Alvotech (ALVO) Earnings Call Transcript & Summary

We're going to get going here with our next company presenter here at the BofA Annual Healthcare Conference. I'm pleased to be introducing Alvotech. Joining us from Alvotech, we have Balaji Prasad, Chief Strategy Officer; and Benedikt Stefansson, VP, IR and Global Communications. So gentlemen, thanks for joining us here at the conference.

Thank you.

Jason, thank you very much for hosting us. We really appreciate the opportunity to present Alvotech and to have this discussion with you.

Great. Great. So maybe just big picture, if you can kind of outline kind of where you see the company. It's a dedicated biosimilar play. You've invested a lot as a company in manufacturing to have that. Strategy-wise, do you see the partnership model as sort of the model that you'll pursue kind of at least in the near to medium term? Is there any strategic ambitions to vertically integrate it all and to take biosimilars to market as a company one day as you grow and get more, I guess, gross profits in the door. Maybe just kind of outline kind of where the company is. I know that biosimilars as a category has not been for the faint of heart. Some companies have come and gone in this space, but I think you guys believe you're positioned well to be one of the sustainable entities in the space.

Thanks, Jason. So a few questions within that. So let me break up each one of those. Starting with our focus, right? When the company was incorporated and set up 10-plus years ago, our focus was really to be a pure-play biosimilars company, have a comprehensive pipeline, which we achieved rather successfully. And there was a specific reason why we went off to the partnership model because that led us have flexibility in multiple ways, which is have a broad pipeline, have multiple developmental projects. And also the company's stated mission of providing affordable biologic drugs globally, that's something that we can do with this partnership model there where we can be present in 90-plus countries. It is not just a U.S. story, it is a global biosimilar story for Alvotech. And so -- which is what we have been able to execute successfully till date. And having this pure-play focus really let us work on our developmental projects. So we were able to get and launch multiple biosimilar projects in it. So what that meant is that today, we have the largest biosimilars pipeline that we know of compared to any of our peers. Yes. We have close to around 30 projects. And as far as we know, this is the largest. And it also lets us be present in most of the key opportunities which are coming up, having partners who successfully execute the commercial front. And so this is a strategy that has worked very well for us. Benny?

Yes. If I just look a little bit more inward, what makes us really different from the competition is that this focus that we have on biosimilars and our ability to both develop and manufacture, which you don't see basically in most of the other players. So we can basically specialize on the subject of biosimilars, find the best targets, select them, create this massive pipeline. We have a development group that is fairly unique. We can go all the way from cell line development down to, of course, approval. And so for example, in cell line development, what we've done over the past few months is that we have developed 15 different cell lines, choosing the best targets from the different molecules that are going to come off patent in the next few years. And these are ready to go. So this year, we're putting 4 to 6 -- sorry, 5 into actually the development pipeline at the early stage, so process development. And we're going to be doing this at this cadence going forward, so 4 to 6 per year going forward. And so then when you move to manufacturing, manufacturing works hand-in-hand with development from the very beginning. So if you are a company that specializes either in development or manufacturing, you don't have the synergy between the 2 groups. So you have to have this technology transfer from the development stage to the manufacturing stage, which is often error prone and can also slow you down or you're relying on CDMOs to manufacture and you have to wait for their capacity, both for the clinical stage plus, of course, when you want to launch. So all of this we can control. It's all under one roof, and therefore, our execution is going to be much faster and more efficient.

And coming to the last part of your question about if we would see or consider vertically integrating, I won't say never say never is a big thing, but I don't think with the way this model has been successful for us till now, that is something under consideration right now. But in the future, if there is demands and changes in the environment, which dictates it, we will consider it. But for the near to medium term, as far as I can see from here, I don't think there's a model that we're looking to change.

Talk about maybe key success-based metrics that you focus on for the business. As I think about biosimilars, you obviously need a steady cadence of launches, right? At some point, products start to face some pricing pressure years 3 through 5 post launch. So it's important to kind of have a steady momentum of products launching through your partners. Not all launches are created equal. So you need to be high-value launches within that. So what are some of the guideposts that like drive your strategy? And what are some of the things that you guys focus on that you want to deliver on?

