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TG Therapeutics (TGTX) Misses Q2 Earnings Estimates
ZACKS· 2025-08-04 13:11
分组1 - TG Therapeutics reported quarterly earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.32 per share, representing an earnings surprise of -46.88% [1] - The company posted revenues of $141.15 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 3.75%, compared to year-ago revenues of $73.47 million [2] - Over the last four quarters, TG Therapeutics has surpassed consensus revenue estimates four times, but has only exceeded consensus EPS estimates once [2] 分组2 - The stock has gained approximately 16.4% since the beginning of the year, outperforming the S&P 500's gain of 6.1% [3] - The current consensus EPS estimate for the coming quarter is $0.26 on revenues of $149.92 million, and $0.88 on revenues of $577.04 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is currently in the bottom 43% of over 250 Zacks industries, indicating potential challenges for stock performance [8]
TG Therapeutics(TGTX) - 2025 Q2 - Quarterly Results
2025-08-04 11:35
[Executive Summary & Recent Developments](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Developments) [Second Quarter 2025 Performance Highlights](index=1&type=section&id=Second%20Quarter%202025%20Performance%20Highlights) TG Therapeutics reported strong Q2 2025 financial results, with total revenue reaching $141.1 million and U.S. BRIUMVI net revenue growing 91% year-over-year, prompting an upward revision of 2025 full-year guidance | Metric | Q2 2025 | YoY Growth | QoQ Growth | | :----------------------- | :---------------- | :--------- | :------------------- | | Total Revenue | $141.1 Million | - | - | | BRIUMVI U.S. Net Revenue | $138.8 Million | 91% | 16% | - CEO Michael S. Weiss stated BRIUMVI is becoming a leading anti-CD20 therapy for adult RMS patients, with strong market acceptance, physician confidence, and patient experience supporting the revised full-year revenue guidance[2](index=2&type=chunk) [BRIUMVI Commercialization & Publications](index=1&type=section&id=BRIUMVI%20Commercialization%20%26%20Publications) BRIUMVI's commercialization expanded beyond the U.S. with approvals in Europe, UK, Switzerland, and Australia, alongside two medical journal publications highlighting its efficacy and differentiated characteristics in MS treatment - BRIUMVI has received approvals in the EU, UK, Switzerland, and Australia, expanding commercialization outside the U.S. through a partnership with Neuraxpharm[5](index=5&type=chunk) - Two medical journal articles were published: one on case series of switching from other anti-CD20 mAbs to Ublituximab, and another on the evolution of anti-CD20 MS therapies, emphasizing BRIUMVI's differentiated features[5](index=5&type=chunk) [Pipeline Development & Future Goals](index=1&type=section&id=Pipeline%20Development%20%26%20Future%20Goals) The company made significant pipeline progress, including initiating a Phase III pivotal trial for IV BRIUMVI Day 1 and Day 15 co-administration and a Phase I trial for azer-cel in autoimmune diseases, with future plans for a subcutaneous BRIUMVI Phase III trial - A randomized Phase III pivotal program evaluating Day 1 and Day 15 co-administration of IV BRIUMVI in the ENHANCE trial has been initiated[5](index=5&type=chunk) - The first progressive multiple sclerosis patient has been dosed in a Phase I clinical trial for azer-cel in autoimmune diseases[5](index=5&type=chunk) - Remaining 2025 pipeline development goals include initiating a Phase III pivotal program for subcutaneous BRIUMVI, continuing to advance the simplified dosing regimen in the ENHANCE trial, and continuing enrollment in clinical trials for BRIUMVI and azer-cel in Myasthenia Gravis (MG) and autoimmune diseases, including progressive MS[5](index=5&type=chunk) [Updated 2025 Financial Guidance](index=1&type=section&id=Updated%202025%20Financial%20Guidance) TG Therapeutics raised its full-year 2025 U.S. BRIUMVI net product revenue and global total revenue targets, reflecting confidence in BRIUMVI's sustained strong performance | Metric | New Guidance (FY 2025) | Original Guidance (FY 2025) | | :----------------------- | :-------------------- | :-------------------- | | BRIUMVI U.S. Net Product Revenue | $570 - $575 Million | $560 Million | | Global Total Revenue | Approx. $585 Million | Approx. $575 Million | [Detailed Financial Results](index=2&type=section&id=Detailed%20Financial%20Results) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) The company achieved significant revenue growth and improved profitability in Q2 2025, driven by substantial increases in BRIUMVI net product revenue, while R&D and SG&A expenses rose due to product