MedinCell S.A. (EPA:MEDCL)
France flag France · Delayed Price · Currency is EUR
23.16
-1.04 (-4.30%)
Apr 24, 2026, 5:35 PM CET
← View all transcripts

H2 22/23

Jun 26, 2023

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Delighted to meet into this meeting, which follows the publication of our annual results. The press release with all the details is available on our website, apparently, there's a problem in the French version, the right French version will be available in a few minutes. I'm here with you, Christophe. Christophe Douat, Chairman of MedinCell's Management Board. To my left, Jaime Arango, our Chief Financial Officer. With us, this is the first time, here is Sebastien Enault, who heads up our business development activities. Live from Philadelphia, we have Dr. Richard Malamut, our Medical Director. Good evening, Richard, or good morning to you. Good morning.

We begin this with the presentation of our results. We will also review the major events of the past year or what has happened since the close of business on the 31st of March. We are also going to talk about the future and answer your questions. You can ask these questions right now using the chat module on the right of your screen. Please do send in any questions. Before we go any further, I would like you to look at the disclaimers concerning any forward-looking statements that might be made this evening. These are on the presentation that will be posted online after this conference on the MedinCell website. Just for 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.

You can also like the questions on the website so that they push that higher in the list. Before we go into the details of the financial results with you, Jaime Arango, I'm going to turn to you, Christophe Douat, on my right, so you can tell us, please, what are the key points of the past year and since the closing on the 31st of last March?

Christophe Douat
Chairman, MedinCell

Thank you, David. Hello, everybody, and thank you for being with us this evening. 2020 to 2023 was a real emotional roller coaster. We started the year preparing the UZEDY's approval, and we found ourselves with a FDA Complete Response Letter a few weeks later. In recent weeks, we've had an avalanche of good news. First of all, the approval of UZEDY on the 28th of April.

We also have 2 phase 3s underway, which started during the year on mdc-TJK and mdc-CWM. Recently, we had the results of phase 1 of mdc-TJK, which are essential. Richard will explain to us later why. In recent weeks, also, the new CEO of Teva presented their 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. The latest event is an increase in capital, which allowed us to increase our visibility in terms of cash flow. A visibility, which is strategic, because this will take us beyond these 2 phase 3s of mdc-TJK and mdc-CWM. UZEDY is our first project to be approved by the FDA. It is also our first project event with Teva 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. UZEDY is tens of millions of potential royalty each year, and royalties that could cover our operational costs as from the end of 2025. It is a complete validation of our technology. It is the first FDA approval, and our business development team, Sébastien will talk about it later, no longer needs to answer questions on our capacity to have an FDA approval and to bring our product to market. That's as far as UZEDY goes. 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. We can consider that TJK is a first-in-class product. It is incredible. A first-in-class product is what all the Big Pharmas dream of. It is a product which is the first in its factor and which has a potential to generate several billion dollars of revenues a year. One of the best Teva analysis, very recently, who is extremely well-known and was awarded as the first pharma analysis more than 10 times, and he's part of the Analyst 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%. You can imagine the pressure that there is internally in Teva to speed up this phase three.

The same analysis, last Friday, had a one-to-one with Teva's CEO and chief medical officer. He reports that 200 patients have already been included in the current phase 3, none to date, have had any PDSS warnings. Richard will explain what that means. I may as well. This is essential to understand. The last point, CWM, which is our second phase 3 study. The phase 3 is going very well. Our partner is confirming the end of the recruitment in the 3rd quarter will be as planned. As you see, all signals are green for our products and even go exceed our expectations. Despite this, it's paradoxical. We're still under pressure on the stock exchange.

It is rated below its real value, as we estimate it, and the analysis has said it, have meant, it's gone from 15 to 17 euros per share. Of course, it's frustrating. We're taking this 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 pipelines for the 12, 18 coming months. The strategic potential of these products, the Teva, the rest of the pipeline, our financial disabilities that will allow us to see this news coming in. 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 -50% that we experienced in 2022.

