MaaT Pharma SA (MAAT) Earnings Call Transcript & Summary

Good afternoon, good evening or good morning, depending on where you are based, and thank you for joining us. Today marks a significant milestone for MaaT Pharma, and I'm proud to share a transformative update on our commercial strategy. We are executing on our road map. And today, I will walk you through how our partnership with Clinigen marks a critical step towards commercialization for Xervyteg. Today, I'm going to be presenting most of the presentation myself, together with Eric for the financial part, our CFO, but also with Frederic Fasano, our Deputy CEO; and Jonathan Chriqui, Chief Business Officer. All of us, we have participated intensively in the discussion around the deal, and we will be happy to take your questions at the end of the meeting. So the first slide on Slide #4, the first slide I want to share with you is about our journey. Since the IPO, we have delivered on our road map, and I would like to focus today on the past 12 months as they marked a significant inflection point on the company direction. The first item is that we have delivered the pivotal Phase III data in GvHD in the so-called ARES clinical trial. The second pillar of the strategy was to submit as fast as we can, the marketing authorization in Europe and this marketing authorization has been accepted by the EMA recently in June '25. And then as a conclusion of this very intense segment of the journey, we are now announcing our partnership with Clinigen. And of course, that will ensure the scalability and make the company commercial ready for the next step of the development of the company. So regarding the partnership. So we have signed an exclusive licensing agreement in Europe with Clinigen for the Xervyteg. That's the scope of the agreement. Xervyteg was known as MaaT013 in the past, and that has been branded recently. Clinigen's track record in critical care and hematology oncology was very important in terms of the selection of the partner. Clinigen has also a strong reputation in early access program and that makes them the ideal commercial partner to scale our innovation. We feel a strong continuum on what we have achieved since the inception of the company in 2014. And now we are in a position to maximize the reach to patients. They bring the market expertise, and we continue to drive innovation in our field. Continuing on Clinigen, that's a global pharmaceutical company with significant activity in services. They have deep roots in rare disease and hospital-based commercialization. On our side, we also had a very good relationship with the team of Clinigen, which was an important criteria when settling this long-term partnership. They are active in 130 countries and bring trusted relationships with prescribers, but also payers. Their focus on hematology oncology perfectly aligns with the need of Xervyteg's patient population. So you have more detail in the slide, including the product that they are already commercializing, focusing on the product in hematology-oncology. In terms of responsibilities, the partnership that we have settled, I think it's fair to say it's a smart deal and a lean model, where Clinigen will take over the early access program in Europe as well as the commercialization, of course. MaaT remains manufacturing and market authorization holder. Clinigen will also handle the market access and the promotion of the product. And the coverage of this agreement cover the 27 European countries plus Iceland, Norway, Liechtenstein and the U.K. This approach will allow us to focus on clinical and regulatory milestones so that we can delegate everything, which is related to the connection with the hospitals to Clinigen, and we will be focusing on where we are good at, meaning the clinical and regulatory developments. So there's many synergies within this collaboration. That's not only supply and distribution. It's mutual strength that we share together. MaaT drives discovery, development and manufacturing, as I said, and Clinigen brings market access, prescriber reach and the infrastructure in terms of the supply chain. We are aligned on our mission, patient access, faster and broader. Focusing a little bit on the early access program. You see here the trend of the demand and you can see that from '23 to '24, the demand of early access program has increased significantly with an increase of 75%. Difficult to say in '25, but if we look at what happened on the first semester, we see that 2025 is scheduled to be a better year as compared to '24. Today, we do report plus 25% in terms of the increase. So that's an important element. As a reminder as well, Xervyteg, when it is used in compassionate use important to get data. So we recently presented during EHA that was in June in Italy, we reported data on 173 GvHD patients. And I want to reinforce the following message. We have reported an overall response rate of 57% as part of this data set and an overall survival of 51%. What I want to recall is that those data, they are really similar to what we have achieved on the pivotal ARES study. So this early access data set comes in confirmation of what we have generated in terms of the pivotal study, which makes us very confident, and that's also one of the value of this early access program, and we want to expand and continue this program so that we can continue to confirm the performance of the product. And as I said also earlier, because we are planning for this program to continue to expand, that also for us important to delegate it to a partner who can support the workload. And we want also to see our internal resources to clinical development and scale operations through Clinigen. So I think that's a moment everybody is waiting for. That's the deal terms. And for that, I'm going to give the mic to Eric. Thank you, Eric.

