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- **Revenue Growth**: CARVYKTI net sales up 84% YoY to $524M, with U.S. sales growing 53% YoY. 9,000+ patients treated globally.
- **Landmark Survival Data**: 1/3 of CARTITUDE-1 patients progression-free for 5+ years, first CAR-T with FDA-approved OS benefit.
- **Profitability Path**: CARVYKTI to reach profitability in 2025, company-wide in 2026 with $1B cash runway.
- **Capacity Expansion**: 10,000+ annual doses by 2026, 132 U.S. sites (1/3 in community), 246 global sites.
- **Innovation Pipeline**: CARTITUDE-10 fludarabine-free trial underway; LUCAR-G39D shows promise in NHL.

**【CEO Summary Section】**
- CARVYKTI net trade sales reached $524 million in Q3 2025, up 84% year-over-year, with U.S. sales growing 53% YoY and 11% QoQ. Over 9,000 patients have been treated globally.
- CARTITUDE-1 trial showed 1/3 of patients remained progression-free and off therapy for 5+ years, marking a potential 'cure' milestone. FDA updated label to include overall survival benefit from CARTITUDE-4.
- CARTITUDE-10 trial initiated to evaluate fludarabine-free lymphodepletion regimen. ASH 2025 will feature data on CARVYKTI's durability in standard-risk myeloma and immune biomarkers.
- Global manufacturing capacity expanded to 10,000 annualized doses, with Tech Lane facility now in commercial production.

**【CFO Financial Commentary】**
- Total revenue $272 million (84% YoY growth), driven by CARVYKTI net sales and collaboration revenue. Adjusted net loss $19 million (vs. $38 million YoY), with operating loss down 38% to $43 million.
- Gross margin stable at 57%. R&D/S&M expenses declining as a percentage of revenue (42%/32%).
- Cash position $1 billion, with $29 million cash flow from operations. Anticipate CARVYKTI profitability by end-2025 and company-wide profitability in 2026.

**【Q&A Highlights】**
- **Capacity & Utilization**: 10,000+ annual doses achievable in 2026, with Raritan expansion on track for FDA approval by year-end. 132 U.S. sites (1/3 in community settings), 246 global sites.
- **Community Growth**: 60% of U.S. scripts from second-fourth line, fastest growth in third line. Outpatient administration now 50% of patients.
- **Competitive Strategy**: CARTITUDE-10 data could support label expansion. MRD as surrogate endpoint under FDA discussion.
- **Pipeline**: LUCAR-G39D allogeneic CAR-T shows encouraging efficacy in NHL. New R&D facility focuses on in vivo delivery innovation.

Legend Biotech Corporation (LEGN) Q3 2025 Earnings Call Transcript

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LEGN

LEGN fundamentals

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