Alvotech (ALVO) Q4 2025 Earnings Transcript

Chief Financial Officer — Linda Jonsdottir Chief Scientific Officer — Joseph McClellan Head of Investor Relations — Mikaela Vilchez 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 biologics. This tells us that the reliance on biologics will only increase over time as more targeted therapies are developed. At the same time, more than 100 biologics are expected to lose patent protection over the next decade. While healthcare systems around the world are under increasing pressure to reduce costs, this creates a very significant opportunity for biosimilars. Another important development for the industry was that FDA draft guidance related to biosimilar development. In practice, it means that large expensive efficacy trial will increasingly not be required. Some studies in the past have costed around $100 million per program and added 1 to 2 years to development times, reducing that requirement substantially lowered the development cost on time needed to bring biosimilars to market. At Alvotech, we anticipated those changes, and we adopted our development strategy already several years ago. The new FDA guidance, therefore, does not change our strategy, but rather validates the approach we have already taken. Importantly, we are now well positioned to benefit from those changes compared to many of the other companies that are still set up for the older model. Joseph will discuss this in more details and explain how these changes may benefit our pipeline. Turning to the next slide. Our ongoing investment into our platform mean that today, we can initiate development of a new biosimilar program roughly every 2 months. This has enabled us to build one of the most comprehensive biosimilar pipeline in the industry. We now have 30 biosimilars in development, representing more than $185 million in global sales. This pipeline is what will drive Alvotech s future growth, and we will continue to, of course, expand it. Before handing over, I would also briefly highlight our financial performance for the year. In 2025, total revenues increased by 20% to $591 million (sic) [21% to $593 million ] while adjusted EBITDA increased by 27% to $137 million. Linda will discuss the financial results in more details shortly. Finally, as we have announced earlier this year, Lisa Graver has joined Alvotech as the Chief Executive Officer. From the beginning, I saw my role as a CEO, to be a time-defined appointment focused on building the company s platform and global partnerships. Lisa and I have worked together over 20 years, and she has served as Alvotech Board member since 2022. Lisa brings a wealth of experience in commercial, R&D, manufacturing and quality compliance. With Lisa appointment as our CEO, Linda s appointment as CFO, and Joseph and Anthony stepping into expanded roles, the key management positions are now all based on-site in Iceland, and the senior leadership has been strengthened. With the platform of people now firmly in place, the company is entering into a new phase focused on operational execution and commercial scale. I will continue to

Alvotech (ALVO) Q4 2025 Earnings Transcript

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Alvotech (ALVO) Q4 2025 Earnings Transcript

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