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]

NEW YORK, May 31, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Presentations are now public and can be viewed using the below links. BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B- ...

NEW YORK, May 31, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Presentations are now public and can be viewed using the below links. Link to Poster Presentation: A Post-Marketing Study Evaluating the Presence and Concentrat ...

ABOUT THE ULTIMATE I & II PHASE 3 TRIALS ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator- controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or terifl ...

Financial Performance - The company reported a revenue of $X million for the quarter, representing a Y% increase compared to the previous quarter[18] - The gross margin for the quarter was reported at E%, reflecting improved operational efficiencies[18] - The company anticipates revenue growth of B% for the next quarter, driven by new product launches and market expansion efforts[10] User Metrics - User data showed an increase in active users to Z million, up A% year-over-year[18] Product Development and Regulatory Approvals - Ongoing clinical trials for product candidates TG-1701 and TG-1801 are expected to yield results by the end of the year, with potential market approval in C months[10] - The company has successfully maintained regulatory approval for BRIUMVI® (ublituximab) in the U.S., EU, and UK, which is crucial for its market strategy[10] - The company is focused on obtaining and maintaining regulatory approvals for its product candidates, including TG-1701, TG-1801, and azercabtagene zapreleucel (azer-cel), as well as maintaining approval for BRIUMVI® (ublituximab) for treating relapsing forms of multiple sclerosis (RMS) in the U.S., EU, and UK[10] Strategic Partnerships and Investments - A new partnership has been established to enhance the supply chain for product distribution, aiming to meet increasing market demand[10] - The company plans to invest D million in R&D for new technologies and product development in the upcoming fiscal year[10] - The company is exploring potential acquisitions to bolster its market position and expand its product portfolio[10] Market Challenges and Risks - The ongoing commercialization of BRIUMVI is critical, with expectations for market acceptance and pricing impacting revenue generation[10] - The company faces substantial competition in its target indications, which may affect its ability to successfully commercialize its products[14] - There is a risk of needing to raise substantial additional capital if revenue generation is insufficient to sustain operations[14] - The company has incurred significant operating losses since inception and may continue to do so in the future[17] - Concerns regarding immunosuppressive products, such as BRIUMVI, may impact their commercial potential due to perceived risks associated with COVID-19[17] - The company relies on third parties for clinical trials and supply of raw materials, which increases the risk of delays or impairments in development and commercialization efforts[17] - The company is subject to extensive regulation, which can be costly and time-consuming, potentially delaying the receipt of required approvals[14] Management and Personnel - The ability to attract and maintain key management and personnel is essential for continuing clinical development and commercialization activities[17] Stock Market Considerations - The stock price is expected to remain volatile, which could limit investors' ability to sell stock at a profit[17]

TG Therapeutics, Inc. (NASDAQ:TGTX) Q1 2024 Earnings Conference Call May 1, 2024 8:30 AM ET Company Participants Jenna Bosco - Senior Vice President of Corporate Communications Michael Weiss - President and Chief Executive Officer Adam Waldman - Chief Commercialization Officer Sean Power - Chief Financial Officer Conference Call Participants Michael DiFiore - Evercore ISI Edward White - H.C. Wainwright Roger Song - Jefferies Matthew Kaplan - Ladenburg Thalmann Mayank Mamtani - B. Riley Securities, Inc. Prak ...

Exhibit 99.1 TG Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results Conference call to be held today, May 1, 2024, at 8:30 AM ET First quarter 2024 BRIUMVI U.S. net revenue of $50.5 million, representing >25% quarter over quarter growth Total revenue for Q1 2024 of $63.5 million, including a $12.5 million milestone payment for BRIUMVI launch in first EU country New York, NY, (May 1, 2024) – TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announc ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023. 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 1-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (Stat ...