MedinCell S.A. (MEDCL) Earnings Call Transcript & Summary

[Interpreted] Delighted to meet into this meeting, which was the publication of annual result. The press release in the details is available on our website. and partly that's a problem in the translation but the right translation will be available in a few minutes. I'm here with, you, Christophe. Christophe Douat, Chairman of MedinCell Management Board. To my left is Jaime Arango, our Chief Financial Officer. And with us for the first time, here is Sebastian Enault, who heads up our business development. And lastly with us here we have Dr. Richard Malamut, our Medical Director. Good evening, Richard or good morning to you. We begin the presentation of our results, we will also review the major events of the past year of what has happened since the close of business on the 31st of March and we'll also get to talk about the future and answer your questions. [Operator Instructions] So please do send in any questions. And we like to look at the disclaimers concerning any forward-looking statements that might be made by screening. These are on the presentation that will be posted online after this conference on the MedinCell website. The information, this video conference is in French and English. There is a live simultaneous translation. So you can ask questions in French or in English. And you can also like the questions on the website so that they can be pushed up higher in this. So before we go into the details of the financial results of U.K. I'm going to send to you, Christophe on my right. You can tell us please what do we -- what are the key points of the last year since the closing on the 31st of last March.

[Interpreted] Thank you, David. Hello, everybody, and thank you for being with us this evening. 2023 was a real emotional roller coaster. We started the year preparing the UZEDY approval, and we've set ourselves at the complete FDA reset a few weeks later. And in recent weeks, we've had an avalanche of peaking. First of all, the approval of UZEDY on the 28th of April. We also have 2 Phase IIIs underway, which started during the year on TJK and CWM. And recently, we had the results of Phase 1 of TJK, which are essential. Richard will explain to us later why. In recent weeks, also a new CEO presented a new strategy, and we realized and you realized also that our products were at the heart of their strategy, and that they were pushed to the forefront. And the latest event is an increase in capital, which allowed us to increase our visibility in terms of cash flow visibility, which is strategic because this will take us beyond these 2 Phase IIIs of TJK and CWM. So UZEDY is our first project to be approved by the FDA. It is also our first project events for schizophrenia. It's a best-in-class product with a significant impact for MedinCell. Firstly, because it is the first time that our technology will be treating patients on a large scale. And you can imagine the boost that this will have on our teams internally. Then UZEDY is tens of millions of potential royalty each year. and royalties that could cover our operational costs as from the end of 2025. Finally, it is a complete validation of our technology. It is the first FDA approval and our business development team, Sebastian will talk about it later, no longer needs to answer questions on our capacity to have an FDA approval and to bring a product to market. So that's as far as UZEDY goes. Now I would really like to draw your attention to TJK, why? Because its potential is even greater. It responds to a tremendous need for patients who today do not have any appropriate solution. And we can consider that TJK is a first-in-class product. It is incredible. A first-in-class product is what all the big pharms dream of. It is a product which is the first in its sector and which has a potential to generate $7 billion of revenues yearly. One of the best Teva analysis very recently, who is extremely well known and was awarded as a first pharma analysis more than 10 times, and he's part of the -- and he's in the hall of fame, even said in one of his recent analysis that TJK alone could have a potential impact on Teva's stock exchange rating to the extent of 50%. So you can imagine the pressure that there is in turn to Teva to speed up this Phase II. The same analysis last from Friday had a one-to-one with Teva CEO and Chief Medical Officer. And he reports that 200 patients have already been included in the current Phase III and none to date have had any PDSS warning. So Richard will explain what that means, and that means well. This is essential to understand. Last point, CWM, which is our second Phase III study. The Phase III is going very well. Our partner is confirming the end of the recruitment in the third quarter will be as planned. So as you see, all signals are green for products and even exceed our expectations. And despite this, it's paradox. We're still under pressure on the stock exchange. It is rated below its real value as we estimated and that said, it's gone from EUR 15 to EUR 17 per share. Of course, it's frustrating. We're taking it very seriously and we're making a lot of efforts in communication to explain the maturity and quality of our products. The potential of major news that is in the pipeline of the 12, 18 coming months. The strategic potential of these products achieved by the rest of the pipeline, our financial visibilities that will allow us to see this news coming in. And therefore, we're very far from a biotech risk profile. Parallel to this, we're evaluating all of the possible strategies, even if certain plan that biotech will bounce back after the minus 50% that we experienced in 2022. In 2015 and in 2020, the crisis was followed by a bounce back of 100%. So in this case, MedinCell will, of course, be very well positioned.

