Good evening, everyone. Welcome to this video conference, where we'll be updating our portfolio following last night's announcement regarding our program, mdc-IRM. I'm Nicolas Gourgues. Tonight, I'm replacing David Heuzé, our Head of Communication and usual presenter, because he's just been a dad. Congratulations to him. With me this evening, we have Christophe Douat, our CEO, Joël Richard, our Chief Development Officer, and Jaime Arango, our CFO. Good evening, gentlemen.
Good evening.
Good evening.
Hello, everyone.
Before giving you the floor, Christophe, I remind you that you can ask us questions through the chat module on the right side of your screen. Christophe, first, I suggest we come back to the news we announced last night about mdc-IRM.
Yes, Nicolas. Thanks a lot. Good evening to all. It's another great day at MedinCell. As you saw yesterday, the FDA accepted the filing of Teva for mdc-IRM. It's the last step now before the approval of the product expected in 2022. I'll remind you that Teva even expects launch in 2022.
Thank you, Christophe. Can you remind us what are the characteristics of the product and tell us a bit, remind us about the phase III study?
Yes. We have developed formulations for Teva on two products, a one-month duration and two-month duration. The phase III that was completed last year showed very strong data, comparing relapses in the treated group versus placebo.
Thank you, Christophe, for this update. If you don't mind, let's talk about schizophrenia and the market of schizophrenia globally and in the U.S.
Yes. Just as a reminder, schizophrenia is a very significant and bad pathology. It's about 1% of the world population with dire consequences on the patients, as you know, hallucinations, et cetera, on the people, their families, their friends, on society, on the health systems that have to cover the cost of treatments and hospitalizations. One number I'd like to mention is that in the U.S., now 20% of hospital beds are related to schizophrenia. You can understand that any treatment that improves compliance, such as a long-acting injectable, has a lot of value for the payers. If we look at the numbers, we can see that the U.S. market today is $3.7 billion, worldwide $6.1 billion. In the U.S., it's growing at 14% CAGR, very regular growth. 14% CAGR means it doubles, if the trend continues, every five to six years.
The value of the compliance that is brought by the long-acting injectables is such that the payers are paying a very significant price for the long-acting injectables in the U.S. market, anywhere from EUR 19,000 - EUR 25,000 per year per patient. Significant numbers, significant market, and significant growth.
Thank you, Christophe, for that update. Jaime, if you don't mind, let's talk about the metrics of that collaboration with Teva.
Absolutely. Thank you very much, Nicolas. In the collaboration with Teva, we have, let me remind you, three products under development with Teva. On the financial metrics, so it's Teva, they paid MedinCell to do the formulation of the three products. In addition to that, Teva is financially developing the three products, and will ensure the commercialization of all of them. When I say that they're responsible, they're assuming all the cost, preclinical and clinical, for the development of the products. Now, the remuneration for MedinCell consists in two parts. First one are milestones that can reach up to $122 million per product. The bigger chunk of those milestones relate to sales, upon the attainment of certain level of sales. MedinCell has already started receiving some of the milestones related to development.
If we aggregate the three products, milestones can reach up to $366 million. In addition to that, MedinCell is entitled to royalties, mid to high single-digit, and that from the first sales that will be generated by the products.
Thank you very much, Jaime, for that update.
Jaime, I think you forgot to mention something we discussed yesterday because Jaime and I were trying to find a way to communicate on what does it mean, a market of EUR 3.7 billion. We checked and we found out that if this EUR 3.7 billion market was a single product today, it would be the 90th product by ranking order of sales in pharma. You can understand how significant this is.
Thank you, Christophe. Christophe, you again, we wanted in this update to address another point which concerns polymers, one of the main ingredients of our technology.
Yes, this is a very important strategic point, Nicolas. As a reminder, the key ingredient in our formulations are our own customized patented polymers. These polymers are what allows us to do better formulations than competition, subcutaneous injections, when most of the products today are intramuscular injections. Very early in the life of the company, we built an alliance with Corbion, the number one manufacturer of biopolymers in the world. It's a Dutch company. It's public on Euronext. This alliance has evolved in a full-blown BV joint venture, which produces all the polymers for our partners. This has allowed us to control the quality, to reduce the risk of scale-up, which is a huge risk for small biotechs, and also to protect the intellectual property related to polymers.
