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]

Core Insights - TG Therapeutics has initiated a Phase 3 trial for subcutaneous BRIUMVI (ublituximab-xiiy) targeting relapsing forms of multiple sclerosis (RMS) [1][2] - The trial aims to evaluate the pharmacokinetics, safety, and clinical effects of subcutaneous BRIUMVI compared to the currently approved intravenous (IV) formulation [2][3] - If successful, subcutaneous BRIUMVI could capture a significant portion of the market, particularly the estimated 40% of RMS patients who prefer self-injectable therapies [2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS in the U.S. and several other regions [27] - The company aims to provide innovative treatment options and enhance patient choice in managing RMS [2][27] Product Information - BRIUMVI is a monoclonal antibody that targets CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through glycoengineering [3] - The drug is currently administered as a one-hour IV infusion twice a year, and the new subcutaneous option aims to offer greater flexibility for patients [1][2] Clinical Trial Details - The Phase 3 trial is a non-inferiority, randomized, open-label study comparing subcutaneous BRIUMVI administered every 8 weeks and every 12 weeks against the IV regimen [2] - The primary endpoint is to demonstrate non-inferior exposure of subcutaneous BRIUMVI compared to IV BRIUMVI at week 24 [2] Market Potential - The introduction of a subcutaneous formulation could significantly broaden the market opportunity for BRIUMVI, potentially increasing its adoption among patients who prefer self-administration [2] - The company anticipates that positive trial results could support regulatory approval by 2028 [2]