Welcome to this call in which we have the opportunity to inform you on the acquisition of SIFI by Faes Farma. We are very excited about this deal. It's a real step forward for the company. As you can see, it's fully aligned with the M&A strategy that we shared with you in the capital markets day a few days ago. We have Eduardo Recoder, our CEO, here to explain it fully. After his intervention, we'll open a Q&A session that you will be able to ask through the platform in writing. Next to our CEO, we'll have our Head of Transformation Office, Juan Veiga, Xavier Arlaud, Chief Business Development Officer, who have been fully involved, and they have been leading this operation with the rest of the team. Without further ado, Eduardo, you've got the floor.
Thank you very much, Maria. Welcome, everybody.
It is a true pleasure to have the opportunity to share with you this transformational step in our M&A strategy for 2030. After many weeks of intense work, a very deep due diligence process, and intense negotiations, I have the pleasure to announce this acquisition. Today's agenda has been structured to help you understand the importance and the structure of this deal. First, by defining the scope of the acquisition. Second, to explain which is the rationale of that transaction. Then, how the new business looks like once combined with the key financial parameters. Then some conclusions. At the end, as Maria mentioned, we would have some time for a Q&A session. Starting by the scope of the acquisition, we are acquiring SIFI fully, so 100% of the shares. We have a structure that we understand this acquisition in three different parts.
First is that, the SIFI is a consolidated product. SIFI is a pharmaceutical group based in Italy, founded in 1935. It has seen an amazing growth in the past 15 years. They have reached sales of EUR 100 million and an EBITDA of around EUR 20 million in 2024. It had a very strong growth momentum with a 12% of compound annual growth based on an extremely good work in internationalization. Their product portfolio is innovative, so wide and diversified, focused 100% on ophthalmology. That internationalization we mentioned has allowed them to be present, a consolidated presence with their own companies in Italy, of course, which accounts for 40% of the revenue, in Mexico, 14%, Romania, 14% of their revenue as well, Turkey 11%, France 8%, Spain 6%, and other regions 7%.
They have a second side, first because they have two manufacturing facilities, one next to another in Italy. They are state-of-the-art manufacturing facilities for drug production on the one hand. Then a second plant for intraocular lenses, which is a bit more of a newer business. The main facility, the main plant, is also able to develop a specialized CMO business that's profitable and in growth. By using the industrial capabilities and the technological differentiation, it's going to be very attractive in terms of a margin. This business, although it is an emerging business, is still not included in 2024 accounts. This will contribute additional sales because there are relevant deals signed. The expected revenues are above EUR 20 million in the short term.
Third, which is also extremely important from the strategic viewpoint, it's fully aligned with our M&A strategy, is the opportunity to have a very important therapeutic program, which is Acantia. It's a strategic opportunity in ultra-rare ophthalmology. It's an innovative drug. It's been commercialized in Europe already. It's also been approved by the EMA and patented until 2040. It's indicated for keratitis by Acanthamoeba, which is an ultra-rare disease, and it can be expanded to further indications. It's already been approved by the EMA. It's been patented in Europe. It's got ongoing launches in different EU markets, and it's already been commercialized in Germany since the end of last year. In the U.K., there's commercialization starting slowly.
This molecule in its indication for Acanthamoeba keratitis has been identified as a new chemical entity with an orphan drug designation, not just in the European Union, but also in the United States as well. In this slide, you can see the part of the consolidated business specialty pharma just around ophthalmology. As we mentioned, and as we already announced in our capital markets day, within our new strategy with Optomia, after the acquisition of Edol in Portugal, it has become a very relevant therapeutical area with a huge potential. We will afterwards elaborate on it. The activity is that we have small doctor targets, some from the viewpoint of commercial structure efforts, small, lower than traditional products of Faes. The product portfolio is quite wide.
