Hi, everybody. Ash Verma here, covering SMID-cap biotech and SMID pharma at UBS. I'm very excited. Today we have Alvotech for a fireside chat, and Balaji Prasad, who's the Chief Strategy Officer. Hey, Balaji. How are you?
Ash, doing great. Thank you very much for inviting us and hosting us on this. Appreciate it.
Thanks a lot. This is our third Virtual Generics and Biosimilar day. A lot of people listening in, so I'm looking forward to having a good discussion with you on the story. A lot of different exciting developments that have happened right in the recent past couple of week. Would love to dive in. I'll just give a quick reminder for folks. As you know, XLII is going on. I'm in the SMID pharma and SMID-cap biotech category. For the investors who are listening in, feel free to, if you like our research, interactions, events, stuff like that, would love to get your support. I know, Balaji, you were also on the same side of the aisle not too long ago, right? You understand the drill.
I'm going to open up to the audience at a later point of time, once we make enough progress on the conversation here between me and Balaji, and then we can ask more investors to come in and ask questions if they want to. With that out of the way, if you can just give us a little bit of a quick overview, Balaji, on the Alvotech platform, like what is your kind of capability as it stands right now, sort of a overview of the business, just briefly, before we get into more specific questions.
Yeah, sure. Absolutely happy to jump into that, Ash. Before that, let me also say thank you for doing this investor event focusing on generics and biosimilars. It is a very important sector. We all should know that, but the fact that you give it a focused attention for a day and host this is commendable, so thank you for that. Coming to Alvotech itself, let me start with a brief overview. We were set up incorporated in 2013. It was set up from the get-go as a pure-play biosimilars-focused company. One of the very few biosimilars-focused company globally. We have completely vertically integrated infrastructure in our large facility in Reykjavik. Based out of there, and over the last 12 years, we have invested more than $2 billion into this platform and the portfolio development.
What we have as a consequence is more than 30+ biologics under various stages of development, commercial ones, five commercial products, all of it, and we believe we have the largest pipeline, if definitely not one of the largest pipelines in biosimilars globally. The big differentiating factor for us within these biosimilars in this pipeline is that a lot of these are differentiated assets where we are first to market or one of few to market. It's a limited competition opportunity, technically difficult, multiple reasons for companies not to have been able to come there. Alvotech has been able to bridge that gap, and we are there. One of the key data points as I was looking at recently was that we expect five or six of our next eight launches to be into a limited competition field.
Couple of them will be one where we'll be the only ones for a fairly long time. We're really excited about this player, the next phase of growth for Alvotech after being a commercial company two years ago in the U.S. when we launched biosimilar Humira. Beyond that, as look, this call today is also very nicely coincidental for us because we just had a couple of major updates from our side, including the resubmission news that we announced last week, late last week.
Yeah.
Also, FDA acceptance of our biosimilar to Entyvio earlier this week. Pretty opportune time for us also to be discussing this. As we look further down, I think over the next couple of years, we'll look to bring many of our differentiated assets into the market. We are at the edge of a critical inflection period for Alvotech, looking at a period of explosive growth over the next couple of years as this large wave of biosimilars comes into the market and the opportunities comes into the market. We are ready to be one of the most critical players in the space.
Yeah. Wonderful. That's great. It seems there is a, we did this analysis just recently as well, kind of what you're alluding to, that there is a massive TAM that is opening up over the next five years. We look at $250 billion and more than 80 product opportunities opening up. Obviously, when you're focusing on biosimilars, it's you've shown, demonstrated pretty decent commercial execution, on the products that you've gotten approval on. When you think about the U.S. market opportunity, what are some of the key winning success strategy, to maximize the revenue opportunity for someone like you?
Sure. Firstly, an overarching statement is that, by design and by intent, we set ourself up as a B2B platform. We do not sell commercially anywhere globally. We have our 19 partners globally who provide us access into 70 - 80 countries. For the U.S. market, our key partner is Teva. Teva is the one who's launched, biosimilar Humira for us, biosimilar STELARA, been a very good partner on multiple ways. We'll also be launching the next wave of our assets, including the EYLEA and SIMPONI and all. We also have a partnership with Dr. Reddy's. We'll be launching PROLIA. Coming to what are the most critical success factors, definitely speed and execution play a big role, we're having a vertically integrated infrastructure that I called out earlier which really helps us.
