Hello, dear guests, and a very, very warm welcome to this very important day in the history of Alvotech. My name is Tina, and I'm here to welcome you all on behalf of Róbert Wessman and the whole Alvotech team here, and to our guests from abroad. Thank you for overcoming the fear of landing on a volcanic island, and we are very happy to see you all. Just wanted to remind you to turn off your phones, and then I want to present the moderator for today, Benedikt Stefánsson. He is our senior director of communication and investor relations. Here you go. Have a great afternoon.
Thank you, Stina, and very welcome in the salon. A hearty welcome to everyone who is here today, both our guests here, of course, who live in Iceland, the guests that speak English and live in Iceland, and those that flew in from somewhere else. So my name is Benedikt Stefánsson. I'm Senior Director of Investor Relations and Communications for Alvotech, and all I'm going to be doing here is basically to moderate the day. So let's just start the program because we have a very tight schedule. The first speaker of the day is Jóhann Geir Jóhannsson , or Hanni, as we always refer to him. He is our VP of capital markets. Before that, he was the VP of mergers and acquisitions for Alvogen, and he's a partner, co-founder of Aztiq, so he has been with this adventure for the whole journey. And without further ado, please, Hanni.
Thank you, Benedikt. Thank you so much. Good to see you all today, and we're really happy to see all of you, both from Iceland and from abroad. Dear guests, very welcome to come from Asia, Europe, or wherever you're coming from. We're really, really happy to see you all and appreciate your to be here with us today. We are sold out, which is very good. Stina, we need a bigger venue for the next time, so that's good news. This is our first capital markets day, Fjällrävenska Tower, and I would like to walk show you a few key capital markets facts. Just briefly, since we are listed the company in 2022, you see the development of the market, and both in the U.S. and in Iceland.
We are both listed in Iceland and in the New York stock, NASDAQ stock exchange, and you see the development, and they are pretty much aligned, those markets, and you see the ups and downs. We're very much based on the FDA decisions in April 2023 and in February this year. You also see the market cap of the company in Iceland, Icelandic billions of krónur, ISK 617 billion. It's the biggest company in Iceland today. We are also happy to tell you about the shareholders' development. We started off with 254 shareholders in the beginning, and we now have almost 4,600 shareholders. And the trading volume has also gone up from $90 million in 2022, first half 2022, and the yellow spots are Iceland and the dark spots are the U.S..
You see how the volume has increased year by year, and it's now $550 million, so far this year, and Iceland is getting bigger than the U.S. on the volume. A little bit about the market cap. We started at $2.2 billion when we listed in 2022, and we are now around $4.4 billion, so almost double the market cap since start. Also, we have raised some funds in the market, about $600 million-$640 million, and since we did the PIPE, the listing in New York and Iceland, it was $175 million, and the latest raise was $166 million in February. So this is a little bit about the market cap and trading information. So, I think this is it for me today.
Very good to see you all, and I hope you enjoy your day, and hope you learn a lot of Alvotech and enjoy. Thank you.
Thank you, Jóhann. We have a bit of a problem here with the screen, so we're going to just fix that right away. Not going to spend a lot of time introducing the next person, which you all know, Róbert Wessman, who is the founder of Alvotech, and before that, of course, of Alvogen. He is the Chairman and Chief Executive Officer of the company, and we have, of course, seen this unfold, this journey over now almost 11 years, and I expect that it will be continuing for quite some time more. I'm not seeing the screens come on, so maybe I'll just invite Róbert to the stage.
Welcome, everyone, to the first Capital Markets Day of Alvotech. Great to see you all, and as Jóhann said, sold out, and I want to extend my gratitude to the people, which are many, which traveled to Iceland for this event and will make this event bigger and better, and we have here among us our key customers like Teva, STADA, Advanz Pharma , Fuji, and they will also be speaking here later on today to explain how they are going to sell Alvotech products. So, before I do anything else, I want to start by why did we establish Alvotech. So, back in time, early 2000s, we strongly believed that biologics would become the future of pharmaceuticals. Those products were gaining popularity.
We knew that they had a medical benefit over everything else, but again, it was obvious that those products were way too expensive to be affordable to everyone because many of those medications cost $80,000, $90,000, $100,000 per patient per year, and we knew that would not be sustainable and would only be then granting access to part of the population in the world. So, with that in mind, we basically decided to build a company which could both develop and manufacture high-quality but lower-cost alternatives, biosimilars, and that's why we founded Alvotech, and that's why we are here. We are on a journey to build one of the leading biosimilar companies in the world, and by that, we are going to increase access to those medications, and by that, we are going to improve people's lives around the world.
So, if you look at the biologics today, today it's obvious that biologics are now the leading therapies. 8 out of the top selling products are biologics, and we are also seeing that around 40% of the global market sales of pharmaceuticals are biologics, and we are also seeing that last two years in the U.S., around 50% of new market products coming to the market are biologics. So how does this look going forward? Best indicator is to look at the top 10 pharma companies in the world and see look at what they are doing. So if you look at the top 10 companies in the world, they have over 500 products in phase 2, phase 3 clinical trials, and they have around 60% out of that portfolio, if you will, are biologics.
So we believe that, going forward, we will see the global sales in coming years move from around 40% closer to 60% when time comes, and this is basically creating the opportunities for a company like Alvotech. Most people already understand the importance of biosimilars because, as I said, there is both growing age of the world population. We are seeing that biologics are becoming more and more important. More of the new therapeutics are biologics, so it's apparent that biosimilars is the only way for the healthcare system to cope with the increased cost. So we feel a lot of support from health authorities around the world towards a company like ourselves.