Thank you. Thank you, Herve. Hello, everyone. I'm now indeed taking a few minutes on the financial terms of this partnership between MaaT Pharma and Clinigen. The closing of the agreement comes with an upfront payment to MaaT Pharma of EUR 10.5 million and then regulatory and sales milestones up to EUR 18 million. Most of those will be upon approval in Europe, and then a steady stream of revenues in the form of royalties on net sales in the mid-30 percentage. And by the way, note that royalties are stable over the duration of the agreement. They are not tiered and the drug supply agreements on Xervyteg at a fixed price. Just to quickly recap the business opportunity for Xervyteg in acute versus -- graft-versus-host disease, aGvHD, we estimate incidence of third-line aGvHD for approximately 1,000 patients in Europe. We believe market penetration for Xervyteg could be between 1,200 to 1,600 patients at peak, and that would translate into peak sales to Xervyteg around EUR 75 million to EUR 100 million. If approved midyear next year, commercialization could commence in certain countries before the end of next year. Taking a step back and looking at the entirety of this partnership agreement, I see personally a number of very positive points. One, financial terms are very well balanced between the 2 partners. Taking into account both royalty net sales and drug supply, it is a well-balanced split of revenues, aligning both partners' interest on optimizing commercial and industrial performance. Second, the upfront payment upon closing extend runway into early 2026 in a non-dilutive manner, and that gives us time to execute on other ongoing financial initiatives and more is to come on that front. Third, this first commercial agreement in Europe sets a benchmark for MaaT Pharma on many accounts, one with new since ARES data and the real-life results from the early access program, as Hervé just recalled, that Xervyteg is clinically promising. This partnership now shows that Xervyteg is also commercially credible. Also, the balanced economics of the deal draw a steady stream of revenue and margin for MaaT Pharma once commercialization starts and a sustainable business case. In other words, these agreements derisk the company while retaining the marketing authorization, controlling the manufacturing and preserving upside on the commercialization with royalties and milestone payments. We believe this is indeed a benchmark that we may replicate in due course with other assets or in different geographies. And finally, that brings MaaT Pharma into a new biotech league and with not that many crossing that line, raising the company profile and making it fit for a new array of funding opportunities. Moving to the next slide. A quick word to remind that MaaT Pharma already invested in a dedicated biomanufacturing cGMP-grade site in partnership with French CDMO, Skyepharma, actually also in Lyon. You can see the picture, it's brand new, it's beautiful, with a capacity set for hem-oncology commercial volumes. This site has been an invaluable asset to develop our proprietary process, and it is now ready to supply our partner with no significant scale-up costs. I am now leaving the floor back to Hervé for concluding remarks, and then we'll, of course, open the call for questions. Hervé, back to you.