Apart from these, I think from a purely commercial standpoint, being early to file or the first to market is a strong differentiator. What we have seen is that there is definitely a first-mover advantage for the first, I would say, two to three players in the market, then it also tends to be fairly sticky, especially from a longer-term share capture and tail perspective. Blend of all of these and maybe further down the not so obvious factors which are pretty important is reliable manufacturing. We have, as I said, one of the largest biologics facility in Europe and Iceland, where we have said that we have enough capacity to supply up to 2030.
We have a very strong channel strategy, our commercial partners and very strong linked partnerships strategy with Teva or with JAMP or with Fuji means that we are fully integrated into the commercial planning and execution. That really also helps us a lot. That is why as we speak today, we have the second-largest market share in biosimilar Humira. We are gaining significant market share in biosimilar STELARA, we are looking forward very eagerly to the launch of SIMPONI and EYLEA regular dose towards the end of the year.
Yeah. Great. I think this is good to get more information on. When we look at some of the filings that you've put in here, like for SIMPONI, EYLEA, Entyvio, I know there has been a big focus on this, in terms of where we are right now. You've submitted the filing, basically, like you said, by end of 2Q it will be in, and we saw that it's worked out perfectly from that standpoint. From here, obviously a lot of focus on regulatory approval and what we'd love to understand is what's your confidence level that you should get an approval. Are there any steps along the way that you would inform investors on any milestone, any interaction with the FDA as you're going through the process? Just help us understand what can be along going forward from here.
Yeah, absolutely. Ash, when, the FDA visited us last late June and early July, issued the Form 483s, later on in September, they came out with a post-action letter stating that there were three pending observations from these Form 483s and considered the other seven resolved by then. As far as the path forward was very clear. What we also wanted to, and Ash, this is extremely important to emphasize, is that we are not just looking to address the FDA questions just from this post-action letter, but to really put the firm in a very strong position of what I could almost say call it FDA approval, regulatory agency proof over the next few years. Which is why we as a management team took the conscious decision to really strengthen the processes beyond more than what was just being asked.
We went over, we implemented nearly 200 CAPAs over this period, collected abundant data that led us to the resubmission now. In the process, and I'm sure we'll discuss it later, we also implemented multiple slowdowns and shutdowns, which had its implications on the P&L of the last couple of quarters too. We decided to take that and invest that into strengthening the firm from a longer-term perspective. Right? We were extremely-
Right.
... happy to have submitted these, resubmitted the BLAs, responded to the FDA, resubmitted the BLAs on June 4th, which sets us on a six-month review clock and a potential approval by December 26. How do we feel about it? We feel extremely confident about it. We think that we have done more than adequate what is needed. Of course, there are always two parties to this. There's still the FDA which will need to say that they're okay with us. With regard to this, one of the things which also played out to our advantage was the surprise inspection by the FDA in the first week. That was a CGMP inspection. What we had last month in the first week of May was a CGMP inspection. The inspectors went through everything in detail, and obviously they had the benefit of the previous observations, too.
In fact, we, as a management team, requested the FDA to look into the specific observations that were mentioned in the post-action letter. One of those few instances where a pharma company actually requests the FDA to inspect us more thoroughly and said, "Please look into this and give us your thoughts." They checked all of it. That gave us the further confidence and validation, not just by some ex-FDA inspectors, consultants, but current FDA itself, too. From here, what is the path forward? We have resubmitted the BLAs, start six-month clock. We do not know at this point whether the FDA would plan to re-inspect us or not. They could or they could not. We will look into that.
Come December first week, I believe and hope that we would have received the approval and be looking to and getting up for a launch immediately.
That's great. I think inspection, from our research perspective, seems a little bit unlikely given that you've just recently gone through that and you've clarified some of the steps with the FDA. For these filings, are we going to get to know when they accept the filing? Do you typically disclose that? I'm trying to understand, is it between now and December first week, is there any information that you would be providing on any interactions with the agency or acceptance?
I think if you look at what almost all our peers have done in a similar circumstance, Ash, there's limited information that we would give out, right? This is an ongoing process. Sometimes it could be an ongoing process. We'd love to provide some updates, unlikely that we'll provide an update before the approval comes through on December.
Got it. Okay.
If there's something incrementally that we can provide some color to for investors, if there is a scope for anything at all, we will always be happy to look at it. At this point, there's nothing that I can guide towards.
Yeah. That makes sense. Okay. In terms of how should we think about the approvability of SIMPONI, EYLEA versus Entyvio? I mean, is there any obviously, your partner submitted the application, right? At the end of the day, the prior CRL was just around the manufacturing facility. There wasn't any type of issue pertaining to the molecule or clinical data that was highlighted by the FDA. Just correct me if I'm wrong.
