Don't stop there. The COO, Joseph McClellan, and the Head of Investor Relations, which is Patrik Ling. There is one page in the presentation with the convertible bond terms. We can go through that afterwards. There must also be a Q&A session, and you can write your questions into the box on the top there. But now I will hand it over to the CEO, Mr. Robert Wessman, W essman, very good.
Yeah, thank you so much. First of all, I want to thank you everyone for joining in here today, and this was on a short notice for some, so thanks for joining. We will have 15 minutes presentation, so we will go fairly fast through the deck, but as mentioned, we will have a Q&A in the end. S o the company was founded in 2013 by myself and other investors which came in later on. We wanted to build out one of the leading biosimilar companies in the world, and the key ingredients being best in class R&D, best in class manufacturing, strong portfolio and pipeline, and then having a global marketing reach. Since 2013, we have invested around $2 billion into the business. We have around 30 products in the pipeline, in the development pipeline.
We have now five products outside the U.S. on some of the key markets. We have two products for now until we clear the CRL, which is out there for the pending approval until next year. We have 19 commercial partners, and I will talk about that a bit more on following slides. The company has been growing around 74% CAGR since 2021 until 2026. But we are releasing today also indicative guidance for both top line and EBITDA. We launched the first products into Europe 2022. We launched the first commercial product into the U.S. market 2024. If you go to the next slide, as I said, we have a very healthy partnership and network of strong commercial partners. All those partners are, we can say, co-investing into our R&D simply because they are paying us milestones for access to our intellectual property.
So you can see in our P&L that milestone revenues now have exceeded R&D costs. So we can say, technically, our partners are basically paying us fees which cumulative are higher than our R&D cost. And then we have exclusive supply arrangements with all those partners. And once we get approval across the world, we start to roll out the products, where we produce those in Iceland. We basically have Teva being the lead partner in the U.S., the biggest market in the world. We have a private label with Quallent. We have then a very strong partners in Europe, which includes STADA and Advanz. And then we have multiple partners covering Latin America, Middle East, and Asia.
The company today has around 1,500 employees and over 1,000 people in Iceland, where we have both manufacturing, the main part of the manufacturing, the main part of R&D. We have then the second biggest function is in Sweden, Stockholm, where we did buy out the R&D function of Xbrane half a year ago or so. We then have supportive units in both Germany, in Switzerland, and India towards the regulatory and R&D. That's kind of our network of offices and team across the world. Before I hand it over to Joseph McClellan, which is our Chief Operating Officer, we have been going through since 2022 multiple regulatory health authorities inspections multiple times through the EMA. We are approved in Canada, Latin America, Middle East, Japan, and multiple other markets, European Union, of course.
We went through earlier this year through EMA and Japan health authorities, which actually resulted in approvals and all those inspections. We got some minor comments. Last year we went through two times FDA inspections a s I mentioned earlier, but it was only mid-year last year we became commercial in the U.S. The first inspection with FDA was one 483 and very late last year, which was a very broad GMP inspection. We got two fairly minor 483s. This time around, we got the team to come in, and this was a pre-approval inspection, which is slightly different than a general GMP inspection, which really resulted in delay of getting through three products approved, actually four BLAs. The company has been working pretty hard since then to make sure that the comments which FDA had on our facility is being addressed.
We believe that we are in a good place. We have implemented close to 200 CAPAs, and we will be hopefully sending FDA soon next year updates on the CAPA and the CAPA effectiveness, which is the basis of getting approval. But with this, I want to hand over to Joseph McClellan. Over to you.
Thank you, Robert. Hello, I'm Joseph McClellan, Chief Operating Officer for Alvotech. I've been with Alvotech now for over six years. I started off as Chief Scientific Officer, and have expanded my responsibilities recently. I've been responsible for helping to drive all of our R&D portfolio, and now looking to continue that good progress with our growing portfolio as well as driving products on market. If we go to the next slide, as Robert said, we have received complete response letters for three of our four BLAs that we submitted in the fourth quarter of 2024. Those are for the biosimilars to Simponi and Simponi Aria and Eylea. We also do anticipate, based on our clarification letter for those CRLs called the PAL, receiving a CRL for our ABT03 for the dual product Prolia and Xgeva.
Since our inspection closed on the 4th of July of this year, we have been working very closely with the FDA to resolve all of the outstanding issues, and we're very optimistic they will be all closed very shortly. As Robert said, as part of our requirements and requests for funding, w e're continuing to build out our R&D pipeline. That does include our strategic acquisitions, as Robert mentioned, for the R&D operations in Stockholm, Sweden, as well as our Ivers-Lee CMO for assembly, pack, and label of our devices. We also are very focused on scaling up and launching our products that are approved recently in Europe and Japan, as we get excited for that exciting information. And so, these fundings, this offering will help support our lead position in development of biosimilars while also enabling our strategic launches of our products around the world.
