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]

Financial Data and Key Metrics Changes - In Q1 2025, the company reported net trade sales of approximately $369 million, representing a 135% year-over-year increase and a 10% increase from Q4 2024 [7][15] - Total revenues for the quarter were $195 million, driven by a 137% year-over-year growth in collaboration revenue [19] - The adjusted net loss was approximately €27 million, while the operating loss was reduced to €51 million from €118 million in the same period last year [19][20] - The gross margin on net product sales improved to 63%, up from 59% in Q4 2024 [20] Business Line Data and Key Metrics Changes - CARVICTI's performance showed strong growth, with U.S. net trade sales of $318 million, a 127% increase year-over-year [15] - The company has treated over 6,000 patients with CARVICTI, marking it as the strongest CAR T launch to date [8][14] - Out-of-U.S. (OUS) sales reached $51 million, more than double compared to the same period last year, driven by expansion in several countries [16] Market Data and Key Metrics Changes - In the U.S., more than half of CARVICTI's utilization is now in earlier treatment lines, with a significant increase in physician preference for CARVICTI in early-line multiple myeloma [8] - The company is expanding its market presence in Europe, with recent launches in Spain, the UK, Denmark, Belgium, and Israel [16] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVICTI by the end of 2025 and overall profitability in 2026, excluding unrealized foreign exchange gains or losses [7][19] - The company is investing in research and development, particularly in in vivo CAR T delivery, which is seen as a significant opportunity for future growth [12] - The company is focused on expanding its manufacturing capacity in Belgium and New Jersey to meet increasing demand [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for the Raritan facility expansion in the second half of 2025, based on current interactions with the FDA [26][32] - Despite macroeconomic uncertainties, the company maintains a strong cash position of approximately $1 billion and is focused on operational efficiency for long-term growth [14][21] Other Important Information - The company has a 97% manufacturing success rate and aims to further reduce turnaround times for CARVICTI delivery [17] - The company is actively working on integrating CAR T therapy into community settings and addressing infrastructure hurdles [102] Q&A Session Summary Question: Price differences between U.S. and ex-U.S. - The price differential is approximately 30%, varying by country [26] Question: Raritan facility approval process - The company is confident in achieving FDA approval without delays [32] Question: Community penetration for CARVICTI - There is high demand for CARVICTI in earlier lines, and the company is increasing efforts to educate community physicians [39] Question: Capacity expectations for Q2 - Modest growth is expected in Q2, with further acceleration anticipated in the latter half of the year [45] Question: Infrastructure hurdles for community adoption - Capacity and staffing are key hurdles, but the company is engaging with centers to address these issues [102] Question: Upcoming clinical data from DLL3 and Claudin 18.2 - Key data will be presented at ASGCT, with further details expected at the conference [105]