Good morning, everyone. My name is Balaji Prasad, the Senior Analyst for the US Specialty Pharmaceuticals sector. Continuing our Spec Pharma track for the day, I'm delighted to have the management team from Alvotech here with us. Alvotech is a company we've been covering for the past couple of years, and one of the very few limited pure-play biosimilars listed by some of these companies globally. We have with us Robert Wessman, the CEO of Alvotech; Joel Morales, the CFO of Alvotech; and Joseph, great seeing you again. Thanks for joining us. Robert, to kickstart the proceedings, could you introduce the company and provide an overview around Alvotech and what it does to investors, and we can then pass through some of the questions there?
Yeah, yeah, sure. Thanks, Balaji. Pleasure to be here, of course. Thanks for inviting. Yeah, so Alvotech, I started up in 2013. We have invested into the business till date around $2 billion, so highly committed to being a pure-play biosimilars. We felt the success would be driven by a few things. First of all, having all the R&D in-house from cell line development, having the production in-house, and we have built out the capacity which will last us for the entire portfolio well north of 2030. The third element was global reach. We have 20 extremely strong commercial partners hand-selected, being the leading companies in different regions and markets. We can cover over 90 countries in the world upon launch and approval. Of course, we have to roll out to get those products approved everywhere.
We can compete with the brands in more than 95% of the addressable market globally. If you look at the biotech industry, we can compete with more than 95% of the global brand sales. Where we are today, what is very exciting, we have launched a biosimilar to Humira, both in the U.S. and Europe and many of the rest of the world markets. Stelara, we were the first to Europe, Japan, Canada, and we are rolling out. Good, strong success with that product in Europe. We are then launching a biosimilar to Stelara into the U.S. market, as you know, this year, already volume shipped. What is more important is that with all this, having the capacity, having amazing R&D capabilities, having the global market reach, we have, in addition to the two products on the market, 10 advanced products in our pipeline.
We will talk about that. We have 15 in addition, early stage. We believe that total addressable market for our pipeline products, excluding the early days products, is around $200 billion. This is, I believe, 40%-50% higher value of pipeline than second in line when it comes to top-tier pure-play biosimilar companies. This is a long-term game for us. We are only in pure-play biosimilars. We are there to stay. There are companies which, of course, are there still today, but some of them have a product or two. The market is at an interesting inflection point where I think long-term winners will be seen. With the commitment we have shown the market with a $2 billion investment, we are in an extremely strong position when it comes to sustaining the industry with biosimilars going forward.
Great. Thanks for the overview, Róbert. I've been watching the company over the last three, three and a half years now from the time listed. Clearly on the path that you have been articulating. What you said in 2025, at that point of time, you're on track to reach there and would love to see where you go. Starting maybe with recent Q3 earnings, you stated that you were on track to do around $600-$800 million for 2025. Help us understand the path to this and what would put you at either end of these ranges for the year.
Yeah, should maybe you cover this one?
Yeah, sure. I think what I can say for 2025 is we do expect 2025 to be another year of growth, both top and bottom line. We do expect to land within the range of the guidance that we've provided. There are a number of pushes and pulls. In particular, as Róbert just mentioned, right now our priority is maximizing penetration of our biosimilar to Humira. That's both across U.S. and ex-U.S. markets. We have the new launch of biosimilar to Stelara in the U.S. as well. We're also preparing for the potential launch in the US of an additional product as we get into the fourth quarter of this year. As I think about our international markets, it's really about driving the already successful launch of biosimilar to Stelara through Europe, again, continued penetration of Humira.
We're also gearing up to launch three new products, introduce three more biosimilars at the end of this year. That's all related to product revenue. As I think about our milestones, Róbert just highlighted the attractiveness of our pipeline. You can expect ongoing milestone revenues as well. We have new partnerships always in discussion. At the right time, we'll be excited to announce those as well, in combination with all of the regulatory milestones that we expect to recognize, in particular when we get approval. I think those are just some of the dynamics. I think maybe one item that's worthy of note is really the strength of our international business as well in Europe. We're really proud of the performance of our launches in that market.
Hopefully, we're excited to report more details on that as we get to our year-end earnings call in a couple of weeks.
Got it, Joel. Thank you for that. If I understand you right, depending on the regulatory advancements of progress, especially on the pipeline side, there are incremental milestones that will take you towards the higher end of this range and potentially, yeah?
We're not commenting on the range, but it is a significant driver. Our milestone revenue, you can see this year, was a significant contribution, not only at revenue, but also at our overall margin. We expect that milestone revenues will continue to be a significant contributor, in particular as we continue to expand our pipeline.
Got it. Great. Maybe let's dig a bit more into Humira. I mean, Simlandi launch has gone extremely well for you last year. Incredible amount of questions. There is this whole partnership dynamic with Cigna. Starting with Simlandi, help us understand where its position and stands in the broader biosimilar market now. What are the share dynamics looking at both the private label and the formulary version?
