Good morning. Welcome to the Jefferies Global Healthcare Conference in New York. My name is Michael Scharfenberger with the Jefferies Investment Banking team. It is my great pleasure to introduce Christophe Douat, CEO, and Grace Kim of Medincell.
Hello, everybody. I will speak in the next few minutes about the upcoming years, which I am calling the most transformative years of Medincell's history, and I hope you will leave the room agreeing with me. We do long-acting injectables. We are based in Montpellier in the south of France, and this is where Professor Michel Vert was located, and this is where the field of resorbable PLA polymers started and where the discipline was structured. We scaled the company up to IPO 70 people with no dilution, no fundraising. Quite remarkable. Only driven by commercial revenue. Last, we built the company as a North American style company with over 25 nationalities in Montpellier. We do long-acting injectables. You see a demo of our technology here.
Upon injection in the subcu space, the formulation will solidify, will form a very tiny depot, which will resorb, and as it resorbs, it will release the drug over a very long period of time, sometimes one month, sometimes six months. This is extremely valuable in all pathologies where the lack of compliance has consequences, like schizophrenia. We like to describe our strategy with three engines. The first one is our first product, which was developed and is being commercialized by Teva. It was approved in April 2023. Teva's initial outlook for this year is $ 250 million-$ 280 million. Quite a spectacular ramp-up. The second product is based on olanzapine, also done in collaboration with Teva. It was filed at FDA in early December 2025. We anticipate FDA approval later this year.
This is a huge product, as you will see, even bigger than the first one, which was even described in The Wall Street Journal as a product that should revive Teva. Third engine, the pipeline, led by the first collaboration we have with AbbVie. This graph is essential to understand our strategy with Teva. On the left, you have Johnson & Johnson and risperidone. On the right, Eli Lilly and olanzapine. Both companies followed the same life cycle management strategy, doing long-acting injectables. You can see on the left that J&J was highly successful. It has become a benchmark in the space. UZEDY is targeting this green box on the left here. On the right, you can see there is no big multi billion-dollar green box. Lilly's product failed commercially because of technical issues.
Medincell solved those issues. We gave Teva the means to grab the full potential of a long-acting injectable olanzapine. I think now you can understand why we are in the most transformative years of Medincell. Long-acting injectables penetration in schizophrenia is increasing steadily. Should reach close to 20% in the U.S. and above 20% in Europe by 2030. Teva has been the ideal partner for Medincell. If you listen to Richard Francis' earnings calls describing his pivot to growth strategy, you will always hear about UZEDY and olanzapine LAI, and Teva is recognized as having the best sales force in the space. UZEDY, the risperidone LAI, was approved in April 2023. Teva obtained an additional indication in bipolar disorder last October and has also obtained approval in FDA-like countries, South Korea, Canada, for example. The trend of prescriptions is increasing steadily.
Over 15,000 patients as we speak use UZEDY in the U.S. Quite a spectacular ramp-up. First commercial year was $117 million. The initial guidance of Teva was $80 million. Second year was $191 when the initial guidance was $160. The initial guidance this year from January is $250 million-$280 million. This translates in royalties for Medincell. Again, increasing steadily as well. Q1 alone was up 62% from Q1 2025. Over the last three years, we have increased our reach with U.S. analysts. As you can see on the slide, the consensus on UZEDY is around $1 billion. We get royalties, mid-single-digit to high-single-digit royalties and commercial milestones for each product of $105 million. Why is UZEDY doing so well, especially when you have Johnson & Johnson across the street? First, it's a subcu injection, not intramuscular.
Second, it has immediate onset when J&J's products take three- five weeks to reach therapeutic levels. Third, it is ready to use. Fourth, you can inject wherever you want, you will get the same therapeutic level. UZEDY has become the golden standard of long-acting injectables. It ticks all the boxes of what an ideal long-acting injectable should be. This is a slide we are really proud of. It is a 700-patient real-world study from last year comparing UZEDY to second-generation oral antipsychotics. The numbers are just compelling. - 42% relapse rates, - 47%, on the upper right, hospitalization rate, and - 29% in cost. This makes me say two things: that there will never be a company in schizophrenia that will not want to do a long-acting injectable of their drug.
