Alvotech

Welcome to Alvitek's earnings call for the first nine months of 2023. 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. I would now like to hand I'd now like to introduce and hand over the call to Benedikt Steffensen, Senior Director of Investor Relations and Global Communications of Alvatech. Please proceed.

Thank you, and good morning or afternoon to everyone joining this call today. Yesterday evening, the company issued a press release that can be found in the news section of our investor portal, investors.alvatech.com. The release outlines key highlights related to our third quarter results. Additionally, presentation slides that cover our call today have been posted on our website in the events section of investors.albotech.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 and the Nasdaq Iceland Stock Exchange. 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 CEO 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, Founder, Chairman, and CEO of Alvotech. Robert?

Thank you, Benedikt. Thank you all for joining us on this earnings call today and the business update. I would like to start today's presentation by going over some key updates to the business. The company continues to prepare for the upcoming inspection with the US FDA, which we now expect to start on January 11 in the new year. This inspection, if successful, could pave the way of approvals in the U.S. for both ABT02 and ABT04. These are biosimilars to Humira and Stellara. Inspection status of our manufacturing facility is the only outstanding requirement in order to gain approval for both of these applications in the U.S. While we understand that the upcoming inspection is of critical importance, we continue to receive positive confirmation to gain global regulatory approvals. Our second product in our portfolio, AVT04, a biosimilar to Stellara, has recently received approval in Japan and Canada. Additionally, we also receive confirmation of a positive CHMP opinion in Europe, which should soon lead to final approval. Finally, in U.S., the review of AVT04 has been completed, and the application is deemed approvable, subject only to inspection status, as noted earlier. Since our last business update, we have secured rights to a proposed biosimilar to solar, identified as AVT23, with CASI Bioscience. This transaction allows us to follow through on our commitments to our commercial business partners. AVT23 is the only program in our current pipeline and portfolio that does not originate in-house. Our global footprint of commercial partners allows us to enter strategic partnerships like we now have with CACI to accelerate our portfolio expansion. In our partner CASIF, we have found a company that has proven ability to develop approvable biosimilars in regulated markets. We look forward to provide further updates on the program. On that note, CASIF announced in October of this year that our AVT23 entered into confirmatory clinical study. Including AVT23, AlvoTech has now four different biosimilar programs that are in active patient studies. We expect in 2024 to file at least three additional products in major global markets, including the US and EU. And with that, I would like to turn the call over to Anil Oke, our Chief Commercial Officer, to provide further updates. Over to you, Anil.