Core Insights - TG Therapeutics reported adjusted earnings of $2.43 per share and $161.7 million in sales for Q3, significantly exceeding analyst expectations of $0.22 earnings per share and $152.1 million in sales [1][2] - The earnings beat was primarily attributed to a one-time tax benefit of $365 million, which, if excluded, would have resulted in earnings closer to $0.15 per share [2] - The company raised its full-year sales guidance to $600 million, with $585 million expected from U.S. sales of its multiple sclerosis drug Briumvi [3] Financial Performance - Q3 adjusted earnings: $2.43 per share [1] - Q3 sales: $161.7 million [1] - Analyst expectations: $0.22 earnings per share and $152.1 million in sales [2] - Previous year Q3 earnings: $0.02 per share and $83.9 million in sales [2] - Revised full-year sales guidance: $600 million [3] Market Reaction - TG Therapeutics stock increased by 4.4% to $36.30 in premarket trading [3] - Shares are trading slightly above their 50-day moving average [3] Ratings and Upgrades - TG Therapeutics received an upgrade in its IBD SmartSelect Composite Rating from 94 to 97 [4][7] - The company is now part of an elite list of stocks with a composite rating above 95 [7]

Core Insights - TG Therapeutics, Inc. (TGTX) reported its Q3 earnings and business updates, with the stock experiencing a decline of approximately 4% in trading on the announcement day [1]. Financial Performance - The article highlights the financials of TG Therapeutics, indicating a focus on the company's earnings and business updates for Q3 [1]. Industry Context - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare sectors, suggesting that understanding key trends and catalysts is crucial for investors [1].

Core Insights - TG Therapeutics, Inc. (TGTX) reported its Q3 earnings and business updates, with the stock experiencing a decline of approximately 4% in trading on the announcement day [1]. Financial Performance - The article highlights the financials of TG Therapeutics, indicating a focus on the company's earnings and business updates for Q3 [1]. Industry Context - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare sectors, suggesting that understanding key trends and catalysts is crucial for investors [1].

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $161.7 million, a 93% increase compared to Q3 2024 and a 15% increase over Q2 2025 [18] - Product revenue totaled $159.3 million, primarily driven by $152.9 million in US BRIUMVI net sales [18] - GAAP net income for Q3 2025 was $390.9 million, or $2.43 per diluted share, compared to $3.9 million, or $0.02 per diluted share, in the same period last year [20] Business Line Data and Key Metrics Changes - BRIUMVI's US net sales in Q3 totaled approximately $153 million, showing strong sequential and year-over-year growth [11] - The company reported that persistence and repeat prescribing of BRIUMVI exceeded expectations, reinforcing confidence in its clinical profile [11] Market Data and Key Metrics Changes - The anti-CD20 class now represents nearly $10 billion in annual US MS sales, with approximately half of all patients still on other types of disease-modifying therapies, indicating significant market opportunity [12] - The subcutaneous portion of the market is estimated to be about 35% to 40% and is expected to grow, potentially doubling the market opportunity for BRIUMVI [34] Company Strategy and Development Direction - The company is focused on continuing to innovate and improve outcomes for patients with MS, with two pivotal studies launched for BRIUMVI [5] - The strategic expansion of the commercial field organization has been emphasized to align with market opportunities and drive growth [14] - The company remains financially disciplined, completing a $100 million share repurchase program and authorizing another $100 million program [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in BRIUMVI's long-term potential, raising the full-year 2025 US BRIUMVI net revenue guidance from $570 million-$575 million to approximately $585 million [16] - The management highlighted the importance of patient retention and the impact of direct-to-consumer efforts on demand growth [25][50] Other Important Information - The company completed enrollment for the ENHANCE study and is on track to finish enrollment for the phase three subcutaneous BRIUMVI study in the first half of next year [6][7] - The third quarter marked the first full quarter of the national television campaign, which is expected to drive awareness and engagement [15] Q&A Session Summary Question: Guidance and Growth Expectations - A question was raised regarding the slight slowing of sequential growth expected in Q4 compared to previous years, with management noting that patient retention and field expansion are key factors supporting growth [24][25] Question: Demand from Permanent J Code - Inquiry about additional demand from the permanent J code was addressed, clarifying that the company has had a J code for several years [28][29] Question: Market Opportunity for Subcutaneous Products - A question was posed about the factors underpinning the estimate that subcutaneous products could double the market opportunity for BRIUMVI, with management explaining the current market dynamics and potential growth [34] Question: Inventory Channel Dynamics - Inquiry about inventory channel dynamics and gross to net changes revealed no notable changes in Q3, with the gross to net remaining within the provided range [38][40] Question: 2026 Trends and Deal Pursuits - Questions regarding 2026 trends highlighted the importance of new patient growth and the company's cautious approach to potential deals, emphasizing a high standard for ROI [49][51][52]

