ALVOW

• Robert discussed the FDA CRL for the BLA of the biosimilar to Simponi, noting the sole issue was from the Reykjavik facility inspection, but the facility remains FDA-approved. He highlighted revenue growth, with 127% average annual growth from 2021 to 2024 and projected 94% CAGR from 2021 to end of 2025.
• Joseph mentioned upcoming product launches: AVT06 (Eylea biosimilar) scheduled for Europe launch, AVT05 (Simponi biosimilar) with expected European launch, and AVT03 (Prolia/Xgeva biosimilar) with European Commission approval anticipated. He also discussed pipeline progress, including submissions for Xolair biosimilar and development of AVT29, AVT16/80, and others.
• Linda covered Q3 financials, noting licensing revenues at $81 million, adjusted EBITDA of $14 million, and year-to-date adjusted EBITDA of $68 million. She revised the full year outlook to $570M-$600M in revenues and $130M-$150M adjusted EBITDA, emphasizing strategic focus on execution, pipeline advancement, and geographical diversification.

• Revised full year 2025 outlook: revenues $570M-$600M, adjusted EBITDA $130M-$150M. Licensing agreements for pipeline assets expected at end of Q4 shifted to 2026. Anticipate strong finish to 2025 and robust growth in 2026 with committed orders and market momentum.
• Targeting 19% year-on-year revenue growth and 30% EBITDA growth at midpoint of guidance, with focus on margin recovery, new launches, and geographical diversification.

For Q3, licensing revenues were $81 million, supporting a 69% gross margin. Year-to-date, total revenues were $420 million, showing 24% year-on-year growth. Product margins were impacted by timing of orders, portfolio mix, and temporary loss in product revenues related to facility improvements. Licensing revenues played a significant role, with strong global interest in the product portfolio driving milestone revenues through partner contracts.

• FDA CRL due to unresolved issues from Reykjavik facility inspection in July 2025, impacting approval timing for the BLA of the biosimilar to Simponi. Potential impact on production efficiency and revenue timing in 2025. Ongoing need to address regulatory concerns to ensure FDA compliance.

Q: Can you explain the observations from the FDA inspection that led to the CRL and the status of resolving them?

A: Joseph McClellan stated there were no repeat observations from the Form 483. Alvotech has committed to over 180 changes to address observations, with 93% completed and ongoing updates to the FDA.

Q: What is the impact of the CRL on Q4 revenue and is there a phasing of shipments into 2026?

A: Linda Jonsdottir said the revision includes timing impacts on licensing agreements shifting to 2026, but there is visibility on year-end performance and confidence in 2026 growth based on committed orders.

Q: How do regulatory changes regarding Phase III trials impact earlier stage biosimilars like Keytruda and Cimzia?

A: Robert Wessman and Joseph McClellan mentioned Alvotech anticipated regulatory changes over 2 years ago, leveraging that to advance the pipeline, with products like Cimzia benefiting from the reduced need for patient efficacy studies.