Thank you for joining this session of the Morgan Stanley Global Healthcare Conference. I am Thibault Boutherin. I am part of the European Equity Research Team based in London. Before we start the session, I need to refer to important disclosures. Please see Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. For this session with Alvotech, I am delighted to have with me Róbert Wessman, Executive Chairman of Alvotech, and Balaji Prasad, Chief Strategy Officer for Alvotech. Thank you very much for joining us. Maybe before we start with the Q&A, if you want to start with some introductory comments on the situation at Alvotech, where we are today and the outlook for the company.
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.
Okay, amazing. Maybe we can start on what you just touched on, which is the sort of evolution of your commercial model, and Alvotech taking a more direct role in commercializing products in the U.S.
Yeah.
Historically, you have been through a commercial partner. Maybe if you can sort of go through what is driving this evolution of the strategy. Are there specific assets or therapeutic categories that are best suited for a direct commercial approach from Alvotech?
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.
Okay. The rationale is clear for HEMLIBRA, but IMFINZI is probably more sort of a challenging place to go in. These are PD-1, PD-1 are probably going to be quite competitive. Here as well, do you think setting up a team is going to be what you are going to do, or is there a different approach for this one?
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.
Okay, amazing. That is very clear. The other relatively recent development is the announce of second manufacturing sourcing from Fujifilm, to add a U.S.-based multi-product manufacturing capacity from next year. How much of this capacity is intended as redundancy capacity with what you have in Reykjavik, and how much is incremental growth from this capacity?
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 Fujifilm to meet demand and potential upsides when they show themselves, if you will.
Okay, amazing. When we think about the impact on the P&L in terms of gross margin, do you expect that this is going to be visible in the next few years?
Yeah. We will see that, as I mentioned, the company is at an inflection point. We have been growing quite a bit throughout when we launched the first product into market. We are less than three years into commercial marketing, if you will, into U.S. market, the biggest one. We are fairly young as a commercial organization, if you will. We will see multiple products coming to market, which means that we should be seeing a strong growth continued going forward. Secondly, if you look at the gross margin, it should be pretty neutral whether products are produced in-house or with a partner like Fujifilm.
Okay, that is clear. You touched a little bit on the resubmission of the BLA, so Eylea, Prolia, Xgeva, and two presentation of Simponi in the U.S. There was an FDA inspection. It closed with, as you mentioned, a Voluntary Action Indicated. Can you just help us assess, is there any risk remaining on the approval? How confident are you that this resubmission will go through, and what makes you confident?
Yeah. Overall, our BLAs were fully reviewed by FDA, which we resubmitted without any observation, if you will. The BLAs have passed the test before, which are now resubmitted. The observation were partly facility related. We think we have spent a lot of resources and energy to continue to evolve our quality system. Again, company being young commercially, but we still are seeing or continuing to invest into our quality system and production process, if you will. The company today is approved by all major health authorities in the world. We just closed out EMA, the European health authorities, an inspection last week, and that inspection went extremely well. We closed out the July inspection with a VAI status. We continue to evolve the quality system, if you will.
We believe that whether FDA comes in for another inspection before they give us approval or not, we as a company organization, we are well prepared and ready for that. We are very confident that we have a good shot at getting approval this time around.
Just to confirm, you are not sure yet if they will require another inspection or?
No, we are not fully because FDA is a discretion of FDA. They just finished the inspection. As I said, it was closed out in July. I think it's not absolutely certain that they will come.
Okay.
Either or, it will be fine with us.
Okay, amazing. You touched a little bit on this, but what kind of structural changes have you made to the manufacturing process, the quality process, beyond just resolving the specific observation?
Yeah, from the inspection where we got. We have been producing for U.S., we have never had any product issues into U.S., that we didn't get approval for three products, which, we resubmitted. We continue to manufacture for the U.S. market successfully. Overall, there were couple of items which FDA pointed out when they gave us the CRL. Actually, it was two issues which we believe we have addressed very well. One was related to customer complaints, the other one using pharma-grade silicone in our filling machine, which has been used last 20 years in the industry, and we have simply removed that. I think when it comes to the palette that we received and preparation from FDA, we always look holistically at what we are doing. We don't dive into one specific issue. We should be well prepared, if you will.
