Niall Alexander's questions to Alvotech SA (ALVO) leadership • Q3 2024
Question
Niall Alexander of Deutsche Bank inquired if the recent FDA inspection could affect the Stelara biosimilar launch. He also asked if the previously communicated 2025 revenue guidance of $600M-$800M remains a reasonable assumption. Lastly, he asked about Amgen's successful Eylea biosimilar launch and what Alvotech needs to do to replicate that success in the U.S.
Answer
Chairman and CEO Robert Wessman asserted that the 'easily addressable' 483s will 'surely not hold off any launches.' He also confirmed it is 'very fair to assume' the prior $600M-$800M guidance for 2025 is still valid until a formal update is provided. Regarding Eylea, Wessman and Chief Commercial Officer Anil Okay noted Alvotech's differentiated product provides an 'amazing opportunity' and that while a U.S. launch strategy is in place, the immediate focus is on gaining filing acceptance.