Financial Data and Key Metrics Changes - U.S. net product revenue for Q1 2025 was approximately $119.7 million, reflecting a 137% increase year-over-year and a 16% increase sequentially from Q4 2024 [14][23] - GAAP net income for the quarter was approximately $5 million, or $0.03 per diluted share [24] - The company closed the quarter with $276 million in cash, cash equivalents, and investment securities, indicating a strong financial position [24] Business Line Data and Key Metrics Changes - BRIONVI U.S. net sales reached nearly $120 million in Q1 2025, exceeding expectations and demonstrating strong adoption by healthcare providers [5][14] - The first three months of 2025 marked the highest total new patient enrollment since the product launch, indicating accelerating demand [15] - Repeat prescriptions have now surpassed new prescriptions for the first time, signaling strong persistence trends [17] Market Data and Key Metrics Changes - The company is capturing approximately 25% of the IV segment market share, with continued growth in patient enrollments [29] - The hospital setting contributed approximately 60% of enrollments in March, the highest percentage to date [16] Company Strategy and Development Direction - The company aims to make BRIONVI the number one prescribed anti-CD20 therapy by focusing on a multi-phase launch strategy and enhancing the patient experience [8][12] - Plans include launching a direct-to-patient television commercial campaign and preparing for lifecycle innovations, including a subcutaneous formulation [19][21] - The company is also exploring new indications for BRIONVI, such as myasthenia gravis, while advancing its CAR T cell therapy pipeline [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth and potential for BRIONVI, citing strong demand and increasing prescriber confidence [20][21] - The company is monitoring potential tariffs but does not anticipate a material impact on gross margins or overall financial performance [26] Other Important Information - The ENHANCE clinical trial is evaluating strategies to simplify the patient experience, with positive feedback on a streamlined infusion regimen [9][10] - The company is on track to launch pivotal trials for both the simplified starting dose and the subcutaneous formulation of BREONVY [52][68] Q&A Session Summary Question: Competitive dynamics with OCREVUS and new patient share - Management noted strong patient enrollments and market share gains, with no impact from OCREVUS observed [29][30] Question: Update on gross to net trends and gross margin - No material change in gross to net was reported, and the pre-launch inventory reserve has been fully depleted, leading to consistent margins going forward [37][38] Question: Subcutaneous BREONVY pivotal trial details - The pivotal trial is expected to include two dosing regimens, with data anticipated later this year [41][42] Question: Physician feedback on the thirty-minute infusion - Positive feedback was received, indicating convenience for infusion centers and patients [49] Question: Phase III trial scale and profitability outlook - The company is not focused on profitability this year but aims to drive cash through the business while meeting revenue targets [54][55] Question: Update on North Carolina manufacturing plant - The North Carolina facility will take several years to reach commercial scale manufacturing [57][58] Question: Product adherence and trends - Persistence trends remain strong and above expectations, with no material changes in switch rates from OCREVUS [63][71]

Financial Performance - BRIUMVI U.S. net product revenue for Q1 2025 was $119.7 million, representing approximately 137% growth year-over-year[5] - The company raised its full year 2025 global net revenue target to approximately $575 million, up from prior guidance of $540 million[8] - The U.S. net revenue target for BRIUMVI for the full year 2025 was raised to approximately $560 million, compared to the previous target of $525 million[8] - TG Therapeutics reported total revenue of $120.856 million for the three months ended March 31, 2025, a 90.5% increase from $63.474 million in the same period of 2024[41] - Product revenue, net for the same period was $119.655 million, compared to $50.488 million in the prior year, reflecting a significant growth of 137.4%[41] - The company achieved an operating profit of $8.622 million in Q1 2025, compared to an operating loss of $9.270 million in Q1 2024[41] - Net income for the first quarter of 2025 was $5.060 million, a turnaround from a net loss of $10.707 million in the same quarter of 2024[41] Expenses - Total research and development (R&D) expenses for Q1 2025 were $46.4 million, an increase from $32.7 million in Q1 2024[8] - Selling, general and administrative (SG&A) expenses for Q1 2025 were $50.3 million, compared to $34.6 million in Q1 2024[8] Cash and Assets - Cash, cash equivalents, and investment securities were $276.2 million as of March 31, 2025, expected to fund operations based on the current plan[8] - Cash, cash equivalents, and investment securities totaled $276.240 million as of March 31, 2025, down from $311.001 million at the end of 2024[42] - Total assets increased to $656.689 million as of March 31, 2025, compared to $577.690 million at the end of 2024[42] - Total equity rose to $237.288 million as of March 31, 2025, up from $222.364 million at the end of 2024[42] Product Development and Commercialization - BRIUMVI is now commercially available in additional countries in the European Union, United Kingdom, and Switzerland[5] - The company is advancing the development of subcutaneous BRIUMVI and azer-cel for progressive MS[2] - A pivotal program for subcutaneous BRIUMVI is set to commence, along with a program based on improved dosing regimens evaluated in the ENHANCE trial[8] - The company is focused on the commercialization of BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis, with approvals in the U.S., EU, UK, and Switzerland[32] Future Outlook - Future revenue expectations for BRIUMVI are contingent on healthcare professional and patient acceptance, as well as maintaining prescription trends[36] - TG Therapeutics anticipates achieving key development milestones for its pipeline products by 2025, including pivotal programs for subcutaneous ublituximab[37]

