Financial Performance & Outlook - Alvotech revised its FY2025 revenue outlook to $570-600 million, compared to the previous $600-700 million[20, 25, 72] - Adjusted EBITDA for FY2025 is revised to $130-150 million, down from the earlier $200-280 million[20, 25, 72] - Total revenues for 9M25 reached $420 million, a 24% increase year-over-year compared to 9M24[53, 54, 58] - Licensing revenues are expected to contribute $250-300 million annually until 2030[25] - The company's cash balance as of September 30, 2025, was $43 million[53, 54, 61] Product Pipeline & Approvals - The FDA issued a Complete Response Letter (CRL) for AVT05 (biosimilar to Simponi®) due to unresolved issues identified during a July inspection[20, 21, 22] - The Reykjavik manufacturing facility remains FDA approved for commercialized products like bHumira and bStelara[20, 22] - Approvals and/or positive CHMP opinions have been received for AVT06 (bEylea), AVT05 (bSimponi), and AVT03 (bProlia/Xgeva) by EMA and Japan's PMDA[20, 22, 33] - Alvotech expects to be among the first to launch a bSimponi in the EU, UK, and Japan[22, 33] Market Performance - Alvotech's biosimilar to Humira (AVT02) holds the second-largest market share of Humira biosimilars in the U S[28] - In Europe, Alvotech's Humira biosimilar volumes continue to grow, with Hukyndra holding a top position in several EU10 markets and experiencing 12% QoQ growth for the last four consecutive quarters[28] - Alvotech is securing formulary coverage for its Stelara biosimilar (AVT04) in the U S, and holds a leading position in Europe with approximately 10% overall share of the total Stelara market[20, 28]