As you can see, I won't elaborate on the details of everything they've got, but it's very much focused around inflammation and infections and else. Portfolios focuses more around glaucoma with over 60 eye care solutions, 44 of them are pharmacological products, eye drops and such, and 22 surgical products. Those are the intraocular lenses. I mentioned earlier, they have an R&D ophthalmology unit that's quite productive with five new products launched in the past two years, 25 patent families. And SIFI globally has 500 employees worldwide in all different factions, including production, commercial networks, and so on. As I mentioned earlier as well, it has very strong financial results and growth as well. EUR 100 million in 2024 in revenue, 57% of its revenues are international already.
It has reached EUR 20 million of EBITDA and an international footprint, as I mentioned, directly present in seven countries that I mentioned earlier. Through different partners and agreements, it is also reaching 60 countries worldwide. In terms of the emerging business of ophthalmic CMO, CFE has specialized facilities and a limited number of competitors in the market, which increases its profitability. Recently, they signed relevant contracts that will bring us to an annual revenue of about EUR 20 million in the short term. It requires very low future CapEx needs due to existing capacity. This generates a very appealing business in terms of margin in the next few years in the short term. Facilities are made up by one new line of MDPF, a multi-dose preservative-free, and two manufacturing facilities in Catania and three manufacturing lines of pharmaceutical products.
Two of those lines are blow-fill seal. The third side of the acquisition is the opportunity brought about by them to access an innovative patented molecule already approved by the EMA in Europe, which is Acantia. It is on its way to be approved by the FDA as well. Commercialization in Europe in the short term, patent until 2040. It is a polymeral anti-amoeba drug in commercial phase for Acanthamoeba keratitis. There is a second indication. It is in preclinical phase for fungal keratitis. It has been patented. It has polyhexidine in a high concentration rate. It is going to be administered in monotherapy through its own standardized protocol. It is the only drug approved for the indication of Acanthamoeba keratitis. Elaborating a bit more in the first indication, it has been authorized in Spain. It was authorized last year. It has been registered in the United States.
We have a trial in phase three, and we are achieving a cure of 80%. It's proof that this disease doesn't just cause potential blindness in some cases, excitation of the eye as well as pain. What this trial shows is that we have a cure level of 87%. The results are spectacular. It is considered an ultra-rare disease, 2,600 patients a year in the United States and 1,400 patients a year in Europe. It has been granted the orphan drug designation by the FDA and the EMA. As I mentioned earlier, we are already in Europe. We are negotiating pricing and access to different markets. We are in pre-registration stage in the U.S.
As I mentioned as well, this is quite interesting because it also adds a product or a project into our pipeline, into our R&D pipeline, which is fungal keratitis, which is in a very critical phase both in the U.S. and the U.K. The incidence is much higher, 33,000 patients in the U.S. and in Europe, and with an incidence in India and China that is actually huge. It is a second orphan infection, not considered ultra-rare in this case, but it is an infection that has no treatment today for the cornea. Today, there are no approved treatments in Europe, Asia, and Japan. Today, there is only one drug that has been approved in the U.S. One in three patients fail with this treatment. There is still a very clear need for it.
It's been granted the orphan drug designation by the FDA and the EMA. It's in preclinical stage. Clinical development is still to be done. Of course, it's included in the price of purchase. Now we can start talking about the rationale behind this acquisition. We already mentioned it in our capital markets day and it's part of our strategy. Ophthalmology is a key strategic area for Faes Farma. We started with the acquisition of Edol. With the acquisition of SIFI, it's going to help us be a leading company in this area. Why ophthalmology? You have a series of data here that show the high prevalence. One out of five Europeans suffer from dry eyes. One out of six have conjunctivitis. 65 million people have vision loss due to cataracts. It's the first cause of blindness.
Seventy-five million people have glaucoma with a focus of 100 million by 2030. Minor severe contactless infections are increasing. Besides that, the trend is for prevalence to keep on increasing, increasing age of population. The use of screens is getting a lot of digital dry eye. Pollution and dryness and air conditioning are also increasing all these pathologies. For Faes, it fits perfectly with our business model. As I mentioned earlier, very clearly defined targets, not very wide, ophthalmologist. There are more small figures. It is an affordable business model with small networks and the ability to expand to new countries and with moderate competitive intensity. Of course, we are not alone in it. These are therapeutical areas in which you can still compete. It also feeds our R&D model perfectly well first because there is high value appreciation. We have unmet needs.