In 2015 and in 2020, the crisis was followed by a bounce back of 100%. In this case, MedinCell will of course, be very well-positioned.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

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 just summarize the financial results for the last fiscal year, which were closed on the 31st of last March? Jaime.

Jaime Arango
CFO, MedinCell

Thank you, David, good evening, everybody. Yes, indeed, when we look at the revenue of the company, we're at EUR 13.7 million, that's a strong growth of 64% as compared to the previous year. In these EUR 13.7 million, EUR 10 million correspond to service revenues and milestones reached.

This amount has more than doubled compared to the previous year, where we generated EUR 4.1 million. It's a very important step. I'd like to recall that we generate a revenue that comes from the services that we provide to the Gates Foundation, to Unitaid, and we also received Teva's milestone when Teva took the decision to initiate phase 3 for mdc-TJK. That was in August 2022, and very important, Sébastien will talk to us about this later on. We generated EUR 1.6 million for feasibility studies. It's quite premature, but this is a strong growth, because in the previous years, we generated only EUR 300,000. 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 research and development. 80% of growth of these expenditures come from research and development, considering the evolution of our different projects. Finally, our operational cash consumption for the year was EUR 21 million, which is aligned with Yes, it's almost identical to the previous years. Exactly. What we can also say is, with our forecast of additional revenue plus expenditure, our cash consumption should reduce greatly this year in the current financial year.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

This may be the time to describe the cash position of MedinCell and explain the direction you're taking for this year, maybe future years .

Jaime Arango
CFO, MedinCell

Absolutely. On third first of March, we're counting on EUR 6.5 million of cash flow. Since then, we have largely increased our financial visibility.

On one hand, we've already received the Teva milestone, $4 million, EUR 3.6 million for the approval of UZEDY. We increased the capital, which generated EUR 23.2 million net. Gross, this was EUR 25.1 million, there was a little bit of lag in the payments of the CIR. We pre-financed the CIR of 2021 for EUR 4 million. 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. Which means that we have EUR 4.2 million that are available or almost available, include in addition to the EUR six and a half million at closing. Exactly. It's a new era.

We're going to start drawing in the royalties. Exactly. That's why I said that previously, the cash consumption should reduce, because we will start receiving royalties in future months. Thanks to UZEDY, each quarter, that will also give a positive cash result for the company.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Jaime, you mentioned this, but we have led two 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 these now, at this point?

Jaime Arango
CFO, MedinCell

Firstly, we're obliged to adapt our financial strategy following the delay in the launch of UZEDY and the approval for marketing.

This is something we were already working on, 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 had 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. We all know that we increased the capital, and that was a tactical decision. It's a very complicated context. This allowed us to gain sufficient visibility to meet the next major step, which are the first sponsor of the first royalties of UZEDY, and the results of phase three, which we hope will be positive for mdc-TJK, which has a tremendous amount of potential. Exactly.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Last question, Jaime. The press release that we disseminated earlier on mentions a non-respected clause for the EIB loan. Can you tell us about that?

Jaime Arango
CFO, MedinCell

Yes, exactly. That is a financial clause which was not respected at 31st of March, 2023. It is a clause which shows that the treasury, plus equity, must be above EUR 1. Since then, we've corrected this, and we obtained a derogation from the EIB, a waiver, and when we do not respect one of the clauses in the contract, the EIB has the right to ask for the total or partial refund of the existing loan. That was solution, no problem. That means they have the right, but it doesn't mean they do it systematically. 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 six years, and they're there to help companies. They're not venture capitalists, but they, of course, have to have a return on investment, and that is to help companies. We have very good relationship with them. 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.

As we said earlier on, the European Investment Bank could have the right to request a total or partial refund, and that's why, at the 31st of March, 2024, we will have cash, not, 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. We could also have, and Sébastien will talk to us about this later on, potential new revenues from licenses from partners. Exactly.

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. 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.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Thank you very much, Jaime. That was very clear. I suggest now that we talk a little bit of development of our product portfolio. We're going to come back to the big piece of news, although it did come along after the closing, and this was the approval of UZEDY by the American FDA and the beginning of marketing the product by Teva's sales team in America.