development and commercialization | Metric (Millions USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :------- | :------- | :----------- | :----------- | | Net Product Revenue | 138.8 | 72.6 | 258.5 | 123.1 | | License, Milestone, Royalty & Other Revenue | 2.3 | 0.9 | 3.5 | 13.9 | | Research & Development Expenses | 31.8 | 17.6 | 78.1 | 50.3 | | Selling, General & Administrative Expenses | 55.6 | 38.8 | 105.9 | 73.4 | | Net Income (Loss) | 28.2 | 6.9 | 33.2 | (3.8) | - Increased R&D expenses are primarily attributed to manufacturing and development costs associated with the ublituximab subcutaneous formulation development[12](index=12&type=chunk) - Increased selling, general, and administrative expenses are mainly due to higher marketing, personnel, and external costs related to BRIUMVI commercialization[12](index=12&type=chunk) [Statements of Operations (Income Statement)](index=7&type=section&id=Statements%20of%20Operations%20%28Income%20Statement%29) Detailed statements of operations show substantial growth in product revenue and net income for Q2 and H1 2025, reversing prior-year losses and reflecting the positive impact of BRIUMVI commercialization | Metric (Thousands USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :------- | :------- | :----------- | :----------- | | Net Product Revenue | 138,843 | 72,596 | 258,498 | 123,084 | | Total Revenue | 141,148 | 73,466 | 262,004 | 136,939 | | Total R&D Expenses | 31,782 | 17,556 | 78,144 | 50,278 | | Total SG&A Expenses | 55,585 | 38,790 | 105,916 | 73,370 | | Operating Income (Loss) | 34,843 | 8,816 | 43,465 | (454) | | Net Income (Loss) | 28,187 | 6,879 | 33,247 | (3,828) | | Basic Net Income (Loss) Per Share | $0.19 | $0.05 | $0.23 | $(0.03) | | Diluted Net Income (Loss) Per Share | $0.17 | $0.04 | $0.20 | $(0.03) | [Condensed Balance Sheet](index=7&type=section&id=Condensed%20Balance%20Sheet) As of June 30, 2025, the company reported $278.9 million in cash, cash equivalents, and investment securities, with increases in total assets and total stockholders' equity compared to year-end 2024 | Metric (Thousands USD) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :----------------------- | :-------------------------- | :-------------------------- | | Cash, Cash Equivalents & Investment Securities | 278,860 | 311,001 | | Total Assets | 702,613 | 577,690 | | Total Stockholders' Equity | 276,432 | 222,364 | [Cash Position and Funding Outlook](index=2&type=section&id=Cash%20Position%20and%20Funding%20Outlook) As of June 30, 2025, the company held $278.9 million in cash, cash equivalents, and investment securities, anticipating that existing funds combined with projected BRIUMVI revenue will support current operations - As of June 30, 2025, cash, cash equivalents, and investment securities totaled **$278.9 million**[12](index=12&type=chunk) - The company anticipates that existing cash reserves, combined with projected BRIUMVI revenue, will be sufficient to fund operations according to current operating plans[12](index=12&type=chunk) [Product Information: BRIUMVI](index=2&type=section&id=Product%20Information%3A%20BRIUMVI) [About BRIUMVI](index=2&type=section&id=About%20BRIUMVI) BRIUMVI (ublituximab-xiiy) is a novel monoclonal antibody targeting CD20-expressing B-cells for relapsing multiple sclerosis (RMS), featuring glycoengineered design for efficient B-cell depletion at low doses, approved in the U.S., EU, and UK - BRIUMVI is a novel monoclonal antibody targeting CD20-expressing B-cells, designed with glycoengineering for efficient B-cell depletion at low doses[9](index=9&type=chunk) - BRIUMVI is approved in the U.S. for adult RMS patients, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; and in the EU and UK for adult RMS patients with active clinical or imaging features[10](index=10&type=chunk) [Important Safety Information](index=3&type=section&id=Important%20Safety%20Information) BRIUMVI carries important safety information, including contraindications, infusion reactions, infection risks, HBV reactivation, PML risk, vaccination considerations, fetal risk, and reduced immunoglobulin levels [Contraindications](index=3&type=section&id=Contraindications) BRIUMVI is contraindicated in patients with active Hepatitis B virus infection and those with a history of life-threatening infusion reactions to BRIUMVI - Contraindicated in patients with active Hepatitis B virus infection[22](index=22&type=chunk) - Contraindicated in patients with a history of life-threatening infusion reactions to BRIUMVI[22](index=22&type=chunk) [Warnings and Precautions](index=3&type=section&id=Warnings%20and%20Precautions) BRIUMVI requires vigilance for infusion reactions, infection risks (including serious bacterial and