Alvotech (ALVO) UBS Virtual Generics and Biosimilars Day summary

Company overview and platform

• Established in 2013 as a pure-play biosimilars company with over $2 billion invested in infrastructure and portfolio development.

• Operates a vertically integrated facility in Reykjavik, supporting more than 30 biologics in development and five commercial products.

• Holds one of the largest global biosimilar pipelines, focusing on differentiated, limited-competition assets.

• Anticipates five or six of the next eight launches will enter limited competition markets.

• Recently announced major updates, including a key resubmission and FDA acceptance for a biosimilar to Entyvio.

Commercial strategy and partnerships

• Operates as a B2B platform, leveraging 19 global partners for access to 70-80 countries.

• U.S. commercialization is managed through partnerships with Teva and Dr. Reddy’s, covering key biosimilars like Humira, STELARA, SIMPONI, EYLEA, and PROLIA.

• Emphasizes speed, execution, and first-to-market advantage as critical success factors.

• Maintains strong manufacturing capacity in Europe and Iceland, with supply secured through 2030.

• Holds the second-largest market share in biosimilar Humira and is gaining share in biosimilar STELARA.

Regulatory progress and outlook

• Addressed FDA observations from a 2023 inspection by implementing nearly 200 CAPAs and strengthening processes beyond requirements.

• Resubmitted BLAs on June 4, starting a six-month review period with potential approval by December 26.

• Recent FDA CGMP inspection provided further validation; management is confident in approval prospects.

• No FDA pushback on product or clinical data quality; delays have been solely facility-related.

• Limited interim updates expected before approval; focus remains on regulatory milestones.