We have the opportunity to be pioneers in some indications. We have the possibility of new molecules and external collaborations. The barriers of entry are quite high due to manufacturing and technologies. Within our strategic plan and our ambition and our 2030 ambition, this acquisition fits perfectly well. As we had defined, and given that we had defined our M&A targets, CFE fits those targets perfectly. This is going to help us get to EUR 1 billion by 2030 and grow 12%, about 12% compound annual growth. EBITDA is also going to grow to be able to get to that 24%, which is where we want to be in 2030. The CFE's product portfolio provides possibilities for innovation. Under advanced development, it helps us diversify a higher value-added portfolio.
The ophthalmology therapeutic area, as I mentioned earlier, is strategic for us. It is going to help us maximize synergies with EDOL, strong positioning in a high-growth area with moderate competitive intensity. Besides that, the geographies that SIFI is providing are very complementary, both in developed and emerging markets. It is a battery to reach over there. They have been able to reach 60 countries, seven with direct presence. The economic profile is very important as well. It has a potential to contribute with a total of EUR 180 million in sales by 2030. It is a pre-synergious EBITDA margin projected to be accretive for Faes Farma by 2026 and a position of indemnities for Faes below two times. That fits perfectly well with what we had defined and what we were looking for.
To summarize our strategy and the rationale behind it, it's a value creation opportunity. We have identified synergies. SIFI's portfolio is complementary, as I mentioned already, to EDOL products and to our ophthalmology range. That makes Faes Farma's ophthalmology range one of the most competitive offerings in the whole market. SIFI provides presence in ophthalmology in three of the main strategic markets for Faes. This is extremely important in Spain, Mexico, and the Gulf. We have synergies opportunities, but we can also push our commercial efforts to accelerate the growth of SIFI's products. It will also increase the efficiency of our operations. Given the robust portfolio of Faes in ophthalmology, this business line can be effectively incorporated into the rest of our subsidiaries or affiliates. In Latin America, this is a huge opportunity.
They license our portfolio as well for our affiliates by increasing the potential for further organic growth. Faes Farma now has established operations in countries like Italy, Romania, France, and Turkey, where we are not present today. We have the opportunity to expand our current portfolio in these markets. We have synergies of R&D capabilities to accelerate innovation and create a platform for future growth in ophthalmology. Acantia is clearly a unique opportunity to transform the lives of European patients and patients in the U.S. as well who are suffering from Acanthamoeba keratitis. It also provides us access to a patented product with a huge potential. Now, we are entering some data that I have been sharing at this stage of the new company by business first. Global presence, you have a map here. I will try to explain it.
I don't elaborate too much. Dark blue, that's where we have new direct commercial presence provided by SIFI. Blue striped color, that's where SIFI and Faes will have both companies, Mexico, Spain, and these countries here. Direct commercial presence in green, dark green, that's where Faes is present. That's where we'll be able to launch SIFI's portfolio. Of course, through the acquisition of EDOL, we can also open door to SIFI's products in Portugal. We can take EDOL products to those countries where SIFI is present as well, and also to our own countries, of course. SIFI's distributors, this is light blue and striped. That's a combination of SIFI and Faes distributors.
At the end, one way or another, we have a global coverage, which is also going to help us with this international lever that's so important for our objectives for 2030. On the proforma position of both businesses, in terms of revenue, Faes and EDOL in 2024, there will be EUR 550 million. Plus EUR 102 million from CFE takes us to sales in 2024 of EUR 652 million. That's the starting point for our ambition and our growth. This, of course, gets us closer today to our objectives. Last, more key financial parameters. This is essential to understand that this opportunity has provided us access to a huge potential with a very interesting multiple. We acquire 100% of the share capital of CFE SPA cash payment. All of it's going to be cash.
