectability and proprietary copolymers that control the release. This simplicity supports robustness, reproducibility and scalability, which are key requirements for development and partnering.

But what makes BEPO powerful is not the chemistry itself, but the level of control it gives us over long-acting product performance. I mentioned that BEPO is simple from a manufacturing standpoint, but it's highly complex from a formulation perspective. The API, solvent and polymer components can be finely tuned, allowing us to control release profiles, injection volume, viscosity, stability and storage conditions. As we have discussed earlier, all these parameters directly affect patient and clinician adoption. This flexibility strengthens reliability and builds partner confidence across our portfolio.

BEPO enables the development of first and best-in-class products such as UZEDY and olanzapine long-acting injectable. However, we wanted to achieve similar outcomes with more challenging molecules, and we wanted to do so by building on the strong foundation of BEPO, and this is how BEPO STAR was developed. BEPO STAR is based on the same proven chemistry as BEPO. But instead of linear polymers, such as the ones that you see on the left of the screen, it uses branched copolymers, which are polymers with more than 2 arms, which are also known as star-shaped polymers.

Our final goal using these polymers was to achieve improved control of drug release, but not only. One immediate benefit of using BEPO STAR is lower injection force and viscosity compared with BEPO. This is what you are seeing on this slide, which compares easiness of injection and viscosity of formulations with either BEPO or BEPO STAR formulations. Lower viscosity and injection force directly improve patient comfort and usability and open the door to the use of auto-injectors. As we have discussed earlier, this strongly enhances adoption.

Another improvement with BEPO STAR relates to depot degradation. Let me explain this graph. This graph shows the rate at which depots made either from BEPO or BEPO STAR resorb after injection, and you can see clear differences. Compared with BEPO, BEPO STAR shows faster resorption at later stages, resulting in more rapid complete degradation. This feature is particularly important for regulators for very long-acting products where rapid BEPO resorption after drug delivery is expected.

However, the most striking improvement with BEPO STAR is release control. I will share some remarkable results on this with you. This graph shows plasma concentrations in rats for a small hydrophilic molecule delivered using BEPO or BEPO STAR. BEPO exhibits a hill, a high initial burst followed by a rapid decline, whereas bipolar achieves minimal burst and sustained exposure. At the end of this study, we recovered the BEPO and approximately 60% of the payload has not yet been released from BEPO STAR whereas BEPO was exhausted. This suggests that delivery could have continued for several additional weeks.

These results illustrate how release can be precisely controlled for molecules with narrow therapeutic windows, which may cause side effects if delivery is not carefully managed. It also demonstrates that BEPO STAR can support ultra-long duration. One class of molecules with narrow therapeutic windows requiring precise control of plasma exposure and duration is GLP-1 analogs. These are typically large peptides that are very difficult to formulate as long as the injectables. On this graph, you can see what we can achieve with BEPO STAR, a very low burst and sustained exposure over 1 month. As you may imagine, this opens significant opportunities for MedinCell, opportunities that could not be addressed with BEPO. And what makes BEPO STAR particularly valuable is that this platform was developed using the same underlying chemistry as BEPO. The polymers are also based on PEG and PLA building blocks.

And why does this matter? Because manufacturing relies on the same synthetic procedures, we can use the same formulation processes, and we have a derisked regulatory foundation. In other words, BEPO STAR enabled immediate internal implementation at MedinCell based on our existing know-how and expertise while significantly expanding value creation potential. This is why BEPO STAR is currently being used across all our development programs at MedinCell.

But we do not stop here. Beyond BEPO STAR, we continue to expand our formulation toolbox and push the boundaries of what is possible in long-acting injectables. Platform innovation may allow us to address narrow therapeutic window APIs, highly soluble molecules, ultra-long-acting indications, higher doses and simplified administration. We are currently developing new families of long-acting injectables and the results so far are outstanding. The direction remains the same.

How can we further improve adoption for patients and clinicians. This slide illustrates why we are so excited. This new technology shows further improvements in ease of injection compared to BEPO STAR. And as we have said several times, this parameter is fundamental for product acceptability. Our platform innovation also demonstrates excellent release control for highly soluble molecules, something that could not be achieved neither with BEPO nor with BEPO STAR. Compared with BEPO STAR, sustained exposure is significantly extended, as shown in this graph depicting plasma concentrations in rats. We are really excited. This new platform opens the door to indications that were previously out of our reach. This innovation is already being tested in several of our programs.

Okay. I have delivered quite a lot of information, but I would like one message to be clear. Our platform expansion strategy is about expanding reach, not about replacing existing platforms. BEPO, BEPO STAR and newer platforms are complementary. And together, they form a robust toolbox for portfolio expansion. This summary slide illustrates that each platform extension expands our capabilities to formulate. The idea is to build a toolbox from which we can select the technology that best fits a given API.

As a final point on platforms, let me give you some visibility on applicability and time lines. The time lines shown here illustrate how these platforms translate into clinical and commercial value over time. BEPO STAR may enter clinical trials in 2028 with a potential commercial launch around 2033. And regarding next platform expansion, we are ready to accelerate development to reach the market as quickly as possible.

So far, I have focused on platform expansion. However, we know that platforms alone do not solve all our challenges. We have complementary R&D initiatives to provide further value. We pursue complementary innovation along 3 dimensions: API optimization, delivery devices and external technology scouting. Over the recent years, we have developed significant capabilities in API optimization with the objective of making difficult to formulate molecules compatible with BEPO. This can be achieved through approaches such as API engineering or the development of new products or salts. We are also exploring advanced delivery devices. As discussed several times, adoption by clinicians and patients is critical and one key moment for longer-acting injectables is the injection procedure itself. Our goal is to make injections as comfortable as possible for patients and as simple as possible for clinicians.

Finally, we have built strong capabilities in scouting external technologies. We closely monitor developments in our field and pay particular attention to academic groups and small companies developing technologies that may complement our platforms. These initiatives are not isolated. They are deliberately combined to expand the opportunity space and accelerate value creation.

Before closing, I would like to spend a couple of minutes on time, which is a key structural challenge in long-acting injectables. Because of the longer duration of action, development inherently takes longer, which is why we focus on generating decision-enabling data earlier, reducing uncertainty sooner and shortening time lines wherever scientifically possible. Through automation, parallel workflows and data-driven approaches, we have reduced formulation time lines by approximately 50%. The objective of this acceleration is to improve capital efficiency, enable earlier partnering and drive earlier value inflection.

So that was it. I conclude here. And I hope that I made it clear that R&D at MedinCell is fundamentally about execution and value creation. We design long-acting injectables for real-world adoption, extend scalable platforms to fuel growth and accelerate development through targeted investments that reduce risk and expand opportunity. This R&D road map is a key enabler of MedinCell shift to growth.

I will now hand over to David Martin, who will explain how we protect this value through intellectual property and know-how.

So firstly, thank you very much Adolfo for his review of R&D topics. My name is Dave Martin. I'm a patent attorney with 25 years' experience in the life science and pharmaceutical industries, and I'm Head of Intellectual Property here at MedinCell.

So, I'll start with this first slide. This shows a top-level review of what we'll be talking about today. And there's 3 main takeaway messages from my talk. Firstly, IP is central to MedinCell's value creation model. This is because the primary revenue for MedinCell in the future will be royalties from patent rights. In this context then, the longer the duration of patent protection that we get for products, the longer we get the royalties. And I'll give you some examples of what this means in reality.

I'll then discuss how MedinCell has a proven strategy to build multilayered patent protection for products incorporating our formulation technology. This gives extended patent protection to our partners, and like I said, is a revenue driver for MedinCell. I'll then highlight our patent portfolio and explain how patents and know-how are important to support partnerships, royalties and build long-term value creation. And this topic will be picked up again by Sebastian, who follows after my presentation.

So firstly, I'll start with UZEDY. As you know, this was the first commercialized product, which incorporates our BEPO formulation technology. UZEDY was launched in 2023 in partnership with Teva. Now on launch, UZEDY had over 19 years of patent protection. And this length of patent protection when launched is very rare for a pharmaceutical product. We achieved this by obtaining multiple layers of patent protection. As you see here, the first layer is our BEPO platform technology patent protection. This expires in the U.S. in 2033. Then we added 2 more layers. One layer protected the combination of the drug product with our BEPO formulation, and then we added another layer of protection to the use of the drug product. And together, these patent rights extend protection and royalties to 2042.

So, our IP protection is not just one patent right, it's a stack of layer protections, each reinforcing the other. This provided value to our partners since there's an opportunity to extend patent protection long beyond our core technology, and it means to have a benefit of exclusivity for the formulation. And as I mentioned before, it creates value for MedinCell by generating revenues over an increased time. Now UZEDY is not just a one-off. In this slide, we consider olanzapine. This will be the next product to be launched that incorporates BEPO formulation technology. This product will again be launched in partnership with Teva in the near future. And on launch, it will have around 17 years of patent protection.

Again, we have different layers of patent rights. One layer protects the formulation and the other layers protect the combination of the drug product with the BEPO formulation and the use of the drug product to treat specific patients. Together, these rights will generate revenue until 2044. Again, this length of time is very rare for pharmaceutical products. And again, it provides value to the partners since they've got exclusivity on the formulation to them. And again, it provides royalties to revenues to revenue in the future.

So how do we achieve this long protection for our products and the partners? Our patent strategy delivers layers patent rights. Each layer adds longer patent protection, which means longer royalty revenue. First, we have the platform technology protection. And importantly, our platform patent rights are granted in all major territories. Then we have the product layer. This protects the drug product through the combination of API with BEPO formulation. And through UZEDY, the product is patented to 2040 and olanzapine 2044, like what I just said. And there's other examples in different programs. So, for example, our pain management program has formulation protection. Our female contraception program has pending formulation protection rights.

So, we have a proven strategy for obtaining product protection. Then we have additional lifespan layers, which extend the lifetime of patent rights. These additional rights relate to different innovations. So, for example, methods of treatment or specific patient populations using our formulations. We patent other opportunities as they arise. So, you can see our IP protection is not just a single patent right, it's a stack of protections reinforcing each other and the stack of protections means a stack of royalty generation. It also optimizes patent duration to protect the commercial life cycle of the product.

Now why is this important? Because partners don't want to just access our platform patent rights. Our IP strategy provides revenue to -- value to partners since there's an opportunity to extend patent protection long beyond corporate technology protection. And this provides revenue to MedinCell long in the future. Now the olanzapine and UZEDY patent rights are excellent examples of the strategy, and we have others in our pipeline. So, this strategy is not theoretical, it's proven. And as Sebastian will explain shortly, the success of our IP strategy is an important part of our business development strategy.

I'll now discuss how our patent rights for platform formulation protection has expanded over time. Here, we see the multiple versions of the BEPO technology. And for each innovation, we restart the clock, meaning the 20 years protection begins again for each of these new formulation innovations. For BEPO Linea, we have first-generation protection to 2033 in the U.S. In what we call internally, BEPO [indiscernible], we have protection to 2038. For BEPO STAR, we have protection to 2040, and we have patents granted in all major territories for all these formulation technologies.

Then for the ongoing platform improvements, which Adolfo was talking about. For each new innovation arising, we'll file for new patent protection, which will run for another 20 years. So, you can see these improvements create additional patent rights and these additional patent rights are opportunities to generate revenue for MedinCell. That by ensuring our IP strategy is placed right at the center of our research activities, we monitor ongoing improvements, and we file patent applications only when we're confident we have the right data to make a strong patent.

Now I want to show you how MedinCell continuously invests in its IP. On the left, you'll see the strong growth in the number of patent families over the years. Now you may see the number can pause or even reduce from time to time, and I don't hide this. This is really important. It shows active management of the IP portfolio. We do this by reviewing the portfolio, and we limit investments in IP rights, which will not provide value to MedinCell, and we instead prioritize investment in innovations that translate into real market value. In this way, we ensure IP decisions are business-driven decisions. But you can see the growth is one direction. You can also see the chart on the right. This is also important. It shows the balance between granted and pending patent rights. The rise in granted patents indicates the success we have in obtaining these rights. And the rise in number of pending patent rights indicates the vibrancy of the patent portfolio.

