Global Healthcare Conference. It's my pleasure to now introduce Róbert Wessman
Yeah, so good morning, everyone, and thanks for joining in. I have to say, I felt like home when I woke up this morning seeing the snow. I'm from Iceland, so thanks for that, guys. I'm going to tell you a little bit about Alvotech, and we believe that Alvotech is a very exciting company. It's a company I founded in 2013. Back in time, we believed that biologics, we can say, would be the future of pharmaceuticals. We knew that those products, of course, are more effective than small molecules. We wanted to establish a company which would be ready to launch products post-2020. The vision was, of course, to create a global company and one of the leading companies in the industry.
We also wanted to make sure that this would be a pure-play biosimilar, so we would be purely focused on biosimilars and nothing else. Today, we have 11 products in the pipeline and in our portfolio, actually two products on the market. We basically have created, which I will be talking about, a very strong infrastructure of both R&D and manufacturing. We have built out the commercial platform with 19 commercial partners, and one of them is Teva, which was presenting here earlier in the U.S. We basically are dual-listed in Iceland and Nasdaq in the U.S. I wanted to start with maybe a few numbers. From 2013 till date, we have spent around $1.9 billion into our platform. This is investment we have made to build out the capacity, the R&D, and the pipeline and the portfolio we have today.
So pretty substantial investment. And we have said this is, of course, a long journey to go from 2013 to 2023 because our plan was to build out the facility and launch the first product in 2023. And we also knew that the journey would most likely spend well north of $1 billion. So the entry barrier into the business is high. And you will see, and I will talk a bit about that, we don't see many pure-play biosimilar companies out there. And we think it will be pretty difficult to enter into the industry on a short term, at least, because it simply takes six, seven years to develop one product. And to build out a facility and get that approved across healthcare authorities across the globe takes simply years.
So we have made 50 biosimilar launches with our first two products, which are biosimilar to Humira and biosimilar to Stelara. I will talk much more about the launches later on. We ended up with $338 million top line first nine months. And the company is delivering first nine months $87 million EBITDA, if you will, despite we had a negative EBITDA in the Q1 because we were not approved until late Q1 into the U.S. market. We are basically targeting with our portfolio and pipeline branded sales of $163 billion, so a pretty substantial amount we are targeting. And we believe that the pipeline is strong and will help us to basically continue to grow the business in a profitable way going forward. And we expect in 2025, on top of those two approved marketed products, to have three additional product approvals.
I'm not going to go through this in any detail here, but this year has been very busy for the team when it comes to both R&D. We are filing three new product biosimilars to Simponi, to Eylea, Xgeva, and Prolia. So that is all happening this year. We have seen substantial commercial agreements being signed, which is very important to us. And collectively, just to put this into perspective, our business model is basically to license out our portfolio globally. We are a business-to-business company. And then we, of course, supply our products like Teva and STADA and others. So we have signed up from beginning north of $1.5 billion milestone revenues, which are being paid to us as we move the portfolio forward. So it's very important that we are moving the portfolio forward this year.
We are collecting north of $200 million only in milestones in full year, and we are also seeing that we had a good success with FDA. We had two FDA inspections, pre-approval inspection, and general GMP inspection, and both of them went very well, and we are also, as I said, seeing great commercial success and business development success during this year, so a little bit about the platform. We are very proud of it because being pure-play biosimilars, we always believed that we had to have both R&D and production in-house. R&D in-house because we wanted to make sure the quality of the development, the similarity to the brand would be there, also the time it takes to develop the product and the cost, so we believed that having this in-house and the full control was vital, and in our case, that's being proven correct.
We have basically five products past all clinicals, as I mentioned, and I think that is a major achievement for a company which only has two products on the market and was founded only 10 years ago, if you will. At the same time, we believe that having everything in-house when it comes to manufacturing to control, again, the quality, supply reliability, and more importantly, access of R&D into the manufacturing because it's a nature of R&D that you have an issue, so you don't have to book a slot and book another slot and wait time because overall the CMO capacity in the industry is limited, and having access to our own manufacturing is critical, so when we laid out the cards in 2013, the key was to be having a strong pipeline of products to maintain the growth and the profitability.
