Good day, and thank you for standing by. Welcome to the Alvotech Q4 2025 and Full Year 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, Mikaela Vilchez. Please go ahead.

Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the full year and fourth quarter of 2025. Material accompanying today's earnings call was also published on our investor portal, investors.alvotech.com in the earnings calendar section. Our press release, presentation and statements that we make on the call today may include forward-looking statements. These statements do not ensure future performance and are subject to risks and uncertainties that are outlined in the 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, Founder and Executive Chairman; Lisa Graver, Chief Executive Officer Designate; Joseph McClellan, Chief Operating Officer; 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 summary of business highlights. Lisa will then present a commercial update. Joseph will discuss the status of our pending biologics license applications with the FDA and our R&D pipeline. Linda will then conclude with a discussion of the financial results. Following the introductions, our team will be happy to take your questions. With that, I would like to turn the call over to Robert Wessman.

Hello, everyone, and thank you for joining us today. 2025 was an important year for Alvotech. We continue to strengthen our position as one of the leading global developers of biosimilars. We expanded our commercial footprint, advanced several pipeline programs and strengthened the financial position of the company through successful capital market transactions and our listing on NASDAQ Stockholm. At the same time, we have addressed the regulatory observation of the FDA inspection of our Reykjavik manufacturing facility, and we implemented a comprehensive quality improvement program. Based on the progress made so far, we expect to resubmit the affected applications to the FDA during the second quarter of 2026. We will, of course, update the market once those submissions have been accepted. We have addressed regulatory observation before in the industry, and we know how to solve them. Our focus has been on strengthening the operational platform so that we can continue to scale the business globally going forward. Alvotech has 30 biosimilars in development today. We are advancing plans to have a second source manufacturing site for some of our key products going forward. This includes manufacturing of drug substance and drug product at a strategic CMO partner based in the United States. This will give us greater operational flexibility and over time, reduce operational dependence on a single manufacturing site. Lisa will provide more details on the progress we are making with this initiative. Stepping back for a moment. The long-term drivers of the biosimilar market remains very strong. Across the pharmaceutical industry, we are seeing a continued shift towards biologic medicines. Today, around 40% of global pharmaceutical sales come from biologics. But if you look at the development pipeline, this shift is even more pronounced, around 60% of Phase II and Phase III pharmaceutical development today involves…

Thank you, Robert, and hello, everyone. In addition to continuing my collaboration with Robert, I'm excited to help maximize the full potential of the robust pipeline Alvotech has built and is continuing to build. Before going into an overview of 2025 achievements, I want to address upfront a key priority of the team and myself. The team has been executing on an extensive improvement plan to address all outstanding issues related to the FDA inspection in July 2025 to ensure we receive FDA approval for all pending applications for AVT03, 05 and 06 this year. Despite continuing to commercialize our existing products in the U.S. and receiving approval for and commercializing AVT03, 05 and 06 in markets outside the U.S. We are committed to addressing all areas where improvement is required. To that end, I want to highlight an initiative that we have been advanced since last year that looks to dual source the manufacturing of some of our key products. As part of strengthening the long-term resilience and scalability of our platform, we are also evaluating opportunities to broaden our manufacturing footprint for selected products. Importantly, any future expansion would build on the strong manufacturing platform we've established in Iceland, which remains the cornerstone of our global production network and a critical source of our technical expertise and operational scale. As we evaluate options to broaden our manufacturing footprint, the United States is a natural area of focus given the importance of the U.S. market for biosimilars and the increasing emphasis on supply resilience within the U.S. healthcare system. Expanding our manufacturing base for selected products would support several important objectives. First, it would strengthen supply resilience by reducing reliance on a single manufacturing site. Second, it will support future launches and increasing commercial volumes across global markets. Third,…