viral infections), HBV reactivation (requiring screening), PML risk (requiring monitoring), vaccination considerations, potential fetal harm, and reduced immunoglobulin levels - Infusion Reactions: Infusion reactions occurred in **48%** of BRIUMVI-treated patients in MS clinical trials, with **0.6%** being serious; pre-medication and post-infusion observation are required[13](index=13&type=chunk)[14](index=14&type=chunk) - Infections: The overall infection rate in BRIUMVI-treated patients was **56%**, with **5%** serious infections and **3** infection-related deaths; administration should be delayed in patients with active infections[15](index=15&type=chunk) - Hepatitis B Virus (HBV) Reactivation: HBV screening is required before treatment, and BRIUMVI is contraindicated in patients with active HBV infection; HBV carriers or HBcAb+ patients should consult a hepatologist[17](index=17&type=chunk) - Progressive Multifocal Leukoencephalopathy (PML): While not observed in BRIUMVI-treated MS patients, it has been reported in patients treated with other anti-CD20 antibodies; BRIUMVI should be withheld and diagnostic evaluation performed if PML is suspected[18](index=18&type=chunk)[19](index=19&type=chunk)[20](index=20&type=chunk)[21](index=21&type=chunk) - Vaccinations: Live or live-attenuated vaccines should be administered at least **4 weeks** before BRIUMVI treatment, and non-live vaccines at least **2 weeks**; live-virus vaccines are not recommended during treatment[23](index=23&type=chunk) - Fetal Risk: Animal studies indicate potential fetal harm; women of reproductive potential are advised to use effective contraception during treatment and for **6 months** after the last dose[25](index=25&type=chunk) - Reduced Immunoglobulins: Serum immunoglobulin levels should be monitored during treatment, especially in patients with opportunistic or recurrent infections[26](index=26&type=chunk) [Most Common Adverse Reactions](index=4&type=section&id=Most%20Common%20Adverse%20Reactions) In RMS clinical trials, the most common adverse reactions (incidence of at least 10%) for BRIUMVI were infusion reactions and upper respiratory tract infections - The most common adverse reactions (incidence of at least **10%**) are infusion reactions and upper respiratory tract infections[27](index=27&type=chunk) [BRIUMVI Patient Support Program](index=4&type=section&id=BRIUMVI%20Patient%20Support%20Program) The BRIUMVI Patient Support Program is a flexible initiative by TG Therapeutics designed for U.S. patients to provide comprehensive support throughout their treatment journey - The BRIUMVI Patient Support Program is a flexible program designed by TG Therapeutics for U.S. patients to support their treatment journey[29](index=29&type=chunk) [Corporate & Disease Context](index=4&type=section&id=Corporate%20%26%20Disease%20Context) [About Multiple Sclerosis](index=4&type=section&id=About%20Multiple%20Sclerosis) Relapsing Multiple Sclerosis (RMS) is a chronic demyelinating disease of the central nervous system, encompassing relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS), affecting approximately one million people in the U.S - Relapsing Multiple Sclerosis (RMS) is a chronic demyelinating disease of the central nervous system, including RRMS and SPMS[30](index=30&type=chunk) - Approximately **one million** people in the U.S. have MS, with about **85%** initially diagnosed with RRMS, most of whom eventually develop SPMS[30](index=30&type=chunk) [About TG Therapeutics](index=5&type=section&id=About%20TG%20Therapeutics) TG Therapeutics is a fully integrated, commercial-stage biopharmaceutical company focused on acquiring, developing, and commercializing novel treatments for B-cell diseases, with BRIUMVI approved for RMS in multiple regions - TG Therapeutics is a commercial-stage biopharmaceutical company focused on the acquisition, development, and commercialization of novel therapies for B-cell diseases[31](index=31&type=chunk) - BRIUMVI has received approvals from the U.S. FDA, European Commission, UK MHRA, Swissmedic, and Australian TGA for the treatment of adult patients with relapsing multiple sclerosis[31](index=31&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) [Cautionary Statement](index=5&type=section&id=Cautionary%20Statement) This press release contains forward-looking statements subject to risks and uncertainties, where actual results may differ materially from expectations due to factors like BRIUMVI commercialization, regulatory approvals, and macroeconomic conditions - Forward-looking statements involve risks and uncertainties, and actual events or results may differ materially from expectations[33](index=33&type=chunk)[34](index=34&type=chunk) - Risk factors