Legend Biotech Corp Q1 FY2025 earnings call

• CARVYKTI Performance: Net trade sales of $369M (+135% YOY), over 6,000 patients treated, strongest CAR-T launch, U.S. utilization in earlier lines increasing, EMA label updated with overall survival, Australia approved in second line plus setting.
• Manufacturing: Tech Lane in Ghent started clinical production, Raritan expansion expected in H2 2025, 97% manufacturing success rate, median turnaround time 30 days.
• Pipeline: Investing in in vivo CAR-T delivery, new research facility in Philadelphia, upcoming clinical data from pipeline programs, including in vivo CAR-T first patient dose in IIT study in June/July and preliminary results by end 2025 for in vivo platform, and clinical readout in H2 2025 for allogeneic cell platform.
• Financials: Total revenues $195M, adjusted net loss $27M, operating loss reduced from $118M to $51M YOY, gross margin 63% in Q1.

CARVYKTI was the key segment. Net trade sales of CARVYKTI were approximately $369 million, a 135% increase year-over-year. U.S. net trade sales were $318 million, growing 127% year-over-year and 5% quarter-over-quarter. OUS sales were $51 million, more than double year-over-year and a 65% increase quarter-over-quarter. CARVYKTI contributed significantly to the company's revenue, with its net trade sales driving the overall financial performance of the segment.

• Anticipate operational breakeven for CARVYKTI by end of 2025, company-wide profitability in 2026 excluding foreign exchange gains or losses.
• Q2 expected growth supported by capacity expansions, with Raritan approval expected in H2 2025.
• In vivo CAR-T platform: First patient dose in IIT study in June/July, preliminary clinical results by end of 2025; allogeneic cell platform: Clinical readout in H2 2025.

• Forward-looking statements subject to risks outlined in SEC filings, including uncertainties that may cause actual results to differ from forward-looking statements.
• Macroeconomic uncertainties impacting the business.
• Competition in the cell therapy space.
• Regulatory approvals and compliance issues.
• Manufacturing and supply chain challenges.

Q: Regarding CARVYKTI price differences between U.S. and ex-U.S.?

A: Alan Bash says the price differential between the U.S. and ex-U.S. is approximately 30%.

Q: On community penetration for CARVYKTI?

A: Alan Bash talks about high demand for earlier line use, educating the community, connecting experts in authorized treatment centers with community physicians, and building a platform for transition of support.

Q: Capacity for Q2 and Raritan approval?

A: Alan Bash says Q2 is expected to be a step up with growth supported by capacity expansions, and Raritan approval is expected in the second half of 2025.

Q: Pipeline data timeline?

A: Guowei Fang mentions in vivo CAR-T first patient dose in an investigator initiated study in June or July and expects preliminary clinical result towards the end of 2025; on the alloplatform side, clinical readout in the second half of 2025.

Q: Community CAR-T accreditation?

A: Alan Bash says industry discussions around providing fact light accreditation are ongoing.