Legend Biotech(LEGN)2024-11-12 19:45Financial Data and Key Metrics - CARVYKTI net trade sales in Q3 2024 were approximately $286 million, representing an 87.6% year-over-year increase and a 53.2% quarter-over-quarter increase [13] - Total revenues for Q3 2024 were $160 million, consisting of $143 million in collaboration revenue and $17 million in license revenue [23] - Net loss for Q3 2024 was $125 million, or $0.34 per share, compared to a net loss of $62 million, or $0.17 per share, in the same period last year [24] - Unrealized foreign exchange losses of $63 million were incurred in Q3 2024, primarily due to intercompany transactions between U S and non-U S legal entities [24] Business Line Data and Key Metrics - CARVYKTI achieved a 45% reduction in the risk of death compared to standard therapies after a three-year follow-up period, marking a significant milestone in multiple myeloma treatment [8] - CARVYKTI maintained significant improvement in progression-free survival compared to standard of care [9] - Over 4,000 patients have been treated with CARVYKTI, with a very low incidence of parkinsonism [10] - CARVYKTI received approval from China's National Medical Products Administration for fourth-line plus treatment [11] Market Data and Key Metrics - CARVYKTI is commercially available in Switzerland, the United States, Germany, Austria, and Brazil [15] - Outpatient treatment now comprises up to 48% of CARVYKTI volume, representing a significant growth opportunity [16] - CARVYKTI has achieved nearly 90% market share in the BCMA CAR-T class of sales in the U S and Germany [16] - OUS sales increased over 100% year-over-year and 35% quarter-over-quarter, driven by capacity expansion and launch efforts [14] Company Strategy and Industry Competition - The company is focusing on expanding CARVYKTI's market share in earlier lines of treatment, with expectations that the majority of patients will be treated in the CARTITUDE-4 population by next year [51] - A new research facility in Philadelphia is being built to expedite innovative cell therapy research, with operations expected to begin in summer 2025 [20] - The company is prioritizing markets such as the U S and Europe over China due to supply constraints and availability of lentiviral vector [103] - CARVYKTI's delayed CRS onset profile allows for extensive outpatient administration, providing a competitive advantage [16][73] Management Commentary on Operating Environment and Future Outlook - Management expects sequential growth in Q4 2024, driven by continued demand and manufacturing efficiencies [14] - The company plans to submit CARTITUDE-4 overall survival results to regulatory authorities in the U S and Europe to update the label [10] - Management highlighted the importance of outpatient treatment as a key differentiator for CARVYKTI, especially as the number of patients increases [16] - The company believes it has sufficient capital to fund operating and capital expenditures into 2026, when it expects to achieve operating profitability [31] Other Important Information - The company appointed Alan Bash as President of the CARVYKTI business unit to oversee its continued growth [17] - Enrollment for the CARTITUDE-5 trial is complete, and enrollment for CARTITUDE-6 is expected to be completed next year [19] - The company is exploring the use of MRD negativity as a potential endpoint for CARTITUDE-6, with plans to discuss this with the FDA [91] - The company is actively engaging with patient advocacy groups and community DPOs to expand CARVYKTI's reach in the outpatient setting [121] Q&A Session Summary Question: What are the key data points to focus on for the upcoming ASH update? - The company emphasized the importance of durability and progression-free survival (PFS) in evaluating CARVYKTI's efficacy, with nearly three years of PFS demonstrated in the CARTITUDE-1 trial [38] - Safety data, particularly the low incidence of neurotoxicity and parkinsonism, was highlighted as a key focus area [39] Question: How should we think about quarter-over-quarter growth in Q4 2024? - Management confirmed expectations of sequential growth in Q4 2024, driven by continued demand and manufacturing efficiencies [46] Question: What are the drivers of outpatient adoption for CARVYKTI? - Outpatient adoption is driven by the delayed CRS onset profile of CARVYKTI, which allows for remote monitoring and reduces hospital burden [55][73] Question: What are the expectations for Europe following the approval of commercial production in Belgium? - Europe's adoption of CAR-T therapies has been slower due to pricing negotiations, but the company expects growth in key markets like Germany [83][84] Question: What is the timeline for updates on CARTITUDE-2 cohorts E and F? - Longer follow-up is needed for CARTITUDE-2 cohorts E and F, as these patients typically have prolonged courses, including extensive PFS [90][111] Question: How is the company managing neurotoxicity concerns in earlier lines of treatment? - The company is exploring the use of steroids and ALC monitoring to mitigate neurotoxicity, with plans to incorporate these strategies into future trials [94][99] Question: What are the company's plans for the China launch? - The company is prioritizing U S and European markets due to supply constraints, with ongoing discussions with Johnson & Johnson regarding the China launch [103] Question: What are the implications of the FDA reconsidering black box warnings on CAR-T products? - The company has not had specific discussions with the FDA regarding secondary primary malignancies but noted that the incidence rate is similar to standard therapies [107][108] Question: What are the drivers of the accelerated approval for commercial production in Belgium? - The approval was driven by the quality of the manufacturing operation at the Obelisc facility, with no additional regulatory requirements needed for commercial production in Europe [116][117]