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 Malamut, our CMO.

Hi, Richard.

Hi, David.

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'll 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. 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 olanzapine LAI. It's a major event for the company, lots of emotions and excitation at MedinCell today.

Last June, I told you that MedinCell was entering the most transformative years of its history, mostly thanks to olanzapine. Here we are.

Our partner Teva filed the olanzapine LAI at the FDA today, and so the clock will start clicking since FDA has 10 months to get back to Teva with a potential approval sometime in the Q4 of '26 for a product that is a major product, a priority at our partner, and of course a priority at MedinCell. Let me remind you of our strategy shift to growth.

You can see that UZEDY, and we'll come back to UZEDY in a second, is the first engine of growth of MedinCell. 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. We at MedinCell gave our partner Teva the keys to grab some of that potential, a real, 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 UZEDY and $105 million for olanzapine LAI.

Richard, could you tell us why olanzapine on a medical standpoint is such a large potential, why Eli Lilly failed, and why tiny MedinCell in the south of France succeeded?

I can do all of that, Christophe, and I will. 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.

Unlike the risperidone franchise, there is only one approved long-acting injectable olanzapine product, and it's not being used for reasons that we'll talk about. 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.

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 US psychiatrists are not used to following, and most impactful, every patient on every injection has to be monitored in the clinic for 3 hours. 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. 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. On the bottom, the MedinCell product, subcutaneous, where there are very few blood vessels, but even if injected directly into human plasma, does not release right away, thereby eliminating the risk of PDSS.

Our partner Teva 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 Lilly drug. On the next slide, you can see the safety data for the Phase 3 study that Teva conducted in 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. 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 a submission in Europe, as Teva has already announced.

Let's go back to our growth engines, and so we've discussed olanzapine, and I think you can all understand now why it is such a strategic, significant product. Let's go back to our risperidone LAI, which is important both because it is bringing us revenue, but also it is a proof of concept of Teva's ability to get a product to market, which bodes well for olanzapine as well.

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 sales as Q2. Teva explained that this was a one-time adjustment of Medicaid gross-to-net.

Now maybe, Richard, you could explain to us why UZEDY is doing so well and why it is such a great drug both for patients and clinicians?

I'd be happy to do that. A reminder that when we formulated UZEDY, 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.

UZEDY is subcutaneous, smaller needle, more comfortable for the patient, whereas the Johnson & Johnson products are intramuscular, more painful, larger needle. UZEDY 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.

UZEDY 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. Finally, Teva had asked US 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.

In fact, UZEDY, whether it's injected in the arm, the abdomen, or the thigh, has the same efficacy and safety, whereas the Johnson & Johnson product, intramuscular, has a variable exposure with different PK up to 30%. For all these reasons, UZEDY has done very, very good and very quickly.

As you would expect, Teva has been collecting real-world data after the launch of UZEDY in May of 2023. Here you can see, on the left, a reaffirmation of the primary endpoint in the Phase 3, which was relapse rate and time to relapse in that study compared to placebo, but here on the left showing significant differences between UZEDY and a second-generation oral antipsychotic on relapse rate and time to relapse.

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. 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 US payers, of course.

On the next slide, we can see two additional pieces of news that Teva had announced this quarter. UZEDY has been approved for the treatment of bipolar I disorder in the United States.

Bipolar I is much more common in the US, and while the adherence rate is better than the 80% non-adherence rate with schizophrenia, still, 50 to 60% of those patients are non-compliant. We know that over 300,000 US patients are already taking a risperidone product for their bipolar I.

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 UZEDY side as well.

Just to give you some numbers, Teva estimates the cumulative peak sales of UZEDY and olanzapine to be between $1.5 and $2 billion. MedinCell's analysts are above $3 billion, of course it could be higher, future will tell, and we are looking forward to getting olanzapine out there as well.

Now let's discuss the third engine. UZEDY was engine number one, olanzapine engine number two, and the leading program of the third engine is the first program we do with AbbVie.

