Good day, and thank you for standing by. Welcome to the Alvotech Q3 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Benedikt Stefansson, Vice President of Investor Relations and Global Communications. Please go ahead.

Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first 9 months and third quarter of 2025. A presentation accompanying today's earnings call was also published under our investor portal, investors.alvotech.com, under News & Events. Our press release, presentation and statements that we make on the call today may include forward-looking statements. Please see our disclaimers on Slide #2 of the presentation. These statements do not ensure future performance and are subject to risks and uncertainties that are outlined in company filings with the Securities and Exchange Commission. Any risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made. Presenting on today's call are Robert Wessman, Chairman and Chief Executive Officer of Alvotech; Joseph McClellan, Chief Operating Officer; and Linda Jonsdottir, Chief Financial Officer. Also with us on the call is Balaji Prasad, Chief Strategy Officer. Robert will begin today's presentation with a discussion of the status of our pending biologics license application with the FDA and facility inspection and present some business highlights. Joseph will discuss the status of our development pipeline. Linda will conclude with a discussion of our financial statement and full year guidance. Following the introductions, our team will be happy to take your questions. And with that, I would like to turn the call over to Robert Wessman.

Thank you, Benedikt, and thanks to everyone for joining us here today. Please turn to the Slide #4 in your deck. We are now approaching the end of very eventful year, marked by increased pipeline development, successful product approvals across multiple markets and growing licensing and products revenues. Alvotech has come a long way in its 12-year history. We have invested approximately $2 billion to build a global pure-play biosimilar company with integrated R&D and manufacturing under one roof. We commercialize globally through a network of nearly 20 partners, reaching over 90 countries worldwide. After launching our first biosimilar in 2022 and second biosimilar in 2024, we entered the U.S. market last year. The 2024 global launches drove a 420% revenue growth in that year, and we are guiding approximately 20% growth for 2025. With exclusivity expiring on dozens of originator biologics each year and the regulators waiving costly efficacy trials, the biosimilar market is set for explosive growth. With resources and strong focus on developing and manufacturing biosimilars, Alvotech is well positioned to lead the charge. In fact, we proactively responded to anticipated changes in regulatory guidelines by expanding our research and development initiatives approximately 2 years ago. More recently, we have further enhanced our R&D capabilities with the establishment of an operational base in Sweden. The result is already evident in our growing pipeline: 5 approved biosimilars, 12 other disclosed development programs and already developed cell lines for additional 15 valuable targets, in total, targeting greater than $185 billion of originator markets. Now let me touch upon a few key points that I will discuss today and described on the following slide. This includes an update on the FDA process, our pipeline, a comment on the revised outlook for the year and update on our marketed products. So…

Thank you, Robert. As described on the next slide, our products, AVT06, a biosimilar to Eylea; AVT05, a biosimilar to Simponi; and AVT03, a biosimilar to the dual products of Prolia and Xgeva, are scheduled for launch in Europe this quarter. AVT06 has received approval in Japan, the U.K. and the European Economic Area. Last week, the U.K. High Court rejected Regeneron's and Bayer's requests to stop Alvotech's manufacturing of its Eylea biosimilar in the U.K. This ruling enables us to manufacture in anticipation of commercial launches after the Eylea supplementary protection certificates expire on November 23 of this year. We are prepared to launch AVT06 prefilled syringes and vials across Europe post expiry of exclusivity and look forward to entering the market with strong partners. AVT05 has already received approval in Japan and the U.K. and we are expecting a favorable decision from the European Commission for the EEA in the later part of November, following the EMA's CHMP recommendation early this summer. We intend to proceed with the launch properly after approval, anticipate being the sole biosimilar to Simponi available on the European market for several months. In Japan, we have secured the necessary rights and plan to initiate launch activities during the first half of 2026. For AVT03, which has been approved in Japan, European Commission approval for the EEA is anticipated in the second half of November, following EMA's CHMP recommendation this summer. The intention is to ship launch supplies to our commercial partners in Europe during this quarter. It is expected that AVT03 will be among the first products available with established partners supporting its market introduction. Turning to our development pipeline on the next slide. We are pleased to report ongoing growth and advancement across our programs. In collaboration with partners, Kashiv and Advanz, we have submitted a biosimilar candidate to Xolair in the EEA and previously filed for approval in the U.K., where the review process is ongoing. The development of AVT29, a biosimilar candidate to high-dose Eylea; as well as AVT16/80, a biosimilar to Entyvio for both intravenous and subcutaneous administration, is proceeding towards regulatory submissions targeted for 2026. Progress continues on our candidate to Keytruda in partnership with Dr. Reddy's, including completion of manufacturing for clinical supplies. Additionally, we have initiated clinical manufacturing for our candidate to Cimzia with positive developments underway. Our investment in the early-stage pipeline remains strong. Today, we are announcing 2 new molecules, biosimilar candidates to Hemlibra and Imfinzi, which are currently in process development. Further, we have over 15 cell lines completed for future development within our expanding portfolio. At this point, I invite Linda to deliver the financial overview.

