Medincell

Hi everyone and thank you for joining us today for this conference following the release of our half-year results which were published earlier today. The press release is available on our website. Today I'm joined by Christophe Douat, our CEO. Hi, Christophe. Hi, David. Dr. Richard Malamud, our CMO. Hi, Richard. Hi, David. And by Stéphane Postic, our CFO. Hi, Stéphane. Hi, David. Hi, everyone. Before we start, I invite you to review the forward-looking statements disclaimer at the beginning of the presentation available on our website. This webcast will last 45 minutes max. We start with the presentation and by a Q&A session if we receive questions. You can send your questions at any time using the chat tool on the right side of your screen. A similar session in French was held earlier, and both replays will be available shortly on our website. But now, I leave the floor to you, Christophe.

Thank you, David. Hello, everybody. We are delighted to have you join us and celebrate the filing of Orlan Zapin LAI. It's a major event for the company. So lots of emotions and excitation at Medincelle today. Last June, I told you that Medincelle was entering the most transformative years of its history, mostly thanks to Oranzapine. And here we are. Our partner, Teva, filed the Oranzapine LAI application. at the FDA today. And so the clock will start clicking since FDA has 10 months to get back to Teva with the potential approval sometime in the Q4 of 26 for a product that is a major product, a priority product. at our partner, and of course, a priority at Made in Cell. So, let me remind you of our strategy shift to growth. You can see that UZD, and we'll come back to UZD in a second, is the first engine of growth of Made in Cell. Olanzapine will accelerate growth, and then the third engine is made out of the pipeline with AbbVie number one leading the way. Let's step back a bit and look at our strategy in schizophrenia. On the left, you have Risperidone. On the right, Olanzapine. Risperidone was a drug of Johnson & Johnson. Olanzapine, Eli Lilly. Both were significant blockbusters for both companies, respectively. Both companies followed the same strategy, lifecycle management with long-acting injectables. You can see on the left that Johnson & Johnson was highly successful, building a franchise which is now $4.8 billion a year. But you can see on the right that there is no big green box. Eli Lilly failed commercially with a long-acting injectable. Richard will tell us why in a couple of minutes. And we at Medincel gave our partner Teva the keys to grab some of that potential, a real potential. appropriate long-acting injectable of Olanzapine. Let me remind you of the metrics that we have on both products. We are eligible to mid to high single-digit royalties, eligible for a $4 million milestone at approval of Olanzapine LAI, plus 105 million of commercial milestones for UZD, and 105 million for Olanzapine LAI. Richard, could you tell us why Olanzapine, on a medical standpoint, has such a large potential? Why Eli Lilly failed? And why Tiny Medincel in the south of France succeeded?

I could do all of that, Christoph, and I will. So first a reminder that oral olanzapine is the most prescribed oral antipsychotic, and that's mostly because it's currently used for the more severe patients with schizophrenia, the patients who are refractory, which can be up to 30% of patients. But unlike the Risperidone franchise, there is only one approved product in – one approved long-acting injectable olanzapine product, and it's not being used for reasons that we'll talk about. So the unmet need is very, very high here to have something in a long-acting injectable form to improve compliance for patients who are exactly the patient you don't wish to have stop their medications. And so for these reasons, the unmet need is quite high. Now, on the next slide, a reminder of the safety finding that has limited the use of the Lilly drug, and that's post-injection delirium and sedation syndrome, PDSS, not very common, seen in less than 0.1% of injections, but is severe enough that the FDA put rather onerous monitoring requirements on the label, including a REMS program, which U.S. psychiatrists are not used to following, and Most impactful, every patient on every injection has to be monitored in the clinic for three hours. So that's not happening and is largely the reason why the product is not being used. Now, PDSS is thought to be due to a burst of olanzapine in the blood. And on the next slide, you can see how MedinCell formulated our LAI olanzapine to eliminate that risk of burst and therefore PDSS. And so what you can see here is that on the top, the Lilly product, when injected directly into human plasma, almost completely releases within the first 24 hours. You can imagine that that would correlate with a burst and then PDSS. But on the bottom, the Medden cell product, subcutaneous, where there are very few blood vessels, but even if injected directly in the human plasma, does not release right away. thereby eliminating the risk of PDSS. And our partner TAVA did negotiate with the FDA the number of injections needed to fully explore the risk of PDSS. That number was 3,600. And as you can see, Teva has conducted more than 4,000 injections in the clinical program with no cases of PDSS. Here, zero is a really good number and bodes well for not needing those onerous monitoring requirements that really limited the use of lowly drug. So on the next slide, you can see the safety data for the Phase III study that TEVA conducted using LAI olanzapine. This was released in September of this year. And the key point is that there were no cases of PDSS and no unexpected or surprising adverse events, and all was comparable to the oral and LAI formulation of olanzapine. So based on this, as you heard, the exciting news that Teva has filed, the NDA today, We should expect a 10-month review time, bringing approval sometime in the fourth quarter of next year, with commercial launch before the end of 2026. And that's to be followed by submission in Europe, as Teva has already announced.

