TG Therapeutics Q2 Revenue Up 91%

TG Therapeutics (TGTX -17.11%), which specializes in treatments for autoimmune diseases, released its second-quarter 2025 earnings on August 4, 2025. The headline news was strong sales growth for BRIUMVI, its infusion therapy for relapsing multiple sclerosis, prompting management to raise its full-year 2025 revenue forecast. Revenue climbed to $138.8 million, missing the $137.98 million analyst estimate, while diluted earnings per share reached $0.17, below the expected $0.21. The quarter showed strong commercial progress but also highlighted sharply higher operating expenses tied to research, development, and marketing. Overall, the period underscored robust execution on BRIUMVI’s growth strategy, albeit with rising costs and continued heavy reliance on a single product.

Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report.

Business Overview and Key Success Factors

TG Therapeutics focuses on developing and commercializing therapies for B-cell mediated diseases, particularly relapsing forms of multiple sclerosis (RMS). Its central product, BRIUMVI, is an anti-CD20 monoclonal antibody delivered via intravenous infusion every 24 weeks. Approved by the Food and Drug Administration in December 2022, BRIUMVI is also cleared in the European Union, United Kingdom, Switzerland, and Australia.

The business today is built around commercial execution in the U.S., supported by partnerships for international markets. Key near-term focuses include capturing RMS market share for BRIUMVI, broadening its usage through new dosing regimens and drug formulations, and expanding the pipeline. For TG Therapeutics, success depends on continued uptake of BRIUMVI, effective commercialization, regulatory progress in new indications, control of rising operating expenses, and maintaining strong intellectual property protection.

Quarterly Performance and Business Developments

The second quarter continued to highlight BRIUMVI’s momentum in the U.S. RMS market. U.S. product revenue grew 91.3% compared to the same period last year, totaling $138.8 million and representing about 98.4% of total company revenue. This result outpaced consensus expectations by $0.82 million, or 0.6%. License, milestone, royalty, and other revenue contributed an additional $2.3 million. The majority of ex-U.S. revenue came from milestone and royalty payments related to commercialization agreements, which are just beginning to scale with BRIUMVI launches in Europe and other regions.

Management noted persistent and rising prescription rates, with robust repeat prescribers and continued adoption in hospital settings. About 60% of new BRIUMVI enrollments in March 2025 were in hospitals, pointing to traction among institutional accounts. Word-of-mouth and positive patient experiences were cited as powerful market drivers. Management reported capturing approximately 25% of the intravenous segment of the anti-CD20 therapy market as of the prior quarter, and BRIUMVI’s differentiation in tolerability and infusion time continues to set it apart from established competitors such as Roche’s Ocrevus.

TG Therapeutics expanded BRIUMVI’s reach through commercialization with Neuraxpharm in ex-U.S. markets, though contributions from these launches remain modest for now. During the quarter, peer-reviewed publications highlighted the benefits of switching to BRIUMVI from other anti-CD20 therapies -- addressing concerns over efficacy and tolerability -- and real-world data reinforced its profile. Additionally, the company raised its full-year 2025 BRIUMVI U.S. net product revenue guidance to $570–$575 million, and its global revenue guidance to approximately $585 million for the full year, reflecting confidence in its growth trajectory.

This spending was primarily related to advancing the subcutaneous (under-the-skin) formulation of BRIUMVI. The quarter saw continued progress in clinical trials, including ongoing phase 1 studies for azer-cel, an allogeneic CD19 CAR-T cell immunotherapy for autoimmune disease, and new trial starts for simplified intravenous dosing regimens. Research and development investment reflects an effort to diversify the pipeline and enhance BRIUMVI’s competitive position as current revenue is highly concentrated in a single product for a single indication.

Selling, general, and administrative expenses also jumped, rising 43% compared to the prior year period, reflecting ongoing marketing, personnel, and external costs associated with BRIUMVI’s commercialization. Despite these ballooning expenses, net income grew to $28.2 million as revenue growth outpaced expense increases. Gross margins normalized in the prior quarter as the company fully depleted pre-commercial inventory reserves, and management guided for stable margins going forward.

Pipeline and Product Advances

Pursuing its strategy to simplify therapy and expand indications, TG Therapeutics advanced key programs for both existing and future products. For BRIUMVI, the company initiated a pivotal phase 3 trial called ENHANCE to evaluate a consolidated Day 1 and Day 15 dosing regimen. The company is also progressing a phase 1 clinical trial evaluating subcutaneous BRIUMVI, which would give patients a self-administered alternative and expand the product’s reach -- important since only one subcutaneous anti-CD20 option currently exists on the market.

Work continued on new indications for BRIUMVI, notably a trial in myasthenia gravis, a chronic autoimmune neuromuscular disease. The first patient was dosed in a phase 1 trial for azer-cel, targeting progressive multiple sclerosis -- a form of MS with high unmet medical need.

Operating and research costs spiked as these development efforts required new manufacturing runs and trial start-up expenses. Management commented that profitability is not a focus in fiscal 2025, stating, “I don't think we're highly focused on profitability this year,” and emphasizing a greater focus on driving revenue and advancing the pipeline. Despite the rapid increase in operating expenses, expense growth was offset by even faster revenue gains, supporting improved profitability.

The company ended the quarter with $278.9 million in cash and short-term investments. According to management, this liquidity level, together with ongoing revenue from BRIUMVI, is expected to fully cover operating plans for the coming year. No major changes occurred in company financial leverage or liquidity risk during the quarter.

Looking Ahead

Looking ahead, TG Therapeutics raised its revenue targets for full year 2025, increasing its BRIUMVI U.S. net product revenue guidance to $570–$575 million and its total global revenue guidance to approximately $585 million. It now expects U.S. net product sales of BRIUMVI to reach $570–$575 million for the full year and global revenue of approximately $585 million for the full year, compared to prior targets of $560 million and $575 million, respectively. Key upcoming milestones for management include commencing patient enrollment in the Phase 3 pivotal program for subcutaneous BRIUMVI, continuing enrollment in studies for myasthenia gravis and azer-cel, and ongoing commercial expansion with Neuraxpharm in Europe. The company is also preparing for its first direct-to-consumer advertising campaign to further boost awareness and adoption of BRIUMVI.

Management did not provide specific earnings-per-share guidance and reinforced that its immediate focus remains on funding growth, expanding BRIUMVI’s reach, and executing on its pipeline. Investors are likely to watch closely for updates on the adoption of new dosing regimens, performance of the subcutaneous formulation, further clinical data from trials in new indications, and signs of sustained U.S. market share gains. As most revenue currently stems from one product, diversification through pipeline success and international launches will be important for longer-term financial health.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.