Good afternoon, everyone. Please join me in introducing Balaji Prasad, Chief Strategy Officer at Alvotech.
Thank you. Firstly, let me thank Jefferies for inviting us here, and it's always a privilege to be presenting here at the conference. I hope it's been a productive one for most of you. Very briefly, we'll just take a couple of minutes to introduce Alvotech for those of you who are not familiar with us. Before I start, I do want to call out a couple of my colleagues here who are in the room with me: Linda, who is our CFO, and Benedikt, our Vice President of Investigations, and Tina on the communications side. Thank you guys for joining us. Alvotech, very briefly, we are a 12-year-old company. We see ourselves as one of the leaders of the global biosimilar space. We incorporated in 2013, and since then, we invested around $2 billion in our state-of-the-art manufacturing facility in Reykjavík.
The key differentiators for us in terms of how we approach the global biosimilars opportunity is our partnership model, which is based on partnering with various firms, commercial firms across the globe, where we see strong leaders in each region. We have around 20 partners, and we sell cumulatively in over 90 countries. For us, the opportunity space, as we see, is vast, with the amount of biologics going off patent over the next 15 years. We see more than a $200 billion opportunity for us, and we believe that we are one of the best positioned to tap into that. What do we see in terms of a tangible opportunity? Clearly, biosimilar biologics have been the fastest-growing part of the pharmaceutical market. Biosimilar units have been growing at around 20% over the last many years, and we see this continuing for the foreseeable future.
Getting into this, what is our strategic advantage here? Why Alvotech? This is where I think probably the crux of our slide lies. We have a purpose-built in-house R&D facility, which is very well integrated with our manufacturing setup. For those of us who have visited us in Reykjavík, people always come out very impressed with what we have built over there over the last decade or so. As I said, we have a pipeline nearly addressing $200 billion of TAM, and we should start seeing that being realized. Apart from the facility in Reykjavík, we are also a very global firm, clearly set up across Germany, Switzerland, Bangalore, Sweden. I want to touch upon the last two things briefly: Sweden and Switzerland. Earlier this year, we acquired the operation of Alvotech's experienced R&D facilities in Sweden.
We got multiple R&D experts, PhDs, along with an asset called Cimzia. After that, we also acquired Eversley in Switzerland. These are a primary and secondary packaging facility. This was not initially known to us. We have had very close relations with them over the last many years, and eventually, we saw synergies in bringing it in-house. That was the second of our acquisitions for the year. Clearly, it has an impact for us on improving our COGS and shortening the lead time, especially. As we transition from having 2-3 programs to 4-6 programs a year, having these advantages in-house made a lot more sense to us that we got it.
As I said earlier, commercial partners, our strategy of choosing this is really looking at the leaders of each regional market, be it Teva in the U.S., or JAMP in Canada, or STADA and Advanz in Europe. That's really the core of our partnerships, and then going across into the rest of the world markets. Coming to where we are currently, we currently have two on-market products in the form of biosimilar Humira and biosimilar Stelara, so both in the U.S., Europe, and the rest of the world markets. Simlandi, or our biosimilar to Humira, was launched in 2024. As we stand today speaking about it, this is the second largest biosimilar in the U.S. by market share, and we see that there is still significant scope overall for the market to grow. The biosimilar conversion in the U.S. at this point of time is around 50%.
For those of you not familiar with this, the biosimilar Humira opportunity opened up in 2023, and now, as we stand at the end of 2025, it's a 50% conversion, and we expect that there will continue to be this conversion, bringing up volume opportunities, which we will be tapping into over the coming years too. We see significant volume growth opportunities with Humira, both in the U.S. and ex-U.S. market also. Stelara, it's a relatively new introduction for us, and that we just got around Q2 of this year. Our partner, Teva, has been an exceptional partner for us and gaining significant commercial traction.
Where it is, I think one of the things that we want to differentiate here is that both of these products have been competitive markets, and we have continued to excel even in a very, very competitive environment, be it with competitors who have used pricing as an advantage. We have stuck to our pricing, and we have continued to win market share with what we consider to be a healthy, sustainable pricing dynamic for us, and we continue to win there. A reflection of the ability for us to supply and of our quality. Right?
Stelara, as we speak, we expect the year for it to end at around a 25% biosimilar conversion, which means that the pathway or the runway to growth over the next few years is still there as it grows from 25% to an eventual 50% and then a 70% market conversion. These are our currently marketed products in the U.S. and elsewhere that are coming to upcoming product launches. This is where the next leg of growth for Alvotech is. It's a significant inflection point for us as we transition from being a two-product company to a six-product company. We have Prolex, Jiva, Symphony, and Eylea coming through, and we have launched this in a couple of markets. We expect to introduce this in the U.S. next year too. Eylea has already been approved in Japan, U.K., and in the European region.