Thank you, Lisa. I will briefly cover 3 areas today. First, the status of our U.S. regulatory submissions. Second, progress across our development pipeline. And third, recent regulatory communications impacting biosimilar development. Last year, Alvotech had 4 active U.S. biologics license applications with the FDA for proposed biosimilars to Simponi, Simponi Aria, the dual products Prolia/Xgeva and Eylea. In the fourth quarter of 2025, we received complete response letters from the FDA for these applications. Further, after receiving the CRLs, we received a post application action letter or PAAL, detailing the remaining open items with the FDA after review of our 483 response. The CRLs were related to issues identified following the FDA's inspection of our Reykjavik facility in July of 2025. No issues were raised regarding the analytical, pharmacokinetics or clinical efficacy and safety data submitted in the applications. The dossiers themselves were considered complete. Following the inspection, we initiated a comprehensive remediation program addressing the FDA's observations. By the end of 2025, we had implemented most of the required corrective actions, our focus since then has been on demonstrating that these improvements are effective and sustainable over time, which is a normal part of the quality process to ensure that improvements are durable before resubmission. Based on current progress, we remain on track to resubmit the BLAs in the second quarter of this year, which would position us for FDA decisions before the end of the year. Importantly, our Reykjavik facility remains an FDA-approved manufacturing site, and we continue to manufacture our on-market products for both the U.S. and the rest of the world markets. Turning to the pipeline. Over the next decade, more than 100 biological medicines are expected to lose exclusivity. Against that backdrop, Alvotech continues to build one of the largest biosimilar pipelines in the…

Thank you, Joe. Indeed, it has been an eventful year for Alvotech. Since joining in July last year, I've had the privilege of witnessing firsthand just how much this team can accomplish in a short period of time. Despite the challenging operating environment, the company delivered important operational, financial and commercial milestones, advancing major launches, expanding our global footprint and strengthening our financial position. What has stood out most for me since day 1 is a strong belief in delivering on our mission, not just at the leadership level, but across the organization. With that context, let me walk you through the fourth quarter and full year financial results. Unless otherwise stated, the figures discussed today are adjusted numbers. Reconciliations to the corresponding IFRS measures are included in our earnings materials. Starting with highlights from Q4 2025, performance landed within our guidance with a strong close to the year. Growth was primarily driven by licensing revenues on the back of continued development progress and successful achievement of several performance milestones related to our new launches outside the U.S. when product sales were softer. Total revenues in the quarter were up 13% compared to the same quarter last year, at $173 million with licensing revenues making up 75% of the total and being the key driver of the quarter. This mix lifted gross margin to 66% and adjusted EBITDA to $69 million or a 40% margin. On the product side, revenues was $43 million and product margin negative by 37%, reflecting timing of orders and planned facility upgrades to support upcoming launches. As noted last quarter, we did expect product margin to be impacted by facility improvements and lower throughput in the second half of 2025. Looking towards 2026, we are expecting operating performance back-end loaded in Q4, in line with…

Thank you, Linda. Before we open the call for questions, I would like to briefly summarize where we are today. Alvotech has built a fully integrated biosimilars platform supported by a broad pipeline, global manufacturing capabilities and strong commercial partnerships. During 2025, we continue to expand that platform while also strengthening our operational foundation through significant investments in quality systems and compliance. Looking ahead, our priorities remain clear. We will continue advancing our biosimilar portfolio toward approval and commercialization in all markets, including the U.S. We will maintain strong focus on operational excellence, efficiency and regulatory compliance, which includes expanding our manufacturing footprint with key dual sourcing initiatives, and we will continue expanding our pipeline in the most cost-effective way and strengthening our global partnerships. The biosimilars opportunity remains large and durable, and we believe Alvotech is well positioned to capture that opportunity. With that, operator, we would be happy to take questions.

[Operator Instructions] We will take our first question, and the question comes from the line of Ash Verma from UBS.

Maybe just like on the U.S. approvals where your -- you said that you completed the remediation program. Can you give us a sense of what are the pending items between now and the filing? How confident are you this time that this would result in an approval, any chances of additional inspection from the FDA? And then second question, just I'm trying to understand like the guidance that you provided, the $650 million to $700 million compared to what you did for 2025 at $593 million. Like is there any assumption of these 3 new products for U.S. market at all at the low end of the guide? If you strip that out, like what would be the outlook for the full year.