These IP rights are key revenue drivers to the company. They grow as we grow in our success. And I want to emphasize another crucial component of our IP strategy, know-how. While patent rights provide strong legal protection, they are published and expire up to 20 years. These are the visible rights. In contrast, know-how does not publish and it does not expire. It's hidden. This is a secret glue that holds our strategy together. We deliberately keep this know-how secret to create an extra barrier to market for competitors.

So, for example, what's the best way to make the polymers, secret know-how. What's the best quality of polymers to use? Secret know-how. How are the formulations developed? Know-how. How do we select the best formulations? Know-how. This know-how is confidential to MedinCell. Like with biologics, how do you make something that is as important as what you make. This know-how and our success in using it commercially is a crucial component to MedinCell's financial future. It's important as we know-how is a barrier to the entry for competitors and it's a control point in our relationship with partners.

So, what does all this matter? It matters because our IP rights are essential for our business development activities, as Sebastian will explain shortly. Partners want to access our patent rights. They're impressed with our multilayer patent strategy. They need to access know-how to make formulations. Together with our expertise in developing successfully commercial products, our IP position is one of the reasons partners choose to work with MedinCell.

And that's the end for me today. I'll hand over now to Sebastian, who will explain how central partners maximize to MedinCell and value creation model.

Thank you, Dave. Hello, everyone. As Chief Business Officer, my objective today is simple to explain how MedinCell creates long-term value from its technology platforms and why partnerships and alliances are central to maximizing that value over time. You've just heard about the evolution of our technologies with Adolfo and the strength of our intellectual property and know-how with Dave. What I would like to do now is to connect the dots, how technology, IP, medical marketing, business insight, business development and alliance management translate into a sustainable long-term value creation.

So today, I have 3 main takeaway. First, MedinCell as a key player in the LAI ecosystem. Second, how we selectively build a portfolio of blockbuster potential LAIs. And third, how we focus on maximizing long-term value through partnerships with big pharma companies and innovative biotech companies. Before talking about strategic road maps that we have deployed to build our portfolio and come up with transformative partnerships, it's important to understand the overall market we are addressing today and the one that we will be addressing in the long-term.

The LAI market is not new. The first LAI was approved in the '60s, but this is really with the introduction of the first antipsychotic LAI in 2003 that the market value significantly increased. Last year, the market was roughly $20 billion, with still the biggest piece of the cake for antipsychotics. And clearly, MedinCell is in a great position with UZEDY and olanzapine approved in 2023 and single crossed 2026, that will ensure accumulated market shares for MedinCell in the long-term.

Adherence issue across chronic diseases is really a structural driver. LAIs directly address nonadherence, which is a major issue in psychiatry, but not only it's also the case in oncology, infectious diseases, endocrinology and other therapeutic areas. Poor adherence leads to relapse, hospitalization, treatment discontinuation. This is a huge economic burden. So, there is a strong incentive for patients, payers and pharma companies to adopt long-acting injectables. In this industry, time lines are pretty long. To develop LAI takes time. So, it's critical to carefully understand the market and its evolution over time. If we look at the LAI market in the coming 20 years, the good news, it will be still growing and even better much faster.

One of the major inflection points in the LAI market is the entry of GLP-1 for type 2 diabetes and obesity, it was a couple of years ago, for which the growth will be the most important from 10%, 15% market share to 30%, 35%. And the need is there. As I said, adherence is a key for chronic diseases. And GLP-1 today show probably the highest discontinuation rate. There was a big analysis last year that revealed that roughly 65% of patients under injectable GLP-1 therapy stopped the treatment after one year and 85% after two years. This knowledge of the LAI ecosystem is very critical to build the long-term strategy of the company and define where to go to maximize the biggest value.

Talking about value, let me start with what I believe is one of meaningful, most powerful and sometimes underestimated assets, our position in the industry. Over the last 2 decades, we put significant efforts to increase the visibility of the company. The best way to do that is to prove to the industry that we are capable to deliver. And this is what we did. Over the last 2, 3 years, only a few LAIs were approved, and none of them show better product features than UZEDY. Everybody agrees on this. Pharma companies, not only Teva, but our existing and new partners, all the analysts and the medical community. Two companies, [Ravi] and Indivior that had risperidone LAI left because of UZEDY.

The industry knows how challenging it is to formulate olanzapine. IVD failed. Zyprexa Relprevv is a clinical and commercial flop. Teva had zero PDSS in Phase III after 3,600 injections. It's unbelievable, and the industry is aware of that. MedinCell is not an early-stage drug delivery company anymore. Our technology is used in products that are given to patients. Companies such as AbbVie has no doubt about our technology and our ability to deliver. This is the reason why in this strategic alliance with AbbVie, MedinCell has full responsibilities for all of the preclinical activities until the IND. No doubt as well in terms of our capability to supply the required quantity of GMP-grade copolymers, thanks to our joint venture with Corbion.

Something that I can witness as well is how the industry and competitors perceive MedinCell as a model to follow in terms of innovation and IP know-how strategies. Great. So MedinCell is a company with real credibility and reputation. Now the question is how we are going to use this position to create value for the company long-term. Whether we're talking about internal or external programs at MedinCell, we deploy our technologies on applications where we see the biggest impact. Our objective is to develop best-in-class products and be much better than the other LAIs.

We have a strong mindset not to just develop a different formulation, but a different treatment paradigm, not only to address treatment adherence. Drug delivery is a powerful tool to improve the performance of a molecule. It can be when a drug cannot be given orally, when pharmacokinetics and pharmacodynamics can really be improved or when local delivery matters, allowing high concentration at the target site while limiting systemic toxicity. Life cycle management. I guess you heard about the patent cliff. Patent cliff is when a company has a blockbuster product that is losing its IP protection. This loss of exclusivity allows generics to come, and it can be dramatic for the originator of the product. Usually, for small molecules, revenues can drop by 80%, 90% in a year, slower with biologics, but still a major erosion of 30% to 70% in a year. A big wave of patent cliff is coming, the largest since 2010.

Between 2025 and 2035, the pharma patent cliff will represent roughly $400 billion to $600 billion of revenues at risk globally for big pharma companies. Merck & Co. with KEYTRUDA, Bristol Myers Squibb-Pfizer with Eliquis, Johnson & Johnson with STELARA, Novo Nordisk with Ozempic, even AbbVie will be impacted on two major products, except if there is a long-term life cycle management strategy in place. This is one of our pillars in our portfolio strategy, not only with approved molecules, but also with assets in late-stage clinical development.

So now let's dig into our pipeline. Today, not necessarily about our late-stage assets, but I wanted to give you the opportunity to learn more about what is behind all the blue boxes for which we have never disclosed much information. We are very cautious to have a good balance in our portfolio and the ratio between internal and external programs and also the level of risk associated with the stage of development for identified molecule candidates, as you can see on the slide.

In terms of therapeutic area, clearly, there is no question. We have firmly established MedinCell as a long-acting injectable leader for schizophrenia. We have not only maintained this position, but expanded it, launching new internal and external programs that reinforce our leadership position. But our ambition doesn't stop there. MedinCell has never been confined to a single therapeutic area or indication. Our motivation is to advance long-acting injectables across a broad range of therapeutic areas and indications. This commitment to being therapeutic-area agnostic empowers us to pursue new horizons and deliver transformative solutions in the future.

To develop best-in-class LAIs, choosing the right molecule is still important, but not sufficient. What truly determines long-term success is having the right partner on board. This is our business model. It works. And our selection criteria are clear. We have to find the right partner that is convinced by the LAI strategy and that will follow this strategy for the coming 10, 15, 20 years.

So, I have two main questions: the first one, when to partner; and the second, which partners. We know that we want to generate maximum value long term. Big pharma and innovative biotech companies are ideal partners and they are greatly complementary. Number one, big pharma. They cover a lot of therapeutic areas and indications. They have the financial strength and all the expertise to reach the market. And post approval, they can deploy significant commercial capabilities. AbbVie was clearly one of our top priorities. The company invested more than $60 billion in terms of R&D over the last 10 years. We are talking about 12 blockbusters in AbbVie's product pipeline. And AbbVie is certainly one of the best companies to protect key assets.

Let's take the example of HUMIRA. HUMIRA is 9 indications, 130 patents and cumulative total sales of $220 billion. Number two, innovative biotech companies. To me, they ensure a new wave of innovative products and new treatment modalities. Some of them could be the future big pharma of tomorrow. I met for the first time Gilead, a biotech company of less than 2,000 employees in 2007. And now the company has a market cap of $165 billion. Similar story for Regeneron, Moderna and many others. Some of our biotech partners have strong financial capabilities and can be the big pharma of tomorrow. One of them recently raised more than $150 million and another one went public, raising almost $300 million.

We know and we already anticipate that potentially some of our biotech partners will be acquired by big pharma.They have already put in place some types of business arrangements with big pharma. This is what we see regularly in the industry. In CNS, I'm thinking about the acquisition of Karuna by Bristol Myers Squibb for $14 billion, Intra-Cellular Therapies by Johnson & Johnson for $14 billion as well; Cerevel by AbbVie for $9 billion. But not only in CNS -- in other therapeutic areas as well.

Let's take oncology with the acquisition of Seagen by Pfizer for $43 billion, Horizon by Amgen in immunology for $28 billion. Also, being at MedinCell for the long-term, it was very important to take into consideration lessons learned from the past. History has told us that pure generic makers are not our ideal partners, with the exception of Teva that deployed the new therapeutic entity strategy in 2010, and now Teva is a great innovative company. Pure generic companies only focus on replicating something that works. They are not originators of the products. Therefore, they do not project themselves in the long-term.

So, to recap, big pharma and innovative biotech companies are target partners. There are 2 different ways to work with them. It can be from scratch when we join our forces since the beginning -- as was the case with Teva on olanzapine LAI. In this configuration, the partner pays for the overall development. After the formulation stage, if we have successfully identified the lead formulation, we execute a licensing agreement where MedinCell will receive an upfront payment and later on development and commercial milestones plus royalties.

Today, our financial standing and our ability to form partnerships are stronger than ever before. It was part of our shift-to-growth strategy that we applied a couple of years ago. This enhanced position allows us to explore a variety of these structures tailored to each asset and potential partner. Our partnering strategy can be deployed in 2 manners. It answers the second question: when to partner. Now we can invest and initiate internal programs when we believe that formulating a given molecule as a long-acting injectable will create substantial long-term value. And our objective is pretty clear: to generate high-value data that position MedinCell optimally to engage partners and negotiate from a strong position.

Our objective is not necessarily to sign partnerships as quickly as possible. Our objective is to sign partnerships at the right time when the data package is strong enough to maximize the value of the deal. This can take time. But over the long term, it is absolutely worth it. Generating this level of data represents an investment of a few million per program. This is not a cost. This is a strategic investment. And the proof is very clear. This is exactly what we did with the first AbbVie program. To make a long story short, we screened the entire AbbVie product pipeline: 247 molecules, 200 molecules approved, 47 molecules in clinical development, 36 molecules were selected as potential candidates for an LAI, 14 were selected based on their physicochemical properties.

Finally, we came up with a preselection of 6 molecules. We decided to take the most promising opportunity that we put in the lab as top priority to generate a data package proving that we can formulate the molecule. At the same time, we started building a robust business case internally with the inputs of physicians, key opinion leaders and payers to validate the pricing and reimbursement strategies. And we initiated first discussions with AbbVie, first positive signals so we kept going. At a certain level of maturity in terms of data, negotiations and due diligence processes started.

