On oncology, multiple Phase III programs progress, including data from pirtobrutinib trials, and EmbER-4 breast cancer trial has fully enrolled.

Lilly reports strong Q4 2025 results with revenue of $19.292 billion, up 43% year over year, driven by volume growth in Mounjaro and Zepbound.

Additional 2025 regulatory highlights include full FDA approval and label expansion for pirtobrutinib in CLL/SLL, and meaningful data from TRIUMPH-4 on retatrutide for obesity and knee osteoarthritis.

The press release includes non-GAAP reconciliations, forward-looking statement notes, and webcast details for the Q4 2025 results conference call.

For the full year’s tailwinds, Mounjaro generated $7.409 billion in Q4 2025 (up 110%), Zepbound $4.261 billion (up 123%), and Verzenio rose 3% to $1.604 billion.

Despite US prices easing about 7%, the mix remained favorable and contributed to the 43% revenue surge in Q4 2025.

Lilly’s obesity treatment candidate orforglipron is expected to launch in the US in 2026 and in most international markets in 2027, with Medicare access anticipated by July 1, 2026 and Medicaid access expanding volume growth.

Regulatory updates include FDA approval of Kwikpen for tirzepatide and expanded indication for Jaypirca, with orforglipron submissions for obesity in the US, Japan, and the EU, plus positive Phase 3 data for combinations like Zepbound with other therapies.

Lilly’s R&D pipeline remains extensive with 36 active Phase III programs, 14 new Phase III programs started recently, 39 BD deals completed in 2025, and an AI collaboration with NVIDIA to accelerate drug discovery.

Global manufacturing expansion continues with investments exceeding $55 billion since 2020 and new sites in Wisconsin and North Carolina, aiming to produce 1.8 times more incretin doses than in 2024.

US direct-to-patient engagement reached one million in 2025, with Zepbound self-pay vials accounting for about one-third of new obesity medication starts.

Lilly announced a U.S. government agreement to expand access to obesity medicines for millions of Americans, highlighting policy progress alongside science.