Good, good afternoon, ladies and gentlemen, welcome to Gedeon Richter's conference call. Today, we would like to provide you a bit of an in-depth discussion of one of our key business units, the Women's Healthcare business, on the back of recent developments in this particular segment, and some corporate transactions we announced. My name is Róbert Réthy. I'm Head of Investor Relations at Richter. For this discussion today, it's my pleasure to welcome two members of the senior management team of the company, Gábor Orbán, our Chief Executive Officer, and equally importantly, Dr. Péter Turek, who is the Head of the Women's Healthcare business at the company. The setup for today is going to follow the usual pattern.
We're gonna be using a presentation, slides of presentation what we published this morning or uploaded this morning to our website. You can also access it on gedeonrichter.com. This will take approximately half an hour. After that, you are going to have a chance to ask questions in a Q&A session either using the Raise Your Hand functionality in the Teams platform or the chat box if you put your questions on the chat box. Before we start, also one request, please keep your line muted throughout the call except for when you are asking questions. Two formal notes or important remarks before we start.
One is that this call is going to be recorded, and we plan to put it on our the recording on our on our website after the call. Secondly, I would like to draw your attention to the cautionary statement at the very back of the presentation regarding forward-looking, potential forward-looking statements. With that, I would like to hand it over to Gábor, who will have a few introductory notes.
Good afternoon, everyone. Thank you for joining this call this afternoon. I'm very pleased to see all of you on the call. Over the number of occasions that we have met in recent months and quarters, I have repeatedly promised to you that we will deliver an important announcement relating to each business unit every quarter this year. I'm pleased to say that so far we have kept our promise because in the first quarter we discussed biotechnology in the context of two transactions that took place in the first quarter or rather that were closed in the first quarter. Now here we are with women's health at a very important juncture, also following two very important transactions. When it comes to social impact, most companies talk about ESG. We don't talk about ESG only.
We start talking about our core business, within our core business, most importantly, we start talking about the social impact that we create by looking after women's health and wellbeing. This social impact is potentially huge, one publication that has attempted to assess the size of that impact was Closing the Women's Health Gap, report by McKinsey that was published this January. I was present in San Francisco at the pre-read or pre-publication meeting that McKinsey organized in San Francisco. I already noted back then that their interpretation of the field is a bit broader than ours. As usual, they got carried away a bit by pronouncing and proclaiming a $1 trillion opportunity.
I don't know if it's really a $1 trillion opportunity, but what I do know is this field is hugely underserved, and to us this is a compelling argument that we should be in this space and look after women's health and wellbeing by providing innovative therapeutic solutions. Despite the underserved nature of this field, despite the unmet need that remains in this area, the pipeline is largely empty. We have spent the past five or so years picking up the late-stage innovative products in the field, finishing development, going through regulatory, launching the product and making them accessible to patients all over Europe and globally.
For us, this is really about moving the obstacles out of the way of equal opportunity for women, so this is a really large-scale global mission that we have committed ourselves to. As a result, we are now known as the main enabler of innovation globally in this field, especially now that big pharma has turned or have turned their back on 50% of world population and this therapeutic area. I have spent a lot of time in Belgium recently for three reasons. One has been working on the two recently announced transactions, Mithra and BCI, the context of which we'd like to explain a little bit and the impact of those two transactions on the women's health franchise and business and the effort generally.
According to all stakeholders and participants, of which there have been many, the Mithra transaction has been the most complicated and the most problem-laden that they have ever seen from up close. It's, for me also, the same is true. I have not seen a more complicated transaction than this one. The reason being Mithra's ailments have been going on for so long. It started such a long time ago and have accumulated to an extent that it made the transaction really complicated. Second reason I spent a lot of time in Belgium was to look after the team that has emerged from these transactions in the city or town of Liège.