And finally, not only on this specific opportunity, we were also proactive enough to have AbbVie committed on 6 programs, whatever the stage of development of the assets or the therapeutic areas. I'll let you think about the real potential of having 6 blockbuster LAIs approved for this collaboration with AbbVie and the long-term value it may represent for MedinCell. By generating substantial derisking data upfront, we were able to secure an upfront payment of $35 million, development and commercial milestones up to $315 million per program and royalty streams in the low double-digit range. Compared to earlier partnerships with Teva, this represented a step change in value capture. And we intend to keep deploying this strategy for very specific assets and identified partners.

Today, all of our internal programs clearly fit with this strategy. The objective is to invest ourselves or alongside our partners to push a little bit further the timing for licensing from early formulation stage to beyond. Going back to Christophe's slide in terms of long-term objectives, as I said, with more data, we are in a stronger position and we can afford to change the financial terms. I am personally convinced that the key driver for the long-term revenue growth of the company is to counterbalance the ratio: early payments versus back-loaded deals with higher royalty payments. Based on previous and ongoing partnering discussions, we know what can be envisioned or not depending on the partners.

I'll let you just imagine the impact that an additional 1% royalty could have on a multibillion-dollar product for MedinCell. Let's do quickly a math exercise. For a $5 billion product, pushing royalties from 7% to 10%, it's $150 million that can be added every year as revenue just for one product without zero expenses on our side, that I would like to remind you. And if this product is above $5 billion for 10 years, it represents $1.5 billion for MedinCell.And again, just for one product.

So just to conclude, let me go back to my 3 main takeaway messages. The first one now: MedinCell is clearly a partner of choice in this LAI ecosystem. We have and we are continuing to build a strong portfolio of blockbuster-potential LAIs. And we focus really on maximizing this long-term value through transformative partnerships, as I said, with big pharma companies and innovative biotech companies. Thank you for your attention.

Thank you all for the presentation. We will now move on to the Q&A session with questions from analysts that joined us from the United States and Europe. [Operator Instructions] Our first question comes from Ram Selvaraju from H.C. Wainwright.

Yes. Can you hear me?

Yes.

Very interesting presentations and congratulations on all the progress, first of all. And I have 4 quick ones. Firstly, maybe you can comment on when you expect approximately in the development of the candidates being advanced under the AbbVie collaboration, you and AbbVie would be in a position to disclose the identities of the APIs in question. That's question number one.

Number two is with respect to the overall approach in neuroscience, could you maybe elaborate on the specific areas within neuroscience beyond schizophrenia where you expect there to be the most significant potential for applicability of your LAI platform technology? Thirdly, this is a patent question. As you look at the difference between BEPO STAR and BEPO platform technologies specifically, what might make BEPO STAR more defensible, more likely to produce more difficult-to-challenge patent claims versus BEPO? And are there, in fact, more layers of protection available because BEPO STAR is a more, let's call it, sophisticated technology platform?

And then lastly, this is a business development question. You pointed out the potential for MedinCell to seek partners among both big pharma and innovative biotechs. And I was wondering, in the case of innovative biotechs, you may partner with a company that is developing the next blockbuster, but it itself does not wish to directly commercialize such a product. Maybe its ultimate goal is to sell itself. So, what strategies can you undertake to optimize MedinCell's intrinsic value in such a partnership when potentially your partner might itself want to be bought by someone else? How do you, for example, ensure that your royalty stream is protected and taken off the top, as it were, from whatever product might ultimately be commercialized even if your original partner undergoes a change of control?

What I suggest is maybe Sebastian, you take questions one and two. David, question three, and I will answer question four.

Yes. So, thanks, Ram. Actually, very, very good questions. Just going back to AbbVie about actually when we can expect the first AbbVie program going to Phase I. And as you know, this is one of our top priorities at MedinCell, but also for AbbVie. The deal that we have, AbbVie has secured rights actually to be committed to 6 LAI programs total, but the top priority is really to move with the first one in clinical studies. So, this is actually our key objective and is going to be the case in the coming months.

About the disclosure of the molecule that is part of this first program, this is not public information. And for confidentiality reasons, AbbVie does not wish – sorry, doesn't want to disclose this information publicly because, as you know, actually, the competition is quite important in the pharma industry. About where to go in beyond schizophrenia. Over the last year, we really wanted to focus on schizophrenia and the development of LAIs in schizophrenia. And this is what we have done. We have this clear position with UZEDY and olanzapine LAI, but there is also a big wave of a lot of different products for the specific indication. And this is what we have executed. We signed actually new programs for this specific indication. We have also integrated a new internal program for this. And there was also a new wave of new drugs covering new mechanism of actions.

I can mention actually muscarinic agonist. And today, there are probably 7 companies working on it. This is not only in schizophrenia. Some of the companies are also focusing on additional indications, focusing on muscarinic agonist. I'm thinking about psychosis in Alzheimer's disease patients, bipolar I mania and a few other indications. So, this is a way to improve our leadership position in this field. But I would say that MedinCell is really a kind of therapeutic area agnostic company. So, we obviously we want to extend the scope of LAIs where there are already existing LAIs, but we also want to develop LAIs in therapeutic area or indications where there is no existing LAI yet. It was actually about beyond schizophrenia.

Thank you very much for your question. It's very interesting to compare the options for patentability between different technology platforms which we have. If I'm right in remembering, you asked about the potential and dependability of the BEPO Linea and the BEPO STAR patent rights. Firstly, to make it clear that we have patents granted on Linea and STAR, the platform technologies in all major jurisdictions. They're good, strong defendable patent rights.

When it comes to building further formulation patents on top of that existing protection, patent strategies really rely on really 2 things, I would say. It's the data that you generate when you're using the formulations, and it's the way in which you build the story behind what's innovative about it. And these options are available for both Linea and STAR. And we see success, as we've seen before in the Linea. And I think for the STAR, we adopt a similar strategy, we should have a success again in the future.

Thanks a lot, David. So, on question four Ram, of course, all the large biotechs have for objective to be acquired. And even it's very rare that they would go commercial. And even when they do, they end up getting acquired. The last example, of course, is Intracellular Therapeutics, which took lumateperone to market to about $700 million in sales and was acquired by J&J for $14 billion. We know the case well. As you know, Sharon Mates, its CEO and Founder, is on our Board.

So, as it's a very likely scenario, we build this scenario in our contracts, legal agreements, of course, from the beginning and to make sure that all the rights get transferred to the big pharma company, which is a good scenario because they are the ones that have the resources and power to commercialize. However, we always, in all our contracts, regardless of the partner, build reversion rights as well in case of a stoppage of the program.

Thank you, Christophe. Next question is from Matt Ersen from Oppenheimer.

Yes, you can hear me?

Yes. We can hear you.

Okay. Perfect. Congratulations on all the progress. So, I wanted to also ask about the potential to apply your LAI technology to the muscarinic compounds. Just considering Cobenfy and the current limitations there with side effects that drive patient discontinuations. How do you envision your LAI formulation overcoming those limitations? And how feasible would an LAI version be for Cobenfy, which obviously combines 2 drugs from a release engineering standpoint, especially when you involve more than one active agent and you to coordinate the release kinetics.

And separately, I was wondering, as you alluded to, there are studies ongoing for Cobenfy and muscarinic beyond just schizophrenia, such as psychosis associated with Alzheimer's dementia. Just curious, especially considering an LAI technology for those patients where adherence might be a little more difficult within the elderly population and the safety that goes along with that. Really appreciate your time. Thank you.

Thanks a lot. It's a great question because it's in a space we know well. And I think Sebastian, you're best placed to answer this one.

Yes. Probably I can start with the business component. I will let Adolfo answer on the technology. You're right, Matt, actually about Cobenfy. This is a very good product in schizophrenia. But this drug also presents some drawbacks. And as you said, actually GI side effects, this is very quite common and even actually a physician, they have to prescribe antiemetic in combination with Cobenfy. Plus we address this question about treatment adherence. And this one for schizophrenia is given twice a day. So, this isn't really optimal for both patients and physicians.

So, in terms of how we can use our drug delivery tool or long-acting injectable platform, well, obviously, there is really something to do. And I know that BMS is thinking about a long-term life cycle management strategy with Cobenfy. They have several Phase III studies for additional indication in addition to schizophrenia, like you said, actually psychosis in Alzheimer's disease patients. BEPO I think also another indication, pediatric indication for autism. But I think in terms of life cycle management strategy, thinking about LAI could really represent a greatest value if BMS wants to keep its position as #1 with muscarinic agonist.

Is it an easy one to formulate? It's not an easy one, but we have demonstrated in the past with different proof of feasibility that we can co-formulate 2 different APIs within the same formulation and achieve the same exposure for both. So, this is something definitely we can do. So, the platform is compatible with the release of several APIs at the same time. And in case of difficulties, as I was explaining during the presentation, we have developed a series of tools that can allow us to tune the APIs for making them more compatible with each other. So, this is definitely something that is not easy, but it's something that we can do.

Next question comes from Shan Hama from Jefferies.

Three questions, if I may. So, in terms of the patents, so for each innovation sort of restarting the clock, what really matters here in terms of preventing generic entrants? Is it the tech protection? Is it the formulation protection? That's my first question. And then my second question, please, is when it comes to business development, how are you thinking about licensing agreements and acquisitions in terms of the tech, therapeutic area as well as urgency timeline to execute? And then my final question, if I may, sort of given the expectation that endocrinology is set to take the largest share of the LAI market by 2045, plus the efforts made with BEPO STAR in terms of incorporating peptides, is this a therapeutic area you're assessing or interested in entering?

Thanks a lot. Dave the first question is for you.

Shan, thank you for your questions. It's a very good one. You asked about the different generations of BEPO and how the patent rights expiry would impact on the entry to generics. So, there's a couple of topics to pick up on here. Firstly, I think looking upon the expiry of the Linea platform technology patent rights, that's one angle. That's one aspect. But you have to remember, like what I talked about in my presentation that our IP rights are a mixture of that and also the know-how. So how do you actually go ahead and prepare these different copolymers that are needed in the formulations and how do you actually know what the formulations are ultimately.

In addition to that, there is, of course, our formulation patent protection, which broadly claims the specific APIs in combination with the BEPO formulations. So, a generic maybe would have difficulty in circumventing that more specifically formulation patent protection as well. When it comes to, I've forgotten the rest of this. What was the next first part of the question?

So, the 2 other questions were for Sebastian.

It was just on the BD side about our licensing strategy. But just to be clear, actually, talking about the licensing out strategy of the company or about licensing in terms of new technology or assets?

Yes, exactly. In-licensing technologies.

In-licensing technology. This is something that Adolfo actually explained actually in this presentation. To me, honestly, we have made a significant progress in the -- in all of the generations of technologies. And I can say that I can witness that now we can formulate molecules. And for us, it was science fiction a couple of years ago. So, this is great. But I think we have also to be pragmatic. And in all of our analysis, I mentioned the patent cliff analysis or sometimes we are in a close relationship with big pharma companies when they give us wishing list in terms of drug delivery needs or molecules to formulate, we know that some of them will be still challenging even if we are going to make additional improvements with our technologies.

So we have deployed internally a kind of scooting strategy road map where we have initiated some close relationship with academic research institutes and biotech companies to complement BEPO, but also to use new technologies as a stand-alone technology that can do things that can really ensure long-term value creation for the company and to address big therapeutic area, big indication and also new treatment modalities.

Sebastian, the third question is about peptides.

Peptides, yes. I think when we talk about peptides, probably 2 categories, I would say, small peptides and medium-size is already committed with a couple of partnerships and also internal programs with small peptides. And when we are switching to, let's say, more than 30 amino acid peptides, thinking about GLP-1, the field actually is growing and it will be actually quite massive. So, the great news that Adolfo has shown actually great data with GLP-1 agonist. And there are plenty of companies in the field. And we know that now we're talking about dual agonist, triple agonist. There are plenty of even not only approved GLP-1 agonists, but late-stage compounds that have recently shown in clinical studies, great data.