I'm going to turn to Richard, who, as I said, is in Philadelphia. Richard, just a simple two questions. The first is: Can you recall what UZEDY is for us? Also, could you explain why this product has the potential of becoming the reference treatment for schizophrenia? Richard.

Richard Malamut
Medical Director, MedinCell

Yes. David, 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 an every other monthly treatment, and it's available in all 4 doses of oral risperidone, 2, 3, 4, and 5 milligrams, in contrast to some of the existing formulations. 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. Even after hospitalization and successful control, another 50% of patients relapse again within 2 months after hospital discharge.

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. 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 psychiatrists like to do. 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 your therapeutic level. That's differentiating, but Teva was able to produce some additional data in their phase 3 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, an increased time to relapse at six months compared to placebo, UZEDY showed some other very interesting findings. First of all, because the study went on for two years, double blind, randomized, controlled, the main symptom score for schizophrenia, the Positive and Negative Syndrome Scale, 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 continued to improve during the two 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. 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?

Speaker 6

I can't hear what you're saying. I'm sorry, I have no sound.

Richard Malamut
Medical Director, MedinCell

Can you hear me, Anita?

Speaker 6

I can hear you, but I have no sound from the phone.

Richard Malamut
Medical Director, MedinCell

I'm going to just talk. Thank you for the question, David. 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. 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. This would begin with patients who are not tolerating their existing long-acting injectable formulations, or perhaps patients who are having relapses due to non-compliance with their oral antipsychotic medicines. This could include switching directly to UZEDY not only from risperidone, but from non-risperidone or oral antipsychotics.

There was a poster at the American Psychiatric Association meeting last month, sponsored by Teva, in which five experts, five 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.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

I don't have a sound. Yes. This product, as we mentioned previously, could cover our operating costs as from the end of 2025. In my experience of pharmaceuticals, the, it takes four to five months to reach peak sales, and then the growth can stabilize. At that point, as we often say. The royalties that we will be receiving from Teva, at the mid to high digits, could represent something between $50 million and $70 million a year, and that would confirm that our product is best-in-class. Apart from that, we can also receive the $105 million commercial milestones in the coming five years. Perfect. Well, I think that we've finished the subject of UZEDY today.

Now the product will live its life, and we will talk about first trends, sales trends in a few months. The second program with Teva, Christophe mentioned earlier, I want you to outline how much this program is important, both for Teva and for MedinCell. It's what we call mdc-TJK. It's also a program for schizophrenia. The pivotal phase three, 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 three?

Richard Malamut
Medical Director, MedinCell

Yes, sir, David. 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. 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. For those patients who have more severe schizophrenia, compliance is even more important. There is no long-acting injectable, olanzapine injectable, that's being used regularly. There is one that's approved, but it's very little used, especially because it can lead to what's called post-injection delirium/sedation syndrome, or PDSS, as Christophe Douat mentioned earlier.

It's serious enough, even though it's rare, that the 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. Most impactful, patients must stay under observation for at least three 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. If this burst, this high peak of olanzapine, could be eliminated or blunted, there's a belief that PDSS may not occur at all.

Teva, our partner, just presented its phase 1 results with the long-acting injectable olanzapine last month at a Schizophrenia International Research Society meeting in Toronto, Canada. In that poster, they showed that there was no burst on single injection, both in healthy volunteers and schizophrenia patients, but also on repeat dosing, up to three monthly injections. It was based on this phase 1 data, that Teva launched its phase 3 study, with a belief that there will be limited to no PDSS in this study. Favorable safety and efficacy results from the phase 3 study, which does include a two-month, double-blind, placebo-controlled efficacy part, using Positive and Negative Symptom Scales of 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. 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 exist with the approved, but not used, long-acting injectable. It would be best-in-class for certain, like UZEDY, but in effect, with no other used product, a first-in-class, as Christophe Douat mentioned. David?