The third reason was this weekend, the Trilateral Commission meetings were held in Brussels, so that's the reason I extended my stay, but it's not directly relevant to the topic here. These 2 deals that were put in place in the past 6 months will allow us to control E4, and this is important for 2 reasons. E4 is estetrol, the natural estrogen compound that you know already because we've been working on it in the market and the technology for many years. The 2 reasons are a financial reason. We have bought back our own royalty obligations and those of our overseas partners in the U.S., Japan, Canada.
The second reason was to secure the development of the next indication, the menopause indication, whose brand name is Donesta, which used to be in the hands of a bankrupt company who had absolutely no hope of meeting the commitments that they had made in terms of finishing the development work on Donesta, not only in the U.S. and Japan, but even in Europe. This transaction means that the probability of Donesta being successfully launched in the market is maximal. I'm not saying it's 100% 'cause there are roadblocks and difficulties along the way, but it in the current arrangement maximizes the probability of a successful Donesta development, registration and launch.
The third and last consequence of these transactions is the creation of an organization in Liege that will pursue new early-stage women's health original research projects going forward. This is why this transaction is much more important than it may look at first sight. The transactions have allowed us to complete the vertical integration of women's health as a business unit, add to it the R&D capability that's been missing so far, in a timely manner, because now is the time when the pipeline has dried up. There's no late-stage projects to be found anymore, it's important that we rely on our own internal in-house capability, which has now been put in place. I'm really excited about working with this new team under Péter's leadership, to whom I'm now handing over for context and for details.
Thank you.
Gabor, thank you very much. I would like to thank you. It's very nice to meeting you over the teleconference. Thank you, Gabor, for this opportunity because it's very important for me that I can talk directly to our shareholders, to our investors, and I do my best to give you the story which we are living since many, many years. Skipping the executive summary, I would like to go straight to our kind of rich history and full of ambitions coming from very early foundation of the company. I'm working personally more than 18 years in the area of women's healthcare. I started marketing and sales, I was a part of full of acquisition and full of milestones which are visible here.
I will do my best to explain you how important this milestone, where we are currently in a phase of acceleration, and what is the last milestone the Mithra acquisition means for us for a short and long-term future. We had a phase of foundation and Gedeon Richter was always a leader in women healthcare in terms of with different regions and different portfolios. We are very proud that already in 1902 we had a gynecological product established on the Hungarian market. Later on, we become to have a state-of-art manufacturing facilities. Already in the early 1930s, we were having the Estrone, and we were supplier, international supplier of the Estrone here.
The company is proud on the first combined oral contraceptive which has been launched in Hungary in 1966. It was only a few years after the seal launch, the oral contraceptives in the state, and it was the first kind of available product in Central Europe. What is important in this pipeline is to see how we grew from the regional player, mainly oral contraceptives producer, selling the products in the region, in the Central Eastern European, in Russia/CIS, how we grew to the international pan-European and now we can say that very soon a global company.
In 2010, there were 2 very important milestones, 2 acquisitions of a Swiss company in Geneva and the acquisition of the Grünenthal portfolio. This gave us a boost that we could go into Western Europe and create our operations there. Between 2010 and 2018, basically, we've been working through smaller and larger license deals and acquisitions. Where I think that the last 10 years we had a very strong expertise was the licensing capability.
We have on board people who are able to look through the different women's healthcare assets, that we are able to negotiate good deals, and we are able to build up a portfolio with a growth, with a strong growth line. This was done in the last 10 years, and we were able to identify several late stage phase III projects from different licensed partners over the globe. Unfortunately, what we see currently that this period is over, so we don't see in the women's healthcare more late stage projects, and this is giving us a gap which we need to fill in some way.
And this is how the acquisitions in the last two weeks coming in, where we see our future and how we can strengthen our portfolio. Going back and presenting our revenues. We wanted to provide you a whole picture between 2,000 and 2025 to see how our top line was growing solely in the Women's Healthcare. This top line was thanks to the internationally acknowledged expertise in steroid chemistry. We are very proud as a company in our Dorog site, which is FDA and our compliant manufacturing site is one of the biggest, largest in the world. Also, we have very strong sales and marketing coverage activities.