There's some piece of news today as we are happy to announce that it will be ready to launch into Phase 1 in 2026, very strategic program for both companies. Lead formulation was chosen in September '24.

MedinCell 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.

Beyond AbbVie, we have a pipeline of products, Richard, that maybe you could tell us about?

Sure. We've talked about the two programs on the right, the partner programs with Teva in psychiatry, but we also have another late-stage program, this an intra-articular celecoxib 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 3 study as well as endpoints, and we look forward to starting that study in the coming year. Then moving to the left, you can see two other programs that we run internally.

The first one is a 6-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 1 sometime in 2026.

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. Some news on that: we've just announced that that program is also funded by the Gates Foundation.

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. We're very excited about that program as well.

Then we also have 10 to 15 or so additional programs, undisclosed. They're early in development, 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. 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, indeed, with pleasure. I'm going to comment the the financials for the half-year that was closed on September 30th, 2025.

First slide, next slide, please. The first slide is on on the revenue growth over the period.

Very nice improvement in the in the revenues for for the period, an increase of 50% compared to the to the same half-year for for the past fiscal year. Three main items are contributing to to the revenues.

First, obviously, the UZEDY royalties, which accounts for approximately 1/3 of the €14 million. I'll come back to to that more in detail in a minute.

Then we have half of it coming from the R&D partnerships, obviously we mentioned earlier the AbbVie first program, and that that represent a big part of this R&D partnerships. On top of that, we mentioned with Rick the Gates Foundation program or the malaria program that were performed on behalf of of foundations.

The third item falling into this R&D partnerships are the 10 to 15 boxes that we saw on the pipeline. Some of them are proof of feasibility studies that were running for undisclosed partners at the moment, but they might be the future of the licensing deal that we will execute over time, they're very important as well.

Third third item in this revenue, a €2.5 million research tax credit that we are benefiting from. Again, it is another proof of the maturity of the pipeline and of the different programs that and it explains why this this amount has increased largely compared to the previous year.

Next slide, please. No, you are not on the right

one.

You went too quickly.

On

on the royalties from from UZEDY, so as Christophe mentioned, UZEDY is doing very well. You you've seen the the prescription curve, which is progressing very well.

Teva has confirmed their guidance for 2025 to $190 million to $200 million of sales. Despite slightly weaker Q3 '25 than than expected, the the 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 the 65%. It's it's only 50%, but it's still very good, and it is it is very nice to have those €4.2 million in on our P&L.

On the next slide, you have the operating expenses of the company, 22% increase compared to last year. I remind you, 50% of increase in revenues, only 22% of increase for operating expenses.

What's important is that 2/3 of the operating expenses relate to R&D activities, and again, it is a proof, an evidence that that the pipeline is progressing and that the the the programs in the pipeline are getting more and more mature. It's it is good news for the future, and I remind you that also most of the of this R&D costs are covered by partnerships and revenues.

It is the Gates it is the case for the the AbbVie first program, also for the the Gates Foundation's program, and again for the the proof of feasibility studies. On the next slide, you have a view on the on the income statement.

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 over the over the the half-year. It is good, could have been even better without this negative impact of the the US dollar, the weak US dollar over the period, which has impacted us badly.

This if if this situation with a weak USD was to to persist over time, it might it might delay our return to profitability, which which we planned for fiscal year '26-'27, but we have time to to see how this evolves. Another comment on the income statement regarding the the financial the financial results: so we have again a a a non-cash impact due to the change in the fair value of the EIB warrants.

This impact is represents €6.8 million for the for the period. It it is linked to the fact that the stock MedinCell stock price has performed very well over the period, plus 65% increase.

Again on on that topic, we are negotiations are progressing, but too slowly compared to what we were expecting with the EIB, and we're hoping to to find a definitive agreement with them that will enable us to waive the put option that exists with the EIB. Without this this non-cash adjustment to to the fair value of the of the warrants, the the net loss would have been drastically reduced to to to €9 million.

