Alvotech

Good day and thank you for standing by. Welcome to the Alvotex third quarter 2024 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 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 first speaker today, Benedikt Stefansson. Please go ahead.

Thank you, and good morning or afternoon to everyone joining us on this call today. Yesterday evening, the company issued a press release that can be found on our website, www.alvotech.com. The release reports financial results for the first nine months of 2024 and provides a business update. Additionally, presentation slides that cover our call today have been posted on our investor website. You'll find all materials posted for the first nine months 2024 earnings call under news and events in the events and presentation section on investors.alvotech.com. Our presentation materials and some of our statements that we make 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. These risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made. With me on today's call are Robert Westman, Chairman and Chief Executive Officer of AlvoTech, Anil Oke, Chief Commercial Officer, Joel Morales, Chief Financial Officer, and Ming Li, Chief Strategy Officer. With that, I would like to turn the call over to Robert Westman. Robert?

Thank you, Benedikt, and greetings to everyone joining us on the call today. We are very pleased with the result on the quarter and the first nine months of 2024, and as well as the continued progress we are seeing in the business overall. Total revenues for the first nine months of 2024 increased nearly nine times when we compared to the same period in 2023. Revenues from the products for the first nine months rose to $128 million, which was driven by an increase in product revenues in the third quarter as compared to the second quarter in 2024. As importantly, the company realized a material setup of underlying product gross margins, which more than doubled in the third quarter when compared to the second quarter. As we have discussed in the past, we expect a material increase in product gross margin in the second half of the year compared to the first half of the year. The drivers of improved margin are increased utilization of the manufacturing site and realization of the scale of activities for on-market products and ex-U.S. revenues for our biosimilars to Stellara. We do expect continued margin expansion due to better utilization and the shift in the product mix that will start to include Stellara biosimilar for U.S., as well as expected contribution from new product, such as AV206, our proposed biosimilar to ILEA, AV205, our biosimilar candidate to Symfony, and AV203, our biosimilar candidate to Prolia and Dextiva. Milestone revenues here today reach over $210 million. While the majority of the revenue came in the second quarter of this year, the third quarter saw expected revenues from existing partnerships and a few new partnerships deals. We are thrilled with our ongoing progress and our path to become a leading global by a similar company. While our historical results are indeed positive, I'm even more excited about the execution of our pipeline and strong business fundamentals we are focusing on today. We believe these efforts are paving the way for sustained growth in the future. And with that, I would like to discuss some recent highlights in our business. In September, the company concluded on inspection by the U.S. FDA of our manufacturing site in Reykjavik, Iceland. This was an extensive general GMP inspection. This is taking place less than a year after the most recent inspection that paved the way for approvals on both the Cimlandi and Celasti. It's common practice by FDA to inspect sites after making their initial commercial entrance into the U.S. market. We, of course, welcome the opportunity to test the company and its system, which has been heavily invested in over the past few years. We received two observations during this inspection, and while we take all observation very seriously, we view the overall results as validation of our past and ongoing efforts to continuously improve compliance of our manufacturing site. We do expect industry standard pre-approval inspections for future filings, and we also expect future FTA general GMP inspections to take place on a two-year cadence going forward. I would like to thank the hardworking team of Alvatech for their commitment to quality and compliance and the excellent results achieved during this latest inspection of our facility. I would also like to extend our gratitude to the commercial partners who routinely inspect our manufacturing facility. This dynamic provides us with the new opportunities to enhance our quality systems and overall compliance and provides us comfort as we will continue to remain in good standing across the global markets. In addition to the recent inspection, We have continued to establish the base for future growth by advancing our pipeline and expanding our partnerships. ABT16, our biosimilar candidate to NTVO, is now in patient trials, and we are the second company to reach this status in this growing market. Furthermore, we have received eMA acceptance on our application for both ABT03 and ABT05. AVTO3 is our proposed biosimilar to both Prolia and Xtiva, and AVTO5 is our biosimilar candidate to Symfony. Finally, in the U.S., we received approval for an additional presentation of Celarthi, our biosimilar to Stellara. And more importantly, we will be launching in the U.S. market in 2025 with all indications, which was expected. but also good to have completed now. Overall, we are pleased with the continued execution by the company that we have seen in 2024. On the next slide, you can see the timelines of events that demonstrate this execution, and we have steadily been updating throughout the year. As important as current financial results are, It is equally important that we continue to execute on our business development progress and our research and development to secure that we have future opportunities. This allows the company to establish a steady cadence of revenue generating possibilities in the future to maintain growth. Additionally, it is an important goal of the company to continue to diversify both products and markets, as we strive to create a sustainable growth engine in the biosimilar space. With that, I would like to turn over the call to Anil Okai, our chief commercial officer, to give additional updates for the markets on the pipeline. Over to you, Anil.