On the next slide, we can talk a little bit more about our current on-market products, where we continue to see a good amount of momentum in growth. We are excited that ABT02, our biosimilar to Humira, and ABT04, our biosimilar to Stelara, are doing very well on both the U.S., European markets, as well as in other markets around the world. Regarding our biosimilar to Humira, it continues to hold the second largest market share of Humira biosimilars in the U.S., and in Europe, we're seeing that it has top position in several of the top 10 European markets. We continue to see very good quarter-over-quarter growth. Our biosimilar to Stelara, we also are seeing a positive impact in the U.S. of our STAD fast strategy with our U.S. partner to grow the business.
In Europe, where we were one of the first to launch in many markets, we are seeing that we continue to have a leading position. So while we continue to see the shift for these two products go from the reference product to biosimilars, we see a very nice runway for our products in the future. On the next slide, I want to talk about our exciting launches for our three products that we have recently gained approval for in the U.K., Japan, and the European Economic Area. These are very important products, ex-U.S., where the total addressable market for these products is approximately $3 billion outside of the U.S., where we're most excited about our biosimilars to Simponi and Eylea. For Simponi, we are the first to launch. We do anticipate being alone in many of the European markets.
And we're also excited for our Japanese launch in the first half of 2026. For Eylea , we are, we were able to launch very early upon the loss of exclusivity, and so have been seeing a very nice, strong order book pulling through our products in Europe and the U.K. And we're also anticipating our Japan launch in the first half of 2026. We also are on the market for ABT03, our biosimilar to Prolia and Xgeva in Europe. So it's wonderful to see that these products are launching, that we have wonderful partners to help us pull through and gain appreciable market share in Europe. On the next slide, I just want to talk briefly before I hand it over to Linda regarding our overall R&D pipeline. As Robert said, we have over 30 molecules in development.
We have been very focused on building our portfolio, building upon the success of our first five molecules to get first pass approval. And we're seeing that we have a few products that we'll be able to submit BLAs and/or MAAs next year. Those are biosimilar to Entyvio and biosimilar to Eylea HD. So these are really exciting that these products are advancing. We also are excited that our potential biosimilar to Xolair is likely to gain approval next year in the U.K. and European markets. After that, we have a growing portfolio. We anticipated in 2023 that the regulations would be changing associated with the expectations for patient confirmatory efficacy and safety studies.
And as a result, we began to really invest in building out best-in-class R&D capabilities from beginning to end so that we can take advantage of the opportunity of having a very large portfolio of potential biosimilars, understanding that many biologics are coming off of patent over the next five to 10 years, and there will be a lot of opportunity for us to provide these very important medicines to patients around the world and provide good value to our stakeholders. With that, I will turn it over to Linda.
Thank you very much, Joe. A quick introduction of myself. My name is Linda Jónsdóttir. I joined Alvotech in July this year, so, a few months in, and very much loving the energy around here on this, very important journey we are on. I was prior working for a big part of my career for a global company in food tech called Marel, lesser than two markets. I was there for 15 years, eight years as CFO and two years as COO. Also been in industries as banking, transportation, and been on a number of boards. There are like a few slides about the financials in the pack, that I'm happy to take questions on, but I would want to jump to the nine months financial slide just to cover a bit the high-level picture.
Alvotech has delivered strong quicker growth in past years since launching of our first biosimilar, and there is strong continued momentum and demand for our on-market products. We are like step by step getting also more and more diversification into our revenue profile as we launch more products to the market, and when I mentioned diversification, it is both with respect to revenues by products and also by geographies as we continue scaling of our commercialized products with our recent approvals of ABT05, ABT06, and ABT03 in Europe, U.K., and Japan. This slide shows like well the trend on our financial side since 2022 to date. To focus on the financials for the first nine months of 2025, we did deliver good revenue growth of 24%, and that is also related to our momentum after U.S. launch of Humira and early traction for Stelara.
Gross margin was at strong level of 59%, also supported by strong licensing revenues. Even though we see improvements in product margins looking at the first nine months of 2025 compared to 2024, we did see some softness in product margins in Q3 2025, where product revenues and product margins were impacted by timing of orders and investments in facility improvements related to FDA matters that Robert and Joe both covered. Looking at adjusted EBITDA, it is at the level of 16% for the first nine months. Margin was comparatively higher in nine months 2024 due to the higher licensing revenues related to three biosimilar submissions and the U.S. launch of our biosimilar to Humira, along with the launch of our biosimilar to Stelara in Europe. We also see impact from higher R&D and G&A in 2025 on our EBITDA.
On the cost side, increased R&D efforts are in relation to the accelerated pipeline expansion, to build up the most valuable portfolio of biosimilars in the industry and to drive future growth that Joe covered well on the previous slide. We are as well higher on the SG&A cost, and that was needed to enable us to scale the operations and the infrastructure and within mind that we want to drive the operational efficiency as we continue our journey. Cash position reflects outflows connected to inventory build up that are needed to support our launches that are taking place now. Also CapEx investments, the company is well invested and M&A activities.
Then if I jump to the guidance slide for 2025, when we issued our Q3 quarterly results, we did come out with a revised guidance for 2025 and are today reconfirming our guidance on strong performance in Q4 2025, both for revenues and adjusted EBITDA. And as you can see highlighted on the slide, the top line guidance is $570 million to $600 million, and EBITDA is in the range of $130 million to $150 million, which then translates into 19% increase in revenues, year- on- year and 30% improvements in adjusted EBITDA.
