Good morning, welcome to the Jefferies Global Healthcare Conference in New York. My name is Marco Baruzzi from the Jefferies Investment Banking team, and it's my great pleasure to introduce you to Róbert Wessman, Founder and Executive Chairman of Alvotech, and Balaji Prasad, Chief Scientific Officer of Alvotech. Maybe to kick things off, would probably be good to get maybe a little bit of background on Alvotech, including the platform, key differentiators, and the current products you have in the portfolio, maybe to start. Good morning. Thanks for the invitation. Pleasure to be here today. We have been building Alvotech since 2013. It's a fully integrated platform, end-to-end when it comes to manufacturing, when it comes to R&D. We have invested in the business around $2 billion, where a big portion of that is in the portfolio. We have currently five products on the market in the rest of the world, but two products on the market in the U.S. With the resubmission, which was published just a few hours ago, we expect to have five products on the market end of this year. Our basically strategic advantage, we believe, is that having a fully dedicated end-to-end biosimilar platform where we have everything in-house, we believe we have one of the strongest pipelines in the industry. Just to say that we have built out the commercial infrastructure over the last six, seven years, and that infrastructure is now spanning over 90 countries. The company is definitely at the inflection point where we are going to use all those tools to basically make the company grow and become more successful going forward. Maybe just going back to what you said earlier. You made a pretty material announcement yesterday evening about the resubmission to the FDA of your U.S. BLA for biosimilars of Simponi and Eylea. Many investors were expecting this to happen probably towards the end of June, ahead of timing. Could you maybe walk us through how significant this is for Alvotech? Yeah. Basically, we have three products being resubmitted. Maybe the most important one is the biosimilar to Simponi Aria. We managed to be the first to launch that product into Europe, and we are seeing that our marketing partner is gaining very strong markets here in Europe already in some of the key markets. We still believe that we will be in the first wave. There's a very limited competition in the U.S. We actually only know of one filer. This is pretty significant for us, and we assume that we will be launching those three products by end of this year. The other two being biosimilar to Eylea, and then Prolia and Xgeva. Róbert, could you maybe remind us of the remediation efforts you've implemented to address the FDA observations on the CRL, and maybe also explain what safeguards you've now put in place to prevent similar issues recurring in the future? First of all, the facility in Iceland is a new one. We have invested $half a billion or more into it. We are approved with all the main health authorities in the world today. We are, of course, approved in the U.S. We got those CRLs for the BLAs we had on file with FDA. We only launched the first product into U.S. mid-year 2024, and since then, we have had four FDA inspections. Iceland is very nice to visit, as you can imagine. We have been, since we got the CRLs, what was pending there was pretty straightforward. We are using pharma-grade silicone oil for our rubber stoppers in our syringe as, I guess, many of the industry competitors, if you will, for a similar machine, which is made by one of the best one in the world. We managed to run that machine without any pharma-grade silicone oil now, so that's off the table. Being a company only 18 months into the U.S. market, we had already been working on the process of customer complaint, meaning if your auto-injector is claimed to be faulty, we have shipped 5 million pens. I think we had around 500 faulty pens, which in ratio is very low, but still the process we have been strengthening. Our marketing partner actually in the end is responsible for customer complaint towards the clients, but the processes we have been strengthening. The last point is multiple continuous improvement, if you will. Over 200 CAPAs implemented, and we feel very strongly and comfortable about the outcome. Of course, being a new facility, which give us a advantage, but overall, I mean. Being less than two years into the U.S. market, this was all ongoing when we got the CRL, and I can say that we have had three very successful FDA inspections. Two as 2024, where we got one 483 and another one where we got two 483. We actually got an in-between now before we resubmitted FDA into the facility, which concluded in May. Again, that was underlining all the strength and changes we have done because we believe that the inspection was very successful. Róbert, in the resubmission, you only included two out of the three products that had the CRL, so Prolia was not included in there. Why is that, when do you expect to resubmit for that product? Yeah, it's a good question. It's actually imminent, but in this, with our partner there, our partner will be holding the marketing authorization in the U.S., and they are responsible for the resubmission. That should be pretty imminent. I'm talking about days. Okay. Given the FDA just completed the routine GMP survey inspection in May, how do you view the likelihood