We have several countries we are present directly. In all these countries, we are benchmarked to the local competitors, so local markets. Our benchmark is a strong marketing and sales capabilities, which are helping us to grow our products on this market. In other markets, we have partners where we have strong partnerships with them. There are 2 ambitions which have been communicated to you at the beginning of this year. The 1 of it was that we, by the end of the year, we would like to be the leading provider in Europe in terms of the regular contraception. It means the oral contraceptive, the emergency and the midterm contraceptives. We already in the 1st quarter of this year, we've seen that we, this ambitions can come true.
If we have the additional three quarters as they are projected, we are, by the end of the year, we can claim that we are becoming the leaders in Europe in the regular contraceptives. How this was done still, it was done with the organic growth and also inorganic growth. In terms of inorganic growth, the two big acquisitions were the Evra in 2021, which give a big boost to our top-line sales. It was a purchase price, HUF 263 million. If you look to our projections and we are comparing the real results comparing to the projections we had at the signature of this deal, we are overperforming our own plans.
This is a good sign of taking care of the project, of the product, which is still innovative and still only batch available in the most of the countries in the world. In terms of Drovelis, this was our first meeting with Mithra. We started to look into the company in early 2018. We identified the E4 as the potential golden standard in the oral contraceptive. We struck the deal with them mainly with the geographic focus on Europe. This has been later extended to the Latin American markets. We launched the product in mid-2021. Here you see on this page the evolution in the market share.
Our kind of first imagination was that we may be able to reach around 5% market share. This is the kind of KPI which we would like to accomplish. You see that in several markets here, we are already about this benchmark, about this KPI, and also what we see that already our customers are perceiving the Drovelis as a golden standard in oral contraceptive. If you go further in our portfolio, with one acquisition in 2016, we entered the fertility field. Our ambition in the fertility field is to have a broad range of complementary solutions for fertility. Why this market?
We see that this market, you can, you can look through different analysis, but all of them shows at least double-digit compound digital growth in the next coming years, up to 2030. We see still a fair growth in the European market, but we see a accelerated growth in the U.S. or on the emerging markets, which is giving us a future possibility to extend. If you look to the fertility itself, we are not only looking to the medical solutions, but we are trying to understand the cause of the fertility. We are looking into the cervical uterine abnormalities. We see the links with our uterine fibroids portfolio and endometriosis portfolio. As endometriosis, for example, one third of the fertility issues are coming from the endometriosis.
We are trying to combine our portfolio and synergize them between each other. You see the fair evolution of the whole fertility franchise, which reached HUF 80 million last year. With the new launches and the new markets, we see the continuous growth. I thought it's important to show also one of our latest acquisition. It has been communicated mid last year. It was a special medical device except from in the field of fertility. This is one product which shows our complementary approach to the to our fertility specialist, and we try to understand the needs of the market.
Based on needs and based on discussions with our clients, we are developing the portfolio for them. The other field where we see a tremendous growth and tremendous potential for the near future, and we already have a tangible result, is the endometriosis. In terms of the global potential, there are more than 190 million women suffering from the endometriosis. We know that currently no cure exists. What do we do? We are only treating the symptoms. We are only treating the pain, the bleeding. If you look across our portfolio now with the launch of Ryeqo and getting the indication since November last year, European indication, we are now completing the whole treatment of symptom management.
If you look to the future, we see a fair chance to look and find a cure, a molecule which can be investigated into managing endometriosis and cure the cause of the disease and not just the symptom. I would like to maybe highlight one slide, which is on the right side, or one picture on the right side, where you can see how was the uptake of the product having the uterine fibroids indication only. After having the endometriosis indication, there was a huge boost into the product, into Ryeqo. These are European figures and it is showing that how large is the unmet need on the field of endometriosis.