Yeah.
If you have addressed the manufacturing plant issue and FDA is comfortable with it, that should mean the same outcome for all three, irrespective of who filed it.
Yes. I would agree with you on that. We were, in fact, very relieved on, of course, there were no observations or pushbacks on the BLA itself, on the quality of the data, on the evidence that we submitted, and the BLA package itself on any of the three drugs that we had submitted. If you look at the CRL, probably in the public domain, but if you look at it, what the CRL states is there are outstanding issues with the facility, and as long as the facility issues are outstanding, we'll not be approving these new drugs. That gives us a lot of confidence. We still need, of course, get the approval in hand-
Yeah.
... to be fully confident. Of course, we believe and are sure that we have done everything that could have been done. Between SIMPONI and Entyvio, I think I'll be speculating at this point. We can't conjecture there, but the one point that I'm going to say is that with all our applications till date, we have never had FDA pushback on the quality of the data, on the quality of the product itself or any such clinical questions. We have had 100% success record with regard to that. It's on the facility side that we have had twice these delays.
Yeah. Got it. Okay. Maybe just take a quick word on the commercial opportunity here. If you look at SIMPONI, obviously, you have potential first to market, and then PROLIA. That's something that'll be done by Dr. Reddy's. Then EYLEA, if you can talk about it, just how do you see the competitive landscape by the time that you get to the market ?
What we have said is, so purely in terms of the commercial opportunity, let me start with how we have thought about these three assets. We are always excited. We have always called out SIMPONI as the one of these three assets, which was the most attractive for us, considering that we'll be in a very limited competition space for this drug, right? SIMPONI, as we speak today, there are only two known filers. It's us and Bio-Thera. Bio-Thera got approved on May 16th or May 17th. Then we saw Fresenius stating that they are looking to launch in Q4 of 2026. Instead of being approved in Q4 of 2025, we are now looking towards approval in Q4 of 2026. The commercial opportunity for us is very much intact, even when we launch in Q4 2026. Yeah.
There is no delta change in the commercial opportunity. Time is intact for us. Of course, what was there is the opportunity cost of not having launched a couple of quarters earlier. I acknowledge that. The second one is EYLEA. Again, EYLEA regular dose. As you know, most of the players in this phase are settled towards a Q4 2026 or a Q1 2027 launch. Again, in terms of a commercial opportunity, even if it had gotten approved last year, we would have come in and launched only in Q4, where we have a settled date with Regeneron. Yeah?
Yeah.
Zero commercial impact per se. The last one was the one which we have always called out as the most competitive and probably the least attractive of the three. The least revenue-generating of the three was PROLIA, and that still is the case. Again, because of how it was in our pecking order and the relative position of this asset within these three drugs, again, no commercial impact there for us.
Yeah.
It didn't contribute much in our earlier plans, and it's the same now, too.
Got it. Okay. All right. Perfect. This is good. Maybe I have lots of questions, but I actually want to just open it up here. Operator, maybe if you can open up and see if any of the investors listening in want to ask questions.
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Okay, perfect. Yeah, let's talk about Fuji Pharma, right? That's a big strategic step for you, obviously, just securing a secondary source of manufacturing capacity. I think where I was trying to understand the implications of this. I think some of the companies, like some of the companies that we're hosting today even, and others that I talk to, they talk a lot about just the advantage of vertical integration through and through. When you think about that for you guys, do you have a reliance on a CDMO for the U.S. market? Does that challenge the notion that vertical integration not necessarily is as big of an advantage as some of the other companies are claiming it to be?
Again, let me clarify that stance, Ash.
Yeah.
I think we also had this discussion probably around post-earnings calls. We are a vertically integrated company, right? Where everything from research and development up to manufacturing happens. It is the commercial front end because of the company involved, priorities and what we are focusing on, it's something where we're partnered with partners globally. This partnership, as I said earlier, brings in significant advantage in that we are able to launch and sell in 80- 90 countries without any challenges. Of course, it also means that we share the economics with partners. The partners also bring us resources to expand our pipeline, carry four to six pipeline programs at any point of time in the year. Right? That's one. Fuji Pharma is our partner for manufacturing and is a second source of commercial supply in the U.S., as I said.