Yes, absolutely. I think Benny alluded to it during his earlier comments, but obviously, the total addressable market is going to be something which is a key determinant. And then we'll also look at what is the competitive landscape? Is this going to be a limited opportunity for us? Is this going to be something which we can take globally and not just be leveraged or tied to 1 or 2 markets. So multiple factors, regulatory, technological barriers, the market size itself determines that. And yes, looking beyond this, of course, what are the success factors. Ultimately -- and again, how fast and quick are we able to take it to the market once we get approval and how well we choose our commercial partners who can take this to the broadest extent and be able to leverage this. You commented about pricing. So I want to spend a minute on it. Ultimately, biosimilars, 3 to 5 years, I think that's a pretty good span that you gave out that we'll see this improvement in market and at some point will plateau. But biosimilars will not see the steep cliffs that generics have seen on day 181 or when we have like 5, 6, 10 players in the market, we will not see that, multiple reasons, right? The cost of development is prohibitive. So your investments are high and you have limited -- with the exception of some companies, some products like HUMIRA or STELARA, most will still be limited competition opportunities. So there is going to be this cadence to it. But what we have done to offset or navigate this cadence is that we have a steady stream of launches coming through, which is where our broadest pipeline in the industry really makes a difference. So we started with HUMIRA last year, STELARA this year. And by the early next year, we'll have 6 products in total with 3 to 4 more products coming out by the end of this quarter -- in Q4. So we'll have a substantial number of launches coming through. What it means is that we are able to navigate the pricing pressure in any one product in any one market effectively, and having a significant portion of our revenues ex U.S. also helps us navigate this. So we have set out our 2028 guidance, and you will see that EBITDA is ramping up substantially to 2028, which offsets any kind of pricing pressure in a particular or 2 particular products.

Okay. So when I think about your criteria for what to go after, it makes me wonder what wouldn't you go after? On the one hand, you have something massive like the PD-1s, which you probably just have to go after, even though you know there'll be 15 players probably, and it will look like HUMIRA and you have a view on how you win there, right? Then you have something like SIMPONI, right, which is smaller. And I imagine you don't want to go sub-$1 billion in revenue unless the FDA changes the requirements and the costs tied to a program. Is that a fair way to kind of think about the range of at least the wider end of the spectrum in terms of opportunity sets?

I think that's a pretty good way to look at it. And I'm sure you and as well as everyone in this room know that there's still numerous biologic drugs, which IQVIA called out earlier in its February report that do not have biosimilars in development. And most of these tend to be between the $500 million to $1 billion range. But again, I think once we see this cost of development go down, which we have reasonable belief to think that, that's something likely in the near to medium term, then we'll probably see greater development programs on this. But I think that's a good metric to look at in terms of the TAM size and what we think is achievable.

Yes. And you -- I mean, Balaji, I think you covered it very well in your earlier answer that we look at these other criteria than the total addressable market, barriers to entry, our ability to differentiate and so on. We have done some of that. So for example, in the HUMIRA market, we're differentiated by our auto-injector design, which is something we've developed very early on and proprietary. We will be using that for other products in a similar space, arthritis as such. And then, of course, it's also like actually our developers like to look at products that are difficult to develop, where there are technical difficulties in development and that also means that we can leverage this expertise of this almost 500 people that we have in R&D already to develop very important products.

And when you think about a steady-state EBITDA margin for your business, is that something that irrespective of what the partnership economics, how they flex, right, if it's private label, if it's a partner like Teva selling more through its commercial formulary type of business as opposed to private label. In the end, that's all going to be kind of captured in your EBITDA margin, not below the EBITDA margin dynamics, if I understand it right. So how do you -- correct me if I'm wrong. And then sort of what do you see as sort of a steady-state EBITDA margin for the business?