Moving to the next therapeutic class, which is important for us from strategic perspective is the menopause. What is our ambition in menopause? We are taking the hormonal management to the next level. There are several hormonal treatments available in the world. There was a big WHI study where the whole menopause market collapsed in U.S. and collapsed in Europe. This was using in the study the old kind of hormonal treatments. We in our portfolio having the latest one, the ones which has several advantages comparing to the available methods on the market. It is a huge market. Again, we are talking about the market and distribution of the population.
Age distribution is going in favor of the menopause. There are several calculations how large is this market globally. In one of the data is showing from this report, which Gábor mentioned, that the size can be between HUF 121-HUF 230. I've seen several analysis when they are guessing the whole potential in HUF 500 million, HUF 600 million. The one slide which we prepared two kind of pictures. One is showing that how huge is the growth already in our own portfolio. You see that we haven't had a tangible menopause portfolio before 2016. We need a big jump from 2020, 2021.
This jump is following up the trends which we see on the market. On the picture next to it, you can see an example. This is how the U.K. market is behaving. U.K. market, during the menopause, there was a lot of social media and a lot of awareness talks about the menopause. This basically boost the market and increase the market three, threefold, comparing to the base. We see a similar trends in the U.S., similar trends Canada and in some other markets. We believe that having a strong portfolio in the menopause can give us a strong growth for the future. The menopause, there is one project which we been looking already for some time.
We believe that this product can revolutionize the oral treatment. Today the golden standard is the transdermal because of the VTE risk. We believe that with a different mechanism of action of E4, this is the product we've been already working over the last 2 and a half years. Due to this different metabolism, there is a chance that the VTE risk is much lower. All the surrogate markers are showing into this direction, and we are working on the differentiating studies how to support those claims. We signed the first license deal for Europe and for LATAM in beginning of 2023.
Now having the whole portfolio and platform of E4 in our hands, we can stimulate the R&D facilities here, facilitate the further development. Well, if you look to our women's healthcare pipeline, we had a very busy last 4 years. It was represented into the fast top line growth between 2021, 2024. There are products which are pro intensive, and we can move this, move the peak sales in the time. We are not worried about the near future of our portfolio. However, if you look to this slide, you see that by the end of the twenties, we may have some gaps.
We need to start to work on these gaps already right now. As there is a limited number of phase III projects outside, we need to change the strategy and need to find something which is fitting the growth strategy of the women healthcare portfolio. This is how we get to the last two acquisitions. The acquiring the Mithra and the estetrol portfolio acquisition completed two weeks ago, is with this enterprise value of EUR 175 million, is giving us access to the platform of the E4, so that this platform is with all the all the research and development rights, IPs. We can select different indication.
We can focus our activities on working the E4 further on. But on the other side, it's also giving us a strong R&D capability. Together with not acquiring only the rights, but also acquiring the two companies from Mithra, Estetra SRL and Neuralis SA, we are also taking over specialists. R&D experts who already made it once. They developed the E4 into the indication of the contraception. Now together, we are developing the second indication. From financial perspective, it's giving us also a boost in terms of the future cash flows and royalty streams from the partners. We are becoming the holder and the owner of the E4 worldwide.
We believe that with the communicating and helping the partners, we can improve the results currently available. If you look to the short term, we see that in 2024, it may have a small negative impact on our EBITDA in Women Healthcare, but from 2025 onwards, it must have a equity impact on the Women Healthcare franchise. From the strategic fit point of view, we understood that we need to have a control over the Donesta development. With a more focused and financially intensive development, we might get a better label. This is important that there is a huge potential in the menopause market.
The other acquisition is very much in line with the previous one. It's acquisition of the BCI Pharma, which has an innovative research in the field of women's healthcare. This acquisition was finalized last week with the enterprise value EUR 12 million. It is not a big amount comparing to the previous one. However, it has a big potential in terms of the libraries that we are obtaining with it. We are obtaining also the staff, the researchers. There are 2 laboratories with the chemistry in Montpellier in France, and with the biology laboratory in Liège. There are more than 2,000 proprietary products, small chemical molecules in this library.
