Financial Data and Key Metrics Changes - U.S. net sales for BRIONVI reached approximately $119.7 million in Q1 2025, reflecting a 137% year-over-year growth and a 16% sequential increase from Q4 2024 [16][24] - GAAP net income for the quarter was approximately $5 million, or $0.03 per diluted share [25] - The company closed the quarter with $276 million in cash, cash equivalents, and investment securities, indicating a strong financial position [26] Business Line Data and Key Metrics Changes - BRIONVI's U.S. net sales exceeded internal expectations, marking the highest months of total new patient enrollment since launch, with March being the highest month for repeat prescribers [16][18] - The company reported that repeat prescriptions have now surpassed new prescriptions for the first time, indicating strong persistence trends [18] Market Data and Key Metrics Changes - The company is gaining approximately 25% of the IV segment market share, with no observed impact from competitive products like OCREVUS [30][31] - The hospital setting contributed approximately 60% of enrollments in March, highlighting a deepening footprint among institutional accounts [18] Company Strategy and Development Direction - The company aims to make BRIONVI the number one prescribed anti-CD20 therapy, focusing on a multi-phase launch strategy and enhancing the patient experience [9][13] - Plans include launching a direct-to-patient television commercial campaign and preparing for lifecycle innovations, including a subcutaneous formulation of BRIONVI [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth and potential for BRIONVI, citing strong demand, increasing prescriber confidence, and broad commercial execution [21][22] - The company is actively monitoring potential tariffs but does not anticipate a material impact on gross margins or overall financial performance [26] Other Important Information - The company is advancing its pipeline with a focus on the ENHANCE clinical trial and exploring new indications for subcutaneous BREONVY [10][12] - The company is also excited about its allogeneic CD19 CAR T cell therapy, azurecel, targeting progressive forms of MS [13] Q&A Session Summary Question: Competitive dynamics regarding OCREVUS and new patient share - Management noted that they are seeing strong market share gains and have not observed any impact from OCREVUS [30][31] Question: Update on gross to net trends and gross margin expectations - There was no material change in gross to net for the quarter, and the margins reported are expected to be consistent going forward [37][38] Question: Subcutaneous BREONVY pivotal trial details - The pivotal trial is expected to include two dosing regimens, with data likely to be available later this year [42][44] Question: Feedback on the thirty-minute infusion data - Positive feedback was received from physicians regarding the thirty-minute infusion, which is seen as a convenience for busy infusion centers [50] Question: Update on North Carolina plant for commercial scale manufacturing - The North Carolina facility will take several years to be operational for commercial manufacturing [58] Question: Product adherence metrics - Persistence trends remain strong and above expectations, although specific adherence metrics were not disclosed [64] Question: Percentage of BRIONVI patients switching from OCREVUS - The company has not seen material changes in the percentage of switches from OCREVUS, maintaining a healthy amount of switches since launch [71]

Financial Data and Key Metrics Changes - U.S. net product revenue for Q1 2025 was approximately $119.7 million, reflecting a 137% increase year-over-year and a 16% increase sequentially from Q4 2024 [14][23] - GAAP net income for the quarter was approximately $5 million, or $0.03 per diluted share [24] - The company closed the quarter with $276 million in cash, cash equivalents, and investment securities, indicating a strong financial position [24] Business Line Data and Key Metrics Changes - BRIONVI U.S. net sales reached nearly $120 million in Q1 2025, exceeding expectations and demonstrating strong adoption by healthcare providers [5][14] - The first three months of 2025 marked the highest total new patient enrollment since the product launch, indicating accelerating demand [15] - Repeat prescriptions have now surpassed new prescriptions for the first time, signaling strong persistence trends [17] Market Data and Key Metrics Changes - The company is capturing approximately 25% of the IV segment market share, with continued growth in patient enrollments [29] - The hospital setting contributed approximately 60% of enrollments in March, the highest percentage to date [16] Company Strategy and Development Direction - The company aims to make BRIONVI the number one prescribed anti-CD20 therapy by focusing on a multi-phase launch strategy and enhancing the patient experience [8][12] - Plans include launching a direct-to-patient television commercial campaign and preparing for lifecycle innovations, including a subcutaneous formulation [19][21] - The company is also exploring new indications for BRIONVI, such as myasthenia gravis, while advancing its CAR T cell therapy pipeline [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth and potential for BRIONVI, citing strong demand and increasing prescriber confidence [20][21] - The company is monitoring potential tariffs but does not anticipate a material impact on gross margins or overall financial performance [26] Other Important Information - The ENHANCE clinical trial is evaluating strategies to simplify the patient experience, with positive feedback on a streamlined infusion regimen [9][10] - The company is on track to launch pivotal trials for both the simplified starting dose and the subcutaneous formulation of BREONVY [52][68] Q&A Session Summary Question: Competitive dynamics with OCREVUS and new patient share - Management noted strong patient enrollments and market share gains, with no impact from OCREVUS observed [29][30] Question: Update on gross to net trends and gross margin - No material change in gross to net was reported, and the pre-launch inventory reserve has been fully depleted, leading to consistent margins going forward [37][38] Question: Subcutaneous BREONVY pivotal trial details - The pivotal trial is expected to include two dosing regimens, with data anticipated later this year [41][42] Question: Physician feedback on the thirty-minute infusion - Positive feedback was received, indicating convenience for infusion centers and patients [49] Question: Phase III trial scale and profitability outlook - The company is not focused on profitability this year but aims to drive cash through the business while meeting revenue targets [54][55] Question: Update on North Carolina manufacturing plant - The North Carolina facility will take several years to reach commercial scale manufacturing [57][58] Question: Product adherence and trends - Persistence trends remain strong and above expectations, with no material changes in switch rates from OCREVUS [63][71]