Alvotech - Earnings Call - Q3 2025

Transcript

Speaker 2

Good day, and thank you for standing by. Welcome to the Alvotech Q3 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press *11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press *11 again. 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 Communication. Please go ahead.

Speaker 1

Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first nine 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 and 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 number two 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 Róbert Wessman, Chairman and Chief Executive Officer of Alvotech; Joseph McClellan, Chief Operating Officer; and Linda Jónsdóttir, Chief Financial Officer.

Also with us on the call is Balaji Prasad, Chief Strategy Officer. Róbert 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. With that, I would like to turn the call over to Róbert Wessman.

Speaker 0

Thank you, Benedikt, and thanks to everyone for joining us here today. Please turn to slide number four in your deck. We are now approaching the end of a 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 biosimilars 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 originated biologics each year, and 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 two 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: five 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 originated markets.

Now, let me touch upon a few key points that I will discuss today and describe on the following slide. This includes an update on the FDA process, our pipeline, a comment on the revised outlook for the year, and an update on our marketed products. Let's turn to the next slide. As announced last week, we received a Complete Response Letter, or CRL, from the FDA for our BLA for the proposed biosimilar to Simponi. The sole reason noted in the CRL concerns unresolved issues identified by FDA during the inspection of our Reykjavik facility, which concluded in July of this year. Let me make it clear: this CRL did not change the status of the Reykjavik manufacturing facility, which continues to be an FDA-approved site that produced and will continue to produce our current marketed products in the US.

Also, the site is approved to manufacture for global markets and continues to get approvals for our new product launches. The facilities referenced in our regulatory application, including our Reykjavik site, are, of course, regularly inspected by several global regulatory agencies as a routine part of the review process. For example, both the European Medicines Agency and Japan's PMDA inspected our Reykjavik site earlier this year in support of our new product approvals in these markets that will occur in the third and fourth quarter, leveraging several successful inspections by many regulatory authorities, including a recent inspection by FDA in the third quarter of 2024, which yielded only two minor Form 483 observations. We remain committed to continuous improvement of our manufacturing operations.

To support consistent and effective leadership at the site, we have expanded the responsibility of Joseph McClellan, current Chief Scientific Officer, by appointing him as Chief Operating Officer. In his role, Joseph will be responsible for technical operation as well as research and development, supply chain, and project management. Before joining Alvotech in 2019, Joseph held positions of increased responsibility at Wyeth and Pfizer in the United States over a span of 17 years. During his tenure at Alvotech, he has played a key role in advancing and strengthening our high-performing research and development organization and its pipeline. His commitment to uphold best-in-class quality standards and operational excellence will position Alvotech to address any concerns raised by FDA at our facility. Although we are disappointed by the approval delay resulting from the CRL, we remain committed to promptly resolve any outstanding matter relating to the facility.

Once FDA provides clarity later this month on the specific issue identified during the inspection, we will address those in a timely manner. Once we respond to the CRL, we anticipate the approval of our BLA may be granted as early as the first half of 2026, in accordance with six-month statutory review periods. With this review timing, we still anticipate being one of the first, if not the only, approved biosimilars to Simponi in the U.S. and other global markets. Of note, we have already received approval in Japan and the U.K., with EMA approval expected shortly for our biosimilar to Simponi. Please turn to the next slide addressing our revenue growth. Later in the call, Linda will discuss our third-quarter financial results and full-year guidance in detail.

When we reported our full-year guidance in March, we signaled that the first half and second half of the year would be relatively balanced, while the fourth quarter would be the strongest of the year due to anticipated product approvals and launches which were occurring later in the year. Following the receipt of the CRL from FDA, we revised our outlook for the full year to $570 million-$600 million top-line revenues and adjusted EBITDA of $130 million-$150 million. We believe the cost incurred and temporary loss in product revenue are necessary investments in our future growth and will make the company stronger as we continue to expand our portfolio of products and launches into additional global markets. As you can see on this slide, Alvotech's revenue growth has been extraordinary, or 127% on average per year from 2021 to year-end 2024.

With the latest guidance we have given, we are projecting a compounded average growth rate of 94% from 2021 till the end of this year. As we are launching three more biosimilars this year, this contributes to both licensing and product revenues, and our strong pipeline and increased R&D will allow license revenues to continue to be a significant revenue contributor. We are very pleased to say that we are seeing very strong global interest in our enhanced product portfolio. We continue to sign numerous contracts with our partners globally, which will continue to deliver strong milestone revenues and secure strong market share globally going forward. Please turn to the next slide. Now, I will turn to how the markets for the existing products have evolved.