We recently had a significant court win where Regeneron's injunction was denied by the U.K. High Court. That was pretty meaningful for us. Similarly, Symphony, again, already approved in Japan and U.K., very material markets for us. EMA CHMP opinion has been received, so we should see a pathway to approval very soon. Right? We are expecting to launch Symphony in Japan in the first half of 2026, and in Europe, we should see it sometime this quarter. We expect to launch Symphony next year in the U.S. market. Again, transitioning from a two-product company in each of these markets to a six-product company. Prolex, Jiva, last two ones, competitive with multiple companies going after this, but we still expect to be in the, for Europe, expect to be in the first wave of launches.
Partners in Europe are STADA and Dr. Reddy's, and in Europe and in the U.S., it's Dr. Reddy's alone. I want to touch upon this a bit because this is a recent event, and of course, is also where I see potential opportunity for investors and where there is scope for Alvotech itself to become a better company and a stronger company as we emerge out of this. We recently received a CRL to our BLA for biosimilar Symphony, and the backstory to that is that the FDA had done a pre-approval inspection of our facility in late June and July, and we had 483s with observations. We have responded to the FDA very detailed, detailing a 180-step process into which we plan to remediate or already remediated many of the observations.
We believe we are 95% of it through. The FDA CRL basically did not point out any deficiency in our biosimilar Symphony application itself, but said that the facility has some observations that are still pending that need to be resolved before they can deem our application as approvable. Clearly, that's where we are at, and we are expecting to hear from the FDA anytime now with the post-action letter, which will detail our next steps and be able to respond very soon to the FDA. With that said, what we are confident of is being able to resolve any of the FDA queries. We believe that we have already strengthened, augmented our processes to incorporate most of FDA's observations, but the post-action letter will give us the next steps in terms of what we need to focus on.
With that said, we believe that we still have a roadmap to being the first to market. Despite the CRL, we still believe that we have a roadmap to be the first to market with biosimilar Symphony in the U.S. for next year, and that would be a fairly meaningful opportunity for us. Right? Clearly left it there, and we shall keep the market and investors updated as and when we have incremental updates. As things stand now, we do expect to come into the market. The one important point that I want to highlight, and that has been a subject of questions, is the facility itself being blocked by manufacturing. There was some misconception there. I want to make it very clear that the facility remains approved. There is no change in the status of the facility.
We are manufacturing Humira, Stelara, and we are supplying it to the U.S., and I want to make that clear. No change to the facility status. It is the observations that we will definitely overcome and resolve in the near future. Three phases to our growth, right? We have the commercial products, two of them. We have the upcoming launches in Europe, Japan, and the U.S. that we have launched and we expect to launch in the near future. Then there is the third phase of our growth, which is a pipeline that we have. We believe we have one of the, if not the largest biosimilar pipeline globally. Right? We have a whole set of pipeline next coming up between biosimilars to Xolair, Entyvio, Eylea high-dose, biosimilars to Symphony, and recently, we also announced biosimilars to Influenza and Hemlibra.
We have a comprehensive pipeline, and beyond this, there's still around another 14 assets that we have not disclosed with more than 30+ pipeline programs. We believe this is one of the strongest globally and reflective of our strong R&D capability and where we can differentiate too. Quite a few of these are very complex to replicate manufacturer programs where we are, in some of these, we are the only ones that we are aware of, and in a couple of these, we are one of two or three other programs. These are limited competition opportunities for us that we see, which underlines for us our medium-term growth outlook, and we'll provide greater color on it in the near future. Right?
As I said, three phases to our growth, and we just went through this, went through with this on the revenue side and what it means in terms of tangible opportunity for us. Coming a bit more towards the P&L side of things, clearly for us, what it means is that we have reached an inflection stage with our revenues. We started being EBITDA positive last year. We will generate around $130 million-$150 million of EBITDA this year on a revenue base of around $600 million with our revised guidance. Focusing here from now on, we'll be looking definitely at driving operational efficiencies, ensuring that our operating costs are amortized on a large revenue base. Working capital efficiency is something which is an absolute focus for our new CFO who has joined, and focus on ensuring that we manage our working capital better, manage our CapEx better.
Quick line on the CapEx, as I said, significant amount of capital invested into the business over the last 10 years. This year, we should have around $100 million of CapEx, but over the next few years, we expect very limited CapEx. The period for us to improve the returns on our invested capital is really now and looking forward over the next three, four years that we will start showing demonstrable progress on improving our return on the invested capital. Yep. What have we achieved till now? For those of you who are not familiar with us, it started with around $40 million of revenues in FY 2021. The green, the darker green bar is the licensing revenues.