So let's go back to our growth engines. And so we've discussed, you know, Olanzapin, and I think you can all understand now why it is such a strategic, significant product. But let's go back to our Risperidone LAI, which is important both because because, you know, it is bringing us revenue, but also it is a proof of concept, you know, of Teva's ability to get a product to market, you know, which bodes well for Olanzapine as well. So you can see that prescriptions keep growing and growing in a very nice, regular fashion. This translates into sales. And you can see on the next slide that Teva confirmed their guidance of $190 to $200 million for 2025, which is the second full commercial year. You can notice as well that Q3 had lower cells as Q2. Teva explained that this was a one-time adjustment of Medicaid gross to net. And now, maybe, Richard, you could explain to us, you know, why UCD is doing so well and why it is such a great drug both for patients and clinicians.

Yeah, I'd be happy to do that. So, a reminder that when we formulated Usady, long-acting injectable risperidone, we were looking to address some of the challenges faced by patients, clinicians, and even payers with the Johnson & Johnson portfolio of risperidone and paliperidone products. So, first of all, Usady is subcutaneous. Smaller needle, more comfortable for the patients, whereas the Johnson & Johnson products are intramuscular, more painful, larger needle. Usady reaches therapeutic levels within the first 24 hours after injection. making it easy to transition from oral risperidone, whereas the Johnson & Johnson products require either oral supplementation or titrating injections over several weeks before they reach therapeutic levels. Uzeti comes in pre-filled syringes, four different doses on a monthly, four different doses on an every other monthly, which correspond to the four used doses of risperidone in schizophrenia, 2, 3, 4, and 5. whereas the Johnson & Johnson products are converted to paliperidone and require reconstitution in the office, which can be somewhat cumbersome for psychiatrists. And finally, Ateva had asked U.S. psychiatrists what one feature of a long-acting injectable product would they desire, and the number one feature was flexibility to inject in different areas of the body. So, in fact, Whether it's injected in the arm, the abdomen, or the thigh has the same efficacy and safety. whereas the Johnson & Johnson product, intramuscular, so has variable exposure with different PK up to 30%. So for all these reasons, Usady has done very good and very quickly. So as you would expect, Teva has been collecting real-world data after the launch of Usady in May of 2023. Here you can see on the left a reaffirmation of the primary endpoint in the Phase III, which was relapse rate and time to relapse in that study compared to placebo, but here on the left showing significant differences between Usati and a second-generation oral antipsychotic on relapse rate and time to relapse. But remember that in schizophrenia, 80% of those patients do not take their medicines. And when they don't take their medicines, they relapse and end up in the hospital. So part of the value here is to keep patients out of the hospital. And in fact, on the right side of the slide, you can see that there was an almost 50% reduction in hospitalization rate, a 50% reduction in time spent in hospital if they needed to be admitted, and a correlation with a reduction in healthcare costs, which is of great interest to U.S. payers, of course. So, on the next slide, we can see two additional pieces of news that Teva had announced this quarter. First of all, Usady has been approved for the treatment of Bipolar I disorder in the United States. Bipolar I is much more common in the U.S. And while the adherence rate is better than the 80% non-adherence rate with schizophrenia, still 50% to 60% of those patients are noncompliant. And we know that over 300,000 U.S. patients are already taking a risperidone product for their bipolar I. And the second bit of news is that Teva has announced approval of long-acting injectable risperidone in South Korea and in Canada. More to come. But those are the two countries that Teva has announced.

Thank you, Richard. Quite exciting on the UZD side as well. Just to give you some numbers, Teva estimates the – cumulative pixels of UZD and Olanzapine to be between $1.5 and $2 billion. Made-in-cells analysts are above 3. Of course, it could be higher. The future will tell. And we are looking forward to getting Olanzapine out there as well. Now, let's discuss the third engine. You know, UZD was engine number one, Roland Zappin engine number two, and the leading program of the third engine is the first program we do with AbbVie. There is some piece of news today, as we are happy to announce that it will be ready to launch into phase one in 2026. You know, very strategic program for both companies. Lead formulation was chosen in September 24th. Made in Cell did all pre-IND activities. AbbVie will conduct clinical development and we are eligible to 315 million of potential milestones with royalties that now get into the low double digit. But beyond AbbVie, we have a pipeline of product, Richard, that Maybe you could tell us about?