Thank you, Joe, and good day to everyone who has joined us on the call today. Today, I will take you through the financials for Q3 and the first 9 months of 2025. The earnings deck is more detailed than usual, and we hope you appreciate the additional insights into the quarterly results provided in the next few slides. As Robert mentioned, Alvotech has delivered strong CAGR growth in the past 4 years since launching our first biosimilar, and there is continued momentum and demand appetite for our on-market products of biosimilars to Humira and Stelara. Turning to the next slide, which highlights our Q3 financial performance. As we communicated, as part of our Q2 results, we were expecting Q3 to be a soft quarter followed by a strong Q4. This was primarily driven by lower product revenues and product margins, which were impacted by the timing of orders, portfolio mix and temporary loss in product revenues related to facility improvements, as Robert noted earlier. In Q3, licensing revenues were at the high level of $81 million, supporting a strong gross margin of 69%. We also finalized the integration of Ivers-Lee into our financials that were acquired in July. Ivers-Lee is a Swiss-based assembly and packaging service provider and will increase our capacity for finished product assembly and packaging. Adjusted EBITDA was $14 million or 13% of revenues and was impacted during the quarter by costs associated with improvements in operations to support new launches. Operating cash flow is then a function of our revenue collections in the quarter, down from a very strong quarter in the second quarter of '25, and outflow driven by inventory build in support for upcoming launches. And looking at the year-to-date on the next slide. Alvotech delivered total revenues of $420 million for the…

[Operator Instructions] We will now take the first question from the line of Ash Verma from UBS.

So yes, I wanted to just get back to the focus on the CRL. So can you kind of explain this, what are the observations this time that are different from the last time? And I think you mentioned that you've effectively taken actions to resolve them. Just give us a status of where we are on that.

This is Joe McClellan, Chief Operating Officer for Alvotech. We have been in a situation where we have done a significant number of improvements since the inspection has concluded. The observations were not repeat observations. Let me say it clearly. There were no repeat observations in the deficiencies identified in the Form 483 from the FDA at the conclusion of the inspection. And so it's a number of things that we have to improve about the facility associated with some of our aspects associated with manufacturing, control of our facility, documentation, investigations. We have committed to the FDA to complete more than 180 different changes to address all of their observations plus more so that we will not be in the situation again. In doing this, we have now completed 93% of these commitments and we have communicated them to the FDA. We're in the process of completing additional actions that we will continue to keep the FDA updated on.

Got it. And just as a follow-up. So I know this Form 483, you have 10 observations. And even for Humira back a while ago, I think you ultimately climbed up to 18. Just taking a step back on the manufacturing facility, if this has been a little bit of a challenge, has that made you think about the strategic value of keeping the manufacturing in Iceland? I'm just trying to understand, is there something that is driven by less of an availability of pharma talent or anything of that regard, and whether if you would not have it at that location or at some other place, then it might ultimately solve the problem in the long run.

