Company Overview - TG Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing treatments for B-cell diseases, including relapsing forms of multiple sclerosis (RMS) [24][25] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [24][25] Product Information - BRIUMVI is a novel monoclonal antibody targeting CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through a process called glycoengineering [5][6] - The drug has shown a favorable tolerability profile in real-world settings, with a lower rate of infusion-related reactions compared to Phase 3 trials [2][3] Clinical Data - The retrospective ENAMOR survey included data from approximately 400 individuals treated with BRIUMVI across 21 MS centers, indicating a favorable tolerability profile [2] - The ENABLE Phase 4 observational study will enroll approximately 500 patients across 100 MS centers in the U.S. to further evaluate the efficacy and tolerability of BRIUMVI [2] - In the ULTIMATE I & II Phase 3 trials, a total of 1,094 patients were enrolled across 10 countries, demonstrating the drug's effectiveness over a 96-week treatment period [4] Safety and Efficacy - After five years of BRIUMVI treatment, the frequency of serious infections remained consistent with Phase 3 trials, with no observed cases of Progressive Multifocal Leukoencephalopathy (PML) [2] - The overall rate of infections in BRIUMVI-treated patients was 56%, compared to 54% in those treated with teriflunomide, with serious infections occurring at a rate of 5% [9] Market Context - Relapsing multiple sclerosis is a chronic demyelinating disease affecting nearly 1 million people in the U.S., with approximately 85% initially diagnosed with relapsing-remitting multiple sclerosis [23] - The global prevalence of multiple sclerosis is over 2.3 million, indicating a significant market opportunity for effective treatments like BRIUMVI [23]

Core Insights - TG Therapeutics published two journal articles discussing the evolution of CD20 treatments for multiple sclerosis (MS) and the experiences of seven patients who switched to BRIUMVI® (ublituximab-xiiy) from other anti-CD20 therapies due to efficacy or tolerability concerns [1][2][5] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing and commercializing novel treatments for B-cell diseases, including BRIUMVI for relapsing forms of multiple sclerosis (RMS) [24][25] - BRIUMVI has received FDA approval for treating adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [24][6] Clinical Trials - The ULTIMATE I & II trials are randomized, double-blind, controlled studies assessing BRIUMVI in patients with RMS over 96 weeks, enrolling a total of 1,094 patients across 10 countries [3] - Patients in these trials were required to have experienced at least one relapse in the previous year or have specific MRI findings, with an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline [3] Treatment Insights - BRIUMVI is a monoclonal antibody targeting a unique epitope on CD20-expressing B-cells, designed to enhance B-cell depletion at lower doses through glycoengineering [4] - The retrospective case series published in Frontiers in Immunology highlights the clinical outcomes of seven MS patients who switched to ublituximab, emphasizing the importance of therapeutic efficacy and tolerability in treatment decisions [5] Market Context - The prevalence of MS is significant, with nearly 1 million people living with MS in the United States, and approximately 85% initially diagnosed with relapsing-remitting MS [23] - The global MS population exceeds 2.3 million, indicating a substantial market for effective treatments like BRIUMVI [23]

Group 1 - TG Therapeutics (TGTX) shares increased by 10.2% to close at $40.84, with a notable trading volume compared to normal sessions, and a total gain of 20.6% over the past four weeks [1][2] - The rise in share price is attributed to positive investor sentiment regarding Briumvi, the company's sole marketed product for multiple sclerosis, which saw sales surge over 200% year-over-year to $313 million [2] - The company is targeting $540 million in sales from Briumvi for the current year based on encouraging sales growth [2] Group 2 - TG Therapeutics is expected to report quarterly earnings of $0.19 per share, reflecting a year-over-year increase of 371.4%, with revenues projected at $117.83 million, up 85.6% from the previous year [3] - The consensus EPS estimate for the quarter has been revised 127.5% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - TG Therapeutics holds a Zacks Rank of 3 (Hold), while Cue Biopharma, another company in the same industry, has a Zacks Rank of 3 (Hold) as well [4][5]

TG Therapeutics ( TGTX ) announced 4Q 2024 earnings that came with a lot of positive commentary towards the future of Briumvi. Expectations were in range coming into the earnings as the company preannounced $103.6M for 4QAnalyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in TGTX over the next 72 hours. I wrote this ...