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

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

Richard Malamut
Medical Director, MedinCell

Well, not soon enough for MedinCell and Teva. However, unlike the UZEDY trial, which took quite a bit of time to complete, due to the length of the study, this phase 3 for LAI olanzapine is very different. It should go much quicker, with only a two-month double-blind, placebo-controlled portion, a 48-week open label with a fixed target of 640 patients. Based on Teva's current reported recruitment projections in clinicaltrials.gov, you can see that top-line data for the two-month results should be available fourth quarter of 2024. 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?

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

[Foreign language], Richard. Thank you, Richard. I'm going to turn to you, Jaime, and I'm going to ask you the same question for UZEDY. A little bit more different, but how can what Richard said translate into figures for MedinCell? Yes, if this phase 3 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. It will meet the needs of many patients. When you have a best-in-class and also a first-in-class, as we saw in the slides earlier on, this market could represent several billion dollars for Teva. 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.

It's a tremendous potential, and we're expecting these results in the coming 18 months, as precisely tomorrow. Major news expected in 18 months regarding that program. I'm turning back to you, Richard. We've commented a lot UZEDY. What are the other remarkable events regarding the rest of the portfolio?

Richard Malamut
Medical Director, MedinCell

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 3 study for our pain product, mdc-CWM, for the treatment of post-operative 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. 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.

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. 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, two confirmatory studies are required, so we know we'll need at least one more, depending on the results of the study. Beyond that, we have three products which we're developing internally, not partnered as of now, in which we plan on taking into phase 1 within the next 12 months.

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 non-compliance with your tacrolimus can lead to organ rejection, a very serious outcome, and a purely global health program, mdc-STM, which uses the endectocidal agent ivermectin against malaria and is funded by Unitaid. If that weren't enough, we have several other programs in the formulation stage that we haven't disclosed yet, I very much look forward to talking about those in the future. David?

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

[Foreign language] Richard. Thank you, Richard. Thank you for this description of our portfolio. We've received a lot of questions, but before we move on to the question, I'm turning to you, Sébastien. Good evening. We're lucky to have Sébastien with us. Sébastien is often all over the place, across the world with his teams, but it so happens that he was in Montpellier today, we got a hold of him and asked him to come with us. This is the first time you've been with us. Maybe a couple of words to introduce yourself.

Sébastien Enault
Chief Business Officer, MedinCell

Of course, I'm Sébastien 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.

The mission of the team is to identify and launch future MedinCell programs, be it internally or with partners. Sébastien, we said earlier on, and Jaime noted this, our financial results show that revenues from partnerships have increased. I'm talking about new partnerships. We talked about feasibility studies that went from 300,000 EUR for the previous financial years to about 1.6 million EUR in the current financial year. What does this correspond to? Well, as Christophe said, we've really entered into a new era for MedinCell. The MedinCell technology was approved by the FDA. I must say, that we didn't wait for the approval of UZEDY to launch new partnerships. This is an exercise we've already done.

We work with a number of partners on different types of products, with molecules that are already approved, but we also work with molecules that are in the clinical development phases, also work in other therapeutic areas. 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. We will say a little more when we can. We're eager to find out! Feasibility studies.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

We've understood that you can't say more on these new programs, on the details, what indications, what partners. What will happen if these feasibility studies are positive?

Sébastien Enault
Chief Business Officer, MedinCell

Well, if the feasibility studies are positive, the next step will be the creation of license contracts as we did with people, with upfront payments, milestones, and policy payments. The startup of all of the other development phases. A story, because you were talking about traveling. I was in the bio conference in Boston a few weeks ago. A big conference. Big conference. I think there were more than 15,000 participants, and there were more than 65 qualified appointments, which is quite a staggering number. Four of my team were there, and I must say that the UZEDY, the approval, really is speeding things up. I think that we've been waiting for this for a number of years, and we're there now. You no longer need to convince people, fight to convince, we can demonstrate what we are able to do.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Well, the two programs in phase 3, 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 non-toxic when we administer it subcutaneously or via other administration pathways, we no longer have that type of question. We even have the luxury of spending time with future partners and screen the partners, all of their products, to identify what is the best molecule that we could develop together. We are impatient. I think I'm not the only one to see what will happen to this.

