8-K: TG Therapeutics Reports Strong Q1 2025 Results, Raises BRIUMVI Revenue Guidance

TG Therapeutics announces positive Q1 2025 financial results, driven by strong BRIUMVI sales, and raises its full-year revenue guidance.

Summary

• TG Therapeutics reported its financial results for the first quarter of 2025.
• BRIUMVI U.S. net product revenue reached $119.7 million, a 137% increase compared to the same period last year.
• The company is raising its full-year 2025 global net revenue target to approximately $575 million.
• The full-year BRIUMVI U.S. net revenue target is raised to approximately $560 million.
• Net income for the quarter was $5.1 million, compared to a net loss of $10.7 million in the first quarter of 2024.
• Cash, cash equivalents, and investment securities totaled $276.2 million as of March 31, 2025.
• The company anticipates that its cash position, combined with projected BRIUMVI revenues, will be sufficient to fund its business based on the current operating plan.
• The company expects full year 2025 target operating expenses of approximately $300 million, excluding non-cash compensation and cost of goods sold.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with strong revenue growth, raised guidance, and progress in clinical trials. While there are some increased expenses, the overall tone is optimistic and suggests a positive trajectory for the company.

Positives

• Strong BRIUMVI sales growth indicates increasing market adoption and confidence in the treatment.
• Raised revenue guidance reflects positive momentum and expectations for continued growth.
• Achieving net income in Q1 2025 demonstrates improved financial performance compared to the previous year.
• Positive long-term data from clinical trials supports the efficacy and safety of BRIUMVI.
• Expansion of BRIUMVI commercialization outside of the U.S. with Neuraxpharm.
• Advancement of subcutaneous BRIUMVI and azer-cel for progressive MS indicates ongoing investment in innovation.
• The company has sufficient cash to fund its business based on the current operating plan.

Negatives

• R&D expenses increased to $46.4 million due to manufacturing expenses related to subcutaneous ublituximab development.
• SG&A expenses increased to $50.3 million due to costs associated with BRIUMVI commercialization.
• License, milestone, royalty and other revenue decreased to $1.2 million compared to $13.0 million for the three months ended March 31, 2024.

Risks

• The company's ability to maintain and continue to maintain a commercial infrastructure for BRIUMVI.
• Trends in prescriptions may not be maintained or that prescriptions are not filled.
• Failure to obtain and maintain payor coverage.
• HCP interest in BRIUMVI will not be sustained.
• Momentum in sales for BRIUMVI will not be sustained during the course of the year.
• The commercialization of BRIUMVI does not continue to exceed expectations.
• The company's BRIUMVI revenue targets will not be achieved.
• The company's reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI.
• Potential regulatory challenges to the Company's plans to seek marketing approval for the product in jurisdictions outside of the U.S.
• The uncertainties inherent in research and development.
• The risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II.
• The risk that the Company does not achieve its 2025 development pipeline anticipated milestones in the timeframe projected or at all, including commencing a pivotal program for subcutaneous ublituximab, commencing a pivotal program based on data from the ENHANCE trial, enrolling patients into a trial evaluating BRIUMVI in an autoimmune disease outside of MS, or enrolling patients into a trial evaluating azer-cel.
• Regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions.

Future Outlook

TG Therapeutics has raised its full-year 2025 revenue guidance for BRIUMVI and anticipates continued growth and adoption of the treatment. The company is also focused on advancing its pipeline, including subcutaneous BRIUMVI and azer-cel, and expanding BRIUMVI's use in autoimmune diseases beyond MS.

Management Comments

• Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, '2025 is off to a strong start, and I'm incredibly proud of the progress made thus far.'
• Mr. Weiss continued, 'Our performance in the first quarter, including BRIUMVI's $119.7 million in U.S. net sales, demonstrates the growing confidence in our treatment and the increasing adoption by healthcare providers.'
• Mr. Weiss continued, 'This momentum, combined with the positive feedback we're hearing from both patients and clinicians, reinforces our belief that we can achieve our long-term goal of BRIUMVI becoming the number one prescribed anti-CD20 treatment based on dynamic market share.'
• Mr. Weiss continued, 'In addition to our ongoing BRIUMVI commercialization efforts, we are continuing to invest in innovation, including simplifying the BRIUMVI treatment regimen, advancing subcutaneous BRIUMVI, and developing azer-cel for progressive MS.'

Industry Context

The announcement reflects the competitive landscape of MS treatments, particularly within the anti-CD20 monoclonal antibody class. TG Therapeutics is positioning BRIUMVI as a leading treatment option, emphasizing its efficacy, safety, and patient experience. The company's focus on innovation, such as subcutaneous administration and new dosing regimens, aims to differentiate BRIUMVI from competitors like Ocrevus (Roche) and Kesimpta (Novartis).

Comparison to Industry Standards

• BRIUMVI's Q1 2025 U.S. net revenue of $119.7 million demonstrates strong initial market penetration, but it is still behind established competitors like Ocrevus, which generated billions in annual revenue.
• The five-year data showing 92% of patients free from disability progression is competitive with other long-term studies of MS treatments.
• The annualized relapse rate of 0.02 during year 5 is a positive indicator of BRIUMVI's long-term efficacy.
• The development of subcutaneous BRIUMVI aligns with the industry trend towards more convenient administration methods, similar to Novartis' Kesimpta.
• The company's focus on simplifying the BRIUMVI treatment regimen is a strategy to improve patient adherence and compete with other MS therapies.

Stakeholder Impact

• Shareholders will likely react positively to the strong financial results and raised revenue guidance.
• Patients may benefit from the development of subcutaneous BRIUMVI and improved dosing regimens.
• Healthcare providers may be more inclined to prescribe BRIUMVI due to its demonstrated efficacy and safety.
• Employees may experience increased job security and opportunities due to the company's growth.

Next Steps

• Commence pivotal program of subcutaneous BRIUMVI.
• Commence a pivotal program based on the improved dosing regimens evaluated in the ENHANCE trial.
• Continue enrollment of participants into the ongoing clinical trial evaluating BRIUMVI in autoimmune diseases outside of MS.
• Continue enrollment of participants into the Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases, beginning with progressive forms of MS.
• Present updated data at major medical conferences throughout the year.

Key Dates

Keywords

BRIUMVI, ublituximab, TG Therapeutics, Multiple Sclerosis, RMS, Revenue, Financial Results, Azer-cel, Commercialization, Pharmaceuticals