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]

Financial Data and Key Metrics Changes - For the full year 2024, U.S. revenues reached $310 million, exceeding target guidance and reflecting a 250% growth compared to 2023 [9][25] - 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] - Total global revenue for 2024 was approximately $329 million, including $310 million from U.S. BRIUMVI net product sales and $12.5 million milestone from a partner [36] Business Line Data and Key Metrics Changes - BRIUMVI's performance in the U.S. market showed significant growth, with strong demand leading to above-expectation revenues [25][29] - The company reported a gross margin impacted by lower margins on products sold to partners, but overall gross margin is expected to remain consistent [38] Market Data and Key Metrics Changes - BRIUMVI is gaining momentum internationally, with successful launches in Germany and other EU countries, receiving positive feedback [26] - The company is focusing on expanding its market share in the relapsing MS market, with a goal to reach more eligible patients [30] Company Strategy and Development Direction - The company plans to launch pivotal trials for a subcutaneous formulation of BRIUMVI and explore its use in other autoimmune diseases [19][20] - A partnership with Precision BioSciences was established to develop azer-cel for autoimmune diseases, indicating a strategic expansion into CAR-T therapies [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of BRIUMVI, supported by strong early performance in 2025 and a robust commercial infrastructure [30][32] - The company anticipates multiple drivers for growth in 2025, including deeper penetration in the RMS market and increased patient education efforts [30][31] Other Important Information - The company received three new patents for BRIUMVI, extending patent protection through 2042 [22] - The company ended the fourth quarter with approximately $311 million in cash, providing a strong financial position for future investments [40] Q&A Session Summary Question: Insights on growth and market segments - Management noted that growth is coming from a broad set of customers, particularly in academic hospitals, and January and February showed strong enrollment trends [48][49] Question: Subcutaneous trial design and expectations - The subcutaneous trial design is not finalized, but the target is to commence by mid-year, with expectations of a gross-to-net range of 70% to 75% [54][58] Question: Size and timing of the subcutaneous trial - The trial size is expected to be similar to Ocrevus' subcutaneous studies, with an enrollment period projected to be around 12 months [63] Question: Feedback on ENHANCE trial data - Feedback from the ACTRIMS conference indicated that many physicians are already comfortable switching patients to BRIUMVI without the introductory dose, although formal label changes are still pending [80][82] Question: Myasthenia gravis expansion opportunity - Management is exploring the potential for BRIUMVI in treating myasthenia gravis, noting that while the market is not underserved, there is room for effective and cost-efficient treatments [85][87]

Revenue Growth - BRIUMVI U.S. net product revenue reached $103.6 million in Q4 2024 and $310 million for the full year, representing approximately 250% year-over-year growth[5] - The company targets approximately $540 million in total global revenue for 2025, including an estimated $525 million from BRIUMVI U.S. net product revenue[5] - TG Therapeutics reported total revenue of $108.185 million for Q4 2024, a significant increase of 146.5% compared to $43.971 million in Q4 2023[38] - Product revenue for Q4 2024 reached $107.347 million, up 148.5% from $43.137 million in the same quarter last year[38] - For the full year 2024, total revenue was $329.004 million, representing a 40.6% increase from $233.662 million in 2023[38] Financial Performance - The company reported a net income of $23.3 million for Q4 2024, compared to a net loss of $14.4 million in Q4 2023[6] - The company achieved a net income of $23.330 million in Q4 2024, compared to a net loss of $14.416 million in Q4 2023[38] - Cash, cash equivalents, and investment securities totaled $311.0 million as of December 31, 2024[6] - Cash, cash equivalents, and investment securities increased to $311.001 million as of December 31, 2024, up from $217.508 million a year earlier[39] - Total assets rose to $577.690 million in 2024, compared to $329.587 million in 2023[39] - The company’s total equity increased to $222.364 million in 2024, up from $160.502 million in 2023[39] Expenses - Total research and development expenses for Q4 2024 were approximately $23.9 million, up from $17.4 million in Q4 2023[6] - Research and development expenses for Q4 2024 were $23.874 million, compared to $17.449 million in Q4 2023, reflecting a 36.5% increase[38] - Selling, general and administrative expenses for Q4 2024 were approximately $39.0 million, compared to $31.2 million in Q4 2023[6] - Selling, general and administrative expenses for Q4 2024 totaled $38.963 million, an increase of 25.2% from $31.152 million in Q4 2023[38] Product Development - The company obtained three additional patents for BRIUMVI, extending patent protection through 2042[5] - Five-year data from Phase 3 trials showed that 92% of patients were free from disability progression after five years of BRIUMVI treatment[5] - The company launched a Phase 1 trial for subcutaneous ublituximab in patients with relapsing forms of multiple sclerosis[5] - The company entered into a global license agreement with Precision BioSciences for the development of an allogeneic CD19 CAR T therapy program[5] - TG Therapeutics has received regulatory approvals for BRIUMVI® in the U.S., EU, and UK for treating relapsing forms of multiple sclerosis, indicating strong market potential[30]

