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]

Financial Data and Key Metrics Changes - For Q1 2024, total revenue was approximately $63.5 million, which includes $50.5 million from U.S. Briumvi net product revenue and about $13 million from license milestones and other revenue [20][21][37] - The company reported a modest net loss of approximately $10.7 million or $0.07 per share, compared to a net loss of approximately $39.2 million or $0.28 per share during the same quarter in 2023 [43] Business Line Data and Key Metrics Changes - Briumvi's U.S. revenue exceeded $50 million in Q1 2024, representing a 25% growth quarter-over-quarter [8][37] - The company achieved over 1,250 new patient scripts in the quarter, with a 25% increase in enrollments [16][37] - The full-year revenue guidance for Briumvi was raised to $270 million to $290 million, up from the previous guidance of $220 million to $260 million [40] Market Data and Key Metrics Changes - The company noted that it was the only CD20 therapy in the MS market to see revenue growth quarter-over-quarter during Q1 2024 [16] - The company successfully added 65 new accounts in the quarter, with prescriptions coming from over 450 centers and over 800 unique prescribers [39] Company Strategy and Development Direction - The company aims to become the number one prescribed anti-CD20 therapy, focusing on expanding Briumvi's market share and exploring additional indications beyond MS [9][12] - The company is preparing to enter human bioequivalence studies for subcutaneous Briumvi, which is seen as a significant opportunity [11] - A partnership with Precision BioSciences was established to acquire a worldwide license for azer-cel, an allogeneic CD19 CAR T cell therapy for autoimmune diseases [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for Briumvi and the positive feedback from healthcare providers and patients [9][19] - The company is targeting approximately $65 million in net revenue for Briumvi in Q2 2024, indicating continued momentum [18] - Management acknowledged the challenges in the first quarter related to payer dynamics but emphasized the successful mitigation of these challenges [16] Other Important Information - The company received three newly issued patents extending Briumvi's patent protection through 2042, which supports its long-term development strategy [10] - The company ended Q1 2024 with $209.8 million in cash and equivalents, providing sufficient capital to fund operations until cash flow positivity [21] Q&A Session Summary Question: What is the impact of the VA contract on revenue guidance? - The VA contract was not factored into the revenue guidance raise as it will gradually increase starting in June, with a 72% discount offered [30][69] Question: How is the repeat infusion rate characterized? - The 24-week persistence rate is in line with expectations at about 85% [55] Question: What is the assessment of the subcutaneous opportunity for Briumvi? - The subcutaneous opportunity is seen as significant, with the potential for a competitive product profile [61] Question: How does the company prioritize potential indications outside of MS? - The focus is on larger indications like RA and lupus, while also considering niche indications for azer-cel [51] Question: What is the current status of the subcutaneous formulation? - The company expects to dose the first patients for subcutaneous Briumvi within the first half of the year [112]

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 ...