MedinCell S.A.

MedinCell S.A.

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Q4 FY2026 · Earnings Call TranscriptJune 16, 2026

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David Heuzé Hello, everyone. Thank you for joining Medincell's annual results call for the fiscal year ended March 31st 2026. Our press release and presentation are available on our website. Before we start, I invite you to refer to slide two for important information regarding forward-looking statements. Joining me today are Christophe Douat, our CEO. Hi, Christophe. Christophe Douat Hi, David. Hello, everyone. David Heuzé Stéphane Postic, our CFO. Hi, Stéphane. Stéphane Postic Hello, David. Hello, everyone. David Heuzé I can now leave the floor to you, Christophe, to start the presentation. Christophe? Christophe Douat Thank you, David. Let me start with Medincell's trajectory. Our Shift to Growth strategy is built around three engines of growth, all powered by Medincell's innovation. The first is risperidone LAI with UZEDY, successfully marketed in the U.S. since 2023 by our partner, Teva. The second is olanzapine LAI, and the third is AbbVie number one, together with our broader pipeline and innovation platform. What is important here is that these are not isolated assets. They are three complementary engines supporting both near-term execution and long-term value creation. As you may recall, one year ago, when I introduced our Shift to Growth strategy, I said that the coming two years would be the most transformative in Medincell's history. One year later, I can confirm that we are exactly in the middle of that transformation. In fiscal year 2025/2026, we delivered strong execution across all our growth engines. We saw continued ramp-up of UZEDY, which is driving royalty growth. Olanzapine LAI progressed toward its expected U.S. launch in the fourth quarter of 2026. On the third engine, we advanced our first AbbVie program toward the clinic while continuing to expand our pipeline and further strengthen our innovation platform. This was a year of broad execution, not just progress on one product, but progress across the company. Starting with UZEDY, momentum continued to build during the year. Net sales by Teva reached $250 million, compared with $141 million in the prior fiscal year, while royalties increased to $10.9 million from $7.1 million. At the same time, prescriptions in the U.S. continued to trend upward, and the product benefited from an FDA label expansion into bipolar I disorder for the one-month formulation in October 2025. The key message is simple

UZEDY is gaining traction, and that traction is translating into growing revenues for Medincell. Beyond the pure numbers, UZEDY provides an important proof point for our business model.

It combines innovation for Medincell, enabling differentiated products with strong commercial execution from our partner. These differentiating features, such as ease of use, flexible dosing, rapid onset, are directly driven by our technology.

At the same time, our partner demonstrates strong commercial execution. Teva's initial 2026 guidance is $250 million-$280 million, with $63 million already delivered in the first quarter of the year.

What UZEDY shows is that differentiated long-acting products combined with strong commercial execution can deliver meaningful market adoption. This gives us confidence as we prepare for the upcoming olanzapine LAI launch, which is built on the same combination, innovation and execution.

Turning now to olanzapine LAI. The regulatory path is clearly defined.

In the U.S., the new drug application was submitted in December 2025 and accepted by the FDA in February 2026. In Europe, the market authorization application has been submitted this year.

We are expecting U.S. launch in the fourth quarter of 2026, subject, of course, to regulatory approval.

We are now entering the final phase before what could be a major inflection point for the company. The opportunity of olanzapine LAI is driven by a clear unmet medical need.

Olanzapine is one of the most widely used oral antipsychotics, both in the U.S. and in Europe.

It is often prescribed for the most severe and refractory patients. Typically, those who would benefit the most from a long-acting treatment option.

Yet today, there is no practical LAI options available. Let me show you this slide again.

On the left, you have Johnson & Johnson and risperidone. On the right, Eli Lilly and olanzapine.

Both follow the same life cycle strategy with LAIs. Johnson & Johnson was highly successful building a $4.8 billion franchise.

Eli Lilly failed commercially. UZEDY is targeting Johnson & Johnson's franchise.

Look on the right, there is no large multi-billion green box. Eli Lilly failed commercially.

FDA imposed a three-hour wait after injection, Medincell gave Teva the keys to grab this potential. This is where differentiation becomes critical.

