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]

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 ...

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- ...

Core Insights - TG Therapeutics, Inc. announced upcoming presentations for post-marketing studies of BRIUMVI® (ublituximab-xiiy) at the 2024 Consortium of Multiple Sclerosis Centers annual meeting [1][2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for relapsing forms of multiple sclerosis (RMS) [25] - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through glycoengineering [4] Clinical Trials - The ULTIMATE I & II trials are Phase 3 studies involving 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3] - Patients in these trials had experienced at least one relapse in the previous year or had specific MRI findings, with an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline [3] Product Information - BRIUMVI is indicated for adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [5] - The drug is administered as an IV infusion, with specific dosing schedules outlined for both BRIUMVI and the comparator drug [3] Safety and Efficacy - Infusion reactions occurred in 48% of BRIUMVI-treated patients, with serious reactions in 0.6% [8] - The overall infection rate in BRIUMVI-treated patients was 56%, with serious infections at 5% [10] - No cases of Progressive Multifocal Leukoencephalopathy (PML) were reported in BRIUMVI-treated patients, although monitoring for symptoms is advised [13] Market Context - Relapsing multiple sclerosis affects nearly 1 million people in the U.S., with 85% initially diagnosed with relapsing-remitting forms [24] - The global prevalence of MS is over 2.3 million, indicating a significant market for effective treatments like BRIUMVI [24]

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 ...