include, but are not limited to: the continued ability to commercialize BRIUMVI, prescription trends, payer coverage, healthcare professional interest, sales momentum, achievement of revenue targets, regulatory approvals, reliance on third parties, differences between patient clinical experience and trial results, achievement of pipeline development milestones, and macroeconomic and political conditions[35](index=35&type=chunk)[36](index=36&type=chunk) - The company undertakes no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of publication[37](index=37&type=chunk) [Conference Call & Contact Information](index=2&type=section&id=Conference%20Call%20%26%20Contact%20Information) [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) TG Therapeutics held a conference call on August 4, 2025, to discuss Q2 2025 financial results, accessible to investors via phone or a live webcast on the company's website - The company held a conference call on August 4, 2025, at 8:30 AM ET, to discuss Q2 2025 financial results[7](index=7&type=chunk) - Participants can access the live audio webcast via a designated phone number or the "Events" page in the Investors & Media section of the company's website[8](index=8&type=chunk) [Contact Information](index=6&type=section&id=Contact%20Information) Investor Relations and Media Relations contact emails and phone numbers are provided - Investor Relations email: ir@tgtxinc.com, phone: 1.877.575.TGTX (8489), Option 4[38](index=38&type=chunk) - Media Relations email: media@tgtxinc.com, phone: 1.877.575.TGTX (8489), Option 6[38](index=38&type=chunk)
TG Therapeutics Reports Second Quarter 2025 Financial Results and Raises BRIUMVI Revenue Guidance
GlobeNewswire News Room· 2025-08-04 11:00
Core Insights - TG Therapeutics reported total revenue of $141.1 million for Q2 2025, with BRIUMVI U.S. net revenue at $138.8 million, reflecting a 91% increase year-over-year and a 16% increase from Q1 2025 [1][5][36] - The company raised its full-year 2025 BRIUMVI U.S. net revenue target to approximately $570 - $575 million, up from a previous guidance of $560 million [1][5] - TG Therapeutics is focused on the commercialization of BRIUMVI, which is gaining traction as a leading anti-CD20 therapy for relapsing multiple sclerosis (MS) [2][5] Financial Performance - BRIUMVI U.S. net product revenue for Q2 2025 was $138.8 million, marking a 91% growth compared to Q2 2024 and a 16% increase over Q1 2025 [5][36] - Total revenue for the first half of 2025 reached $262 million, compared to $136.9 million in the same period of 2024 [36] - The company reported a net income of $28.2 million for Q2 2025, compared to a net income of $6.9 million in Q2 2024 [11][36] Pipeline and Development - TG Therapeutics is advancing its pipeline with ongoing clinical trials, including a Phase 3 trial for a consolidated Day 1 and Day 15 dosing regimen for IV BRIUMVI [5][11] - The company has commenced patient enrollment for a Phase 1 clinical trial evaluating azer-cel for autoimmune diseases [5][11] - BRIUMVI has been approved for commercialization in the European Union, United Kingdom, Switzerland, and Australia, expanding its market reach [5][11] Market Position and Strategy - The company emphasizes the strong uptake of BRIUMVI, supported by physician confidence and positive patient experiences, which are critical to its launch strategy [2][5] - Innovations such as a subcutaneous formulation and combined dosing regimens are being studied to enhance BRIUMVI's market position [2][5] - TG Therapeutics aims to redefine treatment expectations for patients with MS through its strategic initiatives and product offerings [2][5]
TG Therapeutics to Host Conference Call on Second Quarter 2025 Financial Results and Business Update
Globenewswire· 2025-07-30 11:30
Core Viewpoint - TG Therapeutics, Inc. will hold a conference call on August 4, 2025, to discuss its second-quarter financial results and provide a business outlook for the remainder of 2025 [1]. 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 [4]. - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) [4]. - BRIUMVI has also been approved by the European Commission and the Medicines and Healthcare Products Regulatory Agency for treating adult patients with RMS who have active disease in Europe and the United Kingdom [4]. Conference Call Details - The conference call will be hosted by Michael S. Weiss, Chairman and CEO, and will take place at 8:30 AM ET [1]. - Participants can join the call by dialing specific numbers for U.S. and international callers, and a live webcast will be available on the company's website [2]. - An audio recording of the conference call will be accessible for replay for 30 days after the event [2][3].