Let's move on to questions. Here we go. 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. Just to summarize the question. It's basically, why did you try to break the mounting prices of the shares by selling shares just when we're about to make the UZEDY announcement?

Christophe Douat
Chairman, MedinCell

Well, of course, this is a legitimate question, except that nobody tried to break the value of the share. Just to give you the details, and I'm being entirely transparent here, I hadn'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 some 10% in autumn. I have kept 90%. Sorry, to share is a very sensitive subject, but also very highly regulated.

There's a strict framework, so the sales orders that must be given very up, a long time upstream. I gave that order at the beginning of December 2022. On condition of the approval of UZEDY, I out of respect for our shareholders, and with all necessary precautions, so it didn't weigh on the rating. The sale represented only 9% of volume. The circumstances meant that things didn't happen as planned, with a lot of pressure on the value, but it was difficult to imagine that 6 or 7 months beforehand.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Thank you for that clarification, Christophe. We're going to move on to the next question. This is for you, Jaime Arango. We'll ask for more details on the non-respected clause with the European Investment Bank, I think we've already said quite a lot about 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 solve this problem or maybe with new partners.

Jaime Arango
CFO, MedinCell

Absolutely. This ratio is a very simple ratio, but is that equity and plus cash must be above 1. 1. We close 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, we're quite confident that there will either be a solution directly to be found with them or assets, equity, plus cash. To find new partners. Hence, it can be new partners who pay up front, milestones or services rendered, et cetera. There will be solutions. As I was saying just now, the European Investment Bank is there to help companies, not to disrupt them. 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. They know us well, and we know them well, also.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

They're real partners.

Jaime Arango
CFO, MedinCell

Yeah, they're real strategic partners of the company. Absolutely.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Thank you very much, Jaime. Next question.

For you also, Jaime. I don't know how you can answer, but can you give us some details on commercial milestones? Here we're talking about UZEDY, of course, which is being launched on the market. Can you tell us the number of patients treated, the turnover? Maybe you can't go into too many details, but maybe you can put a bit of color behind this.

Jaime Arango
CFO, MedinCell

Unfortunately, I cannot give you the exact amounts of sales of fever that will trigger the payment of these different milestones. In all, it represents $105 million, This is also why, when I was saying that the strong growth will be over the next five years, so it's over that period of time that we expect to hit most of commercial milestones. Thank you.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Just to clarify, to answer the question. It's not a question of number of patients treated, it's a question of an yearly turnover of Teva.

Jaime Arango
CFO, MedinCell

Yearly, 1st of January to 31st of December.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Exactly. How are we going to stay with Teva?

Jaime Arango
CFO, MedinCell

Maybe Christophe, we asked the question about the mdc-ANG, which is a product that has been developed. Yes. Well, this is a product that's in the preclinical phase, and Teva does not wish to communicate on this today. I confirm. We hope we will have news soon of that product.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

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, AIC. Richard, if the phase 3 of the... Is successful, can we extend this antigen to other operations such as the shoulder, the hip, the spine, without going through all of the clinical phases? I mean, can we accelerate the process to approve the product for other indications?

Richard Malamut
Medical Director, MedinCell

Yeah, thanks. Thanks for the question. 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, of this formulation, but we're not ready to go into detail about what those are today.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

[Foreign language], Richard. Thank you, Richard. Next question will be for you, Sébastien, I don't know. You kind of awakened our curiosity, we can see that the accounts show that the feasibility studies brought in a lot more money this year than the previous year. The question is simple: When might we have a communication on new partners?

Sébastien Enault
Chief Business Officer, MedinCell

Well, communication, not on feasibility studies, because there is always a risk that the molecule is not compatible with our technology. That we cannot move on to the next phase, which is after the positive feasibility study, to move on to a partnership license contract. I think it's when we execute this license that we can communicate it on it. Now, as a communicator, I can add... we can talk about the number of partners.

