Legend Biotech (NasdaqGS:LEGN) FY Conference Transcript

Summary of Legend Biotech Conference Call Company Overview - Company: Legend Biotech - Industry: Biotechnology, specifically focused on cell therapy - Key Product: Carvykti, a CAR-T therapy for multiple myeloma - Market Position: World's largest standalone cell therapy company, leading in CAR-T therapy for multiple myeloma [2][3] Core Points and Arguments Financial Performance - Carvykti generated approximately $1.7 billion in net trade sales over the last 12 months [3] - The company has a cash position of nearly $1 billion and has achieved positive operating profit for Carvykti in Q3 [4] - Legend anticipates achieving company-wide profitability in 2026, with Carvykti expected to generate over $5 billion in annual peak sales [5][8] Product Efficacy and Market Penetration - Carvykti has treated over 10,000 patients, demonstrating a 97% manufacturing success rate [6][8] - The therapy has shown a median progression-free survival (PFS) of nearly 35 months in heavily pretreated patients [10] - In the CARTITUDE-4 trial, the median PFS has not yet been reached after nearly three years of follow-up [10][44] - Carvykti is the only CAR-T therapy to achieve a five-year remission survival in one-third of patients after a single infusion [9] Market Expansion and Strategy - The company is expanding its global presence, with 279 treatment sites in 14 countries [6] - A partnership with Johnson & Johnson (J&J) is aimed at maximizing Carvykti's potential, with a 50/50 cost-sharing and profit split in the U.S. [8] - The company is focusing on community settings, where 70% of relapsed and refractory multiple myeloma patients are treated [15] Clinical Trials and Future Directions - Ongoing trials (CARTITUDE-5 and CARTITUDE-6) are evaluating Carvykti in newly diagnosed patients, with the goal of addressing an additional 50,000 patients annually [14] - The company is also exploring allogeneic therapies and in vivo CAR-T programs, with a focus on capital efficiency and rapid clinical proof of concept [21][23] Competitive Landscape - Despite competition in the multiple myeloma market, Legend emphasizes Carvykti's superior survival outcomes and unique one-time treatment benefits [30][37] - The current market penetration for BCMA-targeted therapies is low, with less than 10% in fifth-line treatments and less than 5% in second to fourth-line treatments, indicating significant growth potential [13][35] Additional Important Insights - The National Comprehensive Cancer Network (NCCN) has updated guidelines recommending Talvey as a bridging therapy to BCMA CAR-T therapy, which is expected to be adopted quickly [19] - The company has improved its manufacturing turnaround time to below 30 days, supporting increased supply capacity [31] - The collaboration with J&J includes a 30/70 cost-sharing arrangement for the China market, where Legend leads [32] Conclusion Legend Biotech is positioned as a leader in the CAR-T therapy market for multiple myeloma, with strong financial performance, promising clinical outcomes, and a strategic focus on expanding its market presence and pipeline development. The company aims to leverage its successful R&D model to explore new therapeutic areas while maintaining profitability and enhancing patient outcomes.