Now we start to revise them and to identify those which could be developed into the meaningful women's healthcare products for the future. If you look to this slide of the strategic option for Richter. Basically what we accomplished in the last 20 years with all the acquisitions and building up the strong portfolio in fields as menopause, endometriosis, and contraception, we have a solid business. However, we need to move forward. There are two directions. One is the consumer health. In consumer health, and if you look to the graph, which is basically showing the risk, which in terms of the investments and the complexity and return of investments in terms of the monetized value.
On the low left side, you see the consumer health. In consumer health, we already entered. We entered with the partners. These are the products which are relatively easy to develop. They have relatively high margin comparing to the high-risk products. There is a need from women to use those products. We are already there. However, on the other side, if you look to the high risk, but also high return and highly complex projects, which is the innovative research in the fields of women healthcare, we see that there are not so many companies here. The few which has been very active here in the past are stopping the activities.
This is also giving us a potential to acquire some additional assets. In this field, and I put only the example of the PCOS or the endometriosis, are those fields where we can have a next generation and the next royalty stream product for the future. I would like to finish with the last slide. We outlined the ambition. We would like to have a company which has the Women's Healthcare portfolio at over HUF 1 billion sales. We outlined this in 2018 when we had a kind of strategic revision and we see the opportunities on the market. We set up a very strong KPI.
We are measuring our performance every quarter, and we are measuring our performance comparing to the competitors on the market. You, you can see on the right hand, right-hand slide or right hand part that if you, if you look to the growth between 2011 and basically 2024, we are progressing, and we are getting closer and closer. According our internal projection, we will become the leading women healthcare company within the Europe at this moment, earlier than 2030. This is underlined by the projection and also the HUF 1 billion ambition here. This is what I wanted to tell you about the story and about the importance of the last two acquisitions.
Now we can claim that we are fully integrated companies. We are not only experts in the production, manufacturing and not only having a strong sales and marketing operational team. Now with these acquisitions, we are creating our own R&D capability and with several already interesting compounds in this field. Thank you much. Thank you very much. Thank you very much, Péter. That concludes the formal part of the presentation, and now we are open for your questions. I think as usual, the first one is coming from Alistair. The floor is yours, Alistair. Go ahead.
Thanks very much. Can you hear me okay?
Yes. Yes.
Perfect. If you don't mind, I'll start with three, and then jump off. Just first of all, just to confirm that the EUR 1 billion by 2030 that you're focusing on, is that achievable with your current portfolio, or do you think that's going to be supplementation to get there? Question 2 is really just looking at slide 2. The relative lack of interest in gynecological conditions in terms of industry pipeline. You know, why is it that you're very excited about women's healthcare as an area, but it seems like the competitive landscape doesn't seem so interested or so excited? What do you think is driving that? Just final question is, lots of talk about, you know, revenues and what you hope to achieve at the top line.
In terms of your clean EBIT margin in this division has been between 15% and 20% over the last 3 years. Can you give us a sense of, you know, where you'd like that ultimately to go to, as you approach your 2030 target? Obviously, I'm expecting near term a bit more R&D investment in some of the acquisitions, but broadly what your ambition is for profitability. Thanks so much.
The first question was about the EUR 1 billion top line kind of ambition. What we see here, the EUR 1 billion top line was without the acquisition. This is calculated without the having the E4 global platform, without the partners in Brazil, in Japan, in U.S., in Canada. This is something which we need to develop into the model and which means that this EUR 1 billion top line could be conquered even earlier than it we planned in the last strategic cycle. In terms of the next question, I think.
It was about the lack of interest in this field by the big players. How is it interesting for us, Péter?
Yeah, it's interesting. On one side we see a niche, definitely. That is some of the big players are leaving this is a niche for us. If you look to our top line with the HUF 1 billion top line comparing to the buyer who has HUF 4 billion-5 billion in this segment, giving us room to grow relatively fast, having a good and innovative product. This is one. The second, well, for the big players, probably the niche is not large enough. They are focusing their investments in the other fields where they see a larger potential. One interesting.