Financial Performance - TG Therapeutics reported U.S. net revenue of $119.7 million for BRIUMVI in the first quarter of 2025, representing approximately 137% growth compared to the same period last year [5][9] - The company raised its full-year 2025 global net revenue target to approximately $575 million, up from a prior guidance of $540 million, and increased the U.S. net revenue target for BRIUMVI to approximately $560 million from $525 million [1][10] - The net income for the first quarter of 2025 was $5.1 million, compared to a net loss of $10.7 million for the same period in 2024 [9][41] Product Development and Commercialization - BRIUMVI is experiencing growing adoption among healthcare providers, with positive feedback from both patients and clinicians, reinforcing the company's goal of making BRIUMVI the number one prescribed anti-CD20 treatment [2][5] - The company is investing in innovation, including simplifying the BRIUMVI treatment regimen and advancing subcutaneous BRIUMVI [2][5] - BRIUMVI is now commercially available in additional countries in the European Union, United Kingdom, and Switzerland, expanding its market presence [5][10] Clinical Trials and Research - Five-year data from the ULTIMATE I & II Phase 3 clinical trials showed that 92% of patients were free from disability progression after five years of treatment with BRIUMVI [5] - Ongoing clinical trials include a Phase 1 trial evaluating subcutaneous BRIUMVI and another for azer-cel in patients with primary progressive multiple sclerosis [6][10] - The ENHANCE Phase 3b clinical trial demonstrated that a single 600 mg BRIUMVI infusion was well tolerated, and rapid 30-minute infusions were also well received by patients [5][10] Financial Guidance and Future Outlook - The company anticipates a second quarter 2025 U.S. net product revenue target of $135 million and expects total operating expenses for the full year 2025 to be approximately $300 million [10][41] - TG Therapeutics plans to commence pivotal programs for subcutaneous BRIUMVI and based on improved dosing regimens evaluated in the ENHANCE trial [10][41] - The company aims to continue enrollment in ongoing clinical trials for BRIUMVI in autoimmune diseases outside of multiple sclerosis [10][41]

Conference call to be held Monday, May 5, 2025, at 8:30 AM ETNEW YORK, April 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held, Monday, May 5, 2025, at 8:30 AM ET to discuss results for the first 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.), 1-201-689-8029 ...

Core Insights - TG Therapeutics, Inc. (TGTX) shares have increased by 29.5% over the past three months, contrasting with an 11.2% decline in the industry [1] - The company's primary revenue source is from its marketed drug Briumvi, which has exceeded sales expectations in 2024 [1][2] Group 1: Briumvi Performance - Briumvi's net product sales reached $313.7 million in 2024, a significant increase from $92 million in 2023 [2] - The strong sales performance of Briumvi is a key factor driving the stock's increase [2] - TG Therapeutics anticipates worldwide revenues of approximately $540 million in 2025, with nearly $525 million expected from Briumvi sales in the U.S. [3] Group 2: Patent and Development Updates - The company has secured three additional patents for Briumvi, extending its patent protection until 2042, which will help safeguard against generic competition [3] - TG Therapeutics is developing a self-administered subcutaneous formulation of Briumvi, with a phase I study already initiated for patients with relapsing forms of multiple sclerosis [4] Group 3: Pipeline and Future Prospects - TG Therapeutics entered a licensing agreement with Precision BioSciences for the allogeneic CD19 CAR T therapy, azercabtagene zapreleucel, aimed at treating certain autoimmune disorders [7] - The FDA has cleared the investigational new drug application for azer-cel for progressive forms of multiple sclerosis, with participant enrollment in the phase I study expected to begin soon [7][8] - The combination of strong Briumvi adoption and positive pipeline developments is expected to continue driving TGTX stock performance in 2025 [8]

