Company presenter at the BofA Annual Healthcare Conference, Jason Gerberry, pharma and biotech analyst. Pleased to be introducing Alvotech and Balaji Prasad, Chief Strategy Officer. Balaji, thanks for joining us. Always a pleasure, Jason. Thank you for having us over. Yeah. Maybe first just, if you wanna level set the conversation, can you maybe walk us through some of the key developments at Alvotech over the past couple of years, just to give us a sense of your current partnership structures and approved biosimilar products across your key geographies? Sure. Thank you. It's almost around two years since we started being commercial in the U.S. market with the launch of biosimilar Humira in 2024. Since then we have had a bit of a ride in the globally in the U.S. and all. We launched biosimilar Humira in 2024, and in February 2025, we launched biosimilar Stelara. Just soon after, we filed for couple of biosimilars, including SIMPONI ARIA, PROLIA, XGEVA and EYLEA. We have come through this path where now last year we delivered around $600 million of revenue, just about, and we delivered around $140 million of EBITDA. We have guided to around $650 million-$700 million of revenue this year and around $180 million-$200 million of EBITDA. Now, that's on the what we have done on the commercial side. On the pipeline side, which is where the more interesting story for us definitely is, we believe we have one of the, if not the largest biosimilars pipeline globally. We have a total of 32 assets, of which five are commercial right now, 12 of them in the U.S., five of them in the rest of world markets. We have another 15 disclosed assets and around 15 undisclosed assets for which are still in develop stages. This pipeline, I think, is what truly differentiates Alvotech from a lot of our peers. I believe that six of the next eight to nine launches that we have are going to be limited competition launches for us, where we'll be seeing limited competition, being one of the first to market and definitely look forward to the next phase with a lot of excitement. Just to balance the story, I also definitely want to call out the FDA inspection that we had last year. We are working through fixing the Form 483s that FDA had, and we're working through the process improvements for it. We have commented as recently as last week when we had our 1Q earnings that, we are going to be resubmitting these in June, in the coming month. We're looking forward to getting that done soon. Okay. With respect to that inspection and how that impacts pipeline, that the impact was CRLs to three of your pipeline programs specifically? That is right. Just to clarify, maybe getting back to what happened. Last year, around late June and early July, the FDA had inspected us. This was for a pre-approval inspection. They finished a week of inspection and then gave Form 483s with 10 observations. We had responded to them in detail later on. Unfortunately for us, our PDUFA dates for SIMPONI and PROLIA started hitting soon after, so there was not really enough time for the FDA to get through these things. The FDA issued a CRL stating that they need the observations on the facility to be rectified before they can approve new products. Yep. We had no impact at all on what we are manufacturing and selling to the U.S. every single month. We are shipping out Humira and Stelara, no issues with it. The FDA, to answer your question, didn't have any issues with the product itself, but were more like addressing the facility observations that they wanted to see us fix before approving any new products. Yep. In terms of process, has there been feedback on your responses, or is the next step in all this just we agree that, you know, your steps to mitigate have been successful, and you're gonna get approvals? Yeah. Once we submitted our response, we got a action letter in December 2025, which we are awaiting. There the FDA said ultimately it just boiled down to three observations. We have addressed all of that. Right now we have compiled enough data over the last six months to show that these improvements that we have made are sustainable, can be reproduced, and that we can really ensure that this is valid for a long time. I think one of the decisions that we took, painful decisions we took as a management team, was to really to ensure that we not only go and address the immediate and near concerns that FDA has, but ensure that the processes are robust so that over the longer term we are going to be on the right side of the regulations every single time, of cGMP requirements every single time. Towards that, we also took some production slowdowns, multiple production slowdowns, which was a conscious decision on our part, and we thought that was the right call to do. Of course, that also impacted our last couple of quarters' numbers, but we'll get back to normal normal trajectory soon. For these three, the remediation efforts were, you know, there was, you know, a slowdown so that you could implement, I guess, certain changes in the nature of the three outstanding observations. How would you at a high level frame those? Are they, you know, easier fixes, kind of in the middle, more challenging fixes? The three observations related to use of silicone lubricant. We got in touch with the manufacturer of the machine, and we have done away with using the lubricant. The second one was related to the complaints handling process that we had. The FDA wanted us to fix that. The last one was related to microbial contamination, which is one where we generated a lot of data, did multiple process improvements, and that's one that we'll be now submitting all of this. To continue on, in June, we have said that we are going to resubmit, and that sets us up immediately after resubmission, responding to the FDA, we'll resubmit the three BLAs. Which will set us up for a six-month clock for approval. If we submit in June, we expect approval by December of this year. Somewhere in between there is a re-inspection part of that process? That's a great question because it also segues to something that we announced two days ago on Monday. 