Alvotech

Good day and thank you for standing by. Welcome to the Apple Tech first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, we'll open up for questions. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Benedict Stephenson, Vice President of Investor Relations. 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 quarter of 2026. Material accompanying today's earnings call, including a supplemental earnings report, providing additional operational details and business updates, and the presentation we'll be referring to on today's call We're also published on our investor portal, investors.alvadeck.com, in the earnings calendar section under the heading Q1 2026 Earnings Call. Our press release, earnings report, 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, and Linda Jonstadter, Chief Financial Officer. Robert will begin today's presentation with a summary of our progress with the U.S. regulatory pathway and some key business highlights. Lisa will then present a commercial and pipeline update. Linda will 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.

Good morning, everyone, and thank you for joining us. The first quarter was focused on three priorities. Progressing the FDA resubmission, maintaining a high level of inspection readiness, and continuing to expand our commercial business globally, including the launch of three biosimilars across Europe and rest of the world markets. Last week, the FDA began a routine GMP surveillance inspection at our Reykjavik facility, which is currently ongoing. Routine surveillance inspection are normal part of operating an FDA regulated manufacturing facility, and our previous surveillance inspection took place in 2024. We continue to engage constructively with agency throughout the process and expect it to be concluded by the end of business day tomorrow. Since our most recent pre-license inspection, which took place in July 2025, we have implemented several important enhancements across our quality system and operations. The work to address the findings has been approached in highly structured and disciplined manner and is well advanced. Importantly, we have deliberately taken additional time to substantially de-risk future operational and regulatory disruption and to ensure that when we resubmit, we do so with a package that fully addresses the agency's requirements and supports the long-term growth and value of the company. These actions have impacted manufacturing throughput, resulting in a slowdown at certain points during 2025 and the first quarter of 2026. But I'm very pleased with the progress the organization has made And the resubmission of our biologics license applications for our biosimilars to Symfony, Symfony ARIA, ILEA, Prolia, and Textiva are now in the final stage of completion. As we complete the current resubmission process, we believe there is significant near-term value within our pipeline, which we believe is one of the most valuable in the industry today. We are approaching a number of important milestones across several high-value programs that will drive the company's anticipated strong growth in 2027. This includes submissions in 2026 of biosimilar to Entivio and Ailea high-dose, and the resubmission for biosimilar to Ailea, Symfony, Prolia, and Extiva. These programs target large and growing biologics markets and position us with the first wave of biosimilar entrants in their respective segments. Together with our leading pipeline of 30 biosimilar products, these submissions underscores the strengths and the momentum of our pipeline, which will support Alvotec's long-term growth. More broadly, we have built out one of the strongest integrated by a similar platform in the industry, combining research and development, manufacturing, regulatory capabilities, and global commercial partnerships. With the platform now built, our focus has increasingly shifted towards execution, launches, and converting our pipeline into commercial growth. Alvotec entered the U.S. market in mid-2024, marking the transition from an R&D-focused organization to a global commercial biosimilar company. Today, we have a commercial presence in over 90 countries and continue to expand patient access to biologics throughout the world. We believe the company is well positioned for its next phase of growth, and with that, I will hand the call over to Lisa.