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]

Core Insights - TG Therapeutics, Inc. announced the presentation schedule for data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial for BRIUMVI in patients with relapsing forms of multiple sclerosis (RMS) at the ACTRIMS annual forum from February 27 to March 1, 2025 [1][2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI being 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 enhance B-cell depletion through glycoengineering [5][6] Clinical Trials - The ULTIMATE I & II trials are randomized, double-blind studies involving 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3] - The ENHANCE trial focuses on the safety and tolerability of 30-minute BRIUMVI infusions and evaluates Fc biology and genetic diversity in MS [2][3] Presentation Details - Presentations will include topics such as real-world experiences with BRIUMVI and disease activity trajectories in the ULTIMATE trials [2][4] - Specific presentation dates and authors have been outlined for the ACTRIMS forum [4]

Core Viewpoint - TG Therapeutics (TGTX) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates in determining near-term stock price movements, making it a valuable tool for investors [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling activity that affects stock prices [4]. Company Performance and Outlook - The upgrade for TG Therapeutics indicates a positive outlook for its earnings, suggesting potential buying pressure and an increase in stock price [3][5]. - For the fiscal year ending December 2024, TG Therapeutics is expected to earn $0.09 per share, with a 24.6% increase in the Zacks Consensus Estimate over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - TG Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Group 1 - TG Therapeutics, Inc. (NASDAQ: TGTX) presented at the JP Morgan Healthcare Conference, where CEO Michael Weiss discussed the company's accomplishments in 2024 and provided updates on its progress [2] - The company is part of the Growth Stock Forum, which features a model portfolio of 15-20 stocks, a top picks list of up to 10 stocks expected to perform well, and trading ideas targeting short-term and medium-term moves [2] Group 2 - The article reflects the author's opinion and does not constitute a buy or sell recommendation or investment advice [3][4]

TG Therapeutics (NASDAQ: TGTX ) is a biotech company focused on Briumvi, a treatment for Multiple Sclerosis. I will not go into great detail on the unique mechanisms of this drug, as this is not myLike millions of other investors, I got Robinhood and started trading during the pandemic. Unlike most of those investors, I carefully studied hundreds of earnings reports for clues to future performance, and I was able to identify many future winners, such as OPRX, OTRK, FUBO, and PLUG. My style of investing is i ...

TG Therapeutics (TGTX) announced preliminary net product revenues for the fourth quarter and full-year 2024 for its marketed drug, Briumvi (ublituximab-xiiy), which exceeded the company’s initial expectations.TGTX also provided its guidance for 2025 and outlined some expected milestones related to Briumvi label expansion studies and other pipeline candidates for 2025.Briumvi is approved for the treatment of certain adult patients with relapsing forms of multiple sclerosis (RMS).In the past year, shares of T ...