10 days ago, the FDA landed at our facility in Reykjavik for a surprise inspection. We commented on it in 1Q and also announced on Monday that the inspection concluded with a few observations that we believe are absolutely manageable. A good way to look at this is to think that, okay, if these observations were challenging, then our resubmission timeline next month would not happen. We have said that we are going- Yeah. We will be resubmitting. We believe the observations are manageable, and we'll address it and resubmit next month. For this particular process, it is likely that the FDA may decide to re-inspect us, or there's a possibility that they may also not re-inspect us. We are preparing as a company. We are ready to be inspected by the FDA any single day, and that's the motto. We want to be ready, and we want to ensure that these are processes that we are through. So we'll be ready when the FDA comes to inspect. Yeah. If they come to inspect. Which of these three products do you feel like is maybe, has more of a time sensitivity to it to enjoy maybe better market exclusivity dynamics as you look at the market conditions, competition, things like that you guys would be most eager to get your product into the market on? Yeah, absolutely. The three products were SIMPONI and EYLEA and PROLIA. Of these, SIMPONI is the one we were and we are most excited about. Next is EYLEA, and then PROLIA. PROLIA was a competitive market, and we always expected it to be competitive and so, limited expectations from it. SIMPONI, on the other hand, was one where we were expecting and we still hope to be the first to market. There's only one other player on the market. Not on the market. One other player in contention who has a PDUFA date in this month, in May, and we're looking to see what happens there. Again, the dynamics, it's a buy and bill market, completely different. The commercial opportunity for us, as long as we're concerned, is completely intact for us. We have a strong commercial partner with Teva, we believe that we can completely tap into this. EYLEA, irrespective of whether we got approved in Q4 of last year or Q4 of this year, it's a settlement for us to launch in Q4. The commercial impact is minimal. There's no commercial impact because we would be launching at the same time irrespective of it. Of course, assuming that we will get approval in Q4, and we do strongly believe that we will. Okay. Yeah. Apologies, I SIMPONI, my recollection was part IV, part subcutaneous in terms of. That is right. Is it all buy and bill, or are there different channels? Yeah, I think. Is there channel-specific strategy that you think about here? We'll speak more about the commercial plans and the strategy as we get closer to the launch. You're right in that observation, and we have both formulations and both forms, you know, for this drug. I see. Upon approval, you're saying it w ould be for both presentation forms? Yeah. Okay, cool. Maybe just on the Fujifilm partnership, you recently announced an agreement with FUJIFILM Biotech to expand your global manufacturing network and establishing a second source of commercial supply in the U.S. and the U.K. Maybe if you can just elaborate on what drove the rationale behind that decision. Sure. I'm glad you asked that because that's something that we have been extremely excited about and happy to announce last week. The rationale was, A, we have one of the largest pipelines in the biosimilar companies, in the biosimilar world, and we want to ensure that we have capacity beyond 2030. What we always said in 2024 or 2025 is that we have capacity to meet a global demand from our Reykjavik facility up to 2030. Sorry about that. It's okay. We have announced that we have capacity up to this time, but we also want to be ready for the future. That's where this partnership comes in. More importantly, strategically, it also de-risks some of the dependency on the Reykjavik facility too. There's that aspect which definitely plays a role. We did always think about a U.S. manufacturing base, and it gets us that one too. There are several advantages to having a U.S. manufacturing base. It brings multiple benefits for us in having this partnership around. Currently we are involved in tech transfer to this site, and we said that it takes around 12 months. From second half of next year, we do expect to be manufacturing out of here and selling in the U.S. from this facility. When you think about layering in redundant, manufacturing, capacity, is that something that you, in the future, would envision go to market if you have two sources lined up, or is there, like, a lag? How does that affect the investment costs in getting a biosimilar to market to have dual source as opposed to, say, single source? No, I mean, there are definitely cost aspects to it that we'll consider on a product-by-product basis. We'll see whether it makes sense for us to have a single source or a dual source supply. It's going to be product dependent and also dependent on the competitive dynamics within the product and how attractive it is. Most likely that we'll be looking at core assets and really thinking about how to secure the supply for these assets that we think are extremely important for us from a commercial perspective. I think, we'll definitely give more color on it when we get to each of these products in the future. Anything you guys are saying at this point about