Yes. Thank you for the question. Robert Wessman here, CEO. Overall, I mean, the concept and the vision and the strategy around the business is to keep everything in-house, both R&D and manufacturing. We think creating a platform like we have is extremely important. We can say that in U.S., we are around 18 months into being a commercial company, if you will. We have gone through 3 FDA inspections over the 18 months. And the first two, which was early '24, was only one 483. And then late last year, we had a general GMP inspection, which we only got 2 minor 483s. So overall, I would say it was very disappointing to get this CRL and unexpected. But the company has continued to grow and strengthen further the quality systems, and we have full intention to absolutely stay and be best-in-class when it comes to GMP and quality. And I mean, that's reflected. We have gone through successfully 5 EMA inspections. We have gone through at least 4 inspections from different global health authorities and now 2 successful FDA inspections. So as Joe explained in detail, we took this very seriously. And I think overall, we have done a substantial improvement. And Joseph himself has shown amazing success in R&D and brought all of our 5 currently approved or marketed products to a success and the 12 products which are in late stage in R&D. And he has extensive experience, as I mentioned in my part, from Pfizer. And he lives in Iceland. And that is a big factor, to have the core team living in Iceland to take charge. And I have great expectations with those changes that all future deficiencies hopefully will be behind us. But saying that, of course, we are in pharmaceuticals. We are seeing that companies, whether it is big pharma or biotech or biosimilars or small molecules, there are unfortunately FDA's 483s or even CRLs coming up on a very regular basis. So it's a kind of moving target and we will continue to move with it, if you will.

Got it. Okay. I have just one more question. So I guess just for the 3 products that you've tried to pursue now with the FDA approval, you've gotten 2 CRLs. I mean, I'm trying to understand what type of impact does that create when you're having the conversations with your customers effectively. Is that something that you faced like when you were launching Humira, and now that you have seen this at the time of Stelara, then how do you think that might impact the conversation when you're trying to contract it out?

Yes. I think it's a very appreciated question, if you will. I mean, we continue to see a very strong interest in our products. I mean, we definitely have the broadest portfolio of all biosimilar companies in the industry, and that is our strength. What is of interest, of course, leave aside 11, 12 successful inspection from EMA to U.S. FDA to other health authorities in the world, our clients are doing also inspections or audits on ourselves. So our customers are very much aware of the status of the facility. And overall, we have not seen any reduction of interest in our products. And we keep our key clients up to date, what we are doing to continue to evolve the quality system, if you will. And we highly appreciate that for all of our portfolio of products, there are usually more than one or more than 2 which are showing strong interest in those products at any given time.

We will now take the next question from the line of Thibault Boutherin from Morgan Stanley.

Just a couple of questions on the revenue impact of the CRL in Q4. Our understanding is that the lower revenue is related to fixing the manufacturing process, so basically revenue loss. Should we think about this as a phasing of shipment into next year after the issues are resolved? So is it just a sort of phasing? Or should we understand this as lost revenues? And does that mean that your commercial partner may face supply interruption impacting the revenues? So I'll start there, and I have another one after.

Okay. It's Linda Jonsdottir here, CFO. If I understood your question correctly, it's about the change in guidance that we announced on November 4. I would say it's twofold. The revision is about like actions taken to respond to any issue. So that is slowing us down on the production side and impacting our revenues in 2025. But we are also seeing some of the licensing agreements for pipeline assets that were expected at the end of Q4 are now shifting to 2026. That's just like a timing impact but has sizable EBITDA impact in Q4 since it's like licensing revenues that flows directly into EBITDA. However, like if I also comment a bit on 2026 and our comfort levels there, if I look into the committed orders we have for new launches in markets outside of U.S. and in combination with growth momentum noted in currently marketed products, we are in a very good position to deliver top line and EBITDA growth in 2026.

And can you just confirm that you are confident on how long the operations are going to be impacted in terms of having visibility on how long it's going to take to fix it regardless of the answer you're expecting from the FDA? Or could this change depending on what you get from the FDA?

No. Robert here again. I think we have a pretty clear visibility on that. And the drug product part of the facility is undergoing some minor adjustments as we speak. And we will then close the drug substance for a particular period in December for both general maintenance and adjustments. So I think as Linda said, we have most of the orders which are in the order book to be delivered end of this year produced. They still need to be -- some of them are sample to pack, but mostly they have been produced. And we have a pretty good visibility how the year-end, we believe, and comfort level, how that will end. And as you can imagine, based on the guidance we gave and based on year-to-date EBITDA, it's fairly easy to see how strong the fourth quarter will be. And it's a good, as Linda said, good momentum with order book. So based on what we are seeing, we are fairly confident on growth, both top line and EBITDA for '26, no matter what.