Polymers are a very complex material to manufacture, and you can understand that the quality of the polymer will impact the release of the drug. It's absolutely fundamental to control the manufacturing and therefore control the quality and the release of our products.
Thank you, Christophe, for that update. Before handing over to Joël to continue on our update of the portfolio, Christophe, maybe a sum-up of that amazing news that we announced last night.
Yes. Month after month, mdc-IRM is moving forward. This is the last step now, before the expected approval in 2022 and the launch of the product. Huge news for MedinCell. Very few companies have reached this stage. We are among the happy few. This technology, the underlying depot technology on mdc-IRM, Joël, is the same as all our other products, and therefore this favorable evolution of mdc-IRM benefits all our other programs, Joël.
Yes, you are right, Christophe. This is exactly the same technology or proprietary technology based on our block PEG-PLA copolymers. I would say that the know-how developed, and the data obtained during the development of IRM will enable us to accelerate the development of the other products of the pipeline and de-risk our development projects.
Thank you, Joël.
Thank you, Joël. Let's talk about our other programs now and the two other one we have in partnership with Teva.
Yes, for sure. We have actually exciting news on our portfolio of projects. First, I would like to remind you of the excellent news regarding mdc-IRM and the expected commercialization in 2022. The step that we have gone through yesterday is a really remarkable step for the project and for MedinCell. Believe me, in drug development, this is a major one and we would like to have it very often, of course. Now, I would say that for the other two projects in partnership with Teva, which are mdc-TJK and mdc-ANG, actually, we are expecting news from Teva on the next steps for these projects before the end of the year.
Thank you very much, Joël, for that update on our programs in partnership with Teva. Let's talk about our third product in clinical, mdc-CWM.
Yes. mdc-CWM is a project that we have in partnership with AIC in Canada. I would like to mention that AIC is going to follow now the recommendations from the FDA as regards with safety of phase II study. This phase II study will be rescheduled in 2022. AIC has confirmed that this will not have any impact on the timelines of the project. As you know, this is an open-label study which is not on the critical path for the registration, and the recruitment will be much simpler than the phase III, since actually there are less exclusion criteria. For the time being, AIC is preparing the phase III for efficacy and safety. This is a randomized study with a control.
Actually, AIC is expecting the agreement from FDA on the protocol for the phase III and the IND by the end of 2021. As you know, there will be two phase III, which is absolutely necessary in the treatment of pain, according to the recommendations from FDA.
Maybe, Joël, I'll spend a few seconds reminding you of what mdc-CWM is. It's about reducing pain, inflammation after large surgeries, especially orthopedic surgeries. The first indication is total knee surgery. It's 1 million surgeries a year in the U.S. The most painful surgeries of all. About 20% of patients become addicted to the prescription opioids, with the consequences we know. Remember, before the pandemic, this was the priority of the FDA. The current products in that field treat pain, but for a very small period of time, maximum three days. This product here intends to treat pain for weeks and inflammation for months. It's really a change of paradigm.
Thank you very much to both of you for the update for that project. Now let's move on with two other projects supported by the Gates Foundation and by Unitaid, Joël.
Yes, sure. We have a collaboration with Gates Foundation on a contraception project. This is a six-month formulation, our technology make it possible to get to this release period. We have also another collaboration on the prevention of malaria with Unitaid. Both projects are actually on time and progressing as per plan.
Thank you Joël. Finally, there is three program left, three internal programs, mdc-JAT, mdc-KPT, and mdc-TTG.
Yes, sure. We have these three internal projects which are in preclinical development at the present time. For -TTG, we are a little bit more progressed, and I would like to really focus on another excellent news, actually, since we are launching a phase II of proof of efficacy in prophylaxis of COVID-19 in Europe, including France, with oral administration in continuous dosing over one month to simulate the long-acting formulation, which is actually what we are going to develop. This is a clinical trial with a very rigorous design. We've controlled with placebo, randomized, double-blinding, and multicentric. Just to say that this is a real study with, let's say, a high reference in the field of prophylaxis of COVID-19. Actually, there's, I would say, no means to put these results that will be obtained in doubt.
