TG Therapeutics Inc TGTX on Monday reported first-quarter earnings per share of 3 cents, a shift from a loss of 7 cents a year ago, but below the consensus of 17 cents.The company reported sales of $120.86 million, up from $63.47 million a year ago, beating the consensus of $118.43 million.Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “2025 is off to a strong start, and I’m incredibly proud of the progress made thus far. Our performance in the first quarter, including BRIUMVI ...

A near-doubling of revenue and a flip into profitability on the bottom line apparently weren't good enough for TG Therapeutics (TGTX -11.39%) shareholders on Monday.The company, best known for its multiple sclerosis (MS) drug Briumvi, posted its first-quarter results that morning, and investors expressed their displeasure by trading out of the stock aggressively. In midafternoon action its price was down by more than 14%, comparing most unfavorably to the 0.2% dip of the S&P 500 index at that point.Sales bo ...

If you like what you have just read and want to receive at least 4 exclusive stock tips every week focused on Pharma, Biotech and Healthcare, then join me at my marketplace channel, Haggerston BioHealth . Invest alongside the model portfolio or simply access the investment bank-grade financial models and research. I hope to see you there.TG Therapeutics, Inc. (NASDAQ: TGTX ), the Morrisville, North Carolina-based commercial stage Pharma company that markets and sells Briumvi (ublituximab), approved in the U ...

TG Therapeutics (TGTX) came out with quarterly earnings of $0.03 per share, missing the Zacks Consensus Estimate of $0.18 per share. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -83.33%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.08 per share when it actually produced earnings of $0.15, delivering a surprise of 87.50%.Over the last four quarter ...

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]

First quarter 2025 BRIUMVI U.S. net revenue of $119.7 million Raises full year 2025 global net revenue target to approximately $575 million and raises full year BRIUMVI U.S. net revenue target to approximately $560 million Conference call to be held today, Monday, May 5, 2025, at 8:30 AM ET NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the first quarter of 2025, along with recent company developmen ...

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]

NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting. Links to each presentation are included below. Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, "We were pleased to share three presentations yesterday which we believe demonstrate our continued ...