Sure. So we talked about the two programs on the right, the partner programs with Teva in psychiatry. But we also have another late-stage program, this in intraarticular celicoxib to treat pain and inflammation in patients who have had total knee replacement surgery. We've been discussing with the FDA this year design of our next Phase III study as well as endpoints, and we look forward to starting that study in the coming year. And then moving to the left, you can see two other programs that we run internally. The first one is a six-month subcutaneous contraceptive to differentiate from existing shorter-term subcutaneous contraceptives. It is funded by the Gates Foundation, and we do plan to start phase one sometime in 2026. And then we also have another global health program to prevent the spread of malaria through the use of ivermectin, which kills mosquitoes and is effective in preventing the spread of malaria in endemic areas, particularly in children who are most vulnerable. And some news on that, we've just announced that that program is also funded by the Gates Foundation. And then we have one more global health program we've recently disclosed, and that's a program in tuberculosis using a novel molecule, which in long-acting injectable form, will improve the adherence in these patients who don't tend to take their pills as many months as they need to and reduce the risk of drug resistance. So we're very excited about that program as well. And then we also have 10 to 15 or so additional programs, undisclosed. They're early in development, so we typically don't disclose until a little later. But these are both internal programs as well as programs that are already partnered. They can be already approved, but can also be NCEs, where you need a long-acting formulation to enable use. And, again, we're agnostic to therapeutic area and are developing these in more than five separate therapeutic areas.

Thank you, Richard.

Let's talk about financials. Yes, certainly. With pleasure. So I'm going to commend the financial for the half year that was closed on September 30th, 25. So first slide, next slide, please. So the first slide is on the revenue growth over the period. So very nice improvement in the revenues for the period, an increase of 50% compared to the same half year for the past fiscal year. Three main items are contributing to the revenues. First, obviously, the USD royalties, which accounts for approximately one-third of the 14 million. I'll come back to that more in detail in a minute. Then we have half of it coming from the R&D partnerships. So obviously we mentioned earlier the at the first program and that represents a big part of these R&D partnerships. And on top of that, we mentioned with Rick the Gates Foundation program or the malaria program that were performed on behalf of foundations. And the third item falling into these R&D partnerships are the 10 to 15 boxes that we saw on the pipeline. Some of them are proof of feasibility studies that we are running for undisclosed partners at the moment. But they might be the future of the licensing deal that we will execute over time. So they are very important as well. And third item in this revenue, a 2.5 million research tax credit that we are benefiting from. And again, it is another proof of the maturity of the pipeline and of the different programs. And it explains why this amount has increased largely compared to the previous year. Next slide, please. No, you are not on the right. Oh, sorry. You went too quickly. On the royalties from EUSD, so as Christophe mentioned, EUSD is doing very well. You've seen the prescription curve, which is... progressing very well. TEVA has confirmed their guidance for 2025 to $190 million to $2 million of sales, despite a slightly weaker Q3 2025 than expected. The sales have increased by 65% in USD compared to what they were in the same period last year. Once converted in Euro, the increase is a bit lower than 65%. It's only 50%, but it's still very good. And it is very nice to have those 4.2 million on our P&L. On the next slide, you have the operating expenses of the company. So 22% increase compared to last year. So I remind you 50% of increasing revenues, only 22% of increase for operating expenses. What's important is that two-thirds of the operating expenses relate to R&D activities. And again, it is a proof and evidence that the pipeline is progressing and that the programs in the pipeline are getting more and more mature. So it is good news for the future. And I remind you that also most of these R&D costs are covered by partnerships and revenues. It is the case for the ADVI first program, also for the Gates Foundation program, and again for the proof of feasibility studies. On the next slide, you have a view on the income statement. So if you combine the 50% increase in income with the 22% increase in operating expenses, you end up with an improved operating loss by 13% to 6.6 million euros over the half year. It is good. It could have been even better without this negative impact of the US dollar, the weak US dollar over the period, which has impacted us badly. And if this situation with a weak USD was to persist over time, it might delay our return to profitability, which we planned for fiscal year 26-27, but we have time to see how this evolves. Another comment on the income statement regarding the financial results. So we have, again, a non-cash impact due to the change in the fair value of the EIB warrants. This impact represents 6.8 million euros for the period. It is linked to the fact that the stock, made-in-self stock price has performed very well over the period. plus 65% increase. Again, on that topic, negotiations are progressing, but too slowly compared to what we were expecting with the EIB, and we are hoping to find a definitive agreement with them that will enable us to waive the put option that exists with the EIB. So without this non-cash adjustment to the fair value of the warrants, the net loss would have been drastically reduced to 9 million euros. And finally, a word on the cash position. So at the end of September, we had 53 million euros in bank. That's a bit lower to what we had at the end of March, where it was just after the capital raise that we performed at the end of February. So it was probably a peak in our cash position. That said, it is a comfortable cash position that is sufficient to respect all the covenants that we have towards our banks and especially the EIB and it gives us sufficient visibility for the next two years at least because we obviously will be getting additional royalties on a quarterly basis. from UZE and hopefully from Olan Zepin at the end of 26, plus potentially commercial milestones as well. That's it for me.