of another inspection related to your BLAs? Yes. What happens now when you resubmit is that you start a six-month clock with FDA. We expect to be on the market with those three products and before end of this year. FDA can choose to come, or they can choose to basically use the basis of the inspection which happened in May or concluded in May this year. It can go either ways, but in our mind it doesn't matter because the company, the facility, and the team is fully ready to receive FDA whenever they want to come. Thanks, Róbert. Maybe let's shift topic on your new Fujifilm partnership. You recently announced this partnership with Fujifilm that expands your global manufacturing network. Now you have a second source of commercial supply in the U.S. and in the U.K. Could you elaborate maybe what drove the rationale for doing this? Yeah. First of all, we are of course, super proud of having Fujifilm as a partner. I think we are likely to be one of few or the only one working with them as a biosimilar company. They are mainly working with big branded companies, big achievements to work with them. When we started the business, as I said, it has been a long journey since I founded the company, 2013, $2 billion gone into it. A few years ago, we expected that the FDA would change the requirement when it comes to clinical. We started to evolve the business over two years ago to adjust for that, increasing the capacity in cell and development, process development, and getting ready to scale up. Those changes are taking place now, but we have been working based on back of this for a long while, which is basically the reason why we have most likely the strongest pipeline in the industry when it comes to pure-play biosimilar companies. Even though we have said that the capacity in Iceland out of this amazing facility we have invested over half a billion dollars into, is very strong, we wanted still to have supportive capacity because the pipeline is even broader than we assumed at the beginning when I founded the company. We have to remember that we are launching three products in the U.S. end of this year. We are seeing a very strong growth both biosimilar to HUMIRA, STELARA. We are seeing ourselves taking a very strong market share in biosimilar to Simponi and Simponi Aria, which we recently launched in the global markets. We are submitting or have submitted two major products, which will be approved next year. When it all comes into the funnel at the same time, we felt it was super important to have more capacity to basically be able to be in the lead and service our clients well. Róbert, how are you thinking about this incremental capacity coming online in terms of timing, and will it be more focused towards manufacturing of existing products or pipeline? Yeah, it's a good question. We actually have been working on this for quite a while, so we assume that the supplies out of Fuji would take place after mid next year, so it's pretty imminent, if you will. We will be for different reasons, both having commercial products and pipeline products going in there. Thank you, Róbert. Maybe let's shift to pipeline. You recently submitted an MAA to EMA for your biosimilar ENTYVIO. How do you view the market opportunity for biosimilars ENTYVIO in both Europe and the U.S., and what does the competitive landscape look like? Yeah, it's a very good question because ENTYVIO was not a big product when we started to develop the product. It was a couple of hundreds of millions and not many companies buy similar companies, therefore looked at ENTYVIO as a big opportunity. We assumed when we saw that there was a head-to-head clinical study done between ENTYVIO and HUMIRA that ENTYVIO would be, for some indications, showing some stronger efficacy, if you will. We started to develop that product and with intention to be the first to market. The brand has since launched a subQ version also. We of course chased the brand with that. We believe that we are in the pole position. We believe that we should be first to market with it. Today is a $7.5 billion global sales of the brand. We assume that this year we will be done with the global submission, including U.S. Also in the U.S., you expect to be able to be first to market? We assume that, yes. Okay. With respect to the two of the other three biosimilars in the U.S., the CRLs, Simponi and Eylea, how are you thinking about the relative market opportunity for each? Yeah, I think Simponi Aria is one of the products we did pick back in time because it's a small to medium-sized brand. It's $3 billion-plus globally. We expected to see a very low competition. We have launched now a few months into Europe, where we are still the only one on the market. We are seeing that only a few months in our very strong markets here in Germany, where we are seeing around 20%. We are seeing very strong markets here in Scandinavia, Nordic, Netherlands, and other markets. We are very happy with the outcome there. We, of course, might see a competition both in Europe going forward and in U.S., but it will be most likely excluding the brand, two, three-player market at most. Following 2026, what does the cadence of your launches look like? Yeah, we have a very strong pipeline, as I mentioned. Of course, very busy towards 2026 with the launches and approval happening this year and end of this year into U.S. We will be launching