8-K: TG Therapeutics Exceeds 2025 Revenue, Boosts 2026 Guidance

TG Therapeutics reported strong fourth quarter and full year 2025 financial results, driven by BRIUMVI sales, and raised its total global revenue guidance for 2026.

Summary

• Total revenue for the fourth quarter and full year 2025 reached $192.6 million and $616.3 million, respectively.
• BRIUMVI U.S. net revenue was $182.7 million for Q4 2025, representing approximately 20% quarterly growth over Q3 2025, and $594.1 million for the full year 2025, marking approximately 92% year-over-year growth.
• The company provided 2026 financial guidance, targeting total global revenue of approximately $875-$900 million, including BRIUMVI U.S. net product revenue of approximately $825-$850 million.
• A new share repurchase program was authorized to acquire up to an additional $100 million of TGTX common stock, following the completion of a previous $100 million program.
• Significant progress was made in the clinical pipeline, including approximately 75% patient enrollment for the Phase 3 subcutaneous ublituximab program and completed enrollment for the ENHANCE trial evaluating a consolidated IV dosing regimen for BRIUMVI.
• BRIUMVI's commercialization expanded outside the U.S., with approvals in the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates.
• New six-year data from the ULTIMATE I & II trials demonstrated that 89.9% of patients with relapsing forms of multiple sclerosis (RMS) were free from 24-week confirmed disability progression after 6 years of continuous BRIUMVI treatment, with a consistent safety profile.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a very positive report, driven by strong commercial performance of BRIUMVI, significant revenue growth, and optimistic future guidance, despite increased operating expenses.

Positives

• Strong Q4 2025 total revenue of $192.6 million and full year 2025 total revenue of $616.3 million, significantly exceeding prior year figures.
• BRIUMVI U.S. net product revenue demonstrated robust growth, with a 20% quarterly increase over Q3 2025 and an impressive 92% year-over-year growth for the full year 2025.
• Raised 2026 total global revenue guidance to $875-$900 million, indicating strong confidence in continued commercial momentum and future growth.
• Successful global expansion of BRIUMVI commercialization with approvals in multiple key international markets.
• Positive long-term clinical data for BRIUMVI, showing 89.9% of RMS patients free from 24-week confirmed disability progression after 6 years, reinforcing its efficacy and safety profile.
• Advancement of the clinical pipeline with high enrollment rates for subcutaneous ublituximab Phase 3 and completed enrollment for the ENHANCE trial, promising future product enhancements and market opportunities.
• Completed a $100 million share repurchase program and authorized a new $100 million program, signaling commitment to shareholder returns.
• Net income for full year 2025 was $447.2 million, a substantial increase from $23.4 million in 2024, primarily driven by a non-recurring income tax benefit of $339.8 million.

Negatives

• Research and development (R&D) expenses increased to $160.2 million for the full year 2025 from $94.3 million in 2024, primarily due to increased manufacturing and clinical trial costs for pipeline development.
• Selling, general and administrative (SG&A) expenses rose to $232.0 million for the full year 2025 from $154.3 million in 2024, driven by increased marketing and commercialization efforts for BRIUMVI.
• Cash, cash equivalents and investment securities decreased to $199.5 million as of December 31, 2025, from $311.0 million as of December 31, 2024, although the company anticipates current cash combined with projected revenues will be sufficient to fund operations.

Risks

• The company's ability to continue to commercialize BRIUMVI may not be sustained.
• Trends in prescriptions may not be maintained, or prescriptions may not be filled.
• Failure to obtain and maintain payor coverage for BRIUMVI.
• Healthcare professional (HCP) interest in BRIUMVI may not be sustained.
• Momentum in sales for BRIUMVI may not be sustained during the course of the year.
• BRIUMVI revenue targets may not be achieved.
• Failure to obtain and maintain requisite regulatory approvals, including satisfying post-approval regulatory requirements.
• Potential for variations from projections and estimates about the market for BRIUMVI due to factors like regulatory limitations on labeling (e.g., safety signals).
• The company's ability to meet post-approval compliance obligations (product quality, distribution, supply chain, pharmacovigilance, sales and marketing).
• Reliance on third parties for manufacturing, distribution, supply, and other support functions for clinical and commercial products.
• Risk that any individual patient's clinical experience or aggregate patient experience in the post-marketing setting may differ from that demonstrated in controlled clinical trials.
• Risk of not achieving 2026 development pipeline anticipated milestones or goals in the projected timeframe or at all.
• The subcutaneous Phase 3 program or the ENHANCE Phase 3 trial may not be successful, or if successful, may not be approved by the FDA or achieve commercial acceptance.
• Uncertainties generally inherent in research and development.
• The collaboration with Christina Applegate or the 'Next In MS' platform may not be implemented, go as planned, or gain traction.
• Regulatory developments, legislative actions, executive orders, including tariffs and policy changes, in the U.S. and other jurisdictions.
• General political, economic, and business conditions.