TG Therapeutics (TGTX) Earnings Expected to Grow: What to Know Ahead of Q2 Release
ZACKS· 2025-07-29 15:10
Core Insights - TG Therapeutics (TGTX) is anticipated to report a year-over-year earnings increase driven by higher revenues, with a consensus EPS estimate of $0.32, reflecting a +700% change, and revenues expected at $136.04 million, up 85.2% from the previous year [1][3]. Earnings Expectations - The upcoming earnings report is crucial for stock movement; better-than-expected results could lead to a price increase, while a miss may result in a decline [2]. - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4]. Earnings Surprise Prediction - The Zacks Earnings ESP model shows a positive Earnings ESP of +22.22% for TG Therapeutics, suggesting analysts have become more optimistic about the company's earnings prospects [12]. - A positive Earnings ESP is a strong indicator of an earnings beat, especially when combined with a Zacks Rank of 1, 2, or 3 [10]. Historical Performance - In the last reported quarter, TG Therapeutics had an expected EPS of $0.18 but reported only $0.03, resulting in a surprise of -83.33% [13]. - Over the past four quarters, the company has beaten consensus EPS estimates twice [14]. Industry Context - In comparison, Castle Biosciences, Inc. (CSTL) is expected to report a loss of $0.51 per share, indicating a year-over-year change of -264.5%, with revenues projected at $73.89 million, down 15.1% [18][19]. - Castle Biosciences has a Zacks Rank of 4 (Sell) and an Earnings ESP of 0%, making it challenging to predict an earnings beat [20].
TG Therapeutics: Another Possible Avenue Of MS Growth With Azer-Cel
Seeking Alpha· 2025-06-25 20:05
Company Overview - TG Therapeutics, Inc. (NASDAQ: TGTX) is experiencing significant revenue growth driven by its FDA-approved drug BRIUMVI (ublituximab), which is used for treating patients with relapsing multiple sclerosis (RMS) [2]. Market Position - The company is part of the Biotech Analysis Central marketplace, which provides extensive resources for investors, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2].
TG Therapeutics(TGTX) - 2025 FY - Earnings Call Transcript
2025-06-10 15:40
Financial Data and Key Metrics Changes - The company has provided guidance of $560 million for the full year, indicating confidence in revenue growth driven by new patient starts and persistence of existing patients [8][10][11] - The management emphasized the importance of accurate guidance to avoid misguidance, indicating a focus on reliable financial forecasting [11][15] Business Line Data and Key Metrics Changes - Breumvy, the company's marketed drug, has shown consistent growth in new patient starts, although the growth rate is not linear and can fluctuate seasonally [20] - The persistence of patients on Breumvy is reportedly consistent with or slightly better than initial expectations based on published data from competitors [18] Market Data and Key Metrics Changes - The company has achieved near parity in formulary access compared to competitors, with most plans providing similar coverage for Breumvy and Ocrevus [21][25] - The cost share for CD20 therapies has increased from just below 50% at launch to approximately 50-55% today, indicating a growing acceptance of high-efficacy therapies [56] Company Strategy and Development Direction - The company plans to continue investing in marketing and enhancing the Breumvy experience, while also exploring potential expansions into other therapeutic areas such as myasthenia gravis [134][135] - The management is focused on maintaining and expanding their market share in the CD20 therapy space, aiming to be the number one in dynamic share for CD20s [142] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of Breumvy, citing a steady increase in prescriptions and clinician engagement [67] - The company is also exploring new product opportunities that align with its strengths in multiple sclerosis and other neurological conditions [137][141] Other Important Information - The company has doubled its field force to enhance market penetration and has expanded its marketing efforts significantly after starting with a minimal budget [31][36] - The management is actively pursuing a buyback program to utilize cash flow effectively while continuing to invest in growth initiatives [135] Q&A Session Summary Question: How does the company view its guidance for the year? - The company is confident in its guidance of $560 million, driven primarily by new patient starts and persistence [8][10] Question: What are the key components driving patient growth? - The two main components are new patient starts and the persistence of existing patients, with management focusing on these metrics for future growth [10][11] Question: How does Breumvy compare to competitors in terms of formulary access? - The company has achieved near parity in coverage with competitors, with some plans preferring Breumvy over others [21][25] Question: What marketing strategies are being implemented? - The company has expanded its marketing budget and efforts significantly, focusing on online presence and testimonials to attract new patients [36][38] Question: What is the current state of the subcutaneous market? - The subcutaneous market is growing, and the company plans to enter this space with a product profile that competes with existing options [106][130] Question: What are the company's future product development plans? - The company is exploring enhancements to Breumvy and potential expansions into other therapeutic areas, while also considering new product opportunities [134][137]
TG Therapeutics to Participate in the Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-06-06 11:30
Core Viewpoint - TG Therapeutics, Inc. will participate in the Goldman Sachs 46th Annual Global Healthcare Conference, highlighting its ongoing engagement with investors and the healthcare community [1]. Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on developing and commercializing 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 (RMS) [3]. - BRIUMVI has also been approved by the European Commission and the Medicines and Healthcare Products Regulatory Agency for treating adult patients with RMS in Europe and the United Kingdom [3]. Event Details - The fireside chat with Michael S. Weiss is scheduled for June 10, 2025, at 10:40 am ET during the conference held in Miami, FL [1]. - A live webcast of the fireside chat will be available on the company's website [2].