Yes. Thank you. So we start to converge to the conclusion. So this deal has really a very strong strategic significance for us. We'd like to tell you why with a structure of 3 main items. The first one, the deal structure, that's an exclusive agreement so that Clinigen is free to distribute and commercialize the product. So they are free to do that. There's already questions on the chat regarding how we will launch and everything. So I suggest we address that as part of the Q&A. We can retain the manufacturing. We will continue to retain the manufacturing, and this is a new class of therapeutics. So it's super important that you can control the manufacturing so that you have control on the development of the processes, but also on the cost of goods sold. So that's super important. So we remain -- regarding the deal structure, we remain really on control -- in control about producing the product. And for us, it's very important to ensure the consistency of what we do. And also as part of the deal structure, the early access program is important because that will ensure a smooth transition towards commercialization because we have already a very intensive early access program with more than 100 patients treated in '24 under the EAP, for example. So that will continue to grow, as you have seen from the graphics. So it's a little bit like without the authorization and everything and without the caveat, but it's a little bit like the supply chain has to be prepared because of the high level of demand. The infrastructure has to be prepared like we are commercial. So that will be really an ideal transition for us, and that was relevant to transition the early access program to Clinigen as well because of that. The financial terms, I think they are just well balanced. I think they are very respectful of the added value of each partner. The upfront is in line -- the upfront, they are in line with the size of the market. For us, it's really acceptable. The mid-30s is also reflecting the high added value of the product. So we are very pleased with that. And the fact that we are in a long-term supply agreement was also important for us. As a reminder, we have created a company in 2014. The IP we have generated is our IP. So the first patent are from 2015. So now we have a very long duration in terms of the coverage, and [indiscernible] also for a long-term supply agreement. Regarding the financial update, it's also important to mention that we are now moving the cash runway into January 2026. But more importantly, this deal now provides way more optionalities for MaaT Pharma because we have set a benchmark. So it's not stupid, I would say, to think that we could replicate this kind of model in other regions. So that's an important element. But now we have shown that we can monetize the innovation that we are developing at MaaT Pharma, and that will provide MA Pharma with more optionalities. And I want also to conclude on the fact that Xervyteg will be the first approved microbiome therapy if granted by the EMA. But it's not -- it's only a cornerstone toward next steps. The next step, they will be around MaaT033, which remain [ unpartnered ] as we speak today. So we have additional optionalities for the refinancing of the company. But also the MET-C pipeline, the MaaT034 in immuno-oncology is progressing well. We have recently presented nonclinical data that's progressing pretty well, and that will provide long-term growth engine for the company as well. So this positions us to expand into new geographies and indication in the future. With that, I will maybe just summarize and then go to the questions. This is a capital-efficient, balanced, value-creative partnership. It validates our clinical and commercial strategy. Our cash runway is extended. And we are very pleased that in the morning, we have seen that 2 brokers have increased their target price. Consistently, they were at EUR 15.5. They have increased for one at EUR 17, the other one EUR 16.5. So now we are between EUR 16 and EUR 19 in terms of the target price, which offers for a lot of potential when you think about the share price, which is even if today, it's trading very well. We are close to -- we are navigating between EUR 5 and EUR 6, which is the latest price of the latest capital increase. So there's huge potential. So we are proud to lead the field with the first potential microbiome drug in hematology/oncology. And with that, I will invite my colleagues, Eric, of course, and Frederic and Jonathan to join me for the Q&A sessions. So we have the first questions in the chat. So I'll take them as they come. Sorry if it will be -- maybe not consistent for you.

So the first question is for you, Frederic. What is the planned commercial strategy for launching MaaT013 in Europe? Will it be a country-by-country launch?

Yes. Thank you, Herve, and happy to be with all of you this afternoon, this morning for certain of you. Yes, so about the commercial strategy, there is 2 parts here. Of course, number 1 that I have -- one point -- sorry, that I have to mention is that it will be under Clinigen, our partner responsibility to define the commercial strategy. It is necessarily a country-by-country launch since launches will take place in different ways according also to the pricing question. Some countries are more quick at defining the pricing for reimbursement than others. So necessarily, we have to plan the launching sequence in different ways. So to the second part of the question, the answer is yes. And again, we will be happy to review the commercial plan of Clinigen. Again, they are -- this will take place under their responsibility. But of course, we know the product, we know the disease and we will be sharing that in different working groups and starting as soon as we get the marketing authorization.

Thank you, Frederic. The second one is for you, Jonathan. Can you tell us a bit more about how this deal came about and why Clinigen was selected over other parties?