Difficult for the indication, because it's very strategic. Is to present things as soon as possible.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Next question, which will be for Richard, but I don't know if he can answer. Head of our R&D should be with us, and we'll ask a question, and we'll see who can answer. On the Oxford 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 your strategy, partnership, or do you want to do proof of concept to develop this program internally? Who can answer this? Maybe Sébastien can, or Richard or Christophe, I don't know.

Christophe Douat
Chairman, MedinCell

Well, you know, we've already said that historically, BEPO is highly suited to small molecules, which are hydrophobic.

We're continually looking to develop new technologies, to develop more hydrophilic molecules, in particular peptides and proteins. As we go along, 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. It's this type of work which gives rise to publications, which is also Sébastien's job to show what we can do with our technology. These publications give us information on the potential for this type of molecule. Two partnerships that we engaged for coming months of MedinCell concern molecules, which are not small molecules. That's a very important piece of information. Therefore, peptides and proteins, to be more precise.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

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?

Christophe Douat
Chairman, MedinCell

Well, today, with the phase 3 results of UZEDY, which is spectacular, which far exceed our hopes. As Sébastien said, this has really allowed us to pick up the pace of our partnerships in human health. We have to focus, first of all, on our mission, which is to treat people and 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.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

We have quite a few questions, but we're going to try and ask them by giving very quick answers. Jaime, the current financial year shows a revenue of EUR 1.2 million royalties from Corbion. What are the outlets for 2020 for the entire year?

Maybe you can just remind us what we do with Corbion.

Jaime Arango
CFO, MedinCell

I'm going to explain the framework and how it works. It's a joint venture, where the company is held 50-50 between Corbion and MedinCell. It's called CM Biomaterials. Our partner must purchase the polymer, which is the basis of our technology from this company, but that company outsources the production of the BEPO technology 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 where we see the sale. This can vary. It depends on our partners, on their needs. Batch validations, preparation of launches, of phases 3, et cetera.

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.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

It's a good sign?

Jaime Arango
CFO, MedinCell

Yes, it's a good sign.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

That's what I like.

Jaime Arango
CFO, MedinCell

We're waiting for next year to know what happens. Yes, things are varying a lot, of course. Let's come back to the animal health program. We are asked if with doramectin, which is the molecule used for animal health, whether we plan for development in human health. Well, we assess these, but not for that molecule. I'd like to recall that the F14 program, that Richard was talking about, is an anti-inflammatory molecule, the celecoxib, commercial name being Cerebrexum, which was chosen for that application.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Christophe, we're asked at what stage we will consider introducing partnership for our internal development programs. Does MedinCell doesn't have commercial capacity.

Christophe Douat
Chairman, MedinCell

The main criterion is the quality of the partner. Their capacity to lead the development, like Teva has done remarkably well for mdc-TJK, apart from the CRL, of course, and of course, to market it. In the case of Teva, these projects are a priority in a field where they have the perfect sales force to launch the product. We look at all of these criteria, the development, competencies, access to market, and when the time comes, when all of the stars are aligned, and that the data that we have allow them to have give us access to the ideal partners, we will decide to license the product.

The more advanced we are in the phases, the more financially interesting the contract, and the more partners we'll be able to attract, because the fewer the number of years between the licensing step and the approval, the more partners there will be who will be interested, of course, because the risk is lower.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

The next question I will split into two. The first part is for you, Jaime. We ask: What is the percentage of capital held by employees and founders and ex-employees after the last increase in capital? The second question, you can ask, or maybe Christophe can answer this. Aren't you afraid that Teva or somebody else will buy you out? Founders, management, employees, and ex-employees of the company hold 43% of the capital. About 43% of the capital. Aren't you afraid?

That Teva or another group might buy you out, Christophe?