If you look to one of our competitor, current competitor, they just changed the strategy. I think when they saw the huge opportunity in the menopause market, they revised their programs, and they continue developing some of the indications within the menopause. This is giving us a sign that the probability of focusing on the menopause is a good sign. We see a similar rebound also in the field of fertility and with endometriosis. This is something where we see a huge potential as it was. The problem usually with endometriosis is the late diagnosis.
If we can do something on that, and this is also something we are looking into it, how to speed diagnosis up, this is giving a larger potential. Probably this niche segment and the lack of innovation in the phase III, phase II is something why maybe the big players are not looking in this direction.
Before you answer question three, can I come in and reinforce what you have said by making a point? I think if we look at the landscape of companies, we're in between the very large ones and the very small ones. The very large ones have a problem. The opportunity doesn't look big enough for them, and the opportunity cost looks very high. They have so many more lucrative, more attractive opportunities in oncology, for example, that women's health gets deprioritized. For very small ones, and we see and know personally very well many of these guys, it's not the opportunity cost, it's the actual cost that's very high.
Many of them went and got listed too early, and they don't have access to the funds that it would be required to pursue a proper original research effort. We see a number of them, especially in the U.S., struggling to attract funding and the pipelines are stuck. We are somewhere in between. We have an established business that generates the cash flows that allow us to support the research and development work. Of course, we are too small as a company to be able to take them to the finish line alone. Here the idea is to partner at some point.
Given that the original research projects will have the full global rights to license out, we are confident that we can find the partners in the U.S. that we can co-develop with and who can commercialize in the end the original product. This was my assessment of the competitive landscape and the reason why I think we are just at the right scale to be pursuing this mid-sized opportunity that women's health original research innovation represents. Back to you, Péter.
Thank you. Thank you, Gábor. Very good. The third question was the margin. What we see that we may face some margin pressure establishing the new R&D capabilities. We are aware of that. We have our models which are modeling this in. It is innovation which costs higher resources. We believe that with growing the top line according to plans, we are going to be able to use the reasonable margins of the R&D for the future innovation, which will be paying off in the future, having the big original molecules launched from the portfolio.
Peter's ambition is to grow this EBIT margin to above 20% in steady state. When is steady state? Not yet. In the past couple of years we have been investing in the business unit, mostly in the commercial effort. We'll be investing into the R&D side of the business. The ambition is for the business unit to be able to generate 20-plus% bottom line in steady state.
Thank you.
Thank you. The next question is from, Victoria Lambert. Victoria, go ahead please.
Great. Thank you. My first question is just what do you plan to do differently to Mithra? My understanding was the company had, like, great science, great R&D capabilities, but they just didn't run the business well. You've got a great opportunity here. I just want to know what you might do differently in terms of the sales and marketing or just, I don't know, managing the cash flows of these assets. And then how competitive was the acquisition process? Were you competing with, like, private equity? I know they are very active in the fertility space, but maybe not as active in contraceptive and menopause. And then just what you think.
What you're going to do about sales and marketing, with these, you know, there's a large opportunity with these assets? Lots of people aren't receiving treatments at the moment, I would just like to get a better sense of the sales and marketing effort. Thank you.
Well, thank you, Victoria. I've been expecting this question. What are we going to do differently? Lots of things. The first is not, we want to avoid misleading our shareholders, our employees and our partners, in terms of what the compound is able to deliver and what kind of operations and what kind of commitments can be added on top of this compound. What kind of, how big a burden can this 1 compound shoulder? I think this is where Mithra went terribly wrong and they began taking out debt and then, in the end a lot of secured debt, which meant that they pledged away all of their assets, all of their cash flows, present, past, future, to secured lenders.