Yes. Thank you, Herve. So we've gone through an extensive search and went through with the help of some advisers, went through a competing process, whereby we have different stages and different offers on the table. The reason why we chose Clinigen is for their capabilities in, of course, hospital rare disease. One of the key also was the fit with the team. Because for us, it's important we're a biotech, and we need to make sure that we have the same values and see the endpoint of treating the patients as soon as possible as a major driver of this. Of course, the financials were on the table that were adequate to what we were looking for. And finally, we made it happen.

Thank you, Jonathan. So there's a series of questions that I'll start to answer. So the first one is regarding the governance. What -- could you share a little bit more about the planned governance structure with Clinigen and to which extent MaaT will be involved in decision-making regarding MaaT013 commercial in Europe going forward? So everything regarding the governance has not been settled. We just signed the deal this week. Just can tell that I'll be on the committee together with Jerome Charton, who is the CEO of Clinigen, who I thank for the constructive spirit he has put into the discussion. It's too early to say regarding the governance exactly. And then there's a question regarding the commercial plan. What we want Clinigen to do is to sell the product as much as they can. We will ourselves -- we are committed ourselves to deliver the product so that they are not limited with the supply. And then that's going to be regular meeting we will have together. We have already agreed on the business plan as we speak today. And then it could evolve over time. That will indeed be through the governance that we can make some adjustments. Too early to say, but I see that as being led by -- the commercial plan led by Clinigen, but with a strong inputs from MaaT Pharma, especially when you think about the experience we have developed with the early access program, where we know all the centers. For example, if you get France, we have already with the early access program penetrated 30% of the available market. So we are very knowledgeable on that. And I believe Clinigen will want to leverage on that. So we will be consulted, I believe. There's also a question, will there be additional deals with Clinigen going forward? Why not? I mean, we are investing in our relationship together with Clinigen. So we'll be pragmatic. Changing for changing does not make sense. We need to continue with Clinigen if it makes sense on the other hand, but we are investing into the relationship. We're going to train the team -- the people from Clinigen and anything. If everything goes well, we are super happy to continue. If things could be better, of course, we will continue to seek for the best partner. But today, I have absolutely no reason to think it would be the case. Then there is a question for Eric. Have you explained about -- can you explain about -- so that's probably your shareholder. Can you explain about the tendency of the action? Why is it going down?

Well, it's true that MaaT Pharma has been delivering very good news steadily since the start of the year. The ARES data, the European submission and now this partnership with Clinigen, definitely good news, which is derisking the company. It's true that it has not been fully reflected in the market price to say the least and it can be kind of frustrating. I share that frustration. I believe also it's not unprecedented that for biotech like us, where you had some investors that have been investing in the company for many years and for a number of reasons, different from one case to the other, they may have to shift the position. So taking advantage of the volumes that are created and triggered by the good news is certainly a reason to see this selling pressure that we may have seen from time to time in the recent days. Well, we're addressing this point, I can tell you. And I believe that the market will finally realize the good news that we are delivering on plan on a steady pace. And I'm quite confident that it should finally reflect in the market price.

Thank you, Eric. I have 2 questions I would merge and that's for you. The first one is regarding our financing strategy, knowing that we are announcing the end of cash in early '26 and how do you reach up to the marketing authorization in Europe?

Yes. I think Herve said, well, a few minutes ago that this partnership -- first partnership agreement for MaaT Pharma is a benchmark. It is indeed a benchmark, again, on many accounts, including in terms of financial strategy. First, it's shifts MaaT Pharma to a new biotech league. That's for sure. Again, a company with a positive Phase III under registration process in Europe with commercial activities and market access getting ready, it's not that often. And I think now that we are in that league, it will open a new array of funding opportunities, and we're actually working on a number of them. Those funding opportunities are not necessarily getting back to the market, and that's a good thing because, as you know, financial markets are very challenging these days. And we have shown, starting with that deal that we're able to fully fund -- well, to further fund the company with other options -- non-dilutive options. And as I said earlier, this first partnership that we've just closed in Europe can be the first on -- of other potential partnerships on other assets, other geographies that we may be contemplating in the coming months. So I think, indeed, we have a number of funding options. This new step is opening new opportunities also in terms of financing strategy for the company, and we intend to leverage on those many fronts.