So I think you can take our 2028 target as a good proxy for a steady-state business, right? We have our 2028 target, which is like around $1.5 billion in revenues, out of which around $1.1 billion to $1.2 billion is product revenues. And we're looking at net EBITDA margin of around 40% to 45%. So that factors in upcoming launches that we anticipate in the next few quarters. And I think that's a good metric to go with. And then we also have put out our product margin ranges that we expect product margins to be around the 60% to 65% range. And this is a function, of course, of our revenue share agreements, right? We have clearly stated that we like this partnership model. It's been very successful for us, and we're happy to split revenue 60-40. And that, in general, has been the broad threshold that we have worked with, be it on the formulary side or on even private label deals. That's kind of where the ultimate EBITDA economics comes to almost the same.

Yes. Okay. Maybe shifting gears to SIMLANDI or biosimilar STELARA. Yes, I'd love to get early impressions so far. When I listen to J&J talk about year 1 is going to look like the HUMIRA year 1, right? I take that to mean we're going to get the majority of the volume. We're going to compress price, and that's how to think about our year 1. And so for the biosimilar side of the equation, that means low volume share, low dollars in the door, maybe it becomes like more of a 2026 plus opportunity. I don't know if you'd agree with that sort of logic.

I think there is clearly a ramp to any biosimilar launch. And we should not, of course, be expecting peak biosimilar sales in 2025. And would it ramp up in 2026 and will it also ramp up in 2027? That is possible. That's 2027. But definitely, there's going to be a biosimilar conversion and biosimilar sales ramp up into 2026 for sure. So beyond that, again, just to reiterate a point, not to do it to death, STELARA for us is not just a U.S. opportunity. It is an ex-U.S. opportunity, too. For us, Europe, STELARA has been significantly better than what we anticipated, what we expected. These dynamics continue to carry through. And in the U.S., the market is still forming. We'll see how the competition shapes up and how the market evolves. But I think there's going to be a conversion ramp up at least over the next 5 to 6 quarters. In terms of guidance, what we have said is that by the end of this year, I think with biosimilar STELARA, we would expect to have around low double-digit market share, which I think is a reasonable metric to go with. Anything else Benny?

Yes. I just want to reaffirm basically that some of what you just said and what Balaji described in terms of the dynamics of the market, especially in the U.S., this is already baked into our expectations. So none of this has actually been a surprise to us.

And so when you think about ramp curves for these immunology drugs that are dosed chronically, I guess they're like PBM drugs, right? There's a rebating dynamic. When we saw maybe the first wave of biosimilars in the U.S., they were a lot of oncology drugs. They were like Part B drugs, and they actually launched pretty fast. You think about Coherus with UDENYCA, some of the Amgen biosimilars, I mean, they were getting to $300 million, $400 million in sales pretty quick, for companies that were disclosing revenue. So is the answer really, well, this channel has rebates, it's a chronically dosed, there's grandfathering. There's some of these legacy issues that really slow the adoption curve in, say, the U.S. market, whereas maybe in European or ex U.S. markets, there's more forceful mechanisms in play that help you get a faster uptake. I'm just kind of curious if you can sort some of those dynamics out.

Sure. Parsing it first within the European market and then the U.S. market. So the European market, clearly, I think having -- multiple countries have different models, but ultimately, what it boils down to is single payer mechanics or limited payer mechanics, right? So clearly, that option curve is going to be much faster. We saw that from 2012, 2013 onwards. And while the U.S. still struggled between 2015 to 2019 to achieve biosimilar adoption, Europe was substantially ahead at 70% market conversion in most markets. It is only post 2019 that U.S. really saw steeper biosimilar conversion, for example, with a rather successful launch of UDENYCA in 2019, right, with the pegfilgrastim markets. And clearly, the oncology institutional sales model helped there. Whereas on the formulary side, it's a different metric because there are multiple things which play, market gauging each of those competitive moves. And so the adoption curve has been low. But that said, overall, in general, the U.S. definitely seeing faster biosimilar launches and adoption than what we saw in the period between 2015 to 2019 when innovators were still focusing on and successfully deploying patent tickets and rebate mechanisms to prevent biosimilar offtake.

