Legend Biotech Corporation Q2 FY2025 earnings call

Key Points

• CARVYKTI achieved net trade sales of $439 million in Q2 2025, surpassing previous CAR-T industry records. Over 7,500 patients have been treated with CARVYKTI.
• FDA removed REMS for BCMA- and CD19-directed autologous CAR-T therapies, updating CARVYKTI's label to reduce monitoring requirements and improve patient experience.
• Pipeline candidates: LB1908 showed encouraging antitumor activity in Phase I study; LB2102 had no dose-limiting toxicity and preliminary efficacy signal in Phase I dose escalating study.
• CARTITUDE-1 data: Median PFS of 35 months, median OS not reached; 1/3 of heavily pretreated patients alive and progression-free for 5+ years. CARTITUDE-4 data showed CARVYKTI improved PFS and OS vs standard of care in all subgroups.
• Manufacturing progress: Expect approval for Raritan physical expansion by end 2025; Tech Lane facility to start commercial production for Europe later in 2025.
• Community adoption: Virginia Oncology Associates partnership as a template for expanding into community settings, focusing on engaging treaters, referrers, and patients.

CARVYKTI was the key segment. In the second quarter, CARVYKTI net trade sales were approximately $439 million, representing a 136% year-over-year increase. This segment contributed significantly to total revenues, with global growth driven by share gains and capacity expansion. U.S. net trade sales were $358 million, growing 114% year-over-year, and OUS sales were $81 million, a 4x increase from the same period a year ago and a 59% quarter-over-quarter growth.

Forward-Looking Statements

• Anticipate operational breakeven for CARVYKTI by end of 2025 and company-wide profitability in 2026 (excluding unrealized foreign exchange gains or losses).
• Expect continued growth in CARVYKTI sales driven by global expansion, increased earlier line utilization, and community adoption efforts.
• Manufacturing capacity expansion with Raritan and Tech Lane facilities to support rising demand for CARVYKTI.

Risks

• Uncertainties associated with forward-looking statements, which may result in actual results differing materially from implied projections.
• Regulatory challenges and approval processes that could impact product launches and market access.
• Potential difficulties in maintaining operational efficiency and managing manufacturing costs amidst expansion.

Q: Any update on potential timing of interim readouts from CARTITUDE-5 and CARTITUDE-6?

A: Mythili Koneru mentioned monitoring events closely and discussions with FDA about using MRD as a dual primary endpoint, with no specific timeline provided beyond ongoing evaluations.

Q: Can you provide more details about the Virginia Oncology Associates partnership and its role as a template?

A: Alan S. Bash stated Virginia Oncology Associates is a leader in immuno-oncology, part of the McKesson network, and was excited to partner with CARVYKTI, demonstrating expansion into community and regional hospital settings to drive referrals and activate immuno-oncology practices.

Q: How is demand for CARVYKTI expected to evolve in 2026, particularly in Europe?

A: Alan S. Bash noted increasing contribution from Europe with multiple markets launched, expecting continued growth in 2026 and beyond. Demand in the U.S. will be driven by ASCO data on overall survival, REMS removal benefits, and direct patient engagement efforts.