[Interpreted] Thank you, Christophe. That was a great introduction to talk about last year and what has been happening since. Jaime, I'm turning to you now. Can you please summarize the financial results for the last fiscal year, which were closed on the 31st of last March.

[Interpreted] Thanks David, and good evening, everybody. So yes, indeed, when we look at the revenue of the company, we're at EUR 13.7 million, and that's a strong growth of 64% as compared to the previous year. In the EUR 13.7 million, EUR 10 million corresponds to service revenues and milestones reached and this amount has more than doubled compared to the previous year, where we generated EUR 4.1 million. So it's a very important step. So I'd like to recall that we generate revenue that comes from the services that we provide to the Gates Foundation to United. And we also received Clemens milestone when Teva took the decision to initiate Phase III for mdc-TJK, that was in August 2022. And very important we'll talk to about the stage on, we generated EUR 1.6 million. For feasibility study. So it's quite free, but this is a strong growth because in the previous years, we generated only EUR 300,000. So we multiplied that amount by more than 5. When we look at operational expenses, these amount to EUR 37.7 million. That's a growth of 17%. 74% of our expenses are devoted to reset in development and 18% of growth of this expenditure come from research and development, considering the evolution of our different projects. Finally, operational cash consumption for the year was EUR 21 million which is aligned to -- it's almost identical to the previous years, exactly. And what we can also say is with our forecast of additional revenue plus the expenditure, cash consumption should reduce greatly this year and the current financial year. So this -- maybe it's time to describe the cash position of MedinCell and explain the direction you're taking for this year, maybe future years. Next, since March, we're counting on EUR 6.5 million of cash flow. But since then, we have largely increased our financial visibility. On one hand, we've already received the Teva, EUR 3.6 million for the approval of UZEDY. We increased the capital, which generated EUR 23.2 million. Gross, this was EUR 25.1 million. And there was a little bit of lag in the payment of the CIR, we pre-financed the CIR of 2021 for EUR 4 million. And in addition to this, we now have access at any point because we've already fulfilled the conditions, which was the use of the approval. We have access to the third part of the European Investment Bank loan. So which means that we have EUR 4.2 million of available or almost available in addition to the EUR 6.5 million at closing, exactly. And so it's a new era. We're going to start doing in the royalties, exactly. And that's why I said that previously, the cash consumption should reduce because we will start receiving royalties in future months with packet UZEDY and each quarter, that will also give a positive cash result for the company.

[Interpreted] Rene, you mentioned this that we have led to 2 big funding operations, a new loan with the EIB for EUR 40 million and an increase in capital of EUR 25 million. My question is simple. Why did we do this now at this point?

[Interpreted] Firstly, we're advised to adapt our financial strategy following a delay in the launch of used and the approval for marketing. So we did this and this is something we were already working and we were working with the European Investment Bank. And we signed this contract in November 2022, which allowed us to restructure the debt that we have with them and to gain time to reimburse this loan by the end of 2027. And we also gained EUR 20 million of additional funding. And we all know that we increased the capital, and that was a tactical decision. It's a very complicated context, but this allowed us to gain sufficient visibility to meet the next major steps, which are the first bond of the first route of UZEDY and the results of Phase III, which we hope will be positive for mdc-TJK, which has a tremendous amount of potential.

[Interpreted] The last question with the release that we disseminated earlier mentioned a non-respected clause for the EIB loan. Can you talk about that?

[Interpreted] Yes, exactly. That's a financial clause, which was not respected at 31st of March 2023. It is a clause which says that the treasury plus equity must be above EUR 1. Since then, we've corrected this, and we obtained a derivation from the EIB, a waiver. And when we do not respect what the causes in the contract, the EIB has the right to ask for the total or partial refund of the existing loan. So that was solution. No problem there.

[Interpreted] That means they have the right, but it doesn't mean they do it systematically?

[Interpreted] No. As you know, the European Investment Bank is a partner for us. That's what we consider them to be. We've been working with them for 6 years, and they're there to help companies. They're not venture capitalist, but they, of course, have to have a return on investment, and that is to help companies. So we have a very good relationship with them. And in this press release, we also put that at the 31st of March 2024. There is a risk that this ratio will not be respected. So as we said earlier on, the European Investment Bank could have the right -- would have the right to request a total partial refund. And that's why at the 31st of March 2024, we will have cash, and not necessarily to refund the entire loan, but we're already working with the EIB on a number of solutions, be it a new derogation as has already happened in the past to change these clauses to adapt them to the business model. And we could also have, and Sebastian will talk to us about this later on, potential new revenues from licenses from partners. So if all goes well, and it's on that basis that we are working today. We will find a solution. And when the solution is there, we can confirm today that our financial visibility takes us at least up to the last quarter of 2025. So we have a good financial visibility. And it's an important moment because at that time, UZEDY should be able to cover our operational expenditure.