If you look at also we have talked about increasing access, so what we have seen in the past, and we will see more of going forward, is that once biosimilar launches into different markets and stay there for a while, we have seen treatment of patients increasing dramatically, and we have seen, in many cases, patient treatment increasing 2- to 3-fold. So, and I'm pretty sure that will even increase going forward. So this is our theory of how we want to increase the access to those highly effective medications. If you look at our platform today, we have always believed that we should have everything in-house, both R&D and production, and this, of course, has been a long journey, and it started 11 years ago, as most of you know.
Just to say that and repeat that, we spent over 10 years and over $1 billion to get where we are today, and I'm pretty sure if one would do this again today, it would take another 10 years and spend closer to $2 billion because of cost increases since we started. So this creates an entry barrier for anyone coming into the industry, if you will, and that's why I believe that there are only a handful of companies like Alvotech today, and we will not see too many newcomers as a pure-play biosimilars, which are not doing anything else, which have the R&D and have the production in-house, and is with the global reach as we have. So, as you know, we have built our end-to-end R&D in-house, everything from initiating the R&D cell line to developing the finished product.
We have end-to-end manufacturing in-house, which is critical on timelines and cost and controlling also the variability in the development process, and then again, what we have managed to do is to build a very strong network of amazing marketing partners. Those partners are covering over 90 countries in the world, and those 90 countries are covering over 95% of global biologics sales. So once we develop our product, we can bring it in direct competition with almost every single dollar out there, as a biologics in direct competition, and that is exactly what we are doing by rolling out into new markets. Then the last one I was going to cover, so we are, of course, at an inflection point. We have spent the last 10 years to build out the facility.
We broke ground and building out the R&D platform and getting ready, and if you look at what we have today, we have one of the best technology when it comes to production. Our manufacturing site has been approved by all major health authorities around the world, and the last one in U.S. FDA, even though we had to have fewer on it, but we got through it with only one observation, which is pretty amazing, which underlines the capabilities in-house now, and we at the same time believe that we have one of the best R&D teams. We have already passed 2 products through approval, and we are basically completing 3 next-in-line products in clinicals, which we will be filing, and those should be approved within 12 months, meaning next year.
So we think, this all builds up to the fact that we are at an inflection point, towards 2024. We will be launching the first, high-concentration interchangeable biosimilars to Humira. Humira used to be the biggest, selling product in the world and, was, at its peak selling for $19 billion in the U.S., where the high concentration is 90% of that sale, and, as we knew, because this is a retail dispense product, patients are going to pharmacies to get those products in U.S., interchangeability is needed because you cannot substitute, without a permission from a doctor, a biosimilar, for the brand, and that's why we saw a low uptake in biosimilars last year, but, we have a full confidence through our partner Teva and, of course, through multiple discussions that we have the right product profile and we will be very successful with the product.
More so, just to mention that we are launching a biosimilar to Stelara, the next one in line, both launching into Japan and Canada, and mid-year this year we will be launching into the European Union, which will be a big launch for us, and we will then likely start to produce and ship first launch quantities end of this year to get ready to launch and open up the U.S. market in February next year, and just to say that with that product we actually are second in line to this big market. So all in all I would say towards 2024 will be exciting. We have guided the market to $300 million-$400 million, and Joe will talk more about that.
Going forward 2025 we see us up to doubling our revenues year on year based on the products we have in hand, launch of biosimilar of Stelara into U.S. and out of the filings we are doing this year and going forward. So, we have a very exciting year ahead of us and we will show a strong growth beyond towards 2025. So, very exciting time for the Alvotech team. You will hear that through the presentation today and the company is, and the team is super excited for the future and future launches and show the success here out of Iceland.
So with that, I wanted again to thank you all for attending and I'm pretty sure I will see some of you also in the opening of our extended facility and again important to us to have as many coming and listening in, so thank you for joining in. Thank you. Thank you, Róbert, and now some of you may be asking yourselves, what are biosimilars, how are they made, what are biologics, how are they made, what are they used for. I know there are also many experts in the crowd, and I have just the right person to explain that to you, Joe McClellan, who is our Chief Scientific Officer. Joe joined the company in 2019.
He spearheads our R&D, which is, of course, basically the pillar for our future growth, and about a third of the company is dedicated to R&D, so about 300-350 people. Before he joined Alvotech, Joe was at Wyeth and Pfizer. At Pfizer he shepherded 8 biosimilars into the market. He has a Ph.D. degree in chemistry. He has an M.B.A., and when he's not at work, which is basically 26-28 hours a day, he's walking his Samoyed dogs, these white big dogs that you can sometimes see in pictures, you know, carrying sleds, but in Reykjavík we can just walk them around, of course, because there's so much snow. With no further ado, please, Joe.
Hello. Thank you for the opportunity to take a step back and talk a little bit about biosimilars and biologics.
You heard a lot from Róbert about the promise and excitement we have for the biosimilars industry, and it's built on the fact that biologics have been revolutionizing medical care over the last 30-40 years. So a biologic is a molecule that is manufactured with a living cell and is highly complex. A biosimilar is a biologic as well, right, and it has the same understanding about how we have to manufacture and have the high-quality standards for a biosimilar as we do a biologic, yet it is actually based on an already approved molecule, and we call that molecule the reference product, where we can demonstrate that our biosimilar is highly similar, has the same structure and function and activity as a reference product, and that there are no clinically meaningful differences between our biosimilar and the original reference product biologic.
Biologics have really started to become in the forefront in the late 1980s and into the early 1990s, where there was this idea of actually learning how to manufacture a designed protein through recombinant technologies, where we could actually say, "This is the protein we want to manufacture," and ask a cell to do it, and then we had the technologies to purify it. Now, these molecules are quite large. In Iceland, you have a long history of manufacturing of developing and manufacturing small molecule or, more classic, conventional medicines. Now, these are one 30,000 times less the size of a large protein, such as a monoclonal antibody, and that is the picture on the right-hand side of the screen that is spinning.