We are extremely excited about this because we have always said that we have manufacturing capacity up to 2030 at least from Reykjavik, where we have invested a significant amount of money. As we think about this next stage of growth for Alvotech, as I said earlier, we're going from a two-product company in the U.S. to five products. We already sell five products globally, and next year we'll also have additional products coming through both in Europe and in the U.S. We thought it just makes a lot more sense to have this partnership in place. Fuji is a highly respected manufacturing partner. They have the largest facility in North America for biologics. It gives us immense flexibility, right? Multiple things. One is flexibility in supply. Second, a U.S.-based manufacturing source, which has its own strategic advantages.
Third, Reykjavik will always remain the most important part of Alvotech's R&D and manufacturing network. It will also give us significant operational flexibility, too, based on particular periods of growth or otherwise, that we can leverage and push and pull with these two facilities.
Yeah. Great. Okay. Just a couple of questions in my inbox from investors. In terms of EYLEA high dose, obviously a lot of investors focusing on that. I just wanted to understand from your standpoint, what is the timeline? What is the litigation path? When do you start to think that that market can open up in a big way? I just wanted to understand how does that go.
Yeah, sure. EYLEA, both the low dose and the low dose is an extremely attractive opportunity for us, especially on the high dose side, right?
Yeah.
On the low dose, we discussed the potential approval by the year-end, and that our partners will be looking to launch soon after approval, and allows for market timing with other competitors in 4Q. High dose is very different. We believe we are significantly ahead of all our peers. We have announced that we started clinical trials. That sets us up for a filing and submission over the near to medium term, and a launch soon thereafter. We are confident about navigating the IP landscape around high-dose EYLEA, and we firmly maintain that we expect to be the first to market.
We watch the progress of the EYLEA market or the conversion of the EYLEA market from the low -dose to the high -dose market because it just increases the opportunity that will exist for us when we launch that product in a couple of years from now in terms of how impactful the high -dose market or how relevant the TAM will be at the time.
Yeah.
So-
Oh, sorry. Yeah, have you guided to a timeline for when you think you might be able to enter the market?
We have qualified that as a medium-term opportunity, Ash, because you saw that we recently announced the start of the clinical trials, and sets us up for a path towards a medium-term filing and approval.
Okay.
We're looking towards that as a medium-term opportunity. I think even earlier, we had always called it out as something that's going to be a critical part of our, let's say, 2028, 2029, 2030 growth opportunity.
Okay. Then just on Entyvio. This is another one that I get a fair bit of investors questions on that because I know that you guys are effectively guiding to a 2027 launch whereas the innovator claims that the patent protection goes out to 2030. Is there any additional patent dance, any other process that needs to play out here, or do you think that you have freedom to operate or any nuance around at-risk launch or that type of scenario?
All scenarios are possible. We'll continue to evaluate it, and we are extremely excited about it. As you said, we are going to be on track to we have guided this to a potential launch in the near term, not in the medium term. We know that we are going to navigate and get that through. How exactly we're going to get there, we haven't disclosed that in detail for understandable reasons. Let's discuss the opportunity itself, right? It's a massive opportunity both in Europe and the U.S. $7.5 billion in sale and growing. It's around $2 billion in Europe, around $4+ billion in the U.S. We have both the IV and the subcutaneous presentations, which are extremely important.
We not only expect to be the first biosimilar to be approved for both U.S. and EU for this IV and subcutaneous presentations, but I think some of our peers don't have both forms of presentations too, right? It's with that regard that the Monday announcement of our Entyvio submission being accepted by the FDA was very critical, and the market also saw the importance and recognized it too. I think as we get closer, we'll provide greater details around this.
Yeah. That's great. We are almost out of time, so this is great. Thank you so much for this. Yeah, looking forward to learning more about Alvotech, and good luck with the regulatory review process.
Absolutely, Ash. Thank you very much for this. I appreciate all the engagement and the questions. Also want to flag and call a couple of other opportunities that we have not disclosed, but they are also limited competition opportunities for us beyond EYLEA, Entyvio, SIMPONI. We are also looking at CIMZIA, Taltz, ILARIS. That's also going to be in the next waves of launches, and we're equally excited about the opportunity there and the fact that that's, again, where most of our assets will be first to market or in a limited competition landscape. The next five years looks to be extremely strong for us from a product pipeline and launch and progression perspective. Looking forward to get to the next stage with Alvotech there. Thanks again, and appreciate the questions.
Yeah. All right. Have a good one. Take care. Thanks.
Thank you.
Thanks, everybody. Bye