[Interpreted] Thank you very much, Rene. That was very clear. So I suggest now that we talk a little bit of development of our product portfolio. Going to come back to the big businesses, although it is common. And this was the approval of UZEDY by the American FDA and the beginning of marketing the product by a sales team in America. So I'm going to turn to Richard, who, as I said, is in Philadelphia, which just a simple 2 questions. The first is can you recall what UZEDY is for us? And also the would you explain why this product has the potential of becoming the reference treatment for schizophrenia, Richard.

The answer, David. So UZEDY is a long-acting injectable formulation of risperidone, which is the molecule most commonly used as an antipsychotic in schizophrenia. It's available as a monthly or in every other monthly treatment, and it's available on all 4 doses of oral risperidone 2, 3, 4 and 5 milligrams in contrast to some of the existing formulations. Now antipsychotics, the oral antipsychotics work very well for the treatment of schizophrenia. The problem is that patients don't take their drugs. They don't have adequate compliance, which leads to a relapse. After relapse, they require hospitalization to get back under control. And this happens in up to 80% of patients with schizophrenia within the first 5 years of treatment. And even after hospitalization and successful control, another 50% of patients relapse, again, within 2 months after hospital discharge. So there are many long-acting injectable risperidones available on the market, but they have limitations and it's why we believe that UZEDY will be a best-in-class, long-acting injectable risperidone. So first of all, UZEDY is subcutaneous with a smaller needle and so less painful than the intramuscular formulations, which make up most of the approved products. Second, it's available in a prefilled syringe. So psychiatrists don't need to reconstitute it, to mix it in their office, which is not something psychiatrist like to do. And third and most important, it reaches therapeutic levels within the first 24 hours of injection. There's no need for oral supplementation or titrating injections. You immediately reach a therapeutic level. So that's differentiating, but Teva was able to produce some additional data in their Phase III study that further differentiates UZEDY from existing formulations of LAI risperidone. In addition to meeting its primary endpoint for both monthly and every other monthly injections for a reduction in relapse rate and increased time to relapse at 6 months compared to placebo, UZEDY showed some other very interesting findings. First of all, because the study went on for 2 years, double-blind, randomized controlled, the main symptom score for schizophrenia, the positive and negative symptom score showed improvement beyond the initial expected phase. In other words, we expected an improvement in the PANSS early on, but what was surprising and quite beneficial for patients is that their symptom scores continue to improve during the 2 years of the study. And that's not been seen with the other agents. There was also a statistically significant improvement in quality of life measures, and that's rarely demonstrated in central nervous system studies. I was at the American Psychiatric Association Meeting at the end of last May in San Francisco, which is the largest American Congress of psychiatry. And I can tell you that there was quite a bit of interest in UZEDY by the practicing psychiatrists who attended the meeting with quite a bit of interest at the Teva booth at the meeting and physicians calling it a game changer in schizophrenia treatment. David? So thank you for the question, David. So while many psychiatrists wait before prescribing a newly approved medication to assess how it's performing and to understand any reported safety issues, key opinion leaders are often early adopters and can influence community physicians. And as risperidone is a known molecule and the differentiating from existing long-acting injectable risperidone formulations is quite clear, as I've just told you, it may be that UZEDY will be prescribed earlier for an individual patient than is typical. And this would begin with patients who are not tolerating their existing long-acting injectable formulations or perhaps patients who are having relapses due to noncompliance with their oral antipsychotic medicines. And this could include switching directly to UZEDY not only from risperidone, but from non-risperidone oral antipsychotics. And there was a poster at the American Psychiatric Association Meeting last month, sponsored by Teva, in which 5 experts, 5 key opinion leaders in the treatment of schizophrenia wrote that patients are not hesitant about a long-acting injectable, and they recommended early use of long-acting injectables in general in the treatment paradigm of schizophrenia.