the timing for, say, established products that you already make and the timing for manufacturing capacity coming online? Is this gonna be more about the future pipeline? No, I think the tech transfer that we are currently involved in, that is for the currently commercial products right now. Okay. That's one way want to get out of this facility to start with. Okay. Maybe then shifting gears to pipeline, and last week you announced that you've submitted an MAA with the European regulator for biosimilar Entyvio. Maybe how you're thinking about this, you know, market for Entyvio both in Europe and the U.S. and, you know, what does the competitive landscape look like now? Sure. Amongst our next wave of launches, apart from the three that we hope to get in December, where I called out SIMPONI, I think the next ones that we're most excited about is Entyvio. We expect to be the first to market, we expect to see this limited competition, have a fairly long window of this competitive advantage period, with no other company coming through. We're excited about it. I mean, it's a multi-billion dollar market, both in the U.S. and in Europe, and we just launched in a couple of markets in Europe on approval. All of the assets that maybe not Entyvio, beg your pardon. We're set that we'll be expecting to get approval so next year, and we'll be looking to launch. Got it. The status of the biosimilar Entyvio is it's sorta filing ready, or there's still some additional steps to getting it to be filing ready? Yeah, we have said that we will be looking to file this year- Okay. for the U.S. market and, get approval next year. You said limited source. What's the visibility? How many potential entrants could be there? As far as we can see with our market intelligence, there's another company out there, and, at least in terms of being, in one of the first waves. Then we'll see. We believe that we have at least one to two years of competitive advantage period. Okay. It's a little surprising, just given size of that, right? Isn't the revenues north of $5 billion or so? Yeah. Yeah, I think we have seen those, we have seen those for multiple reasons. Either companies have not gone after it, and we have had this, we've had this thing or woken up to the commercial attractiveness of it a bit late, and that gives us that advantage where we've been able to get it. It, it's ties up to a bit something that I've commented quite often, that we are one of the best development teams in the biosimilars universe. Best research and development teams in the biosimilars universe, and which is why we have been able to have this asset like Entyvio or EYLEA high dose. We just announced that we started confirmatory trials. That's again another critical asset that we believe that we have at least, like, one to two years of advantage over our closest competitors. That's one of the things which really differentiates us to bundle in with this. We have like another four to five assets where we expect to see limited competition in the near future. Yeah, I mean, my general understanding is you need a constant cadence of launches to be really successful in this business. Perhaps some of the companies have started to exit the space. T hat is to the advantage to you, right? Where you see these opportunities now where, you know, an entity like Organon may be under-invested in biosimilars because of balance sheet constraints and trying to manage certain EBITDA targets against challenging growth dynamics. Do you feel like there's some competitive whittling away finally? I know it's, like, been, like, the long promise is last man standing, right? Yeah. You would stand last or something like that. We have said this out in the public too. I think the industry, we won't be surprised to see some consolidation continue in the biosimilars industry. I mean, you and I know, we have seen a couple of exits in the last few years. No need to name them, but we have seen a couple of exits. from the biosimilars space. I as an analyst at the time thought that was a strategically a wrong decision, and I still believe that. It does whittle down the competition for us, last man standing. I think there are a few who are serious contenders with pipelines of 25 to 30 assets coming close to us, and we think these are the ones that will stand out and really differentiate in the market. Okay. Yeah, is the observation that changed in terms of what the typical product life cycle is before, you know, a biosimilar launch may turn from a source of positive growth to a decline? You know, some analysis when I looked at maybe the first generation, second generation of biosimilars was you got about three to four years of growth and then you started to see some compression. I don't know if those factors were price or more kind of just competition and volume driven. Yeah, it will be a function of competition, competitive dynamics for sure. I mean, we have seen, I would say, three waves of differentiated biosimilar launches. Let's say 2015 to 2019, biosimilars struggled, as we saw, to really gain traction. The innovators managed to really build a ticket, a moat around their brand and just use patent thickets to protect their assets. We saw it's come, we saw biosimilars struggle, right? 