It's a quite large molecule where, over, say, probably the early 2000s, they really started to get approved, and the value of this molecule is that we can design it to go and interact specifically with a protein of interest in the human body, capture that protein, and then have it be sequestered away from the body. So you can imagine if your body is producing a protein that is leading to something that it shouldn't, cancer, inflammation, we can put a monoclonal antibody in that system, sequester that molecule, and move it away. But these molecules are quite large, and they're complex. We have this concept of similarity for our biologics because we can't make the same thing.
For a small molecule, it's a few hundred atoms, you can actually copy that identically, and when you have a generic, you can show that you have sameness, but for a biologic, you cannot, and it's something that is similar if you want to have a biosimilar. This has complexity for manufacturing these large biological molecules. They're complicated. They require living cells to actually produce the medicine of interest, and it can take 1-3 months to actually go through the full manufacturing process for a biologic, whereas for a small molecule you can do it maybe in a few hours. Also, it's very important when we're manufacturing these products that we understand the stability of them.
Our proteins are typically susceptible to changes in their stability, which can diminish safety or efficacy, so it's really important for the manufacturer, such as Alvotech, to ensure that we have a manufacturing process and conditions that keep that biologic very stable, so that we can ensure that for many years, we can have a product on the market after it's been manufactured and still would have the same safety or efficacy. And these biologics are used in a lot of different ways. As I said, in the late 1980s and 1990s we started off things that were replacement proteins. These were things that went after diseases such as hemophilia, where we would actually try to put a recombinant protein in the body to replace something that was missing.
Lately, we've been focused a lot on monoclonal antibodies, throughout the industry because they are something that allows us to direct a specific action that we want that molecule to take, and this has revolutionized how we think about things such as treatment of cancers, and autoimmune diseases, and we're excited that our first two products, AVT02 and AVT04, go after two, different pathways to impact, patients who have, autoimmune diseases and look for some of those cures. Some of those autoimmune diseases are rheumatoid arthritis. That's the picture on the left of the hands.
When it goes untreated, there's a protein called tumor necrosis factor that gets into your joints, causes inflammation, and leads to malformations of things such as your hands, and that is a picture of something where it's been treated without any biological medicine, but if it was treated, that patient would not lead to that. They would have a normal functional hand. We are also looking at inflammatory bowel diseases. These are diseases that cause inflammation in your digestive tract, severe abdominal pain, significant cramping, and just a very poor quality of life, where you really can't feel like you actually can go outside comfortably. Both of our products, AVT02, adalimumab, are biosimilar to Humira, and AVT04, ustekinumab, are biosimilar to Stelara. Both have different ways of treating those inflammatory bowel diseases, both ulcerative colitis and Crohn's disease, so that we can actually help these patients improve.
And then the last is a picture on the right: psoriasis. Psoriasis is a scaly, itchy formation that, when patients have it, goes across a large part of their skin. There are 3 million new cases of this in a year in the U.S., right? So it's a significant concern, right? Their patients are constantly being treated for this, and so it's something that we continually look to see how can we improve access to these really important biological medicines to have a significant impact to patients' lives, and that's why biosimilars is really a way to do that, a cost-effective way to get patients the therapy they need, whether it's in the U.S., Europe, or around the world, and that really is the focus of Alvotech to improve patient lives globally.
Biosimilars, we have to first fully characterize and understand what the reference product looks like, and then try to make a copy of it as exact as we can. It's never perfect. It's never quite exact, but we try to get as close as possible. What we want to do is show that we are similar between what we develop and that of the reference product, and we must do that without knowing what the manufacturing process is for the reference product. We have to come up with our own brand new manufacturing process and develop something that, in the end, has the same structure, function, and efficacy that the reference product has, and we have this concept of totality of evidence. It's not any one thing that leads to an approval of a biosimilar.
It is not whether we get a positive clinical study, a positive PK study alone by themselves. We actually have to pull that all in together, where we have to show there's comparison and similar structure and function. Pharmacokinetic activity means that it circulates in the body the same, whether it's a biosimilar or the reference product biologic, and then, as some of the health authorities still require, we also do a patient study then to show, in a given patient population there's no differences in safety and efficacy.
Now, we run that clinical study in one patient population, and we use the concept of extrapolation to allow us to say that we can have approval for all indications that a reference product has, even though we only might study it in one or no patient indications. And this is something where we really use the science to lead us, right, because if we have something that has the same structure and the same function and circulates in the human body in the same way, why would we ever think that we're not going to have the same clinical impact, right? And so that is the idea of extrapolation, that we can justify based on our totality of evidence that we generate to get one of our biosimilars approved, combining it with the well-characterized nature of the reference product.
Typically, a reference product, when we're getting a biosimilar approved, has been around for 10, 15 years, so there's really good history about the activity of that reference product so that we know what we're trying to compare and how we get the same, clinical safety and efficacy.
In the US, we also have a very important concept called interchangeability, and you heard Róbert talk about that AVT02 is the first high-concentration interchangeable adalimumab, and why that's really exciting is because that allows for the substitution at the pharmacy level without physician intervention of a reference product, so Humira, for our product, AVT02 high concentration, right, and so we're really excited that we're the first high-concentration 40 mg in 0.4 mL product for biosimilar to Humira, and as Róbert said, it's about 90% of all of the Humira that adalimumab that's given out to patients, so this is something that really is going to give us an advantage as a company, but it also really helps the idea of patients having really good access to medicines, right, so they're going to get a high-quality biosimilar at a lower cost, and that lower cost not only helps, you know, the, the, the pharmacies, it actually helps the entire healthcare system because if you're spending less on these really important medicines, you're going to have more money to spend on new medicines as they're coming along, right, so we can spread that along with the idea that globally more and more patients will have access to proteins.
