TG Therapeutics FY Conference Summary Company Overview - **Company**: TG Therapeutics (NasdaqCM:TGTX) - **Product**: Briumvi, an anti-CD20 therapy for multiple sclerosis (MS) - **Market Presence**: Briumvi has been on the market for approximately 2.75 years, with a revenue target of $585 million for the current year [4][4] Financial Performance - **Revenue Target**: $585 million for FY 2025, with expectations for significant growth in FY 2026 [4][4] - **Future Guidance**: No specific guidance provided for next year, but anticipated to be a larger number than the current year [4][4] Market Dynamics - **CD20 Market Share**: Briumvi captures approximately 20% share among the CD20 class and about 10% share among all new MS starts [11][12] - **Patient Awareness**: Patient awareness was around 35% previously, with plans to double this over the next one to two years [19][19] Sales Strategy - **Sales Force Expansion**: TG Therapeutics plans to expand its sales force strategically, focusing on underperforming areas rather than a broad geographical expansion [25][27] - **Community vs. Hospital Practices**: The company is currently the second most prescribed in community settings and aims to become the number one in that category [26][26] Product Development - **Subcutaneous (Sub-Q) Program**: The Sub-Q program is progressing well, with enrollment expected to complete in the first half of next year and data anticipated by the end of next year [5][38] - **Formulation and Patents**: The new Sub-Q formulation is highly concentrated, with provisional patents filed that could extend protection until 2045 [42][42] Competitive Landscape - **Azer-cel and Cell Therapies**: The company is optimistic about the potential of cell therapies but acknowledges that current advancements are not yet transformative for patients with progressive forms of MS [50][51] - **Market Positioning**: TG Therapeutics aims to achieve parity coverage with competitors upon the launch of the Sub-Q formulation, expected in 2028 [45][45] Challenges and Considerations - **Gross-to-Net Spread**: The gross-to-net spread may be affected by 340B discounts, particularly in the hospital segment [33][33] - **Resource Management**: The company believes it can manage the expansion of its commercial and R&D efforts without significant strain, utilizing outsourcing for R&D as needed [59][60] Key Takeaways - TG Therapeutics is focused on increasing market share and patient awareness for Briumvi while strategically expanding its sales force - The company is optimistic about the future growth of its Sub-Q program and the potential of cell therapies - Resource management strategies are in place to handle potential growth in both commercial and R&D sectors without compromising execution quality [59][60]

Core Insights - TG Therapeutics, Inc. will participate in the 8th Annual Evercore Healthcare Conference from December 2-4, 2025, with a fireside chat scheduled for December 2, 2025, at 12:30 PM 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) to treat adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [3] - BRIUMVI has also received approval from several regulatory agencies outside the U.S. for treating adult patients with relapsing multiple sclerosis who have active disease defined by clinical or imaging features [3]

Core Insights - TG Therapeutics, Inc. ranked 27th on the Deloitte Technology Fast 500™, highlighting its status as one of the fastest-growing technology companies in North America [1][4] - The company's growth from fiscal years 2021 to 2024 was primarily driven by revenues from BRIUMVI®, which received FDA approval in December 2022 for treating relapsing forms of multiple sclerosis [2][3] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing and commercializing novel treatments for B-cell diseases, with BRIUMVI® being a key product approved for multiple sclerosis [7] - BRIUMVI® is a monoclonal antibody designed to target CD20-expressing B-cells, facilitating efficient B-cell depletion at low doses [9] Financial Performance - The company’s revenue growth is attributed to the successful adoption of BRIUMVI®, reflecting the trust from patients and healthcare providers [3][2] - To qualify for the Deloitte Technology Fast 500™, companies must demonstrate significant revenue growth, with TG Therapeutics achieving a growth rate of 50% or greater [5][4] Industry Context - The Deloitte Technology Fast 500™ has been recognizing fast-growing companies for 31 years, covering various sectors including technology, media, and life sciences [4] - The biopharmaceutical industry is increasingly focused on innovative treatments for autoimmune diseases, with BRIUMVI® positioned as a significant player in the market for multiple sclerosis [7][9]

Group 1 - TG Therapeutics (TGTX) has shown strong execution this year, with a largely expected beat-and-raise performance throughout the year [2] - The company's pipeline is progressing well, particularly the parts that are being closely monitored [2] Group 2 - The Growth Stock Forum focuses on identifying growth stocks, especially in the biotech sector, and emphasizes attractive risk/reward situations [1] - The forum includes a model portfolio of 15-20 stocks, a top picks list of up to 10 stocks expected to perform well, and trading ideas targeting both short-term and medium-term moves [1]

Group 1 - TG Therapeutics (TGTX) has shown strong execution this year, with a largely expected beat-and-raise performance throughout the year [2] - The company's pipeline is progressing well, particularly the parts that are being closely monitored [2] Group 2 - The Growth Stock Forum focuses on identifying growth stocks, especially in the biotech sector, emphasizing attractive risk/reward situations [1] - The forum includes a model portfolio of 15-20 stocks, a top picks list of up to 10 stocks expected to perform well, and trading ideas targeting both short-term and medium-term moves [1]

