Legend Biotech's Q1 2025: Unpacking Key Contradictions in CARVYKTI Pricing, Market Expansion, and Manufacturing Challenges

CARVYKTI price differential and U.S. reimbursement, outpatient therapy expansion and accreditation, manufacturing capacity and supply chain, CARVYKTI market penetration and community uptake, autologous CAR-T manufacturing capacity and FDA regulations are the key contradictions discussed in Legend Biotech's latest 2025Q1 earnings call.



Revenue and Operational Efficiency:
- Legend Biotech reported net trade sales of CARVYKTI at $369 million in Q1 2025, marking a 135% year-over-year increase.
- The growth was driven by increased global ATCs, patient treatments, and operational efficiency improvements.

Manufacturing and Capacity Expansion:
- The company's manufacturing success rate stands at 97%, with 95% of deliveries on or before the promised date, and a median turnaround time of 30 days.
- This was achieved through significant capacity expansions at Raritan and Tech Lane facilities, ensuring supply to meet increasing European and U.S. demand.

Clinical and Regulatory Milestones:
- Legend Biotech's CARTITUDE-6 study is on track to complete enrollment this year, and the EMA added overall survival to CARVYKTI's label based on CHMP positive opinion.
- These milestones are crucial for moving CARVYKTI into the frontline setting and expanding its reach globally.

Pipeline and R&D Investments:
- The company continues to invest in research and development, focusing on in vivo cell therapy platforms for oncology and autoimmune indications.
- These efforts are aimed at driving innovative new assets to expand its therapeutic pipeline and maintain leadership in cell therapy.