[Interpreted] Yes. This product, as we mentioned previously, could cover our operating costs as from the end of 2025. In my experience of pharmaceuticals. There are -- it takes 4 to 5 age peak sales and then the growth can stabilize. At that point, as we often say, the royalties that we will be receiving from Teva, the mid- to high digits, could represent something between $50 million and $70 million a year. And that would confirm our product is best-in-class. And apart from that, we can also receive a $105 million of commercial milestones in the coming 5 years. I think that we've finished the subject of UZEDY today, how the product will live its life, and we will talk about as trends sales. The second program today, Christian you how much this program is important for Teva and for MedinCell is what we call mdc-TJK. It's also a program in schizophrenia. The pivotal Phase III, which is the final stage before marketing approval if the results are good, began last January Richard, can you tell us a bit more about this product and this Phase III.

The answer, David. So mdc-TJK is a long-acting injectable of olanzapine, which is another molecule widely used in schizophrenia but it's not a competition to UZEDY, it's complementary because it's intended for more severe patients with schizophrenia who have more severe symptoms or for patients who are refractory, who are not responding to existing oral antipsychotics. And for those patients who have more severe schizophrenia, compliance is even more important. So there is no long-acting injectable olanzapine injectable that's being used regularly. Now there is one that's approved, but it's very little used, especially because it can lead to what's called post-injection, delirium and sedation syndrome or PDSS, as Christophe mentioned earlier. It's serious enough, even though it's rare that the U.S. FDA imposed significant constraints on its use, such as including a black box warning in the label and a requirement that patients must be monitored long term in a REMS program, in which psychiatrists have to enroll and track, follow and then report back to the FDA how patients do on this long-acting injectable olanzapine. But most impactful, patients must stay under observation for at least 3 hours in the clinic after each injection. It's believed that PDSS occurs due to a burst of olanzapine after intramuscular injection of the approved long-acting injectable. And so if this first, this high peak of olanzapine could be eliminated or blunted, there's a belief that PDSS may not occur at all. And Teva, our partner, just presented its Phase I results with long-acting injectable olanzapine last month at a schizophrenia Investigator Research Society Meeting in Toronto, Canada. And in that poster, they showed that there was no birth on single injection, both in healthy volunteers and schizophrenia patients, but also on repeat dosing up to 3 monthly injections. And so it was based on this Phase I data that Teva launched its Phase III study with a belief that there will be limited to PDSS in this study. So favorable safety and efficacy results from the Phase III study, which does include a 2-month double-blind placebo-controlled efficacy part using positive and negative symptom scale as a primary endpoint would be sufficient to lead to NDA filing, and this was confirmed with the FDA. It must demonstrate that efficacy during the 2-month portion, but also must confirm safety over the total study duration of 56 weeks because after the 8-week double-blind portion, there is a 48-week open-label portion in which PDSS occurrence will be assessed with each injection. If the study completes with no PDSS cases, it may allow the FDA to eliminate the stringent monitoring requirements and black box warning that exists with the approved but not used long-acting injectable. So it would be best-in-class for certain, like UZEDY, but in effect with no other used product, a first-in-class, as Christophe mentioned. David?

[Interpreted] My question TJK is quite simple. When will we know whether the product is safe and effective?

Well, not soon enough for MedinCell intel. However, unlike the UZEDY trial, which took quite a bit of time to complete due to the length of the study, this Phase III for LAI olanzapine is very different. It should go much quicker with only a 2-month double-blind placebo-controlled portion, a 48-week open label with a fixed target of 640 patients. And based on Teva's current reported recruitment projections in clinicaltrials.gov, you can see that, that top line data for the 2-month results should be available fourth quarter of 2024. But because of the potential impact of this product, we would expect that Teva will attempt to speed recruitment, which could allow for early completion of the study and earlier time to market. David?

[Interpreted] Thank you, Richard. I'm going to tell to you, Jamie, and I'm going to ask you the same question for UZEDY. How can one translate into figures for MedinCell?

[Interpreted] So yes, if this Phase III and the results are achieved in 2024, if the results are positive, as Richard just explained, it could be a first-in-class product. It could be considered to be a first- in-class product and it will meet the needs of many patients. So when you have a best-in-class and also first-in-class, as we saw in the sites earlier on, this market could represent several billion dollars for Teva. And what does this mean? For us, well, with UZEDY, we would move from tens of millions of dollars of royalties to be received to hundreds per year. So it's a tremendous potential and we're expecting these results in the coming 18 months. No major news expected in 18 months regarding that program.

[Interpreted] I'm turning back to you, Richard. We've commented about UZEDY. What of the other remarkable events regarding the rest of the portfolio?

