Legend Biotech(LEGN) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - CarVicti net trade sales reached approximately $439 million, representing a 136% increase year over year and a 19% increase from the first quarter [8][17] - Total revenues were RMB 255 million, driven by collaboration revenue growth of 136% year over year [30] - The company reported a net loss of RMB 10 million but achieved RMB 10 million in adjusted net income after excluding unrealized foreign exchange losses [30] - Operating loss improved from RMB 41 million to RMB 22 million year over year, indicating enhanced operational efficiency [30] Business Line Data and Key Metrics Changes - U.S. net trade sales of CarVicti were $358 million, growing 114% year over year and 13% quarter over quarter, with nearly 60% utilization in earlier line settings [18][21] - Outside the U.S., sales reached $81 million, a fourfold increase year over year and a 59% increase quarter over quarter, driven by expansion in Germany, Switzerland, Austria, and Brazil [19] Market Data and Key Metrics Changes - The company has treated over 7,500 patients with CarVicti, marking it as the strongest CAR T launch to date [8][16] - The number of authorized treatment centers in the U.S. has increased to 123, with significant expansion in community and regional hospitals [22][27] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CarVicti by 2025 and company-wide profitability by 2026, excluding unrealized foreign exchange gains or losses [9][30] - The company is focused on solidifying its leadership in cell therapy and expanding into new indications, including solid tumor programs [14][15] - The company is investing in a new research facility in Philadelphia to enhance its capabilities in innovative therapies [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's decision to remove risk evaluation and mitigation strategies for CAR T therapies, which is expected to improve patient experience and access [9] - The company anticipates continued strong performance for CarVicti, supported by recent long-term survival data presented at ASCO [21][30] Other Important Information - The company maintains a strong cash position of approximately $1 billion, allowing for continued investment in its core differentiators in cell therapy [16][32] - The manufacturing success rate remains at 97%, which is believed to be the highest in the CAR T industry [20] Q&A Session Summary Question: Update on interim readouts from CARDISUDE V and VI - Management is monitoring events closely and is in discussions with the FDA about using MRD as a dual primary endpoint [36] Question: Community oncology expansion efforts - Approximately 70% of patients come from the community setting, and over half of patients are administered in outpatient settings [41][43] Question: Breakdown of treated patients in early line settings - Nearly 60% of orders are from the second through fourth line population, indicating significant growth potential [47] Question: Impact of recent efficacy data from a competitor - Management emphasized that CarVicti is best in class with demonstrated overall survival benefits, differentiating it from competitors [63] Question: Enrollment progress for CAR T2 VI - Enrollment is progressing well, with global completion expected soon, and confidence in driving capacity expansion remains high [68][70] Question: Future demand and supply dynamics - The company plans to drive both supply and demand simultaneously, with increasing contributions expected from Europe [83] Question: Community adoption and FACT accreditation - Efforts are underway to lift the requirement for FACT accreditation, facilitating broader access to CAR T therapies [90][91]