So it didn't just happen that we got approval as an interchangeable. We actually had to do an additional clinical study, in this case to demonstrate that given this is a chronic product that it's expected to have the same efficacy and safety in any given patient who would receive an adalimumab, and we wanted to also make sure that there would be no concerns about a patient switching back and forth between Humira and a biosimilar, right, our biosimilar AVT02, because you can imagine a patient might go to one pharmacy where they're able to actually substitute and another one they maybe not, so maybe they have to go back and forth. We hope that doesn't happen, right?
We hope they always go to having our AVT02 in the U.S., but it is something that we wanted to make sure there's no greater risk of any diminished efficacy or safety concerns if they did switch back and forth. And so kind of have this idea about the puffin here on the right-hand side. It's really this idea that these products are indistinguishable, right, and so to a patient, they're going to have the same clinical effect whether they get our biosimilar or Humira. And you know, we talked a little bit about how complicated biologics are, and I'm excited to be in my fifth year here at Alvotech where we have really built a wonderful engine across research and development, our manufacturing, and our quality organization, but specifically our research and development organization.
We now have all of the tools that we need to develop our portfolio and thrive, whether it's, you know, making sure that we have the ability to develop a very high-quality cell line, whether we can move our really do our good structural and functional analytical work. We have a number of wonderful labs in Reykjavik, and excited to have some of you all see our new lab that just is opening up this month, and so we have some expertise in there as well as in Germany. We have some sites that we do our analytical work. Our engine for developing our process, product, and device is all based fully here in Reykjavik, and so we've been really really proud of the fact that we've built up a really strong organization here in Iceland.
And not only do we have the capabilities to actually develop a high-quality manufacturing process, we also have the ability to do really high-quality clinical development, and drive our programs through all the health authorities. We have a lot of interactions with all of our health authorities around the world. We interact with Fuji, with Japan, and talking to the PMDA, STADA.
We interact a lot with EMA to get advice, obviously very close with Teva, and focusing on how we get FDA advice, and so along the way we are getting advice from all these really important health authorities, so that when we actually bring our product to approval, it's going to happen in a first-pass way, right, so we're really proud that our dossiers get first-pass approval because of the fact that we know what the health authorities are expecting and we deliver on that. And so just in that delivery piece, right, we're in the space now where AVT02 is approved in all of the major global markets, obviously after getting approval in the U.S., and yes, very exciting, and we've already launched it a lot. Thank you.
We already launched it in a number of countries, and so that's really exciting, and now we're in the space where we're actually launching our AVT04, a biosimilar to Stelara. We've shipped products to certain places around the globe. We're looking forward to getting ready to go, we're launching in Europe later this year, so a lot of fun's happening with our AVT04 program, and as we've stated, we're anticipating approval here in August, in April, for this product too, so a lot of things are good going on, a lot of very excitement for our programs, and we have a lot more to come. So with that, I say thank you very much. I appreciate your time and attention.
Thank you, Joel. So, after you develop it, you make it, and then you have to sell it, so I saw I said that, Joel has a department of about 300 people, but the next person to speak actually has a tiny department of a handful of people, but why can they do so much? Because, of course, we have these great partners all around the world, as we've been talking about, and we will learn more about in the second hour. Now, Anil Okay is our Chief Commercial Officer. He's from Turkey. He joined the company in 2018. He's a math and computer whiz. Studied math sciences and computer sciences as a major in Turkey and then moved on to Austria, where he got a degree and an MBA degree. He worked earlier at Sanofi, Abdi Ibrahim, and Helm AG.
Now, outside of work, he's a basketball player, and you will see that he's a pretty tall guy. Anil.
Thank you, Benedikt. Very nice to see you all. Thanks for flying here and visiting us in Iceland. It's a really proud day being along with the company. It's very nice to see this day happening for us. Very exciting. 2024 is the most exciting year probably for me and my team in Alvotech because we are launching into multiple markets together, so let me go a little bit back in 2018 when I joined the company. Róbert already mentioned that we put over $1 billion investment into the business, and of course we knew that it's critical to control the value chain in biosimilars from A to Z.
As you know and heard from Joel, Alvotech is doing from cell line development until finished product everything in-house, and we know that this has been over a $1 billion investment, and we had to somehow fund this investment, and we knew that we had to be also finding a unique business model to find this, fund this investment. Scratching our head, we came up with a very unique business model which has been very sustainable last 6+ years, and we created a regional, milestone-based partnership business model, and based on this business model, we were also very, selective. We didn't want to have one, global commercial partner, which some of our competition was doing, but we did the really hard work. We went to the U.S. We found Teva. We went to Europe. We found STADA Advanz. We went to Japan. Found Fuji.
We went to Canada, JAMP, Latin America, Middle East, North Africa, Asia, all these markets one by one. We have found single partnerships to maximize the value for the company. Through these milestones, as of today, Alvotech has signed up over $1.3 billion cumulative license fees, just the license fees through the partnerships. I believe this is our this is the industry record in the biosimilars because most of the biosimilar deals are public. You can track what are the terms, what are the license fees, and the commercial terms. If you look into Alvotech's business model and the terms that we have succeeded together with our partners, these are all win-win and is really very sustainable for the future as well. This was really first fundamental for our business model to be unique in the market.
Secondly, we also from day one, even though when we were doing our IPO, we were really slammed by many analysts to say, "What are you talking about differentiation? How can you differentiate in biosimilars? There is no differentiation in biosimilars," all this type of stuff, but from day one, we believed in interchangeability. We believed in device will matter. We believed in perfusion technology will matter. We believed in that vial to PFS switches will matter. We believed that enzyme technology will come. We believed in many theories that was not approved at that time, but we had the vision to go there, and as of today, sitting with Teva together with the PBMs, with the payers in Europe, STADA is doing a great job with AVT02, what we clearly see, interchangeability matters, device really matters, and you know what?
