Legend Biotech(US:LEGN)2025-11-12 14:02Financial Data and Key Metrics Changes - In Q3 2025, CARVYKTI net trade sales reached approximately $524 million, representing an 84% year-over-year increase [7][17] - Total revenues for the quarter were $272 million, driven by collaboration revenue growth of 84% year-over-year [26] - The company reported a net loss of $40 million, with an adjusted net loss of $19 million after excluding non-core items [27][29] - Operating loss improved by 38% to $43 million compared to the same period last year [28] Business Line Data and Key Metrics Changes - CARVYKTI's U.S. net trade sales were $396 million, growing 53% year-over-year and 11% quarter-over-quarter [18] - International sales reached $128 million, nearly five times the amount from the same period a year ago, representing a 58% increase quarter-over-quarter [18] Market Data and Key Metrics Changes - The company has treated over 9,000 patients with CARVYKTI, marking it as the strongest CAR-T launch to date [7] - The number of authorized treatment centers in the U.S. has increased to 132, with about one-third being community and regional hospitals [22] Company Strategy and Development Direction - The company aims to solidify its leadership in cell therapy and expand CARVYKTI into frontline settings [15][16] - Plans include increasing manufacturing capacity to support the treatment of over 10,000 patients annually [19][23] - The company is focused on educating physicians about CARVYKTI's overall survival benefits and the importance of early treatment [21] 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 [16][29] - The company is optimistic about the long-term growth potential in both the U.S. and international markets, particularly in community settings [15][18] Other Important Information - The FDA has approved an update to include CARVYKTI's overall survival benefit in its label, enhancing its market position [9] - The company is investing in operational efficiency and disciplined expense management to support long-term growth [26] Q&A Session Summary Question: What will be the best way to prioritize cash in terms of pipeline assets? - The company plans to maximize the CARVYKTI franchise and invest significantly in its CAR-T platform [33] Question: Is the Raritan site expansion on track? - The expansion is on track, with the facility expected to support 10,000 doses annually [36] Question: What are the expectations for authorized treatment centers in 2026? - The company aims to expand coverage to match competitors, targeting over 160 sites [40] 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 [44] Question: What is the impact of loosening REMS requirements? - The changes are expected to facilitate quicker patient transitions back home, enhancing patient access [95] Question: What are the expectations for international growth? - Strong uptake is noted in Germany, Spain, and Belgium, with TechLane expected to enhance capacity for European launches [88]