The transaction's been valued at an enterprise value of EUR 270 million. There are no additional payments for SIFI's established business or the CMO business. All of it is in here. Within those EUR 270 million, we get access to Acantia Europe. There are some earnouts for Acantia's success both in Europe and the United States. In the case of Europe, potential self-financed, self-funded earnouts on the electrician with the achievement of some certain sales levels exceeding our projections. Not only are they self-funded, but they're actually only activated above a certain figure. Maximum amount of the earnouts will not be above EUR 50 million spread over six payment milestones until 2041. That gives us access to a huge business opportunity in a very cost-effective way. It's self-funded.
In the case of the U.S., it is important to explain that we have agreed on an upfront of EUR 30 million. When we hear we say in commercial launch, but that means that this is how it's been included in a deal. We had to get FDA approval, patent for the United States. First, cash coming from the American market. That's when those EUR 30 million are triggered. Then we have some additional payments, single digit or low-level digit percentage points until U.S. loss of exclusivity. They are only going to be triggered upon the achievement of certain figures. They will not be above a single digit. For high values, this earnout would be quite advantageous for Faes.
It is also a way to, well, to pay them for the work they have done until now to get positioned to be successful in the United States. Which are the financial impacts? Sorry.
The P&L impact, the immediate addition of a business that is going to generate important revenue and EBITDA and projected accelerated growth in margins in the short and medium term thanks to the expansion of international business, also the execution of CMO business, and the sales of Acantia in Europe. From the balance sheet position, the transaction is funded with debt while maintaining the net debt EBITDA ratio pro forma below 2 times. We expect it to decline rapidly by the repayment of the debt principal plus the growth of EBITDA. The shareholder value creation is clear.
We expect the acquisition of SIFI to provide EPS, well, to provide EPS starting from year one, even before commercial and then cost synergies. Enterprise value to EBITDA of 2026 is expected to be a single digit, decreasing over the next few years due to the synergies created and business opportunities. We are keeping our dividends policy for 2024. It remains unaffected. It is 50% payout as the dividend policy on a go-forward basis. We are paying or recapping everything we mentioned as some conclusions and next steps. I believe we have been able to express the importance. Oh, sorry. Someone was unmuted, and there was some echo. I'm sorry. This is a transformational pact for 2030. It strengthens Faes Farma presence in key markets, emerging as a leader in ophthalmology, which is a strategic therapeutic area defined by our team.
is the acquisition of a portfolio that complements EDOL and creating one of the most comprehensive market offerings, enabling direct access to new geographies, attracting licensing and expanding licensing app. It is essential to achieve our strategic plan objectives and ensuring growth beyond 2030. It provides shareholder value by boosting profitability, maintaining dividends, and adhering to financial discipline criteria. Closing the transaction is subject to the antitrust authorities and also the approval of Faes Farma shareholder approval at a general shareholders meeting that will take place shortly. Closing is expected in the third quarter 2025, subject to all the previous considerations. I believe, having said that, we have provided visibility around the whole project. I guess there are going to be some questions. I am going to give the floor now to Maria so she can help us moderate this Q&A session. Thank you.
Thank you, Eduardo, for all the explanations. Now we are opening the Q&A session. As I mentioned, you can ask your questions in writing in the platform, and we'll be delighted to answer. Thank you. We have one first question from Renta four. There are several questions. I'll ask them one by one. First is, which synergies do you expect from EDOL and SIFI's merger?
Yes, that is right. The integration of the ophthalmology products from EDOL and SIFI and commercial networks that we can also strengthen with our presence as Faes Farma. I'm sorry. I need you to mute. Yes, because otherwise. Thank you very much. Oh, please, yes, if you can mute your mics. Thank you. First of all, product portfolios are complementary. They complement each other. SIFI focuses more on inflammation and infection. Then, of course, rare disease with Acantia is a great opportunity.
EDOL focuses more on glaucoma than EDOL is present basically in Portugal. SIFI is not in Portugal. However, SIFI is present in many other markets that EDOL is not part of. Those are commercial networks that we will be able to take advantage of. We do have some work to do around how to integrate all different factions, corporate factions, to be able to get the, well, the most of the know-how in both companies in Mexico, for example. I guess the questions about those countries as well. In Mexico, we are able to use the commercial structure in Mexico. All the other structures are synergic as well. From then on, you will be able to strengthen ophthalmology products. EDOL will also be able to be brought to Mexico.