Existing olanzapine LAIs are constrained by PDSS-related monitoring requirements. PDSS is an overdose-like reaction that can happen at each administration if the injection is made into the vein by mistake.

With Medincell's subQ formulation, more than 4,000 injections have been performed across clinical studies with no PDSS observed. This is supported by in vitro data showing a controlled-release profile even in plasma, in contrast to the rapid release observed with intramuscular existing formulations.

Plus, there is only 10-20 micron-wide blood vessels in the subQ space when they can reach 1 cm-2 cm in the muscle. This could significantly expand the use of olanzapine in long-acting injectable form.

Beyond UZEDY and olanzapine, we are building our third growth engine. This includes developing a portfolio of long-acting injectables, many with blockbuster potential.

We are continuing to expand our technology platform and leveraging partnerships to scale development and commercialization. We are not just building around two products.

We are building a broader engine for sustainable growth. This third engine is already supported by concrete progress.

With equity partners like AbbVie, our first program is progressing toward clinical development, with CMC work expected to complete this year, supporting a clinical start in 2027 by our partner. For mdc-CWM in post-TKR pain, phase III preparation is ongoing, with initiation still expected in 2026.

More broadly, we now have 15 active programs at formulation stage across internal and partnered assets, with increasingly focused on high-value indications. This is a pipeline that is both broad and actively advancing.

Underlying all this is the continued expansion of our innovation platform, as highlighted during our recent R&D Day. Our capabilities now extend across a broader range of molecules, from small molecules to increasingly complex peptides.

This expansion enables us to address more opportunities and supports the growth of our pipeline and future partnerships. Overall, we have strong execution on UZEDY, a clear path toward olanzapine launch, and a growing third engine driven by our pipeline and platform.

With that, let me now turn to the financials. Stéphane?

Stéphane Postic Thank you, Christophe. As already mentioned by Christophe, we are really entering into a new era, and that's specifically true in terms of business model, as we are now scaling a portfolio of innovative products generating royalties.

Let me highlight three key messages here that illustrate this change. First, we are generating strong and regular revenues, which includes a massive growth in UZEDY royalties.

This will continue to drive the expansion of our recurring revenue base and to support our path to operating profitability. Second, we see a strategic voluntary increase in the operating expenses to support future growth and value creation.

Third, we have a much stronger balance sheet, with EUR 85 million of cash available that provides clear long-term financial visibility. Now starting with UZEDY, we all see that UZEDY's strengths are really exciting.

We continue to see the strong commercial momentum reflected in sustained growth in net sales reported by Teva. They reached $250 million during our fiscal year from April 1st, 2025 to March 31st, 2026.

This translated into a very significant increase in royalties at 54% in U.S. Dollars and slightly lower once converted in euros.

Still a very nice increase of 42%, reaching EUR 9.3 million. I'd like also to remind everyone that we really see a regular acceleration in UZEDY sales.

Q1 2026 net sales reached $63 million, up 62% compared to last year. Q1 2026 was the strongest quarter ever for UZEDY, confirming strong underlying demand and continued adoption by doctors and patients.

Ahead of olanzapine launch, UZEDY remains the short-term key driver of our expanding royalty base. Now moving to the revenue dynamics.

Total income for the period was EUR 24.3 million, slightly lower compared to the EUR 27.7 million posted last year. Why is that?

There is some variability coming mainly from the milestone payments. In fiscal year 2025/2026, we did not get any milestone versus a EUR 4.8 million milestone linked to olanzapine phase III result the year before.

Milestones are triggered by one-off events, they happen in certain years, not in others. Of course, they are valuable when they occur, they are not the best way to read the underlying trajectory of the business.

What is most important and relevant is illustrated on this slide. We are clearly switching into a more royalty-driven revenue model.

Royalty income continues to increase as a share of the total revenue, reaching 38% this year versus 22% last year. Excluding the milestone effect, the underlying revenue increased from EUR 22.9 million-EUR 24.3 million, reflecting the continued progress in our core business.

