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TG Therapeutics(TGTX) - 2025 Q2 - Quarterly Report
2025-08-08 20:38
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpo ...
TGTX Down as Q2 Earnings Miss Mark, Briumvi Sales Drive Top Line
ZACKS· 2025-08-05 17:15
Core Insights - TG Therapeutics (TGTX) reported Q2 2025 earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.32, compared to $0.04 per share in the same quarter last year [1][6] - Revenues for Q2 reached $141.1 million, a nearly 92% increase year over year, driven by strong demand for Briumvi, surpassing the Zacks Consensus Estimate of $136 million [1][6] Revenue and Sales Performance - Briumvi's net product sales in the U.S. were $138.8 million in Q2, reflecting a 91% year-over-year increase and a 16% sequential increase [4][6] - License, milestone, royalty, and other revenues amounted to $2.3 million in the reported quarter, up from $0.9 million in the year-ago quarter [4] Financial Guidance - TG Therapeutics raised its 2025 revenue guidance to approximately $585 million, up from the previous expectation of $575 million, with Briumvi net product sales projected between $570 million and $575 million in the U.S. [9] - Operating expenses for 2025 are expected to remain around $300 million, unchanged from previous guidance [10] Research and Development - Ongoing studies for Briumvi are targeting other autoimmune diseases, with plans to begin patient enrollment for a phase III pivotal program for subcutaneous Briumvi in RMS later in 2025 [11] - The company is also developing azer-cel, an allogeneic CD19-directed CAR T cell therapy, currently in a phase I study for primary progressive multiple sclerosis [12] Market Reaction - Shares of TG Therapeutics fell 18% on August 4, likely due to the mixed earnings announcement [2] - The stock has declined 4.6% year to date, contrasting with a 0.2% increase in the industry [3]
TG Therapeutics(TGTX) - 2025 Q2 - Earnings Call Transcript
2025-08-04 13:32
Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $141.1 million, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and a 16% growth over Q1 2025 [21][22] - GAAP net income for the quarter was $28.2 million, or $0.17 per diluted share, compared to $6.9 million, or $0.04 per diluted share, for Q2 2024 [23] Business Line Data and Key Metrics Changes - The flagship product, BREONVY, generated net sales of approximately $139 million in Q2 2025, exceeding internal expectations and building on robust growth from Q1 [14] - The adoption rate of BREONVY is estimated at nearly one in every three new IV anti-CD20 patients, indicating significant market penetration [7] Market Data and Key Metrics Changes - The CD20 class generates over $8 billion in annual U.S. MS sales, with BREONVY steadily increasing its market share within this expanding market [15] - The company is focused on expanding its addressable market by developing a subcutaneous formulation of BREONVY, which could unlock access to 35% to 40% of the anti-CD20 market segment that prefers self-administered options [8] Company Strategy and Development Direction - The company aims to position BREONVY as the most prescribed anti-CD20 therapy for relapsing MS, with ongoing efforts to enhance patient experience and expand treatment options [6][11] - A national television campaign has been launched to increase patient awareness, with early signs indicating a positive impact on brand recognition [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth for BREONVY, raising full-year U.S. revenue guidance to $560 million to $575 million for 2025 [19] - The company anticipates stronger growth from Q3 to Q4, accounting for seasonal trends and increased patient enrollments [27] Other Important Information - The company reported total operating expenses of approximately $71 million for Q2 2025, an increase from $46.9 million in 2024, driven by R&D investments [22][23] - The company closed the quarter with approximately $279 million in cash and equivalents, maintaining a strong capital position for future investments [24] Q&A Session Summary Question: Guidance and Growth Expectations - Management acknowledged seasonality in summer and expects stronger growth from Q3 to Q4, which is reflected in the raised guidance [26][27] Question: Market Dynamics and Competitors - The company captures about one-third of the IV segment, with competitors sharing the remaining market [31] - There are no current signs of demand for subcutaneous options outpacing IV, but the company is actively developing its own subcutaneous formulation [32] Question: Subcutaneous Product Development - The subcutaneous product will initially be tested with a syringe from a vial, followed by a bridging study to an auto-injector [36] Question: Revenue Guidance and Market Trends - Management noted that the overall IV market is stable, with limited enthusiasm for competitor products [43][44] Question: Product Adherence and Q3 Guidance - The company did not provide specific Q3 guidance but indicated strong persistence rates for BREONVY [54][55]