Thank you, Eric. There is also a request to update on the U.S. plan. So in the U.S., we are in active discussion with the FDA. So what we have announced in June is that after having communicated with the FDA, we know the European data by themselves will not be sufficient. We will need a clinical trial. So where we are now is that we are discussing what the clinical trial in the U.S. As you know, we have an IND open in the U.S. for pivotal study that was already authorized by the FDA. However, we need to adjust it because now we have the full package of data from the European data. So what we have seen in Europe requires a small adjustment within the U.S. clinical trial. So that's typically what we will be discussing with the FDA. We do plan to start the clinical trial in the U.S. in '26. There is also a request on other regions, especially Asia. Do you have any plan in Asia? So that's the question. Thus far we have been concentrating ourselves indeed in Europe and in the U.S. We see more and more demand coming from Asia. So I know there are Asian people connected today in the call. So I just can confirm that now we are also opening the potential of the company to Asia as well. So that's something we would clearly consider and we are already adjusting the organization at MaaT Pharma to make that possible to understand, at least to have a readiness phase to understand if the potential is confirmed. But if you take China only, it's the same number of allogeneic HSCT as compared to Europe in total. That's roughly 50,000 allo-HSCT in China performed every year and the use of corticosteroids. They use ruxolitinib and so the same setting. So there's a huge potential there. And we are in a ready next phase to understand if we will go there or not. Then there's other questions coming. One is for Frederic. Does the current capacity cover the demand for European countries? I think it's the manufacturing capacity. Or do you have to -- yes, that's -- or do you have to extend the manufacturing site? Can you elaborate a little bit more?

Yes, of course. So it's a very good point. You will recall that actually, MaaT did a lot of reforms to be manufacturing by itself. So we have today a plant that is already supporting all the supply for clinical, but also for the EAP. So importantly, the sum up is that no more CapEx is required to supply the market, the European market for commercial products. So everything is in place. The plant is up and running. And of course, what will be done now in the scale-up program is adopting all the process and starting material to -- and collection of material actually to support the commercial supply. But again, it's about OpEx and not any more CapEx. And we will be, at the end of the day, very happy to have an important scale up as the sales are rising because it will mean that the launch actually is successful. So of course, it's a long term -- just to remember, it's a long-term agreement of supply as well and we are well equipped to start as soon as the product will be launched.

Thank you, Frederic. And there is a question for Jonathan. It has been said that the microbiome therapeutics, they are new. How have you seen the reaction from the pharmaceutical company during the selection of the partner? Maybe you can share also that we had a process, I would say.

Yes, exactly. So we had a process, but we reached out to a number of potential partner at the beginning. And then I have seen a lot of evolution. I started in the company about 1.5 years ago and [ reached through ] partners at that time. And from 1.5 years to now where we are, things have changed. The vision of the product has changed for several reasons. The first one being that we are actively developing a drug, not a probiotic, not anything like that. We're actively moving a drug to the market through a centralized procedure, which is something that now is standard. And whether you look at, I don't know, a small molecule, you do never ask yourself what you're dealing with. So here it's the same. Our vision -- the vision of the partners has evolved over time, and it's way better understood now. And especially since the data are so good and we save patients' lives. This has been, let's say, gathering a lot of interest from the different partners. So yes, there would have been a change in the way people have looked at the product. And I think we are pioneering that in our ecosystem, which is extremely exciting and bringing a lot of innovation to the market.

