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]

Core Insights - TG Therapeutics, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference scheduled for September 8-10, 2025, with a fireside chat on September 8 at 10:30am ET [1] Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on developing and commercializing novel treatments for B-cell diseases [3] - The company has received FDA approval for BRIUMVI (ublituximab-xiiy) for treating adult patients with relapsing forms of multiple sclerosis, and it has also received approvals from regulatory agencies in Europe, the UK, Switzerland, and Australia for the same treatment [3]

Core Insights - TG Therapeutics reported a significant earnings miss for Q2 2025, with earnings of 17 cents per share compared to the Zacks Consensus Estimate of 32 cents, although revenues increased by nearly 92% year over year to $141.1 million, driven by strong demand for Briumvi [2][4] Financial Performance - Briumvi's net product sales reached $138.8 million in the U.S. for Q2 2025, marking a 91% year-over-year increase and a 16% sequential increase [4] - Total revenues included $2.3 million from license, milestone, royalty, and other revenues, up from $0.9 million in the same quarter last year [4] - Research and development expenses rose approximately 83.3% year over year to $27.5 million, primarily due to increased manufacturing costs for Briumvi's subcutaneous formulation [5] - Selling, general, and administrative expenses totaled $43.5 million, up nearly 36.8% from the previous year, attributed to higher commercialization costs for Briumvi [5] - As of June 30, 2025, TG Therapeutics had cash and investments totaling $278.9 million, slightly up from $276.2 million at the end of Q1 2025 [6] Guidance and Estimates - The company raised its full-year revenue guidance for 2025 to approximately $585 million, up from the previous estimate of $575 million, with net product sales of Briumvi expected to be between $570 million and $575 million in the U.S. [7] - Operating expenses for the full year are projected to remain around $300 million, unchanged from prior guidance [8] - Following the earnings release, there has been a downward trend in fresh estimates, with the consensus estimate shifting down by 5.38% [9] Stock Performance and Outlook - TG Therapeutics currently holds a Zacks Rank 3 (Hold), indicating an expectation of an in-line return in the coming months [11] - The company has a strong Growth Score of A but is lagging in Momentum with a score of F, resulting in an overall VGM Score of D [10]

TG Therapeutics (TGTX) Conference Call Summary Company Overview - **Company**: TG Therapeutics (TGTX) - **Event**: 2025 Conference on September 03, 2025 - **Key Speaker**: Mike Weiss, Chairman and CEO Key Points Product Launch and Performance - **Bremvio Launch**: Launched approximately two and a half years ago, exceeding internal and Wall Street projections consistently each quarter and year [4][5] - **Focus on Healthcare Providers**: Initial strategy focused on educating healthcare providers about Bremvio, with a shift towards direct-to-patient programming now underway [5][6] - **Advertising Initiatives**: First commercial aired on traditional and connected TV platforms, indicating a significant push in marketing efforts [6][7] Drug Profile and Market Position - **Efficacy and Tolerability**: Bremvio demonstrated an annualized relapse rate (ARR) of 0.08 in phase three trials, with a long-term follow-up showing an ARR of one relapse in every fifty treatment years [9][10] - **Competitive Pricing**: Bremvio is priced approximately 25% lower than competitors, which is a significant factor for price-sensitive customers [11][12] - **Market Share Dynamics**: CD20 drugs hold over 50% market share, with Bremvio capturing about one in three dynamic patients in the IV class [14][18] Guidance and Financial Performance - **Conservative Guidance Philosophy**: The company maintains a conservative approach to guidance, aiming to avoid missing projections, with a current target of $575 million for the year [20][21] - **Gross to Net Dynamics**: The gross-to-net ratio is expected to range between 70% and 75%, influenced by 340B hospital utilization [29][30] Pipeline and Future Opportunities - **Subcutaneous Formulation**: The subcutaneous version of Bremvio is anticipated to represent a significant market opportunity, potentially doubling the market size for the product [58][59] - **Ezrcel Development**: Early-stage development for primary progressive MS is ongoing, with expectations for increased enrollment in 2026 [60][62] Capital Allocation and Share Buyback - **Share Buyback Authorization**: A new $100 million share buyback was announced, with $70 million already executed, indicating confidence in the company's valuation [65][68] - **Business Development Strategy**: The company is actively evaluating business development opportunities, focusing on early to mid-stage assets rather than major acquisitions [70][72] Competitive Landscape - **Impact of Ocrevus**: The CEO views the potential introduction of a biosimilar Ocrevus as an opportunity rather than a threat, expecting continued market share growth for Bremvio [43][44] Market Trends and Seasonality - **Seasonal Trends**: July showed record enrollment, while August was slower, consistent with historical trends in the MS market [24][25] Additional Insights - **Direct-to-Consumer Investments**: The company is investing in direct-to-consumer marketing, with patient awareness levels reportedly increasing [39][40] - **Long-term Market Dynamics**: The CEO expressed confidence in the long-term growth potential of Bremvio, emphasizing the importance of patient accumulation in market modeling [48][49] This summary encapsulates the key insights and strategic directions discussed during the TG Therapeutics conference call, highlighting the company's performance, market positioning, and future opportunities.