TG Therapeutics(TGTX) - 2025 Q2 - Earnings Call Transcript
2025-08-04 13:30
Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $141.1 million, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and a 16% growth over Q1 2025 [21][22] - GAAP net income for the quarter was $28.2 million, or $0.17 per diluted share, compared to $6.9 million, or $0.04 per diluted share, for Q2 2024 [23] Business Line Data and Key Metrics Changes - U.S. net sales for BREONVY in Q2 totaled approximately $139 million, exceeding internal expectations and building on robust growth from Q1 [14] - The adoption of BREONVY continues to grow, with nearly one in every three new IV anti-CD20 patients being prescribed BREONVY [6][15] Market Data and Key Metrics Changes - The CD20 class generates over $8 billion in annual U.S. MS sales and continues to grow, with BREONVY steadily increasing its market share [15] - The company estimates that approximately 35% to 40% of the anti-CD20 dynamic market segment currently prefers a self-administered option [7] Company Strategy and Development Direction - The company is focused on expanding choice and flexibility for patients through the development of subcutaneous BREONVY, which is expected to significantly expand the addressable market [7][8] - The strategic plan includes initiating patient enrollment into a pivotal Phase III trial for subcutaneous BREONVY in the coming weeks, with a BLA filing anticipated in 2027 and a potential launch in 2028 [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of BREONVY revenues, raising full-year U.S. net revenue guidance to $560 million to $575 million for 2025 [19] - The management highlighted strong execution across commercial and clinical fronts, with a growing confidence in BREONVY from both physicians and patients [11] Other Important Information - The company reported total operating expenses of approximately $71 million for Q2 2025, an increase from $46.9 million in 2024, driven by ongoing investments in R&D [22][23] - The company closed the quarter with approximately $279 million in cash and cash equivalents, maintaining a strong capital position for future investments [24] Q&A Session Summary Question: Guidance and Growth Expectations - The management acknowledged seasonality in summer and expects stronger growth from Q3 to Q4, which is reflected in the raised guidance [26][27] Question: Market Share and Competitors - The company captures about one-third of the IV segment, with the remaining market share divided among competitors [31] Question: Subcutaneous Product Development - The subcutaneous product will start with injections from a vial, followed by a bridging study to an auto-injector, with a target filing in 2027 and approval in 2028 [36][37] Question: Revenue Guidance and Market Trends - The management noted that they are not seeing significant impact from competitors and that the overall market for IV therapies is stable [42][43] Question: Product Adherence and Q3 Guidance - The company did not provide specific Q3 guidance but indicated strong persistence rates for patients on BREONVY [53][56] Question: Subcutaneous Dosing and Volume - Preliminary bioavailability information suggests that both every other month and quarterly dosing are achievable for the subcutaneous product [60]
TG Therapeutics(TGTX) - 2025 Q2 - Quarterly Results
2025-08-04 11:35
Exhibit 99.1 TG Therapeutics Reports Second Quarter 2025 Financial Results and Raises BRIUMVI Revenue Guidance Second quarter 2025 total revenue of $141.1 million, including BRIUMVI U.S. net revenue of $138.8 million Raises full year 2025 BRIUMVI U.S. net revenue target to approximately $570 - $575 million Conference call to be held today, Monday, August 4, 2025, at 8:30 AM ET New York, NY, (August 4, 2025) – TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial ...
TG Therapeutics to Host Conference Call on Second Quarter 2025 Financial Results and Business Update
Globenewswire· 2025-07-30 11:30
Conference Call to be Held Monday, August 4, 2025, at 8:30 am ETNEW YORK, July 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held, Monday, August 4, 2025, at 8:30 AM ET to discuss results for the second quarter of 2025 and provide a business outlook for the remainder of 2025. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-68 ...
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]