Infusion related reactions in patients receiving 30-minute BRIUMVI infusions were all mild (Grade 1) and resolved completely Data also demonstrate patients switching from prior anti-CD20 treatment can successfully eliminate initial BRIUMVI infusion NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today presented updated data from the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Europe ...

During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated data presentations including new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BR ...

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of upcoming data presentations, highlighting data from both the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 18 – 20, 2024, in Copenhagen, Denmark. Abstrac ...

E i i 1 E i # [ I i ■ l r l = ri i - r l = = t F l l 1 i i i = iQoncept TG Therapeutics (NASDAQ:TGTX) beat Q2 Street consensus estimates and my $67-69 million estimate range by reporting Briumvi net sales of $72.6 million and total revenues of $73.5 million. The company also achieved positive cash flow one quarter ahead of my expectations, the full-year guidance range was raised by $15 million at the mid-point, and the company secured a new $250 million credit facility to retire the existing facility with H ...

TG Therapeutics (TGTX) came out with quarterly earnings of $0.04 per share, beating the Zacks Consensus Estimate of a loss of $0.04 per share. This compares to loss of $0.34 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 200%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.03 per share when it actually produced a loss of $0.07, delivering a surprise of -133.33%. Over the last four ...

Revenue Growth - Second quarter 2024 U.S. BRIUMVI net revenue reached $72.6 million, representing over 350% growth compared to the second quarter of 2023[3] - Full year 2024 U.S. BRIUMVI net revenue guidance raised to approximately $290 - $300 million, up from the previous guidance of $270 - $290 million[5] - Total product revenue for the six months ended June 30, 2024, was approximately $123.1 million, compared to $23.8 million for the same period in 2023[5] - Total revenue for Q2 2024 reached $73.466 million, a significant increase from $16.074 million in Q2 2023, representing a growth of 357%[25] - Product revenue for Q2 2024 was $72.596 million, compared to $16.036 million in the same quarter last year, marking an increase of 353%[25] Patient Prescriptions - Approximately 5,850 new patient prescriptions for BRIUMVI received since launch, with over 1,400 prescriptions in the second quarter of 2024[3] Financial Performance - Net income for the second quarter 2024 was $6.9 million, a significant improvement from a net loss of $(47.6) million in the same quarter of 2023[5] - The company reported a net income of $6.879 million for Q2 2024, a turnaround from a net loss of $47.610 million in Q2 2023[25] - Operating income for Q2 2024 was $8.816 million, compared to an operating loss of $44.674 million in the same quarter last year[25] - Total costs and expenses for Q2 2024 were $64.650 million, slightly higher than $60.748 million in Q2 2023[25] Research and Development - R&D expenses for the second quarter 2024 were approximately $17.6 million, a decrease from $28.1 million in the same quarter of 2023[5] - Initiated a phase 1 clinical trial for subcutaneous ublituximab in RMS patients, with first patients now treated[3] - Received FDA IND clearance for azer-cel, an allogeneic CD19 CAR-T therapy, for patients with progressive MS[3] Financial Position - Established a $250 million credit facility to repay $107 million in existing debt and fund a share repurchase program of up to $100 million[4] - Cash, cash equivalents, and investment securities stood at $217.252 million as of June 30, 2024, compared to $217.508 million at the end of 2023[25] - Total assets increased to $401.207 million as of June 30, 2024, up from $329.587 million at the end of 2023[25] Product Development and Commercialization - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for treating adult patients with relapsing forms of multiple sclerosis[21] - TG Therapeutics anticipates ongoing commercialization and availability of BRIUMVI in the U.S. and Europe, with expectations for future revenue growth[22] - The company is focused on developing its pipeline products, including subcutaneous BRIUMVI and trials for other autoimmune diseases[22]

Core Viewpoint - TG Therapeutics, Inc. will hold a conference call on August 6, 2024, to discuss its second quarter financial results and provide a business outlook for 2024 [1][2][3] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing and commercializing treatments for B-cell diseases, with a research pipeline of investigational medicines [4] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for treating adult patients with relapsing forms of multiple sclerosis, and it has also received approvals from the European Commission and the Medicines and Healthcare Products Regulatory Agency for the same treatment in Europe and the UK [4]

NEW YORK, Aug. 05, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held, Tuesday August 6, 2024 at 8:30 AM ET to discuss results for the second quarter of 2024 and provide a business outlook for 2024. 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 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter Earnin ...

Core Viewpoint - TG Therapeutics has faced challenges following the launch of Briumvi, with initial expectations not aligning with actual performance, leading to a more conservative approach in guidance and management tone [3][18][19] Company Guidance and Performance - In early November 2023, the company provided Q4 2023 net sales guidance of $33-37 million, ultimately delivering $39.9 million [3] - For Q1 2024, guidance was set at $41-46 million, with actual net sales reaching $50.5 million, indicating strong performance [3] - The company increased its Q2 2024 guidance to $65 million and raised the full-year net sales guidance to $270-290 million, reflecting positive sales trends [3][18] Market Dynamics - The U.S. anti-CD20 market is experiencing significant growth, with a year-over-year increase of 19% in Q2 2024, leading to an annualized net sales run rate approaching $8 billion [13][22] - Ocrevus and Kesimpta, key competitors, have shown strong performance, with Ocrevus growing 9% year-over-year to $1.89 billion and Kesimpta achieving 63% growth to $799 million [4][11] Patient Metrics - New patient starts for Briumvi are estimated to be between 1,400 to 1,500 in Q2 2024, which would indicate a market share approaching 15% in the anti-CD20 class [25] - Approximately 10% to 20% of patients are being prescribed Briumvi outside of the company's patient hub, which could further enhance market penetration [7] Financial Outlook - The company is expected to reach cash flow breakeven as soon as Q3 2024 and non-GAAP profitability by Q4 2024, with GAAP profitability anticipated by Q1 2025 [17][18] - There is potential for share buybacks and pipeline expansion through in-licensing deals, contingent on stock performance and financial health [17][18]

Company Overview - TG Therapeutics, Inc. is a fully integrated, commercial stage biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases [3] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for the treatment of 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] Upcoming Events - Michael S. Weiss, the Chairman and CEO of TG Therapeutics, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference from June 10-13, 2024 [2] - The fireside chat is scheduled for June 11, 2024, at 1:20 PM ET [2] - A live webcast of the fireside chat will be available on the company's website [4]