Okay, amazing. That is very clear. Moving on to your portfolio and your pipeline, maybe starting with U.S. Eylea. The market formation should be around the first quarter of this year, based on when the IP goes away. For Alvotech specifically, do you expect the approval to be gated by the IP or by your own approval, assuming that they give you clearance for U.S. Eylea?
Yeah, we have a settlement with Regeneron, which is allowing us to basically launch upon approval in December. We have seen Amgen, of course, been first to market, if you will, and over a year been able to convert, I believe they are close to 40% from the brand sales. I believe that Alvotech with two other players are coming in now, so we feel pretty excited about the opportunity. It is close to a $4 billion market, so we are still seeing the market exciting, even though this time around we are not first in, but we are in the second wave now, meaning Amgen was the first. Pretty good, strong opportunity in this one.
Amazing. As a follow-on to Eylea, you are working on the high -dose formulation, the 8 mg. Can you update us on the regulatory status? You are filing in some regions in 2026. Maybe starting here, which sort of major regions can you file this year for the high -dose?
Yeah. High -dose is a very interesting program for us. We started developing high -dose before the brand launched 8 mg. When the brand launched, we had one of our formulation matching the brand. What we did is, the formulation of 2 mg - 8 mg is not fully identical. We made sure that 8 mg was a bit different because of the IP. The European health authorities, they believe that no efficacy or safety study was required. We are working hard on filing this year. Basically in U.S., based on requirement by FDA, we are running a safety and efficacy study, which will be basically running next year, if you will.
Okay.
Submission most likely early 2028.
Okay. To confirm on the high-dose, because there was slightly different molecule, this is going to be the approval that is going to condition the launch. It is not a residual IP situation on the high-dose?
No, we believe that we are in a very strong position with IP, and especially with the final tweak we did to the formulation, we are very confident that we are not infringing any of the patents. All IP situation are partly complex, but they can also be fairly simple when you know the way you are going. That is in this particular case, we know well where we are, and we think we are in a good position. It does not mean that we will not have some litigation challenges or that we might be sued, but we are in a good position to bring the product to market.
Okay.
Maybe to say that also, we are also with a safety device. As you know, the high-dose in Europe is 80% with OcuClick and safety device, 20% is the vial. I think we are the only one I know of at least which have developed the safety device, which is important.
Okay. That's clear. Moving on to Simponi in the U.S. I think the only competitor here is Bio-Thera. They are gearing up for launch in the fourth quarter. If your CRL is resolved, do you think you can launch around the same time? Is there a remaining IP challenge? As I think Bio-Thera is dealing with a lawsuit from Johnson & Johnson on Simponi.
Yeah, I think on IP, again, without going into that in specifics, we are in a very strong legal position or IP position with the product. Basically, the patent is basically put forward by J&J on potential PI. We are absolutely certain we are not infringing that. We think that the launch should be at approval. We have, of course, launched the product into Europe, and we have been on the market since late last year. Bio-Thera got approval, which you mentioned, which is the only known other party with the product, and they have had their own GMP challenges, so they have not been on the market last, I believe, nine or 10 months. It remains to be seen, but we are in the same wave at launch in U.S. as they are or if we manage to get there first.
Okay. Amazing. Maybe another important pipeline asset you are working on is the ENTYVIO biosimilar, where you file in Europe, in the U.S. I guess here the question is on the timing of launch in both regions and what the IP situation is for ENTYVIO.
ENTYVIO, yeah.
Yeah.
Yeah. Again, we feel strongly about it. We think this is a near-term opportunity. We would not go into details on launch timing in different countries. But again, having a strong position, and we think we will be already launched in quite a few markets towards 2027.