Mithra behaved as if they had a blockbuster drug in their bag and made every decision with that assumption in mind. We have a very different approach, and those of you who followed us for many years would agree, hopefully. The sustainability of the Mithra model has been questionable for a number of years now. It would be unfair, and given the due diligence, given that we've known them for many years, I've seen the way they have conducted business. I don't want to go into much detail, but they really acted like they were running NVIDIA and not a small company based out of Liège. Okay. I think that gives you a color of what went wrong there.
Did we compete with anyone in the transaction? We were competing with time, and we were competing with the sheer number of stakeholders, suppliers, partners, creditors, shareholders, bankruptcy lawyers, employees who were all making claims on Mithra's assets. We were not directly in competition with any one buyer, and the reason in the end, and the reason is the following. This asset came with risks and liabilities and a lot of work to do. That work, and being able to deal with those risks and liabilities, we are best equipped to do that in the world. We were not. We were a natural owner of this asset and we are a natural owner of this asset. We can extract the best value out of it.
This is the reason this asset came so cheaply, so to speak. We barely put up enough cash to pay for secured lenders claims and left hundreds of million HUF creditors at a loss, let alone shareholders. Anyway, does that answer your question?
Yes, thank you. I guess just on the sales and marketing, how you're gonna approach that?
No, I didn't address that because Mithra didn't have any commercial capability. They outsourced all of it to partners. I think partner management is also something that we can do much better than Mithra did, including Fuji, including Mayne, including Searchlight, including all the partners. This is why I didn't talk about commercial activity. We can do better here. Péter will give you some more color on this and more.
Yeah, maybe. Like, no, I. What I expect regarding, I think they, their business model was not bad, but they were not realistic. They had an unrealistic expectation from the very beginning. This one, we already started to do a business with them. We understood that that is not realistic. We made our own forecast, we made our own assumptions and we are very much aligned on that. What we know, and our marketing and sales organization are capable, we launched Lenzetto 7 years back in menopause, and it's getting to be one of the top brands. We launched several oral contraceptives in Europe. Now we're launching in Latam.
We know what we can expect from a product and we know how to do it. This is now much easier if you don't have the partner behind who has unrealistic expectation in terms of the pricing, in terms of the indication. With Donesta, what we mentioned in the presentation, we wanted to have the full control over the last phase of development because we knew that there are some points in the indications which can be improved better, which is a little bit higher investments, but they will be repaid in the midterm. These are probably two points.
We understand the market better and with this market knowledge we can review all this information back into the R&D of the new product with the old compound. I think we can do a better partners management, sharing experience and also follow up on the activities which we already tested in our market.
One more thing. We are the suppliers of this compound and the finished product. Mithra lost a lot of margin by outsourcing everything. The product could have allowed for all of those players to have their cut if it were as big a product as they had imagined it to be. We're talking about forecasts in the billions.
Mm-hmm
... for both indications. If that were the case, yes, they could, they could have afforded to buy E4 at 5 times what we are manufacturing it at. The compound wasn't big enough to allow for all those dreams and for all those suppliers and for all those nonsense technologies and so on, nonsense contracts. We're getting rid of all of that, simplifying the model massively, and that's how we'll make this into a successful compound and make it available to a broad, a large number of women.
Yeah. No, that's really helpful. Just last one on Donesta. Are you still working towards an approval in 2025?
Yes
in Europe?
Yeah. There's been a little bit of delay in the development of the portfolio.
Yeah
... parts of the research. This is fixed now, immediately after acquisition we are fixed all the underfunding. We took over the control and we are trying to keep our timelines for the U.S. and for the European submissions.
Great. Thank you.
Thank you very much. Next question is from Can Ozgizer. Can?
Hi. Thank you Róbert, and thank you for doing this call. I was gonna ask again on Donesta, where we are currently on the approval process, what you need to do to complete the application. I was gonna ask about the timeline. When do you think you can start application for U.S., Europe, and hopefully commercialize it? For the U.S., if you have an estimate, I was wondering what is the potential revenue in the U.S. market. Whether you want to go to start FDA process with a partner or even start the process without a partner. If you have any preference and strategy there, it will be good to listen it.
