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]

Financial Performance - Total revenue for Q3 2025 was $161.7 million, with BRIUMVI U.S. net revenue at $152.9 million, representing 84% growth year-over-year[5] - The company raised its full-year 2025 global revenue target to approximately $600 million, up from a prior guidance of $585 million[6] - BRIUMVI U.S. net product revenue for the full year 2025 is now targeted at approximately $585 million, an increase from the previous guidance of $570 - $575 million[4] - Product revenue for Q3 2025 reached $159.3 million, a 91.2% increase from $83.3 million in Q3 2024[44] - Total revenue for the nine months ended September 30, 2025, was $423.7 million, compared to $220.8 million for the same period in 2024, reflecting a 92.0% growth[44] - Operating income for Q3 2025 was $29.4 million, up from $12.4 million in Q3 2024, representing a 136.5% increase[44] - Net income for Q3 2025 was $390.9 million, significantly higher than $3.9 million in Q3 2024, driven by a non-recurring income tax benefit of approximately $365.0 million[13] - Basic net income per share for Q3 2025 was $2.69, compared to $0.03 in Q3 2024, marking a significant improvement[44] Expenses - Research and development expenses for Q3 2025 were approximately $40.9 million, compared to $20.1 million in Q3 2024, reflecting increased costs in clinical trials and development[13] - Selling, general and administrative expenses for Q3 2025 were approximately $63.4 million, up from $42.0 million in Q3 2024, primarily due to increased marketing and personnel costs[13] - The company reported a total cost of revenue of $28.1 million for Q3 2025, compared to $9.3 million in Q3 2024, reflecting increased operational costs[44] - Research and development expenses for the nine months ended September 30, 2025, were $119.0 million, up from $70.4 million in the same period of 2024, indicating a focus on innovation[44] Shareholder Actions - The company completed a $100 million share repurchase program, purchasing approximately 3.5 million shares at an average price of $28.55 per share, and authorized an additional $100 million program[2] Market and Product Development - BRIUMVI is now approved in multiple international markets, including the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates[5] - The company commenced patient enrollment into the Phase 3 pivotal program for subcutaneous ublituximab and completed enrollment for the ENHANCE trial[5] - The company presented three data presentations at the 2025 ECTRIMS annual meeting, showcasing positive outcomes from ongoing clinical trials[5] Assets and Equity - Cash, cash equivalents, and investment securities totaled $178.3 million as of September 30, 2025, down from $311.0 million at the end of 2024[44] - Total assets increased to $1.025 billion as of September 30, 2025, compared to $577.7 million at the end of 2024[44] - Total equity rose to $607.2 million as of September 30, 2025, up from $222.4 million at the end of 2024[44]

Group 1 - The article does not provide any specific information or insights regarding a company or industry [1]

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]

Core Points - TG Therapeutics, Inc. will hold a conference call on November 3, 2025, at 8:30 AM ET to discuss Q3 2025 results and provide a business outlook for the remainder of the year [1] - The call will be hosted by Michael S. Weiss, Chairman and CEO of TG Therapeutics [1] - A press release detailing the financial results will be issued prior to the conference call [3] Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on developing and commercializing novel treatments for B-cell diseases [4] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for treating adult patients with relapsing forms of multiple sclerosis [4] - BRIUMVI has also received approval from several regulatory agencies outside the U.S. for treating adult patients with active relapsing multiple sclerosis [4]

Core Insights - TG Therapeutics has completed enrollment in the randomized cohort of the Phase 3 ENHANCE trial for IV BRIUMVI, aimed at evaluating a consolidated dosing schedule for patients with relapsing forms of multiple sclerosis (RMS) [1][3][4] - The primary endpoint of the trial is to demonstrate non-inferior exposure in terms of area under the curve (AUC) at week 16 compared to the existing regimen [1][4] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI being its primary product approved for RMS [28] - BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody designed for efficient B-cell depletion at low doses, currently approved in the U.S. and several other countries [2][5][6] Trial Details - The ENHANCE Phase 3 trial is a randomized, double-blind, placebo-controlled study assessing the pharmacokinetics, safety, and efficacy of a modified BRIUMVI regimen [4] - Participants are divided into two arms, with one group receiving a single Day 1 infusion and the other receiving infusions on both Day 1 and Day 15 [4] Market Potential - If the trial data is positive, the new dosing regimen could be launched in 2027, enhancing patient convenience and efficiency for infusion centers [3][4] - The current one-hour infusion of BRIUMVI is already considered best-in-class among available IV anti-CD20 therapies [3] Patient Demographics - It is estimated that nearly 1 million people in the U.S. are living with multiple sclerosis, with approximately 85% initially diagnosed with relapsing-remitting multiple sclerosis (RRMS) [27] - The majority of RRMS patients eventually transition to secondary progressive multiple sclerosis (SPMS), indicating a significant market for effective treatments [27]