No. I mean I think as you described, the dynamics in the U.S. market have been a little bit different compared to previous history with the biosimilars entry in the U.S. and plus compared to Europe. But I would think that the U.S. market will, in the near future, start behaving a little bit more like Europe. So the ramp-up will be faster. We'll also have products now coming on in our portfolio that are stronger ex U.S. than they are in the U.S. So that's also going to be an interesting dynamic to see play out. Yes. So I think in general, just we'll see.

Okay. So for SIMLANDI, at least in the U.S., do you see sort of the adoption curve for biosimilars looking somewhat like HUMIRA, at least in year 1, 2? And how do you see the private label mechanism, which seemed like it got a lot of traction with HUMIRA. Is that sort of the -- do you see that having a meaningful slug of the market that effectively payers are going to want to have some aspect of the economics and control with private label product? And do you see that as like an important trend to think about?

So when you say SIMLANDI and HUMIRA, do you mean STELARA and HUMIRA or...

Yes. Sorry, STELARA, HUMIRA, just adoption curves year 1 and year 2. And did that look a lot like HUMIRA?

So the adoption curves are likely to look similar, taking around, I would say, 2 years, give or take, 2 years to achieve like a biosimilar conversion of around 50%. The competitive dynamics are also rather similar with both seeing fairly high number of companies launching. And so we'll see what our expectation is and that we have communicated is 50% market conversion by the end of '26, and we would expect to have low double-digit market share with STELARA, too. As regards to private label deal, again, we saw that being fairly meaningful with biosimilar HUMIRA. But with STELARA, it is still a market in evolution. We're still in the early days of market formation. We'll have to see how private label deals or unbranded deals will play out.

Yes. And then if you juxtapose that with sort of the expectation for Europe or OUS markets broadly, however you want to define that for biosimilar STELARA?

So as I said, biosimilar STELARA in Europe, especially has been significantly better than what we expected. So I think in the near term, that will still likely be a stronger driver of growth for us, and we will see a more gradual ramp-up in the U.S. market.

Okay. Yes. And then maybe just some of the early pricing action in the U.S. on biosimilar STELARA seems like they're may be coming in at $500, $600 a month, which is maybe similar to like the price discounts that ultimately got implemented for HUMIRA. Was this like a surprising level of discounting to you? I know you had some comments on your recent earnings call about sort of we don't want to go to this race to the bottom with other entrants who are compressing pricing. And so I'm just kind of curious how you guys think about that?

It's a great question. And I'll address that in 2 points. As tied up to my response with the first question as to what makes Alvotech different is we see ourselves as being a very dominant sustainable long-term player in the biosimilars field, not just in the U.S. but globally, which means that there is a threshold below which we will not go because we don't think that is sustainable. So we may have 1 or 2 companies come in, take pricing down for a particular product, but we don't see that as a sustainable competitive dynamic for those companies and nor see them as serious competitors in the longer run. That's one. Specifically with STELARA and how it played out, this was something we anticipated and that we baked into our guidance. So our guidance, which was very well received, and we recently raised it upwards, already factored this pricing dynamic with STELARA into our thoughts and our guidance.

Okay. Maybe can you address -- I think -- I don't know this is a misperception with investors because we oftentimes think of like OUS pricing is way worse than U.S., right? But what you're suggesting is perhaps that maybe the OUS pricing is as good or better OUS. And so these are better maybe markets to play in than the early experience may be seen vis-a-vis HUMIRA or STELARA.

I think that's a pretty fair observation. And being analysts in the space over the last 20 years that I've been covering the space, clearly, that has come as a surprising or a positive revelation for me over the last couple of years, where the European pricing mechanism has been very profitable. That was unlike, let's say, pre-2010s or 2010s when the U.S. was always the more profitable market. And we've seen that play out and not just being more profitable, but it's also very stable and sustainable. So again, that really helps us with our focus on the European market and the ex U.S. markets, it really helps us. And so I don't expect the dynamic to change anytime in the near future.

