Legend Biotech Corporation Q3 FY2025 earnings call

• CARVYKTI has treated over 9,000 patients, with net trade sales up 84% YOY. The company presented long-term survival data from CARTITUDE-1 showing 1/3 of heavily pretreated patients alive and progression-free for 5+ years.
• FDA approved an update to CARVYKTI's label including overall survival benefit from CARTITUDE-4 study.
• Upcoming ASH presentations include data on CARTITUDE-4 subgroup analysis and correlated biomarker data.
• Initiated CARTITUDE-10 Phase II trial to further characterize efficacy and safety of CARVYKTI.
• Manufacturing network growth with Tech Lane facility initiating commercial production and Raritan facility expansion underway.
• Focus on community setting growth in U.S. and international market leadership expansion, with 132 U.S. treatment sites and growing international sales.

CARVYKTI net trade sales were approximately $524 million in the third quarter, an 84% increase year-over-year. U.S. net trade sales were $396 million, growing 53% year-over-year and 11% quarter-over-quarter. International sales were $128 million, nearly 5x the amount of the same period a year ago and a 58% increase quarter-over-quarter. CARVYKTI's revenue contribution is significant, driving overall segment performance.

• Anticipate profitability for CARVYKTI by end of 2025 and company-wide profitability in 2026.
• Expect continued revenue growth from CARVYKTI driven by demand from long-term survival data and overall survival benefit.
• Manufacturing capacity to expand with Raritan facility expansion and Tech Lane commercial production supporting increased demand.

• Uncertainties in clinical trial outcomes and regulatory approvals for new studies.
• Competition in the cell therapy market impacting market share.
• Operational challenges in scaling manufacturing capacity to meet growing demand.

Q: About cash allocation and Raritan site progress A: Carlos mentioned prioritizing CARVYKTI franchise and capital investments in manufacturing, with Alan stating Raritan site expansion is on track.

Q: On ATC numbers and manufacturing capacity A: Alan noted 132 U.S. treatment sites and over 250 total sites globally, with plans to expand, and Ying mentioned nearly 100% capacity utilization at manufacturing nodes.

Q: On ASH abstract withdrawal and Raritan site timeline A: Alan explained abstract was withdrawn due to limited data, and Raritan site expansion is on track with submission process started.

Q: On community progress and VOA network A: Alan discussed community strategy including leveraging existing community sites, engaging referring physicians, and starting patient treatment with VOA, with plans to expand.

Q: On ASH abstracts and delayed neurotox A: Ying stated effective bridging therapy and tumor burden reduction are key to mitigating delayed neurotox, with more real-world data and ASH presentations to come.

Q: On CARTITUDE-10 study and MRD as endpoint A: Ying explained CARTITUDE-10 is evaluating fludarabine-free lymphodepletion, and ongoing discussions with FDA on MRD as a registrational endpoint.