TG Therapeutics Updates Business and Reports Q1 2024 Financials

TG Therapeutics, Inc. (NASDAQ: TGTX) has announced its financial results for the first quarter of 2024, highlighting significant growth and recent developments. The company reported BRIUMVI U.S. net revenue of $50.5 million, marking an impressive growth of over 25% quarter over quarter. Total revenue for the quarter reached $63.5 million, bolstered by a $12.5 million milestone payment for launching BRIUMVI in its first European country.

The company's Chairman and CEO, Michael S. Weiss, expressed satisfaction with the strong sales performance, which surpassed their guidance. Weiss anticipates continued momentum throughout 2024 and has updated the annual guidance for BRIUMVI U.S. net revenue to $270-$290 million. Furthermore, the company is focusing on its clinical goals, including improving the dosing convenience of IV BRIUMVI, developing a subcutaneous version, exploring additional indications beyond multiple sclerosis (MS), and progressing azer-cel, an allogeneic CAR T therapy, into clinical development.

During the first quarter, TG Therapeutics achieved several notable milestones. In the U.S., they received approximately 1,250 new BRIUMVI patient prescriptions, representing over 25% growth from the previous quarter. BRIUMVI was also included in the VA National Formulary as the preferred agent for anti-CD20 antibody indications for relapsing forms of MS.

In Europe, the company launched BRIUMVI in Germany through a partnership with Neuraxpharm Group. Additionally, TG Therapeutics presented updated data from the ENHANCE Phase 3b trial at the ACTRIMS annual forum and obtained three new patents from the USPTO, extending BRIUMVI's patent protection through 2042. They also entered a global license agreement with Precision BioSciences for the development and commercialization of azercabtagene zapreleucel (azer-cel) for autoimmune disorders and other non-oncology indications.

For Q2 2024, TG Therapeutics targets BRIUMVI U.S. net product revenue of around $65 million. The company has raised its full-year U.S. net product revenue forecast for BRIUMVI to $270-$290 million, up from the prior guidance of $220-$260 million.

Financially, TG Therapeutics reported a net product revenue of $50.5 million for the first quarter, compared to $7.8 million in the same period last year. License, milestone, royalty, and other revenue totaled approximately $13.0 million, primarily due to a milestone payment from the Neuraxpharm agreement. Research and development (R&D) expenses increased to $32.7 million from $15.9 million in the previous year, driven by licensing and milestone expenses related to the Precision agreement and costs associated with ublituximab subcutaneous development. Selling, general, and administrative (SG&A) expenses also rose to $34.6 million from $28.1 million, attributed to the BRIUMVI commercial launch scale-up. Overall, the company posted a net loss of $10.7 million, improving from a net loss of $39.2 million in the first quarter of 2023.

As of March 31, 2024, TG Therapeutics held $209.8 million in cash, cash equivalents, and investment securities. The company expects these funds, combined with projected BRIUMVI revenues, to support operations until achieving cash flow positivity.

BRIUMVI (ublituximab-xiiy) is a monoclonal antibody targeting CD20-expressing B-cells, approved in the U.S., EU, and UK for treating relapsing forms of multiple sclerosis. It is designed to lack certain sugar molecules, enhancing B-cell depletion at low doses. The company plans to commence clinical development of a subcutaneous version and explore BRIUMVI's potential in additional autoimmune diseases.

TG Therapeutics is committed to acquiring, developing, and commercializing novel treatments for B-cell diseases. With a robust pipeline and recent achievements, the company continues to make significant strides in the biopharmaceutical industry.