Yes. So with all the excitement around the UZEDY approval and the progress being made with the long-acting injectable olanzapine product, we have to remember that there is yet a third later-stage product that we've partnered with AIC, a biotech based in Toronto, Canada, who began the first Phase III study for our pain product, mdc-CWM for the treatment of postoperative pain in patients who have had total knee replacement surgery, which, as a reminder, is quite painful, typically requires high dose opioids and frequently in as much as 15% of patients leads to opioid addiction. And so this product, which is an intra-articular celecoxib is designed to not only produce analgesia at beyond 3 days and as long as 2 weeks after surgery, but also mitigate opioid use, decrease the risk of addiction and improve patient function after surgery. And so recruitment is going quite quickly, and we expect completion later this year with data available on the top line results by the end of the year. And we know that there's going to be one additional study at least, but this will depend on the strength of the data and our discussions with FDA. In the pain division, typically 2 confirmatory studies are required. So we know we'll need at least one more depending on the results of the study. And then beyond that, we have 3 products, which we're developing internally, not partnered as of now, in which we plan on taking into Phase I within the next 12 months. And these include a 6-month subcutaneous contraceptive, which is funded by the Bill & Melinda Gates Foundation, a 1-month long-acting injectable formulation of tacrolimus for organ transplant rejection, where noncompliance with your tacrolimus can lead to organ rejection, a very serious outcome and a purely global health program, MDCSTM, which uses the endectocidal agent, ivermectin against malaria and is funded by Unitaid. And if that weren't enough, we have several other programs in the formulation stage that we haven't disclosed yet. And I very much look forward to talking about those in the future. David?

[Interpreted] Thank you, Richard. Thank you for the description of our portfolio. We received a lot of questions. But before we move on to the questions, I'm turning to you, Sebastian. Good evening we're lucky to have Sebastian with us. Sebastian is often all over the place across the world with his team but is so happens that he was here today. So we got a hold of him and asked him to come with us. So is the first time you've been with us? Use a couple of words to introduce yourself.

[Interpreted] Of course, I'm Sebastian Enault. I'm the Chief Business Officer of MedinCell, I manage the business and medical marketing team. That's a team of 10 people with very international profiles. We have 6 different nationalities on our team. And the mission of the team is to identify and launch future MedinCell programs, be it internally or with partners.

[Interpreted] So, Sebastian we said earlier on and my note this, our financial results show that revenues and partnerships have increased. I'm talking about new partnerships. We talked about usability studies that went from EUR 300,000 for the previous financial year to about EUR 1.6 million in the current financial year. What do this sum to?

[Interpreted] Well, as Christophe said, we've really entered into a new era for MedinCell. The MedinCell technology was approved by the FDA. But I must say that we didn't wait for the approval of UZEDY to launch new partnerships. This is the next month which already we work with a number of partners on different types of product with the molecules that are already approved but we also work with molecules that are in the clinical settlement phases as we often work and also work in other therapeutic areas. So we've launched feasibility studies whose objective is to make sure that we have real chances of success of finding the right formulation. As you can understand, these feasibility studies are highly strategic for our partners and we will say a little more when we can, when we get to find out.

[Interpreted] So feasibility studies, and we've understood you can't say more on these new programs, and the details, what indications of what partners. But what will happen is these feasibility studies are positive?

[Interpreted] Well, if the feasibility studies are positive, the next step will be the creation of license contracts as we see with upfront payments, milestones and quality payments and the start-up of all of the other developments. And a story because when you were talking about company, I was in the bio conference in Boston a few weeks ago. A big conference Day conference. I think there were more than 15,000 participants, and there were more than 65 qualified appointments, which is quite a staggering number. 4 of my team were there. And I must say that the UZEDY approval really is speeding things up. And I think that we've been waiting for this for a number of years and we're there now. So we no longer need to convince people, fight to convince. We can demonstrate what we are able to do. Well, there are 2 programs in Phase III with a technology that has been FDA approved with the approval of UZEDY. All of the questions we had in the past as to whether our technology is truly nontoxic when we administered sub continuously or via other administration pathways, we no longer have that type of question. So we even have the luxury of spending time with future partners and screen the partners, one of our products to identify what is the best molecule that we could develop together.

[Interpreted] We are impatient. I think I'm not the only one to see. We'll have to this. So let's move on to questions. We're going to take all of the questions, even those that are a little bit tricky. We're going to start with those that are tricky and just to summarize the question.. As basically why did you try to break the mounting prices of the shares by selling shifts just when we're about to make the UZEDY announcements?