This is Joseph McClellan. Thank you for the question. I'll take the first part, and then I'll hand it over to Linda for the second. So we, as I said, completed our remediation efforts. We are now gathering the information showing that our changes are effective. And so we're compiling that information and putting that forth. So that is why we're in the final stretches of being ready to submit. We're working really hard to do it by the end of the first quarter, but we're also prepared that it could be in the second, but definitely in the first half of this year. The approval process has been a 6-month clock based on the BsUFA guidelines. And then, yes, there is an opportunity for them to inspect the FDA again. However, we are working to have as comprehensive as a response as possible that would potentially could not require them to come and inspect again. Linda?

Yes. And on the guidance question, like, on the outlook for 2026, like in the lower end of the range, we are not including revenues from our U.S. launches. So yes, I think that's the answer to that one. I mean, I just think about the upper end as like -- I mean I would just think about the lower end as no revenues from the U.S. and then the upper end is what we're striving for.

The question comes from the line of Glen Santangelo from Barclays.

Just 2 quick ones for me. Linda, I did also want to follow up on the guidance. And I think I hear you loud and clear that you're not really building much in terms of the U.S. approvals into the guidance. But when I sort of walk that bridge from the $593 million you generated this year to the $650 million to $700 million for fiscal '26. Can you just give us a sense for what type of incremental commercial approvals outside of the U.S. may be required to sort of get into that range? Or are you not building in any incremental approvals into that guidance? And then secondly, Lisa, kind of curious to follow up on your comments about expanding the manufacturing platform. I just wonder if you can give us a better sense for timing, how you're thinking about that, the cost associated with that? And also to follow up on Joe's comments with respect to the FDA draft guidance changes, how that may impact your R&D costs and your operating expenses. I'm just trying to get a sense for how the cap structure may evolve here over the next sort of 12 to 18 months based upon your ambitions. Thanks so much.

Yes. On the guidance question, like what we're building in there is just the momentum on the launches we've already gotten approval on. So looking at Europe and rest of world. And then as I stated before, like what we are firmly targeting is then to get before year-end and getting to the upper end of the range. The approvals in the U.S.

Thank you for the question. It's Lisa. So regarding the dual sourcing and the capacity, so it's something that we've been evolving. It's certainly something that, as Joe has detailed in the past, as we look at our expanding portfolio and pipeline, that certainly is needed in order for us to capitalize and maximize on commercial potential. So from a timing point of view, I think we're -- this is a first half event in terms of being able to secure that. We're not in a position today to sort of name the party or parties we're talking about, but we will certainly, once we've secured that. I think from a cost and a CapEx perspective, I mean, this does somewhat dovetail with the changes that we had been anticipating in terms of R&D expenditure. For us, this allows us to do more for the same cost base that we've been anticipating over the last few years. So it allows us to do more in terms of actual programs, but it also allows us to be able to build into that the anticipation around capacity building. So I think what we'll see as we unfold the year is it's very much within scope of our expectations in terms of spend, both CapEx and I include in that R&D spend as well.

The question comes from the line of Christopher Uhde from SEB.

Christopher Uhde from SEB. I guess I'd like to start with some big picture things. And so maybe Lisa, congratulations on the new role. As you take the reins, how should we think about your aims and ambitions? Is this continuation, evolution or revolution. And I know you highlighted, of course, manufacturing investments, but what do you see as the most pressing short-term priorities and in particular, anything you think needs to be done differently or emphasize differently, both short term and long term?

So I think it's very much evolution, not revolution. I think the team has certainly built a solid platform, as I've said in my remarks. And as you've heard, from Joe and others. So I think it's really ensuring that we execute truly on the pipeline that we're building and continue to make sure that we launch those programs through our partners, of course, but that partnership model really is very heavily reliant on our performance, not only on R&D, but ultimately approval and being able to supply. So from a priority perspective, there is no question, and I think that was outlined as well in our remarks, that is sort of #1, 2 and 3 across the board. And I think working alongside on the compliance piece, I mean, the U.S. market obviously continues to be important to us. Europe and other markets continue to perform very well for us, as you saw through our '25 and we anticipate that continuing in '26. So we do need to make sure, and it's certainly my intent to work with the team that we continue to build upon the scaling that we've done so far from a commercial production perspective.