[Operator Instructions] Our next question comes from the line of Arvid Necander from DNB Carnegie.

So going back briefly to the CRL and the slowdown in production you anticipated after it came. Could you be as concrete as possible? What amendments did you do to the ongoing production lines? And you touched on this a little bit, but is it fair to say that you're more or less back to operating at full capacity for the approved products? And secondly, on the R&D spend. At the beginning of the year, I think you were expecting R&D spend of roughly $160 million to $165 million for the full year. It seems to be trending higher than this. Do you anticipate a meaningful step down for Q4? I'll start there. [Technical Difficulty]

One moment, please. Your conference will resume shortly.

Okay. If I continue. So as I was saying, observations around putting in manufacturing controls, improving the way we do investigations, laboratory controls, documentation practices, those kinds of aspects. So we committed to doing over 180 different actions to the FDA, things such as ensuring that we have the microbial controls by putting measures in to prevent actions that could be considered. Because it's clear that the FDA made observations, for example, around our manufacturing controls that may lead to lack of sterility, but not that actually it was observed, right? So we did things to then strengthen that, putting practices in terms of how we do, say, for example, visual inspection, how we make sure that our air flow is correct to make sure that our procedures associated with changing and gowning are all improved, right? So we did all of those improvements over the last few months since the 4th of July. Since then, we have begun manufacturing. The product that we are delivering in the fourth quarter is product that has been manufactured in both the third and the fourth quarter. So there are actions progressing. We are manufacturing. As Robert said, there's always going to be the need for minor actions for maintenance. Those things are taken into account, and we make sure that we improve those. But in general, we are manufacturing and delivering product that for this quarter that we have recently manufactured since the slowdown we referenced in the press release. Linda?

Yes. And to touch on your cost question, like on the R&D side, we had elevated levels on R&D both in Q2 and in Q3. That's also related to timing of clinical and manufacturing activities as well as launch preparation for our upcoming launches. In Q3, we also had impact in R&D related to the improvement Joe was covering. And we are expecting that also to touch our R&D numbers in Q4. But I can confirm that like we're still expecting lower R&D in Q4 than both in Q2 and Q3.

We will now take the next question from the line of Thibault Boutherin from Morgan Stanley.

Just a question on the impact of the change in regulation you mentioned with the lower requirement for Phase III trial. Can you talk a little bit about how that impacts your plan for your earlier stage biosimilars, in particular, thinking about Keytruda and Cimzia where the timelines could move based on your decision to run an efficacy study or not?

Yes. Robert Wessman here again. I will hand this over to Joseph, but I just want to underline. So we anticipated this change over 2 years ago. And based on that, we changed our approach to R&D, if you will. And as we have already stated on this call and the previous calls, we have all in all, between marketed products, approved products, late-stage development, early-stage development, over 30 products in the pipeline. So we think we have used the time very well and taking advantage of the changes which are coming now by kind of assuming and expecting this to come. So we are already bearing the fruits of that vision we had back in time. But for the detailed answers maybe, Joe, if you take that.

Yes, absolutely. So this is Joseph. For sure, right, we are doubling down on our strategy. We have a proven development engine. We are leveraging that. As Robert said, we forecasted and anticipated that the need to do patient efficacy studies was going to go away from a regulatory perspective. It has. And because we made the bets over 2 years ago, we are now in a good position to take advantage of that. And we are doing that for products as we're developing them, right? So you can imagine that, yes, Cimzia would be one of those as well.

Thank you. There are no further questions at this time. I would like to hand back over to Benedikt Stefansson for closing remarks.

Yes. Thank you. So on behalf of the Alvotech team, I would like to thank everyone who called in and listened to our call today. And we look forward to speaking with you again, and wish you a good rest of the day.

Thank you.

Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect.