Alvotech (NASDAQ:ALVO) Q3 2023 Earnings Conference Call November 29, 2023 8:00 AM ET
Company Participants
Benedikt Stefansson - Senior Director of IR and Global Communications
Robert Wessman - Chairman and CEO
Anil Okay - Chief Commercial Officer
Joel Morales - CFO
Conference Call Participants
Mikaela Franceschina - Barclays
Niall Alexander - Deutsche Bank
Thibault Boutherin - Morgan Stanley
Operator
Welcome to Alvotech's Earnings Call for the First Nine Months of 2023. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]
I would now like to introduce and hand over the call to Benedikt Stefansson, Senior Director of Investor Relations and Global Communications of Alvotech. Please proceed.
Benedikt Stefansson
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.alvotech.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.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's 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 Wessman, Chairman and CEO of Alvotech; Anil Okay, 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 Wessman, Founder, Chairman and CEO of Alvotech. Robert?
Robert Wessman
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 U.S. FDA, which we now expect to start on January 11th in the new year. This inspection, if successful, could pave the way of approvals in the U.S. for both AVT02 and AVT04. These are biosimilars to Humira and Stelara.
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.