2019 probably was the one where we saw some meaningful launch with [Hukyndra] and the pegfilgrastim space. Since then, we saw a couple of biosimilars achieve pretty good success in the U.S. market. Again, addressing this from a U.S. market perspective. Humira was the one where it, the third wave I would say, which had totally different dynamics. Pharmacy reimbursement, eight to nine players. Stelara was also close by. Both of them were similar in terms of that nature. Competitive pharmacy dynamic, reimbursement, private label played a role, all of it, right. I think the next wave of assets that are coming through are mostly in the buy and bill space. Very different competitive dynamics for these two. In terms of peak size and sales, so that's why I said coming to it, four to five years would be a good number to look at, again, depending on what the competitive dynamics is, but four to five years. More importantly, after you reach a peak, you're not falling off a cliff. There's still going to be a fairly stable tail life to these assets. Unlike, let's say, in the generics world, which makes us, I would say on a general observation, not so dependent on new launches, unlike in the generics world, where you had to get, like, 20 new launches every year to be able to sustain the revenues. Yeah. Do you see the role of private label as a long-term trend in this space? You talked about some buy and bill launches versus sort of an outpatient, you know, subcu. I&I drug like Humira or SKYRIZI eventually. Like, are those, you know, the sort of categories where the private label entities will just opportunistically swoop in on? I think private label is going to be of less importance for the next wave of launches compared to Humira or Stelara, just for very obvious reasons around the way the drug is dispensed and all of it. I think it's going to be of less importance. Even with Stelara, I think we had said that we were de-emphasizing on the channel, and we had other ways where we thought we could gain better traction and better value for our product, and we de-emphasized the private label route. Okay. Maybe just thinking about the commercial opportunity for SIMPONI and low-dose EYLEA. For starting with SIMPONI, you have one other identified potential competitor. Yeah. You get approval sometime in second half. Potentially, this is roughly a $1 billion-ish net sale product, I think, in the U.S. Correct me if I'm wrong. It sounds like with having a subcu, having an IV, you can kind of compete broadly here? I think we're in a very strong competitive position with regard to SIMPONI, and so we definitely look forward to getting approval and getting this product out in the market, through our partner as soon as possible. Just of course, the competitive nature of it and the fact that the other company that we have spoken about, we'll see if they get into the market and when they do enter the market, if they're post-approval. I think the opportunity is intact for us, and I think we are in a very strong position competitively for it, so it should be a attractive one for us to look forward to. Yeah. EYLEA, there are a few players in this market. Again, for us, with the fact that we have high EYLEA dose in a couple of years from now and we just started trials on it. I think the fact that combination of these gives us some strategic advantage. Yep. When we look at the behaviors of, say, an AbbVie with Humira or a J&J with Stelara in the U.S. specifically, right? Can you kind of discern how much that seems like they may be dropping price somewhere 30%-50% year one and hanging on to volume? Is that a playbook, so to speak, for the brand companies where they're seeing how they lifecycle manage and mitigate the impact and pain that biosimilars drive to their brand? I think, ultimately anything where biosimilar penetration has not been achieved is only going to invite regulators and policymakers to look at this and say, "Why is this product even four years after patent expiry, why are biosimilars not, like, getting more than 50% share? Why are they not at 70% or 80% share? Cause in Europe, I mean, we have seen 80%-90% penetration for most of the biosimilars. Yeah. If you don't get there, I'm sure at some point, policymakers will need to and will be looking at this and wondering what's happening here. Yeah. Yeah. Is that gonna be driven by, what is it, AAM or the policy group that represents low-cost providers of medicines in the U.S.? Like, is there a push at all to drive some of those changes? What makes that something more concrete, I guess, is my question. I think it definitely is. I think AAM, of which we are a member to, has been quite in the forefront for this in terms of ensuring that there's greater access to lower-cost medicines, both on the generics and biosimilar side, and especially now the biosimilar side because lot more value, cost savings that can be achieved on the biosimilar side and that has been the focus, and they've been able to gain significant traction with the regulators on this. Okay. EYLEA HD, is this going to be a situation wherein you launch this, is a lot of the volume shifted to EYLEA HD, and so you're trying to drive maybe a shift away from the HD utilization to the low-cost LD? I don't cover Regeneron, so I don't know where the splits are at the moment in terms of the opportunity there. Yeah, I mean, high dose is the large one of course, and Regeneron is definitely shifting significant amounts of volumes from regular to high dose. Understandably because you'll have like, you'll have a few biosimilar versions coming through by the end of the year. Yeah. They want to protect their EYLEA franchise. Understandable. For us, I think this competitively it just makes it better for us because EYLEA we expect to be one of the first market. Yeah. Have this period of where we think that we are a couple of years ahead of most of the competitors there. Okay. It works out well for us in terms of like, future assets and future value that we can generate from it. If you wanna outline, if you could, just the cadence of launches post-2026. We've called out biosimilar Entyvio, and then we have Xolair in Europe. We have a couple of other assets that we have called out on near to medium-term opportunities. Beyond this, we're looking