Legend Biotech(LEGN)2025-03-11 16:06Financial Data and Key Metrics Changes - In Q4 2024, Legend Biotech reported total net sales of CARVYKTI at approximately 187 million, consisting of 18 million from license revenue, with a net profit of 0.07 per share compared to a net loss of 0.40 per share in the same period last year [24][25] - The adjusted net loss for Q4 was 0.16 per share, an improvement from an adjusted net loss of 0.24 per share for the same period last year [32] Business Line Data and Key Metrics Changes - CARVYKTI's sales trajectory has been strong, with a significant increase in demand and capacity expansion contributing to the sales growth [11][14] - The collaboration cost of revenue for Q4 was 32 million year-over-year, reflecting increased manufacturing capacity expansion [26] - Selling and distribution expenses rose to 34 million in the same period last year, driven by commercial activities for CARVYKTI [29] Market Data and Key Metrics Changes - In the U.S., the number of certified hospitals to treat with CARVYKTI has increased to 104, with outpatient administration expected to account for a majority of the volume by the end of the year [15][112] - Internationally, sales outside the U.S. reached $31 million, a 138% increase year-over-year, attributed to capacity increases and launches in several countries [14] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVYKTI by the end of 2025 and anticipates company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8][33] - Legend Biotech is expanding its pipeline programs to include blood cancers, next-generation multiple myeloma therapies, solid tumor programs, and autoimmune diseases [20][21] - The company is also building a new research facility in Philadelphia to support its pipeline investments [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of CARVYKTI, highlighting its unique profile and the strong demand in the market [11][12] - The management team noted that the FDA's recent recommendations regarding MRD negativity as a potential surrogate endpoint could open up further opportunities for CARVYKTI [9] - The company is optimistic about its ability to meet increasing demand through capacity expansions in both the U.S. and Europe [19][100] Other Important Information - The company has treated over 5,000 patients with CARVYKTI, creating a comprehensive patient dataset that continues to generate new data on its benefit-risk profile [17] - The company has received reimbursement approval for CARVYKTI in Spain, enhancing its market presence in Europe [13] Q&A Session Summary Question: Inquiry about safety profile and trial plans for managing ICANS and neurotoxicity - Management discussed ongoing efforts to harmonize ALC cut-offs for risk mitigation strategies and plans for future investigator-initiated trials [36][40] Question: Plans for ASCO updates - Management indicated excitement about data to be presented at ASCO but could not disclose specifics until abstracts are accepted [46] Question: Commercial revenue breakdown and demand for CAR-T therapy - Management reported strong receptivity to CARTITUDE-4 data and noted nearly 60% of usage has shifted to earlier lines of therapy [53][54] Question: Share count and pipeline data expectations - Management clarified the increase in share count and provided insights into upcoming data from early pipeline programs [58][62] Question: Revenue growth cadence and capacity expectations - Management expects modest growth in Q1 due to seasonal factors but anticipates significant growth in Q2 and Q3 as manufacturing capacity increases [68][70] Question: Positioning of CAR-T therapies in solid tumor treatment - Management discussed ongoing dose escalation studies for DLL-3 and Claudin18.2% CAR-T therapies, with plans for data presentation later this year [75][78] Question: Demand fulfillment in Europe - Management acknowledged challenges in meeting demand in Europe but emphasized ongoing efforts to ramp up supply from their facilities [145]