Even more striking, when you look back at the revenue evolution over a longer period, you can clearly see that our revenues, excluding milestones, have been multiplied by three over the last two years. A couple of additional words on the other revenue items.

AbbVie collaboration is progressing well and as planned. As Christophe said, we are now getting closer to the IND.

The revenue recognition, which is based on the received upfront, reflects the activities performed during the fiscal year and represented EUR 6.4 million last year. Among the R&D partnerships, you find also the early-stage collaboration revenues.

They nearly double last year to EUR 1.6 million, and they cover eight partner-funded programs. That's very promising, because it means as many potential future opportunities for licensing deals with pharma or large biotech companies.

Finally, one comment on the research tax credit contribution, which has also doubled year-on-year. This is actually a nice transition to the next slide and the continued R&D effort that I will comment on in a minute.

Moving to the operating expenses that have increased to EUR 45 million compared to EUR 38.5 million last year. This reflects a deliberate and disciplined increase in the expenses to support our future growth.

We'll start with R&D. First, a comment on R&D.

Instead of talking of operating expenses, I would rather call them investment, because a big portion of them is there to create value in the long term. R&D remains the largest component of our expenses, representing around 60% of the total.

We shared more information on our innovation strategy during the recent R&D day. Accelerating innovation is at the heart of Medincell strategy.

We have two core priorities in terms of R&D: the product pipeline and the technological platforms behind them. Advancing our pipeline to generate high-value data is really key to our business model.

It enables us to engage with partners under attractive economic conditions. We currently have 15 programs in formulation, seven internal, eight already partner-funded.

For all of them, the aim is to generate high-value data to support future licensing discussion, like we did in the past with AbbVie, where we started to work on one of their assets before the deal execution. Secondly, we are continuing investing to strengthen our technology platform through BEPO Star, and other future generations.

This is mandatory if we want to expand our capabilities to formulate more and more molecules. Beyond the R&D, business development expenses have also increased.

It's reflecting our willingness to intensify partnership activity and to expand globally. Finally, G&A are increasing to support the scaling of the company, mainly with personnel-related costs and also expenses relating to IT and cybersecurity infrastructure.

On the next slide, you have the income statement. Medincell is really today at an inflection point.

Christophe has been telling our investors repeatedly that the current years are the most transformative ones, and they are. We anticipated that fiscal year 2025-2026 would be a transition year from a financial perspective because of the absence of any milestone and some variability in the R&D revenues.

We end up with an operating loss representing EUR 20.8 million. Below this line, the financial result is a loss of EUR 10.6 million, including a EUR 5.4 million of non-cash impact related to the EIB warrants revaluation.

You know that we have successfully negotiated with the EIB a waiver on the put option in March 2026. This non-cash impact should disappear in September 2026 once we get the final approval at the general meeting on the revised terms for these warrants.

And this will definitely ease the reading of our accounts when it will be gone. Total annual net loss was EUR 31.3 million.

Again, as a conclusion, I'd like to say that this loss reflects a deliberate acceleration. We are building scientific, technological, and partnership assets that will drive future revenue growth and value creation.

Next slide is on the balance sheet. I guess it speaks by itself.

We continue strengthening our balance sheet to support our growth strategy. We ended the period with EUR 80.8 million in cash and financial deposits.

More than that, our cash position, net of debt, is also positive for the second year in a row at EUR 15.3 million. This really highlights that we are gaining the financial flexibility needed to support our growth strategy.

Now let me conclude with the growth outlook for the next years. We are really building a clear multi-engine model.

First, UZEDY is already generating and scaling royalties. The current sales expectation for 2026 are close to $300 million.

If you compare this sales figure to other existing products on the market, UZEDY is already on track to become a blockbuster by the beginning of the 2030s, meaning tens of millions in royalties for Medincell by then. Second, olanzapine LAI should be approved in the coming months in the U.S.

and then in the EU. This will trigger nice milestone payments, and even more important, first royalties are expected as early as Q4 2026.