I'm thinking about obesity data in terms of weight loss, so what we have done in schizophrenia with the Hali waves, and this is something that we can anticipate in a bunch of new indications, new therapeutic areas, and we don't want to miss this GLP-1 wave for sure.

Adolfo, maybe for some of our audience, which is not as knowledgeable about APIs, could you explain what the peptide is? And why is it different from small molecules?

A peptide is a chain of different amino acids. So that means that typically, a peptide is going to be of a larger molecular weight than amino acid. So, if you keep growing a peptide and you keep adding amino acids, you will reach a protein. So, a peptide -- large peptides is in the border line between a peptide and a protein. They are small peptides typically are hydrophilic, which make them difficult to formulate. And that's why I think that explains why we are so happy with the results we have shown. And then large peptides can be even more complex because they can have sometimes confirmations that are related to their activity. So, they are not easy molecules to formulate at all, which makes, again, which gives additional value to the results that we have shown today.

Next question is from Nicolas Pauillac of Kepler Cheuvreux.

Maybe 3 questions on my end. The first one is just a follow-up on the discussions on GLP-1. Given the fact that we already have some products that are in late-stage development for like 1 month getting version of GLP-1. Don't you think that the market might already be there when it comes to long-acting? So maybe just a follow-up on that.

And then the 2 other question is more big picture question, but you mentioned during the slides that you intend to maximize the deal value. Are we to understand that there is a world in which in the future because you have, let's say, stronger cash flow that are going to happen, you'd be willing to fund the Phase I or the Phase II of the study to make sure that you get to, as you mentioned, this 10%, 15% royalties rate. And then lastly, just to understand the decision-making process when it comes to this licensing. Is it more you that are looking at the pipeline of company and say, okay, maybe we can plug the technology there. And once you see that it's working, you are kind of knocking on the pharma door or it's more the other way around of people coming to you and knocking on the door?

Maybe I will get Sebastian to answer the first and last question, and I will answer the next one.

Thank you, Nicolas. I'm sorry, I was taking notes at the same time, just not to forget something. About GLP-1, yes, you're right. And going back to schizophrenia and LAIs for this indication, this is what we have seen at the very beginning, a daily, weekly, monthly, 3-month, 6-month product. And this is something that it will be reproduced actually with GLP-1. It was actually daily. It's now weekly, monthly with some products, including also the acquisition of Metsera by Pfizer. But we know the need. And again, we are pretty close to the big pharma company and innovative biotech companies in the field. And we know that the trend will be more quarterly injection rather than monthly in the future.

As I said, actually, the discontinuation rate is pretty long. We are talking about chronic diseases. So, 3 months will be better than 1 month. And we know that MedinCell is well positioned in the field. I don't know if we will have questions about competitors, but one of them actually signed a deal with a company, but we know that with this technology to go beyond 1 month is impossible. So, they cannot actually develop long-acting formulation of a big peptide above 1 month. So MedinCell will be in a strong position to do that.

Going back to the question about how we can maximize the value long term. And if we go a little bit beyond actually where we are, we have 2 strategies. And again, we have a strong BD team at MedinCell is now actually based in France, but not only we reinforced actually our BD team. Now we have people in Asia, people in the U.S. They are super active. We screen probably 2,000, 3,000 companies every year to find actually the future great candidates to be integrated within our platform. And we have some partnering requests and more and more. So, this is actually a great thing because now we have a pretty good position in the LAI field. So, we spend time to look at each opportunity.

Sometimes we take the -- I would say, the opportunity, but the risk to invest ourselves and to generate data. This is what happened with the first AbbVie case. And this is often question internally, if we can go further. I think, yes, we can generate more value long term and switching about from, I would say, single-digit was the case previously to low double digits. I think we can expect higher royalties if we spend more money in some key programs in the future. And about the process, about decision-making, we usually do a very exhaustive long exercise.

Clearly, with big pharma, we have taken probably 25 big pharma companies, and we screen our entire pipeline, all of the big pharma companies to really from hundreds and hundreds of molecules, we identify only a few. And we have now internally a great expertise. We have medical marketing business insight. We are in connections with key opinion leaders, payers, physicians. We can know, anticipate what can be the pricing reimbursement strategies. We can invest. We can discuss with partners, and then we can select and pick up the right opportunity, both for the company, but also for MedinCell.

Next question is from Leszek Sulewski from Truist.

So, first, Christophe, maybe you can address the milestone timing perspective. I guess, can you speak to the quantum and expected time lines of the commercial milestones from Teva on the UZEDY and olanzapine LAI programs? Second question is, how many active feasibility studies are ongoing today versus a year ago? And have you shifted to BEPO STAR for all these studies? Or is there still a valid use for the future formulations with the original BEPO technology? Or is the shift mostly because of the longer IP protection? And then lastly, you briefly mentioned the ability for BEPO STAR use with auto-injectors. Could you comment around the progress with this administration method?

So, I'll answer the first one, and maybe Adolfo, you can answer the other ones. So, I remind everybody that on Teva, we have $115 million of milestones due along the commercial life of the product and based on sales levels. On AbbVie, the total amount of milestones development plus commercial is 315 million. The split is not known, but if you use the same ratio as Teva, which is an NPV ratio, you would end up around 60 and maybe 250 million for commercial milestones. and which are built, obviously, on levels that we thought would be attainable. On Teva, in particular, those milestones were negotiated in 2013 when the lead program in long-acting injectable in schizophrenia had just above the $1 billion mark in sales. Adolfo?

Yes. So, first question was about the number of programs that we have nowadays compared to one year ago. I honestly don't have a figure in mind. What I can tell you is that we are much, much busier in the lab. And there I think we are much -- I don't want to give a number. But this is -- I think this is related to two facts. First, and I've been in MedinCell for some time now. The success it uses.

How many years?

11 years now, 11.5. Not as old as you guys but getting there. So, I witnessed that with UZEDY and the success of UZEDY, the doors are opening much easier. And second, as Sebastian just said that BD efforts are multiplying and we see the results of this. And we are really, really busy in the lab, I can say this.

Now you mentioned you were wondering about the utilization of STAR versus BEPO. So just to be clear, as I was saying during the presentation, our politics is not about excluding one of the technologies. It's about using the technology that fits the best. However, of course, every new program that enters the lab today is tested both with BEPO and BEPO STAR. This is our strategy and the product that works the best is the product that is moved forward. I think that answered the question. The second question.

Question about injectors.

Autoinjectors, yes. There was a question about STAR being more compatible with autoinjectors. And this is an active research line that I mentioned before. We are actively working on evaluating different types of injectors that can answer different needs. Obviously, autoinjectors is one of them, making the injection process easier for the patient is one of our focuses. And obviously, STAR, since they present lower viscosity and a lower force to inject are better suited for this type of device than BEPO.

Maybe if you can give us an idea of how much less viscous are STARs versus BEPO Linea?

You have seen figures on the presentation. But I mean, first, we have to convert things that can be compared. And I'm sorry, I'm going to be a little bit technical here. Polymers are large molecules. So, we do have to compare polymers that have the same molecular weight, okay, the same size. And this is what we are comparing because otherwise, we would just be cheap. So, when we compare BEPO and BEPO STAR formulations with polymers with the same molecular weight and the same content, I think the figures show that we can lower the viscosity by a factor of 4 or 5, which is huge.

Next question comes from Marc Goodman of Leerink.

This is Basma on for Marc. I would like to follow-up further on the indications beyond schizophrenia. And more specifically within neuroscience. We were just wondering if you can provide some color on why the LAI hasn't entered a market like depression, for instance, or epilepsy. Does it have something to do with the chemical structure of the standard molecules used in this indication or basically the unmet need was not as pressing as it was for schizophrenia? The second question we have is on the sweet spot for the duration for the LAI. So, I heard that the quarterly injection seems to be the optimal for the GLP-1. Is it the same across all the indications? Is it 3 months seems to be like a nice sweet spot? That's it for us.

Sebastian, I think these 2 questions are for you.

Yes. In neuroscience, what have you seen actually our obviously is to extend the applications of BEPO and all of the new generations of BEPO outside schizophrenia. So, schizophrenia Bipolar Disorder, but there are a bunch of indications that we can target with LAIs because we're talking about chronic diseases, adjuvant is a key pre. Also, that we want to do, and this is also the case with some biotech companies, it's not necessarily about this question about treatment adherence. There are some drugs that we are working on. They have to be improved in terms of PK and PD profile. And there are some --many other aspects for which we can apply our technology.

About epilepsy, this is an indication that we are looking at like many of us. Every time we are looking at about the treatment regimen for specific indications, and for some indications like epilepsy, sometimes we are talking about not a monotherapy, but patients that are epileptic, they have to take several drugs at the same time. So, we can actually argue about having LAI could be really beneficial on that compared to poly medications. About sweet spot in terms of duration for LAI, it's very important to anticipate what will be the market need for GLP-1 from weekly to monthly and potentially in the future with quarterly injection. But this is not the case for all of the indications and even for all of our partners. We have partners today. They have NCEs in clinical development, but we're considering life cycle management. It can be from daily sub cut injection to weekly and as a second life cycle management layer, a monthly injections.

So sometimes it's not necessary to go very far in terms of extended durations, because development of LAIs takes time. And sometimeslooking at the competitive landscape of our partners, it's not necessarily a good fit to develop 3 or 6 months because we know that with the one month knowing the loss of exclusivity of the molecule, knowing the advancement of competition, we have to reach the market as soon as possible. So, there are several components and sometimes longer duration doesn't mean this is something that we'll have to follow.

Maybe you could elaborate a bit on the peptide case, which is a bit different in terms of duration.

Yes, because peptides by definition, actually, they have very short half-life. And sometimes some companies we are working with for them, it's really a nightmare actually because they really have to inject even actually twice daily the peptide that can really show great efficacy. But now there is something to do with the formulation. And this is something we want to insist today, BEPO and BEPO generations are great drug delivery tools to maximize performance of molecules and not only just to extend duration between injection.

Next question comes from Mike DiFiore of Evercore.

A few questions for me. Just to clarify BEPO STAR exactly how large of a peptide can this platform formulate in terms of amino acids versus, I guess, your next-gen platform innovation? And when would platform innovation be ready for the clinic? I recognize it's pretty early. Second question, in terms of GLP-1s and incretin therapies, will the BEPO STAR platform be applicable to the entire class, including amylin? And how might a product's lipidation technology interfere with your technology? And the last question is kind of a general legal question. I know that you emphasized the know-how as kind of being unpublished. But I'm not a patent lawyer, but in the event of litigation, how might your unpublished know-how work against you in terms of providing adequate description, which is often kind of required in patent litigation?

So maybe Adolfo you take question one and two and Dave, question three.

Yes. So, if I understand correctly, your first question was around how large the peptides are that we can formulate with BEPO STAR. With the results that you have seen on the screen, it's a BEPO. It's a peptide that is beyond 30 amino acids. So that's already quite a large peptide. We have experience in the past with peptides larger than 40 amino acids. We have worked, and we are actively working with some others. You were wondering about the arrival to the market for the next generation that we have introduced today. And the answer there is that we will get there as soon as necessary.

So, we have the capabilities today and the knowledge and experience from BEPO and BEPO STAR to accelerate if we need. So, as I mentioned during the presentation, we are already evaluating this new generation in the market, in the lab with molecules with the market potential. So, if results are positive, we are ready to push the accelerator and move as quickly as possible.

Adolfo, maybe give us some color about the excitement that this new generation is creating in the house.