Thank you, Jonathan. And there's a question, which I will take. There's a question about the kind of changes we will need for the U.S. regarding the clinical trial. What I said is more adjustments than changes. For example, the calculation of the power of the trial will be different because of the strength of the signal. I would also say that that's not only the MaaT Pharma that has changed. There is a lot of evolution within the administration within [Audio Gap] division. And they have their also own views on how we should be developing drugs in rare disease. So we need also to accommodate with that. The world is not exactly the same as it was a year ago or even when we had the authorization for the APOLLO trial, the twin protocol as compared to ARES. So we need also to make sure that what we are doing is also compliant with the most recent regulatory policy. So it's not -- I think it's prudent to go that way as well. On our side, it's more about adjustments based on what we have learned in Europe. There is also another question. Do you expect to continue the early access program in EU. If yes, can you describe the benefit? How do you choose the suitable candidates and will Clinigen be involved in this strategy until drug approval? So Clinigen will be running the show. So there will be, I would say, 3 steps: EAP up to the point that we get on approval. Then you enter the second phase where you have an approval, but you do not have a price reimbursed and then you have a reimbursement. So I think it's clear for everyone that from the reimbursement step, Clinigen will commercialize. In between the marketing authorization and the reimbursement, there's an opportunity to sell the product under what we call unlicensed product. That's a product which is in between [indiscernible] continue and each country has its own framework. And before we get the approval, we will continue with the compassionate use with Clinigen. Why? Very simply because there's patients. I'll take an example. We received this week a request for a patient of 18 years old to allo-HSCT, 5 line of treatment for GvHD if there is no drug that works for this patient. If we don't come with Xervyteg, we might not save the patient. But if we don't try, we will never know. So we want to continue to provide the product to the patients just because they are severe patients and they have no option. There's also a question to you, Eric. What do you mean by long-term supply agreement? Minimum purchase per year per Clinigen or more detail on what do you mean by long-term supply agreement?

Yes. Thank you, Herve. So it is in the long term because it's over the duration of the agreement, which is for 14 years in line with the duration of our intellectual property. It's an agreement on supply, meaning that we have agreed together with our partner on minimum purchase per year, which is in line with the shared commercial plan as well in terms of revenue. So indeed. So it's like a marriage. We are fully aligned on the plan. And it, indeed, does translate into some minimum requirements. And that's why also I was speaking about a steady stream of revenue. And we have this -- now this better clarity on the plan going forward. And again, with a steady stream of our financial resources for the company, of course, we need to we need to bridge that gap to the start of commercial sales, which is, again, about 18 months from now. And as I said earlier, with these agreement, we have new funding opportunities that are now open that were not accessible before that deal and that are now getting real and accessible. Because again, when you have a steady stream of revenue, you have some additional options that are suddenly getting possible.

There is also another question, which has nothing to do with the topic today, but I think it's also relevant. That's regarding the use of MaaT013, now Xervyteg, in other indications such as in immuno-oncology. So that probably refers to the Phase II clinical trial for which we are expecting the results for the second part of '25, and that makes sense. It's relevant also because it's part of the value creation of the company. And indeed, we are expecting the results for the PICASSO trial that's metastatic melanoma patients where we want to improve the response to immune checkpoint inhibitors by modulating the microbiome. And this trial is also the first randomized controlled trial in multicenters, which could show that mobile modality could improve the efficacy of immune checkpoint inhibitors. So that will be the first time in the world that we can demonstrate such a result with a very strong methodology being on RCT. And that's also something we do expect in H2 '25. If it's successful, we will continue, of course, the IO program, immuno-oncology program. And you could expect the next development phase in mid '26, which will even further fuel the value creation within the company. And with that, I'm looking at the chat and please, on the back office, let me know if I'm wrong, but I do not see any other questions. So yes so I have a beep, so that means I have a response, no. So I think we good. Okay. There are no other questions. So thank you very much for your attention. Once again, we are very happy to be in front of you today. We are super proud to lead the field with the first potential microbiome drug in hematology-oncology. And I will let you with that. That's really what we are proud of. We will continue to deliver as per plan and connect with you again in the near future. Thank you very much, and talk to you soon.

Thanks a lot.

Thank you. Bye-bye.

Thank you, bye.