Given the strong expected demand and the current competitive landscape, we anticipate that revenues could become meaningful from the second half of 2027 with a faster ramp than for UZEDY. Third, we are building a broader pipeline and more partnerships, including AbbVie and others.

All exciting things ahead. That's it for me.

Christophe, back to you for a word of conclusion. Christophe Douat Thank you, Stéphane.

To conclude, I will repeat what I said earlier. One year ago, when I introduced our Shift to Growth strategy, I said that the coming two years will be the most transformative of Medincell's history.

One year later, I confirm that we are exactly in the middle of that transformation. Thank you.

David Heuzé Thank you, Christophe, and thank you, Stéphane. We can now open the call for questions, with the first questions coming from Ram Selvaraju of H.C.

Wainwright. Hi, Ram.

Can you hear us? Ram Selvaraju Can you hear me?

Christophe Douat Yes. Ram Selvaraju Can you hear me?

Christophe Douat Yes, we can hear you, Ram. Go ahead.

Yes, Ram? Ram Selvaraju I cannot hear you, I wanted to ask three quick questions.

Firstly, I wanted to know if it would be possible for you to comment on the guidance that Teva has historically been providing regarding UZEDY, which clearly appears very conservative, and if you expect this pattern to continue, not just with UZEDY in the future, but also once olanzapine LAI arrives on the market. Also, if you could give us any granularity regarding how rapidly you expect Teva to be able to make olanzapine LAI available in the United States.

Secondly, I was wondering if you could clarify the business development expenses delineated in one of the slides that Stéphane showed. What do these consist of precisely?

Lastly, I was wondering if you could comment on the level of exposure to foreign exchange fluctuations and the degree to which you might be able to hedge against these in the future, especially given the possibility of future depreciation in the value of the U.S. dollar versus the euro, and/or if there are any specific provisions made in the agreement between Medincell and Teva to take account of this potential eventuality.

Thank you. Christophe Douat Hi, Ram.

Maybe I'll answer the first two questions, Stéphane, you can answer the others. It is Teva's policy to be very conservative on guidances.

The first year of UZEDY, the initial guidance was EUR 80 million. They ended up at EUR 120 million.

On year two, it was initial guidance of EUR 160 million, ended up at EUR 191 million. We expect them to keep being conservative.

That's Richard Francis' strategy. On the next question, when do we expect olanzapine LAI to be available?

Teva said clearly that they would launch right away upon approval. Stéphane Postic Right.

To answer your question on the BD expenses, they cover personal costs for our business development and market insight people. We've built up a very nice team.

As I say, the will of the company is to expand globally. We have now people all around the world looking for additional partnerships and opportunities.

On the second question regarding the exposure to USD fluctuation, it's only versus USD that we have a small difficulty. No other currency at the moment.

Indeed, all the royalties are labeled in USD. The best way to hedge against that is to repay as much as we can in USD.

I'm trying hard to sign agreements with suppliers that are also issued in USD. Apart from that, it's a bit difficult because indeed, a good portion of our expenses are in euros.

David Heuzé Thank you. Next question comes from Shubham Sharma of Jefferies.

Hi, Shubham. Shubham Sharma Hi there.

Thank you so much for taking my questions. I've got three, if I may.

Firstly, I know in the release it states that for the AbbVie first candidate, the initiation of clinical development will be in 2027. To be clear, we'll know the candidate in 2027, not in 2026.

Secondly, I saw a bit on the potential delayed initiation of the six-month contraceptive program due to changes in the regulatory pathway. Could you expand on what those changes are, please?

Finally, of course, it's very sad to hear that Richard has retired. Obviously, we wish him the best.

Obviously, he was very valuable to the company in his role, given he'd previously been at Teva within the psychiatry team. Just wondering, what sort of candidates are you looking for, and are you looking internally and externally?

Thanks so much. Christophe Douat Thanks a lot, Shubham.

Hello. Yes, the AbbVie number one program should start clinicals in 2027, and we expect AbbVie to disclose the name of the underlying drug at that time.

As we said, there is a change in the expected regulatory path for mdc-WWM, and we do not comment on that. On the third point, as you noticed, Richard, which has been my strong arm, as I say in France, for many years, is retiring, but still consulting for us, especially in the psychiatry field.