This is exactly what we want to develop right now. The regulatory dossier has been filed in France first, last week, and will be also filed in other European countries beginning of September. The protocol will be available on clinicaltrials.gov site in the next weeks. The results are expected in the next months. Actually, our objective for this phase II are three thoughts. I would say first, we would like to confirm the efficacy in prophylaxis in controlled conditions and under conditions that cannot be in doubt, I would say. This is, I would say, controlled by the placebo, the randomization, double blinding, that will really provide confidence into the results that we will get. Second point is to define and optimize the development plan for the long-acting injectable formulation, which is our goal.
Third point is that in the present context, where the regulatory agencies are not so favorable regarding ivermectin, we would like to convince them to prioritize this approach and accelerate the processes for regulatory approval.
Yeah, Joël, I think I will like to interrupt you for a couple of seconds and pay tribute to Professor Jacques Descotes . Jacques was a professor emeritus, world-known toxicologist. He has been working with MedinCell for 10 years, and he contributed significantly to our ivermectin COVID program by making a full review of ivermectin safety, a landmark study that is now used worldwide, and also by helping us look at all the scientific data and clinical data, and all the work we've done in the last year and a half. Thank you, Jacques.
Yeah. I just would like to add that regarding this project, based on the strong phase II results that we will get, we have selected also a long-acting injectable formulation, which is ready to go to regulatory and clinical development.
Thank you, both of you, for that update. That's the complete update of our portfolio. Now let's have a look a bit further. Let's see what is expecting in a year from now. You can see on your screen the portfolio in a year. Maybe, Joël, you want to say a few words about it?
Yes, sure. As you can see, the pipeline is really progressing very well and very efficiently. What is really impressive is that in 2022, we would have one product on the market based on our technology, six other products in clinical development with a major progress of these projects towards filing of a product. We have excellent perspectives on the year to come. I would also say that we have new programs that have been initiated in early development. A significant part, actually, of my teams are working today on new projects in a proof of feasibility step.
Thank you very much, Joël. Before moving on to the question we received, maybe Christophe, you want to add a few words to sum up that presentation?
Yes. Thanks, Nicolas. Thank you, Joël, for the comprehensive explanations. First, we are seeing a formidable franchise in long-acting in antipsychotics being built, with our lead program, mdc-IRM and potentially two more following the first one. This is an extremely important program for MedinCell, which validates the technology. BEPO is used in all our programs, and any favorable evolution of the lead program is, of course, benefiting and de-risking the others. These steps are increasing dramatically the visibility, the credibility of MedinCell, and which should allow us to execute new partnerships in the next few years. Of course, if I summarize again the coming news flow before the end of the year, potential news on the two other programs with Teva, the start of phase III on mdc-CWM, and the start of our phase II with oral ivermectin.
Thank you Christophe. Now let's move on to the question we received. The first one we received via email a bit before this conference. Are you aware of the PR of Janssen issued today about six months injectable of paliperidone? Is it intramuscular? Christophe?
Yes, of course. We are fully aware of this. Yes, it is intramuscular. The only thing I can tell you is that we fully trust our partner.
My mic was off. Let's move on to the question we received from the chat module on the right side of your screen. Bertrand is asking us, "Hello, is there any PDUFA date for mdc-IRM application? Or if confidential, can you guide for the usual review length under 505(b)(2)?
Yes. Sure. I would say that typical review time is expected to be about 12 months. We are expecting approval in 2022.
Yes. As a reminder, not only approval, but Teva expects the launch in 2022.
Thank you, Joël and Christophe. Next question. Whom is going to manufacture the product? I think we are referring to mdc-IRM, Teva or MedinCell? Joël.
Yes, the product will be manufactured by Teva.
Okay, thank you. That was very easy to answer. Next question. When will the phase III data on your LAI schizophrenia be published, and what do you believe peak sales in the U.S. could be? Christophe, maybe.