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

Okay. So on the first question... The best educated guess can be done by looking at the pipeline. So 26 should be approval of Olanzapine. And then you can see in the pipeline you have CWM, potentially, WWM, which has commercial potential, ABDI number one, and then the rest of the pipeline in formulation. As far as technology leadership, that's a very good question. And I will give a bit of context here. Ten years ago, you know, Johnson & Johnson was probably doing about a billion in schizophrenia. That became five billion worldwide ten years later. So every single company now in schizophrenia, bipolar, want to do a long-acting injectable of their drug. And we believe that the number of indications with long-acting injectable will increase in the next 10 years. Some analysts believe that the global long-acting injectable market will go from about 15 billion today to 50, 5, 0 in 10 years. And we want to be best positioned to do that. And so to do that, I predict that at the end of the day, half of our innovation will come from internal innovation, half from external. We already have people scouting the world for new technologies in either academic settings, small companies. And we'll probably do alliances at some point. We are also working hard at developing the new generations of BIPO. And that is a very significant effort to keep maintaining our lead. We've shown that in our space, we are the best positioned company. We could do things that Johnson & Johnson could not do. We could do things that Eli Lilly could not do. We were the first company, you know, that could maybe meet the dream of Melinda Gates. And so, you know, we want to maintain that lead for sure. And we'll keep investing in technology.

Thank you, Christophe. Stéphane, next question. What are the revenues linked to the joint venture with Corbillon for H1?

So for H1, they're fairly limited, less than 100K, and that's because when you understand the business model of the JV, at the moment, the orders that the JV is receiving from their different partners is not linear because we are at the beginning of the commercialization.

so there they can be big orders one one out here and smaller ones uh on the next one so uh over time it will increase and become more stable but for the moment it's uh it's limited okay next question also for you stefan opex has gone up quite notably largely due to rnd spend how should we anticipate this this to look for the full year and in outer years

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

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

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

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

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

Thank you, Christophe. Next question. You frame the deal as up to six programs, so deal with AbbVie, okay? Have AbbVie and Medincelle already done, selected a second and third candidate? And if so, what's the role scheduling for CMC ProChemical starts across 26, 27? And are the candidates adjacent category of therapeutic areas are differentiated? Sorry, this is, sorry. No one at the top.

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

Yeah. We're just going to add that we stated when we announced the collaboration that it can be in different therapeutic areas. That's only what we can say today. Next question. The board of directors of MedinCell has been strengthened with additional appointments of prominent industry leaders. Do you see partnership arising from operations tied to these individuals, potentially including Intra-Fedular or Novartis?

You know, obviously we selected board members for their competencies, experience, and the two new board members have incredible experience and competencies. if they can help us like other board members using their networks we would love to use that capability thank you

Next question for you, Richard. Is it feasible for both MDC STM and MDC WM to enter clinical development in 2026, or are you prioritizing one of the programs?

Yeah, so we expect all our programs to succeed. And the timelines are based on the data accumulation on the programs. And so as of today, we're looking for the WWM to enter Phase 1 sometime towards the end of 2026. STM, we think, may be a little later.

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

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

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

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

Thank you, Christophe, and thank you all for your time. Questions it was a very good discussion before we leave Christophe.

Yeah Thank you for being with us tonight and sharing this amazing news You can you can see that it's quite emotional. We've been working on all of that in LAI for you know over ten years Against all odds, you know our team here Really knew we could solve it and we did and but we also convinced eva that we could teva has been a formidable partner on this taking the product you know through clinicals and here we are with a major major first-in-class product that could be launched in about a year. So exciting news. You know, as I said in our French meeting just earlier today, here we'll be drinking champagne tonight to celebrate this news. And we are looking forward to our next discussions and following all the progress. You see that even beyond Roland-Zapin, UZD is progressing well and the rest of the pipeline as well. And the three engines are really performing well. Thank you.

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