But more importantly, we built out fully the capacity to service our pipeline before we launched the first product. So we have the capacity to service our pipeline and the portfolio as it is now, which we believe is super important. When we are meeting, for instance, the private label companies in the U.S., they are looking at the quality and they are looking at the pipeline and they are looking at the reliability because they don't want to be converting a huge amount of patients and then be out of stock. So this is what we will be true to, and this has always been our vision. And we are in a position now, as I said, to continue with our profitable growth going forward without having any supply challenges. We have around 1,000 people in the company.
Most of them are in Iceland, where we have our manufacturing, most of our R&D, and the interesting part of it is that we are seeing between 2023 and 2024, we are threefolding the sales in volume. We are basically filing, submitting with multiple health authorities, as I mentioned, three products, but we are still not increasing the headcount. Actually, the headcount went slightly down between 2023 and 2024, and that's basically because our platform is very scalable, and we have been working very hard the last 12 months to streamline both the quality systems and everything we have to produce in-house, so this is going to be the same between 2024 and 2025, even though we will be increasing substantially the volume year on year. We are not going to see a substantial increase in headcount. This would not happen without a great team.
We have a great team in Alvotech. As you can imagine, founding a new biosimilar company, there are not many pure-play biosimilar companies, so finding qualified resources, we had to go pretty far. In Iceland, we have 63 nationalities working for us. So I sometimes say this is almost like a United Nations in our headquarters with all those different nationalities, but that's also what makes the company interesting because we are having different perspectives from different nations. And I'm not going to call out the people here, except I'm going to call out Joseph McClellan, which is the Head of R&D. He was leading all the biosimilar development for Pfizer back in time. And he has been the one which has been leading the team to success when it comes to R&D. So building the platform, building the R&D capabilities, building the production was one thing.
But what is very important also is to have very strong commercial partners globally. So we wanted to open access to patients which could not afford the brands. The brands are very expensive. We are seeing some brands costing $100,000, $150,000 per year per patient, like in the U.S. So it was important to have a strong network. And we have, as I mentioned, 19 different commercial partners. We are covering over 90 countries, and we are covering more than 95% of markets, which include 95% of all the branded biologic sales in the world. So we can compete with every single biologic almost to every single dollar they have globally when we launch. And that is basically the journey we are on. So we have Teva in the U.S. as a main partner. We have Quallent as a private label in the U.S.
We are seeing that's quite important because of conversion, especially in Humira, biosimilar to Humira. And we are gaining a very strong market share when it comes to that product, basically thanks to Quallent and, of course, Teva. And then if you look at Europe, STADA is a big partner. Advanz is a big partner, and Dr. Reddy's is a partner of ours. And then we decided to select the most or strongest partner in every single country or region of the world to make sure that we would be playing with typically top three companies in any given market where we go. So if you look at the pipeline a little bit, as I mentioned, biosimilar to Humira and Stelara is already out on the market. We have basically 100 approvals in different countries between those two products.
We have already launched in 50 countries or markets, I would say, collectively with those two. We are still rolling out into 50 different markets, if you will, collectively with those two products. The big launch, of course, will be for biosimilar to Stelara into the U.S., which will happen now in February next year. The company is gearing up to that launch, and we are actually producing to stock, if you will, to get ready for that launch. As I mentioned, we have filed this year three new products, biosimilars to Simponi, a product which we are very excited about because we are one of two players in that market going forward as biosimilars. There's only one competitor in there, and we believe that we are ahead of that competition. Very exciting product.
We will be launching close to an approval, which should happen in late 2025. Prolia, Xgeva, we have also filed and ready to launch that product through Dr. Reddy's in the U.S. We are then already submitted biosimilar to Eylea. We believe that with our formulation, especially in the U.S., we will, of course, launch in Europe upon approval. We think biosimilar to Eylea might give us a very interesting opportunity, and the plan is to launch as soon as we feel feasible. We feel that we are in a very strong position with that product. You see we are advancing, for instance, with Entyvio biosimilars. It's a $7 billion-$8 billion product. It's only one competitor which is advancing in clinics. Very strong product for us. We have multiple other pipeline products, if you will.