Future Outlook

TG Therapeutics projects strong growth for 2026, targeting total global revenue of $875-$900 million, with U.S. BRIUMVI net product revenue expected to be $825-$850 million. The company anticipates several key clinical milestones, including pivotal topline data for the ENHANCE trial mid-2026, preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026, and pivotal topline data for subcutaneous BRIUMVI by year-end 2026/1Q 2027. They also plan to commence registration-directed trials for BRIUMVI in new indications and additional exploratory studies for BRIUMVI and azer-cel in autoimmune diseases outside MS.

Management Comments

• "2025 was a strong year of execution for TG Therapeutics, driven by continued momentum for BRIUMVI and meaningful progress across our organization."
• "BRIUMVI delivered significant year-over-year growth in the U.S., supported by increasing adoption and expanding global availability, while we advanced multiple late-stage clinical programs and strengthened our financial position."
• "As we enter 2026, we are focused on building on this foundation. With strong financial guidance, several important clinical milestones ahead, and a disciplined approach to operations, we believe we are well positioned to continue delivering value for patients, healthcare providers, and shareholders."

Industry Context

StockSavvy.ai notes that TG Therapeutics' strong BRIUMVI performance and expanded global approvals position it well within the competitive multiple sclerosis treatment market, particularly in the anti-CD20 monoclonal antibody class. The focus on new formulations (subcutaneous) and expanded indications for BRIUMVI, alongside the development of azer-cel for autoimmune diseases, aligns with broader industry trends towards patient convenience and addressing unmet needs in chronic conditions. The collaboration with Christina Applegate also represents a strategic move to enhance patient engagement and brand awareness in a highly competitive therapeutic area.

Comparison to Industry Standards

• BRIUMVI's 92% year-over-year U.S. net revenue growth for 2025 demonstrates robust market penetration and adoption, potentially outpacing some established MS therapies in their early commercialization phases.
• The 6-year open-label extension data from ULTIMATE I & II trials, showing 89.9% of RMS patients free from 24-week confirmed disability progression, provides strong long-term efficacy and safety data, which is critical for differentiating against other anti-CD20 therapies like Ocrevus (ocrelizumab) or Kesimpta (ofatumumab) that also target B-cells.
• The development of a consolidated IV dosing regimen and a subcutaneous formulation for BRIUMVI aims to improve patient convenience, a key competitive factor in the MS market where adherence and ease of administration are significant considerations, similar to how other therapies have evolved (e.g., subcutaneous interferon beta products).

Stakeholder Impact

• Shareholders: Positive impact due to strong financial performance, raised guidance, share repurchase program, and pipeline progress, potentially leading to increased share value.
• Patients (MS): Positive impact through continued availability and expanding access to BRIUMVI, potential for more convenient dosing (subcutaneous, consolidated IV), and ongoing research into new indications and autoimmune diseases.
• Healthcare Providers: Continued access to BRIUMVI as a treatment option for RMS, supported by new clinical data and real-world evidence.
• Employees: Continued growth and stability for the company, potentially leading to job security and opportunities.
• Partners (Neuraxpharm): Positive impact from successful global commercialization and expansion of BRIUMVI.

Next Steps

• Announce pivotal topline data for ENHANCE trial (consolidated Day 1 and Day 15 doses of IV BRIUMVI) mid-year 2026.
• Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026.
• Announce pivotal topline data for subcutaneous BRIUMVI (ublituximab) year-end 2026/1Q 2027.
• Commence registration-directed trial for BRIUMVI in an indication outside of MS.
• Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS).
• Host a conference call on February 26, 2026, at 8:30 AM ET to discuss results.

Key Dates

Recommendation

The company delivered exceptional 2025 financial results, significantly exceeding prior year performance, particularly with BRIUMVI's 92% year-over-year U.S. net revenue growth. The raised 2026 revenue guidance of $875-$900 million demonstrates strong confidence in continued commercial momentum. Coupled with positive long-term clinical data, pipeline advancements for new formulations and indications, and an active share repurchase program, the outlook is highly favorable for sustained growth and shareholder value creation.

Keywords

TG Therapeutics, TGTX, BRIUMVI, ublituximab, multiple sclerosis, MS, biotechnology, pharmaceuticals, financial results, revenue guidance, clinical trials, share repurchase, autoimmune disease, CD20 antibody, relapsing forms of MS, Q4 2025, Full Year 2025, 2026 outlook