In the U.S., we continue to hold the second-largest market share in the Humira biosimilar segment, and our products remain the fastest-growing Humira biosimilar. The originated share is eroding and expected to fall below 50% of its original volume by year-end, with most volume continuing to shift to biosimilars and a much smaller portion transitioning to novel therapies. In Europe, our partner's data continues to grow volumes for Yukindra. We have seen average quarter-on-quarter growth of 12% the last four quarters. Yukindra now holds the top position in several of the 10 largest EU markets, including Austria and Sweden, and has reached 10% share in France, competing against nine other biosimilars. In Canada, Symlandi, marketed with JAMP Pharma, remains the fastest-growing Humira biosimilar.

With respect to our biosimilar to Stelara in the U.S., our partner, Teva, continues to secure formulary coverage, and we are among the top three biosimilars on the market for this reference product. In Europe, we were first to launch Stelara biosimilar, and while the competition has increased, we are still holding a leading position in the European markets where we have launched our product, with about 10% share of the total Stelara market and 25% share of the biosimilar segment. We expect 50% of Stelara's European market to transition to biosimilars by year-end. With that, I will hand the call over to Joseph McClellan, who will discuss our portfolio, including the near-term launches. Over to you, Joseph. Thank you, Róbert.

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 request 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 23rd of this year. We are prepared to launch AVT06 pre-filled 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 European Economic Area 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, anticipating 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 European Economic Area 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 Kishive and Advance, we have submitted a biosimilar candidate to Zolair in the European Economic Area 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 and AVT80, 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 two 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, Joel, 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 nine months of 2025. The earnings stack is more detailed than usual, and we hope you appreciate the additional insights into the quarterly results provided in the next few slides. As Róbert mentioned, Alvotech has delivered strong KCAL growth in the past four 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 Róbert noted earlier. In Q3, licensing revenues were at a 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 2025, and outflow driven by inventory built in support for upcoming launches. Looking at the year-to-date on the next slide, Alvotech delivered total revenues of $420 million for the first nine months, which represents strong 24% growth year-on-year. This shows our strong commercial momentum following the launch of our biosimilar to Humira in the U.S. and early traction for our biosimilar to Stelara in both Europe and the U.S. Gross margin was at 59% and underscores the strength of our licensing model, while product margin of 27% reflects Q3 softness. Adjusted EBITDA in the first nine months was $68 million, or 16% margin.

When compared to prior year, it is important to note that 2024 included very high licensing revenues tied to three biosimilar submissions and the U.S. launch of our biosimilar to Humira, along with the launch of our biosimilar to Stelara in Europe. Cash balance at the end of September was $43 million and reflects outflows connected to inventory build-up ahead of product launches, CAPEX investments, and M&A activity. If we then double-click on the revenue and EBITDA trends on the next slide, our revenue model as a B2B company naturally leads to quarterly fluctuations related to timing of orders from our partners. However, despite these fluctuations, we delivered strong double-digit growth in revenues, both in the quarter and in the first nine months, up 11% and 24% respectively, with a trailing 12-month run rate of $571 million in revenues.

Adjusted EBITDA margin for the first nine months 2025, however, was at 16% compared to 26% last year. This was driven by higher R&D investments to accelerate pipeline expansion, as well as higher DNA cost to scale operations and infrastructure to be able to drive operational efficiency across the organization. Finally, I would like to highlight that we continue to diversify geographically, with growing contributions from Europe as market share in Europe and other markets outside of the U.S. continues to grow. Moving to cash flow on the next slide. As I touched on earlier, cash flow in the quarter was a function of lower revenue collection due to timing and planned inventory build-up in support of upcoming launches. We also continued strategic investments in CAPEX and in fundables to expand capacity to support new launches and our growth plans.

New working capital option of $100 million will be used to capture swings in working capital. Cash is impacted by the cost associated with acquisition of Ivers-Lee and interest payments since from June 2025, we are paying cash interest on our loans. Next, I would like to quickly touch on the balance sheet on the next two slides. Our asset base remains strong, supported by recent bolt-on acquisitions and continued investment in R&D to drive future growth. Current assets are stable overall, with expected shifts in inventory and trade receivables during the period. Looking into the equity and liability side, a couple of things to mention here: our equity position strengthened by $236 million, driven by profit for the period and the inflow of capital contributions from our most recent Swedish listing. Derivative financial liabilities decreased by $167 million, mainly due to fair value change on earn-out shares.

