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]

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 [7][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 non-core items [30] - Operating loss improved from RMB 41 million in the same period last year to RMB 22 million [30] - Gross margin on net product sales was 57% [30] Business Line Data and Key Metrics Changes - CarVicti's U.S. net trade sales were $358 million, growing 114% year over year and 13% quarter over quarter [18] - Outside the U.S., sales were $81 million, which is four times the amount from the same period a year ago, representing a 59% increase quarter over quarter [19] Market Data and Key Metrics Changes - Over 60% of CarVicti utilization is now in earlier line settings [8] - The company has treated over 7,500 patients with CarVicti, marking it as the strongest CAR T launch to date [7][16] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CarVicti by 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8][30] - The company is focused on solidifying its leadership in cell therapy and expanding into new indications such as solid tumor programs [14][15] - A new research facility is being built in Philadelphia to focus on in vivo delivery, enhancing innovation capabilities [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 approved CAR T therapies, which is expected to improve patient experience and access [8] - The company anticipates continued strong performance for CarVicti, driven by recent long-term survival data presented at ASCO [21][28] Other Important Information - The company has a cash position of approximately $1 billion, allowing for continued investment in core differentiators in cell therapy [16][32] - 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 [37][38] Question: Community oncology efforts and Virginia Oncology Associates - Virginia Oncology Associates is a key milestone for community adoption, having previously administered CAR T therapies and is part of the McKesson network [39] Question: Revenue contribution from community expansion efforts - Approximately 70% of patients come from the community setting, with over half of patients administered in outpatient settings [42][43] Question: Breakdown of treated patients in early line settings - Nearly 60% of orders are from the second through fourth line population, which is expected to grow significantly [48] 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: Future demand and supply dynamics - The company plans to drive both supply and demand simultaneously, with increasing contributions expected from Europe [83][85] Question: Novartis commercial supply ramp-up - Novartis is expected to reach full capacity by the end of the year, contributing to growth [107] Question: Impact of recent tariff changes - The company believes any potential exposure to tariffs will not be material based on current evaluations [103]

Core Insights - Legend Biotech Corporation announced long-term results from the CARTITUDE-1 study, showing that 33% of heavily pretreated relapsed/refractory multiple myeloma patients remained progression-free for five years after a single infusion of CARVYKTI [1][4][6] Group 1: Study Results - In the CARTITUDE-1 study, at a median follow-up of 61.3 months, patients treated with CARVYKTI demonstrated a median overall survival (OS) of 60.7 months [4] - Among 97 patients, 32 (33%) remained progression-free for five years or more without further myeloma treatment [4][6] - A subset analysis of 12 patients who underwent minimal residual disease assessments showed all remained progression-free and MRD-negative for five years [3] Group 2: Safety and Efficacy - Safety signals were consistent with the known profile of CARVYKTI, with no new movement or neurocognitive treatment-emergent adverse events reported [5] - Two new cases of second primary malignancies were reported, both solid tumors [5] - The CARTITUDE-4 study indicated that CARVYKTI improved progression-free survival (PFS) and overall survival (OS) compared to standard therapies in high-risk subgroups [7][9] Group 3: Future Developments - Ongoing Phase 1 studies of LB1908 and LB2102 in gastroesophageal and lung cancers, respectively, show promising early results, indicating potential for next-generation cell therapies [8][11] - Legend Biotech entered an exclusive global license agreement with Novartis for certain CAR-T cell therapies targeting DLL3, including LB2102 [15][17]

Investment Rating - The biotechnology industry in North America is rated as Attractive [4]. Core Insights - Initial Phase I/II data for Genmab's Rinatabart sesutecan (Rina-S) in advanced endometrial cancer shows an unconfirmed overall response rate (ORR) of 50% for the 100 mg/m² dosing cohort and approximately 45% for the 120 mg/m² cohort, indicating competitive efficacy [3][6]. - Legend Biotech's Carvykti demonstrates promising outcomes in high-risk multiple myeloma (MM) with a median progression-free survival (mPFS) of 13 months compared to 4 months for standard of care [12]. - The pipeline updates for DLL3 and Claudin 18.2 programs from Legend Biotech show early efficacy signals, warranting further observation [6]. Summary by Relevant Sections Genmab (GMAB) - The report highlights initial data from the GTC1184-01 study, focusing on Rina-S for advanced endometrial cancer, with a median follow-up of approximately 19 weeks [3]. - The safety profile indicates that over 15% of patients required dose reductions, with one Grade 5 event noted [3][7]. - The efficacy signal is considered strong when compared to Merck's TROP2 ADC, which had an ORR of about 34% [3][7]. Legend Biotech (LEGN) - The CART-4 subgroup analysis shows promising outcomes in high-risk MM, with 5-year CART-1 data indicating a functional cure in about one-third of patients [6]. - The ongoing Phase I study of LB2102 in relapsed or refractory small cell lung cancer (SCLC) shows strong tolerability and initial signs of dose-dependent efficacy [10]. - Preliminary results from LB1908 in advanced gastroesophageal adenocarcinoma indicate tumor reductions of 1% to 41% in treated patients [11]. Overall Industry Insights - The report anticipates limited stock impact for both Genmab and Legend Biotech from the ASCO abstracts, with further details expected from full presentations [6]. - The biotechnology sector is viewed positively, with expectations for continued advancements and potential market opportunities [4].

Core Insights - Legend Biotech Corporation is presenting new data on CARVYKTI (ciltacabtagene autoleucel) for multiple myeloma at the 2025 ASCO and EHA meetings, highlighting its status as a market leader in CAR-T therapy for this condition [1][2] - The company is also showcasing preliminary results from ongoing Phase 1 studies targeting solid tumors, specifically lung and gastric cancers, indicating an expansion of its cell therapy pipeline [1][2] CARVYKTI Data - Long-term data from the CARTITUDE-1 study will be presented, showing that heavily pretreated patients with relapsed or refractory multiple myeloma achieved a median progression-free survival of over 5 years after a single CARVYKTI infusion, with a median follow-up of 60.3 months [3][10] - Data from the CARTITUDE-4 study will support a positive benefit-risk ratio for CARVYKTI across various patient subgroups, including those with high-risk cytogenetics [4][10] Solid Tumor Pipeline - Preliminary results from Phase 1 studies of LB2102 and LB1908, targeting small-cell lung cancer and gastroesophageal adenocarcinoma respectively, will be featured in poster presentations at ASCO [6][10] - LB2102 has been licensed to Novartis for further development, with Legend Biotech responsible for the Phase 1 clinical trial in the U.S. [7][8] Clinical Presentations - The company will present data at ASCO and EHA, including an oral presentation on long-term survival outcomes for CARVYKTI and poster presentations on subgroup analyses and preliminary results from solid tumor studies [10][12]