Amazing. Then, so we mentioned some of the sort of key and closest launch in your pipeline. What other asset would you highlight within your pipeline in the next wave of development? Maybe Cimzia or anything else you want to sort of point out as being very attractive in your pipeline?
Yeah, I think, of course, ENTYVIO and high-dose Eylea are two extremely exciting opportunities. ENTYVIO being $7 billion plus, where there will be a very limited competition. We believe that we might be first to market globally with both the vial and prefilled syringes, if you will. Other opportunities, we have seen, as you mentioned, Cimzia, where we are seeing very few companies engaged in that product. Ilaris, which we think we are in a very strong position. Plus, where we are in a very strong position. Keytruda, even though there is a lot of players in that, it is a co-development with Dr. Reddy's. I think our company will be extremely competitive when it comes to cost of goods and being able to stay in the markets. These are all kind of fairly near term or slightly midterm opportunities we are seeing.
Okay. Amazing. We went through pipeline. Maybe moving on to sort of commercial assets. You mentioned the launch of the Simponi biosimilar in Europe. Around the same time, you also launched Eylea and denosumab. Overall, how is the uptake going in terms of these ex-U.S. opportunities that you launched at the end of last year?
Yeah, we are extremely excited about especially Simponi being alone in the market. We have seen launches in over 10 European countries, including being first in Japan. Very strong markets share in many of the countries. We are seeing a very strong uptake in Germany, in Spain, and we continue, or our commercial partner continues to roll out the product. Overall, strong conversion and very exciting opportunity. Same with Eylea. It has been rolled out in over 10 countries and Advanz, which is our commercial partner, doing extremely well there.
Okay. Amazing. Maybe turning to the U.S. and HUMIRA, can you give us some insight on the commercial performance of your HUMIRA biosimilar in the U.S.? Maybe if you can make a distinction between private label channel on one side and the sort of the rest of the commercial channel. From here as well, how far do you expect biosimilar penetration will go, and what kind of market share do you think you can ultimately achieve with HUMIRA biosimilar in the U.S.?
Yeah. I think HUMIRA had a little slower start than some of the others. But still, today, we have seen 60% conversion from the brand to biosimilars, which I think is a strong and good position to be in. Teva, our commercial partner, is having the second-largest market share in the U.S., and we are seeing that they are growing this year on volume quarter -by- quarter. We are extremely happy to be having Teva as our commercial partner, if you will. With the private label, as you might know, private label is not really a part of IQVIA, was not really at the beginning. It's a little bit more complicated to track how private label is doing.
My high-level estimate would be around 20%. The biosimilar part is 80%, or biosimilars plus branded part, if you will. We believe that the growth is happening on the biosimilar side more than private label side, if you will.
Okay. That's clear. Staying on HUMIRA, but looking at ex-U.S., here it's been partnered to your partner, STADA. Obviously, it's been a harder market to go into later and after competitors. Is there room to accelerate market share gain here, or should we have moderate expectations for HUMIRA outside of the U.S.?
No, HUMIRA, we came in with a high -dose, but the market had already formed a few years before we came. We stopped developing low dose when we saw that the brand switched to other high-dose. We launched basically the high -dose right into a very formed biosimilar low dose market. I think in that environment, STADA has done a good job. With the biosimilar to Stelara, we are seeing mostly second or third position in all the key markets in Europe, and we are still going to see, I think, more volume coming our way going forward.
Okay. That's great. Strong performance of Stelara ex-U.S. Stelara U.S., similar question to HUMIRA on penetration of biosimilars, how much more room to go, what is your market share here, and to what extent is private label playing any role for Stelara compared to what we are seeing with HUMIRA?
I think Stelara with the private label is very small, if anything.
Teva is in top three to four with Stelara, I believe, and is gaining share there also. The market has converted around 60%. The Stelara market converted two years faster, I can say. They're at the same place as HUMIRA, if you will. Overall, the market is still exciting. We are seeing overall holistically for those two products for Alvotech that we have not peaked in sales. We are looking forward to continue with those products and we will see some growth going forward on those two molecules, if you will.
