Release Date: August 09, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Legend Biotech Corp (LEGN, Financial) reported an 18.5% sequential growth in capacity sales for the second quarter of 2024.
- The company received label expansion approvals from both the FDA and EMA, enhancing its market potential.
- Legend Biotech Corp (LEGN) demonstrated a significant survival benefit in the CARTITUDE-4 study, showing improvement in overall survival compared to standard therapies.
- The company achieved net trade sales of $186 million for the second quarter, marking a 50% increase year over year and an 18.5% increase quarter-over-quarter.
- Legend Biotech Corp (LEGN) has a strong cash balance of $1.3 billion, providing financial runway into 2026 and supporting ongoing production and expansion efforts.
Negative Points
- The company reported a net loss of $18 million for the quarter ended June 30, 2024, although this was an improvement from the $199 million loss in the same period last year.
- Research and development expenses increased to $113 million for the second quarter, up from $96 million in the same period last year.
- Administrative expenses rose to $35 million for the three months ended June 30, 2024, compared to $28 million for the same period last year.
- Selling and distribution expenses increased to $30 million for the three months ended June 30, 2024, up from $21 million in the same period last year.
- There are ongoing concerns about potential political risks and biosecurity impacts, which could affect the company's operations and stock performance.
Q & A Highlights
Q: Can you provide more color on the potential political risks and biosecurity impacts on Legend Biotech?
A: We have carefully evaluated the draft bill and engaged with stakeholders in Washington, DC. We do not believe there will be any direct impact on Legend Biotech given our operational model and data/IP flow. We are not overly concerned about the potential impact of the bill. (Huang Ying, CEO)
Q: With outpatient use now up to 45%, can you explain the dynamics driving this increase?
A: The increase is primarily driven by large academic centers. Outpatient treatment is more efficient, and we are seeing a significant jump from 35% last quarter to 45% this quarter. (Steve Gavel, SVP of Commercial Development, US & Europe)
Q: How do you see the demand and use in second-line patients changing over time?
A: We are seeing about 50-60% of new patient orders related to the CARTITUDE-4 indications. This is a good leading indicator of future demand. We expect more objective data towards the end of this month. (Steve Gavel, SVP of Commercial Development, US & Europe)
Q: Can you comment on the Galapagos BCMA CAR-T study and its findings on Parkinsonism?
A: Movement and neurological toxicity (MNT) is not unique to BCMA or CAR-T. Our real-world data shows a decrease in MNT cases, and our risk mitigation strategies are effective. (Huang Ying, CEO)
Q: What are the expectations for manufacturing capacity and its impact on future growth?
A: We expect commercial production to start at various facilities between the end of this year and the second half of 2025. We are also exploring additional capacity options to meet growing demand. (Huang Ying, CEO)
Q: Can you provide an update on the CARTITUDE-5 and CARTITUDE-6 studies?
A: CARTITUDE-5 enrollment is complete, and we expect data readouts in 2025. CARTITUDE-6 enrollment is ahead of expectations, and we anticipate completion in 2026. (Huang Ying, CEO)
Q: How does the overall survival data from CARTITUDE-4 impact your marketing strategy?
A: Physicians are very excited about the survival data. We plan to submit this data to regulatory agencies for label expansion, which will be a powerful tool in our promotions. (Steve Gavel, SVP of Commercial Development, US & Europe)
Q: What are the downstream effects of an improved out-of-spec rate on operations?
A: Improved out-of-spec rates will help reduce costs and improve vein-to-vein time, ultimately driving down our cost of goods sold. (Lori Macomber, CFO)
Q: Can you discuss the potential for using MRD as an intermediate endpoint for accelerated approval in frontline studies?
A: We plan to discuss with the FDA the possibility of using MRD negativity as a registration endpoint, which could significantly reduce the time to market entry for CARTITUDE-6 in the frontline indication. (Huang Ying, CEO)
Q: How are you targeting larger community centers in your expansion strategy?
A: We are running pilots with academic centers partnering with community affiliates to offload capacity constraints. This strategy will be crucial as we move into earlier lines of therapy. (Steve Gavel, SVP of Commercial Development, US & Europe)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