CFE's products still have, I mean, pathway in furthermore in Mexico. They haven't been that long there. They have EUR 50 million in revenue with a good profitability. I hope I answered. Thank you.
Yes. Next question is about Acantia in Acanthamoeba keratitis in Europe and potentially in the United States. Please allow me to mention that there's some confidentiality here still due to the negotiation of the contract. I'm going to give you the floor in case we can add some comments. As I mentioned, these are all ultra-rare diseases. The number of patients is quite limited, but these are products of very high value. The combination of both things allows us to first have quite a clear idea of the sales potential by prices.
In the United States, prices are higher than in Europe, and the number of patients is also higher. The opportunity in the United States is higher than in Europe. Commercial structures needed are limited, and the profitability that can be provided by Acantia both in Europe and in the United States is much higher than the profitability that we are dealing with both in Faes and SIFI. This is going to help us a lot in margin. The moment we start getting some sales traction, we will start to see it truly in 2027, 2026 probably in Europe, and then in the United States. As Maria mentioned, of course, we cannot provide much more detail today. Next question is about the third-party manufacturing. SIFI has some manufacturing deal, about EUR 20 million in the short term.
What's the, well, between self-production and deals closed, what is the manufacturing capabilities, including closed deals and own production for products that are already being sold at SIFI?
We have taken into account our plan to be able to plan our CapEx in the future, both facilities at SIFI. Right now, we're talking about, well, those are very modern plants. They have not got a low capability, but they have room for growth as well. For our plan that's talking about EUR 180 million of turnover, we need an increase in industrial capacity. In terms of CapEx, it's under EUR 10 million throughout the period. Additional investment needs are small. It is small because there is not much to invest in more space or buildings. We have to optimize. I can use it not as much building. We have to optimize lines.
We are going to be able to grow both in terms of CMO and internal clients with EUR 10 million in CapEx of increased capacity. Of course, of that, we have maintenance. It is a very modern plant. If we have to make some additional CapEx investment, that will be great news. It will probably mean that we have exceeded our sales plans, both in CMO and in own product.
There is one more question on organizational charts and execution. Can you share how you are planning to tackle those challenges in terms of organizational chart, internal capabilities, and the retention of SIFI's team?
Yes, I can actually start with the last part of the question, which I believe is actually quite relevant. One of the main parts of the deal is structured around the three main executives for the company, who are from SIFI. Fabrizio, he is the present CEO, Carmelo.
He's a brother, and he's in charge of operations, of manufacturing and quality. Then Armando, who is their cast, and he's in charge of the financial aspects. Part of the agreement is for these three persons to continue. In the case of Fabrizio, he will be part of my team, and he will be a member of the global executive team, and he will be responsible for Acantia globally, which makes sense because he is the one who knows it better. That also provides us the guarantee to keep that know-how. Fabrizio is a true talent, and we are very lucky to be able to include him in our team, just like the other two executives. This is already going to give us some opportunity to keep key talent. We'll be able to tackle the integration process.
With firsthand knowledge of the three persons who have actually made SIFI the company today. In terms of details on how the organizational chart is going to look like, the idea is basically for ophthalmology businesses to be included in, to be part of the commercial activities of Faes. We want operations. Of course, that's going to be capped because we, just due to the contracts, not just for third parties, but and CMO, we are going to need for the next growth plan. There will be reporting to our chief officer. The financial side, there will be reporting to Faes CFO globally. Of course, we would take a look at where are some duplicities.
That's a piece of work we have to carry out in detail and calmly in the next few weeks once while the acquisitions are finalized. There's not much we can do about it right now. We still have to wait.
Thank you, Eduardo. There are some other questions, and some of them have already been answered. Some, as we mentioned, cannot, I mean, cannot be disclosed yet. There are questions on which are the points also for Acantia, but there are, I think, who's their competition right now? I'm just going to elaborate on what Eduardo mentioned. It is the only product for that with this indication. That actually limits the competitive environment quite a lot. In terms of the development of other products, there really are no other products in clinical trials today for that indication.