Perfusion technology in Stelara matters, so all these things have been really proven to be right. These were big bets. Just don't get me wrong. These are not easy decisions when you make. Interchangeability costed us $60 million, but today we have the best product profile in the U.S. market, and the third, fundamental to our commercial strategy was having a broad portfolio because back in 2018, 2019, what we were seeing, an Indian company or a single Korean company coming with one product, offering $30 million global rights, and all of a sudden people think, "Oh, these biosimilars are the next generics." These companies are all disappeared. The Chinese biosimilar companies disappeared.
What we see right now, very long-lasting, very reliable companies like Celltrion, Samsung, Sandoz is still there, engine is still there, so the companies remaining in the game are sustainable and here for the long haul, and Alvotech is one of those companies, and we believe that being a having a long portfolio has been fundamental to that success, and this really helped me last 6.5 years here in Alvotech to go to market and say, "We are not a one-product company. We have 10+ products," which was a big advantage, so these were the three fundamentals to our commercial strategy. If we go to 2024, 2024 is a year of diversification. 2023 and before, we were really just warming up, right? We had launched our AVT02 in Europe, Canada, and a few other markets.
We were getting significant license fees from our partners, but if you look into 2024, we have a lot to do. Just to share with you a few things, we are launching into the U.S. with Teva AVT02. The launch is imminent, so the goods will be there very soon, and we will announce this, of course, to the market together with Teva. This is a fundamental news because we are the first and only high-concentration interchangeable adalimumab in the U.S. market, and what is also very interesting, and we again, we always debated that we will get exclusivity. People were telling us, "You won't get exclusivity. Who cares exclusivity? Exclusivity doesn't exist." Here we go. Today we are launching.
We have 12 months exclusivity on our high-concentration interchangeable products, so what I'm trying to say, the vision that we believed in, we are so proud that this vision is materializing today, and it's giving a big commercial advantage in the market space for us. If you look into Canada, we launched ustekinumab. We were first to market. Do you know who is Alvotech's competitors in Canada for ustekinumab? It's engine. It's Pfizer. It's Fresenius Kabi. It's Sandoz. Alvotech, a small Icelandic company, is the first into the market, and we are first for a long while, and remember, we are the first and only high-concentration interchangeable AVT02 in the U.S. market, again, a small Icelandic company with a great partnership with Teva, so we have done that, and this gives us a lot of confidence to do more in the future.
If you look into Japan, again, Japan sounds very far away, and we have actually 10% of this room here is Japanese, which is very interesting, and in Japan, we are first to ustekinumab approval, and also we are launching in Q2 in May, as the first to ustekinumab. Again, who is our competition in Japan? engine, Daiichi Sankyo, all these big Japanese companies, a small Icelandic company with a partnership with Fuji. We are the first. These are absolutely fundamental news. It's so important to really highlight how important it is to be first in those markets because these are multi-billion dollar markets. If you look into Europe, with STADA partnership, we believed in that.
STADA was one of the first companies together with Fuji, believed in our story, and committed to work with us, since 2019, and today we are launching AVT04 in Europe as the first company end of July, and it's a close to $3 billion market. We are the first, and what is more interesting, we will be alone at least for 3-6 months in certain markets because our competition is slow in moving, and in Europe, just to say, there is only one more approval that is coming literally next month. It's coming from Samsung, which is a company with trillions of dollars and a lot of government support, and it's coming still 3-6 months after Alvotech, so these are the achievements really very exciting for us, and 2024 will be an amazing launch year for us with AVT02 and AVT04.
I would like to double-click on Simlandi opportunity in the U.S. Simlandi is our trademark, that we are using for AVT02 in the U.S. market. The product profile I already mentioned, interchangeability, high concentration, 12 months exclusivity, is fundamentally big differentiation points for us to drive market share. As you know, in the U.S. market, biosimilar traction for adalimumab was less than 2%. We believe one of the fundamental reasons that interchangeable product was missing, so we are coming there, and with Teva together, we believe in moving this market forward. Secondly, Teva is one of the best commercial partners in the U.S. market when it comes to biosimilars marketing, and Teva, of course, being an expert of the market, decided to go with the top, two-tier pricing, a high WAC and low WAC. This will give us a flexibility in the channel to capture all the customers possible.
If we look into supply, we sometimes underestimate that. We have STADA's Nordic head here. I'm pretty sure she will mention her experience. European supply chain matters. Vertical integration matters. Making a medicine in Iceland matters. These things really matter, actually, if you think about biologics and biosimilars, and if you look into the U.S., U.S. supply chain, we got the approval of AVT02 only in end of February. The first goods are going to the U.S. end of March. You cannot do this if you do not own manufacturing sites and if you don't if you are not vertically integrated. No way you can do that because you need to place a PO to CMO. CMO will say, the PO is at your risk. You need to wait. You need to pay in advance.
You need to start paying rush fees, acceleration, this and that," and something will go wrong for sure, and then, you will launch the product in six months from now, so you see these are really big fundamental differentiations of Alvotech in actual operations when we launch the product. Launch is imminent, and of course, we will announce when it happens. The device, I have a special slide for that one. Let me go into that one. Again, this is a very interesting story. Back in the day, we invested a lot of money into this device. Probably the many competing biosimilar companies were thinking, "We are crazy. Why are we spending so much money on a device like this?" We have, I think, three huge machines. I went to see the machines personally.
The one of the machines is like almost this room size, and we have three of them in Switzerland in Ypsomed facilities that we have invested, and thanks to these machines, we have significant plant capabilities, plant manufacturing capabilities, but the matter of the fact is the following. This is a custom-made device, and secondly, this is a patent-protected device, meaning none of our competition can take this device and apply it to their own product. They cannot do that. This is a platform device of Alvotech. They cannot use this device, and what we are doing as a commercial strategy, we are using this device for our future programs as well to ensure that we can utilize the platform successfully.