I mean, it's not only internal. I think that I'm sure that in the audience, there are many people that have worked in drug delivery that know how extremely difficult it is to control the delivery of a small hydrophilic molecule. And for those that are not familiar, this is very, very difficult with our type of formulations, with polymer-based formulations, especially when we're speaking about injectables and active formulations. This is extremely, extremely positive. I mean in the time I have been in MedinCell, obviously, we have not seen anything like this.

Yes. It's probably the more excitement you've seen in-house.

Absolutely.

On internal innovation.

Absolutely. It is.

Just for some of the audience, can you explain what is a hydrophilic molecule and why it is difficult to formulate versus hydrophobic molecules like risperidone and all of that?

Exactly. And actually, just to be more precise, I say hydrophilic, but we should actually be speaking about aqueous solubility. So a product that is very soluble is very difficult to control the release. You can imagine that you will have the molecule inside the depot or inside the reservoir. And then diffusion will happen from the depot. If the molecule is very soluble in the environment, the diffusion is going to happen very, very easily. So this s -- I think this is easy to understand. So, what we have managed to do is to make networks or depots that actually hinder this diffusion. That's really difficult, and we are very proud of what we have.

Big achievement. Congratulations.

There was a second question around the fact of GLP-1 peptides being lipidated. And definitely, this is something that complexifies the formulation of this type of molecules. And once again, that's why I just keep saying it, but it's reality. That's why we are so happy and so proud with the results that we have shared with you today. The fact that despite the lipidation and despite the fact that these molecules are very easy to disperse and dissolve in water, we have managed to achieve sustained exposure for 1 month and even more importantly, with a very reduced burst at the beginning, with a really reduced peak of concentration just after administration, which is a must for this type of molecule.

So exciting things, as we said in the presentation, more to come. And Dave, please, question number 3.

Okay. This is a question about know-how and how it can be used in litigation and enforcement procedures basically. So there's a couple of points to make about this. Know-how can be things like unpublished best ways to manufacture copolymers, for example. And in this sort of situation, the barrier to market would be primarily how is the best way and most optimal way to make the copolymers in sufficient quantities of commercial grade to be used commercially.

The second thing to remember about know-how, it's more about experience and selection criteria. How do we know which is the best sort of candidate to go forward from the feasibility study into lead formulation selection. This is really where our experience just really comes to the fore. As far as the fact that these are unpublished know-hows, we do have internally catalogs of what the know-hows are. So, if we were needed to be used in any sort of litigation or enforcement procedures, we can rely on the fact we know what our know-hows are and recorded internally to support that.

And I should say, David, that one of the reasons you joined us is to do just that, is to prepare for potential future litigations in the future. We all know that it happens regularly in pharma companies, and you work with the best litigation lawyers worldwide.

Indeed.

We have time for last question. Seems Nicolas Pauillac of Kepler Cheuvreux, you have another question?

Sorry for making you over time. You had this slide about the expected LAIs and the patent cliff over the next 10 years. They're interesting. But it would be interesting to know as of today in your portfolio, how much of the development is focused on kind of the life cycle management that might happen on these drugs? And how much will be really focused on innovative drugs in which you are starting from 0 with the companies?

And just on the timeline when it comes to this kind of life cycle management product, do you think that you have the right commercial opportunity when we know that, for instance, Gilead that you mentioned, they have the long-acting capabilities in HIV already. So, is it really finding what they are missing and knocking on the door?

Thank you. Just this table of the loss of exclusivity with a lot of drugs from big pharma companies, this is exhaustive list because it goes until, I think, 2035. Internally at MedinCell, we are looking at actually molecules that will be losing IP protection beyond that. So today, actually, we are looking at drugs, future blockbuster drugs that will be off patent in 2038, '39. So just to give you the big picture. This is a very long exercise, but at the end, it works because we know that we can win out into a real opportunity for the company that really want to protect the assets. And this is also very important to have clear timelines in mind.

If we develop 1-month product, how long it is going to take, when we can expect the approval. And we can also make sure that the company will still have the commercial teams, the sales force to have a clear strategy in terms of life cycle management. And the proportion about innovative drugs versus approved drugs for which we apply life cycle management -- this is very important to have a good equilibrium. There are plenty of opportunities to take approved drugs and to do life cycle management. The risk is much lower. The drug has been already approved. We use the 505(b)(2) procedures through the FDA. So, we can go fast and the risk is lower, as I said. But we see that there are great molecules even in late-stage clinical development, even with new mechanisms of action that can really be blockbusters of tomorrow.

So, this is something that we want to keep controlling and to have the good balance between really innovative and approved assets. And then the other question was about Gilead HIV. Yes, for HIV prophylaxis, yes, you're right. We are talking about cabotegravir and many other products that are already super long acting. And this question about timelines of development, this is also something key. That can be internal or a program that we may have with a partner, we know it's going to take time. So, should we be very relevant with a 12-month product for HIV prophylaxis in many, many years? This is a challenging question that we are actually asking internally, I would say.

And the last question, in fact, is from Martial Descoutures of ODDO.

Sorry, very, very short question. Do you see maybe any changes on the production of the next BEPO generation? So, is it possible to have an update on your capacity of production and where we could expect on the next step? Plus in parallel, could we have maybe a new strategy with the new BEPO generation such as maybe to be more focused on the new molecular entities, for example?

Yes. Thank you very much, Martial. That's a very, very interesting question. So, regarding the development of new generations of BEPO, BEPO STAR, we can consider it derisked. We are there. We are already implementing it in our development programs. So, I don't see any risk on this one. As I explained before, we built on the same chemistry as BEPO just to be able to move forward as quickly as possible, and that's exactly what is happening.

And regarding the future generations or any generations to come, as I was explaining during the presentation, what matters for us is adoption. And that comes from the very beginning of any kind of platform development that we do. So, this means that we are using building blocks for future generations that are already derisked, that are going to be simple or easy to move forward. So, we foresee -- and that's why we are being so optimistic that there will be no issues for moving forward any of these new platforms to come when we decide to do so.

And about the use of new generations of BEPO with NCEs versus approved molecules, I would say it depends. It depends on the molecule. It depends also on the partners. Sometimes there are some partners that we have, big pharma companies, because of this pressure of the competitive landscape and loss of exclusivity where they're going to lose the patent protection. Some of them, they prefer to use actually the first generation of BEPO because there was already this kind of stamp approved by the FDA. It's already in UZEDY, and will be soon with olanzapine LAI. But we have some partners today that are applying life cycle management strategy even quite early in the development.

And sometimes they have a drug just in Phase II, but they are already anticipating life cycle management strategy with a long-acting injectable formulation. So, in that case, we prefer to use actually the next generation of BEPO and not necessarily the first generation. So again, this is really a proportion and something that we discuss with our partners, what is the best strategy to follow.

Thank you. We come to the end of the meeting. A replay of the webcast will be available on our website just right after this meeting. As a reminder, our next scheduled update will be the publication of our financial results on Tuesday, June 16. And one more time, thank you again, guys, for the presentation. Thank you all for your interest in MedinCell, and we look forward to speaking with you again soon. Thank you all. Bye.

Hi, everyone, and thank you for joining us today for this conference following the release of our half-year results, which were published earlier today. The press release is available on our website.

Today, I'm joined by Christophe Douat, our CEO. Hi, Christophe.

Hi, David.

Dr. Richard Malamut, our CMO. Hi, Richard.

Hi, David.

And by Stephane Postic, our CFO. Hi, Stephane.

Hi, David. Hi, everyone.

Before we start, I invite you to review the forward-looking statements disclaimer at the beginning of the presentation available on our website. This webcast will last 45 minutes max. We'll start with a presentation and a Q&A session if we receive questions. [Operator Instructions] But now I leave the floor to you, Christophe.

Thank you, David. Hello, everybody. We are delighted to have you join us and celebrate the filing of Olanzapine LAI. It's a major event for the company. So lots of emotions and excitation at MedinCell today.

Last June, I told you that MedinCell was entering the most transformative years of its history, mostly thanks to Olanzapine. And here we are. Our partner, Teva, filed the Olanzapine LAI at the FDA today. And so the clock will start clicking since FDA has 10 months to get back to Teva with a potential approval sometime in Q4 of '26 for a product that is a major product, a priority at our partner and of course, a priority at MedinCell.

So let me remind you of our strategy shift to growth. You can see that UZEDY, and we'll come back to UZEDY in a second, is the first engine of growth of MedinCell. Olanzapine will accelerate growth. And then the third engine is made out of the pipeline, with AbbVie #1 leading the way.

Let's step back a bit and look at our strategy in schizophrenia. On the left, you have Risperidone. On the right, Olanzapine. Risperidone was a drug of Johnson & Johnson; Olanzapine, Eli Lilly. Both were significant blockbusters for both companies, respectively. Both companies follow the same strategy, life cycle management with long-acting injectables.

You can see on the left that Johnson & Johnson was highly successful, building a franchise, which is now $4.8 billion a year. But you can see on the right that there is no big green box. Eli Lilly failed commercially with the long-acting injectable. Richard will tell us why in a couple of minutes. And we, at MedinCell, gave our partner, Teva, the keys to grab some of that potential, a real, appropriate long-acting injectable of Olanzapine.

Let me remind you of the metrics that we have on both products. We are eligible to mid- to high single-digit royalties, eligible for a $4 million milestone at approval of Olanzapine LAI, plus $105 million of commercial milestones for UZEDY and $105 million for Olanzapine LAI.

Richard, could you tell us why Olanzapine, on a medical standpoint, has such a large potential, why Eli Lilly failed and why Tiny MedinCell in the south of France succeeded?

I could do all of that, Christophe, and I will. So first, a reminder that oral Olanzapine is the most prescribed oral antipsychotic, and that's mostly because it's currently used for the more severe patients with schizophrenia, the patients who are refractory, which can be up to 30% of patients.

But unlike the Risperidone franchise, there is only one approved product in -- one approved long-acting injectable olanzapine product, and it's not being used for reasons that we'll talk about.

So the unmet need is very, very high here to have something in a long-acting injectable form to improve compliance for patients who are exactly the patient you don't wish to have stopped their medications. And so for these reasons, the unmet need is quite high.

Now on the next slide, a reminder of the safety finding that has limited the use of the Lilly drug, and that's post-injection delirium and sedation syndrome, PDSS, not very common, seen in less than 0.1% of injections, but is severe enough that the FDA put rather onerous monitoring requirements on the label, including a REMS program, which U.S. psychiatrists are not used to following.

And most impactful, every patient on every injection has to be monitored in the clinic for 3 hours. So that's not happening and is largely the reason why the product is not being used.

Now PDSS is thought to be due to a burst of Olanzapine in the blood. And on the next slide, you can see how MedinCell formulated our LAI Olanzapine to eliminate that risk of burst and therefore, PDSS. And so what you can see here is that on the top, the Lilly product, when injected directly into human plasma almost completely releases within the first 24 hours. You can imagine that, that would correlate with a burst and then PDSS.

But on the bottom, the MedinCell product, subcutaneous, where there are very few blood vessels, but even if injected directly in the human plasma, does not release right away, thereby eliminating the risk of PDSS.

And our partner, Teva, did negotiate with the FDA the number of injections needed to fully explore the risk of PDSS. That number was 3,600. And as you can see, Teva has conducted more than 4,000 injections in the clinical program with no cases of PDSS. Here, zero is a really good number and bodes well for not meeting those onerous monitoring requirements that really limited the use of Lilly drug.

So on the next slide, you can see the safety data for the Phase III study that Teva conducted in using LAI olanzapine. This was released in September of this year. And the key point is that there were no cases of PDSS and no unexpected or surprising adverse events and always comparable to the oral and LAI formulation of Olanzapine.

So based on this, as you heard, the exciting news that Teva has filed the NDA today, we should expect a 10-month review time, bringing approval sometime in the fourth quarter of next year, with commercial launch before the end of 2026. and that's to be followed by submission in Europe, as Teva has already announced.