TG Therapeutics (TGTX) 2025 Conference Transcript
2025-06-04 17:50
Summary of TG Therapeutics Conference Call Company Overview - **Company**: TG Therapeutics (TGTX) - **Event**: 2025 Jefferies Global Healthcare Conference - **Focus**: CD20 MS (Multiple Sclerosis) treatment pipeline Key Points on CD20 MS Market - **Market Dynamics**: The CD20 market is the leading treatment for MS patients, with a dynamic market share of approximately 50-55% for new starts, indicating growth from previous levels around 50% [5][20] - **Shift in Treatment**: Younger MS clinicians are more inclined to use CD20 therapies, which is expected to increase patient adoption [5][6] - **IV vs. Subcutaneous (SubQ)**: - IV remains the leading mode of delivery, but SubQ is growing, currently accounting for about 35-40% of new starts [7][15] - SubQ products are gaining traction due to convenience and cost-effectiveness compared to IV infusions at academic centers [8][9] - **Future Expectations**: The overall CD20 market is expected to continue growing, with no significant threats to its position in the near term [21][24] TG Therapeutics' Positioning - **Market Share Goals**: TG Therapeutics aims to become the number one player in the CD20 market, currently positioned at number three [27][28] - **Competitive Advantages**: - TG's product is priced as the lowest branded treatment for MS, which is a key driver for market share growth [29] - The company emphasizes having a strong team with an average of 12 years of experience in MS [30] - **Marketing Strategy**: The marketing approach focuses on targeting impactful clinicians and expanding outreach [40][41] Product Development and Innovations - **Enhanced Regimen**: TG is working on a combined dosing regimen to improve patient convenience, aiming for a pivotal trial to start soon [53][54] - **SubQ Development**: Plans for a SubQ product are underway, with potential for every other month dosing, which would be less frequent than the current monopoly product [62][66] - **Timeline for SubQ**: Expected to start pivotal studies soon, with potential filing by mid-2027 and approval by mid-2028 [66][70] Financial Outlook - **Revenue Growth**: TG anticipates revenue growth from $310 million last year to approximately $560 million this year, while keeping operational expenses relatively stable [72][73] - **Focus on Top-Line Growth**: The company is prioritizing revenue growth over immediate profitability, with no current focus on bottom-line metrics [78][79] Additional Insights - **Patient Awareness**: Awareness of TG's product, Brionvi, is currently around 30%, compared to over 70% for competitors, indicating room for improvement [43][44] - **DTC Marketing**: The company has initiated direct-to-consumer marketing efforts to enhance product awareness [45][46] - **Long-Term Strategy**: TG is open to exploring new opportunities and indications beyond MS, which may impact future operational expenses [76][77]
TG Therapeutics to Participate in the Jefferies Global Healthcare Conference
Globenewswire· 2025-06-02 12:00
Core Insights - TG Therapeutics, Inc. will participate in the Jefferies Global Healthcare Conference from June 3-5, 2025, with a fireside chat scheduled for June 4, 2025, at 12:50 PM ET [1] Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on developing and commercializing 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 (RMS) [3] - BRIUMVI has also been approved by the European Commission and the Medicines and Healthcare Products Regulatory Agency for treating adult patients with RMS who have active disease [3]