Legend Biotech (LEGN) 44th Annual J.P. Morgan Healthcare Conference summary

Key business highlights and financial performance

• Achieved $1.7B in net trade sales for CARVYKTI in the last 12 months through Q3 2025, treating over 10,000 patients globally and maintaining a 60%+ gross margin with improved operating margins since mid-2023.

• Revenue has scaled nearly 4x since 2Q23, with 84% YoY growth in Q3 2024 and 111% CAGR since launch in 2022.

• CARVYKTI is available at 279 global sites in 14 countries, with 141 activated US sites and a 97% manufacturing success rate.

• Cash position is nearly $1B as of September 2025, with positive operating profit for CARVYKTI in Q3 and expectations for company-wide profitability in 2026.

• Plans to double manufacturing capacity to 20,000 doses over the next three years, with further capital investment in Belgium.

CARVYKTI® market leadership and clinical impact

• CARVYKTI is the top-selling CAR-T in a single quarter and the first/only CAR-T with demonstrated overall survival benefit in multiple myeloma.

• Demonstrated median overall survival of 60.7 months and ≥5-year remission in one-third of patients in CARTITUDE-1, with median PFS of 35 months in late-line and over 50 months in earlier lines.

• Early-line (second to fourth line) use now accounts for 60% of CARVYKTI revenue, targeting 75% by year-end, with market penetration in these lines at only 5% and ambitions to reach 20%.

• Earlier use leads to higher overall survival and improved safety, with parkinsonism rates reduced from 6% to 1% in recent studies.

• Community and outpatient adoption is a key growth driver, with about one-third of U.S. sites in community settings, over half of treatments now outpatient, and 80% of the US market within 50 miles of a CARVYKTI site.

Strategic partnerships and expansion

• Partnership with Johnson & Johnson features a 50/50 global profit split (30/70 in China), supporting global expansion and de-risking execution.

• Largest multiple myeloma CAR-T program to date, with four operational manufacturing sites worldwide.

• Expansion into earlier lines of therapy through ongoing CARTITUDE-2, -5, and -6 studies, with enrollment complete for key Phase II/III trials and readouts expected between 2026 and 2029.

• Updated NCCN guidelines now recommend Talvey as bridging therapy to BCMA CAR-T, supporting safer and more effective CARVYKTI use.

• China commercialization will focus on off-the-shelf, lower-cost CAR-Ts due to supply and pricing constraints.