Finally, a word on the cash position: so at the end of September, we had €53 million in bank. That's a bit lower to what we had at the end of March, where it was just after the the capital raise that we performed at the end of February, was probably a peak in our 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 for the next 2 years at least, because we obviously will be getting additional royalties on a quarterly basis from UZEDY and hopefully from olanzapine at the end of '26, plus potentially commercial milestones as well. That's it for me.

Thank you, Stéphane. 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? How do you plan to maintain technological leadership as competitors enters the LAI space potentially, including big pharma?

Okay. 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, AbbVie 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.

10 years ago, Johnson & Johnson was probably doing about a billion in schizophrenia. That became $5 billion worldwide 10 years later.

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 billion in 10 years, and we want to be best positioned to do that.

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 BEPO, and that is a very significant effort to keep maintaining our lead. We've shown that in our space, we're 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 that could maybe meet the dream of Melinda Gates. 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 Corbion for H1?

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. They can be big orders one half-year and smaller ones on the next one.

Over time it will increase and become more stable, but for the moment it's limited.

Next question also for you, Stéphane: OpEx has gone up quite notably, largely due to R&D spend. How should we anticipate this to look for the full year and in outer years?

Indeed, it has increased for the first half-year. As I mentioned, it is the evidence that we are gaining credibility and enriching the company portfolio, more programs, more mature programs.

I would say that it's a good news if we are continuing investing in this R&D costs because it is the future of MedinCell and the future licensing deals that is there.

Next question: the press release that we issued today states that MedinCell 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's three directions we could work on.

First is highly hydrophobic molecules. Second is the dose, cuz sometimes we are limited by the dose, because you don't want to have a depot which is too big subQ.

Then the highly hydrophilic. Yes.

Thank you, Christophe. Next question: last winter, you indicated the first AbbVie program was targeting IND in 18-24 months.

Where we are on that clock today: formulation, CMC readiness? Can you share more about the timeline?

When do you expect IND filing and clinical start? What remaining gating items could push IND beyond mid-2026?

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 phrased the deal as up to six programs, deal with AbbVie, okay.

Have AbbVie and MedinCell already selected a second and third candidate? If so, what's the rough scheduling for CMC, preclinical starts across '26-'27, and are the candidates adjacent category of therapeutic areas or differentiated?

At the top.

Okay.

As I said, I think, in our French presentation, I can't comment on the status of our discussion with AbbVie. I'll go back to the first product, which is on track to go into a clinical stage in '26.

We just can 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-Cellular or Novartis?

Obviously we select 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, Christophe. Next question for you, Richard: is it feasible for both mdc-STM and mdc-WWM to enter clinical development in 2026, or are you prioritizing one of the programs?

We expect all our programs to succeed, and the timelines are based on the data accumulation on the programs. As of today, we're looking for the WWM to enter Phase 1 sometime towards the end of 2026.

STM, we think maybe a little later.

Thank you, Richard. Next question, Stéphane: outside of the $4 million for the potential approval of olanzapine next year, are there any other milestones to anticipate for 2026?

I'm not sure I can disclose much on that, but we hope indeed to have more milestones in '26-'27, and you know that we are eligible to several types of development and commercial milestones from Teva on one side, also from AbbVie. 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 5 years?

Okay. Obviously I can't comment on the current collaborations, but I can comment on what we are building here.

The image I will take is a string of pearls, meaning blockbuster potential drugs. We have UZEDY, then olanzapine, AbbVie number one, and now 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 questions. It was a very good discussion.

Before we leave, Christophe, I leave

you the floor. Thank you for being with us tonight and sharing this amazing news.

You can see that it's quite emotional. We've been working on olanzapine LAI for over 10 years against all odds.

Our team here really knew we could solve it, and we did, but we also convinced Teva that we could. Teva has been a formidable partner on this, taking the product through clinicals.

Here we are with a major, major, first-in-class product that could be launched in about a year. Exciting news.

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 olanzapine, UZEDY is progressing well, and the rest of the pipeline as well.

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 MedinCell, and hope to see you soon.

Thank you. Bye.