Business
Alvotech Reports Financial Results for Full Year 2022 and Provides Business Update
Full year 2022 total revenue, including other income, increased by 114% to $85.0 million, compared to $39.7 million in 2021, driven by both milestone revenue
About this update from Alvotech
[{"type":"text","content":"Full year 2022 total revenue, including other income, increased by 114% to $85.0 million, compared to $39.7 million in 2021, driven by both milestone revenue and product revenue from commercialization of AVT02, a biosimilar to Humira®, in 17 countriesThree biosimilar candidates, AVT03 (Prolia®/Xgeva®), AVT06 (Eylea®) and AVT05 (Simponi®/Simponi Aria®), advanced into clinical development in 2022 Marketing applications for AVT04, a proposed biosimilar to Stelara®, were submitted in major markets including the U.S. and EuropeU.S. Food and Drug Administration (FDA) confirmed a new goal date for AVT02 Biologics License Application (BLA) of April 13, 2023, and is expected to commence a reinspection of the Reykjavik manufacturing site on March 6, 2023Management will conduct a business update conference call and live webcast on Thursday, March 2, 2023, at 8:00 am ET (13:00 pm GMT) REYKJAVIK, Iceland, March 01, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for full year 2022 and provided a summary of recent corporate highlights. \"Alvotech made significant progress in 2022. We were publicly listed, achieved a remarkable 114% increase in revenue, and were able to continue investing in and shaping our future through the ongoing advancement of our product pipeline,” said Robert Wessman, Chairman and CEO of Alvotech. “Looking ahead, 2023 is expected to be equally important. We’re currently preparing for a reinspection of our Reykjavik facility by the FDA, which, if satisfactory, could pave the way for the approval and subsequent launch of our interchangeable, high concentration biosimilar to Humira® in the U.S. market on July 1, 2023.\" Recent Highlights In December 2022, Alvotech announced that the FDA has confirmed that the goal date for Alvotech’s original BLA for AVT02 as biosimilar to high-concentration Humira® is April 13, 2023, and that the FDA has completed its review of Alvotech’s BLA of AVT02 as an interchangeable to high-concentration Humira. Approval requires satisfactory outcome of an upcoming FDA reinspection of Alvotech’s facility in Reykjavik, Iceland, that is scheduled to start on March 6, 2023. In January 2023, Alvotech hosted a general Good Manufactu...