TG Therapeutics(US:TGTX)2024-05-03 02:21Financial Data and Key Metrics Changes - For Q1 2024, total revenue was approximately $63.5 million, which includes $50.5 million from U.S. Briumvi net product revenue and about $13 million from license milestones and other revenue [20][21][37] - The company reported a modest net loss of approximately $10.7 million or $0.07 per share, compared to a net loss of approximately $39.2 million or $0.28 per share during the same quarter in 2023 [43] Business Line Data and Key Metrics Changes - Briumvi's U.S. revenue exceeded $50 million in Q1 2024, representing a 25% growth quarter-over-quarter [8][37] - The company achieved over 1,250 new patient scripts in the quarter, with a 25% increase in enrollments [16][37] - The full-year revenue guidance for Briumvi was raised to $270 million to $290 million, up from the previous guidance of $220 million to $260 million [40] Market Data and Key Metrics Changes - The company noted that it was the only CD20 therapy in the MS market to see revenue growth quarter-over-quarter during Q1 2024 [16] - The company successfully added 65 new accounts in the quarter, with prescriptions coming from over 450 centers and over 800 unique prescribers [39] Company Strategy and Development Direction - The company aims to become the number one prescribed anti-CD20 therapy, focusing on expanding Briumvi's market share and exploring additional indications beyond MS [9][12] - The company is preparing to enter human bioequivalence studies for subcutaneous Briumvi, which is seen as a significant opportunity [11] - A partnership with Precision BioSciences was established to acquire a worldwide license for azer-cel, an allogeneic CD19 CAR T cell therapy for autoimmune diseases [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for Briumvi and the positive feedback from healthcare providers and patients [9][19] - The company is targeting approximately $65 million in net revenue for Briumvi in Q2 2024, indicating continued momentum [18] - Management acknowledged the challenges in the first quarter related to payer dynamics but emphasized the successful mitigation of these challenges [16] Other Important Information - The company received three newly issued patents extending Briumvi's patent protection through 2042, which supports its long-term development strategy [10] - The company ended Q1 2024 with $209.8 million in cash and equivalents, providing sufficient capital to fund operations until cash flow positivity [21] Q&A Session Summary Question: What is the impact of the VA contract on revenue guidance? - The VA contract was not factored into the revenue guidance raise as it will gradually increase starting in June, with a 72% discount offered [30][69] Question: How is the repeat infusion rate characterized? - The 24-week persistence rate is in line with expectations at about 85% [55] Question: What is the assessment of the subcutaneous opportunity for Briumvi? - The subcutaneous opportunity is seen as significant, with the potential for a competitive product profile [61] Question: How does the company prioritize potential indications outside of MS? - The focus is on larger indications like RA and lupus, while also considering niche indications for azer-cel [51] Question: What is the current status of the subcutaneous formulation? - The company expects to dose the first patients for subcutaneous Briumvi within the first half of the year [112]