Yeah, I think overall, I mean, we were very pleased with 2024. We shipped 1.3 million units into the US market, which would represent around 12% market share. Of course, this has a lag because our clients are basically taking the product and then placing it. So it's not all converted into script yet. I would say that if you take first the private label, private label was successful. We saw that Cigna announced 50% conversion. They did better than we expected, to be honest, and done a good job. We are also seeing that Teva is gaining momentum. Teva has now secured formulary at two out of the three big PBMs, which is very important. Many would say then what is the inflection point next when it comes to biosimilar to Humira?
As we know, Humira was excluded on the formulary last year with CVS, was excluded by Optum and ESI beginning of this year. We believe that there might be some grandfathering on current patients, that it will not be a full hard switch. There might be towards the second half of the year more momentum on the formulary. We think that biosimilar conversion exit rate end of this year should be at least 50%, we believe.
Understood. Just on the formulary front, two of the three major PBMs have been placed in the preferred formulary list. From a commercial standpoint, what else is left to do there? To speak about acceleration in the second half, would it be like a step-up acceleration, or would it be like a hockey stick acceleration? How do you think about it?
Yeah, I think the main milestone for the conversion is basically the exclusion of Humira. We will have to see how fast kind of the grandfathering will happen. There will be some grandfathering. Patients which are on Humira today, we see some indication that some of the formularies are not going to do a hard switch overnight. They might allow patients to stay on there until mid-year, we think. We believe that the stronger conversion will happen second half of this year. Of course, we will see not necessarily hockey stick, but we will see hopefully a nice growth in the formulary business second half. The private label has been the majority of our business so far.
Got it. Maybe shifting towards biosimilar Stelara, now that the volumes have been shipped, the partners have launched here. How should we think about the opportunity from a 2025 standpoint? Could we see the size and scale of Stelara be similar to Humira in year one, considering that there is much less competition versus what you saw in Humira?
Yeah, I think so basically with Stelara, we could be seeing exit markets share of biosimilar being somewhere, I think, 20%-25%. And this will be both private label and formulary business, if you will. With this, as with biosimilar to Humira, we are not chasing markets share. Some of the companies think the valuations are counted by markets share, not profitability. That's not us. We are there long-term for our customers with, we believe, the strongest pipeline in the industry with one of the best capacity, proven having excellent quality, a novel approach to high dose on Humira. We believe that with perfusion on Stelara, we are in a better position. I mean, our value proposition to our key long-term customers is not nickel and diming down to the bare cost plus.
We believe that we will gradually get more than fair share out of the market. The market is still a bit playing out. How much will be private label, how will be the formulary, both will be important, I think. Overall, I mean, for us, based on what we have already in the back, we see that the rest of the world is going to be the majority of our volume. That is simply because of the conversion, as I mentioned, and the time it takes to convert the U.S. market. Secondly, I mean, if you look at last year, Europe was already 20% converted, where we had 30% market share. The majority of our volume will go outside the U.S. to capitalize on profitability long-term.
Got it. I definitely do plan to speak about the ex-U.S. market. I think most investors tend to focus on the U.S. dynamics. For you, the ex-U.S. part of the business is equally important and as large. We will cover that too. I have a question around interchangeability. Could you compare and contrast the interchangeability and how important it is with Simlandi versus Stelara? How would you think about the role of interchangeability with regard to Stelara, especially to gain market share?
Yeah, I think overall the interchangeability, when you have a retail product, if you will, is important. We saw, though, Cordavis CVS converting biosimilar to Humira without interchangeability. It is possible, but it is much more effort, much more commitment. Yeah, overall, I think interchangeability is playing a big role. We are, with preliminary approval for interchangeability ourselves, end of April, we will get the final approval as interchangeable when Amgen exclusivity expires. Overall, I mean, it is difficult for us to judge whom else will be there when it comes to interchangeability. We are not really able to comment on that, to be honest.
Understood. As I said, I do want to focus on the OUS part of the business. Can you provide an overview around it again? Very unique model in terms of partnerships across every geography. How critical will the ex-US business be in driving the next three, four years of the growth for the company?
Yeah, I mean, if you look at the investment into R&D, it's pretty substantial per product. To get the best return of that investment, create more opportunities and balance the risk in the business, we decided back in 2013 to focus on global reach. Europe, of course, being us, if you look at Europe as one market, being the second far biggest outside the U.S. We have built out the business throughout the world. Our approach to it is business to business. We have our early commitment from our marketing partners. They are investing into our R&D with us. We are covering all of our R&D costs annually and more than that with the milestones which we are paid for the access to the intellectual properties. This is signed up with up to 20 different partners to cover 90 countries plus in the world.
Typically we either have a profit sharing or we have a revenue sharing. This model allows us to be flexible, allows us to have a risk sharing in R&D. We do not have any marketing cost. We think this model will drive this year through the best-in-class marketing partners throughout the world.
Got it.
I would add that we've mentioned in the past that our ex-U.S. business is roughly a third at product revenues as well. We can expect that to grow proportionally to our total product revenue business. It is a significant contributor.
Great.
Yeah, yeah. I mean, like Joel is saying, it used to be 30 and growing. You can imagine how important this is. Typically when you have a product launched into 60-70 markets, there are some markets doing not as well as you hoped for, but there are other markets doing better than you hoped for. It is kind of the balance of not only having a strong portfolio, but having the access to different countries and markets, if you will.
