Alvotech Ordinary Shares Morgan Stanley 24th Annual Global Healthcare Conference

Yeah, thanks. It's great to be here, and I think it's fair to say that we have seen a lot of involvement, positive development with the company last months. First of all, we resubmitted our four BLAs for three products, which we have pending with FDA. We are very hopeful that that will be approved by FDA by end of the year. We got filing or submission confirmation from FDA on biosimilar to ENTYVIO, both vial and prefilled syringe. We strongly believe that we are the first, and hopefully first to market with both presentation in Europe and U.S. going forward. We concluded FDA inspection end of July, general surveillance inspection, and that went well. We got a VAI status, and we just concluded now EMA inspection a few days ago. We are not seeing any major observation there.

Overall, with the inspection of the facility, we are getting very hopeful and very certain on approval, hopefully in coming months or beginning of December. In addition to that, we have seen we made a good license contract with Lotus. That's a contract which allows us for the first time to go direct ourselves in U.S. with HEMLIBRA and IMFINZI, which is quite exciting. Overall, a lot of other things happening within the firm. Overall, I think we are in a good position after strong inflection point with all the coming launches.

Yeah, I think it is a good question. Overall, our model is business to business globally, and in this particular case, with those two products, we felt those two were strategically well geared to be marketed directly by Alvotech. Even we, as I said, our model is business to business. If you take, for instance, HEMLIBRA, which is north of $6 billion product, it is a very limited patient pool, if you will, and more targeted to hemophilia patient treatment centers, if you will. On that end, it felt like in a wheelhouse of Alvotech being able to assemble a small group of team to market the product. That was an exciting opportunity for us. Of course, the concept is being able to capture more of the value chain, if you will. Quite exciting. It was more strategic approach with selecting two products which we felt could be easier to approach the market with.

The team has been in the market, including Marcel, last in the U.S. market over 20 years. We know the channels, we know the players, and so overall, it is not the overall change in how we think about our marketing. We felt we were in part of our journey or we were in a time of our life where this was a natural next step for a strategic selected products. Might well be that we have a few more products like this coming in U.S. going forward.

No, I think, again, it is still quite targeted, if you will. The channels are, of course, a bit different from the big three PBMs, as you know. We have worked with some of those in the past, clearly. We have launched oncology products not through Alvotech, but through other portfolio companies Yeah in the past.

So we felt, still being in oncology, that this could be a decent fit for Alvotech to market themselves also.

Yeah. I think overall, we as end-to-end biosimilar company, we are selling what we basically develop and manufacturing. So everything we have in our portfolio is in-house developed. So Alvotech, I believe, has one of the broadest own in-house developed portfolio pipeline in the industry. So overall, we felt having a second source of some of the product would allow us to be more flexible. We have, of course, invested dramatically into our manufacturing sites, if you will. I think our investment is north of $500 million, if you will. So we have pretty substantial capacity, but we also are seeing lot of our approvals coming through, and there are not many companies with so many BLAs on file which are going to be approved in short timeframe.

We felt that having the flexibility to meet the upside potential extra demands, being able to maintain a strong service level, it would be important or very important to have alternative sites. We had a conversation with different potential partners. Fujifilm has a very strong track record in U.S., and it came natural to us to sign up with them. I think to answer the question, we will still allocate manufacturing to optimize Reykjavik, which is our main facility, and utilize that facility we have invested in. Having a strong capacity and partner in Fuji to meet demand and potential upsides when they show themselves, if you will.