We are getting very close to get a new CMO on board, which actually it should be a woman who will be adding a lot of value to Medincell with all the core competencies that we need especially in preclinical and opportunity identification. David Heuzé Thank you.

Next question— Shubham Sharma Thank you. David Heuzé Next question comes from Mike DiFiore of Evercore.

Hi, Mike. Cannot hear you, Mike.

I think that you're on mute. Mike DiFiore I'm sorry.

Could you hear me now? Christophe Douat Yeah.

Mike DiFiore Thanks so much for taking my question, guys, and congrats on the continued progress. Two questions from me.

Number one, you've spoken about becoming more selective and generating more data internally before partnering. Today, is the challenge primarily finding technically feasible opportunities or finding opportunities that are large enough to justify the level of investment and economics you are now targeting?

That's question number one. Number two is that at the R&D Day, you showed progress with larger peptides, GLP-1 type molecules, and highly soluble compounds.

As you look at the platform today, what remains the biggest technical challenge you're still trying to solve? And what would solving it unlock in terms of new partnership opportunities or addressable markets?

Thank you. Christophe Douat Thanks a lot, Mike.

On the first question, Yes. About half of our formulation early-stage pipeline is made out by internal programs that we have identified, like with AbbVie number one.

We look at the pipelines of big pharma, large biotechs, then we evaluate the potential as a LAI and look at technical feasibility on a paper base. If we think it's positive, as we explained during the R&D Day, then we move into early formulation.

With the objective to trigger licensing. Some of those programs are quite exciting and have significant potential as long-acting injectables.

On the second question, the biggest challenge in the formulation. I should remind that BEPO and BEPO Star, their sweet spot is small hydrophilic molecules.

We definitely have the best technology in the world for those molecules. All the molecules in psychiatry are small hydrophobic molecules.

We are making some very nice inroads into more hydrophilic molecules. The large hydrophilic is definitely one objective that we have.

Obviously, GLP-1s fall into that category. The second direction in which we want to expand our technology is higher doses.

When you inject a depot under the skin, you are limited by the volume. Usually, we inject at most 1.5 mL, then you have to take out the volume by the pharmaceutical solvent, the polymers.

What is left is the volume for the API. In some cases, we are limited by the dose as well.

As we said, there is innovation in the lab ongoing as I speak. Innovation which is, I think, generating the most excitement I've seen at Medincell in the last 15 years.

There are things we need to confirm in the next few months. We definitely will use that as the next generation.

We just need to define the scope. Confirm the scope.

Mike DiFiore Excellent. Thank you.

David Heuzé Thank you. Next question comes from Marc Goodman of Leerink.

Hi, Marc. Marc Goodman Thank you.

With olanzapine LAI coming into the franchise alongside UZEDY, can you help us think about how you'd segment the two products commercially? Specifically, what patient profiles do you expect new to LAI patients to opt for an olanzapine LAI versus risperidone based, like UZEDY?

To what degree do you expect switches from UZEDY to olanzapine LAI? Secondly, on the AbbVie collaboration, should we think about the 2027 clinical start as a single lead candidate moving forward first and then the rest of the collaboration programs progressing stepwise behind it, or multiple candidates moving forward in parallel today?

Thank you. Christophe Douat The first question is a very good question.

Both compounds, risperidone and olanzapine, are not in competition. They are complementary.

Risperidone is a standard treatment in first intention. Olanzapine is for the most severe and refractory patients, and there is no overlap or very little overlap between both, which made Teva say that with both products, they could cover 80% of patients.

On the second question, AbbVie number one should start its phase I in 2027. As a reminder, the agreement with AbbVie allows AbbVie to do five more programs with the same financial metrics.

I cannot comment on the status of discussions with AbbVie on the other programs. David Heuzé Thank you.

Next question with Nicolas Pauillac of Kepler Cheuvreux. Hi, Nicolas.

Nicolas Pauillac Hi, guys. Hopefully you can hear me.

