Financial Data and Key Metrics Changes - The company reported recognized revenue of $9 million for Q1 2025, marking a strong start for the U.S. launch of Ocassel [8][42] - Cost of sales totaled $18 million, which includes costs for all commercial products delivered to authorized treatment centers [44] - The net loss for Q1 2025 was $70.2 million, compared to a net loss of $52.7 million for the same period in 2024 [46] Business Line Data and Key Metrics Changes - The company aims to increase the number of centers authorized to deliver Ocassel from 39 to approximately 60, targeting 90% access to patients across the U.S. [11] - Research and development expenses decreased to $26.7 million from $30.7 million in the same period in 2024, primarily due to cost shifts following the approval of Ocassel [44] Market Data and Key Metrics Changes - As of April 1, CMS published codes for inpatient and outpatient use for Ocassel, formalizing reimbursement for patients on government programs [9][43] - The company is preparing for market expansion in the UK and Europe, having received conditional marketing authorization from the MHRA in the UK [12] Company Strategy and Development Direction - The company plans to expand its market share for CAR T products and is exploring opportunities in acute lymphoblastic leukemia and pediatric populations [12][14] - The strategy includes a fast-to-market approach for lupus nephritis, focusing on a refractory patient population with a clear objective endpoint [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial momentum seen in Q1 and expects this to carry into the second quarter [10] - The company is well-capitalized with $516.6 million in cash and equivalents, which supports ongoing commercialization efforts [46][52] Other Important Information - The company is evaluating the implications of the April 1 coding update on revenue recognition policies [57] - The safety profile of Ocassel is favorable, with no high-grade cytokine release syndrome observed in patients [19] Q&A Session Summary Question: Can you clarify the revenue recognition for Ocassel? - Management confirmed that revenue recognition for Q1 was based on patients receiving both doses, and they are evaluating the implications of the new coding update [54][56] Question: What is the potential exposure to UK or pharma-specific tariffs? - Management noted that blood products are typically exempt from tariffs, but the final impact remains uncertain pending government announcements [60][62] Question: Can you provide details on the cost of goods sold (COGS) for the quarter? - Management indicated that the majority of COGS is driven by the cost of products sold and those delivered but not yet booked as sales, with smaller contributions from patient assistance programs [71][73] Question: What is the median turnaround time for manufacturing success? - Management reported that the turnaround time is tracking towards the target of 16 days, consistent with previous trials [86]

Financial Data and Key Metrics Changes - The company reported recognized revenue of $9 million for Q1 2025, marking a strong start for the U.S. launch of Ocassel [7][42] - Cost of sales totaled $18 million, which includes costs for all commercial products delivered to authorized treatment centers [43][44] - Research and development expenses decreased to $26.7 million from $30.7 million in the same period in 2024, primarily due to cost shifts following Ocassel's approval [44] - Selling, general, and administrative expenses increased to $29.5 million from $18.2 million in the same period in 2024, driven by increased headcount for U.S. commercialization [45] - The net loss for Q1 2025 was $70.2 million, compared to $52.7 million for the same period in 2024 [46] Business Line Data and Key Metrics Changes - The company is focusing on expanding the number of centers authorized to deliver Ocassel therapy from 39 to approximately 60, aiming for 90% patient access across the U.S. [9][11] - The company is also planning to present key updates based on long-term follow-up from the FELIC study, which is expected to provide encouraging data for Ocassel [10] Market Data and Key Metrics Changes - As of April 1, CMS published codes for Ocassel, formalizing reimbursement for patients on government programs, which is expected to enhance market access [7][43] - The company has received conditional marketing authorization from the MHRA in the UK and is engaging with NICE for reimbursement processes [11] Company Strategy and Development Direction - The company aims to increase the number of treatment centers and expand market share for CAR T products, with a focus on geographic expansion into the UK and Europe [11][12] - The company is exploring the utility of its products in earlier stages of treatment and in pediatric populations, with plans for investigator-sponsored trials [13][14] - The company is also looking into opportunities beyond acute lymphoblastic leukemia, targeting a broader range of B cell malignancies and autoimmune diseases [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial momentum seen in Q1 and expects this to carry into Q2 [8] - The company is well-capitalized with $516.6 million in cash and equivalents, which is expected to support the launch and commercialization of its products [46][52] - Management highlighted the importance of medical need in regulatory assessments and the potential for accelerated access to therapies [66] Other Important Information - The company is preparing for updates and data presentations for various studies, including the Carlyle study for lupus nephritis and a phase I study for progressive MS [47][48] - The company is also evaluating the implications of recent coding updates on revenue recognition policies [56] Q&A Session Summary Question: Revenue recognition for Ocassel and impact of coding update - Management confirmed that revenue recognition for Q1 was based on patients receiving both doses, and they are evaluating the implications of the April 1 coding update on revenue recognition [54][56] Question: Potential exposure to tariffs - Management noted that blood products are typically exempt from tariffs, and the customs value used for tariff calculations is linked to manufacturing costs rather than product sales [61][62] Question: Manufacturing turnaround time and success rate - Management indicated that the turnaround time is tracking towards the target of 16 days, and while it is premature to discuss success rates, initial results indicate good quality products [87][88]