Christophe Douat
Chairman, MedinCell

Thank you, David. Teva's already tried in the past. We thought, and rightly so, that MedinCell had a 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 scope of action, because MedinCell wants to have the biggest scope of action possible, and that would be usually, we wish to extend our partnerships. If I were the CFO of Teva, with the initial figures, right, with UZEDY trends and positive results of phase three, I would do my sums. Any CFO, worthy of that name, would do that. 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.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Christophe or Sébastien, in the different interviews of June, we talked about diabetes. Where do we stand on that topic? As I said, Christophe, I mentioned that. I can say that we're working in different therapeutical areas, not just CNS. We also work in fields where there is an interest in developing a long-action, injectable form. Generally speaking, this is cardiometabolic scope, there's an interest. There are already existing NAI where the technology could be appropriate. You won't tell us anymore? We have to wait.

Okay. Next question is a little bit tricky, Jaime or Christophe, I'll let you answer. Simple question: You think that the share is worth EUR 15, why did you increase the capital at EUR 7.31? I've already given you some information in introduction.

Jaime, maybe you can add to these and complete them.

Jaime Arango
CFO, MedinCell

This increase in capital was a tactical maneuver. It was not in an ideal context, of course, we must remember the context, the macro context, the context of the spectrum of biotech, where companies lost 40%-50% of their value without having any bad news. Just quite simply, there were no investors. On the equity market, the money is there today, and maybe not tomorrow. Very often, we have this question: Why did we increase our capital at that point? Why didn't we wait until the stock exchange went back up? Given the context of rising interest rates, there was the bank crisis in the United States. Today, we're talking about deflation and the economic situation in Germany. There was news also this weekend in Russia.

It's an extremely volatile market, extremely complicated market. As I said, I don't know if I'm going to manage to say it correctly this time, "It's better to have one in the pocket than two in the air." We are the first to be disappointed, but the most important message is that with this tactical action, if any company could do it was MedinCell. Here, we are securing the future of the company, knowing that, if my memory is good, there are only three transactions of a capital research took place, and MedinCell is one of the two main ones. The two others were operations in which DVC was guaranteeing all of the industrial side of things. We're the only company who did a normal increase in capital on the French market.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Thank you for that answer.

What, for you, is the ideal partner strategy for the future? Would it be new multi-product partners such as Teva, with or without Teva or somebody else, or a partner approach per application with different partners?

Sébastien Enault
Chief Business Officer, MedinCell

I think we have to stay very practical. When we have a partner, we have to develop the pipeline of potential partners we can develop with this partner. Very often, the partners have a strategic focus. Teva, thanks to us, is developing a long-acting injectable for schizophrenia, and this will no doubt be the case with other partners. 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.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Sébastien, okay, putting this back on the table again. We're asked, with what type of company we work currently, who we're talking with, who will be doing feasibility studies, and if among these, there are what we call any big pharma.

Sébastien Enault
Chief Business Officer, MedinCell

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. We have an entire range of partners and future partners of business.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

Public or private? Good! This is the last question for this evening. Christophe, a Nasdaq, is a Nasdaq quotation envisaged in the near future?

Christophe Douat
Chairman, MedinCell

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 by Teva on his strategic orientations on the importance of our product, we are called upon increasingly. American funds are turning to contracting Jaime Arango and to increase the visibility of our company to get 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. Our goal is to achieve values that are key. For Euronext or Nasdaq, we must go beyond the bar of EUR 500 million, which puts us on the radar, and beyond which we can have cash, which is just normal, with efficient markets, hedge funds, big investment funds.

This is really, our next objective is to achieve that level of valorization, which will make our lives easier.

David Heuzé
Head of Corporate and Financial Communications and ESG, MedinCell

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 appointments this week, tomorrow in Lyon, then Bordeaux, Christophe and Jaime, you're going around the country. Our shareholders who wish to be with us can be there. You should have received an invitation, but if not, send us a mail. We'll be happy to meet with you to take these discussions a bit further. It's something very important for us.

Beyond that, we're also broadening out our communication to Europe, because during the summer, we will be in Brussels or 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. Yes, today, we are, our coverage is very French. We have, 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. A great challenge. Any other questions among yourselves or?

In any case, thank you very much, for all of you, for being with us, for having been through this complicated year this year, the increase in capital and the macroeconomic context and biotech context, it 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. Thank you for your trust, and see you soon. Thank you, everybody. Have a great evening. Goodbye, Richard.

Powered by