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]
Autolus(AUTL) - 2025 Q1 - Earnings Call Transcript