Financial Performance - Total revenue for Q3 2025 was $161.7 million, with BRIUMVI U.S. net revenue at $152.9 million, representing 84% growth year-over-year[5] - The company raised its full-year 2025 global revenue target to approximately $600 million, up from a prior guidance of $585 million[6] - BRIUMVI U.S. net product revenue for the full year 2025 is now targeted at approximately $585 million, an increase from the previous guidance of $570 - $575 million[4] - Product revenue for Q3 2025 reached $159.3 million, a 91.2% increase from $83.3 million in Q3 2024[44] - Total revenue for the nine months ended September 30, 2025, was $423.7 million, compared to $220.8 million for the same period in 2024, reflecting a 92.0% growth[44] - Operating income for Q3 2025 was $29.4 million, up from $12.4 million in Q3 2024, representing a 136.5% increase[44] - Net income for Q3 2025 was $390.9 million, significantly higher than $3.9 million in Q3 2024, driven by a non-recurring income tax benefit of approximately $365.0 million[13] - Basic net income per share for Q3 2025 was $2.69, compared to $0.03 in Q3 2024, marking a significant improvement[44] Expenses - Research and development expenses for Q3 2025 were approximately $40.9 million, compared to $20.1 million in Q3 2024, reflecting increased costs in clinical trials and development[13] - Selling, general and administrative expenses for Q3 2025 were approximately $63.4 million, up from $42.0 million in Q3 2024, primarily due to increased marketing and personnel costs[13] - The company reported a total cost of revenue of $28.1 million for Q3 2025, compared to $9.3 million in Q3 2024, reflecting increased operational costs[44] - Research and development expenses for the nine months ended September 30, 2025, were $119.0 million, up from $70.4 million in the same period of 2024, indicating a focus on innovation[44] Shareholder Actions - The company completed a $100 million share repurchase program, purchasing approximately 3.5 million shares at an average price of $28.55 per share, and authorized an additional $100 million program[2] Market and Product Development - BRIUMVI is now approved in multiple international markets, including the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates[5] - The company commenced patient enrollment into the Phase 3 pivotal program for subcutaneous ublituximab and completed enrollment for the ENHANCE trial[5] - The company presented three data presentations at the 2025 ECTRIMS annual meeting, showcasing positive outcomes from ongoing clinical trials[5] Assets and Equity - Cash, cash equivalents, and investment securities totaled $178.3 million as of September 30, 2025, down from $311.0 million at the end of 2024[44] - Total assets increased to $1.025 billion as of September 30, 2025, compared to $577.7 million at the end of 2024[44] - Total equity rose to $607.2 million as of September 30, 2025, up from $222.4 million at the end of 2024[44]

Group 1 - The article does not provide any specific information or insights regarding a company or industry [1]

Core Insights - TG Therapeutics reported a total revenue of $161.7 million for Q3 2025, with BRIUMVI U.S. net revenue at $152.9 million, reflecting strong growth and prompting an increase in full-year revenue guidance to $600 million globally and approximately $585 million for BRIUMVI in the U.S. [1][9] Financial Performance - BRIUMVI U.S. net product revenue for Q3 2025 was $152.9 million, representing an 84% increase compared to Q3 2024 and a 10% increase from Q2 2025 [5][9] - Total product revenue, net for Q3 2025 was $159.3 million, compared to $83.3 million in Q3 2024, indicating significant growth [9][41] - The company achieved a net income of $390.9 million for Q3 2025, a substantial increase from $3.9 million in Q3 2024, largely due to a non-recurring income tax benefit [9][41] Strategic Developments - The company successfully completed a $100 million share repurchase program and authorized an additional $100 million program, reflecting confidence in long-term business potential [2][9] - TG Therapeutics is advancing its pipeline with two Phase 3 programs, focusing on subcutaneous ublituximab and a simplified BRIUMVI IV dosing schedule [2][5] Market Expansion - BRIUMVI has been approved for commercialization outside the U.S. in several regions, including the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates [5][9] - The company presented new data at the 2025 ECTRIMS annual meeting, showcasing the efficacy and safety profile of BRIUMVI in treating relapsing multiple sclerosis [5][9] Research and Development - Total R&D expenses for Q3 2025 were approximately $40.9 million, up from $20.1 million in Q3 2024, driven by increased manufacturing and clinical trial costs [9][41] - The company is focused on expanding patient awareness and advancing enrollment in ongoing clinical trials to drive growth [2][5]

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].