ENTYVIO next year. We have another one which we are very proud to have, and we believe we are the first also, which is the high dose to Eylea. We have been extremely successful going after the brand and all the changes you are seeing in the brand. I've been in this business for now 26 years and created seven global companies. We know that the branded companies like to move into different forms and strengths and what have you. We have been super successful. When Regeneron announced that they would go from two milligram to eight milligram high-dose Eylea, which we agree is in many ways much more convenient for patients due to dosing frequency or less frequency, we basically started to develop the same before we saw the brand. We started to mimic how the brand could look like. When the day they launched, we already had our formulation, six different formulations, and one of our formulation matched perfectly what Regeneron is doing. We believe that we are the first one there. We are seeing that 40% of Regeneron sales of Eylea has converted to high dose, which is exciting both in Europe and U.S. We are also super excited about the Eylea, which Regeneron is coming with, because we have a strong belief that we will be most likely the only one with that device competing with the brand going forward. On the Eylea high dosage form, where are you currently in the development of that? Sorry, on Eylea high dose? Yeah. We are basically done with the development for rest of the world. We started clinical because U.S. FDA did not give any sorts of clinical favor, and we announced the start of the clinical a few months back. Your next set of potential launches will be in the buy and bill market. Could you maybe help us better understand how you expect this market dynamic to evolve compared to the pharmacy benefit channel? What differentiates success factors across the two? Yeah, it's a very good questions because pharmacy benefit we have seen, of course, biosimilar to HUMIRA, and HUMIRA being the biggest, we can say retail product, being the biggest pharmacy benefit product, if you will. We saw dynamics there where private label was playing a big role, as you know, with the three big PBMs. When you have a medical benefit, the role of the big three is different. It's at different channels, and the role of any kind of private label is much less or not even existing. In medical benefit, we are seeing more number of clients and customers, and we are seeing different dynamics when it comes to pricing, if you will, in favor of biosimilars. Thanks, Róbert. Maybe let's shift to the broader biosimilar market. It's a massive opportunity over the next decade. Could you maybe frame the LOE outlook for the category overall and what portion of that market you're currently targeting? Yeah. As we all know, 40% of the $1.8 trillion pharmaceutical market is now biologics. We are seeing 60% of phase II, phase III with the top 10 pharma companies, 60% being biologics. I assume the 40% will move towards 50%-60% going forward. This industry, in my mind, is very exciting because to maintain healthcare in all global markets you need biosimilars, because it's impossible to treat patients with the brands because of the cost. As we know, cost per patient can easily cost $80,000, $90,000, $100,000. For chronic use products like HUMIRA, to maintain that for any healthcare systems is not possible. Brands and biosimilars kind of needs to hold hands to both continue with the innovation and then opening up access. If you look over the landscape, there are only handful of existing pure-play biosimilar companies which have, as I mentioned at the beginning, both R&D end-to-end from cell line to finished BLA to filing and regulatory in-house and manufacturing from drug substance, drug product fill finish, and even assembly of devices like auto-injector in-house like we have. It's a different dynamics going forward, I believe. This industry is a very young industry, as we know, and we only started to see market share being gained by biosimilars around 2018, 2019. This is here to come. The world markets are We are seeing strong conversion in most of the markets in the world of biosimilars. For us, this is very exciting. Having a company which took us 13 years to build, did cost us $2 billion to build. The entry barrier is big because for many others which want to get into the business, they have to spend the same time, most likely well north of $1 billion at least, if they want to have a decent portfolio. I think Alvotech is in a unique position with only a handful of likes of Celltrion, Samsung, and a few others, which will be opening up access to all those medications for patients going forward. As I mentioned, having five products on the market, and soon five in U.S. from two, having 30 products in the pipeline, we have most of the valuable products in our pipeline which are going off patent going forward. When I say valuable, it has to be products where we are basically opening up access, because otherwise we are not adding any value. We are not offering anything new to patients. If you believe there will be five or 10 other competitors, that's not a value-add product. We believe we have a very strong pipeline which we can use and engage to open access across the world. Just following up on that, how do you actually select your pipeline? How do you pick the pipeline