Yes. And then as it pertains to OUS markets are more fragmented, but your partnerships with OUS entities are as a percent of gross profit. So if there is added SG&A costs tied to commercializing that in a fragmented revenue base, that doesn't impact your bottom line ultimately.

No. Typically, our partnership model focuses on revenues and it's a revenue split. And so really, the SG&A cost and all doesn't really come down to us and we're not [indiscernible] in it. So our partners decide how much they want to spend and what they want to do. But for us, it's a revenue split with most partnerships. So really no bearing there in terms of how they decide to tackle the market. But again, having this partnership model really helps us capitalize on numerous markets across the globe effectively.

Yes. So I realize like it sounds like there's a lot more enthusiasm for what's going on OUS as opposed to U.S. With respect to U.S., you are getting some momentum with HUMIRA from a volume share perspective. I think AbbVie likes to make a lot of like the category shifting to innovative brands like SKYRIZI and RINVOQ. But when we look at the IQVIA data, only down mid-single digits, and that may not account for private label biosimilars as well. So just wondering kind of if you can just speak to the dynamics. Do you see kind of like the market is still pretty large and there is incremental value capture there for you.

Absolutely. You hit the nail on the head, especially with the stable market trends. And what we have seen, 2 points to it, right? When our biosimilars enter a market, especially in Europe, we have seen the overall volumes expand substantially as there's greater adoption and greater prescription of biosimilars. So lower affordable biologics clearly has expanded the volumes. Coming to the U.S. and your question around HUMIRA, I mean, it is still an extremely relevant drug and having this dynamic of lower-cost biologic drug for HUMIRA clearly, again, gives us some volume advantages. And that's in net what we are seeing here. Anything else, Benny?

Yes, absolutely. I think as you alluded to, we saw, for example, the STELARA market in Europe increased by 10% last year. And that is because of biosimilar entry. Volumes, sorry, yes. And that was actually -- we were the first to enter. So we probably played a pretty big part in that. So you will see similar dynamics also playing out, I think, for these products in the U.S. And HUMIRA is certainly still a biologic that a lot of people are using and have had great benefits from. So I see that market having the potential to expand even further.

And how should investors think about Alvotech and CapEx investment? Should manufacturing facility that you have as you take on more volume, I don't know if you have characterized what proportion of your capacity is being utilized as you take on more, how well you're positioned to do that? Or is there an incremental CapEx investment that needs to be made?

Great. Two things. Firstly, our current capacity that we have installed. And this is, again, I would say, I would chalk it up to the foresight of the management with sort of the company and established. So we are good for capacity, not just up to 2030, but beyond 2032. So we do not need any substantial incremental CapEx. So our CapEx requirement for this year is around $60 million to $70 million. And this is not going to increase substantially. So we are really good on current capacity. And what it means, of course, is that as we have more products in the market, as we get more products commercial, we will see the benefits of this capacity translate into a substantial operating leverage advantage as we start to expand further and our revenue goes from $600 million at the end of this year to, let's say, $1.5 billion by the end of 2028, we'll see the operating leverage impact come through with no incremental capacity, no incremental or no substantial investments needed.

Yes. And remind us, I mean, you have one dedicated facility, right? So how do you sort of approach the idea of having some redundancy manufacturing-wise in the event of if there were ever any sort of FDA inspection issues that maybe emerge, how reliant are you on a single facility and those dynamics?

Yes. This is, of course, not something where we can publicly talk about all the different aspects of it, but we do have some contingency planning for this. And we have already put in place some contracting.

So it's inevitable, right? When we have a business like this, and you rightly called out because ultimately, having this HUMIRA set back 2 years ago was really a lesson for us also, right? So we have multiple partnerships, multiple discussions in place, and we have MSAs in place with partners as a contingency plan, as business contingency plan. So not something where our revenues or targets should be threatened if something happens.