[Interpreted] Well, of course, this is a legitimate question, except that nobody tried to break the value of the share. So just to give you the details that I'm being side transparent here. I haven't sold any shares since we've entered the stock exchange, and it so happened that I needed to sell some, and I decided to sell 10% in autumn. So I have kept 90%. So the sale of -- sorry, to share is a very sensitive subject but also very highly regulated as a straight framework. And so the house orders that must be given very long-time upstream again that order at the beginning of December 2022 on condition of the pivotal of UZEDY by shareholders. I made all necessary precautions so didn't weigh on the rating So the sale represented only 9% of the circumstances meant that things didn't happen as planned with a lot of pressure on the value, and it was difficult to imagine that 6 or 7 months beforehand.

[Interpreted] Thank you for that clarification, Christophe. Again to move on to the next question. This is for you, Rene. I'll ask some more details. On the non respective clause with the European Investment Bank, but I think we've already taken that. Maybe the second part of the question is interesting. What is our level of confidence in the possibility of solving this problem? Maybe this will be the opportunity of identifying how we can sell this product or maybe with new partners?

[Interpreted] Absolutely. So this ratio is a very simple ratio. It's equity and plus cash must be above 1. So we closed the accounts on the basis that we have visibility. We have more than 12 months visibility. This is also the reflection of the trust in that Christophe and myself have in finding a solution as we already have in the past with the European Investment Bank. We know them, they know us. Now we've moved on to another stage. And so we're quite confident that there will either be a solution directly to be found with them or asset equity plus cash to find new partners. It can be new partners who pay upfront, milestones or services rendered, et cetera. So there will be solutions. And as I was saying, the European Investment Bank is there to help companies not to stop them. And that is what they showed us already in 2018 before we were listed on the stock exchange, also during the pandemic we renegotiated with them. Last year, following the CRL, we also obtained a new loan. So, they know us well. And we know them well also. So real partners. Yes, they're real strategic partners of the company. Absolutely.

[Interpreted] Next question for you also Jaime. I don't know how you can answer but can you give some details on the commercial milestones. So here, we're talking about UZEDY, of course, which is being launched on the market. And can you tell us the number of patients treated, the turnover? Maybe you can't go into much detail but maybe a bit of color behind this?

[Interpreted] Yes. Unfortunately, I cannot give you the precise amount of sales of Teva that will trigger the payment of these different milestones. In all, it represents $105 million. And this is also why, when I was talking, when I was saying that the strong growth we'll be able to at the next 5 years. So it's over that period of time that we expect to hit most of the commercial milestones.

[Interpreted] Just to clarify to answer the question. It's not a question of number of patients treated? There's a question of yearly turnover of Teva yearly. 1st of January to 31st of December. Maybe Christophe, we can ask the question about the mdc-ANG, which is a product that has been developed?

[Interpreted] Yes. Well, this is a product that's in the preclinical phase and Teva does not wish to communicate on this today. So we hope we will have a new soon of that product.

[Interpreted] I'm going to take the next question. This one concerns F14. And maybe for Richard. Richard regarding F14 is the name given to mdc-CWM with our Canadian partner, the AIC. Is the Phase III of this successful? Can we extend this to other operations such as surgery of the shoulder, the head, the spine without guiding all the clinical phases? Meaning can we accelerate the process to approve the product for other indications?

So we are focused, laser-focused on postoperative pain in knee replacement surgery. We're focused on executing on the ongoing study and then planning with the FDA for the next study to get approval. Now everything goes well and the studies are positive, we have approval, and we can launch. Of course, we'll be looking at other indications, other potential uses of this formulation, but we're not ready to go into detail about what those are today.

[Interpreted] Next question will be for you, Sebastian. I don't know. You've kind of awaken our curiosity and we can see that the accounts show that the feasibility study is brought in a lot more money this year than the previous year. The question is simple. Might we have a communication on new partners?

[Interpreted] Well, communication not on feasibility studies because there is always a risk that the molecule is not compatible with our technology. And that we cannot move on to the next phase, which is after the positive feasibility study to move on to a partnership license contracts. So I think it's when we execute this license that we can communicate on it. Now as a communicator I can add we can talk about the number of partners. That's difficult for the indication because it's so strategic. Our ambition is to present things as soon as possible.

[Interpreted] Your next question, which will be for Richard, but I don't know if he can answer. Head of R&D should be with us and will ask question, Marty, he can answer. On the Global site in April 2023, there is a presentation on the possibility of delivering proteins for prostate cancer in the field of oncology. What is the strategy, partnership, or do you want the approval concept to develop this program internally? Who can answer it, maybe Sebastian can or Richard or Christophe.