These are the revenues that we get from our partners who fund our development costs, and then also some of the royalty revenues that we get are reflected in the product revenue side. Two parts of the equation. What you'll see is a clear story where we have grown by nearly 120% or more than 125% CAGR over the last four years. This year, we expect to grow from $420 million to nearly $600 million of revenues. The milestone part of our equation is something, again, that I think bears emphasis that milestones will be a recurring part of our business model. These are not one-offs. This is going to be our standard model as we expand further into the pipeline, bring assets from preclinical to development stage. We will be clocking milestones for the next five years, next 10 years.
That's going to be a recurrent part of our revenue and would, as such, need to be considered. Not one-offs for sure. Leave it at that point of time. I think we have five minutes, is that right? Open it up for Q&A. Thank you for listening to us.
Can you say something about profitability?
About the?
Profitability.
Yeah, sure. Absolutely. As I said, we turned EBITDA positive last year. We were expecting to be cash flow positive this year. In terms of our earlier guidance that we had given out at the beginning of the year, we were looking at a revenue at around midpoint of $650 million and an EBITDA to midpoint of $250 million, between a $200 million-$300 million EBITDA revenue range that we had given. Because of the remediation processes that we incorporated immediately after the FDA's observations, we had a temporary stop to our facility. We incorporated these remediations, which led to a slowdown, a temporary slowdown in production. We revised our EBITDA guidance to $130 million-$150 million. Do we expect to get back onto the EBITDA path where we should have been? Absolutely.
Over the next few years, we will expect to see both absolute EBITDA and EBITDA margins continue to ramp up. I think you can probably have a look at some of the earlier margin guidances that we have given and kind of bake that into your thoughts as you think about it. For us, clearly, this is an opportunity. What the profitability that we saw, especially in the second half of the year, it's going to be a one-off, and we will just get back onto our normal EBITDA trajectory in the near future. Thank you for the question. Any others? Please.
Thanks. Are you concerned at all that the abolition, if you like, of the need to do phase III clinicals for biosimilars now in the U.S., obviously, as well as in Europe, will lead to a lot more developers coming in from China and India, for instance?
Thank you. It's a great question and one that I've been explaining since morning or from the time this happened. This is something that we had been anticipating for more than one and a half, two years. I mean, this is something that we were expecting to, the writing on the wall had been clear from quite some time. What does this mean for us? There are two paths to this, right? One is what happens in the competitive landscape and two, what happens in the development landscape. Firstly, let me address your question on the competitive landscape. Where we are today, we've invested $2 billion into having this facility. Even for any company today to start looking at biosimilars and saying, "Hey, the FDA has done away with phase III trials. Let's get into this. It makes it easier for us.
It reduces the technology barriers." Not really. It does not reduce the technology barrier. It does not reduce the fact or take away the fact that facility is required. It reduces the development cost a bit, but still, there is substantial investment needed either upfront for the facility or on the development program. I'll just throw a number for me. Do not hold me to it, but if it takes development costs from $150 million for a biosimilar program to $100 million, the $100 million is still pretty meaningful. For a company to be a material contender, you probably need to have 3-4 or 3-5 programs at least. That is like you are looking at a $500 million investment again. It is not something that is going to be easy to come by. Will there be one or two incremental players? Absolutely.
I think that is to be expected, which is inevitable, right? That is the development landscape. Again, coming to a question of Indian and Chinese players, there have been some incredibly strong companies from here and have done extremely well for themselves in the last 20, 30 years. Then again, there have been multiple Indian companies which way back in the mid-2000s when I was speaking to them, we were speaking about entering the biosimilars in the U.S. market in 2012 or 2015. We have not seen them yet. I think when they come we will be ready. I think ultimately what will differentiate us is our quality, our ability to supply. We have the ability to supply globally for the next few years without needing incremental capacity. That really is a differentiator for us, which should be our competitive edge too.
I'll also address it on the development side of things. As I said, it will reduce the cost a bit. It will also reduce the time to market a bit, but there is a significant opportunity for us because one of the key criteria as we look at manufacturing biologics or biosimilars is that, A, is it difficult to manufacture, and B, is the opportunity size big enough for us to go after it? This reduction in cost means that we can actually expand, go from 4-5 programs to 5-6 programs a year. There will be that incremental products which are not clearing the filter earlier, which can now we can actually start looking at meaningfully. Of course, the Xbrane acquisition or acquiring the R&D assets of Xbrane comes in at the right time when we can do this further.
It gives us more bandwidth to expand our programs too. It is clearly an advantage for us, and I would think a couple of similar peers like us should see that as an advantage too, comparable in size to us. Thank you.