Yes. Okay. Maybe shifting gears to another product-specific question, biosimilar EYLEA, which is an interesting target. Amgen recently launched, it looks like they're having pretty good early momentum with -- I believe they have a low-dose version of EYLEA, which I think makes up 70% of the dollars for the innovator company. You have a low-dose product that's pretty far along. Maybe just level set in terms of timing there and kind of how you're seeing that market evolve?

Yes. So this is a very interesting space to launch into right now. Most of our competitors are either exempted or are in litigation. So we see that unless that is settled, they will not be able to launch until 2027, but we will have the ability probably to launch very soon after we get approved. We have also basically been working on the formulation as Amgen did. So that's another factor why we're in this position that we are in right now rather than what the others are facing.

We expect to be in market next year.

Yes.

And is it important to -- do you feel like based on what you're seeing with Amgen and where the market splits that a low-dose alternative to EYLEA can be highly competitive in the space? I know you have a high dose that's earlier back in development, but just trying to understand the importance of does the high dose enable you to more fully compete maybe in a smaller subsegment of the market and what's the value of each of those presentations?

Yes. We see the dynamics in the EYLEA market. I'm talking about the originator with respect to the high dose versus a low-dose version is still playing out. And as you pointed to, actually, in value terms, they are already -- it's a significant share of their revenues from this EYLEA molecule. And so we think that is still evolving. There are certain dynamics of, for example, the delivery mechanism is still being approved, and that could also increase or ramp up the adoption of the high-dose version. So we certainly want to be ready for that, and we are ahead of the competition with our development of the high-dose version.

And is there any -- we oftentimes hear about this space and the buy-and-bill dynamics as something that will the eye care professionals that do these intravitreal injections have a bias to the brand. And I guess we have one example with the Lucentis launch to point to and how these behaviors evolve when you have a low-cost alternative available to you. So I'm just kind of curious, if you see that as a barrier to the biosimilar adoption curve? Or you see this as a -- and where this kind of fits in the spectrum of the oncology launches and biosimilars, you have these PBM immunology drugs and now you have the ophthalmology products.

I'll address that in general, and then Benny will have some more specific comments around EYLEA itself. I think in overall, with the buy-and-bill segment, what we have seen and I'll go back to the earlier example that we discussed of UDENYCA, clearly, there are incentives for prescribers to move to biologics -- to biosimilars, beg your pardon. Having this ASP plus 8% reimbursement is a substantial incentive to them, and we saw one of the reasons why UDENYCA had such a rapid conversion, right? So we would expect similar dynamics here. Anything on EYLEA that you want to share?

Yes. I mean I think we've seen some data from surveys of ophthalmologists and so on that show that they are certainly open to this, to prescribe biosimilars to the patients. And I think this is just something where this is going to be sort of one of the first markets to evolve in this way in the ophthalmology segment. So we'll see how that plays out, but we still see that the biosimilars have an entry.

Last question, your current mix of partners, do you see these as partners that are committed to the space and partners that you want to continue to like sort of do business with and simplify your business dealings versus having a disparate set of partnerships? I'm kind of curious how you think about that?

It's a great question and probably a good one to leave it, too. I mean we have gone through extensive search before ultimately landing on these partners, right? I mean take, for example, Teva has been a phenomenal partner for us. The partnership has been great for us, even going back as far back as helping with the regulatory approval, as we all know, 2 years ago. And then there is Dr. Reddy's and Advance Pharma or STADA. These are all like very, very dominant players in their respective geographies. Reddy's has been a phenomenal competitor in the U.S. The company has been present for 3 decades and has a great brand and reputation in Europe, too. So -- and likewise with Advance and STADA. So clearly, we would think that any partner that we chose will be similar in terms of commercial strength and reputation as these partners. And the current existing partnerships, again, have been holding us in very good stead. We don't see any substantial changes to that.

Okay. We're out of time. So gentlemen, thanks for joining us.

Jason, thank you so much for inviting us, and have a great conference.

Thank you.

Thank you very much.