Group 1 - The article discusses the author's long-term investment experience with TG Therapeutics, Inc. (NASDAQ: TGTX), marking the fifth anniversary since the initial purchase of TGTX stock [1] - The Total Pharma Tracker (TPT) service offers tools for DIY investors, including a software that provides extensive curated research material for any ticker [1] - TPT also provides hands-on support from in-house experts who identify the best investable stocks along with buy/sell strategies and alerts [2] Group 2 - The TPT service includes a free trial for potential investors to access tools and evaluate the service without any cost [2]

Core Viewpoint - TG Therapeutics reported strong Q4 and full-year 2024 results, leading to a significant increase in stock price, with a nearly 27% rise week to date following the announcement [1][2]. Financial Performance - The company generated approximately $108.2 million in revenue for Q4 2024, more than double the nearly $44 million from the same period in 2023 [3]. - TG Therapeutics achieved a GAAP net income of $23.3 million ($0.15 per share), a turnaround from a net loss of $14.4 million in the previous year [3]. - Both revenue and earnings per share exceeded analyst expectations, with consensus estimates being less than $98 million for revenue and $0.07 for earnings per share [4]. Product Performance - The strong financial results were primarily driven by robust sales of Briumvi, the company's commercialized drug for multiple sclerosis, which benefited from its launch in Europe in partnership with Neuraxpharm [4]. Future Outlook - The company provided optimistic guidance, projecting total revenue of approximately $540 million for 2024, with around $525 million expected from Briumvi sales in the U.S. [5]. - Operating expenses are anticipated to be around $300 million [5]. - Despite its current pipeline being in early stages, TG Therapeutics shows promise for future growth, particularly with Briumvi's potential in international markets [6].

Core Insights - TG Therapeutics, Inc. announced the presentation schedule for BRIUMVI (ublituximab-xiiy) data at the American Academy of Neurology 2025 annual meeting, focusing on its efficacy in treating relapsing forms of multiple sclerosis (RMS) [1] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS treatment in the U.S., Europe, and the UK [24] - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through glycoengineering [5] Clinical Trials - The ULTIMATE I & II trials are Phase 3 studies involving 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3][4] - The upcoming presentations will include various studies on BRIUMVI's long-term effects, infusion tolerability, and real-world efficacy [2] Presentation Details - Presentations will cover topics such as the association between serum immunoglobulin levels and serious infections, infusion tolerability, and results from the ULTIMATE studies [2][3] - Key presentations are scheduled for April 7 and April 9, 2025, at the AAN meeting [3]

Financial Performance - Company generated net income recently but has incurred significant operating losses since inception, indicating potential future losses[17] - Company’s financial performance and cash burn management are critical for sustaining operations[17] - Company is subject to various risks including regulatory changes, competition, and market acceptance that could adversely affect financial performance[14] Regulatory Approval and Commercialization - Company anticipates maintaining regulatory approval for BRIUMVI® (ublituximab) for the treatment of relapsing forms of multiple sclerosis (RMS) in the U.S., EU, and UK[13] - Company is focused on obtaining regulatory approvals for product candidates, including BRIUMVI® (ublituximab) for relapsing forms of multiple sclerosis, with ongoing efforts to adapt commercial infrastructure[13] - Company is focused on expanding its commercial infrastructure to market and sell BRIUMVI and other product candidates[13] - Company anticipates ongoing commercialization efforts for BRIUMVI, with expectations for market acceptance and pricing strategies[13] Capital and Funding - Company may need to raise additional capital in the future, which could delay or limit drug development programs[17] - Company’s ability to maintain and establish collaborations is essential for funding and commercializing drug products[20] - Company is dependent on collaborations and partnerships for further development and commercialization of its drug products[20] Competition and Market Risks - Company faces substantial competition that may impact its ability to commercialize drugs successfully[17] - Company faces substantial competition which may impact the commercialization of its drugs, potentially reducing revenue opportunities[17] - Company’s stock price is expected to remain volatile, affecting investors' ability to sell shares profitably[20] - Company’s stock price is expected to remain volatile, which may affect investors' ability to sell shares profitably[20] Operational Risks - Company relies on third parties for clinical trials and manufacturing, increasing risks related to product supply and quality[20] - Company has identified a material weakness in internal control over financial reporting, which has been remediated[20]