candidates? What criteria do you use to select the products to develop? Yeah. As I said, it has to be a value add, meaning opening up access. We have to have a conviction that we will be in the first wave or first to market. When we start developing a product, I can almost take every single product in our pipeline which is late stage, including HUMIRA. When we saw that HUMIRA was changing for low dose to high dose, we stopped even developing the low dose and we were the first to come out with the high dose. As I mentioned, high dose EYLEA, we saw ENTYVIO coming, we saw subQ coming of ENTYVIO. It's both choosing the right products, but on the way, adopting, adjusting, because the value add might be different than you think when you start the development compared to where it ends when it comes to change of the formulation dose of the brands during the development period. Róbert, on the regulatory front, the FDA seems to be focused on lowering the barriers to be able to allow companies to expedite the process of development overall. In your view, how does this impact the market? How should we look at the trade-offs between obviously the opportunity, but also the competitive risk of more people coming into the biosimilar space? Again, a very good question. I think overall, the reason why we expected this is that you need to show, of course, biosimilarity with the brand without the phase III clinical. The phase for the patient study was really not adding anything to the development in our minds. If you pass the PK, you had to do, of course, a lot of analyticals before you went into the PK. We felt always that the patient study would not add a lot. It is in many ways you need to show the biosimilarity through different ways. I would not say that the bar has been reduced because it's done through a different means, and then you have to prove that the similarity through the PK study. I don't think the barrier as such has been lowered, but a clinical trial which was not really adding any value was kind of eliminated. This means that it still will cost between $60 million-$100 million to develop a biosimilar. It will take most companies six years. We are down to around five years ourselves after optimizing our processes. It doesn't really change the fact that it takes over 10 years to build a company like this and requires a massive investment north of $1 billion if you want to be a player in this industry. I don't think it will necessarily change the dynamics. It will allow us instead, we were doing like some are still doing, adding one new R&D every year into our pipeline. We are now adding new R&D into our pipeline every second month. That's our change, but that is basically the effect and the result of the heavy investment we have already made and the infrastructure we have already built. Thanks, Róbert. Maybe moving to 2026 guidance. You gave for 2026 a revenue range of $650 million-$700 million and EBITDA of $180 million-$220 million. Expectations are that with implied those ranges across products, what's included? Are there milestones? What's the impact of the CRLs potentially in the ranges you provided? I think just to say that Alvotech is at an inflection point this year. Those numbers you are mentioning includes on the upper level, higher end of range, a small revenue launch into U.S. end of this year, and we wanted to give the downside to the investors just so they would see what it means if you would get further delays, which we actually don't assume as we speak. This year is also, and last year, is being reflected by the fact that because we decided on purpose to continue to elevate the facility, which is brand new we did have a slowdown in production, which impacted the revenues, not only because of the 3 CRLs, but because we had less of a capacity last year than this year. Even though those product revenues, and I would say EBITDA being only less than two years into commercial into U.S. with the immense pipeline in front of us they are still reflecting that we both last year and this year had a slowdown, which is all behind us. That's why, again, I'm talking when I'm looking at the coming five years saying that the company is at an inflection point today. Thank you, Róbert. I think we have 30 seconds left. I don't know if there's any questions from the public. You have to speak fast. Maybe one question for Balaji, since you were a very senior analyst before. What made you join the company, and why were you excited about joining the company? Yeah, sure. Absolutely. When Alvotech listed on Nasdaq in 2022, I started following the stories closely, having multiple conversations with Róbert and saw the pipeline. I thought that Alvotech is probably one of the best positioned companies in the biosimilars world, and I've always been championing the biosimilars industry and saying that this is the decade for biosimilars and Alvotech is one of the best positioned companies there. That was during my days as an analyst. When Róbert reached out last year inviting me to join him, I was absolutely thrilled. I thought, "This is a great place to be in a company which is making a huge difference to the world, bringing access to low-cost, high-quality biosimilars across the world, improving access," and joined Róbert on his mission there. Absolutely thrilled to be in, even 14 months later on. Great to be on this ride. Thank you.