Last, on the Drovelis, is there any potential revenue in other markets or, put differently, is the Drovelis well covered globally or do you think you can find new partners in new geographies and maybe, yeah, do a better job than Mithra? Yeah. Thank you.
Thank you much for the question. Regarding the Donesta, what we can confirm that the phase III has been finished, the efficacy safety studies are done. We are compiling now the results. There has been a little bit of delay into that. We are compiling and we are also having discussions about the indications. What additional studies could be started and run to support the indication on the market. For FDA, definitely would like to keep the DCR submission. It means the compiling the file, submitting to the FDA.
With the European Union, we have the same ambition and there are a few information missing to confirm this completely, but we are working on this now with a lot of efforts on both sides. The teams which we took over or who joined the Richter group are working full speed with highly motivated being the part of the Gedeon Richter and also on our side, our project managers and business development people, we are well working on that.
This regarding the Donesta, with if the question what we, what exactly we would like to do and how we want to commercialize, we are already started the partner search since kind of last year thinking. We intensified the partner search this year, this May. There are few partners who we are talking with, but there is nothing final we can probably disclose right now. Regarding Drovelis, it's the same thing. Definitely we can grow in geography. Several areas where the product has not been launched. There are several areas where the launch has been delayed.
We are very much for now discussing with Fuji Pharma who's supposed to launch the product in the third, fourth quarter of this year. For the potential of growth. I personally think that there is a relatively high potential in the U.S. market. There are some market dynamics in U.S. which are hindering the sales development. I had a meeting with the partner or the beginning of this year. We discussed the options how to improve the conditions there. We would like to follow up on that immediately. Obviously, they were not close as the owner of the asset.
It was more costs like trying to understand why the U.S. market is not performing according the expectation of the company itself. This is now having the full license and being able to sit down with our partners and discuss how can we improve the situation helps a lot.
Let me join in on this question too, and I'd like to circle back to what Victoria had asked, because the two are related. Mithra's viability was dependent on Donesta being a huge success. If Donesta had been a success, they would have gotten a down payment, which would have kept them ticking for a while longer. The royalties that they would have collected would have kept them going for even longer. What's the difference between Mithra and Gedeon Richter? This company's success is not dependent on Donesta's success, or this company's, let's say, viability, financial sustainability is not dependent on Donesta's success. I'll go one step further. Even the transaction's success is not dependent on Donesta. The entire Donesta story is an upside to the value of the transaction.
Value of the transaction was. Reflects the value of Drovelis being on the market in U.S., Europe and Japan. Everything over and above is upside. We can afford to have this risk. Mithra could not afford to have that risk 'cause their lives depended on Donesta being a success. They couldn't wait for it to become a success. Those roadblocks have to be removed. Once they are, partnering opportunities will emerge. We'll see what kind of partner we can find. That will determine to a large extent, because the resources and so on of that partner will determine the commercial prospects of Donesta. This is a few steps away. What I'm trying to say is treat all of that as upside. Those challenges have to be tackled. Registration, partnering, and then commercialization.
All of that, we have a lot of faith in it. All of that will represent net gain from the transactions point of view.
Thank you. Thank you for the time as well.
Thank you very much. Actually, I don't see any other question, neither any hands raised or in the chat box. If that's the case, we would like very much thank you for all of you dialing in today and being with us, and listening to our story in this particular business segment. We hope to continue this series of introducing our pillar businesses to you in the coming months or quarters or while on the road. Thanks very much again. Any question left unanswered, please just reach out to us as usual, Investor Relations, we are more than happy to help. Otherwise, we're gonna be seeing you, all of you, in a little bit more than a month's time with our first half results.
We'll keep you posted on the developments in these projects that we have now described to you.
Thank you very much. Have a great day. See you soon. Bye-bye.
Thank you very much. Thank you.