Lastly, the overall contract liabilities decreased due to recognition of licensing revenues. If we then turn to the next slide featuring our revised full-year outlook. On November 4, we revised our outlook following the CRL from the FDA. We updated our outlook for the full year to a range of $570 million-$600 million in revenues and adjusted EBITDA range of $130 million-$150 million. This revision reflects action taken to respond to any issues identified by the FDA inspection impacting production efficiency in 2025. Some of the licensing agreements for pipeline assets that were expected at the end of Q4 are now shifting to 2026. Despite these short-term headwinds, we expect a strong finish to the year, especially with licensing revenues that translate directly to EBITDA. At the midpoint of the guidance, we are targeting to deliver 19% year-on-year revenue growth and 30% EBITDA growth.

Fundamentals remain strong. We expect margin recovery and accelerated revenue contribution will follow new launches and continued geographical diversification. More importantly, we continue to see growth in markets outside the U.S., which helps balance our revenue profile. Based on the committed orders we have for our new launches in markets outside the U.S., combined with the growth momentum we are seeing with our currently marketed products, we are well-positioned to deliver top-line and EBITDA growth in 2026. Management will provide new future guidance no later than with the Q4 2025 results. Our strategic focus for the next 18 months is on focused execution to unlock long-term growth, advancing the pipeline, realizing multiple global launches to deliver solid sales growth and diversification of revenues across geographies and products. At the same time, we will drive cost optimization and operational efficiencies to support margin expansion.

Working capital management will also be our key focus to achieve positive free cash flow and support our growth trajectory. This brings me to my final slide. I think it's always good to look a bit backwards and see where we're coming from, where we are today, and where are we heading. Alvotech's journey from its 2013 foundation to today reflects a transformation into a leading biotech company with one of the industry's most valuable biosimilar pipelines. From 2013 to 2023, the focus was on building a vertically integrated platform, investing in R&D and talent, and establishing global partnerships to enable successful launches of Humira and Stelara biosimilars. In the 2024 to 2025 period marks a major inflection point: multiple global approvals, including those referencing Humira and Stelara in the U.S., accelerated pipeline development, and fivefold revenue growth from 2023 to 2024.

We achieved positive EBITDA in 2024 and are targeting around 30% growth in 2025 on EBITDA level. Looking ahead to 2026, our priorities are diversification and scale, advancing our pipeline, executing multiple global launches, and critically adhering to regulatory standards and ensuring FDA compliance as a cornerstone of success. With a $20 billion addressable market for upcoming biosimilars, we are positioned to deliver sustainable growth and long-term shareholder value. I'll now turn the call back over to the operator for Q&A. Thank you. As a reminder, to ask a question, please press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again. We will now take the first question from the line of Arsh Verma from UBS. Please go ahead. Hi, good morning. Thanks for taking our question.

Yeah, I wanted to just get back to the focus on the CRL. Can you kind of explain this, what are the observations this time? They're different from the last time. 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 Joseph 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 that clearly. There were no repeat observations in the deficiencies identified in the Form 483 from the FDA at the conclusion of the inspection. 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. All right. Thanks for that. Just as a follow-up, I know this Form 483, you have 10 observations, and even for Humira back a while ago, I think ultimately it 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 this something that is driven by less of an availability of pharma talent or anything of that resort, 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? Yeah. Thank you for the question, Róbert 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 the U.S., we are around 18 months into being a commercial company, if you will. We have gone through three FDA inspections over the 18 months. The first two, which was early 2024, was only one 483.

Late last year, we had a general GMP inspection, which we only got two minor 483s. Overall, I would say it was very disappointing to get this CRL and unexpected. The company has continued to grow and strengthen further the quality systems. We have full intention to absolutely stay and be best in class when it comes to GMP and quality. I mean, that's reflected. We have gone through successfully five EMA inspections. We have gone through at least four inspections from different global health authorities and now two successful FDA inspections. As Joe explained in details, we took this very seriously. I think overall, we have done substantial improvements.

Joseph himself has shown amazing success in R&D and brought all of our five currently approved or marketed products to a success, and the 12 products which are in late stage in R&D. He has extensive experience, as I mentioned in my part, from Pfizer, and he lives in Iceland. That is a big factor to have the core team living in Iceland to take charge. I have great expectations with those changes that all future deficiencies hopefully will be behind us. 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. It is a kind of moving target, and we will continue to move with it, if you will. Cool. Okay.

I have just one more question. I guess just for the three products that you've tried to pursue now with the FDA approval, you've gotten two 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 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? Yeah. 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.

This of interest, of course, leave aside 11, 12 successful inspections from EMA to US FDA to other health authorities in the world. Our clients are doing also inspections or audits on ourselves. Our customers are very much aware of the status of the facility. Overall, we have not seen any reduction of interest in our products. We keep our key clients up to date on what we are doing to continue to evolve the quality system, if you will. We highly appreciate that for all of our portfolio products that are usually more than one or more than two, which are showing strong interest in those products at any given time. Great. Thank you. Thank you. We will now take the next question from the line of Thibault Bouderin from Morgan Stanley. Please go ahead. Thank you very much.