Okay. Great. If I could ask just a little bit more of a specific question. Could you talk a little bit about Iran war disruption risk to your supply chain and logistics? I mean, where is there more exposure, manufacturing like disposables, tissue culture, media, other items or shipping costs?

Yes. I think from our point of view right now, I mean, we do have markets that we're expanding to in the Middle East, but those are still early days in terms of expansion. Most of what we're anticipating from a contribution point of view continue to come from the key markets, U.S., EU, Japan. So right now, we are not seeing that as an immediate direct impact on procurement or supply.

Okay. Great. And if I could just ask one more bigger picture question before getting back into the queue. The big concern we hear back from investors is around the competitive landscape. So would you please just walk us through, let's say, an update on your thinking around how you can mitigate competitive exposure, whether that be development strategy or niches or some other kind of innovation at some level that could insulate you?

Yes. Yes, absolutely. So I think as we've said, I think we anticipated some of the changes on the regulatory front, particularly in the U.S. I think we started early, which allowed us to do a larger subset of programs, I think being first and forming in the first wave, but ultimately being first to market is our goal, that it comes from the speed of our development, which I think has been fantastic, and we have a good track record with I think it then comes to approval and our IP positioning, which, again, I think we're very strategic in terms of how we design our products, both from an IP perspective in U.S. as well as other markets. So very complementary from that perspective. And so for us, we try and choose programs where we can enable that first-mover advantage, and that comes from both the complexity of the program, our investment in it as well as our strategy, ultimately, commercially, both from an IP entry point of view as well as how we tackle contracting in the U.S. and the partnerships we have with very, players that have the ability to penetrate quickly like STADA and Advanz.

[Operator Instructions] We will take our next question, and the question comes from the line of Arvid Necander from DNB Carnegie.

So first off, a question, just trying to understand the underlying momentum of the established portfolio here. So product sales have been a bit on the software side over the past 2 quarters. Data that we can track is incomplete, but it seems like TRx growth for 02 seems to be moderating into 2026 and PBM dynamics are, of course, intensifying. So just wondering if the scripts and sales trends represent a true signal here or if it's just noise. And if you can say anything on the revenue growth trajectory that you're expecting for 02 and how it will evolve through the year? And then secondly, on R&D spend, which steps down quite significantly in Q4 while your guidance, I guess, implies an increase on a total spend basis for 2026. So how should we think about the sequencing of R&D through 2026? Is this more likely to be back-end loaded. Yes, I'll stop there.

Maybe I'll start just on some of the performance pieces on our commercialized programs. So when we look at '25, I think we're certainly exiting the year from a sales out into the market perspective in the U.S., we've seen growth in 02 and 04. We are continuing and expect to see that growth in '26. A lot of that growth is through certainly in the U.S., our partnership with Teva. In rest of world markets, we do have shot up for 02 and 04. I think 02 in Europe, a little more challenging from a growth perspective, but we're still anticipating it. We did form that market last but we have been able to secure leading positions in some of the European markets like Austria and Sweden. So we are still anticipating top line growth on 02, certainly on 04. There is, we believe, continue to be opportunity in '26, especially when we look at our exit position in '25. I think we were sitting at around a 5% share in the U.S., about a 9% share on 02 in the U.S. So we do think that there's continued momentum certainly in the very near term. And we're positioned well, I think, with our partners, even given some of the PBM pressures, our formulary business continues to contribute our unbranded business as well, is also contributing to that overall growth perspective. And maybe finally, just to say it, these markets are still evolving in terms of generic erosion of the branded base. So I think we're going to continue to see AbbVie get excluded in '26, which will help, obviously, our additional ability to secure new business, but just to maintain and grow just through volume the business we've secured today. Maybe I'll turn it to Linda on revenue piece.

