Core Insights - TG Therapeutics reported a significant increase in revenue and achieved profitability, but the stock price fell sharply due to investor disappointment [1][4][7] Revenue Performance - The company's revenue for the first quarter was nearly $121 million, almost double the $63.5 million from the same period in 2024, driven primarily by Briumvi sales [2][6] - Analysts had a collective revenue estimate of $117 million, indicating that the actual revenue exceeded expectations [4] Profitability - TG Therapeutics posted a net profit of just over $5 million, or $0.03 per share, compared to an almost $11 million loss in the first quarter of 2024 [4] - The consensus estimate for earnings per share was $0.16, suggesting that the actual profit fell short of analyst expectations [4][7] Pipeline Developments - The company is conducting two phase 1 trials for Briumvi: one for subcutaneous use in relapsing MS patients and another for myasthenia gravis [5] - Additionally, TG is developing a CAR T cell therapy, azercabtagene zapreleucel, which is currently in enrollment for a phase 1 trial [5] Guidance Update - TG Therapeutics raised its guidance for domestic Briumvi sales in 2025 to $560 million, up from a previous estimate of $525 million [6] - Overall revenue guidance was also increased to $575 million from $540 million [6]

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]

AUCATZYL Launch and Expansion - Autolus' AUCATZYL received FDA approval on November 8, 2024, triggering a $30 million milestone payment from Blackstone[12] - As of March 19, 2025, 33 treatment centers are authorized for AUCATZYL, covering over 60% of the target patient population, with a goal to reach approximately 60 centers covering 90% by the end of 2025[12, 23] - Over 85% of total U S medical lives are covered for AUCATZYL[22] - The anticipated payor mix for AUCATZYL is approximately 60% commercial and 40% government/other[23] Obe-cel Development - The FELIX trial data for obe-cel was published in the New England Journal of Medicine in December 2024[12] - The FELIX trial showed an overall remission rate of 77% in all patients, 75% in morphological disease, 96% in measurable residual disease, and 71% in isolated extramedullary disease[13] - In the FELIX trial, the estimated 6- and 12-month overall survival rates were 80 3% and 61 1%, respectively, with a median OS of 15 6 months[19, 20] - Regulatory decisions from MHRA and EMA regarding obe-cel are expected in H2 2025[12] Financial Performance - Autolus' cash, cash equivalents, and marketable securities totaled $588 023 million for FY 2024, compared to $239 566 million for FY 2023[35] - Total revenue, net, for FY 2024 was $10 120 million, compared to $1 698 million for FY 2023[35] - The net loss for FY 2024 was $(220 844) million, compared to $(208 383) million for FY 2023[35]