Core Insights - TG Therapeutics reported significant growth in 2024, with BRIUMVI U.S. net revenue reaching $103.6 million in Q4 and $310 million for the full year, marking approximately 250% year-over-year growth [7][10] - The company anticipates total global revenue of approximately $540 million for 2025, including U.S. net product revenue of about $525 million [6][10] - The CEO highlighted strong adoption of BRIUMVI for relapsing forms of multiple sclerosis (RMS) and progress in patent protection and clinical trials [2][6] Financial Performance - For Q4 2024, total revenue was approximately $108.2 million, compared to $44.0 million in Q4 2023, while full-year revenue was $329.0 million, up from $233.7 million in 2023 [43] - The net income for Q4 2024 was $23.3 million, a significant improvement from a net loss of $14.4 million in Q4 2023 [43] - Cash, cash equivalents, and investment securities totaled $311.0 million as of December 31, 2024, up from $217.5 million a year earlier [45] Product Development and Pipeline - BRIUMVI has been launched in Europe and is now available in several additional countries [7] - The company has strengthened its patent portfolio for BRIUMVI, extending protection through 2042 [7] - Ongoing clinical trials include a Phase 1 trial for subcutaneous ublituximab and a pivotal program based on data from the ENHANCE trial [7][11] Market Position and Strategy - BRIUMVI is indicated for the treatment of adults with RMS in the U.S., EU, and UK, with a focus on enhancing patient experience and expanding market reach [14][15] - The company has entered into a global license agreement with Precision BioSciences for the development of CAR T therapy for autoimmune disorders [7] - TG Therapeutics aims to present updated data at major medical conferences throughout the year to bolster its market presence [11]

Core Insights - TG Therapeutics presented data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial for BRIUMVI at the ACTRIMS annual forum, highlighting its efficacy and safety in treating relapsing forms of multiple sclerosis (RMS) [1][2] 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. and Europe [27] Clinical Trial Details - The ULTIMATE I & II trials involved 1,094 patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks, with specific dosing regimens for both treatments [6] - The ENHANCE trial demonstrated a consistent safety profile for BRIUMVI, with over 80 patients receiving a 30-minute maintenance infusion [2][3] Presentation Highlights - An independent study presented by Dr. John Foley showed real-world data from over 160 patients treated with BRIUMVI, confirming its safety and tolerability [2][5] - Additional presentations included studies on disease activity trajectories and the design of a study evaluating Fc biology in multiple sclerosis [4][5] Product Information - BRIUMVI (ublituximab-xiiy) is a monoclonal antibody targeting CD20-expressing B-cells, designed for efficient B-cell depletion at low doses [8] - It is indicated for adults with RMS, including clinically isolated syndrome and active secondary progressive disease [9]

Core Points - TG Therapeutics, Inc. will hold a conference call on March 3, 2025, at 8:30 AM ET to discuss the fourth quarter and full year 2024 results and provide a business outlook for 2025 [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 been approved by the European Commission and the Medicines and Healthcare Products Regulatory Agency for similar indications in Europe and the UK [4]