Just a couple of questions on the revenue impact of this year, having 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? Is it just a sort of phasing, or should we understand this as lost revenues? Does that mean that your commercial partner may face supply interruption impacting their revenues? I'll start there, and I have another one after. Okay. It's Linda Jónsdóttir, your CFO. If I understood your question correctly, it's about the changes in guidance that we announced on November 4th. I would say it's twofold. The revision is about actions taken to respond to any issues, so that is slowing us down on the production side and impacting our revenues in 2025.

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 a timing impact, but has sizable EBITDA impact in Q4 since it's licensing revenues that flows directly into EBITDA. However, if I also comment a bit on 2026 and our compass levels there, if I look into the committed orders we have for new launches and markets outside of the U.S., and in a combination with the growth momentum noted in currently marketed products, we are in a very good position to deliver top-line and EBITDA growth in 2026. Thank you.

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 is going to take to fix it, regardless of the answer you are expecting from the FDA, or could this change depending on what you get from the FDA? No, I think Róbert is here again. I think we have pretty clear visibility on that. The drug product part of the facility is undergoing some minor adjustments as we speak. We will then close the drug substance for a particular period in December for both general maintenance and adjustments. 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, assembled or packed, but mostly they have been produced.

We have pretty good visibility how the year end, we believe, and comfort level how that will end. As you can imagine, based on the guidance we gave and based on year-to-date EBITDA, it is fairly easy to see how strong the fourth quarter will be. It is a good, as Linda said, good momentum with the order book. Based on what we are seeing, we are fairly confident on growth both top-line and EBITDA for 2026, no matter what. Very clear. Thank you. Yeah. Thank you. As a reminder to ask a question, please press star one and one. Our next question comes from the line of Arvid Nekander from DNB Carnegie. Please go ahead. Good afternoon, and thanks for taking my questions. 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? 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? Secondly, on the R&D spend, at the beginning of the year, I think you were expecting R&D spend of roughly $160 million-$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. Thanks. One moment, please. Your conference will resume shortly. Sorry. Okay. If I continue, as I was saying, observations around putting in manufacturing controls, improving the way you do investigations, laboratory controls, documentation practices, those kinds of aspects.

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 is 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? 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 airflow is correct, to make sure that our procedures associated with changing and gowning are all improved, right? 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. There are actions progressing. We are manufacturing. As Róbert says, there is 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. In general, we are manufacturing and delivering product for this quarter that we have recently manufactured since the slowdown we referenced in the press release. Linda? Yeah. To touch on your cost question, on the R&D side, we had elevated levels on R&D both in Q2 and in Q3. That is also related to timing of clinical and manufacturing activities as well as launch preparation for upcoming launches. In Q3, we also had impact in R&D related to the improvements that Joe was covering.

We are expecting that also to touch our R&D numbers in Q4. But I can confirm that we're still expecting lower R&D in Q4 than both in Q2 and Q3. Great. Those were all my questions. Okay. Thank you. Thank you. Thank you. We will now take the next question from the line of Thibault Bouderin from Morgan Stanley. Please go ahead. Thank you. Just a question on the impact of the change of regulation you mentioned with the lower requirement for phase three trial. Can you talk a little bit about how that impacts your plan for your earlier stage biosimilars? In particular, thinking about K3DA and CMDR, where the timelines could move based on your decision to run an efficacy study or not. Thank you. Yeah. Róbert Wessman here again. I will hand this over to Joseph, but I just want to say on the lines.

We anticipated this change over two years ago. Based on that, we changed our approach to R&D, if you will. As we have already stated on this call and previous calls, we have all in all between marketed products, approved products, late-stage development, early-stage development, over 30 products in the pipeline. We think we have used the time very well and taken advantage of the changes which are coming now by kind of assuming and expecting this to come. We are already bearing the fruits of that vision we had back in time. For the detailed answers, maybe Joe, if you take that. Yeah. Absolutely. This is Joseph. For sure, right? We are doubling down on our strategy. We have a proven development engine. We are leveraging that.

As Róbert said, we forecasted and anticipated that the need to do patient efficacy studies was going to go away from a regulatory perspective. It has. Because we made the bets over two years ago, we are now in a good position to take advantage of that. We are doing that for products as we're developing them, right? You can imagine that, yeah, Cimzia would be one of those as well. Thank you. 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. On behalf of the Alvotech team, I would like to thank everyone who called in and listened to our call today. 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.