Maybe just a quick question from my end, too. First to come back on a previous question about the kind of gap there is between Teva's guidance on the potential of these two drugs and what you kind of implied, like the blockbuster potential for UZEDY, for instance.

When you look at the consensus on Teva today, I think it's sitting around EUR 500 million, EUR 600 million of sales for UZEDY. What is making you so much more confident that you can almost double what the market is seeking today in terms of sales for this asset?

Also for the whole franchise, I think Teva has been pretty vocal about this EUR 1.5 billion-EUR 2 billion cumulative sales on that. Just trying to understand what is making you so much more confident than what Teva has guided for in the past and has kind of consistently guided for.

That's my first question, just to come back on what was asked before. Just a much more easier question, let's say.

On the OpEx, any guidance on how things might evolve into next year? Linked to this AbbVie disclosure, when we think about modeling, should we put some upfront into this fiscal year, 2026, 2027?

Will it be rather, let's say, smarter to put it next year? That will be the three.

Thank you. Christophe Douat Okay, thanks a lot, Nicolas.

On the first question, on UZEDY. As I said earlier, Teva's strategy, and its CEO in particular, is to always underestimate guidances, to always provide good news to the markets.

What we know now, after three years of commercialization, as Stéphane said earlier today, is that it follows the same curve as some LAI in psychiatry, which have reached the $1 billion mark. The third point I would say is, I think UZEDY was underestimated by Teva's analysts at first, because it was one product among many others at Teva.

UZEDY has Johnson & Johnson across the street with all its power. Not many analysts try to understand the differentiation of UZEDY, which is an amazing product.

The ideal LAI, it ticks all the boxes, and its profile, combined with Teva's execution, is showing that it can take a dent from the $3.5 million out of the $4.8 billion from the U.S. part of the Johnson & Johnson franchise.

There is room to go. Olanzapine, similar scheme.

Olanzapine, I think was better understood by analysts because here there is no competition. It's an open road in front of olanzapine.

We think that those guidances will be updated as the ramp-up goes. The initial guidance of UZEDY was extremely low at first.

Here we have a product that has no competition with the most used oral antipsychotic as the underlying drug, and for patients that are the most severe, that need the long-acting injectable the most. Here we also have a benchmark.

We know that Johnson & Johnson is doing $4.8 billion with risperidone LAIs. We know, as we said earlier, that olanzapine is used more than risperidone.

In theory, of course, in theory, Teva's could exceed what Johnson & Johnson is doing today on risperidone. Time will tell.

It will depend on execution. We know that Teva has done great execution on UZEDY in the U.S., that they are getting aggressively worldwide, filing into Europe, and conducting some trials in China as well.

Stéphane Postic Right. The second question you had, Nicolas, was on the OpEx for next year.

I'm not going to comment or give any figure for next year. What I can say is that everyone has to bear in mind two things.

First, a good portion of our R&D expenses are covered by our partners. We have many collaborations with AbbVie, with the Gates, and with also some undisclosed partners for now that cover the R&D fees.

The second thing I'd like to reemphasize on is the fact that we have clearly this willingness to build this portfolio of programs. It is the way that we are going to create value in the long term.

Definitely, the OpEx will reflect this strategy of going to the next stage. Lastly, you had a question on AbbVie and if we should expect another upfront for the coming year or when it should come.

I'll just state again what Christophe said a couple of minutes ago. We cannot comment on the next AbbVie program.

David Heuzé Thank you, Stéphane. This concludes the Q&A session.

Christophe, a last word? Christophe Douat Yes.

We are really excited at Medincell. We are in the middle of what should be the most transformative years of Medincell's history.

UZEDY is growing significantly. Olanzapine is about to be approved.

The countdown has started. It's a matter of months.

The third engine is accelerating both on its pipeline and the technology progress. Very exciting times for us at Medincell.

David Heuzé Thank you, Christophe. Thank you, Stéphane, and thank you all for joining us and for your continued interest in Medincell.

A replay will be available shortly on our website, just right after this meeting, and we look forward to speaking with you again soon. Thank you.

Goodbye.