Legend Biotech (LEGN) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Company Overview and Market Position

• Leading standalone cell therapy company with over 2,500 employees across three continents, pioneering CAR-T therapies for cancer care.

• CARVYKTI® is the first and only CAR-T therapy to show superior overall survival versus standard of care in multiple myeloma, with over 4,500 patients treated and $286M in net trade sales in Q3 2024.

• Carvykti is the fastest launch among FDA-approved CAR-T therapies, co-commercialized with Johnson & Johnson, with approvals in the U.S., Europe, China, Japan, Brazil, and Canada.

• U.S. remains the primary focus, but European expansion is underway with new facilities in Belgium.

• Worldwide collaboration with Johnson & Johnson targets a $5B+ market potential for CARVYKTI®.

Commercial Strategy and Manufacturing Expansion

• Focused on maximizing Carvykti's market leadership, with a record launch trajectory among CAR-T therapies.

• Manufacturing capacity ramping up, targeting 10,000 doses per year by end of 2025, with plans to double again by 2027-2028.

• Four-node manufacturing approach, with main facilities in New Jersey and Belgium, and Novartis as a CMO; new commercial production at Novartis and Tech Lane expected in 2025.

• Out-of-spec rates have decreased to 10-11%, with a goal to reach single digits.

• Outpatient administration now accounts for 48% of U.S. volume, up from 30% a year ago, with expectations for majority outpatient use by end of 2025.

Clinical Development and Pipeline

• Extensive lifecycle management with over 2,000 patients in the CARTITUDE-2 program.

• Early line studies (CARTITUDE-2, -5, -6) aim to expand Carvykti's indications; CARTITUDE-5 completed enrollment, primary completion expected in 2026.

• CARTITUDE-6 frontline trial is enrolling ahead of expectations, with regulatory discussions planned for accelerated approval endpoints.

• Pipeline includes 11 programs across hematologic malignancies, solid tumors, and autoimmune diseases, with next-generation CAR-Ts and collaborations with Novartis for DLL3-targeted therapies.

• Phase I data for DLL3 and Claudin 18.2 programs may be presented in 2025; allogeneic and autoimmune programs advancing.