8-K: TG Therapeutics Reports Strong Q3 2025, Raises BRIUMVI Guidance

TG Therapeutics announced robust third-quarter 2025 financial results, driven by strong BRIUMVI revenue growth, and raised its full-year revenue guidance.

Summary

• Third quarter 2025 total revenue reached $161.7 million.
• BRIUMVI U.S. net revenue for Q3 2025 was $152.9 million, marking an 84% increase over Q3 2024 and 10% growth over Q2 2025.
• Full-year 2025 global revenue target has been raised to $600 million, up from the prior guidance of $585 million.
• Full-year 2025 BRIUMVI U.S. net revenue target has been raised to approximately $585 million, up from the prior guidance of $570-$575 million.
• The company completed its initial $100 million share repurchase program, acquiring approximately 3.5 million shares at an average price of $28.55 per share.
• An additional $100 million share repurchase program has been authorized by the Board of Directors.
• Pipeline advancements include commencing patient enrollment for a Phase 3 pivotal program for subcutaneous ublituximab and completing patient enrollment for the randomized Phase 3 pivotal program to evaluate a consolidated Day 1 and Day 15 dosing regimen for IV BRIUMVI in the ENHANCE trial.
• BRIUMVI has expanded commercialization outside the U.S., with approvals in the European Union, United Kingdom, Switzerland, Australia, Kuwait, and the United Arab Emirates.
• New data from the ULTIMATE I & II trials' open label extension showed 89.9% of RMS patients were free from 24-week confirmed disability progression after 6 years of continuous BRIUMVI treatment, with a consistent safety profile.
• Net income for Q3 2025 was $390.9 million, significantly boosted by a non-recurring income tax benefit of approximately $365.0 million.
• Cash, cash equivalents, and investment securities stood at $178.3 million as of September 30, 2025, which, combined with projected revenues, is anticipated to be sufficient to fund the business.

Sentiment

Score: 8

Explanation: The company reported strong revenue growth for its key product, BRIUMVI, and raised its full-year guidance, indicating robust market demand and operational success. Significant pipeline advancements and a new share repurchase authorization underscore management's confidence and commitment to shareholder value. While expenses increased, they are tied to growth initiatives. The substantial net income, though aided by a tax benefit, reflects a strong financial position.

Positives

• Strong Q3 2025 total revenue of $161.7 million.
• Exceptional BRIUMVI U.S. net revenue growth of 84% year-over-year and 10% quarter-over-quarter.
• Raised full-year 2025 global revenue guidance to $600 million, indicating increased confidence in market performance.
• Raised full-year 2025 BRIUMVI U.S. net revenue guidance to approximately $585 million.
• Successful completion of a $100 million share repurchase program, demonstrating commitment to shareholder value.
• Authorization of an additional $100 million share repurchase program, signaling continued confidence in the company's long-term potential.
• Advancement of two Phase 3 pipeline programs (subcutaneous ublituximab and simplified IV BRIUMVI dosing), indicating future growth potential and product innovation.
• Positive long-term efficacy and safety data from ULTIMATE I & II trials' open label extension, reinforcing BRIUMVI's clinical profile.
• Expansion of BRIUMVI commercialization into multiple international markets.
• Significant net income of $390.9 million for Q3 2025, primarily due to a $365.0 million non-recurring income tax benefit.

Negatives

• Research and development (R&D) expenses increased to $40.9 million for Q3 2025 from $20.1 million for Q3 2024, reflecting increased development and clinical trial costs.
• Selling, general and administrative (SG&A) expenses increased to $63.4 million for Q3 2025 from $42.0 million for Q3 2024, primarily due to increased marketing and commercialization costs for BRIUMVI.
• Cash, cash equivalents and investment securities decreased to $178.3 million as of September 30, 2025, from $311.0 million as of December 31, 2024.

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.
• The commercialization of BRIUMVI may not continue to exceed expectations, and 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 further limitations regulators may impose on labeling (e.g., from post-marketing 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 individual or aggregate patient clinical experience in the post-marketing setting may differ from that demonstrated in controlled clinical trials.
• Risk of not achieving 2025 development pipeline anticipated milestones or goals in the projected timeframe or at all, including for subcutaneous ublituximab, ENHANCE trial, BRIUMVI in MG, or azer-cel.
• The subcutaneous Phase 3 program may not be successful, approved by the FDA, or achieve commercial acceptance.
• The ENHANCE Phase 3 trial may not be successful, approved by the FDA, or achieve commercial acceptance.
• Uncertainties generally inherent in research and development.
• Regulatory developments, legislative actions, executive orders, including tariffs and policy changes.
• General political, economic, and business conditions.