[Interpreted] We've already said that historically, BEPO is highly suited to small molecules, which are hydrophobic. We continue looking to develop new technologies to develop more hydrophilic molecules in particular peptides and proteins. So as we go on, we test these on molecules such as this one, which is not a product that is being developed in MedinCell today, but which allow us to assess the potential for this type of molecule. So this type of work is used to publications, which is also Sebastian's job to show what we can do with our technology. Yes. So these publications give us information on the potential for this type of molecule. And I can just add that 2 partnerships that we engaged for coming months of MedinCell molecules, which are not small molecules.

[Interpreted] Christophe, the next question is for you. It's simple. I think that this question has been asked twice. Why did we stop our animal health program?

[Interpreted] Today with the Phase III results of UZEDY, which was spectacular, which exceeded our hopes, as Sebastian said. This has really allowed us to pick up the pace of our partnerships in human health. So we have to focus first of all on our mission, which is treating people are not animals. Of course, there's a bigger financial potential as well. Of course, this program is no longer a strategic priority for MedinCell today.

[Interpreted] We have quite a few questions, but we're going to try to ask them by giving very quick answers. Any of the current financial year shows revenue of EUR 1.2 million royalties from Corbion. What are the outlooks for 2023 for the entire? Maybe you can just remind us what we do with Corbion.

[Interpreted] It's a joint venture. The company has held 50-50 between Corbion and MedinCell. It's called CM Biomaterials. So our partner must purchase the polymer, which is the basis of our technology from the company. But that company outsources the production of the biotechnology to Corbion. There is a difference in profit margins that are created in the joint venture between the purchase cost of the joint venture and the sales price to our partners. These profit margins are split 50-50 between MedinCell and Corbion. It's the sale of polymer. That's why we see the stuff. So this can vary. It depends on our partners, on their needs, batch validations, preparation of launches of Phase III, et cetera. So it goes up and down. This year, it was EUR 1.2 million. The previous year, it was EUR 100,000. And the year before that, it was EUR 40 or EUR 50, I think. So it's a good sign. Yes, it's a good sense. That's what I like. We're waiting for next year to know what happens. Yes, things are varying a lot.

[Interpreted] Let us come back to the animal health program. We are asked if celecoxib which is the molecular use of animal health whether we plan for development in human health.

[Interpreted] But we assess these, but not for that molecule. I'd like to recall that the F14 program that Richard was talking to about is an anti-inflammatory molecule celecoxib, commercially being [indiscernible] which was chosen for that application.

[Interpreted] First off, were asked at what stage we will consider introducing partnership for internal development program. Does MedinCell doesn't have any commercial capacity?

[Interpreted] Main criterion is the quality of the partner. Their capacity leads the development. Like Teva has done remarkably well for UZEDY and TJK apart from the CWM, of course And of course, marketed. In the case of Teva, the projects are a priority. In a field where they have the perfect sales force to launch the product. So we look at all of those criteria meet competencies use market and when the time comes, when all of the stars are aligned and the data that we have allowed them to give us access to the ideal partners, we will decide to license the product and the more advanced we are in the phases, the more and actually interesting contracts and the more partners we'll be able to attract because the few or the number of years between the licensing step and the approval. So more partners that will be here will be enchanted, of course, because the risk is lower.

[Interpreted] Your next question, I will split it to 2. First pass is for you Jaime. Ask what is the percentage of capital held by the employees and founders and ex-employees after the last increase in capital. And the second question, you can ask all or maybe Christophe can answer this. Aren't you afraid that Teva or somebody else will buy you out?

[Interpreted] So founders management, employees and ex-employees of the company hold 43% of the capital. About 42% of the capital.

[Interpreted] Aren't you afraid that Teva or another group might buy you out? Christophe?

[Interpreted] Teva has already tried in the past. We saw that MedinCell had potential with Teva and other indications. Well, if one day, we have a partnership that is too strong with a partner, it will restrict our separation because MedinCell also have the biggest scope of action possible. And that would usually we wish to extend our partnerships. If I were the CFO of Teva, with the initial figures with UZEDY trends and positive results of Phase III, I would do my sums. And any CFO working at that time would do that. So now it's up to us to show our capacity to extend our partnerships and also to develop our products internally in an effective manner.

[Interpreted] Christophe, the question in the different interviews of June, we talked about diabetes. Where do we stand on that topic?

