Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- CARVYKTI achieved significant growth with a 53% increase quarter-over-quarter and 87% year-over-year.
- CARVYKTI demonstrated a 45% reduction in the risk of death compared to standard therapies in multiple myeloma patients.
- Legend Biotech Corp (LEGN, Financial) received approval for CARVYKTI production in Belgium, expanding its manufacturing capacity in Europe.
- The company reported strong financial performance with net trade sales of CARVYKTI reaching approximately USD 286 million in Q3 2024.
- Legend Biotech Corp (LEGN) has expanded its outpatient treatment options, with outpatient administration now comprising up to 48% of CARVYKTI's volume.
Negative Points
- The company reported a net loss of $125 million for Q3 2024, compared to a net loss of $62 million in the same period last year.
- Unrealized foreign exchange losses amounted to $63 million, primarily due to intercompany transactions.
- Research and development expenses remained high at $96 million, similar to the previous year.
- Selling and distribution expenses increased significantly to $44 million, up from $21 million in the same period last year.
- The company faces supply constraints and prioritizes markets like the U.S. and Europe over China due to limited availability of lentiviral vectors.
Q & A Highlights
Q: What are the key data points investors should focus on regarding the upcoming data update for CARTITUDE-1 and IMAgINE-1 trials?
A: Ying Huang, CEO, explained that the IMAgINE-1 trial involves a less sick patient population compared to CARTITUDE-1. Key metrics include the number of prior lines of therapy and refractory patient populations. Efficacy is measured by ORR and CR rates, with CARTITUDE-1 showing a 97% ORR and 67% CR rate. Durability and PFS are crucial, with nearly three years' PFS in CARTITUDE-1. Safety management strategies are also discussed, including patient selection and proactive management.
Q: How should we think about quarter-over-quarter growth going into Q4, and is there an FDA cap on CAR-T production?
A: Ying Huang, CEO, confirmed expectations for sequential growth in Q4, although no quantitative guidance was provided. Regarding FDA regulation, both CARVYKTI and Abecma have experienced capacity regulation by the FDA, which applies to all CAR-T manufacturing facilities. Legend Biotech has been able to supply the market effectively, achieving the highest revenue and slots among commercial CAR-T brands.
Q: Can you elaborate on the ramp-up cadence for the second-line launch and the expected shift in CARVYKTI use from late to early lines?
A: Steve Gavel, SVP of Commercial Development, stated that the majority of patients treated will be in the CARTITUDE-4 population, with a two-thirds to one-third ratio expected by next year. The early line adoption is ahead of expectations, driven by recent overall survival data, and this trend is expected to continue.
Q: How is the evolution of inpatient versus outpatient use of CARVYKTI progressing, and what drives this shift?
A: Steve Gavel, SVP of Commercial Development, explained that the shift to outpatient use is driven by the need to manage increased patient volumes in the second line plus setting. Major academic sites are leading this adoption, with outpatient use reaching up to 50% in some locations. The delayed CRS onset of CARVYKTI facilitates outpatient administration, allowing for remote monitoring and later hospital admission if needed.
Q: What are the expectations for Europe now that commercial capacity is up and running, and how do European physicians select CAR-T over other options?
A: Steve Gavel, SVP of Commercial Development, noted that the European market differs from the U.S., with slower CAR-T adoption due to pricing agreements. Germany is the key driver for CARVYKTI in Europe. Ying Huang, CEO, added that survival data is crucial for European single-payer systems, and CARVYKTI's demonstrated survival benefit is a significant advantage in discussions with European agencies.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