What is also very interesting, if you touch the device, and we have tried the device with the PBMs, payers, and also there is a real market experience in the market in Europe, we got significant positive feedback. For instance, in Canada, we were fifth company to launch the product after Pfizer, engine, all these big companies, and literally within 6, 16, 18 months, we captured 10% market share. We are number 3 in Canada, and when I asked the partner, because Canadian market is not about pricing, it's all about marketing and branding and so on, because the price is regulated in Canada, you cannot go and give additional rebates, what was the differentiation? What did you do differently?
Our partner was telling us, "Your device is appreciated a lot in the market space," so we heard the same from our STADA colleagues in Europe, and even STADA came up to us and said, "Can we use this device also for other programs and so on?" So this is really big differentiation, and as you see on the device, there is hidden needles, 29 gauge needles. We have, it's a two-step device, and the grip that you see here, the latex-free grip, it helps especially for the RA patients when they inject the medicine to hold it stronger. When we give this device and the Humira device to anyone in this room, you will quickly figure it out that you feel more comfortable with Alvotech device versus Humira device.
We even have done a human factor study to prove that, and we have proven that with the study that our device was even much more user-friendly, patient-friendly than the originator device, so this is a big advantage for us, and we will continue to build upon that advantage for our future programs. I talked about broad portfolio. I cannot emphasize how, how important it is to be a serious company, and we know, one biosimilar development costs anywhere around ±$200 million, so if you have 11 programs, just ballpark, you are investing over $2 billion just to the programs, just to say, so this is a big commitment from Alvotech. We have two programs that are approved. AVT04 is even de facto approved in the U.S. It's just waiting for the PDUFA date in April. For us, it's an approved product.
We already launched AVT04 in Canada, Japan. We are launching Europe. We are launching all. AVT02 is being rolled out in all global markets, so we have two products which are approved and launched, and then we have this year four programs which are super advanced. I don't know if any other biosimilar company can really file four products within 2024. I think Alvotech, if you put, would be one of the top two, potentially in terms of number of filings in 2024. A few words on that: AVT06, aflibercept, Eylea, globally $10+ billion product. This is the largest ophthalmology product in the world, and that product is basically already positively, we got the positive results. We are filing within this year, and we will be in the market before the LOE. LOE in Europe is November 25, so we will be in the market before November 25.
Then AVT03 is over a $7 billion product, coming with two brands. Also, the study is very advanced. We will be filing that program also in Q3 this year, and it's again a market opening in November 2025, and we will be in the market before the competition. Another asset which is my personal favorite, everyone knows that. We had a lot of debates on that: Simponi, Golimumab, is an asset that we don't have any competition. That's the best spot to be, and we partnered on that asset with Advanz Pharma . Steffen is here already, CEO of Advanz Pharma , and this asset is very attractive on multiple fronts. First of all, it comes with perfusion technology. It comes with an autoinjector, and also it comes with no competition. Teva is our partner in the U.S.
We really think this asset is an underdog in our portfolio and will be definitely overperforming our forecasts. Xolair, we in-license this program from Kashiv BioSciences, which is a sister company of Amneal Pharmaceuticals. We have the European rights. Again, with Advanz Pharma , we are filing in the U.K. within this year in Q2. We are hoping to be one of the first to file, and also, the study is continuing, and we will be rolling out the product into European markets in 2025. As you see, four programs, super advanced, and cumulative market size of these four programs are already above $30 billion. Last but not least, AVT16. I remember vividly the day, with Faisal when we have chosen this product. 2018, it was a very hot summer day. I remember making the decision. That's why it's very vivid in my mind.
It was an $800 million asset when we said we should develop AVT16, $800 million asset. We said, "Let's develop it." Today is a $7 billion product because there was a study going on head-to-head with Humira, and the study passed, and since then, the product was growing. Analyst forecasts are over $9 billion for that asset. We only see one competitor. Again, an amazing program in our portfolio. I would say another underdog which is not really, high in our forecasts. And last but not least, Keytruda, as you know, the biggest product as of today in the world and will be the biggest product for a long while, and we are, basically in a very advanced position here. We are literally in the edge of starting our clinical trials, one of the few companies that are going to be starting clinical trials this year on this asset.
It's a $30+ billion product, and we have multiple advanced partnership negotiations and several other pipeline assets. Just to wrap up, why we have chosen this commercial strategy? First of all, it keeps us lean. You heard Benedikt saying, "I have the smallest team," but not only that, we also mitigate our commercial risk because if we give a product to Teva or if we give a product to STADA or Advanz Pharma , they know how to commercialize these products better than us building it up next 10 years with a lot of capital investment, so that's the biggest advantage for us.
And secondly, thanks to this business model, we create, over the years, we were creating $120 million-$200 million per year just from the license fees, which is significant because license fees go as straight 100% profit, as 100% straight to the EBITDA line, as Joel will speak later. That's a very scalable and very unique business model. We will continue to do that, and last but not least, it gives us global access. I talked about local partnerships. Today, we are covering over 90 markets globally. Last but not least, we use the infrastructure which we can leverage even further and also the partner infrastructures.
When we launched AVT02 with Teva, they will start putting AVT04 into the same engine, then they will put AVT05 into the same engine, so there is a lot of leveraging going on there which will, of course, support our future profitability in the partnership. This is the list of our partnerships. As you see, there is not one single partner who has the global rights. We have purposefully chosen that model. We know that our competition is signing one global deal. It sounds very sexy on the, on the table, but actually, when you look into operational, complexity, what we see in the, on the ground is that working with local champions, working with the companies who care about their home markets is bringing much more value in return.