Core Viewpoint - Wall Street anticipates a year-over-year increase in earnings for TG Therapeutics, with a focus on how actual results compare to estimates, which could significantly impact stock price [1][2]. Earnings Expectations - TG Therapeutics is expected to report quarterly earnings of $0.24 per share, reflecting a year-over-year increase of +1100% [3]. - Revenues are projected to be $150.66 million, representing a 79.6% increase from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised down by 5.81% over the last 30 days, indicating a bearish sentiment among analysts regarding the company's earnings prospects [4][12]. - The Most Accurate Estimate for TG Therapeutics is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -17.36% [12]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, with a strong predictive power for positive readings [9][10]. - TG Therapeutics currently holds a Zacks Rank of 3, making it challenging to predict an earnings beat conclusively [12]. Historical Performance - In the last reported quarter, TG Therapeutics was expected to post earnings of $0.32 per share but only achieved $0.17, resulting in a surprise of -46.88% [13]. - Over the past four quarters, the company has only beaten consensus EPS estimates once [14]. Industry Comparison - Kymera Therapeutics, another player in the biomedical and genetics industry, is expected to report a loss of $0.72 per share, with revenues projected at $26.57 million, up 610.4% year-over-year [18][19]. - Kymera's consensus EPS estimate has been revised up by 0.7% over the last 30 days, but it also has a negative Earnings ESP of -25.87% [19][20].

Core Insights - TG Therapeutics announced updated six-year data for BRIUMVI (ublituximab-xiiy) showing a low annualized relapse rate of 0.012, indicating one relapse every 83 years of treatment [1][2] - The overall safety profile of BRIUMVI remained consistent over six years, with no new safety signals emerging [1][3] Efficacy and Safety Data - After six years of continuous treatment, 89.9% of patients remained free from disability progression, and 10.1% experienced confirmed disability progression lasting 24 weeks [3] - The annualized relapse rates decreased over the years: 0.053 in Year 3, 0.032 in Year 4, 0.020 in Year 5, and 0.012 in Year 6 [3] - 17% of patients achieved confirmed disability improvement lasting at least 24 weeks compared to 13.3% of those who switched from teriflunomide to BRIUMVI [3] Clinical Trial Background - The ULTIMATE I & II trials involved 1,094 patients with relapsing forms of multiple sclerosis (RMS) across 10 countries, comparing BRIUMVI to teriflunomide [5][29] - BRIUMVI is administered as an IV infusion, with a dosing regimen designed to optimize patient convenience and minimize infusion-related reactions [5][6] Real-World Observations - In the ENABLE observational study, 99.5% of participants reported no relapses on BRIUMVI, with infusion durations consistent with clinical trial expectations [9] - The safety profile in real-world settings was consistent with clinical trial data, showing lower rates of infusion-related reactions compared to pivotal studies [9] Company Overview - TG Therapeutics is focused on developing novel treatments for B-cell diseases, with BRIUMVI approved for RMS in the U.S. and Europe [29][30] - The company emphasizes the importance of early treatment with ublituximab for better disability outcomes in RMS patients [2][29]

