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]

Financial Performance - The company reported a significant operating loss since inception, indicating potential future losses if current trends continue[13] - The company has incurred significant operating losses, raising concerns about its financial sustainability[13] - The company has incurred substantial operating losses and may need to raise additional capital to fund its drug development programs[17] Regulatory and Market Challenges - The commercialization of BRIUMVI is ongoing, with expectations for market acceptance and pricing still uncertain[12] - Regulatory approvals for BRIUMVI and other product candidates remain a critical focus, with potential delays affecting commercialization[12] - Future regulatory developments could impose additional costs and affect the company's ability to market its products[13] - The company acknowledges that unfavorable pricing regulations and reimbursement policies could adversely affect its business[17] Competition and Market Opportunities - The company has faced substantial competition, which could limit its market opportunities for BRIUMVI and other products[13] - The company faces substantial competition in the pharmaceutical industry, which could limit its commercial opportunities[17] Supply Chain and Development Risks - The company relies on third parties for clinical trials and manufacturing, which poses risks to timely product availability[22] - The company relies on third parties for clinical trials and manufacturing, increasing risks related to product supply and regulatory approval[22] - The company anticipates challenges in maintaining a reliable supply of products to meet market demand, which could impact commercialization efforts[12] Intellectual Property and Personnel - The company is subject to various risks related to intellectual property, including potential challenges to patent validity and enforcement[22] - The company emphasizes the importance of attracting and retaining key personnel for successful product development and commercialization[22] Market Volatility - The company is subject to market volatility, which may impact stock price and investor confidence[21] - The incidence and prevalence of target patient populations for BRIUMVI have not been precisely established, potentially affecting revenue projections[13]

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market strategies, including daily updates, research reports, and stock screens [1] - The Zacks Style Scores are designed to help investors select stocks with the highest potential to outperform the market within a 30-day timeframe [2] Zacks Style Scores Overview - The Style Scores categorize stocks into four main types: Value Score, Growth Score, Momentum Score, and VGM Score, each focusing on different investment strategies [3][4][5][6] - Value Score identifies undervalued stocks using financial ratios [3] - Growth Score assesses a company's future earnings and financial health [4] - Momentum Score capitalizes on existing price trends and earnings outlooks [5] - VGM Score combines all three styles to highlight stocks with the best overall potential [6] Zacks Rank and Performance - The Zacks Rank is a proprietary model that uses earnings estimate revisions to identify stocks, with 1 (Strong Buy) stocks historically yielding an average annual return of +23.93% since 1988, significantly outperforming the S&P 500 [7][8] - Investors are encouraged to focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal returns [10] Stock Highlight: TG Therapeutics (TGTX) - TG Therapeutics is focused on developing therapies for B-cell diseases and currently holds a Zacks Rank of 3 (Hold) with a VGM Score of B [12] - The company is projected to experience substantial growth, with an expected year-over-year earnings growth of 893.3% for the current fiscal year [12] - Recent analyst revisions have increased the earnings estimate for fiscal 2025, with the Zacks Consensus Estimate rising to $1.49 per share [13] - TGTX has demonstrated a strong average earnings surprise of +217.5%, making it a noteworthy consideration for growth investors [13]

Core Insights - TG Therapeutics (TGTX) reported earnings of $2.43 per share for Q3 2025, significantly exceeding the Zacks Consensus Estimate of 24 cents and up from 2 cents per share in the same quarter last year [1][7] - Revenues for Q3 totaled $161.7 million, representing a year-over-year increase of 92.8%, driven by strong demand for Briumvi, the company's sole marketed drug [2][7] - The company raised its 2025 revenue guidance to approximately $600 million, up from the previous estimate of $585 million, reflecting continued growth in Briumvi sales [11] Financial Performance - Total product revenues in Q3 were $159.3 million, an increase of 91.2% year over year, including $6.4 million from sales to licensing partner Neuraxpharm in ex-U.S. markets [4][8] - Briumvi's net product sales in the U.S. reached $152.9 million in Q3, up 84% year over year and 10% sequentially [8] - Research and development expenses surged 107.7% year over year to $35.5 million, attributed to higher manufacturing costs and ongoing clinical studies [9] - Selling, general, and administrative expenses rose 53.6% year over year to $51 million, driven by increased commercialization costs for Briumvi [10] Market Position - Shares of TG Therapeutics have increased 12% year to date, closely matching the industry's rise of 12.1% [3] - The company has ongoing studies for Briumvi targeting other autoimmune diseases and has commenced patient enrollment in a pivotal phase III program for a subcutaneous formulation [13] Future Outlook - For full-year 2025, net product sales of Briumvi are expected to be around $585 million in the U.S., an increase from the earlier projection of $570-$575 million [11] - Operating expenses for 2025 are anticipated to be around $300-$320 million [12]