So let's go back to our growth engines. And so we've discussed Olanzapine, and I think you can all understand now why it is such a strategic significant product. But let's go back to our Risperidone LAI, which is important both because it is bringing us revenue, but also it is a proof of concept of Teva's ability to get a product to market, which bodes well for olanzapine as well.

So you can see that prescriptions keep growing and growing in a very nice regular fashion. This translates into sales. And you can see on the next slide that Teva confirmed their guidance of $190 million to $200 million for 2025, which is the second full commercial year. You can notice as well that Q3 had lower sales as Q2. Teva explained that this was a onetime adjustment of Medicaid gross to net.

And now maybe, Richard, you could explain to us why UZEDY is doing so well and why it is such a great drug both for patients and clinicians?

Yes, I'd be happy to do that. So a reminder that when we formulated UZEDY, long-acting injectable Risperidone, we were looking to address some of the challenges faced by patients, clinicians and even payers with the Johnson & Johnson portfolio of Risperidone and Paliperidone products.

So first of all, UZEDY is subcutaneous, smaller needle, more comfortable for the patients; whereas the Johnson & Johnson products are intramuscular, more painful, larger needle. UZEDY reaches therapeutic levels within the first 24 hours after injection, making it easy to transition from oral risperidone; whereas the Johnson & Johnson products require either oral supplementation or titrating injections over several weeks before they reach therapeutic levels.

UZEDY comes in prefilled syringes, 4 different doses on a monthly, 4 different doses on every other monthly, which correspond to the 4 used doses of Risperidone in schizophrenia, 2, 3, 4 and 5; whereas the Johnson & Johnson products are converted from -- converted to Paliperidone and require reconstitution in the office, which can be somewhat cumbersome for psychiatrists.

And finally, Teva had asked U.S. psychiatrists, what one feature of a long-acting injectable product would they desire? And the #1 feature was flexibility to inject in different areas of the body. So in fact, UZEDY, whether it's injected in the arm, the abdomen or the thigh; has the same efficacy and safety, whereas the Johnson & Johnson product, intramuscular, so has variable exposure with different PK up to 30%.

So for all these reasons, UZEDY has done very good and very quickly. So as you would expect, Teva has been collecting real-world data after the launch of UZEDY in May of 2023. Here, you can see on the left, a reaffirmation of the primary endpoint in the Phase III, which was relapse rate and time to relapse in that study compared to placebo. But here on the left, showing significant differences between UZEDY and a second-generation oral antipsychotic on relapse rate and time to relapse.

But remember that in schizophrenia, 80% of those patients do not take their medicines. And when they don't take their medicines, they relapse and end up in the hospital. So part of the value here is to keep patients out of the hospital.

And in fact, on the right side of the slide, you can see that there was an almost 50% reduction in hospitalization rate, a 50% reduction in time spent in hospital if they needed to be admitted and a correlation with a reduction in healthcare cost, which is of great interest to U.S. payers, of course.

So on the next slide, we can see two additional pieces of news that Teva had announced this quarter. First of all, UZEDY has been approved for the treatment of bipolar I disorder in the United States.

Bipolar I is much more common in the U.S. And while the adherence rate is better than the 80% nonadherence rate with schizophrenia, still 50% to 60% of those patients are noncompliant. And we know that over 300,000 U.S. patients are already taking a Risperidone product for their bipolar I.

And the second bit of news is that Teva has announced approval of long-acting injectable Risperidone in South Korea and in Canada, more to come, but those are the 2 countries that Teva has announced.

Thank you, Richard. Quite exciting on the UZEDY side as well. Just to give you some numbers, Teva estimates the cumulative peak sales of UZEDY and Olanzapine to be between $1.5 billion and $2 billion. MedinCell sales analysts are above $3 billion. Of course, it could be higher, future will tell. And we are looking forward to getting olanzapine out there as well.

Now let's discuss the third engine. UZEDY was engine #1, Olanzapine engine #2. And the leading program of the third engine is the first program we do with AbbVie.

There is some piece of news today as we are happy to announce that it will be ready to launch into Phase I in 2026. Very strategic program for both companies. Lead formulation was chosen in September '24. We did -- MedinCell did all pre-IND activities. AbbVie will conduct clinical development. And we are eligible to $315 million of potential milestones with royalties that now get into the low double digit.

But beyond AbbVie, we have a pipeline of product, Richard, that maybe you could tell us about.

Sure. So we've talked about the 2 programs on the right, the partnered programs with Teva in psychiatry. But we also have another late-stage program. This is an Intraarticular Celecoxib to treat pain and inflammation in patients who have had total knee replacement surgery. We've been discussing with the FDA this year design of our next Phase III study as well as endpoints, and we look forward to starting that study in the coming year.

And then moving to the left, you can see 2 other programs that we run internally. The first one is a 6-month subcutaneous contraceptive. To differentiate from existing shorter-term subcutaneous contraceptives, it is funded by the Gates Foundation, and we do plan to start Phase I sometime in 2026.

And then we also have another global health program to prevent the spread of malaria through the use of ivermectin, which kills mosquitoes and is effective in preventing the spread of malaria in endemic areas, particularly in children who are most vulnerable. And some news on that. We've just announced that, that program is also funded by the Gates Foundation.

And then we have one more global health program we've recently disclosed, and that's a program in tuberculosis using a novel molecule, which in long-acting injectable form will improve the adherence in these patients who don't tend to take their pills as many months as they need to and reduce the risk of drug resistance. So we're very excited about that program as well.

And then we also have 10 to 15 or so additional programs, undisclosed. They're early in development, so we typically don't disclose until a little later. But these are both internal programs as well as programs that are already partnered. They can be already approved, but can also be NCEs, where you need a long-acting formulation to enable use. And again, we're agnostic to therapeutic area and are developing these in more than 5 separate therapeutic areas.

Thank you, Richard. Let's talk about financials.

Yes, certainly, with pleasure. So I'm going to comment the financials for the half year that was closed on September 30, '25.

So first slide -- next slide, please. So the first slide is on the revenue growth over the period. So very nice improvement in the revenues for the period, an increase of 50% compared to the same half year for the past fiscal year.

Three main items are contributing to the revenues. First, obviously, the UZEDY royalties, which accounts for approximately 1/3 of the EUR million. I'll come back to that more in detail in a minute.

Then we have half of it coming from the R&D partnerships. So obviously, we mentioned earlier the AbbVie First program, and that represents a big part of these R&D partnerships. And on top of that, we mentioned with Rick, the Gates Foundation program or the malaria program that were performed on behalf of foundations.

And the third item falling into these R&D partnerships are the 10 to 15 boxes that we saw on the pipeline. Some of them are proof-of-feasibility studies that we are running for undisclosed partners at the moment, but they might be the future of the licensing deal that we will execute over time. So they are very important as well.

And third item in this revenue, a 2.5 million research tax credit that we are benefiting from. And again, it is another proof of the maturity of the pipeline and of the different programs, and it explains why this amount has increased largely compared to the previous year.

Next slide, please. You are not on the right, you went too quickly. On the royalties from UZEDY, so as Christophe mentioned, UZEDY is doing very well. You've seen the prescription curve, which is progressing very well. Teva has confirmed their guidance for 2025 to $190 million to $2 million of sales, despite a slightly weaker Q3 '25 than expected, the sales have increased by 65% in USD compared to what they were in the same period last year.

Once converted in euro, the increase is a bit lower than the 65%. It's only 50%, but it's still very good. And it is very nice to have those EUR 4.2 million on our P&L.

On the next slide, you have the operating expenses of the company. So 22% increase compared to last year. So I remind you, 50% of increase in revenues, only 22% of increase for operating expenses. What's important is that 2/3 of the operating expenses relate to R&D activities. And again, it is a proof and evidence that the pipeline is progressing and that the programs in the pipeline are getting more and more mature. So it is good news for the future.

And I remind you that also most of the R&D costs are covered by partnerships and revenues. It is the case for the AbbVie First program, also for the Gates Foundations program and again, for the proof-of-feasibility studies.

On the next slide, you have a view on the income statement. So if you combine the 50% increase in income with the 22% increase in operating expenses, you end up with an improved operating loss by 13% to EUR 6.6 million over the half year.

It is good. It could have been even better without this negative impact of the U.S. dollar -- the weak U.S. dollar over the period, which has impacted us badly. And this -- if this situation with a weak USD was to persist over time, it might delay our return to profitability, which we plan for fiscal year '26, '27, but we have time to see how this evolves.

Another comment on the income statement regarding the financial results. So we have again a noncash impact due to the change in the fair value of the EIB warrants. This impact represents EUR 6.8 million for the period. It is linked to the fact that the stock MedinCell stock price has performed very well over the period, plus 65% increase.

Again, on that topic, we are -- negotiations are progressing, but too slowly compared to what we were expecting with the EIB, and we are hoping to find a definitive agreement with them that will enable us to waive the put option that exists with the EIB. So without this noncash adjustment to the fair value of the warrants, the net loss would have been drastically reduced to 9 million.

And finally, a word on the cash position. So at the end of September, we had EUR 53 million in bank. That's a bit lower to what we had at the end of March, where it was just after the capital raise that we performed at the end of February. So it was probably a peak in our cash position.

That said, it is a comfortable cash position that is sufficient to respect all the covenants that we have towards our banks and especially the EIB, and it gives us sufficient visibility for the next 2 years, at least because we obviously will be getting additional royalties on a quarterly basis from UZEDY and hopefully from Olanzapine at the end of '26, plus potentially commercial milestones as well. That's it for me.

Thank you. Thank you, Stephane. And now let's move on to the Q&A session. First question for you, Christophe, maybe what does progress beyond 2026 look like, number of approved products, revenue scale or global partnerships? And how do you plan to maintain technological leadership as competitors [ enter the AI ] space potentially, including big pharma?

Okay. So on the first question, the best educated guess can be done by looking at the pipeline beyond. So '26 should be approval of Olanzapine. And then you can see in the pipeline, you have CWM potentially WWM, which has commercial potential; AbbVie #1, and then the rest of the pipeline in formulation.

As far as technology leadership, that's a very good question. And I will give a bit of context here.

10 years ago, Johnson & Johnson was probably doing about $1 billion in schizophrenia. That became $5 billion worldwide 10 years later. So every single company now in schizophrenia, bipolar want to do a long-acting injectable of their drug. And we believe that the number of indications with long-acting injectable will increase in the next 10 years.

Some analysts believe that the global long-acting injectable market will go from about $15 billion today to 50, 5-0, in 10 years, and we want to be best positioned to do that. And so to do that, I predict that at the end of the day, half of our innovation will come from internal innovation, half from external. We already have people scouting the world for new technologies in either academic setting, small companies, and we probably do alliances at some point.

We are also working hard at developing the new generations of people. And that is a very significant effort to keep maintaining our lead. We've shown that in our space, we are the best positioned company. We could do things that Johnson & Johnson could not do, we could do things that Eli Lilly could not do. We were the first company that could maybe meet the dream of Melinda Gates. And so we want to maintain that lead for sure, and we'll keep investing in technology.

Thank you, Christophe. Stephane, next question, what are the revenues linked to the joint venture with Corbion for H1?

So for H1, they are fairly limited, less than 100,000. And that's because when you understand the business model of the JV, at the moment, the orders that the JV is receiving from their different partners is not linear because we are at the beginning of the commercialization. So there can be big orders, one half year and smaller ones on the next one. So over time, it will increase and become more stable. But for the moment, it's limited.

Okay. Next question also for you, Stephane. OpEx has gone up quite notably, largely due to R&D spend. How should we anticipate this to look for the full year and in outer years?

So indeed, it has increased for the first half year. As I mentioned, it is the evidence that we are gaining credibility and enriching the company portfolio, more programs, more mature programs. So I would say that it's a good news if we are continuing investing in this R&D cost because it is the future of MedinCell and the future licensing deals that is there.