Second, when you say this, my belief is that sooner or later, all schizophrenia patients should be using long-acting injectables. Very long patent life. Let's go to olanzapine, which is often called the jewel of the crown of Medincell. As I said, Teva filed at FDA in December 29th, and in April in Europe. Actually, the European filing was accepted a couple of weeks ago as well. Olanzapine LAI has a big potential for several reasons. First, olanzapine is the most used antipsychotics, both in the U.S. and in Europe. Second, olanzapine is a very unique drug which targets the most severe and refractory patients, the one that need compliance the most. None of the new generation of schizophrenia drugs will compete with olanzapine. It has really its segment on its own. Third, as we saw, Eli Lilly failed.
We'll explain why in a second. There is no competition, and there won't be for a long time because no other company but Medincell attempted to solve the issue Lilly had. The consensus here is higher, and the metrics are exactly the same as with UZEDY. What could really be the potential of an olanzapine LAI? We have a benchmark on the left. We know that J&J is doing close to EUR 5 billion with risperidone, which is used less than olanzapine and for less severe patients. In theory, olanzapine LAI could do better. We'll see. It will depend on execution and adoption, but the potential is very significant. What happened to Lilly? You have to understand that when you do a long-acting injectable that will last one month, you are putting under the skin one month worth of drug.
If you don't control the release, and if you have a burst or an accidental release of the drug, you are in trouble. This is what happened to Lilly. Their formulation was not controlled on all patients. On a very small number of patients, the whole monthly load is released within 24 hours. Of course, the patient is not doing well, can't go home. FDA put drastic constraints on the use of their product. Every single patient has to wait for three hours on site, which of course, clinicians do not like, and they have to be monitored through a REMS Program. We knew that our technology could solve this. We convinced Teva that we could, and Teva trusted us. They discussed with FDA that 3,600 injections with no PDSS, this release, was needed to not have the same constraints. We succeeded.
We reached even 4,000 injections with no issue during the clinical trials. On the right, you will see why Lilly had the issue and why we didn't. First, theirs is an intramuscular product, and inside the muscle you have vessels that are up to one or two cm wide. So there's a risk to inject and have direct access to the blood system. Look at how their formulation behaves when it is just injected in straight plasma. You can notice that within 24 hours, 90% is released. It's extremely soluble. The fact that you have this risk of blood vessels and a very soluble formulation, had a very high risk for Lilly. Look at our formulation in green. Even when it's injected in plasma, it releases the drug very slowly. Remember the first picture I showed you, the video? Our depot loves water.
That water makes it stronger, makes it more solid, and this is why we are getting this green curve. When you inject sub-Q, the largest vessels are between 10 and 20 microns. The phase III had very positive results. Here again, the timelines, with potential and the acceptance at the end of this year, and EU submission just in Q2. Teva said publicly they would launch the product right away, of course. Very long patent life here. I will repeat that there is no competition, there won't be for a while, and I would assume that any potential competitor in the future would have to prove to FDA that they don't have this PDSS issue as well. April 24th, we executed a deal with AbbVie on a formulation we had started to develop in-house with very good data. We received the EUR 35 million upfront.
We are conducting all activities up to IND. AbbVie will conduct all clinical development. We are getting on this one, mid-single digit to low double-digit royalties and potential milestones of $315 million. Third engine. We talked about UZEDY, we talked about olanzapine LAI, and AbbVie, which is actually the first product in the third engine. We had a R&D day. The replay is available on the net, just from a month ago, where we gave more information on our technology progress and the product progress as well. With this engine, there's three objectives. Increase the reach of our platform, I will explain in a second. Expand our portfolio with more blockbuster potential LAIs. Extend our partner network. You can see on the right risperidone LAI, then olanzapine LAI. You can see AbbVie number one.
