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.