Alvotech (ALVO) investor relations material

Regulatory and operational updates

• Four BLAs for three products resubmitted to FDA, with approvals expected by year-end; recent FDA and EMA inspections concluded positively, supporting confidence in upcoming approvals.

• Strategic licensing agreement with Lotus enables direct U.S. commercialization of HEMLIBRA and IMFINZI, marking a shift from a pure B2B model for select assets.

• Second manufacturing source secured with Fujifilm in the U.S. to provide redundancy and flexibility, supporting anticipated demand growth and maintaining service levels.

• Manufacturing and quality systems have been enhanced, addressing FDA observations and ensuring readiness for further inspections and approvals.

• Gross margin impact from external manufacturing expected to be neutral; production running at full capacity to meet strong order book.

Commercial strategy and market positioning

• Direct commercialization in the U.S. for HEMLIBRA and IMFINZI targets niche, high-value markets, leveraging internal expertise and aiming to capture more value.

• Additional products may follow this direct approach, though the core model remains B2B globally.

• U.S. HUMIRA biosimilar has achieved 60% market conversion, with Teva as a key partner and private label estimated at 20% of the market.

• Ex-U.S. launches of Simponi, Eylea, and denosumab have seen strong uptake, especially where first-to-market advantages exist.

• STELARA biosimilar in the U.S. has reached similar conversion rates as HUMIRA, with continued growth expected.

Pipeline and product development

• Eylea biosimilar expected to launch in December, with high-dose formulation filings planned in Europe this year and U.S. submission likely in early 2028.

• ENTYVIO biosimilar filings completed in both Europe and the U.S., with launches anticipated in several markets by 2027.

• Simponi biosimilar positioned for U.S. launch alongside or ahead of Bio-Thera, with strong IP confidence.

• Pipeline highlights include Cimzia, Ilaris, and Keytruda biosimilars, with competitive positioning and cost advantages.

• Ongoing R&D and device innovation, such as the safety device for high-dose Eylea, support differentiation.