Core Insights - TG Therapeutics, Inc. announced the schedule for presentations on BRIUMVI (ublituximab-xiiy) data for patients with relapsing forms of multiple sclerosis (RMS) at the 2025 ECTRIMS annual meeting in Barcelona, Spain [1][2] Presentation Details - An oral presentation will cover the long-term efficacy and safety of ublituximab based on six years of data from the ULTIMATE I and II open-label extension studies [2] - ePoster presentations will include updates on a modified dosing regimen from the ENHANCE study and real-world clinical experiences from the ENABLE Phase 4 observational study [2] Clinical Trials Overview - The ULTIMATE I & II trials are randomized, double-blind, and active comparator-controlled studies involving 1,094 patients with RMS across 10 countries, treated for 96 weeks [3] - Patients were randomized to receive either BRIUMVI or teriflunomide, with specific dosing regimens outlined for both treatments [3] Product Information - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to enhance B-cell depletion at lower doses through glycoengineering [4][5] - It is approved in the U.S. and Europe for treating adults with RMS, including various forms of the disease [5][26] Safety and Efficacy Data - The incidence of infusion reactions in BRIUMVI-treated patients was reported at 48%, with serious reactions occurring in 0.6% of patients [7] - The overall infection rate in BRIUMVI-treated patients was 56%, with serious infections at 5% [9] Company Background - TG Therapeutics is focused on developing and commercializing treatments for B-cell diseases, with BRIUMVI being a key product in their portfolio [26]

TG Therapeutics FY Conference Summary Company Overview - **Company**: TG Therapeutics (NasdaqCM:TGTX) - **Focus**: Development and commercialization of therapies for relapsing multiple sclerosis (MS) and other autoimmune diseases Industry Context - **Market Size**: Approximately 1 million individuals in the US have relapsing forms of MS, with 300,000 to 400,000 treated annually. About 80,000 patients seek new treatments each year [3][4] - **Treatment Landscape**: The anti-CD20 monoclonal antibody class includes three drugs, with TG Therapeutics' product, Brionvy, being one of them. The market is competitive, with a significant portion of patients switching therapies frequently [4][5] Key Points and Arguments Product Differentiation - **Administration Options**: Brionvy is administered intravenously (IV), while competitors offer both IV and subcutaneous (subcu) options. Approximately 35% to 40% of patients prefer subcu options, while 65% choose IV [6][9] - **Infusion Time**: Brionvy has a one-hour infusion time compared to competitors' two to three and a half hours, potentially offering significant time savings for patients [8][9] - **Cost Advantage**: Brionvy is priced 20% to 25% lower than its main competitor, which may influence clinician choice [9] Revenue Guidance and Market Penetration - **2025 Revenue Guidance**: Projected revenue for 2025 is between $5.70 billion and $5.75 billion, driven by new start forms and patient persistence on therapy [10][12] - **Market Share**: Brionvy is approaching a 33% market share in the IV segment, up from 25% at the beginning of the year [17][18] Patient Demographics - **Switching Patterns**: The majority of patients starting on Brionvy are switching from other therapies, not just other anti-CD20 treatments [19][20] Real-World Efficacy - **Patient Experience**: Anecdotal evidence suggests that patients on Brionvy are experiencing good outcomes, with lower rates of infusion-related reactions (IRRs) compared to competitors [21][24][25] Commercialization Strategy - **Launch Approach**: TG Therapeutics has focused on educating clinicians before direct-to-patient marketing. Recently, they launched a TV commercial to increase patient awareness [28][29] - **International Plans**: The company has partnered with Nurax Farm for ex-US commercialization, but expects US sales to dominate overall revenues [30][31] Development Pipeline - **Subcutaneous Formulation**: Enrollment for a pivotal trial for a subcu formulation has begun, with potential approval expected in 2028 [37][38] - **Other Indications**: The company is exploring the use of Brionvy in myasthenia gravis (MG) but has not committed to moving forward yet [44][46] - **CAR T Development**: TG Therapeutics is also developing a CD19 CAR T therapy, with ongoing trials in progressive MS [47][50] Upcoming Milestones - **Revenue Updates**: Anticipated revenue surprises as the company updates forecasts [54] - **Data Releases**: ENHANCE data expected in 2026, subcu data in 2027, and potential updates on the CAR T program [55][56] Additional Insights - **Market Opportunity**: The company aims to capture a significant share of the subcu market currently dominated by competitors [42][43] - **Patient Enrollment**: Expansion of protocols to include various MS types and other indications is planned [51][52]