[Interpreted] As I said, I can say that we're working in different therapeutical areas, not just CNS. We also work in fields that there is an interest in developing a long action injectable form. And generally speaking, this is cardiometabolic scope. There's an interest. There are already existing LAIs where the technology could be appropriate. So you want to this anymore, no, we have to wait.

[Interpreted] Next question. It's a little bit cheeky. So Jaime or Christophe, I'll let you answer. If you think that the shares were EUR 15, why did you increase the capital at EUR 7.31?

[Interpreted] I've already given you as an introduction. Jaime maybe you can add to these and complete them?

[Interpreted] Yes, there's increasing capital. It was a tactical maneuver. It was not in an ideal context of that but you must remember the context, macro context, the context of the structural biotech, where companies lost 40% to 50% of their value without having any bad news. Just quite simply, there were no investors. On the equity markets, the money is there today and maybe not tomorrow. So very often, we have this question. Why did we increase our capital at that point? Why didn't we wait until the stock essence went back up. Given the context of rising interest rates, then there was the bank prices in the United States. Today, we're talking about deflation and the economic situation in Germany. There was news also this weekend in Russia also. It's an extremely volatile market. It's extremely complicated market. And as I said, I don't know if I'm going to manage to say correctly this time, it's better to have one in the pocket than 2 in the year. We are the first to be disappointed, but the most important message is with this tactical action, if any company could do it, it was MedinCell. And here, we are securing the future of the company. Know that if my memory is good, there are only 3 transactions of capital and MedinCell is one of the 2 main ones. Yes, the 2 others, well operations in which TVC was guaranteeing all of the industrial side of things. So we're the only company who did a normal increase in capital on the French market.

[Interpreted] So what you is the ideal partner strategy for the future? Would it be new multiproduct partners such as Teva with or without Teva or somebody else or a partner approach application with different partners?

[Interpreted] I think we have to stay very practical. And of course, the pipeline we have to develop the pipeline of protection policy so we can develop this partner. Very often, the partners have a strategic focus. Teva, thanks to us is developing a long injectable for schizophrenia and this will no doubt be the case of other partners but, of course, we won't stop ourselves working with a partner on a single product if it meets a significant medical need. And if Jaime tells me that it's worthwhile investing in the relationship.

[Interpreted] Sebastian, putting this back on the table again. What type of company we work currently, who we're talking with, who we're doing visibility studies? Among the list, there are what we call any big pharmas.

[Interpreted] Well, I can say that there are companies of all sizes really. Even with the ultra-innovative biotechs in the North American market to larger companies. So we have an entire range of partners and future partners.

[Interpreted] Public or private?

[Interpreted] Both.

[Interpreted] The last question for this evening. Christophe, is NASDAQ quotation a vision in the near future?

[Interpreted] Well, this is something we're looking at closely and we asked Jaime to get ready for this. When the time comes, maybe, especially as in the past week, with all of the noise made my take on its strategic orientation on the importance of our products, we are called upon increasingly American contracting [indiscernible] and to increase the visibility of our company and to gain access to capital and also cash. It would no doubt be a step that we will take in the future. For the time being, the value is too low. So our goal is to achieve values that are key for our next on states. We must go beyond the bar of EUR 500 million. which puts us on the radar and beyond which we can have a cash which is such normal with efficient markets, hedge funds, big investment plans. And this is really our next objective is to achieve that level of valorization, which will make our lives easier.

[Interpreted] Thank you very much. Thank you, gentlemen. Thank you, Richard. Thank you for being with us and for answering all of these questions. Some more important employments this week. Tomorrow in Lean, Christophe and Jaime you're going around the country as our shareholders who wish to be with us can be there. You should have received an invitation, but if not send us a mail. I'll be happy to meet with you to take these discussions a bit further. So beyond that, we're also broadening out our communication to Europe. Because during the summer, we will be in Brussels, Geneva, Luxembourg and we're also preparing with our American agency of Investor Relationships and future roadshows across the United States. Jaime, maybe you can say a few words also on our analyst strategies.

[Interpreted] Yesterday, we had coverages, right, French. We have 5. Of course, even though we're working actively to attract more coverage and international coverage, with a great coverage in Europe and in the United States. So we're going to carry on working in this direction.

[Interpreted] A great challenge. Any other questions among yourselves? In any case, thank you very much for all of you for being with us. For having you into this complicated year this year, the increasing capital in the macroeconomic context on biotech context was extremely complex I think that you can see that we have a lot ahead of us and above all the financial visibility to see things coming. So thank you for your trust and for your zeal. Thank you, everybody. Have a great evening. Goodbye. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]