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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) Misses Q2 Earnings Estimates
ZACKS· 2025-08-04 13:11
TG Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $141.15 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 3.75%. This compares to year-ago revenues of $73.47 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on manageme ...
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
TG Therapeutics (TGTX) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the s ...
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]