Financial 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]

Core Insights - TG Therapeutics reported a total revenue of $161.7 million for Q3 2025, with BRIUMVI U.S. net revenue at $152.9 million, reflecting strong growth and prompting an increase in full-year revenue guidance to $600 million globally and approximately $585 million for BRIUMVI in the U.S. [1][9] Financial Performance - BRIUMVI U.S. net product revenue for Q3 2025 was $152.9 million, representing an 84% increase compared to Q3 2024 and a 10% increase from Q2 2025 [5][9] - Total product revenue, net for Q3 2025 was $159.3 million, compared to $83.3 million in Q3 2024, indicating significant growth [9][41] - The company achieved a net income of $390.9 million for Q3 2025, a substantial increase from $3.9 million in Q3 2024, largely due to a non-recurring income tax benefit [9][41] Strategic Developments - The company successfully completed a $100 million share repurchase program and authorized an additional $100 million program, reflecting confidence in long-term business potential [2][9] - TG Therapeutics is advancing its pipeline with two Phase 3 programs, focusing on subcutaneous ublituximab and a simplified BRIUMVI IV dosing schedule [2][5] Market Expansion - BRIUMVI has been approved for commercialization outside the U.S. in several regions, including the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates [5][9] - The company presented new data at the 2025 ECTRIMS annual meeting, showcasing the efficacy and safety profile of BRIUMVI in treating relapsing multiple sclerosis [5][9] Research and Development - Total R&D expenses for Q3 2025 were approximately $40.9 million, up from $20.1 million in Q3 2024, driven by increased manufacturing and clinical trial costs [9][41] - The company is focused on expanding patient awareness and advancing enrollment in ongoing clinical trials to drive growth [2][5]

Financial Data and Key Metrics Changes - For the full year 2024, U.S. revenues reached $310 million, exceeding target guidance and reflecting a 250% growth compared to 2023 [9][25] - Fourth quarter U.S. net sales for BRIUMVI were $103.6 million, representing a 24% growth quarter-over-quarter and 160% growth year-over-year [25][36] - Total global revenue for 2024 was approximately $329 million, including $310 million from U.S. BRIUMVI net product sales and $12.5 million milestone from a partner [36] Business Line Data and Key Metrics Changes - BRIUMVI's performance in the U.S. market showed significant growth, with strong demand leading to above-expectation revenues [25][29] - The company reported a gross margin impacted by lower margins on products sold to partners, but overall gross margin is expected to remain consistent [38] Market Data and Key Metrics Changes - BRIUMVI is gaining momentum internationally, with successful launches in Germany and other EU countries, receiving positive feedback [26] - The company is focusing on expanding its market share in the relapsing MS market, with a goal to reach more eligible patients [30] Company Strategy and Development Direction - The company plans to launch pivotal trials for a subcutaneous formulation of BRIUMVI and explore its use in other autoimmune diseases [19][20] - A partnership with Precision BioSciences was established to develop azer-cel for autoimmune diseases, indicating a strategic expansion into CAR-T therapies [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of BRIUMVI, supported by strong early performance in 2025 and a robust commercial infrastructure [30][32] - The company anticipates multiple drivers for growth in 2025, including deeper penetration in the RMS market and increased patient education efforts [30][31] Other Important Information - The company received three new patents for BRIUMVI, extending patent protection through 2042 [22] - The company ended the fourth quarter with approximately $311 million in cash, providing a strong financial position for future investments [40] Q&A Session Summary Question: Insights on growth and market segments - Management noted that growth is coming from a broad set of customers, particularly in academic hospitals, and January and February showed strong enrollment trends [48][49] Question: Subcutaneous trial design and expectations - The subcutaneous trial design is not finalized, but the target is to commence by mid-year, with expectations of a gross-to-net range of 70% to 75% [54][58] Question: Size and timing of the subcutaneous trial - The trial size is expected to be similar to Ocrevus' subcutaneous studies, with an enrollment period projected to be around 12 months [63] Question: Feedback on ENHANCE trial data - Feedback from the ACTRIMS conference indicated that many physicians are already comfortable switching patients to BRIUMVI without the introductory dose, although formal label changes are still pending [80][82] Question: Myasthenia gravis expansion opportunity - Management is exploring the potential for BRIUMVI in treating myasthenia gravis, noting that while the market is not underserved, there is room for effective and cost-efficient treatments [85][87]