The plan, and that comparative environment, that comparative environment is quite good actually for us. We have another question on the CMO business, and they were asking about the margin. Maybe we can provide some indications, but not specific figures. If potential sales are EUR 20 million, or if we could be expecting more. One?
Sure. As you mentioned, we cannot give you figures on margins, but what we can say is that this is a very specialized business. CMO businesses for us are only interesting if the margins are above our own products. It is really hard to get that. That is why we were focusing on our own plans. When we are talking about such specific contexts, as a European plan for something as specific as sun formulations, competitive environment is small. Margins are higher than in the traditional CMO business.
I believe that's what we have to stick to. There's much more we can say. If we could go beyond EUR 20 million, that's, of course, our intention. The EUR 20 million are forecasted with the execution of projects that have already been signed. Our intention is to keep on looking for other projects, and these projects that have already been signed. I'm not talking about the launch of new products to see if they have traction in the market and then see if they work at the origination of the product. Looking for. It's actually a product that's already been manufactured elsewhere, and the sales level are there. We have to transfer these volumes to the Saeface plant. We trust this over EUR 20 million are going to materialize. Of course, we will work to make sure that's small. Thank you. One.
There's another question from Joaquín García Quirón from JV Capital in 2025, 2030 outlook. In 2025, you're not including EDOL sales. Does that mean that with EDOL, EDOL plus the acquisition, this acquisition, the sales for 2030 could be above €1 billion? Second question is, do you expect the improvement of margin for the portfolio without including CMO in SIFI?
I can answer that question. On the one hand, from a margin perspective, of course, the first thing we need to do will be to land and understand properly, well, the details of their productivity and its ability for ongoing improvements. Those are projects we're working on for our own plants in Leioa and Linderio. That's something that should help us improve those margins.
From a commercial perspective, of course, by using the structure and our presence, that is going to give us the opportunity to and the potential to keep on growing and improving those margins as well. Of course, we are talking about average prices in Latin American markets. There is an opportunity to manage pricing in quite an interesting way. We are going to get some improvements. What is going to push margin is CMO, of course. No doubt about it. Acantia, of course, as well. The first part of the question, can you please repeat it?
Yes. If we, after those two acquisitions, expect to go beyond the EUR 1 billion we had planned. I would not say anything about it right now. We are quite ambitious to double our size and grow in double digits, so 12%-13%. There is still a lot to do.
Before we start increasing those figures, let's go for it. I believe we are, well, going in the right direction.
Thank you. Thank you, Eduardo. I believe this is the last question because we have to finish the call. It seems the price is quite appealing for you. How were you able to get such a, what seems to be such a low price?
A lot of interaction. It is true that it started as a competitive process. We did our job very well and all the commercial due diligence. We analyzed the product portfolio deeply, product by product and country by country, assessing very, very deeply Acantia potential. We had different rounds with different offers.
What's actually been quite important as well was the conversations we have had with management and the owners, with Fabrizio and his team, and the commitment, and our commitment to drive Acantia forward and launch it in the United States. Our commitment with, well, keeping production neatly because in Linderio, we are going to produce many, many things in our present portfolio. We haven't got this, so we need that plant as well. That was also quite important for them. Important for them as well, everything that is linked to, I'm being told they cannot hear us. Can you hear us now? Yes? Yes? Can you hear us? Okay. This has helped us. Last, probably to be able to show the management and the owners of the company, their plan for them, their future.
I think they liked it. They were happy. They were going to be able to continue, both Carmelo, who's in charge of operations, as well as Armando in the financial team, and for Fabrizio, making his project, which is Acantia, basically, having the chance to maximize it linked to earnouts. Everything's well organized and structured. I believe that somehow, that gave us that opportunity to win this acquisition opportunity.
Eduardo, Xavier, Juan, and the rest of the team, thank you very much for the call. As you know, we're here for you. If there are more questions, we will be delighted to try to answer. Thank you very much.