Alvotech

Good day and thank you for standing by. Welcome to the Arvitek Q4 2025 and full year 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 this session, you will need to press star 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michaela Vilches. 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 investors portal, investors.albotech.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 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 Westman, Founder and Executive Chairman, Lisa Graver, Chief Executive Officer Designate, Joseph McClellan, Chief Operating Officer, Linda Young-Stathier, 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 the 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 Westman.

Hello, everyone, and thank you for joining us today. 2025 was an important year for our tech. 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 SDA inspection of our radioactive 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. Alvotek 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 2 and phase 3 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 one to two years to development timelines. Reducing that requirement substantially lowered the development cost and time needed to bring fire seminars to market. At Alvotrack, we anticipated those changes and we adapted 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 two 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 billion in global sales. This pipeline is what will drive AlvaTech'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, 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 Kraver has joined AlvoTech as a 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 an AlvoTech board member since 2022. Lisa brings a wealth of experience in commercial, R&D, manufacturing, and quality compliance. With Lisa's appointment as a 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 and people now firmly in place, the company is entering into a new phase focused on operational execution and commercial scale. I will continue to serve as executive chairman and be actively engaged in the business. And I'm very much looking forward to work closely with Lisa and the leadership team. We, as a team, will, of course, continue to build Alvotek into a leading global biosimilar company. And with that, I will hand the call over to Lisa.