Future Outlook

The company has raised its full-year 2025 global revenue target to $600 million and its BRIUMVI U.S. net revenue target to approximately $585 million, reflecting continued strong market demand. Management remains focused on expanding patient awareness for BRIUMVI, advancing enrollment in ongoing clinical trials for subcutaneous ublituximab and a simplified IV dosing schedule, and driving long-term value for shareholders.

Management Comments

• Michael S. Weiss, Chairman and CEO, stated: "We are pleased to see that the third quarter marked another strong period of performance across our strategic priorities, driving continued BRIUMVI growth, advancing our pipeline with two Phase 3 programs... while maintaining a disciplined capital allocation approach."
• Mr. Weiss continued: "We also successfully completed our initial $100 million share repurchase program and authorized an additional $100 million program, underscoring our confidence in the long-term potential of our business."
• Mr. Weiss added: "Building on this momentum, we are again raising our full-year U.S. BRIUMVI revenue guidance to approximately $585 million, reflecting the continued strong market demand."
• Mr. Weiss concluded: "As we move through the fourth quarter, we remain focused on expanding patient awareness, advancing enrollment into our ongoing clinical trials, and driving growth and long-term value for our shareholders."

Industry Context

BRIUMVI's strong performance and expansion into international markets position TG Therapeutics favorably within the global multiple sclerosis (MS) treatment landscape. The drug's mechanism, targeting CD20-expressing B-cells, is a well-established and important therapeutic approach for autoimmune disorders like RMS. The company's efforts to develop subcutaneous and simplified IV dosing regimens for BRIUMVI, along with positive long-term and real-world data, aim to enhance patient convenience and reinforce its competitive standing against other MS therapies, catering to the nearly 1 million people living with MS in the United States and over 2.3 million worldwide.

Comparison to Industry Standards

• The filing notes that targeting CD20 using monoclonal antibodies is a proven therapeutic approach for autoimmune disorders like RMS, indicating BRIUMVI operates within an established and effective class of treatments.
• The ENABLE real-world observational study demonstrated clinical outcomes consistent with those observed in pivotal clinical studies of BRIUMVI, suggesting its performance in broader patient populations aligns with controlled trial results, which is a positive indicator for real-world effectiveness.
• No specific comparable companies, projects, or global benchmarks were explicitly detailed in the filing for direct comparison of financial or clinical results.

Related Party Transactions

• Sales of BRIUMVI to ex-U.S. licensing partner, Neuraxpharm, totaled $6.4 million for the three months ended September 30, 2025.
• License, milestone, royalty and other revenue for the nine months ended September 30, 2024, included a $12.5 million milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the European Union.

Stakeholder Impact

• Shareholders: Positive impact due to strong revenue growth, raised guidance, and the authorization of an additional share repurchase program, signaling increased shareholder returns and confidence.
• Patients (RMS): Potential for improved treatment options with the advancement of subcutaneous ublituximab and a simplified IV dosing schedule, along with continued access to BRIUMVI with proven long-term efficacy and safety.
• Employees: Continued company growth and pipeline development may lead to job stability and potential for expansion.
• Customers (Healthcare Professionals): Consistent clinical outcomes in real-world settings and ongoing development of more convenient dosing options may enhance adoption and prescribing confidence.
• Partners (Neuraxpharm): Continued successful commercialization and expansion of BRIUMVI in ex-U.S. markets contribute to mutual benefit.

Next Steps

• Expand patient awareness for BRIUMVI.
• Advance enrollment into ongoing clinical trials, including the Phase 3 pivotal program for subcutaneous ublituximab.
• Continue enrollment for patients with progressive multiple sclerosis into the ongoing Phase 1 clinical trial evaluating azer-cel.
• Drive growth and long-term value for shareholders.
• Host a conference call on November 3, 2025, at 8:30 AM ET to discuss financial results.

Key Dates

Recommendation

The company has demonstrated exceptional financial performance with significant revenue growth for its flagship product, BRIUMVI, and has proactively raised its full-year guidance, indicating robust market penetration and demand. The strategic decision to complete and authorize substantial share repurchase programs underscores strong management confidence in the company's valuation and commitment to enhancing shareholder returns. Furthermore, the advancement of key pipeline programs, particularly for more convenient BRIUMVI formulations, positions the company for sustained future growth and competitive advantage in the multiple sclerosis market. Despite increased operational expenses, these are strategic investments supporting commercialization and R&D, which are essential for long-term value creation. The overall positive momentum and strategic initiatives make this a compelling investment opportunity.

Keywords

TG Therapeutics, TGTX, BRIUMVI, ublituximab, Multiple Sclerosis, RMS, Biopharmaceutical, Q3 2025, Financial Results, Revenue Guidance, Share Repurchase, Clinical Trials, Pipeline, CD20, Autoimmune