Okay. Next question. The press release that we issued today states that MedinCell has decided to accelerate certain activities related to technological innovation to further extend its capabilities in terms of formulation. Is this perhaps related to peptide or protein capabilities?

Yes, but not only. There's three directions we could work on. First is highly hydrophobic molecules. Second is the dose because sometimes we are limited by the dose because you don't want to have a depot, which is too big subcu. And then the highly hydrophilic, yes.

Thank you, Christophe. Next question. Last winter, you indicated the first AbbVie program was targeting IND in 18, 24 months. Where we are on that clock today, formulation, CMC readiness? Can you share more about the timeline? When do you expect IND filing and clinical start? And what remaining getting [ attempts ] could push IND beyond mid-'26?

I think we answered that question during the presentation. As we stated that, yes, we were expecting the start of clinical activities during 2026, which means that all other pre-IND activities, including CMC, are on track.

Thank you, Christophe. Next question. You frame the deal has up to 6 programs, so deal with AbbVie, okay? Have AbbVie and MedinCell already done selected a second and third candidate? And if so, what's the [ growth rate ] for CMC preclinical starts across '26, '27? And are the candidates adjacent category of therapeutic areas are differentiated?

So as I said, I think, in our French presentation, I can't comment on the status of our discussion with AbbVie. And so I'll go back to the first product, which is on track to go into a clinical stage in '26.

Yes. We just can add that we stated when we announced the collaboration that it can be in different therapeutic areas. That's only what we can say today.

Next question. The Board of Directors of MedinCell has been strengthened with additional appointments of prominent industry leaders. Do you see partnership arising from operations tied to these individuals potentially, including Intra-Cellular or Novartis?

Obviously, we selected -- we select Board members for their competencies, experience, and the 2 new Board members have incredible experience and competencies. If they can help us, like other Board members, using their networks, we would love to use that capability.

Next question for you, Richard. Is it feasible for both mdc-STM and mdc-CWM to enter clinical development in 2026? Or are you prioritizing one of the programs?

Yes. So we expect all our programs to succeed. And the timelines are based on the data accumulation on the programs. And so as of today, we're looking for the WWM to enter Phase I sometime towards the end of 2026. STM, we think maybe a little later.

Thank you, Richard. Next question, Stephane. Outside of the $4 million for the potential approval of olanzapine next year, are there any other milestones to anticipate for 2026?

So I'm not sure I can disclose much on that, but we hope, indeed, to have more milestones in '26, '27. And you know that we are eligible to several types of development and commercial milestones from Teva on one side, also from AbbVie. So there are different sources of milestones that can be achieved in '26, '27, and it's -- there's a probability to it.

Next question and last question. You've indicated that you currently have multiple collaborations, deals ongoing. Could you please comment on the pace for future partnerships that might materialize and get announced in the next 5 years?

Okay. So obviously, I can't comment on the current collaborations, but I can comment on what we are building here. And the image I will take is a string of pearls, pearls meaning blockbuster potential drugs. So we have UZEDY, then Olanzapine, AbbVie #1. And now all our focus and efforts are trying to work on the next pearls after those programs.

Thank you, Christophe, and thank you all for your questions. It was a very good discussion. Before we leave, Christophe, I...

Thank you for being with us tonight and sharing this amazing news. You can see that it's quite emotional. We've been working on olanzapine LAI for over 10 years against all odds, our team here really knew we could solve it, and we did, but we also convinced Teva that we could. Teva has been a formidable partner on this, taking the product through clinicals.

And here we are with a major, major first-in-class product that could be launched in about a year. So exciting news. As I said in our French meeting just earlier today, here, we will be drinking champagne tonight to celebrate this news. And we are looking forward to our next discussions and following all the progress. You see that even beyond Olanzapine, UZEDY is progressing well and the rest of the pipeline as well. And the three engines are really performing well. Thank you.

Thank you, guys. Thank you, everybody, for joining us today. We truly appreciate your trust and your interest in MedinCell and hope to see you soon. Thank you. Bye.

Hello, everyone. Thank you for joining us today for this conference following the release of our annual results. We published them earlier today with a press release that is available on our website. Today, I'm joined by Christophe Douat, our CEO. Hi, Christophe.

Hello, David. Hello, everyone.

Stephane Postic, our CFO.

Hi, David, hi everyone.

Dr. Richard Malamut, our Chief Medical Officer.

Hello, everyone. Hello, David.

Before we start, I invite you to review the forward-looking statement disclaimer at the beginning of the presentation, which is available on our website. This webcast will last max 45 minutes. And we will start with a presentation followed by a Q&A session. [Operator Instructions]. Now Christophe, it's time to start the presentation. I give you the floor.

Thank you, David. I am delighted to join you today. But before we go into this past year, let me remind you of where we are. The next couple of years will be the most transformative years of MedinCell's history. Why? Well, let me share our financial strategy shift to growth and it's 3 engines, which are now firing simultaneously. UZEDY will take us to operational profitability in a year. Olanzapine will add exponential growth on top of UZEDY and the rest of the pipeline as well are as our technology innovation will extend the growth further. The time lines were UZEDY approved in 2023, Olanzapine expected to be approved in 2026 and engine number three, impacting the company significantly from 2029.

So a year ago, I told you that '24, '25 would be a spectacular year. And we can all agree that it was. UZEDY had a great first commercial year. Olanzapine reached key milestones, no PDSS, completion of Phase III. And our R&D pipeline progressed with the great agreement with AbbVie last April, the first program already in preclinical and the implementation of our new technology BEPO star throughout. It was spectacular financially as well. Our revenue was multiplied by 3, and the losses cut in half.

Let's go back to UZEDY. So '24, '25, first commercial year, sales of UZEDY were $141 million, which translated in EUR 6.5 million to MedinCell. You can see the trend of prescriptions, very impressive. And you can see the last -- the first 2 months of this fiscal year, April and May as well, continuing the very positive trend. What's next? Potential FDA approval for the bipolar disorder extension by year-end. And of course, the continuation of the ramp-up in the next years.

Olanzapine, many of you joined us because of its blockbuster potential. We can even consider Olanzapine LAI as a first-in-class, the dream of any pharma company. This for 3 reasons. Olanzapine is the most used antipsychotic in schizophrenia. It is used for most severe patients and the ones refractory to other treatments, which are the ones that need a long-acting injectable the most, and it is potentially the first long-acting Olanzapine that is appropriate.

It is -- it had a great '24, '25 year. As I said, study completion, no PDSS, positive efficacy results. Our partner even had a pre-NDA meeting with FDA on April 9. I mentioned the exact day because on this program, every day counts, the next steps will be FDA submission in the second half of '25, which will be followed by a 10-month review time by FDA, which, hopefully, will lead to a commercial launch in 2026 next year.

This slide may be the most important financially of the whole presentation as 2 of the key patents on the 2 products were granted in the U.S. in this '24, '25 fiscal year extending the patent protection to 2042 for UZEDY, 2044 for Olanzapine. I'll repeat 2042 for UZEDY, 2044 or Olanzapine.

Before I give -- I'll let Richard describe the pipeline, I will spend a couple of minutes describing our strategy to bring partners on board. And it is related to the box that you see on the left in-house and partnered programs because here, we have a demo strategy, either we partner from scratch on a molecule that a partner would like to develop and test as a long-acting injectable or we start the development on our own, the formulation development on targets that we think will trigger partner interest later. This allows us to save time and also build value. And the AbbVie #1 program was in this category.

Richard?

Thanks, Christophe. So starting on the right of the slide. Christophe already alluded to our engine #1 and engine #2, UZEDY and Olanzapine. I'll spend a little time on both of those in just a few minutes. And then the intraarticular celecoxib program for postoperative pain in total knee replacement surgery, I'll also spend a few minutes on in a little bit. What I want to talk about now is some of our programs that are approaching the clinic. So the first of these is our first of potentially 6 programs with AbbVie, which had lead formulation announced last fall.

While we haven't disclosed the actual target date for IND filing, it is typically 18 to 24 months after announcement of lead formulation. And currently, our CMC teams and nonclinical teams are performing activities needed to support the IND. I'm particularly excited about our long-acting subcutaneous contraceptive program, WWM, it is while owned entirely by MedinCell, it's funded by the Gates Foundation, and we'll be entering Phase I sometime a little later this year. And then our ivermectin 3-month program, a purely global health program designed to prevent the spread of malaria in -- predominantly in children in endemic areas where treatments for malaria are very much needed.

And then a few added words on the formulation side with our 10 blue boxes. This includes programs from multiple disease areas with multiple indications and includes NCEs where a long-acting injectable may be needed to allow for approval and then marketing.

Next slide. So UZEDY, we've spoken about a lot before. Just a reminder, that UZEDY is a subcutaneous formulation, a smaller needle, less pain, reaches therapeutic levels within 24 hours of the first injection. So no need for titrating injections or oral supplementation. It comes in prefilled syringes, at 4 doses for the monthly, 4 doses for the every other monthly without need for reconstitution in the office. And then finally, you have the same effect on efficacy and safety independent of the location of the injection, whether in the arm, the abdomen or the thigh, giving greater flexibility to clinicians.

Next slide. So this is some very interesting data that Teva presented last month at the Psych Elevate Conference in Las Vegas, Nevada. So on the left side of the slide, you're seeing data versus not placebo as with the Phase III studies, but second-generation oral antipsychotics. And when we run late-stage studies, we very often see favorable results and hope that they translate and are reproduced in the real world. And here, they very clearly were with a relapse rate of 42% less than that seamless second-generation oral antipsychotics. And a mean time to relapse increased by 54% over second-generation oral antipsychotic. So a confirmation of the positive results of the Phase III.

And then on the right side of the slide, we see some of the impact of having UZEDY available for use by clinicians, for patients. You can see that the inpatient rate is down by 47% for UZEDY versus second-generation oral antipsychotics. For those patients that do require hospitalization, the mean length of hospital stay is reduced by 50%. And this all translates into a mean all-cause reduction in health care costs by 29% versus second-generation oral antipsychotics. So a reaffirmation of real-world benefits confirming the very strong data we saw from the clinical program.

Next slide. So again, to reiterate what Christophe had said, Olanzapine is the most used oral psychotic in schizophrenia, both in U.S. and in EU. It is not a competitor for risperidone. It's typically used by clinicians for patients with schizophrenia, who have more severe symptoms or who are refractory which accounts for up to 30% of patients.

Next slide. And so developing a LAI Olanzapine would be a great value to clinicians and patients. And the one existing approved LAI Olanzapine, as Christophe said, has not had success, predominantly due to the risk of post-injection delirium and sedation syndrome. While not that common, 0.1% of injections, 2% of patients. The FDA put a black box warning on the label required REMS program, which is not that common for psychiatrists to have to follow. And every patient for every injection has to be followed in the clinic for 3 hours after injection. So Patients are not willing to do that, psychiatrist offices are not set up for that.

So when MedinCell formulated the long-acting injectable Olanzapine, it was with the goal of mitigating or eliminating the risk of PDS which is believed to be due to a burst of Olanzapine after injection. And in fact, there were no cases of suspected or confirmed PDSS in the clinical program. And this suggests that there would be no future risk of PDSS after what we hope will be an approval.

Next slide. And then CWM. This is our intraarticular celecoxib program, which has demonstrated in a completed Phase II clear differentiation from approved and investigational therapies around both duration of pain relief and measures of inflammation. And in fact, it demonstrated a unique impact on long-term functional outcomes, most driven by the presence of ongoing inflammation. So MedinCell and our development partner, AIC, met with the FDA earlier this year and confirmed clear guidance for a second Phase III study design, focusing on a group of patients who had not had prior total knee replacement and AIC is actively preparing the next Phase III study. Stephane?