We can't comment on the peak sales. I gave the numbers on the market potential, its growth. It will depend, of course, on the ramp-up and the market share that Teva will obtain. You can check on Teva's website. They are planning to disclose further the data on the phase III on the mdc-IRM as soon as October, and will publish as well in peer-reviewed journals.
Thank you. Next question may be for you, Jaime. When do we expect or do you expect the next milestone payment from Teva?
Right. If we're talking about mdc-IRM, let me remind you that for the last fiscal year that ended on the 31st of March of 2021, we registered some sales related to milestone. Milestone that corresponds to the positive phase III results of mdc-IRM that was published in the beginning of the year. We accounted for $5 million. The next milestone that we'll receive for this product, I cannot disclose the amount, but it will be upon the approval of the product. From then on, we will touch milestones upon the commercial milestones that I described earlier on. Now, when we look at the other projects, we're expecting milestones as the other products like TJK, ANG move forward, we will be able to account for these milestone payments.
Thank you, Jaime. Next question regarding mdc-CWM. Olivier is saying, "On clinicaltrials.gov and websites, we see that the safety phase III is on standby. Is this a strategic choice made in partnership with the FDA? In a favorable scenario, when could we have the final results of phase III of efficacy and safety for this program?" Joël?
Yes, sure. FDA has asked for further data regarding both safety and efficacy obtained in controlled study under blinding conditions. This is the reason why actually the strategy has been adjusted, and a decision has been made by AIC to first get to this phase III under controlled conditions to get this additional safety and efficacy data, and then to come back later on the safety study, which is the open-label one. Exactly, there's a lot of communication between FDA and AIC, and this is the best way now to develop the product.
Thank you, Joël. Next question. Can you share details of mdc-TJK, like the generic molecule being used and route of administration? Christophe, maybe?
No, we cannot. There will be information on clinicaltrials.gov once and if phase III starts.
Thank you, Christophe. I think that's the last question we received today about mdc-TTG program. As per the communication from today, a phase II study's in the pipe. Will you take help from a partner, or will MedinCell continue this program alone?
Well, that's one of the objectives, is that with rigorous phase II, sorry, with rigorous data and favorable results, it is obvious that this will raise interest for partners, given the context.
Thank you, Christophe. We just received a new question at this stage, still about mdc-TTG. At this stage, could you say there are indeed proof, preclinical or confidence that ivermectin can heal COVID-19? Christophe.
This program is the consequence of a year and a half of work from our scientists, our teams. We've pretty much talked to every principal investigator in the world that's conducting trials on ivermectin, looked at the data, and scrutinized all the favorable signs and even more any sign that could be not favorable. We are doing a weekly watch on all the papers that are being published on ivermectin. We organized even an international workshop a year ago. Yes, all the signals in prophylaxis are extremely encouraging and have actually higher statistical significance than ivermectin in early treatment, even. There is also scientific foundations from people such as Jean-Pierre Changeux at Institut Pasteur supporting the mode of action. There's a lot of data out there. There is a need for an extremely rigorous randomized double blind placebo-controlled study, and this is what we are doing.
Thank you very much, Christophe. I think someone's asking us to show again the slide, where you show standard one year from now. I'm going to put it back on the screen. Maybe, Joël, you can comment it again just to be sure so we all have the same information about the targeted portfolio in one year.
Yes, sure. As already mentioned, actually, we are going to see tremendous progress of our portfolio in the next 12-18 months. Actually, as you can see here, we have a situation which is very impressive since we could get to the situation where we would have one product on the market based on our technology, six other products in clinical development with a major progress towards the filing of our projects and the NDA application. Actually, we have excellent perspective for the year to come, I would say. We have also other new projects coming which are initiated in early development, and a significant part of my teams are working on these new projects in early development and proof of feasibility. These are excellent news for the next year to come, and I think we are all proud of this situation.
Yes, we are. Thank you, Joël. There is no more question for tonight. I think that's it. We're going to wrap it up now. Thank you to Christophe, Joël, and Jaime for being with me today in the studio for that update. I guess we'll talk to you soon when we have more news. Bye.
Thank you.
Thank you.
Thank you. Bye.
Take care. Bye.