In a global partnership, typically, partners are focusing on the U.S. and Europe, and the rest of the markets always come as wave two, wave three. We didn't want this to happen because Alvotech is developing globally those years. We are doing European, U.S., Japanese, in some cases also, clinical trials, so we want to go all global markets with the same dossier. With this, I would like to say thank you very much for your attention, and if you have any questions, I'm around and looking forward to talking to you. Thank you.
Thanks, Anil. So I could say a lot of things about our next speaker, but of course, we are about to run out of time, so but he is actually one of the funniest persons I've ever met. Joel Morales is our Chief Financial Officer.
He has been with the company basically since 2018, but before then, he was also the CFO of Alvogen. So, before he joined the Alvogen family, he learned to be a licensed accountant. He was at Endo, Merck, and Schering-Plough. Now, Joel works all the time, flies between Iceland constantly, and the most common thing I hear from him is basically that the flight from New York is too short, so he can't get sleep. So if there's anybody from Iceland there listening, please fly a little slower. Thank you. Joel. Thank you, Benedikt. It's a pleasure to be here with you all today. Some things just don't change.
Finance always is asked to present last and then told to hurry it up, which is a difficult thing to do, and to make things worse, I'm being told that I stand between you and maybe some coffee and refreshments, and so I'll do my best to address all the key points and not get too detailed on you in this short time that we have here together.
I think, you know, before I flip to the slides and even cover off on some of the highlights, both on 2024 as well as our outlook for, I'm sorry, on 2023 and also our outlook for 2024, you know, I have to say, you know, for those of you who enjoy to pore over our financial statements the way I do, when you look over our financials over the last several years, really what you see is a company that's going through a period of transition, and so when I first joined the company, we had just some simple P&L lines.
It was really just some milestone revenues, and it was R&D and G&A, but as our company has transitioned from a development phase to a full-scale global commercial operation, the face of our financial statements have fundamentally changed, and they've gotten more mature, to a certain extent, more complex. In addition, we're a company that's gone from being private to public, and being public also introduces a certain maturity, and a certain complexity to the financial statements that's correlated to our our capital structure, and I'll speak more on that in just a few minutes. And so all all this is to say that we're really excited about our business, and we're really excited about this transition that we're going through, and our financial statements are really a reflection of some of the comments that you've heard throughout the course of this afternoon.
And so firstly, as it relates to liquidity, we're incredibly excited to have closed on our private placement in the first quarter of this year. On a pro forma basis, we started the year with about $172 million, and that's a really good start for us as, you know, we continue to invest behind our R&D, which is really the pillar of our future growth. From an operating performance perspective, we achieved 10% growth overall in 2023, and that's also something that we're incredibly proud of year-on-year.
From a product revenue perspective, we almost doubled our product revenues in 2023, and in particular, in the fourth quarter, we delivered a significant contribution from product revenues, and that's in great partnership with our partners, and you heard Anil mention all of the commercial partners that we're engaged with as well, and they're continuing to expand on share of AVT02 both across Europe, as well as in Canada, but also we launched into Australia in the final months of the year. In addition, we recognized milestone revenues during the year. The screens are working now, $42.7 million of milestone revenues, and that's driven by our advancement of the pipeline, in particular with the announcement of our top-line results for AVT06, and so we're incredibly proud of that as well. And so 2023 was a very busy year for us.
We were able to achieve some very positive top-line results in the face of hosting the FDA, responding to their observations, scaling up our operations. I can say that it's been a busy year for us, and that's certainly an understatement. As it relates to the rest of our P&L, I spent quite a bit of time explaining to the external community this transition on the face of our P&L, and you see that as you start looking at COGS. And so as it relates to cost of goods sold, you do see that cost of goods sold are disproportionate to our product revenues, meaning that they're higher than product revenues, which is not really the trajectory that we planned for, but it actually makes sense given the phase that our company is in right now.
The expectation, and you'll see that in our 2024 guidance, is that as we continue to scale up our operations, as we launch into more markets, as we launch more products, you begin to see revenue overtake the cost of product revenue line, and you begin to see that margin contribution drop down to the P&L, and so that's quite a bit of time that I spend essentially just getting the market comfortable with that profile. Beneath product revenues, you also have our investment in R&D, as I mentioned before, which is the pillar to our long-term growth.
You'll see that our R&D spend is growing year-over-year, and also you'll see that we have our G&A spend as well beneath that, which is a reflection of the investment and the administrative team's efforts to get this company moving throughout the year. And, finally, we closed the year with about 267 million shares outstanding. So overall, good year. A point that I made for those of you who may have joined the call yesterday that we had for the fourth quarter is the fact that as we look ahead towards 2024, we are looking to, and we're looking forward to a more simplified capital structure.
In particular, as I mentioned earlier, with our public listing, we inherited some financial instruments, and those financial instruments are things like warrants, earnouts, and also some convertible instruments that we've raised along the way, and some of those instruments contain features that require me to account for them as derivative liabilities on the balance sheet. And all this is to say that, under IFRS, the derivative liabilities have to be marked to market every single quarter, and that results in either a benefit or a charge to the P&L that's highly correlated to changes in our stock price, which is a little bit counterintuitive. In that, when we do well in our stock price increases, you see that I take a charge to my P&L, and you see that in the non-operating line.
And when the stock price decreases period over period, then I'm taking a benefit, and so that creates a lot of distortion. And so for me, it's probably more than anybody, it's exciting to see that, you know, I can look forward and hope to see our cap structure much more simplified. And there are some key events this year that we're expecting to transpire that will help do that, and it comes in the form of, first and foremost, in terms of the warrants. We are seeing warrants being exercised, getting called in, because our share price is so high relative to the exercise price, and so those are essentially getting exercised, which means that they fall off the balance sheet, and it improves my overall liabilities balance, meaning that it reduces it.