Yes. Thank you, Richard. So now on the financial side, some very positive news as well. First of all, Christophe already alluded to that. Indeed, we have revenues for the fiscal year '24, '25 multiplied by 3x what they were in the previous year, amounting to EUR 25.4 million. So what are the main contributors to this very strong increase in the revenues? First of all, obviously, royalties from UZEDY. We mentioned that already. EUR 6.5 million multiplied by almost 4x compared to what they were last year and operate -- an additional milestone from Teva for EUR 4.8 million coming at the completion of the Phase III study for Olanzapine AI. EUR 0.6 million coming from the royalties from our joint venture, CM Biomaterials.

And the last big part is coming from the different commercial partnerships that we have with different partners, and they represented EUR 13.5 million in total, including EUR 9.5 million coming from AbbVie for the first program that we mentioned, and that is progressing very well. So that's a partial revenue recognition coming out of the $35 million upfront payment that we got from AbbVie back in April '24. The rest of the EUR 4 million from service revenues are coming from the different collaboration with the Gates Foundation with Unitaid for the 2 global health program and also from the proof of feasibility studies that we are running for different partners. So a very nice top line with EUR 25.4 million. It is indeed very sensitive.

So next slide is on income statement, where we see also a very nice improvement at all levels. So I mentioned already the strong increase in revenues. This strong increase in revenues has enabled us to reduce by -- cut out the operating loss. In the meantime, operating expenses have increased by 17% at a much lower pace than the improvement in revenues. And those operating expenses as expected, they are coming from the good progress of the different programs that are in our portfolio. So EUR 10.8 million of operating loss, an improvement of 48% compared to last year.

Now on the financial results side, a loss of EUR 7.4 million, which corresponds mainly to the interest paid on our debt and also that include a noncash impact related to the change in the fair value of the EIB warrants or EUR 2.8 million. And we are actively working with the EIB to eliminate this warranty impact and the floating liability that we have on our balance sheet due to the those were. So hopefully, next year, they won't be there anymore. So at the bottom line, we end up with a net loss of EUR 18.4 million, an improvement of 26% compared to last year. And again, we are very pleased with these results because they put us on track for our short-term objective to be profitable at the operating level in the next year.

Now another interesting and very positive news on the cash position, which is much stronger than what it was last year with EUR 72 million in bank at the end of March '25. This is obviously coming from several nice additions, the successful fundraising that we performed in February '25, that generated EUR 43 million of additional cash, also the collection of the upfront payment from AbbVie in May 24 for $35 million or EUR 33 million plus the quarterly royalties that we are getting from Teva for UZEDY and the milestone for the end of study for Olanzapine that I mentioned already. So very, very nice cash position, which will enable us to bridge to operating profitability in '27.

Next, if we step a little bit back, and if we look at the longer term, so obviously, the first milestones in terms of a financial perspective is, again, to be profitable for the next fiscal year ending March 31, '27. That's tomorrow. And on the longer term, around 2030, financial analysts that are covering our stock predict several hundreds of millions of dollars of annual pure profit coming from UZEDY and Olanzapine LAI products mainly, but also obviously, from other partnerships existing or to be executed in the coming years. And because you understood the beauty of our business model where we don't have any additional operating expenses associated to these revenues. We are confident in saying that EBIT should represent more than 70% of the revenue in the early 2030s.

One slide now on the investor bases. We mentioned last year that it was a priority for us to expand our shareholder bases to increase the visibility of the company globally worldwide. And indeed, we are very proud to have now on board almost 20% of shareholders that are coming from the U.S., the U.K. and Australia. So very, very nice name that you can see here on the screen. And they started for some of them to invest directly on the Euronext market, which is quite unusual and we can be proud of that. And they also participated very strongly in the fund raising in February. So they are coming on top of very, very strong also supportive European and French investors that we have on board for a long time, like Mirova or Groupe Dassault, or BNP for instance, very positive support for the company.

So that -- all of that increases the visibility of MedinCell globally. And also as a side effect, you can see on the right, it's improving the liquidity of the share. Now it is trading around EUR 2 million on a daily basis. So it is a very interesting and very promising for the next steps. Christophe?

Thank you, Stephane. Thank you, Richard. So again, last year was a great year. UZEDY has a beautiful first commercial year. Olanzapine reached key milestones. Our entire pipeline progressed. We implemented our new technology BEPO Star, with record financial results. Last word...

Maybe the question?

Yes. Okay.

Yes. So thank you, guys. Let's move on to the Q&A session. And so you can see the question on the screen, but I will -- I don't know maybe we shall...

So the first question, maybe I will answer the first one?

The first question is about a new patent. New patent application -- no, sorry. It's about a -- okay. So I read the question. You mentioned the improvements that BEPO Star can bring to MedinCell. What are the limits in terms of molecule size? Do you have peptides and biologics in the 10 programs in-house and partnerships in the pipeline? Do you plan to address markets such as oncology or obesity or GLP-1 immunotherapy? So Christophe?

So the first question limits in terms of molecule size, it's hard to answer with a given number because it really depends on the molecule plus it's confidential information. But I would say that it is appropriate for smaller peptides, hydrophilic molecules but not quite where we would like for larger peptides.

On the second question, do we have peptides in the 10 programs? Yes.

Okay. Next. Do you plan to address markets such as oncology, obesity, GLP-1 immunotherapy. The question is yes, we will address any indication where we can make a difference, significant difference, where there is a financial return that is significant and where we can do a best-in-class treatment.

Next question about, yes, a new pattern published in May '25 concerning a pre-combination of antineoplastic antibody. So it refers to agents used to treat cancer. Does it mean that you have patented the formulation with monoclonal antibody on active partner.

It's a great question, but I'm sorry, I cannot answer.

I have nothing there.

Nothing to add. Okay. So next question. So a question about AbbVie, when do you expect to provide additional updates on the AbbVie collaboration, including the time line to initiation of clinical development for the first candidate. Maybe Richard?

Yes. So again, typical industry metrics are about 18 to 24 months from identification of lead formulation. AbbVie has not opted to disclose either the API or the timing of the IND filing. We will certainly do so in advance of the IND filing. So I would just ask you to wait for that announcement.

Thank you, Richard. So next question, what is factored into your operational profitability outlook for fiscal year 2027. And is the latest R&D spend, a good proxy moving forward? Stephane?

So what is basically taking into consideration for now are the existing elements, the ones that are already ongoing and executed. So I will mention, obviously, royalties coming from UZEDY, which is, as we mentioned, has already started well from a commercial standpoint, and we expect this to continue. We'll have also the addition of Olanzapine LAI starting from end of '26. So additional royalties. And again, we said that the first-in-class status of Olanzapine should lead to much higher royalties, thanks to the ramp-up of the sales. Also a commercial milestone that we can expect for '26, '27, hopefully.

And to answer to the second part of the question, basically, yes, the existing cost basis for -- that we have just communicated for '24, '25 is a good reference. So maybe a bit of change, but nothing dramatic because, again, our business model is for now to go until the IND in most cases, and especially for AbbVie, I'm thinking about AbbVie because it's among the next program to get to that stage. And so nothing much to expect in terms of additional operating expenses.

Next question. How can your BEPO technology transforms the global contraception landscape, particularly in areas with poor access to health care. I think it's for you Richard.

Yes, I think it is. So there is value of a 6-month subcutaneous contraceptive in the developed world in the U.S. and EU. But in the developing world, LMIC countries, there's a particular need because of poor access to contraceptives, sometimes related to geography where they live, access to clinics to receive oral contraceptives or shorter acting contraceptive. So having a 6-month subcutaneous contraceptive, which can be stored at room temperature would be transformative for those women who do desire and would benefit from a longer-acting contraceptive.

Next question maybe for you also. Celecoxib, will this to be extend to hip, shoulder. When will [ phase III ] cover Europe?

Yes. So the current program is focused on total knee replacement. And our next studies will use post-op pain and total knee replacement as the indication. However, it's an excellent question because the need exists, particularly in shoulder. Pain and inflammation at their shoulder and also hip. So we do have that in mind for life cycle management, nothing to disclose on that today. And then in regard to Europe, we're still discussing the timing of when we might wish to expand the program into Europe.

Thank you, Richard. Next question. How has the funnel of new partnerships progressed over the second half? Is there a potential we could see additional signing over the next 12 months with similar sized deals to Teva or AbbVie? Christophe.

So yes, the funnel continuously progresses. As I said, in our French presentation, doing a deal is very complex with a lot of steps going from evaluation of technical feasibility, which could be positive or not and the negotiation. So yes, there is potential, but we don't -- as I often say, a deal is not a deal, until it is signed.

Next question, what progress has been made in integrating BEPO Star technology into your formulations? Is it already being used in preclinical research programs?

So as Adolfo described in our R&D Day, it has a significant impact on viscosity, therefore on the size of the needle and as well on the burst. So -- and gives us more parameters to play with, which is why we've decided to switch all our new programs with -- to BEPO Star as of 2024.

Next question about risperidone bipolar disorder. When do you think Teva will submit the dossier to the FDA? Is it likely that additional studies will be requested by the FDA. I think that...

Yes. So the good news is that Teva has filed the supplementary NDA with the FDA. And the better news is that in February of this year, they reported acceptance of the file. Typically, that would lead to another 8 months of review time. So we would expect approval sometime in the end of the year. And then Teva did file with the strategy not to conduct additional studies and to rely on completed studies for the 2-week long-acting injectable risperidone in that indication and oral risperidone, which has that indication. So no additional studies should be needed for that indication for UZEDY.

Good news. next question. You have invested EUR 13 million in short-term financial investment, what is your approach to cash management and returns in this context? Stephane.

So I'll -- that's a good question. And don't worry. We are not investing in silly things. So those EUR 13 million are just monetary bank deposit. But the only difference with the other deposits that we have in hand is that those ones are issued in USD and not in euros. So for some very tricky accounting policy because of very tricky accounting policy, they are classified as short-term investment but they are low-risk investment. They are available very quickly if they're needed, and there's no risk, no real risk associated to those investments. So we are very prudent. Just at the moment, the interest rates served on USD deposits are more interesting than on the euro. So we do a little bit of -- we take profit of that.

Next question, maybe for you, Christophe, do you plan to quote MedinCell on NASDAQ to unlock the value?

So it's a subject we evaluate continuously. Because of the potential, but more for access to U.S. investors and potential growth for acquisitions in the future, more than valuation. The finance department is also getting ready for it so that the day we decide we can get there in a matter of months, not of years. However, we have not made the decision and future will tell when we decide and whether we decide to go there.

Thank you, Christophe. Richard, I know it's important for you and for everybody. But after a full year of commercialization, what is the feedback from health care professionals and patients on UZEDY. Teva presented several posters I think.

Yes. So UZEDY has been on the market now for a full 2 years and Teva is actively conducting post-approval research. As you've mentioned, David, there's been several posters that have been published, including the 2 that I referred to earlier in the presentation on impact on health care costs and confirmation of the Phase III study results. Teva continuously follows these patients and also continually interviews patients as well as clinicians about their level of satisfaction.

More to come on that, look for future Teva posters and publications on the topic. I guess the thing I could say is given the strong growth and the strong prescription and sales data, I think we can assume that clinicians are quite satisfied with UZEDY.

Christophe, last question.

Maybe Stephane, what do our Analyst say on the potential revenue...

Not the revenue. The market size in dollar for Olanzapine LAI in 2030.

Yes, financial analyst forecast between $2 billion and $3 billion in 2030. So only 4 years after commercialization of the product. So very, very nice figures that could even be higher considering the lack of competition on the product. And that's it. So very nice multibillion market.

So we can bridge with a conclusion, Christophe, now?

Yes. Last year, I said that '24, '25 should be a spectacular year, and I think we can all agree that it was. Today, I am saying that the next 2 years will be the most transformative years of MedinCell's history so far. Thank you.

Thank you, Christophe. Thank you for your attention. We appreciate your trust, and we hope to see you soon. Good night, and see you soon, guys. Thank you.