Q4 2025 will therefore be the strongest quarter, like, for licensing revenues, which is driven by significant contributions from early phase assets combined with newly signed licensing agreements, where we have been like getting marketing approval and launches of new products across Europe and also continued advancement of mid to late stage asset in development. So, reconfirming the guidance we gave out around our Q3 and then touching finally, the 2026 guidance, which is new. We're giving, coming out with a guidance for 2026, during this process. We are anticipating revenues in the range of $650 million to $700 million, reflecting continued double-digit sales growth. Adjusted EBITDA expected to increase to $180 million to $220 million. I want to highlight that the lower end of the guidance assumes a cautious view on the timing of U.S. market entry for our pending launches.
We are investing a lot in R&D, around $250 million planned for 2026, which will then allow us to continue having such a strong and valuable biosimilar pipeline, and the new funding will support us on that journey. We are going to be cash flow positive in Q4 2026, and this new funding will bridge us to that cash flow positivity. Just a bit like on the overall picture, the strategic focus for the next 18 months is like very much on execution to unlock long-term growth. We will continue advancing the pipeline, and also supporting multiple global launches to deliver the solid sales growth. And I would say also the diversification of revenues across geographies and products is also very important. So, yeah, very much looking forward to working on this with the team. So I'll stop here and hand it over, h and it back over.
We're down to Q&A now.
Yeah, Christian, are you, are you going to assist us with that, I think?
Yeah, no, it's absolutely. So it is possible to ask questions in the, in the chat or the, in the Q&A function there. If you just click on that box, you can, you can ask questions, incoming questions. So I'll start with one question then, and it's regarding if you can say a little bit more about the, you know, you mentioned the, the revenues and the EBITDA for 2026. Can you give a little bit more update on how you see the CapEx in 2026, roughly?
Yes, so like on tangible, CapEx, I would say like the company is very well invested. We have been investing a lot in building up the foundation, so I do see opportunities to lower the investment amount going into tangible CapEx for the year 2026, and at the same time, we are like in a position to continue our growth journey despite that. On the R&D part, we will continue as planned. Like, we are planning to, yeah, continue having this pipeline that Joe was walking you through, and that will mean continued investment on that front.
Yeah, very good. I don't see any question here, but we'll do one more question, which I think we have been receiving some questions on, and it's regarding the complete response letter. Maybe you can just briefly describe what that was all about.
Yeah, Joseph, I think maybe you take the top three items there, if you will.
Yes, thank you, Robert, h appy to. Yeah, so, we, as we said, we, we concluded this inspection in July of 2025, which led to our complete responses that we received so far for our BLAs. In that, it was clear that there were three issues of concern from the FDA as they rank them. The FDA always, when they provide their deficiencies, they put them in the order of what they believe is the perceived severity. Observation one was regarding the application of silicone oil to our drug product machinery. This is something that we've been doing since 2018, at the guidance of the manufacturer for the machine, and it also is associated with our earlier approved products, and they asked that we just remove it. We've ultimately agreed that we will remove the silicone oil from our drug product manufacturing parts, and we can manage around that.
The second was regarding how we handle our product quality complaints. We saw reasonable uptake in product quality complaints in the U.S. between our two inspections, one of which was in September of 2024, followed by the one that we had in June, July of 2025. Understandably so, we went from approximately 100 to 200,000 products in the market in the U.S. to over 2 million. And so we had an increase. The FDA had some concerns about how we just manage that. We've been working through that with them, and we've fully overhauled the way that we do our product quality complaints and have an improved process that we're very confident in moving forward with and addresses the FDA concerns. Lastly, an opportunity for environmental monitoring, microbial control. We look at this as something that's very much a continuous improvement for us.
We agree with the FDA that there always can be improved safeguards. However, it's important to note that the FDA's deficiencies and observations were about concerns that things that could happen to the product that nothing, but nothing actually has. We've never had any sterility issues with our drug product manufacturing. We passed all media fills that we've done over the last seven to eight years, and we have never had a failure in our product that we produced from a sterility or a microbial contamination perspective. So a lot of confidence that our product is very safe. You know, that's why we're still in very good standing with EMA, with PMDA. They've inspected us, and even the FDA, right?
The FDA, it's very important to note that none of these concerns led to us changing the classification of our site, nor prohibiting the manufacture and supply of our biosimilars to Humira and Stelara to the U.S., which we have continued to manufacture and deliver. That's that.
So we answered that question.
Yeah, you answered them, very good. There is actually a question regarding the CRL here, and actually you have answered, you know, some of it. So the question here, you seem confident that the issues related to the CRL for 04 can be resolved shortly. Could you please provide a bit more detail on what remains to be addressed and where you are in the process?
Yeah, these were actually the three main topics, which was in the CRL. So I think, Joseph have already answered that.
Yeah. Okay. I think we covered the CRL then, and there are no further questions. So with that, I think we will conclude this global investor call.
Yeah, thank you so much for joining. Great pleasure to have a chance to tell you all about Alvotech, and hope to see some of you in the booth. So thank you so much.
Thank you very much.
Thank you.