We have a product which releases celecoxib to treat pain and inflammation, post-operative pain, which should start its phase III, its second phase III this year. On the left we have 15 programs in formulation. I will deep dive in them in a second. You can see on the bottom that we have three global health programs. The first one in contraception is funded by the Gates Foundation, which has given us $23 million to take it to clinicals. It will be a breakthrough best-in-class contraceptive. We have kept all commercial rights. We also have a very significant product in malaria to break the malaria transmission vector, and one in tuberculosis. In this formulation segment on the left, we have 15 active programs. Seven internal, eight are already partnered.
Nine of them are based on commercial-stage APIs, and six are based on clinical-stage APIs in a variety of therapeutic areas. On the technology side, our current technology, which is called BEPO, B-E-P-O, works really well and probably better than anybody else with small hydrophobic molecules, like you see in psychiatry. The next generation, BEPO Star, started to be implemented in all our programs in 2024. It allows us to do hydrophilic small molecules and more peptides. Our target with the next generation currently in the lab is to do even better in peptides and long peptides. I'm sure you can understand why. This slide is a representation of our product strategy. We are building a string of pearls. risperidone LAI, UZEDY being the first one, olanzapine the second one, AbbVie number one the third one, and the third engine of our strategy to build the next ones.
The addition of all those pearls will result in layers of royalties, which should increase over time. Financials, I will let Grace do a short summary of our financials.
Sure. With pleasure. Thank you, Jefferies. Thank you all for joining us. Financials. I think that we should start with a mention that we are in the middle of a transition period. Ahead of a really transformative anticipated approval and launch of olanzapine, we are in a transition period wherein we are receiving a healthy stream of royalty revenues from UZEDY. As you can see, 50% year-on-year total revenue growth, including these UZEDY royalties, R&D partnerships, and as well that includes a research tax credit. 65% increase in UZEDY royalties, as you can see. Everything is looking really well, operating on or above schedule. Here's our income statement. Operating expenses full year. Of mention, we will be having our earnings call June 16th, and we will be able to share more then.
Our cash position reported September 30th, 2025, EUR 53.5 million, and that did not include a nice capital raise, which we did earlier in the year, in 2026, and that included a EUR 48 million capital raise, and we brought in some new investors, including Perceptive, Affinity, and several others, as well as had great participation from some of our existing shareholders. A really healthy balance sheet. Again, our risperidone, olanzapine LAIs value proposition driving Medincell's accelerated growth. Royalties mid to high single digits for both programs. Milestones, commercial milestones, $ 105 million for UZEDY and as well $ 105 million for olanzapine and also a 4 million payment upon approval. Our shift to growth strategy. Again, our value proposition, our string of pearls, if you will, royalty stacking model includes, number one, our risperidone UZEDY program.
Revenues, sales doing really well and even better this year, outperforming forecasts year- over- year. Of course, our blockbuster olanzapine, which we anticipate approval of later this year. Of course, AbbVie is our other major pharma partner. Program one of up to six. We anticipate being able to share more news on that as well later this year. Of course, our powerful pipeline, our powerful innovation. Again, it's our value proposition, which includes our powerful platform, our partners, our programs, and of course, thanks to our people. 2026 anticipated news flow. Again, our catalyst-rich year, including UZEDY sales. Q1, Q2, Q3, Q4, you see we are anticipating those sales guidances to trend upward, and really excited about that revenue. Of course, again, our blockbuster olanzapine, which will de facto be first mover. Really excited about that program.
We anticipate that approval and launch in Q4, potentially Q3, but PDUFA date of October Q4 currently. Then, of course, our pipeline, our earlier stage products, as well as our formulation products and programs. Of course, our partnership with AbbVie we're really excited about. Again, a really catalyst-rich year ahead, 2026 and beyond. With that, this concludes our presentation. Many thanks to Jefferies and all of you for joining us. Thank you