Group 1 - The core viewpoint is that TG Therapeutics (TGTX) has experienced softer sales growth for its product Briumvi in recent quarters, leading to a hold rating due to potential for a TV campaign to boost sales in the near term [1] Group 2 - The article emphasizes the importance of trading around significant events such as trial results and NDA/BLA approvals in the biotech sector [1]

Group 1 - The core viewpoint indicates that TG Therapeutics (TGTX) experienced softer sales growth for Briumvi in recent quarters, leading to a hold rating due to potential for a TV campaign to boost near-term sales [1] Group 2 - The article emphasizes the importance of trading around significant events such as trial results and NDA/BLA approvals in the biotech sector [1]

TG Therapeutics Conference Call Summary Company Overview - **Company**: TG Therapeutics (NasdaqCM:TGTX) - **Event**: Conference Call on November 12, 2025 Key Points Product Performance and Market Position - **Briumvi Launch Success**: Briumvi has established itself as a trusted product among physicians, with many moving it to the first IV slot due to its data and patient convenience [3][5] - **Patient Support Programs**: TG Therapeutics maintains the most generous patient support programs, unlike competitors who have cut back, contributing to its market position [5][6] - **Crossover Patients**: A significant portion of Briumvi's patients are switching from other therapies, with a stable distribution among naive patients, switches from non-CD20 therapies, and switches from other CD20 therapies [9][10] Clinical Trials and Future Expectations - **Enhanced Trial Enrollment**: Impressive enrollment rates in the enhanced trial combining initial doses, with expectations for a successful outcome based on area under the curve measures [12][13] - **Subcutaneous (SubQ) Version**: The company is optimistic about the SubQ version of Briumvi, targeting non-inferiority to IV dosing, with enrollment expected to complete in the first half of next year and data anticipated in late 2026 or early 2027 [29][32] Competitive Landscape - **Ocrevus and BTK Inhibitors**: Current market dynamics show limited impact from Ocrevus SubQ on Briumvi's uptake. The company believes BTK inhibitors will compete more in the oral category rather than against CD20 therapies [17][19][20] - **Market Dynamics for SubQ**: The SubQ version is expected to capture a significant market share, potentially doubling the total addressable market, with a competitive edge in convenience over existing products [33][34] Revenue and Growth Expectations - **Q4 Guidance**: The company is confident in meeting or exceeding Q4 guidance, citing positive dynamics typically seen in the fourth quarter [23][24] - **2026 Growth Initiatives**: Plans to expand direct-to-consumer (DTC) campaigns and enhance field team effectiveness to drive growth in 2026 [26][27] Pipeline and Future Projects - **Exploratory Programs**: The company is cautiously optimistic about ongoing exploratory programs, including MG trials and azer-cel, with potential for clearer direction in 2026 [35][36] Additional Insights - **Patient Awareness**: The DTC campaign has reportedly raised awareness, with patients actively requesting Briumvi after seeing commercials, indicating a positive trend for future sales [26][27] - **Team Performance**: The field team has received positive feedback, and the company is considering adding more personnel to strengthen market presence [27][28] This summary encapsulates the key insights from the TG Therapeutics conference call, highlighting the company's strategic positioning, product performance, competitive landscape, and future growth initiatives.

Company Announcement - TG Therapeutics, Inc. will participate in the TD Cowen Immunology & Inflammation Summit virtually from November 12 – 13, 2025, with a fireside chat scheduled for November 12, 2025, at 10:00 AM ET [1] - A live webcast of the fireside chat will be available on the Company's website [2] Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on the acquisition, development, and commercialization of 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, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [3] - BRIUMVI has also received approval from several regulatory agencies outside the U.S. for treating adult patients with relapsing multiple sclerosis who have active disease defined by clinical or imaging features [3]

Core Insights - Roche's fenebrutinib demonstrated "unprecedented" test results for multiple sclerosis, impacting TG Therapeutics negatively [1][2] - Roche's stock increased by over 3% to $43.33, while TG Therapeutics' stock fell more than 5% to $30.53, reaching a two-month low [2] - Fenebrutinib showed significantly fewer relapses compared to teriflunomide in relapsing multiple sclerosis patients [3] - In primary progressive MS, fenebrutinib slowed disability progression comparably to Roche's Ocrevus, the only approved treatment for this condition [4] Roche's Competitive Position - Roche's fenebrutinib uses a different mechanism than TG Therapeutics' Briumvi, targeting BTK, which is involved in immune response to inflammation [7] - Roche's stock performance improved, gapping above its 50-day moving average following the news [7] TG Therapeutics' Market Performance - Briumvi's sales grew by at least double-digit percentages year-over-year, with a notable 84% increase to $152.9 million in Q3 [6] - Despite the sales growth, Briumvi still lags behind Ocrevus in overall sales [6] - TG Therapeutics maintains a strong IBD Digital Composite Rating of 97, ranking in the top 3% of stocks for performance [8]