Company Overview - TG Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing treatments for B-cell diseases, including relapsing forms of multiple sclerosis (RMS) [24][25] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [24][25] Product Information - BRIUMVI is a novel monoclonal antibody targeting CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through a process called glycoengineering [5][6] - The drug has shown a favorable tolerability profile in real-world settings, with a lower rate of infusion-related reactions compared to Phase 3 trials [2][3] Clinical Data - The retrospective ENAMOR survey included data from approximately 400 individuals treated with BRIUMVI across 21 MS centers, indicating a favorable tolerability profile [2] - The ENABLE Phase 4 observational study will enroll approximately 500 patients across 100 MS centers in the U.S. to further evaluate the efficacy and tolerability of BRIUMVI [2] - In the ULTIMATE I & II Phase 3 trials, a total of 1,094 patients were enrolled across 10 countries, demonstrating the drug's effectiveness over a 96-week treatment period [4] Safety and Efficacy - After five years of BRIUMVI treatment, the frequency of serious infections remained consistent with Phase 3 trials, with no observed cases of Progressive Multifocal Leukoencephalopathy (PML) [2] - The overall rate of infections in BRIUMVI-treated patients was 56%, compared to 54% in those treated with teriflunomide, with serious infections occurring at a rate of 5% [9] Market Context - Relapsing multiple sclerosis is a chronic demyelinating disease affecting nearly 1 million people in the U.S., with approximately 85% initially diagnosed with relapsing-remitting multiple sclerosis [23] - The global prevalence of multiple sclerosis is over 2.3 million, indicating a significant market opportunity for effective treatments like BRIUMVI [23]

Core Insights - TG Therapeutics published two journal articles discussing the evolution of CD20 treatments for multiple sclerosis (MS) and the experiences of seven patients who switched to BRIUMVI® (ublituximab-xiiy) from other anti-CD20 therapies due to efficacy or tolerability concerns [1][2][5] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing and commercializing novel treatments for B-cell diseases, including BRIUMVI for relapsing forms of multiple sclerosis (RMS) [24][25] - BRIUMVI has received FDA approval for treating adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [24][6] Clinical Trials - The ULTIMATE I & II trials are randomized, double-blind, controlled studies assessing BRIUMVI in patients with RMS over 96 weeks, enrolling a total of 1,094 patients across 10 countries [3] - Patients in these trials were required to have experienced at least one relapse in the previous year or have specific MRI findings, with an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline [3] Treatment Insights - BRIUMVI is a monoclonal antibody targeting a unique epitope on CD20-expressing B-cells, designed to enhance B-cell depletion at lower doses through glycoengineering [4] - The retrospective case series published in Frontiers in Immunology highlights the clinical outcomes of seven MS patients who switched to ublituximab, emphasizing the importance of therapeutic efficacy and tolerability in treatment decisions [5] Market Context - The prevalence of MS is significant, with nearly 1 million people living with MS in the United States, and approximately 85% initially diagnosed with relapsing-remitting MS [23] - The global MS population exceeds 2.3 million, indicating a substantial market for effective treatments like BRIUMVI [23]

Group 1 - TG Therapeutics (TGTX) shares increased by 10.2% to close at $40.84, with a notable trading volume compared to normal sessions, and a total gain of 20.6% over the past four weeks [1][2] - The rise in share price is attributed to positive investor sentiment regarding Briumvi, the company's sole marketed product for multiple sclerosis, which saw sales surge over 200% year-over-year to $313 million [2] - The company is targeting $540 million in sales from Briumvi for the current year based on encouraging sales growth [2] Group 2 - TG Therapeutics is expected to report quarterly earnings of $0.19 per share, reflecting a year-over-year increase of 371.4%, with revenues projected at $117.83 million, up 85.6% from the previous year [3] - The consensus EPS estimate for the quarter has been revised 127.5% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - TG Therapeutics holds a Zacks Rank of 3 (Hold), while Cue Biopharma, another company in the same industry, has a Zacks Rank of 3 (Hold) as well [4][5]

TG Therapeutics ( TGTX ) announced 4Q 2024 earnings that came with a lot of positive commentary towards the future of Briumvi. Expectations were in range coming into the earnings as the company preannounced $103.6M for 4QAnalyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in TGTX over the next 72 hours. I wrote this ...

I wrote 19 articles on TG Therapeutics, Inc. (NASDAQ: TGTX ) in my Seeking Alpha career, and today happens to be the fifth anniversary since I first bought TGTX stock. I recommended it to our TPT members, and for a while, we did well. However, long-termAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated ...