Financial Data and Key Metrics Changes - In Q2 2025, net product revenue was $20.9 million, up from $9 million in Q1 2025, indicating strong momentum in the product launch [14][6] - The net loss for Q2 2025 was $47.9 million, reduced from a loss of $58.3 million in Q2 2024 [17] - Cash, cash equivalents, and marketable securities totaled $454.3 million at the end of Q2 2025, down from $588 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - Product sales for the first six months of the launch reached $29.9 million, with a total of 46 centers authorized for the use of Ocatsol [6][7] - Cost of sales in Q2 2025 was $24.4 million, which includes costs for products delivered but not yet administered [15] - Research and development expenses decreased to $27.4 million in Q2 2025 from $36.6 million in the same period in 2024 [16] Market Data and Key Metrics Changes - The company has achieved 90% total US medical lives covered and aims to reach over 60 authorized centers by year-end [7] - The company does not expect EU sales in 2025 and 2026 due to limited resources and the need for economically viable market access [9] Company Strategy and Development Direction - The company is focused on expanding the use of Ovicell beyond adult patients with relapsed-refractory ALL and is making progress in autoimmune diseases [12][20] - The company is taking a disciplined approach to market access in Europe, evaluating country by country for economically viable launches [9][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the product's reception and the potential for increased patient enrollment as administrative adjustments are resolved by Q4 [8][30] - The company plans to release updated data from its Phase I study at the ACR meeting in October and expects to dose the first patients in several upcoming studies [20][98] Other Important Information - The company received conditional marketing authorization in the UK and from the European Commission, with ongoing market access discussions [8][9] - The company is broadening real-world experience in the US to support market access conversations elsewhere [9] Q&A Session Summary Question: What is the status of the Germany launch? - Management indicated that market access methodologies in Europe are challenging, particularly for CAR T programs, and emphasized a methodical approach to launching in different countries [24][26] Question: How will revenue recognition change with the split reimbursement? - The CFO clarified that revenue recognition has shifted to a 50/50 split between the first and second administration, with expectations for enrollment and sales to accelerate post-implementation [28][29] Question: What is the feedback from the US community regarding the product? - Management reported very positive feedback, with early reorder activity from treatment centers indicating strong acceptance [38] Question: What is the timeline for the UK and Germany launches? - Management expects potential launches in the UK by early next year, contingent on favorable negotiations, while Germany's timeline remains uncertain [65][66] Question: How many patients were treated in Q2? - Management did not provide specific numbers but indicated that the revenue can be backtracked based on therapy costs [90] Question: What is the expected data release for the lupus Phase II trial? - Management stated that it is premature to provide a timeline for data from the lupus nephritis study, as patient enrollment is just beginning [99]

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]