Okay. That's great. If we move to your financials and your guidance, for this year, you are guiding for $650 million - $700 million of revenues, between $180 million and $220 million of adjusted EBITDA, and positive cash flow in Q4. You told us the guidance is back-ended to Q4. Can you just touch a bit on your level of confidence in achieving this? Are there any key milestones that you need to reach on the business to basically be able to meet the guidance?
Yeah. Overall, we mentioned when we gave out the guidance that the higher end was geared towards successful launch in December for the pending products. I think overall, the main, I would say, what we are working towards to hit the guidance as it is presented is basically our manufacturing as we speak. Since June, we have gone to full capacity in our production. It's going very well to meet all the demands. The order book is strong. Basically deliver, the question was basically what are the challenges or opportunities to hit the guidance is basically mainly hitting the order book and deliver the products before year-end.
I think the company is in a good place to meet that all, or a good portion, and then, of course, the milestones revenues, which both will come with approval, and then we are always very busy active licensing out. Overall, we feel that the company is in a good place to plant itself, landing in the guidance range, if you will.
Okay, amazing. If you can just touch a bit maybe on funding capital need. You recently raised $165 million in equity. You secured a $75 million terms facility. Can you come back on what this funding is going to be used for? From here, do you expect to need further funding down the line, or do you feel like you are capitalized for the future?
Yeah, I think, so overall, Alvotech, we are having one of the broadest portfolios mentioned. When you look at companies which are doing the in-house development. We did the funding rounds mostly because we wanted really to continue the pace we are on. We feel the opportunities we are building today for future growth is extremely important, and there is amazing opportunity we are in front of being able to continue the pace in R&D we are in. Most of the funding was secured to make sure that both working capital for the launches and the R&D, we could keep that pace. Overall, I would never rule out opportunistic or strategic funding, if you will, but that just remains to be seen.
That makes sense. Maybe thinking about the profitability in particular long term, so if I look at our 2026 guidance, it suggests an EBITDA margin of around 30% this year. Your previous long-term guidance was suggesting the business could achieve sort of 40%, 45% EBITDA margin. Should we see this as the potential long-term margins for the business? What could be your peak margin in the long -term once you've achieved more scale and you have a broader portfolio on the market?
Yeah. The company, of course, is coming out of 12 months where we had a slowdown to make sure that we had the proper response to FDA, and we would be ready to do all the launches we wanted. We are out of that phase now, and with the slowdown, of course, the company did not have the same throughput through the facility as it should have if it would be producing at full capacity. I think with the new launches coming in December, we should be in a very strong position to continue to grow and strengthen the EBITDA margin going forward.
We are, of course, looking at some of the benchmark in the industry, whether it is Samsung or Celltrion. They are at the level which you are mentioning, and go forward, we have a similar pipeline as Samsung. We believe that we should not be very much different from the EBITDA margin those companies do have today.
Okay. That's very clear. Maybe a final question on the CapEx and capital intensity. The CapEx so far, I mean, the last three years have been very light considering that you're primarily R&D and manufacturing business. How far can the current capacity you have sort of carry you for the future? Obviously, there is a Fujifilm capacity on top. Should we expect Alvotech to enter another CapEx cycle at some point to build more capacity to address the biosimilar opportunities?
Yeah, it's a good question. As I mentioned, we have invested a lot into the facility. As I mentioned, the facility is fairly new, and on the facility itself, it's not requiring a major investment going forward. We still can increase the capacity in Iceland. We still have both one suite for drug product and one suite for drug substance, which we will be fitting out. Most of the equipments and investment there, at least the big parts of it, building out the facility has been done. Then, of course, we have Fujifilm, as you mentioned. We believe that with this combination, the company does not need to go into a massive investment in coming five years or so, I believe.
Okay. I think we're at the end of the time. Ró bert, Balaji, thank you very much for joining us today at the conference.
Yeah. Thank you so much. Thank you.
Thank you for hosting us, Thibault. Thank you.