So perhaps also just to comment a bit on the revenue piece, unlike with quarterly fluctuations, I think it's also good to keep in mind, like we are a B2B company. So you can always expect to see some fluctuations between quarters, depending on like timing of quarters. But if I move into the R&D spend, like I would say, it's fairly -- going to be fairly balanced throughout next year. We continue to invest in our R&D efforts, which have been paying off a lot looking at our pipeline. Perhaps also to mention that, as I mentioned in the call itself, we are expecting '26 to be back-end loaded towards the end of Q4, so just also keep that on in mind.

The question comes from the line of Christopher Uhde from SEB.

So I guess, maybe on the question that we just heard a follow-up around the dynamic with Simlandi. So what can you say about the overall market dynamics over the past year for the Humira biosimilar market? And what's the future of private label sales for you in the U.S. And I guess for both products, I mean, do you see -- in the past, I think we've heard management say that you could have probably 3 or 4 years of sales growth from a given product before erosion could start? Do you still see that as the case? Or obviously, we'd be looking for a return to growth at this point?

Yes. Yes. So I do think that what we've seen through the end of '25 has been that continued growth. I think that a lot of that is truly coming from the continued loss of business for the innovative product. So I think the exit was a biosimilar sitting at a roughly 55% share. So I think there's still that continued opportunity amongst the subset of players that are out there today, and we're sitting at a decent spot with that 9% share in terms of AVT02. So we do think there's more continued growth on that formulary business just as a factor of that erosion of the branded space. In terms of private label for 02, I do think we continue to seek opportunity there. I'll never say that there's no opportunity, but I think the formulary business will continue to be a focus for us, certainly in '26 and beyond. 04, as I mentioned, we are seeing decent growth. I mean that's a more recent launch. And certainly, we're still young in terms of the overall erosion. I think the exit was about 41% in '25 for biosimilar share. So there's still opportunity there. And Teva has been very a very good commercial partner in terms of how they're growing the market and partnering on the unbranded space as well as on the formulary piece. So we're optimistic still that we will continue to see growth over this -- over the next few years. For us, we're not ready to say this is plateaued by any stretch, just given the fact that we're still seeing that brand erosion continue to happen.

And if I could then ask about whether you could quantify the sum of sales for the 3 new launches that happened in 2025. So product sales that is?

We don't quantify it specifically, but it is like -- I mean, it is definitely a part of our contribution in Q4.

Okay. And -- then I guess, for the guidance high end, well taken on the revenue of new products of the U.S. launches not being part of the low end, but at the high end, would it be licensing revenues only or also product sales?

It will be both like on the high end.

The high-end, Robert here. The high end is mainly reflecting growth in supply revenues. It is both.

Okay. And then -- is it still fair to say that just with respect to the cadence that you discussed, is it still fair to say that your 6 months visibility remains extremely high, I mean, essentially that the orders have been placed.

Yes. We have good visibility into the next 6 months.

Okay. Great. And then I guess -- so then the last thing I wanted to ask about was just in terms of the product gross margin, and I might have missed this, I didn't quite catch it in your comments, obviously, negative for the past 2 quarters. When do you expect the portfolio to deliver leverage again there?

So I would say like -- I mean, we are definitely seeing impact from our facility improvements, both in Q3 and in Q4, and that's in line with what we also commented on in Q3, but it will flow into Q4. I mean, I think things are moving well on that front. So we should be seeing this trending up now in '26.

Maybe to add to that, Robert here. If you look at our gross margin because we need to look at the gross margin, which includes then, of course, both licensing and supply revenues, because there is always a trade-off, I mean, if you have a lower milestones, you would get a higher margin on vice versa. So we are basically seeing 62% gross margin in our business towards '25. And if you look at the comparable companies like Samsung and Celltrion, we are delivering today a gross margin, which is higher than those 2. But as mentioned by Linda, those revenues can be lumpy, both the license one and of course, how we ship. But just to underline that, we have, of course, been in a shutdown due to FDA remediation a few times this year. That is, of course, reflecting a bit how we ship also.

Thank you. This concludes today's question-and-answer session. I'll now hand back for closing remarks.

Thank you. On behalf of the team presenting today and all of us at Alvotech, I want to thank everyone who joined us for this webcast. We look forward to talking to you again and wish you a wonderful day.

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