Legend Biotech(US:LEGN)2025-11-12 14:00Financial Data and Key Metrics Changes - In Q3 2025, CARVYKTI net trade sales reached approximately $524 million, representing an 84% year-over-year increase [5][16] - Total revenues for the quarter were $272 million, driven by collaboration revenue growth of 84% year-over-year [25] - The company reported a net loss of $40 million, with an adjusted net loss of $19 million after excluding non-core items [25][26] - Operating loss improved by 38% to $43 million compared to the same period last year [26] - The gross margin on net product sales remained consistent at 57% [26] Business Line Data and Key Metrics Changes - CARVYKTI's utilization in the U.S. is primarily in earlier line settings, with 60% of utilization occurring there [16][19] - U.S. net trade sales of CARVYKTI grew 53% year-over-year, while international sales reached $128 million, nearly five times the amount from the same period last year [17] Market Data and Key Metrics Changes - The company has expanded its authorized treatment centers to 132 sites in the U.S., with about one-third being community and regional hospitals [20] - Internationally, the company has launched in 14 markets, with strong uptake in Germany, Spain, and Belgium [22][90] Company Strategy and Development Direction - The company aims to solidify its leadership in cell therapy and expand CARVYKTI into frontline settings [12][14] - Plans for capacity expansion are underway, with expectations to treat over 10,000 patients annually [22][39] - The company is focused on educating physicians about CARVYKTI's overall survival benefits and the importance of early treatment [19][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026 [15][27] - The company anticipates continued strong demand for CARVYKTI, driven by its unique clinical outcomes and operational efficiencies [25][27] Other Important Information - The company has a cash position of nearly $1 billion, allowing for continued investment in core differentiators in cell therapy [15] - The FDA has approved an update to CARVYKTI's label to include overall survival benefits [7] Q&A Session Summary Question: How will the company prioritize cash allocation in 2026? - The company plans to maximize the CARVYKTI franchise and invest in manufacturing and expanding its CAR-T platform [30][31] Question: What is the status of the Raritan site expansion? - The expansion is on track, with completion expected before the end of 2025 [33] Question: What are the expectations for authorized treatment centers in 2026? - The company aims to expand coverage to match competitors, targeting over 160 sites [37][38] Question: How will the company mobilize demand to fulfill new supply? - The focus will be on educating physicians about the benefits of early treatment and leveraging community networks [41][43] Question: What is the impact of loosening REMS requirements? - The changes are expected to facilitate quicker patient transitions back home, enhancing overall patient experience [95] Question: What are the expectations for international growth? - Strong demand is noted in Germany, Spain, and Belgium, with TechLane expected to enhance capacity for European launches [90][91]