Similarly, we have the sponsor and the predecessor earnout shares. The earnout shares are really the largest bolus of that comprise that derivative liabilities balance on my balance sheet, and those earnout shares, again, because of where our stock has been trading, have vested. All of the sponsor earnout shares have vested. One half of the predecessor earnout shares have vested, and so my expectation is that as those become equity classified, you begin to see a lower derivative balance, as well as less volatility on the face of my P&L in terms of the finance costs that you see there. In terms of magnitude, our finance costs were almost $270 million in 2023, and half of that is really driven by this mark-to-market adjustment that I'm making just to put things into perspective, and so it does create a lot of volatility.
Then lastly, we also have the convertible bonds, which do have a conversion feature that becomes available in June, and we're—we fully expect that conversion feature to be exercised, and so that means also smaller overall derivative liability balance, overall borrowings coming down, as well as our overall finance costs, and so as we look forward, hopefully some of the complexity that we inherited as a result of going public is kind of leaving us, and now it leaves the P&L a little bit cleaner for us to really understand true underlying performance quarter-over-quarter. In terms of our 2024 and 2025 outlook, top line, you heard from Róbert earlier, $300 million-$400 million in the top line, and this is an exciting year. I know that, I'm, I'm coming last year, so I'm kind of hammering home some points already made.
We're super excited about our launch in the U.S. for AVT02, and those conversations in contracting are underway, led by our commercial team and Anil, who you saw here, and several others who are around the table, but we are also launching AVT02 into other markets such as Latin America. We have Middle Eastern countries in our existing markets as well where we're continuing to drive penetration, so we're excited about our AVT02, our biosimilar to Humira across the globe, really.
As it relates to AVT04, you heard Róbert mention launching, launched already in Canada, about to launch in Japan, and soon after that, Europe, and I even mentioned in my presentation that we have the potential to recognize revenue for the pre-launch shipments that we will send out in preparation for our launch in the U.S. of AVT04, and we have the potential to recognize that in the November-December time frame towards the end of the year, and so that's an incredibly exciting launch as well that we're excited about not only in the U.S., but across the globe, across all of our markets, and it's reflected in the range we have, a broad range here.
We acknowledge in terms of top-line revenue, but it's important just because we're again launching multiple products across multiple major markets, and while it's exciting, it does create sort of a wide range of outcomes for us this year, but at the same time, what these launches do provide is diversification, and diversification from the very beginning, we've been saying, has been a tremendous pillar for our long-term growth and for stability in terms of our underlying revenues, and so we're launching multiple products, multiple markets, diversified not only in the portfolio offering that we're offering in multiple products but also geographically as we're now launched into multiple markets across the globe.
From a milestone revenues, and so just to maybe to keep things somewhat simple, Anil has mentioned that we have our commercial contracts in place globally, and while they're all unique, on the fringes, at its core, milestone revenues for our company, we typically recognize revenue when we initiate the clinical phase of development, when we've achieved positive top-line results, when we have submitted our marketing authorizations, and upon approval. Those are essentially the big pillars from a revenue recognition for our company. It's a reflection of progress from a development perspective over time. In addition, we also recognize revenue based on performance-based milestones, and that includes when we launch a product in a unique market.
It also includes certain net sales targets, cumulative net sales targets along the way, and so as we think about our milestone revenues, we're saying about 40%-50% of our total revenue range. It is a significant contribution for us this year that we're incredibly excited about, not only because it's a demonstration of the advancement of our pipeline. You heard that we're planning to submit three BLAs this year, and those submissions, both the completion of clinical and the submission, are milestone revenue triggers for us.
We're also initiating clinical for AVT16, our biosimilar to Entyvio, which is also a revenue recognition trigger for us, and so we have multiple events that are really a demonstration of the pipeline advancing, and that is key for us in particular because it's a reflection of our long-term revenue growth, not just our near-term product launches, and that has an impact, obviously, as you look into 2025, and it's reflected in our top-line guidance, and so that's our milestone revenues, and I also mentioned on our call that we're expecting a large share of that milestone revenue to be recognized in the second quarter of this year, and so I'm looking forward to being able to speak to that on our second quarter earnings call.
One other point to highlight maybe as it relates to milestone revenues is we have ongoing licensing discussions as well, that's led by our BD team and our commercial team, and we also recognize revenue as we begin to secure contracts for our earlier phased programs or for programs that we haven't licensed out to our commercial partners, and those also represent opportunities for us as well. It's just an ongoing, what I would call, evolution of our pipeline from beginning all the way down through launch and all things that we're incredibly excited about, and taken together, I think when you look at the year between our near-term launches, the pipeline opportunity that shows continued advancement, and the licensing opportunities for our early phase program, I think that there's a lot there for us to be really excited about as we start thinking about our future.
Overall, we have cash and interest payments of $70 million-$80 million, CapEx of $30 million-$35 million, which is a reflection of the ongoing investments that we're making into our manufacturing facilities and capacity expansion to address all of our pipeline, which we're also very excited about, and as I mentioned in our 2025 outlook, we're saying up to 2x revenue growth from this year's delivery, and that's also something that we're incredibly looking forward to achieving, but right now our focus in particular of our management team is on setting the foundation for that growth this year, and so that brings my presentation to a close. I want to thank you for your time. Thank you.
Thank you, Joel. Now this brings our web stream officially to a close because we're moving to the second hour.
It's actually, of course, more than a, more than an hour already. Now for the people here in the room, you will have refreshments on your table, and the waiters will be bringing out something to nibble on as well. Of course, we are kind of tight on time, so we maybe don't, won't have the full 10-minute break that we were hoping for, but I'll, of course, let you know when we start again, so please.