This is important in particular because we are in a period of high growth. What you are seeing is in the early stages, you have certain markets, as Robert just mentioned, that are performing better. You have other markets that are maybe taking a little bit longer to develop and evolve than we had expected. Overall, net net, you can see that we are balancing the risks and driving overall growth in the meantime.
Understood, Joel. I do want to spend some time on the pipeline because, I mean, clearly one of the most comprehensive biosimilar pipelines that we're aware of. Help us understand the current state of the pipeline, the next key milestones that we need to look for, Joel, and what is exciting you the most currently.
Yeah, absolutely. Thank you. First, I want to just say thanks to Róbert and the compliment of our R&D organization. We've spent a lot of time over the last five plus years really building a very integrated R&D organization from cell line development all the way through a very strong regulatory affairs organization. That does give us strengths that other biosimilar companies do not have, having that integrated R&D, especially since the fact that we're co-located with our in-house manufacturing, which makes us very strong. With that, we've been very much focused on developing what we believe is the best pipeline in the industry. Not only do we have our two marketed products, we have 10 named programs that are currently in development, and they're moving quite quickly through.
Three of them are currently under global regulatory review, where the second half of this year we are expected to start seeing approvals for our proposed biosimilars to Prolia, Xgeva, to Simponi, and to Eylea. Those are moving nicely, and we are looking forward to them launching quickly after approval in as many markets as possible. If we think about what is exciting us next, it is really about where we can differentiate ourselves by being first to launch, especially in an uncrowded market, which we do expect for Simponi, but also beyond that, Eylea high dose, where we believe we are in lead for that development. Also Entyvio, once again, where we do believe we are in lead. Those are also molecules that are moving quickly through. We continue to invest in our early pipeline.
We have over 15 molecules that we have started in early phase and are looking to bring them forward. With that, as Robert said, we have approximately $200 billion, not including those early products, in total addressable market, which we believe is larger than the other tier one pure-play players that are between $100 billion-$140 billion.
Got it.
Maybe just one or two points just to underline what Joel said is that, I mean, biosimilar to Simponi, we will get approval end of this year. We believe global reach, we will be the first on the market for a while. We are super excited about that. That's a product which we will start to roll out, as I said, end of this year, beginning of next year. Also the Eylea, I mean, the high concentration we have, we are super excited about that. We saw that the conversion is happening with the high dose of Eylea itself, even though Alvotech has not yet been launched in the US, which we think will be kind of the turning point of conversion.
On the low dose, we did a different approach to it, different formulation approach to it, which is pretty unique and strong. We know that Amgen launched at risk. We have not committed to launch that product into the U.S. at all. We think we are in a very strong position with that product because we know that others, at least three companies, have injunction for now, which will take quite a while to untangle, if you will.
Yeah, we're tracking those litigations closely, and we'll see when there's some clarity there. Good to see you're clearly differentiated both with Simlandi and Eylea. Maybe just to cover it fully, also thoughts around Prolia and what should we think about the opportunity and the competitor dynamics?
Yeah, I mean, overall, we have strong partners in Europe. We went for semi-exclusivity with Stelara and Dr. Reddy's. We have Dr. Reddy's, which have a strong outlet in the US to market our product there. I think the competitive dynamics overall in the U.S., especially, will be quite a bit. We expect the competition around the product to be pretty strong. Contracting will start in near term. We have not started contracting for U.S. as we speak.
Understood. You are speaking about investment in the cell line and all. Two years ago, I think one of the questions I was getting the most was around capacity. Does Alvotech have the capacity to supply 10% of the market of biosimilar Humira or like 20% of biosimilar Stelara market? Your comments around capacity being fully set for 2030 are very interesting.
Yeah, I mean, if you want to turn into a biosimilar Humira plant, we can supply the entire globe more. We are in a good position. The company, as I said, before we launched the first single product to the market, because this company was built out from 2013, as I mentioned. Before the first product came to market, I built out and doubled the capacity in Iceland. We have this beautiful facility which counts now, I believe, 40,000 square meters in Iceland with everything, which is going to support our pipeline because all those investments have to be backed up with a best-in-class facility. We really have that.
Yeah, I think we'll say more on our call at the end of the month. You'll see in terms of the volumes that we delivered in the fourth quarter, it's a testament to the capacity. This is early days. We expect that capacity to continue to grow. It is an early sign of what we're capable of. As Róbert mentioned, we've been investing behind this for quite some time. We have our R&D and our manufacturing colleagues, which are co-located at the site, which we think is a differentiating factor for us from a capacity perspective, but also from a speed and execution. It de risks the entire development process when you have the same teams working from early phase development to launch. We're excited about what we've done here in Iceland.
Absolutely.
Fantastic. We'll look forward to that and look forward to more updates from you and your progress. Róbert, Joel, and Joseph, thank you so much for joining us this morning. I wish you a very productive conference at.
Yeah, thank you so much. Thanks for the invitation. Pleasure. Thank you so much.
Thank you.