Legend Biotech Reports 66% Q4 CARVYKTI Sales Surge as Capacity Ramps and 2026 Profit Nears

Overview

• CARVYKTI net trade sales reached $555 million in Q4, including $420 million in the U.S. (up 38% year over year) and $135 million internationally (more than tripling), with availability across 14 markets and 294 treatment sites.
• Installed manufacturing capacity stands at 10,000 annual doses with a plan to expand to 20,000 through the Johnson & Johnson partnership, supported by 97%–99% manufacturing success rates.
• Long-term CARTITUDE data showed a median progression-free survival of 50.4 months in triple-class-exposed patients, with standard-risk cohorts 80% progression-free at 2.5 years and 93% alive and off treatment if progression-free at one year.
• Use is shifting earlier in care, with 65% of patients treated in the second-to-fourth-line setting and Spain reporting 70%–75% early-line adoption, alongside evolving bridging-therapy practices and updated NCCN guidance to enhance safety.
• Quarterly revenue totaled $306 million with a 61% gross margin, operating loss improved to about $20 million and adjusted net income was $2.5 million, as management projects roughly 50% CARVYKTI top-line growth in 2026 and targets enterprise profitability next year.