What is very interesting is that also we basically have one of the strongest cell line development capabilities, we believe, with a cell line development with a very high similarity and strong yield. And we have actually developed, in addition to this, 15 new cell lines, which we will take forward, some of them ourselves. And this will give us tremendous opportunities going forward, being able to pick and choose from what we feel is the best and potentially then partnering with others where we are not going to take through our own full development in-house. A little bit about our launches. So the opportunities, this is how the launch profile of the company is looking in 2025. 2024 was all about biosimilar to Stelara and Humira, 2025 biosimilar to Stelara into the U.S. But as I mentioned, launching three new products, biosimilar to Eylea, Prolia, Xgeva, and Simponi.
And then, 2026 and beyond, we have, as I said, I called out Entyvio, which is super exciting to us, being only one out of two in clinics. And I would want to call out also the high dose of Eylea. We believe that we are in the forefront of the high dose. We started pretty early with the high dose. We kind of made a number of formulations which we thought at least one or two would match the brand. And when the brand launched, we already had our formulation ready. So we believe that we will be in a pole position with a high dose, and we believe that the high dose will be taking a good portion of the volume of the Eylea market going forward.
Just to summarize this a bit before we open up for Q&A, we say that Alvotech is at the inflection point this year. We are basically seeing the top line rising substantially, close to $340 million year to date. We gave out a guidance of $400-$500 million top line this year. We are seeing positive EBITDA this year, $86 million, and our guidance was $100-$150 million for this year. We are launching into multiple markets. The company is definitely already past the inflection point. Previous 10 years was all about building out the platform, building out the manufacturing, building out the capacity, the R&D, the pipeline. Going forward, 2025 and onwards, we will see multiple launches of new products, multiple launches of our current products into new markets.
And we believe the company is in a pole position to take a lead in the industry as biosimilars. And at the same time, we will see sustainable, profitable growth going forward. And with that, we have the colleagues here, Anil Okay, which is head of commercial, and Joel Morales, which is our CFO, and Ming Li, which is heading the strategy. So we are happy to spend the last minutes on Q&A, if you will. So thank you, guys. Who wants to shoot first?
Yeah, thanks for taking my question, guys. Róbert, I just wanted to come back to something I found very interesting you said about the Eylea two milligram. Obviously, five U.S. approvals and only one launch and a lot of litigation still ongoing. But it seems like that's not something that you're very concerned about. You sound quite positive about Alvotech's formulation.
So I just wondered if you could talk about that a little bit more. Yeah, basically, we are not committing to launch upon approval, but I would say we are in a very strong position. We have seen that Entyvio launch at risk. And our formulation is keeping in mind some of the patents out there. So we feel that we are in a very strong position and quite optimistic going forward. Walter, I see that you have a question. Thank you. Anything else we can answer, guys? Thanks. I guess just how should we think about the economics of the deals that you're doing or that you've already done versus the ones you're doing in the future in different projects? Sure. So we have a very diversified business model. So we have actually three business models as of now.
One of them is the conventional licensing, where the partners are paying significant upfront payments. As Róbert mentioned, today we have cumulative $1.5 billion. I think among the all biosimilars, we have the most, let's say, hefty deals in that sense. So this is one part of the revenue stream. Secondly, also we get, as we publicly announced that, we get 40% of the partner in market sales as a revenue stream. On top of that, the third model we have in the private label, which, as you know, we are manufacturing for Quallent. And over there, we have a kind of a profit-sharing model with Teva and Quallent. This is a high-margin business. So, as you know, biologics are expensive products. And since we control the value chain, this is a very high-margin business.
Do we have a last question before we call it a day?
If not, thank you so much for joining in, and pleased to see you all.
Thank you very much. Thank you.