TG Therapeutics(US:TGTX)2025-11-03 14:30Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $161.7 million, a 93% increase compared to Q3 2024 and a 15% increase over Q2 2025 [18] - Product revenue totaled $159.3 million, primarily driven by $152.9 million in US BRIUMVI net sales [18] - GAAP net income for Q3 2025 was $390.9 million, or $2.43 per diluted share, compared to $3.9 million, or $0.02 per diluted share, in the same period last year [20] Business Line Data and Key Metrics Changes - BRIUMVI's US net sales in Q3 totaled approximately $153 million, showing strong sequential and year-over-year growth [11] - The company reported that persistence and repeat prescribing of BRIUMVI exceeded expectations, reinforcing confidence in its clinical profile [11] Market Data and Key Metrics Changes - The anti-CD20 class now represents nearly $10 billion in annual US MS sales, with approximately half of all patients still on other types of disease-modifying therapies, indicating significant market opportunity [12] - The subcutaneous portion of the market is estimated to be about 35% to 40% and is expected to grow, potentially doubling the market opportunity for BRIUMVI [34] Company Strategy and Development Direction - The company is focused on continuing to innovate and improve outcomes for patients with MS, with two pivotal studies launched for BRIUMVI [5] - The strategic expansion of the commercial field organization has been emphasized to align with market opportunities and drive growth [14] - The company remains financially disciplined, completing a $100 million share repurchase program and authorizing another $100 million program [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in BRIUMVI's long-term potential, raising the full-year 2025 US BRIUMVI net revenue guidance from $570 million-$575 million to approximately $585 million [16] - The management highlighted the importance of patient retention and the impact of direct-to-consumer efforts on demand growth [25][50] Other Important Information - The company completed enrollment for the ENHANCE study and is on track to finish enrollment for the phase three subcutaneous BRIUMVI study in the first half of next year [6][7] - The third quarter marked the first full quarter of the national television campaign, which is expected to drive awareness and engagement [15] Q&A Session Summary Question: Guidance and Growth Expectations - A question was raised regarding the slight slowing of sequential growth expected in Q4 compared to previous years, with management noting that patient retention and field expansion are key factors supporting growth [24][25] Question: Demand from Permanent J Code - Inquiry about additional demand from the permanent J code was addressed, clarifying that the company has had a J code for several years [28][29] Question: Market Opportunity for Subcutaneous Products - A question was posed about the factors underpinning the estimate that subcutaneous products could double the market opportunity for BRIUMVI, with management explaining the current market dynamics and potential growth [34] Question: Inventory Channel Dynamics - Inquiry about inventory channel dynamics and gross to net changes revealed no notable changes in Q3, with the gross to net remaining within the provided range [38][40] Question: 2026 Trends and Deal Pursuits - Questions regarding 2026 trends highlighted the importance of new patient growth and the company's cautious approach to potential deals, emphasizing a high standard for ROI [49][51][52]