at CIMZIA, we're looking at TALTZ, and many of these are limited competition products too. I think those ones we'll be looking forward to. You know, we were talking before this, right? There's some big chunky biologics that come off patent technically by the end of the decade. Yeah. We know these are gonna be competitive spaces. How do you approach that? Do you just say, "Hey, we have to be there because we're a leader in the space," or do you forgo those types of opportunities? We've disclosed KEYTRUDA amongst our assets and it's going to be a competitive market. The economics for this, just the sheer size of the market molecule, it may not directly reflect it, but at least it's still such a large market that there'll be something for everyone. That's the way we think about it. Secondly, I think also having this portfolio approach too, helps, especially for us with these, some of the assets that we are launched by then, just having this portfolio really helps in getting some traction there too. Would it be something that we would be really excited about and flag and call it out? Rather unlikely, but it is an asset that we will be getting it out. What we did strategically, though, which is very interesting, is, we have partnered with [Operatis] on it and where we share the development cost. We bring down the cost of development for us by half. We share the development cost, and we'll be, looking to get it out when, at the right time, so. This segues to, you know, when we think about some of the more established products like Humira, how does the portfolio benefit you with, like, the new product introduction, right? If you're trying to win the big contract with CVS, right? A big contract within the space, how does having a lot of other things to offer give you, basically give you a foot in the door? Is there the opportunity to maybe do bundling or anything along those lines? Yeah. I'll address this rather in a generic way, but I think it's a no-brainer, right? There, over the next 15 or 10 years, 12 years, there are around 120 biologics going off patent. Having a bundle of these biosimilars, biosimilar versions of this, definitely helps in having discussions. As we started discussing around the industry and the trends of consolidation, if you are just a one or two trick pony, I think you will be irrelevant in a couple of years from now. Which is where I think having this broad portfolio, this pipeline, really gives us a strong seat at the table. Okay. Maybe just with Humira, Stelara, current U.S. or U.S. market dynamics, where you see the growth opportunities with each. Sure. Let's take the one that we launched last year, Stelara. We have said that we are de-emphasizing the private label. The formulary partner, Teva, is doing a great job on the formulary side and getting a lot of traction. Humira, we have the second-largest market share, with 10%+ market of the biosimilars. Stelara, we are winning multiple downstream contracts, so non-branded side. We are gaining a lot of traction there, at a economics which really reflects the value that we bring to the table. We are definitely getting wins on both sides. Is pricing holding up better for you as a biosimilar entity in U.S. or OUS market? It ultimately translates to sort of revenue and margin, but, you know, when you think about those markets. Yeah. We have said that, in general, I think with some of these assets, Europe has been a pretty attractive market for us. Japan again is another pretty attractive market. The U.S., I think, Humira because we have the interchangeability and the exclusivity on it, that helped. Stelara is one where we called out that the pricing as one which we saw some of competitors go down to pricing that we decided not to compete on pricing at all. We'd just be undermining the value that we bring to the table in following the pricing curve. We stuck to what we think is reflects the value that we bring. There are different dynamics definitely on the Stelara side. In the next wave of launches, I think those things will probably be less material just because the nature of the products, the reimbursement dynamics, and the limited competition nature of this. Let me get you out of here on this. FDA seems to be lowering some barriers to entry and expediting review process. How does this impact either development costs, like speed to market? How should we think about some of those trade-offs between opportunities and competitive risks? Yeah. I can think of four ways that it impacts us and impacts it, right? Firstly, development cost definitely goes down, not having to do clinical trials for at least some of the assets, not for all, brings down the overall cost of development. Two, it also compresses the timeline. I think where we would say initially six to seven years, we now say five to six years. Three, what it does, I think, which I think benefits us a lot, is that FDA, while it may not ask for clinical trials, is going to focus a lot more on analytical data on the data that that's generated. I think that is one of our strongest points. It really plays to our strength there. A function of all of these means that we also are able to now go after more programs at the same time, just in terms of being able to use the limited resources that we have and just expand it to by one or two more programs. Which we anticipated two years ago, and which is why we have, like, one of the largest pipelines in the world on the biosimilar side. We did anticipate this and factored this in and expand our programs accordingly. All right. Great. We're out of time. Thank you so much for joining us. Of course, Jason. Always a pleasure, and thank you for inviting Alvotech. Always a pleasure to speak to us, and thank you for this. Yeah. Great. Thank you.