From GlobeNewswire: 2025-03-03 07:00:00

TG Therapeutics, Inc. reported 2024 BRIUMVI U.S. net revenue of $103.6 million for the fourth quarter and $310 million for the full year. Aiming for $540 million in total global revenue for 2025. Conference call scheduled for March 3, 2025, at 8:30 AM ET. Highlights include strong BRIUMVI adoption and patent portfolio expansion through 2042.

BRIUMVI commercialization saw significant growth with $103.6 million in U.S. net product revenue for Q4 and $310 million for the full year of 2024. Obtained additional patents extending protection through 2042 and launched in Europe with partner Neuraxpharm. Five-year data showed 92% of patients free from disability progression and positive safety profile.

Pipeline developments include launching a Phase 1 trial for subcutaneous ublituximab in MS patients and enrolling Myasthenia Gravis patients in a Phase 1 trial. Signed a license agreement with Precision BioSciences for allogeneic CD19 CAR T therapy program and launched a Phase 1 trial in primary progressive multiple sclerosis. Targeting $540 million in total global revenue for 2025, including BRIUMVI U.S. revenue. TG Therapeutics reported a net product revenue of around $525 million for 2024 and plans to have operating expenses of approximately $300 million for 2025. The company will be focusing on pivotal trials for subcutaneous ublituximab and enhancing patient experience with BRIUMVI. Financially, the company saw an increase in product revenue, net income, and cash position.

In the fourth quarter of 2024, TG Therapeutics had a net product revenue of approximately $107.3 million and $313.7 million for the full year. R&D expenses were about $23.9 million for the quarter and $94.3 million for the year, while SG&A expenses totaled $39.0 million for the quarter and $154.3 million for the year. The company reported a net income of $23.3 million for the quarter and $23.4 million for the year.

TG Therapeutics anticipates that its cash position of $311.0 million as of December 31, 2024, combined with revenue from BRIUMVI, will be enough to fund its business based on the current operating plan. The company will be hosting a conference call on March 3, 2025, to discuss its financial results from the fourth quarter and full year ended December 31, 2024. Investors can participate by calling 1-877-407-8029 or listening to the live webcast on the company’s website.

BRIUMVI is a novel monoclonal antibody designed to target CD20-expressing B-cells, an important therapeutic approach for autoimmune disorders like RMS. The antibody is glycoengineered to efficiently deplete B-cells at low doses. BRIUMVI is indicated for use in the U.S. This news comes as TG Therapeutics plans to focus on pivotal trials and enhancing patient experience with their products throughout 2025. BRIUMVI is approved in the US, EU, and UK for treating adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. A list of authorized specialty distributors is available on the official website. Safety information includes contraindications for patients with active Hepatitis B infection and history of life-threatening infusion reactions.

Infusion reactions, including serious ones requiring hospitalization, can occur with BRIUMVI. Patients must be monitored during and after infusions for at least one hour. Serious infections, including some fatal cases, have been reported in BRIUMVI-treated patients. Delay treatment in those with active infections. Consider the risk of Hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy (PML) with BRIUMVI therapy. Lower PML-related mortality and morbidity reported in asymptomatic patients with discontinuation of another MS medication. Treatment with BRIUMVI should be stopped if PML is confirmed. Vaccinations should be administered according to guidelines, with live vaccines given at least 4 weeks before BRIUMVI. Infants born to mothers on BRIUMVI need B-cell count assessments before live vaccines. BRIUMVI may cause fetal harm, so pregnancy tests are recommended. Immunoglobulin levels may decrease with BRIUMVI treatment, monitor levels closely. Most common adverse reactions are infusion reactions and upper respiratory tract infections. For more information, visit www.briumvi.com. Multiple sclerosis is a chronic disease of the CNS affecting millions worldwide, with RRMS being the most common form. TG Therapeutics focuses on developing treatments for B-cell diseases, including BRIUMVI approved for RMS treatment in the US, EU, and UK.



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