Group 1 - TG Therapeutics, Inc. (NASDAQ: TGTX) stock is experiencing a significant surge, indicating strong market interest and potential growth [1] - The company has transitioned from a developmental stage to generating substantial revenue, showcasing its progress and market viability [1] Group 2 - The article highlights the investment strategy of BAD BEAT, which focuses on blended trading and income approaches to enhance returns [2] - There is an invitation for potential investors to try the service with a money-back guarantee, emphasizing confidence in the investment ideas provided [2]

Financial Data and Key Metrics Changes - TG Therapeutics reported full year 2024 U.S. revenues of $310 million, exceeding guidance and reflecting a 250% growth compared to 2023 [9][25] - The 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] - The company achieved a GAAP net income of approximately $23 million, or $0.15 per diluted share, for both the three and twelve-month periods ending December 31, 2024 [40] Business Line Data and Key Metrics Changes - BRIUMVI's total net product revenue for the fourth quarter was $107.3 million, including approximately $3.7 million from products sold to Neuraxpharm for the ex-U.S. launch [36] - The company reported total global revenue of approximately $329 million for the full year, predominantly from U.S. BRIUMVI net product sales [36] Market Data and Key Metrics Changes - BRIUMVI is gaining momentum internationally, with successful launches in Germany and other EU countries by Neuraxpharm [26] - The company is seeing strong adoption among high-volume infusion centers and academic neurologists, contributing to its market share growth [29] Company Strategy and Development Direction - The company plans to develop and commercialize a subcutaneous formulation of BRIUMVI, which could significantly expand market opportunities [19][33] - TG Therapeutics has entered a partnership with Precision BioSciences to develop azer-cel for autoimmune diseases, indicating a strategic expansion beyond MS [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of BRIUMVI, with expectations to meet or exceed full year U.S. guidance of $525 million for 2025 [31] - The management highlighted the importance of ongoing clinical trials and the potential for new treatment options in the autoimmune disease market [21][33] Other Important Information - The company received three new patents for BRIUMVI, providing patent protection through 2042 [22] - Management noted that the gross-to-net ratio is expected to be in the 70% to 75% range, with fluctuations quarter-to-quarter [57] Q&A Session Summary Question: What are the biggest segments of growth for 2025? - Management indicated that growth is coming from a broad set of customers, particularly in academic hospitals, and that January and February were the best months for new enrollments [48][49] Question: What are the expectations for the subcutaneous trial design? - The subcutaneous trial design has not been finalized, but the target is to commence by mid-year [58] Question: How are you thinking about the size of the subcutaneous trial? - The trial size is expected to be similar to Ocrevus' subcutaneous studies, likely around 150 to 200 patients per arm, with a projected enrollment period of about 12 months [63] Question: What is the feedback on the ENHANCE trial data? - Feedback has been positive, with many physicians already switching patients to BRIUMVI without the introductory dose, indicating comfort with the safety profile [80] Question: How is the company approaching the myasthenia gravis opportunity? - Management believes there is potential for BRIUMVI in myasthenia gravis, but further exploration is needed before committing to a development program [86]